Specialty Pharmacy Continuum - November / December 2020 by McMahon Group

Se ee SPEC CIA AL REPORT mon nograph polybagged with this issu ue

Serving managed care, health-system and specialty decision makers Volume 9 • Number 6 • November/December 2020 • specialtypharmacycontinuum.com

A Rare Opportunity

POLICY PAPs help hospitals recover lost funds .............

CLINICAL Payors have a stake in ensuring efficacy of ART for HIV ...................

ICER among stakeholders addressing high cost of rare disease therapy

OPERATIONS & MGMT Health systems band together to strengthen specialty reach ................

TECHNOLOGY Data help drive successful specialty launches .............................. 36

Real-World Data A New Force In Managed Care

s the introduction of costly new targeted cancer therapies continues to increase, health care payors are turning more to real-world evidence (RWE) to help resolve formulary and patient coverage dilemmas, according to speakers at the AMCP Nexus 2020 Virtual meeting. “We’re starting to see more and more managed care organizations use realworld data to inform their decisions,” said Daniel Malone, PhD, RPh, a professor at the University of Utah College of Pharmacy, in Salt Lake City. Real-world evidence includes information drawn from electronic health

REVIEW ARTICLE

Continued on page 14

Medicaid Moves To Gain Control Over Drug Prices Fertility Treatments: The Role of Specialty Pharmacy See page 27.

NEW PRODUCT

Fagron launches first sterile topical anesthetic LET Gel produced in CGMPcompliant operations. See page 36.

reparing for a packed rare disease drug pipeline and a new method for assessing the efficacy and value of the high-cost medications were two of the main themes to emerge from sessions on this challenging area of specialty pharmacy practice at the AMCP Nexus 2020 Virtual meeting. Sometimes referred to as single or short-term therapies (SSTs), some of these treatments can cost six figures, with just a few affected patients taking a huge bite out of a provider and/or payor’s bottom line. It’s therefore not surprising that the Institute for Clinical and Economic Review (ICER) is developing modifications to its existing analytical approaches to evaluating the value of a new drug or therapy. “These SSTs challenge us to think about how we assess them, price them, pay for them and make them available,” ICER Founder and President Steven D. Pearson, MD, MSc, said during the AMCP Nexus meeting.

tate Medicaid programs have been winning some key battles in the fight against soaring drug prices, including a $95 million rebate that Massachusetts wrested from a manufacturer under a negotiated value-based deal, and $300 million in rebates resulting from similar efforts in New York State. But on a national level, many challenges remain, including the huge cost of breakthrough therapies, stakeholders reported at the AMCP Nexus 2020 Virtual meeting. In the past two years, the Centers for Medicare & Medicaid Services has given Medicaid programs in eight states the authority to negotiate for

Continued on page 10

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Managed care pharmacy has its eye on high-cost specialty medications for hemophilia, spinal muscular atrophy, choroideremia, AADC deficiency and other rare diseases.

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Specialty Pharmacy Continuum • November/December 2020

POLICY

Highmark and BCBS Share Risk on Cimzia Highmark, a Pittsburgh-based licensee of the Blue Cross Blue Shield Association, announced it has entered into an outcomesbased contract with UCB Inc. for certolizumab pegol (Cimzia). The tumor necrosis factor blocker is approved for use in adults with chronic inflammatory conditions such as Crohn’s disease, plaque psoriasis and psoriatic and rheumatoid arthritis. The agreement, for the health care professional–administered injection formulation of the product, applies to all of Highmark’s commercial members in Delaware, Pennsylvania and West Virginia. Approximately 380 Highmark members have prescriptions for the drug.

Real-World Data The health plan, which previously entered other outcomes-based contracts (OBCs), has been looking at autoimmune conditions as a key area for such arrangements, said Corey DeLuca, PharmD, the vice president of clinical and specialty pharmacy services for the company. “We’ll be looking to measure how patients are performing on this medication in the real world,” DeLuca told Specialty Pharmacy Continuum. “Are they staying on the medications as prescribed, or are patients—for whatever reason—discontinuing the medications early?” Outcomes will be tracked for at least a

year or two, because it can take time to see the impact, she said. “When we enter into these arrangements, we are honestly hopeful that a medication does perform as expected based on clinical trials, but we know there ultimately could be some variance in patient response in the real world,” DeLuca said. The primary aim of any OBC is to “validate the real-world effectiveness of therapy,” she said. “And if potentially the medication is not performing as expected, [OBCs] help better align the cost of the medication with the real-world value.” Certolizumab pegol was first approved by the FDA in 2008 for adults with moderate to severe Crohn’s disease. Most recently, the drug was approved in 2019 for adults with active non-radiographic axial spondyloarthritis. Highmark had announced OBCs with Boehringer Ingelheim for empagliflozin (Jardiance), with Takeda Pharmaceuticals for vedolizumab (Entyvio), and with AstraZeneca for budesonide-

formoterol (Symbicort). According to the health plan, its contract for budesonideformoterol demonstrated “positive results in improving patient outcomes for the treatment of asthma and chronic obstructive pulmonary disease [COPD],” noting that “the number of patients taking Symbicort who saw a worsening of symptoms requiring them to visit a health care provider or hospital were substantially lower than expected.” Additionally, more than half of Highmark members with asthma or COPD taking budesonide-formoterol “experienced a stabilization or improvement of their symptoms.” DeLuca declined to provide additional information, saying company staff are still combing the data. “We very much want to share outcomes information whenever they become realized, after we feel we’ve had a long enough period to assess the outcomes of interest,” she said.

A Trend Worth Watching Sarah Butler Donovan, the head of Client Solutions, Marketing & Ops at Avalere Health, a Washington, D.C.– based health care consulting firm, said the proliferation of OBCs is a trend worth watching. She noted that 60% of commercial health plans already have these arrangements in place. Although many stakeholders initially saw these contracts as “really just fancy rebate agreements,”

EDITORIAL BOARD

they have been shown to lower health care spending while improving patient outcomes, Butler Donovan said during an Avalere webinar on 2020 health trends. She noted that plans and health systems are becoming aware that the administrative costs of engaging in OBCs they previously saw as too onerous can be overcome. “Once you get past the first couple of contracts and you learn how to integrate the data that you need and how to report on the metrics that you’re assessing, you’ve already got the infrastructure and it’s easier to do another one,” Butler Donovan said. “Now we can say with confidence that outcomes-based contracts are here to stay for the foreseeable future.” —Karen Blum and David Wild The sources reported no relevant financial relationships other than their stated employment.

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Specialty Pharmacy Continuum • November/December 2020

POLICY

Do 90-Day Refills Place Pharmacists at Risk? M

ore relaxed medication refill requirements rolled out during the COVID-19 pandemic ensured patients receive their medications, but experts at NASP 2020 wondered if those changes mean increased liability for pharmacists. “Many states have implemented varying protocols enabling pharmacists to authorize additional refills when the prescriber cannot be reached for the renewal request,” Jill Regan, RPh, the director of relationship management at LexisNexis Risk Solutions, in Glenview, Ill., explained during a session at the meeting. States such as Florida, Tennessee and Texas limit these refills to 30 days, but pharmacists in Arizona can dispense 90-day refills without receiving prescriber sign-off, she said. In Alabama, pharmacists can also refill Schedule II substances in some circumstances without prescriber authorization, Regan added. Given a scenario in which a pharmacy dispenses large quantities of medications that pose complex management issues, without prescriber approval, John Heller, the senior director of sales at LexisNexis Risk Solutions, urged pharmacies to ensure each refill is backed by a prescriber operating with a valid state license and their details have not changed. And then there are issues that go beyond medication management. “[You] potentially expose your pharmacy to risk if you accidentally fill a prescription for, say, a deceased prescriber,” Heller said, pointing to internal and unpublished LexisNexis data to underscore the point: each week in the United States, the data show, an average of 104,000 prescriber state license numbers expire, more than 30,000 primary practice addresses change, along with changes to more than 2,000 fax and phone numbers and more than 1,000 Drug Enforcement Administration (DEA) licenses. If a pharmacy dispenses a medication from a prescriber who has died, retired or been sanctioned by the DEA, Heller said, “this could lead to exposure at the time of an audit by various state and regulatory agencies. While the DEA focuses their attention on chain pharmacies, specialty pharmacies can still expose themselves to unnecessary risks and potential audits from a state or federal licensing agency.”

Additionally, he said, specialty pharmacies risk losing reimbursement if prescriber details are inaccurate. Although payors may approve a submitted claim initially, if a retrospective audit reveals that a prescriber’s state license or National Provider Identifier (NPI) number has expired, the payor could seek recoupment of their expenses, Heller said. To ensure pharmacies are not exposed to unnecessary risk for regulatory penalty or financial loss, he encouraged organizations to incorporate measures such as real-time prescriber validation into their dispensing workflow. “Real-time validation enables the pharmacy to take action before the prescription has left the pharmacy” by ensuring the prescriber has a valid and active NPI and, when relevant, a DEA number, Heller said.

Mitigating the Risk Kyle Turner, PharmD, an assistant professor, department of pharmacotherapy, University of Utah College of Pharmacy, in Salt Lake City, said the potential for operational risk exposure with new COVID-19–related scenarios is “potentially mitigated” in a health system like his. “We have some pretty high-level and in-depth protocols in place, and a lot of people in the organization are paying attention to COVID-19 and the various effects on the health system from their perspective,” said Turner, who was not involved in the NASP presentation. “I think that in a health system, we would be given n complete information and

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guidance and so it would be rare for us to run into a scenario where a pharmacist is placed at increased liability in a situation [with which] they are unfamiliar.” Other mechanisms that could protect pharmacists include collaborative practice agreements, such as the one under which Turner operates. “If something happens to a provider, I would be informed and would take an alternative approach to make sure the patient has the medications and refills they need,” he said.

and if they are experiencing any medication-related side effects. Other questions to assess are whether the treatment is meant to manage an acute condition, and if so, whether the refill request accounts for the end date of therapy, whether there are any events or conditions—planned surgery or unstable renal function, for example—during the refill that may affect the control of their condition or increase the risk of an adverse event, and whether the patient requires laboratory monitoring during the refill period that may affect the decision to continue the medication, Kliethermes explained. “Depending on the answers to these questions, the pharmacist must do due diligence to investigate and consult with the appropriate health care team member to assure the patient has an amount of medication that is both safe and appropriate,” Kliethermes said. “Not performing and documenting this standard duty of a pharmacist, which under the COVID-19 relaxation allows the pharmacist to be the decision maker on extending refills and continuing the medication, would expose the pharmacist to liability if a resulting adverse event occurred.”

ASHP Expert’s Take

A Moving Target

Mary Ann Kliethermes, PharmD, the director of medication-use safety and quality at ASHP, said it behooves pharmacists to assess the safety and efficacy of a prescription before dispensing it without physician authorization. “Pharmacists are trained to collect the necessary information to make that assessment, and doing so is a responsibility outlined in both state practice acts and OBRA-90 [Omnibus Budget Reconciliations Act of 1990] regulations,” Kliethermes said. “The duty of the pharmacist before providing the additional medication is to gather the necessary information to assess how well the medications are working for the condition and if the medications are causing any problems for the patient.” She said pharmacists should determine if dispensing the requested amount is appropriate and safe, including whether the patient’s health is stable on the treatment, if their condition is adequately controlled by the medication

Toni Fera, PharmD, an independent hospital and ambulatory pharmacy consultant in Pittsburgh, acknowledged that regulations governing extended prescriptions likely will remain a moving target during COVID-19. “Several new rules were implemented in a short period of time to ensure there were no gaps in care,” Fera told Specialty Pharmacy Continuum. “Some of the changes may stick, but others may need to be clarified or changed if any public safety concerns arise. Important things a pharmacist can do when exercising their professional judgement when dispensing a prescription in one of these special, emergency circumstances is to be aware of their state law guidance and requirements, and to clearly document their rationale, including any due diligence exercised (such as a failed attempt to contact the prescriber).” —David Wild The sources reported no relevant financial relationships.

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Specialty Pharmacy Continuum • November/December 2020

POLICY

One facility collects $236,000 in August alone

PAPs Help Hospitals Recover Lost Funds Specialty pharmacies have been using patient assistance programs (PAPs) as a staple strategy for easing the financial burden of high-cost medications. During COVID-19, hospitals also have been benefiting from the programs—with the help of wholesaler and manufacturer partnerships. Health care providers at Phoebe Putney Memorial Hospital in Albany, Ga., are a case in point. The clinicians thought they were conducting business as usual back in February, when they admitted and treated a patient visiting from Atlanta for chronic obstructive pulmonary disease and other concerns, and later released him. In a story covered widely by the media, the patient, who had come to town for a funeral, had COVID-19 but didn’t know it. That funeral later became known as a “superspreader” event, leading to hundreds of cases of the coronavirus. By the time health care workers at the hospital were notified that they were potentially exposed to the virus, it had been a week, said Marty Kelvas, DPh, RPh, the corporate director of pharmacy services at Phoebe Putney Health System. “It just mushroomed after that because there were no precautions taken at that time,” Kelvas said. “We found ourselves in the middle of a significant crisis, and had to make quick adjustments [sidebar].”

All Hands on Deck With an all-hands-on-deck effort required to care for COVID-19 patients, the last thing on Kelvas’ mind was looking for PAP help from drug manufacturers for indigent or uninsured patients, even when the hospital began using tocilizumab (Actemra, Genentech)—normally used for rheumatoid arthritis—to manage the exaggerated immune response known as a cytokine storm in some patients. That’s where their PAP partner, McKesson RxO, stepped in, he said. Program representatives contacted the pharmacy and worked with Genentech, which offered to provide replacement product for eight patients who qualified for assistance, amounting to about $18,000 in drug cost. The PAP team identified qualified patients by reviewing pharmacy claims to pinpoint where the hospital could receive product replacement for uninsured or self-paying patients. The program also can prospectively identify patients by looking at scheduling data, ensuring patients are enrolled in a timely manner, said O’Mally Monahan, MPH, the senior director of patient assistance services at McKesson. As regular operations slowly resumed, patient assistance recovery funds shifted

more to other areas, such as outpatient cancer therapies. In August 2020, the health system hit a record of $236,000 in recovered funds from PAPs, the most since starting its program 1.5 years ago, according to Kelvas. Health care experts expected to see a surge of need for PAPs at the beginning of the COVID-19 pandemic, Monahan said. “But because people started to social distance, and that included social distancing from medical care, that spike we expected wasn’t truly a spike,” she said. The initial increase was seen in certain geographic hot spots for COVID-19, such as the New York/New Jersey metropolitan area, Monahan said. “But patients and hospitals around the country who continued to receive benefits from their manufacturer-sponsored PAPs relied on the McKesson team heavily,” she said.

A Costly Path to the ER COVID-19 created illness that was “not ignorable,” said Mark Jordan, PharmD, the director of pharmacy at Yuma Regional Medical Center, in Arizona. “There are a lot of folks in our community who would benefit from health care services but don’t access them for all the usual reasons,” he said. “When it came to this pandemic, people who normally would not seek health care for their day-to-day ailments and needs really had no choice, so they would end up following the ER path into our hospital.” The nature of treating COVID-19 brought with it the novel use of drugs such as remdesivir (Veklury, Gilead) and tocilizumab, so patient assistance became “even more valuable,” Jordan said. The

Yuma Regional’s PAP program helped it recover ‘a significant number of tocilizumab doses [in COVID-19 patients]. Given that each dose cost us just over $2,000, the product replacement was meaningful.’ —Mark Jordan, PharmD PAP they use, also McKesson RxO, helped them recover “a significant number of tocilizumab doses used in that patient population,” he said. “Given that each dose cost us just over $2,000, the product replacement was meaningful.” Although PAPs are heavily regulated, Monahan said, drug manufacturers made several modifications due to the pandemic to make receipt of free and reduced drugs easier for patients. For example, they allowed the use of electronic signatures so patients wouldn’t have to bring a physical application to the hospital. They also temporarily allowed patients to verbally confirm their income instead of requiring hard documents, and extended the reenrollment period for patients who normally renewed in March to July. Now is the time for hospitals to ensure they’re effectively utilizing PAPs, Monahan advised. “We’ve seen hospitals

Phoebe Putney’s COVID-19 Scramble

n the wake of a “super-spreader’ event, Phoebe Putney Memorial Hospital in Albany, Ga., was admitting up to 45 patients per day, many directly to the three critical care units, according to Marty Kelvas, DPh, RPh, the corporate director of pharmacy services at Phoebe Putney Health System. The emergency department was overwhelmed, he said. Personal protective equipment was running low, and the pharmacy was scrambling to get needed medications. The operating rooms were shut down except for emergency surgeries, and staff repurposed the postanesthesia care unit and another area to serve as two extra critical care units. Meanwhile, the health system expanded one of its hospitals to handle the COVID-19 patients, and the hospital pharmacy, which normally closed in the evenings, had to rapidly convert to a 24/7 operation. Kelvas, who tested positive for COVID-19 in late March, found himself spending his recovery time at home on the phone interviewing temporary pharmacy staff. “We were basically trying to respond to this overwhelming crisis,” Kelvas said. “This was an unbelievable period of time. I’ve been practicing 44 years as a pharmacist, and I’ve never seen anything come close to this.” —K.B.

take hard hits with the financial impacts of COVID-19,” she said. “Now they should be looking internally to say, ‘Are we doing this well?’ It’s real dollar savings to patients enrolled in PAPs, and hospitals receive medication back directly.”

Uptick in PAP Enrollment Having an avenue to help purchase therapeutics can reduce some of hospitals’ financial burden in caring for uninsured patients, said Corey Ford, MHA, the director of reimbursement and policy insights at Xcenda, a consulting and reimbursement services firm. There has been an uptick in request for and enrollment in PAPs, he noted, which could result from unemployment benefits provided by the federal economic stimulus package running out. In addition, as medical offices have become more savvy in their protocols to protect patients from COVID-19, patients have slowly become more comfortable resuming medical visits and drug therapies. A concern now, he said, is what to expect going forward. “Patients are still struggling with outof-pocket costs to pay for their medications,” Ford said. “This doesn’t appear to be the kind of V-shaped recovery that economists were predicting earlier in the spring; this is going to linger well into 2021. PAPs are really going to have to be prepared for this moving forward.” —Karen Blum The sources reported no relevant financial relationships other than their employment.

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Specialty Pharmacy Continuum • November/December 2020

POLICY

Medicaid Scores Savings continued from page 1

supplemental rebates in value-based contracts. At AMCP Nexus, pharmacists from MassHealth—the state’s combined Medicaid and Children’s Health Insurance Program—reported early success in negotiating, and collecting on, the rebates. “Over the past year, we have been able to achieve agreements on supplemental

identified about 200 drugs from about 75 manufacturers where we needed to spend our time focusing on a strategy,” said Paul Jeffrey, PharmD, the director of pharmacy at MassHealth and a clinical associate professor of family medicine and community health at UMass Medical School. Before the rule change, the Medicaid

3 Rebate Tips for Success 1. Prioritize value and understand where you need to focus your time. 2. Gather data and understand what the market looks like, including what generics and brand-name drugs may be coming to market, as well as the history and trend of product price increases over time. 3. Put ongoing monitoring in place of outcomes, new evidence, new indications and new National Drug Codes. Source: Kimberly Lenz, PharmD.

rebate contracts with 13 manufacturers on 35 drugs, with a total annual value of $95 million,” said Kimberly Lenz, PharmD, a clinical pharmacy manager at MassHealth and an assistant professor in the Department of Family Medicine and Community Health at UMass Medical School, in Worcester. “We are also in ongoing negotiations for about 45 additional medications right now, on which we expect to save about $15 to $20 million.” These contracts, referred to by CMS as supplemental rebate agreements (SRAs), take multiple forms, Lenz said. One is a true outcomes-based contract (OBC), aimed at a specific clinical outcome in patients using the medication; a second such contract is likely to be signed soon. “We also have stopgap contracts, which look at the total duration of time someone is on treatment. That doesn’t hold us financially accountable if the treatment exceeds a specific duration,” she said. “We also have a portfolio contract for about 12 to 15 drugs from one manufacturer.” (For more on OBCs, see page 3.) MassHealth targeted drugs for its rebate negotiations in four categories: 1. agents with the highest net spending in the previous fiscal year; 2. those with the average highest spending per member per year; 3. medications with low historical rebates; and 4. medications of which utilization continued to grow annually. “Based on these four categories, we

program in Massachusetts was bound by the same procurement rules as other state agencies, Jeffrey noted. “We went through the same process to secure supplemental rebates for drugs that the Department of Transportation goes through to buy snowplows. It was a laborious process with bids, and best and final offers and things document through particular formats that tied our hands.” The new process still has its constraints. “It requires additional data gathering and understanding what your system can capture,” Lenz said. “For some high-cost specialty drugs, the data for the contract is so specific that you may need to have your pharmacists reach out and work with providers to capture medical records data, and add fields to your medical record.” For other Medicaid programs negotiating supplemental rebates, Lenz highlighted several key lessons learned (Box). But one of the most important things to remember “is when to cut your losses,” she said. “Know when to go back to the table and renegotiate because the market changes.”

The Scope of SRAs Almost every state Medicaid plan includes the authority to negotiate SRAs with drug manufacturers that provide rebates at least as large as those set forth in the Medicaid national drug rebate agreement. Since Medicaid is a federal and state partnership, CMS reviews all

state plan amendments, including SRAs. For more information, see the program announcement at go.cms.gov/3kRblAB. Given the volume of patients managed by the states, the potential for drug costs savings from SRAs and other initiatives is huge. Between Medicaid, state employee benefit plans and the individual and small group commercial market, U.S. states have the authority to regulate prescription drug spending affecting about 119 million covered lives. But even with the historical tools that they have used, such as joint purchasing consortiums, SRAs and preferred drug lists, they have struggled to deal with the cost of breakthrough therapies, Melissa Andel, the principal of CommonHealth Solutions, said during a separate session at the AMCP Nexus 2020 Virtual meeting. “With a lack of action at the federal level, increasing Medicaid pharmacy budgets, and increasing costs for employee and retiree health coverage, states are feeling increasing pressure to do something about prescription drug prices,” Andel said. Among the strategies they are employing include legislation focused on cost sharing, copay accumulators and coupons. “California was the first state to look at this,” Andel said. “In 2015, the state passed legislation requiring health plans to cap copayments for a 30-day

early indications that this may be one of the next hot topics in 2021 and 2022 at the state level,” Andel said. Rate-setting initiatives focused on “budget-busting” drugs also could be a state-level trend, she added. “These are bills typically focused on drugs with a wholesale acquisition cost of $30,000 or more per year, or a price increase greater than $3,000 in a three-month period.”

$300 Million in Rebates Andel noted that New York state is an early adopter of rate setting, with pharmacy-specific budget caps added to its Medicaid program in 2017 and a new high-cost drug initiative put into place in 2020, focused on newly launched high-cost drugs. “Since 2017, the state has negotiated approximately $300 million aggregate additional rebates for about 50 drugs,” she said. “But it’s worth noting that the FY [fiscal year] 2020 total pharmacy budget for New York Medicaid is $1.43 billion, so as a relative share of overall spending, over the past three to four years, they have negotiated savings of approximately 2% of their annual drug spend, which is a relatively modest impact on overall spending.” Other states, including Maine and Maryland, have enacted less specific price review legislation. “The takeaway so far is that this has been a modest success, but states are still required to cover these drugs, so that complicates their negotiating position,” Andel said. In August 2020, the National Academy for State Health Policy rolled

‘Over the past year, we have been able to achieve agreements on supplemental rebate contracts with 13 manufacturers on 35 drugs, with a total annual value of $95 million.’ —Kimberly Lenz, PharmD supply of a drug at $250, once the plan’s deductible was met. They also limited pharmacy deductibles for the majority of health plans to $500, and limit plan formularies to four tiers.” At least 10 other states have followed suit, but with a limited focus on insulin copayments only. Copay accumulators, which require health plans to include the value of patient assistance when calculating a patient’s progress through deductible and out-ofpocket limits, are an increasing focus of state policies. “Four states—Arizona, Illinois, Virginia and West Virginia—prohibit the use of copay accumulators, and eight additional states have pending legislation that would prohibit their use, so there are

out model legislation that would use Canadian reference pricing at the state level, modeled after legislation passed by the U.S. House of Representatives that also includes international reference pricing. “It establishes an upper payment limit for drug prices, limited to the 250 most costly drugs in the state,” Andel said. “The model legislation excludes Medicaid, only including commercial plans regulated by the state. We could conceivably see legislation like this percolate in the states as early as next year.” —Gina Shaw The sources reported no relevant financial relationships.

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Specialty Pharmacy Continuum • November/December 2020

CLINICAL

A Rare Opportunity continued from page 1

With treatments that are potential cures coming forward in ever-greater numbers, ICER undertook a yearlong project seeking input from patient groups, payors, clinicians and life science companies regarding the adaptation of its usual methods for these SSTs. “Why should we make changes for these therapies? These kinds of treatments offer so much promise and potential, and the conditions they treat are often so serious that we have to provide them, which changes the dynamic of how we think about them,” Pearson said. “But they also offer increased uncertainty, and a single treatment may have very high unrecoverable costs associated with that uncertainty, which challenges our traditional cost-effectiveness modeling.” For SSTs, ICER has developed additional modeling with both optimistic and conservative benefit scenarios around duration and magnitude of benefit and quality of life, as well as threshold analysis for durability of effect. “Let’s say you

have two years’ worth of good effectiveness data on a new curative or transformative treatment,” Pearson said. “Based on the drug’s price, how long would that effectiveness have to remain durable in order to be considered cost-effective? Five years, 10 years, 50 years?” The new modeling includes hypothetical shared savings analyses, one in which 50% of cost offsets are assigned to the health system and one in which cost offsets are capped at $150,000 per year. Pearson showed examples for these possible models in several economic scenarios: the chimeric antigen receptor (CAR) T-cell therapy for non-Hodgkin lymphoma, axicabtagene ciloleucel (Yescarta, Gilead/Kite Pharma); the gene therapy medication for spinal muscular atrophy, onasemnogene abeparvovec (Zolgensma, Novartis); and a hypothetical cure for hemophilia A (Table, page 13). Pearson said ICER soon will release some of the results of these hypothetical new scenarios for valoctocogene roxaparvovec (Roctavian, Biomarin), the

gene therapy for hemophilia A whose approval was delayed by the FDA in August. “Even though it’s now on hold, we want to present some possible

No Silver Bullet for Managing High Cost of Cell and Gene Therapies T

he pipeline for cell and gene therapies is indeed exploding, with nearly 400 products in development and more than 100 mostly rare diseases and conditions under study for potential treatment, Brian Corvino, MBA, a managing director at Deloitte Consulting, said at the AMCP Nexus 2020 Virtual meeting. “We have the prospect of therapies that are truly curative in nature,” Corvino noted. “They’ve shown both high efficacy and the potential to disrupt existing therapy paradigms.” But will the high cost of these highly individualized therapies be sustainable? That was a question that Corvino and his colleague, Jennifer Sturm, MBA, a senior manager at Deloitte Consulting, explored during a presentation on patient access to cell and gene innovations, the financial impact of these products on payors, and long-term affordability to the nation’s health system. Although it’s difficult to draw definite conclusions, they said, it was clear that manufacturers and government and private payors are working diligently to build financial models to balance the therapeutic needs of patients with individual therapy costs that can run to hundreds of thousands, and even millions, of dollars. “These are therapies with a single administration, a high up-front acquisition cost and often resource-intensive administration,” Corvino said, adding that “by definition,” they are personalized “often for a very small targeted patient population.” A major challenge for payors, Sturm noted, is “they’re not set up to be able to tailor their offerings and capabilities to a very small subset of the population.” She added: “All of their infrastructure processes and financing vehicles” are geared to support “the broad range of the members and patients they cover. Given that in today’s world cell and gene therapies really target an incredibly small number of patients, they have to think about things very differently.” Another concern, Corvino said, is the “uncertainty around clinical safety and effectiveness” of these new therapies,

“due to limitations in study design and outcome measures” as well as “the size and duration of clinical trials and the risk of high unrecoverable cost.” In addition, Corvino said, “these therapies are often accelerated in the development pipeline.” As a result, “their impact is not known over long durations of time—either the impact on efficacy or on safety.” Sustainability questions aside, Corvino cited one major study (Value Health (ISPOR) 2019;22[suppl 2]:S263) that found “the average health gains for cell and gene therapies exceeded the gains in the biologic as well as conventional therapies by a substantial order of magnitude.” Sturm noted that pharmacy benefit managers and payors are exploring different payment models and strategies for managing the cost of cell and gene therapies because of the significant up-front payments and the uncertainty of recovering those costs through long-term avoidance of catastrophic claims. She predicted “a combination of different metric-based structures that may even vary based on therapeutic class.” One possibility, she said, might involve outcomes-based payments that provide insurance against significant future outlays. Another might be arrangements that combine an initial partial down payment and installments to “mitigate the impact of large up-front lump sum payments.” Overall, “it’s an incredibly complex problem,” Sturm said, one that will require payors, regulators, pharma, technology and pharmacy benefit managers to work on collectively. Government entities, she added, will need to “step up” and provide guidance to organizations about bringing innovative therapies to patients and still maintain the broader health system’s sustainability. “No one approach is going to be the silver bullet that covers all of the innovation in the market today,” Sturm said. —Bruce Buckley The sources reported no relevant financial relationships.

scenarios and stimulate this dialogue among stakeholders,” he said. These SSTs are spurring changes to ICER’s review process overall. “We have added a new subsection in our clinical and economics section on ‘subgroups and heterogeneity,’ and our evidence reports will include subgroup analysis when evidence is available,” Pearson said. “We are also working to promote a societal perspective analysis that allows us to incorporate effects on areas like work productivity and education in a way that is coequal with health effects for conditions where the majority of costs are incurred outside the health care system.” He pointed to voretigene neparvovec-rzyl (Luxturna, Spark Therapeutics), the gene therapy for childhood blindness, as an example.

Pipeline Keeps Pumping As ICER and other groups grapple with the best ways to define efficacy and value of rare disease treatments, the pipeline for these agents just keeps pumping. Granted, approvals of drugs for rare diseases slowed slightly in 2019, with 25 new drugs approved by the FDA compared with the record-shattering 35 approvals in 2018. But the pipeline remains packed with novel agents for rare diseases that will have a major impact on both therapeutic options and health care economics, said experts in a separate AMCP Nexus session. Of drugs currently under review by the FDA, 39% are orphan drugs, as are 35% of drugs in phase 3 clinical trials, see RARE DISEASES, page 13

Specialty Pharmacy Continuum • November/December 2020

CLINICAL

Payors Keep an Eye on Best ART Regimens in HIV With HIV at or near the top of the specialty drug spending trend for both Medicaid and commercial payors, it’s important to improve managed care decision-making for patients with HIV, said experts in a 2020 PRIME Education webinar. “HIV is associated with the highest per member per year cost for Medicaid in the specialty spend,” said Melissa Badowski, PharmD, MPH, a clinical associate professor of pharmacy practice, Section of Infectious Diseases Pharmacotherapy, at the University of Illinois at Chicago College of Pharmacy, citing data from the Express Scripts 2018 Drug Trend Report (Table). “And it is among the top five expenditures for commercial payors. This is, in part, because HIV therapies are almost entirely branded drugs or branded generics.” In a 2017 study, people with HIV had 800% to 900% higher costs than those with conditions such as cardiovascular disease, diabetes and stroke, with the largest proportion of cost expenditures resulting from prescription medications (Int J Equity Health 2017;16[1]:188). “Because we know that delays or interruptions in therapy can be very detrimental to these patients, it is important to minimize prior authorizations and formulary restrictions,” Badowski said. “The Department of Health and Human Services’ guidelines for the use of antiretroviral agents in adults and adolescents with HIV recommend that ART [antiretroviral therapy] be initiated at the time of diagnosis or soon afterward, to improve ART uptake, linkage and retention in care, and outcomes.” Unfortunately, many patients do not experience such prompt initiation of therapy—particularly those on Medicaid. A recent study found that only 18.3% of commercially insured patients and 12.8% of Medicaid patients were started on ART within a week of diagnosis; four weeks after diagnosis, only 35.6% of Medicaid patients had been started on therapy, compared with 64.4% of commercially insured patients. Eight weeks after diagnosis, 100% of commercially insured patients were on therapy, but only 56.8% of Medicaid patients still were receiving ART (J Manag Care Spec Pharm 2020;26[2]:129-141). “It is important to ensure no break in coverage when developing a rapid ART initiation model,” Badowski said. “Here, states that have expanded Medicaid have a distinct advantage.” She pointed to a study conducted at a community federally qualified health center in Louisiana, where ART was initiated within 72 hours of diagnosis—or same day, in some cases—with expedited insurance enrollment. More than 50% of the study

population was enrolled in Medicaid. “Nearly all patients accepted treatment on their first visit, and viral suppression

was achieved in almost all patients,” Badowski said (Open Forum Infect Dis 2019;6[4]:ofz161). Selecting an evidence-based firstline therapeutic regimen can be the key to shortening the time from HIV diagnosis to ART initiation, Badowski said. As the HHS guidelines note, achieving viral suppression requires the use of combination antiretroviral regimens that generally include several active drugs

from two or more drug classes. There are five recommended initial regimens for most people with HIV, all of which combine an integrase strand transferase inhibitor (INSTI) with one or two nucleoside reverse transcriptase inhibitors. “All of the preferred first-line regimens are integrase-based,” said Babafemi O. Taiwo, MBBS, chief of the Division of Infectious Diseases at Northwestern University see PAYORS EYE ARVS, page 12

online: Catch us binutrition.com

www.fre

seniuska

Be S.U.R.E. about your lipid injectable emulsion (ILE) SMOFlipid follows expert recommendations to the letter.

Supplement parenteral nutrition with lipids1 Use alternative ILEs as a source of energy and essential fatty acids2 Reduce the load of soybean oil3 EPA- and DHA-containing ILEs should be considered4,5

SMOFlipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitations of Use: The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in SMOFlipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. Contraindications: Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients. Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1,000 mg/dL.

>(9505.! +,(;/ 05 79,;,94 05-(5;: +LH[OZ PU WYL[LYT PUMHU[Z HM[LY PUM\ZPVU VM PU[YH]LUV\Z SPWPK LT\SZPVUZ OH]L ILLU YLWVY[LK PU [OL TLKPJHS SP[LYH[\YL (\[VWZ` Ä UKPUNZ PUJS\KLK PU[YH]HZJ\SHY MH[ HJJ\T\SH[PVU PU [OL S\UNZ 7YL[LYT PUMHU[Z HUK SV^ IPY[O ^LPNO[ PUMHU[Z OH]L WVVY JSLHYHUJL VM PU[YH]LUV\Z SPWPK LT\SZPVU HUK PUJYLHZLK MYLL MH[[` HJPK WSHZTH SL]LSZ MVSSV^PUN SPWPK LT\SZPVU PUM\ZPVU

Please see Brief Summary of Prescribing Information including Boxed Warning for SMOFlipid on the next page.

Specialty Pharmacy Continuum â&#x20AC;˘ November/December 2020

CLINICAL

PAYORS EYE ART

Table. Top 5 Drugs Ranked by Medicaid Spend Therapy Class

continued from page 11

Feinberg School of Medicine, in Chicago. â&#x20AC;&#x153;For most patients, these INSTI-containing regimens will be highly effective and have relatively infrequent adverse effects and few drug interactions,â&#x20AC;? he noted, citing HHS guidelines. â&#x20AC;&#x153;In several headto-head comparisons between boosted [protease inhibitor] PI- and INSTI-containing regimens, the INSTIs were better tolerated and caused fewer treatment discontinuations.â&#x20AC;?

PMPY Spend

Trend

1. HIV

14.3%

2. Diabetes

7.4%

3. Inflammatory conditions

23.4%

4. Asthma

-10.0%

5. Mental/neuro disorders

13.1% 0

100

150

200

250

PMPY Spend PMPY, per member per year cost; Source: Adapted from Express Scripts 2018 Drug Trend Report.

SMOFlipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral intakes of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of PN products. â&#x20AC;˘ Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): PNALD has been reported in patients who receive PN for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. Intravenously administered phytosterols (plant sterols) contained in plantderived lipid formulations have been associated with development of PNALD, although a causal relationship has not been established. If SMOFlipid-treated patients develop liver test abnormalities, consider discontinuation or dose reduction. â&#x20AC;˘ Hypertriglyceridemia: Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome. â&#x20AC;˘ Monitoring/Laboratory Tests: Routinely monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, blood count including platelets, and coagulation parameters throughout treatment. Monitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended. â&#x20AC;˘ Interference with Laboratory Tests: Content of vitamin K may counteract anticoagulant activity. The lipids contained in this emulsion may interfere with some laboratory blood tests (e.g., hemoglobin, lactate dehydrogenase [LDH], bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream.

Limitations of Use:

ADVERSE REACTIONS

SMOFLIPID (lipid injectable emulsion), for intravenous use BRIEF SUMMARY OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information, including Boxed Warning for Smoflipid (lipid injectable emulsion), for intravenous use at www.freseniuskabinutrition.com/products/smoflipid.

>(9505.! +,(;/ 05 79,;,94 05-(5;: Â&#x2039; +LH[OZ PU WYL[LYT PUMHU[Z HM[LY PUM\ZPVU VM PU[YH]LUV\Z SPWPK LT\SZPVUZ OH]L ILLU YLWVY[LK PU [OL TLKPJHS SP[LYH[\YL Â&#x2039; (\[VWZ` Ă&#x201E;UKPUNZ PUJS\KLK PU[YH]HZJ\SHY MH[ HJJ\T\SH[PVU PU [OL S\UNZ Â&#x2039; 7YL[LYT PUMHU[Z HUK SV^ IPY[O ^LPNO[ PUMHU[Z OH]L WVVY JSLHYHUJL VM PU[YH]LUV\Z SPWPK LT\SZPVU HUK PUJYLHZLK MYLL MH[[` HJPK WSHZTH SL]LSZ MVSSV^PUN SPWPK LT\SZPVU PUM\ZPVU INDICATIONS AND USAGE

The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in SMOFlipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.

DOSAGE AND ADMINISTRATION The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. SMOFlipid 1000 mL is supplied as a Pharmacy Bulk Package for admixing only and is not for direct infusion. Prior to administration, transfer to a separate PN container.

CONTRAINDICATIONS Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients. Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides > 1,000 mg/dL.

WARNINGS AND PRECAUTIONS â&#x20AC;˘ Death in Preterm Infants: (see BLACK BOX WARNING) â&#x20AC;˘ Hypersensitivity Reactions: SMOFlipid contains soybean oil, fish oil, and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut oil. Signs or symptoms of a hypersensitivity reaction may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, or chills. If a hypersensitivity reaction occurs, stop infusion of SMOFlipid immediately and undertake appropriate treatment and supportive measures. â&#x20AC;˘ Risk of Catheter-Related Infections: Lipid emulsions, such as SMOFlipid, can support microbial growth and is an independent risk factor for the development of catheterrelated bloodstream infections. The risk of infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions or drugs. â&#x20AC;˘ Fat Overload Syndrome: This is a rare condition that has been reported with intravenous lipid emulsions. A reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may result in a syndrome characterized by a sudden deterioration in the patientâ&#x20AC;&#x2122;s condition including fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, fatty liver infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g., coma). â&#x20AC;˘ Refeeding Syndrome: Reintroducing calories and protein to severely undernourished patients with PN may result in the refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. â&#x20AC;˘ Aluminum Toxicity: SMOFlipid contains no more than 25 mcg/L of aluminum. During prolonged PN administration in patients with renal impairment, the aluminum levels in the patient may reach toxic levels. Preterm infants are at greater risk because their

Fresenius Kabi USA, LLC Three Corporate Drive, Lake Zurich, IL 60047 Phone: 1.888.386.1300 www.fresenius-kabi.com/us

Most common adverse drug reactions >1% of patients who received SMOFlipid from clinical trials were nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, increased blood triglycerides, hypertension, sepsis, dyspepsia, urinary tract infection, anemia and device-related infection. Less common adverse reactions in ) 1% of patients who received SMOFlipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash and thrombophlebitis. The following adverse reactions have been identified during post-approval use of SMOFlipid in countries where it is registered. Infections and Infestations: infection. Respiratory, Thoracic and Mediastinal Disorders: dyspnea.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda. gov/medwatch. DRUG INTERACTIONS Coumarin and Coumarin Derivatives, Including Warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters.

USE IN SPECIFIC POPULATIONS â&#x20AC;˘ Pregnancy and Lactation: There are no available data on risks associated with SMOFlipid when used in pregnant or lactating women. â&#x20AC;˘ Pediatric Use: The safety and effectiveness of SMOFlipid have not been established in pediatric patients. â&#x20AC;˘ Hepatic Impairment: Parenteral nutrition should be used with caution in patients with hepatic impairment. Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive PN, including cholestasis, hepatic steatosis, fibrosis and cirrhosis (PN associated liver disease), possibly leading to hepatic failure.

OVERDOSE In the event of an overdose, fat overload syndrome may occur. Stop the SMOFlipid infusion until triglyceride levels have normalized. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from serum. 9,-,9,5*,:! Singer P, Berger MM, Van den Berghe G, et al. ESPEN guidelines on parenteral nutrition intensive care. Clin Nutr. 2009; 28(4):387-400. Vanek VW, et al. A.S.P.E.N. position paper: Clinical role for alternative intravenous fat emulsions. Nutr Clin Pract. 2012;27(2):150-192. 2015 Canadian Critical Care Nutrition Clinical Practice Guidelines. https://www.criticalcarenutrition.com/resources/cpgs/pastguidelines/2015. Weimann A, Braga M, Carl F, et al. ESPEN guideline: clinical nutrition in surgery. Clin Nutr. 2017;36(3):623-650. McClave, S.A., et al. (2016). â&#x20AC;&#x153;Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.).â&#x20AC;? JPEN J Parenter Enteral Nutr. 40(2): 159-211.

New research suggests that INSTIbased ART also is associated with a lower risk for cardiovascular issues. Investigators from Washington University School of Medicine in St. Louis, for example, found that INSTI-based regimens were associated with a 43% decreased risk for cardiovascular disease compared with PIbased regimens (J Acquir Immune Defic Syndr 2020;84[4]:396-399). Recommended first-line regimens include bictegravir-emtricitabinetenofovir alafenamide (BIC/FTC/TAF; Biktarvy, Gilead); dolutegravir-abacavir-lamivudine (DTG/ABC/3TC; Triumeq, ViiV Healthcare); DTG+TAF or tenofovir disoproxil fumarate (TDF)+FTC or 3TC; DTG/3TC (Dovato, ViiV Healthcare); and raltegravir (Isentress, Merck)+TDF or TAF+FTC or 3TC. Each regimen has its contraindications. For example, DTG/3TC should not be prescribed to patients with pretreatment HIV RNA greater than 500,000 copies/mL, active hepatitis B coinfection, or for whom genotype or HBV results are not yet available, according to the 2019 HHS guidelines.

Incomplete Information Another challenge is how to manage a patient for whom there is incomplete information about viral load and/or other parameters. â&#x20AC;&#x153;Rather than waiting for more information, we recommend promptly initiating an ART combination that is safe and well tolerated across the board, has activity at any viral load, and can be used regardless of renal impairment,â&#x20AC;? Badowski said. â&#x20AC;&#x153;For example, itâ&#x20AC;&#x2122;s not safe to initiate a TDF-based regimen if you are unsure of a patientâ&#x20AC;&#x2122;s renal function, so instead, you should be more conservative with a TAF-based therapy. In terms of convenience for the patient, Symtuza [darunavir-cobicistat-FTC/TAF] is the first one to come to mind for me.â&#x20AC;? Taiwo added that two-drug regimens should be avoided in patients with incomplete information on resistance, baseline viral load or hepatitis B status. With complete information and lab values, in contrast, two-drug regimens are now a possibility. â&#x20AC;&#x153;For the longest time, itâ&#x20AC;&#x2122;s been the standard of care that HIV patients should be on at least three active drugs, but now we have new data telling us that two-drug regimens can be safe and effective,â&#x20AC;? he noted. Based in part on such data, in April 2019, the FDA approved the first twodrug complete regimen for treatmentnaive HIV patients, DTG/3TC, a oncedaily single tablet. Taiwo repported serving on advisory panels for Gilead and Merck, and as a consultant to ViiV. Badowski reported no relevant financial relationships.

Specialty Pharmacy Continuum • November/December 2020

CLINICAL

RARE DISEASES continued from page 10

said Yuqian Lu, PharmD, the director of specialty clinical solutions for Magellan Rx Management (MRx Pipeline Quarterly Report, July 2020). “Overall, rare diseases affect a very small number of patients, but the spend is super high,” she said. “The top 10 highest-cost drugs by annual cost per patient are almost all drugs for rare diseases.”

AADC Approval Coming The pipeline session spotlighted a range of new therapies that are likely to reach the market by the end of 2021, and others that are in the less immediate but still relatively near future. Perhaps the most imminent is PTC-AADC, PTC Therapeutics’ investigational gene therapy for aromatic l-amino acid decarboxylase (AADC) deficiency, an often fatal genetic and neurometabolic disease, usually diagnosed in infancy or childhood and caused by mutations in the DDC gene. “In open-label trials involving 26 children, PTC-AADC lowered the number of oculogyric crises, which involve involuntary upward eye movements that are characteristic of AADC

(LentiGlobin), a one-time gene therapy for patients with transfusiondependent beta-thalassemia, and timrepigene emparvovec (BIIB111), a viral vector from Nightstar Therapeutics for the treatment of choroideremia, an X-linked recessive form of hereditary retinal degeneration that affects about one in 50,000 males. “Biomarin’s Valrox [valoctocogene roxaparvovec] was expected to be the first gene therapy for hemophilia to enter the market,” Lu said. “But approval has been delayed until at least 2022 after a complete response letter from the FDA asked for full completion of the phase 3 study, based on concerns about differences between the phase 1/2 study and early phase 3 regarding durability of effect. More than half a dozen other gene therapies are also in the pipeline for hemophilia, most of them targeted at hemophilia A.” (A complete response letter reflects the FDA’s complete review of the data submitted for a drug in an original application, abbreviated application or resubmission, as well as any amendments that the agency has reviewed.) CAR T-cell therapy is expected to move beyond the cancer sphere in the near future, Lu noted. The near-term non-

Table. Impact of Shared Savings Scenarios

Value-Based Price at $150,000/ QALY

Price With Cost Offset Cap at $150,000/ year

Price With Cost Offset Cap at 50%

Price With Cost Offset Cap at 50% Plus 50% QALY Share

Axicabtagene ciloleucel

$424,000

$399,000

$66,000

Hyopthetical cure for hemophilia A

$86 million

$3.6 million

$40.85 million

$40.836 million

$825,000

$504,000

No calculable price

Drug Name

Onasemnogene $899,000

QALY, quality-adjusted life-year Source: ICER Value Assessment Methods and Pricing Recommendations for Potential Cures: A Technical Brief. Published Aug. 6, 2019; bit.ly/3l4XIOF.

deficiency, as well as recovery of weight and improved ability to sit, walk and talk,” Lu said. (The results were presented at the 2019 annual meeting of the Child Neurology Society; posters P207 and P231). “Those documented benefits lasted at least five years after treatment, which is amazing for a condition like this. We expect approval by the end of this year.” The anticipated gene therapy pipeline for 2021 includes Bluebird Bio’s elivaldogene autotemcel (Lenti-D), a treatment for cerebral adrenoleukodystrophy, betibeglogene autotemcel

oncology CAR T-cell pipeline includes metachromatic leukodystrophy gene therapy (OTL-200, Orchard), up for FDA approval in 2021.

Guidelines Lag? “With more new and novel treatments for a number of rare and orphan diseases coming with a substantial price tag, and given that no or few treatments existed previously, governing bodies may struggle to keep up with practice guidelines,” said Magellan’s Brian MacDonald, PharmD, the senior manager of Specialty Clinical Programs.

‘Overall, rare diseases affect a very small number of patients, but the spend is super high. The top 10 highest-cost drugs by annual cost per patient are almost all drugs for rare diseases.’ —Yuqian Lu, PharmD

MacDonald recommended that payors employ a number of strategies to manage these high-cost therapies, including the development of a national network of expert key opinion leaders with specific expertise in a variety of rare, complex and orphan diseases. “Their function can include making recommendations on challenging

or complex prior authorization cases to help ensure medical necessity and appropriate dosing, supporting medical appeals and providing peer-to-peer services to providers.” —Gina Shaw The sources reported no relevant financial relationships.

Specialty Pharmacy Continuum • November/December 2020

CLINICAL

Real-World Data continued from page 1

records, patient claims and billing accounts, disease registries, and “even data collected through personalized devices and health care apps,” Malone explained.

Breaking Through Rx Denials In conducting focus groups of managed care pharmacy and medical directors, Malone said he and his colleagues found “a pretty strong thread” that when patients are denied a therapy and they or their physicians appeal, “organizations turn to real-world evidence to see if there might be additional data to support or reject the appeal.”

• Payors value all types of RWE, economic information and patientreported outcomes data to help inform decision making. • Early prelaunch information helps with the initial decision and was highly encouraged. • Post-launch evidence helps validate decisions that have been made and how future decisions will go forward in reviews and treatment pathways. • Payors prioritize total cost of care and effects on current standards of care and appreciate data that help inform short- and long-term impacts

& Therapeutics] Committee, many times these data are not available,” Barrington noted. “So we’re making clinical and coverage decisions without real-world evidence, and we have to rely on what we’ve been given in randomized controlled trials [RCTs].” In such cases, she said, “everyone is adherent to the medication, but ‘the real world’ is different. It is also important that through real world evidence, we gain experience and clinical insights with specific oncology agents and therapies to be able to deliver better personalized care for our patients.”

A Comparative Tool in Cancer Real-world evidence also can help clinical oncologists evaluate the comparative efficacy of the cancer therapies they’re administering.

the economic ability to travel to a clinical trial,” McAneny told Specialty Pharmacy Continuum. “That isn’t the people I treat. So when I’m applying the information from those trials, how confident can I be that it really reflects the patients that I take care of every day?” RWE can be a useful tool for health care providers to augment clinical trial data and extrapolate that information for the patient sitting in front of them, McAneny said. She added that the National Cancer Care Alliance is setting up a group of 18 oncology practices from across the country that will deposit their clinical data into a common data warehouse. The goal, she said, is to encourage the development of a “clinical trial of the future” that enables researchers to evaluate a given regimen, “test it against everything else on actual, everyday people and look at the outcomes using significant data science.” One limitation of RWE, McAneny noted, is that it may be hard to establish that the performance status of patients is all due to the drug being tested, “when they may be diabetic and have had heart attacks, and were overweight and drank too much—and all of the other stuff that real-world people do.”

Access to Clinical Trials

One downside of RWE, Malone added, is “the ongoing fire hose of information” on products that has to be evaluated and the time it takes to do the research. “So time is a factor,” he said, and the “biggest barrier” to decision making based on RWE is that often “it’s not as timely as we like.” Diana Brixner, PhD, RPh, the executive director of the Pharmacotherapy Outcomes Research Center in Salt Lake City, said a survey of payors conducted at the University of Utah found high interest in using RWE in oncology drug decisions. “The high cost of therapies, of which clearly oncology is one, and the small population that these drugs impact, drive payors’ increased demand for economic information in oncology,” Brixner said. “Oncology remains one of the top three spending areas for health plans, despite representing a relatively small percentage of the membership.” Brixner summarized several key takeaways from the survey:

‘Through real-world evidence, we gain experience and clinical insights with specific oncology agents and therapies to be able to deliver better personalized care for our patients.’ —Christina Barrington, PharmD on outcomes and costs in oncology. Christina Barrington, PharmD, the vice president of pharmacy programs for Priority Health, a regional health insurer based in Grand Rapids, Mich., agreed that “real-world evidence is becoming fundamental in oncology.” For Priority Health, she added, oncology is “one of the two areas of highest cost, fluctuating with diabetes by quarter, but most of the time it’s No. 1 for us.” Timeliness of evidence is a key factor for Priority Health, according to Barrington. “When we’re conducting our formulary reviews for the P&T [Pharmacy

Barbara L. McAneny, MD, the chief executive officer of New Mexico Hematology Consultants, in Albuquerque, noted that “the gold standard of research has always been the randomized controlled trial [RCT]. But for those of us who have dedicated our lives to taking care of patients, [RCT patients] do not tend to reflect the people we treat.”

Alexandre Chan, PharmD, MPH, a professor and the founding chair of the Department of Clinical Pharmacy Practice at the University of California, Irvine, agreed that the “inclusion– exclusion criteria” typically used to qualify patients for clinical trials have barred entry to many cancer patients. “These are very expensive therapies,” Chan said. “So when [these agents] are approved and used in the real world, clinicians worry whether they should offer them to cancer patients who are older, sicker and have more comorbidities. “In the last few years,” Chan added, “we’ve started to see more real-world evidence” showing the same kind of responses experienced in clinical trials. “It’s good that we’re keeping track of how these drugs are being used in the real world. As a pharmacist, I want to make sure I’ve got the infrastructure and the right support for patients who are getting these drugs so that they’re able to get through any toxicities they may experience.” Still, he noted, what’s lacking right now are the long-term data that can show the durable value of these newer cancer therapies in clinical practice. —Bruce Buckley

‘Triathletes With Cancer’ Sometimes, it can feel as if the patients admitted to randomized cancer therapy trials are virtual “triathletes with a cancer, with no coexisting conditions and

Brixner reported that the research conducted at the University of Utah was funded by an unrestricted grant from Pfizer. None of the other sources reported any relevant financial relationships.

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Corporate Profiles

2021 Accreditation Commission for Health Care Acute Care Pharmaceuticals Amneal Pharmaceuticals, Inc. Associates of Cape Cod, Inc. Fagron Sterile Services US ICU Medical International Medical Industries, Inc. McKesson Medical Surgical Medi-Dose/EPS Specialty Pharmacy Continuum Visante

The profiles in this section were submitted and/or reviewed by the advertisers.

Accreditation Commission For Health Care AT A GLANCE 139 Weston Oaks Court Cary, NC 27513 Phone: (855) 937-2242, ext. 458 Email: customerservice@achc.org

Accreditation Commission for Health Care (ACHC) has more than 30 years of experience promoting safe, quality patient care, and is known for providing value, integrity and the industryâ&#x20AC;&#x2122;s best customer service.

As a recognized national accreditor, ACHC develops solutions trusted by health care providers nationwide and is committed to offering exceptional, personalized service and a customized, collaborative accreditation experience tailored to individual needs. We focus on giving providers a positive, educational experience that continually enhances quality of care and business efficiencies. ACHC is a nonprofit based in Cary, N.C., in the Research Triangle. ACHC has deeming authority from the Centers for Medicare & Medicaid Services (CMS) for durable medical equipment, prosthetics, orthotics and supplies; home health; home infusion therapy; hospice; and renal dialysis. ACHC also offers accreditation programs for ambulatory care, behavioral health, pharmacy, private duty and sleep. The recent merger of ACHC with the Healthcare Facilities Accreditation Program (HFAP) gives ACHC additional recognition by CMS. ACHC now also has deeming authority for accreditation programs under its HFAP brand for hospitals, critical access hospitals, ambulatory surgery centers and clinical laboratories. In addition, under the HFAP brand, ACHC offers recognition for office-based surgery, stroke care, laser and lithotripsy services, joint replacement programs and wound care. As a recognized leader in pharmacy accreditation, ACHC provides a full range of accreditation and compliance programs tailored specifically to the pharmacy, home care and alternate-site health care industry. We offer a broad suite of pharmacy solutions, including accreditation options for specialty pharmacy, infusion, long-term care and mail order services, and accreditation by the Pharmacy Compounding Accreditation Board (PCAB) for sterile/nonsterile compounding services. Companies seeking to distinguish themselves further within the pharmacy market also can obtain accreditation distinctions from ACHC in rare diseases and orphan drugs, oncology, infectious disease specific to HIV, nutrition support, and hazardous drug handling. In achieving ACHC Accreditation, pharmacies confirm their commitment to quality care, safety and operational excellence. By adhering to ACHC Accreditation Standards, pharmacies demonstrate their compliance with all applicable and current rules and regulations

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to regulators, payors and patients. Achieving PCAB Accreditation confirms compliance with USP standards. Our standards are relevant, realistic and easy to understand, and were developed by industry experts to align with the latest requirements and industry best practices. ACHC Surveyors are licensed pharmacists who use a collaborative, educational accreditation approach that helps pharmacies achieve their business goals while facilitating a standardized level of service through sound procedures, documentation and training to promote continuity of care. ACHC is committed to providing you with the best possible experience before, during and after your accreditation survey. Providers receive assistance throughout the accreditation process and have access to personal account advisors, clinical and regulatory support, and program-specific educational resources. For more information on ACHC Accreditation programs, or to download ACHC Accreditation Standards, please visit www.achc.org, email customerservice@achc.org, or call (855) 937-2242, ext. 458.

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Acute Care Pharmaceuticals The nation’s leader in USP <797> and <800> compliant supplies specifically designed for your advanced health care environment Acute Care Pharmaceuticals has been servicing the health care industry for more than 20 years, delivering exceptional products and service to health care providers nationwide. We offer a wide range of U.S. Pharmacopeial Convention (USP) Chapter <797> and <800> compliant disposable products that are manufactured under the highest standards. With numerous group purchasing organization (GPO) and integrated delivery network (IDN) contracts, our goal is to make your buying experience simple and easy. Our Pharma-Choice™ brand of products is stocked at AmerisourceBergen, Cardinal and McKesson, where you can receive your special discounted GPO contract pricing. Stay tuned for more information about Acute Care Pharmaceuticals’ integration into Hospeco Brands Group. Customers will have an expanded breadth of lines in the Hospeco Signature Bundle of essential products.

AT A GLANCE

• PHARMA-SAT PLUS™ 70% IPA, Poly/Cell, Low Endotoxin 12225 World Trade Drive • PHARMA-WIPE™ Polyester/Cellulose (Sterile Suite A and Non-Sterile) San Diego, CA 92128 • PHARMA-WIPE PLUS™ Non-Sterile Polyester/ Phone: (888) 909-7700 Cellulose, Low Endotoxin Fax: (858) 675-9380 • PHARMA-POLYESTER WIPE™ 100% Polyester Email: Info@acutecareonline.com • PHARMA-HOL™ Sterile 70/30 Isopropanol/ Website: www.Pharma-Choice.com USP WFI (16 oz, 32 oz and gallons) PRODUCT LINE • PHARMA-D SURFACE DISINFECTANT™ • Pharma-Choice™ Brand Sterile Quat, Virucide, Fungicide • Full line of USP <797> and <800> • PHARMA-SURFACE GUARD™ Chemo Spill Compliant Supplies Wiper + Neutralizing Wiper, 2-Step Kit • PHARMA-MOP COVERS™ Polyester Universal Mopping System • PHARMA-MINI MOP COVERS™ Polyester and Poly/Cell • PHARMA-SAT MOP COVERS™ 70% IPA/30% DI Pre-Saturated Poly Covers • PHARMA-TACKY MAT + FRAME™ Mat removes up to 99% of footborne contaminants • PHARMA-CHEMO MAT™ Sterile Non-Linting, Absorbent Mat with Impervious Poly Backing • PHARMA-GLOVE™ Sterile Nitrile 12”, Chemo Approved-ASTM Tested, PF • PHARMA-COAT™ Lab Coat Polypropylene Elastic Wrist, No Pockets, White • PHARMA-COAT KNIT WRIST™ Lab Coat Polypropylene Knit Wrists, No Pockets, White • PHARMA-CAP™ Polypropylene Bouffant Cap, White or Blue • PHARMA-SHOE COVERS™ Polypropylene Anti-Skid, Blue

GPO/IDN CONTRACTS

Product Overview Improve facility operations with Acute Care Pharmaceuticals’ Pharma-Choice brand of products. The quality manufacturing of our Pharma-Choice brand of cleanroom disposables demonstrates our commitment to the continued success of USP <797> and <800>. All wipers are manufactured to meet International Organization for Standardization Class 5 and USP <161> endotoxin limits for medical devices of 0.06 EU/mL. Our sterile alcohol is manufactured with USP-grade water for injection and is available in various sizes. From the inception of USP <797>, we have been a trusted provider for the majority of hospitals nationwide in cleanroom disposables. Our constantly expanding USP <797> product line includes sterile alcohol, nonlinting wipers, disinfectants, media test kits, gloves, apparel and more. We have taken the same approach to USP <800> with our comprehensive line of products developed with you in mind, because your safety and the safety of your employees matter. Our USP <800> products include chemo gowns, chemo gloves, goggles, respiratory masks, sterile apparel, chemo spill mats and a two-step neutralizing kit.

• • • • • • • • • • • • •

Amerinet/Intalere APCI Ascension (The Resource Group) Asembia AvMedical Fairview Pharmacy Services GeriMed HealthTrust (HPG) MHA Northside Hospital System Premier Roi Vizient

MARKETS SERVED • • • • • • • • •

Hospital/Acute Home infusion Surgery centers Clinic Retail Long-term care Veterinary Pharmacies Oncology If you want quality products and customer service you can count on, call us today at (888) 909-7700 or email us at info@acutecareonline.com for more information.

PHARMA-CHOICE BRAND OF PRODUCTS INCLUDES: • PHARMA-SAT PLUS™ 70% IPA Polyester/Cellulose Low Endotoxin (Sterile and Non-Sterile) • PHARMA-SAT CANISTER™ 70% IPA Non-Sterile Polyester/ Cellulose

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Corporate Profiles 2021

Amneal Pharmaceuticals, Inc. Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated pharmaceutical company powered 400 Crossing Blvd by a robust U.S. generics Bridgewater, NJ 08807 business and growing Phone: (866) 525-7270 branded business. HeadEmail: sales@amneal.com quartered in Bridgewater, N.J., Amneal operates six manufacturing facilities in the United States as well as five abroad. A dedicated packaging plant in New Jersey and three distribution warehouses in Glasgow, Ky., round out its commercial operations.

AT A GLANCE

Since its founding in 2002, Amneal has grown organically and through mergers and acquisitions. Today, Amneal markets a portfolio of roughly 250 generic products spanning multiple therapeutic categories and a selection of branded pharmaceutical products focused primarily on central nervous system disorders, hypothyroidism and parasitic infections.

Broadening Portfolio For the past few years, Amneal has enhanced its generics business by focusing on more complex formulations, broadening its portfolio of injectable medications, and is investing in biosimilar development. Currently, Amneal is within the top 5 generics manufacturers in market share for its institutional products and looks to remain among the top players. Of the ANDAs that Amneal has filed with the FDA, 15% are injection dosage form. Injectables represent nearly 25% of the company’s development pipeline as well. To meet the expected production requirements of its growing institutional business, Amneal expanded its parenteral facility in 2020, with the addition of a new ophthalmic line and an upgrade to a vial line. Amneal has launched 20 products to date this year. Among those are generic Precedex® (dexmedetomidine HCl 200 mcg/50 mL and 400 mcg/10 mL), the generic for Depo-Medrol® (methyl-

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prednisolone acetate, USP 40 and 80 mg/mL), and the first generic for Demser® (metyrosine capsules (250 mg).

In-house Expertise Unlike many of its competitors, Amneal holds expertise in both complex product manufacturing and development, which reduces its reliance on third parties and delivers better economics on high-value products. Amneal development capabilities span all dosage forms, including complex oral solids, ophthalmics, liquids, topicals, inhalants and transdermals along with the aforementioned injectables and growing biosimilars program, which today includes one filed product, one near-term filing opportunity and one product under development.

Customer Focus Amneal’s institutional business is anchored by a unit of sales and marketing experts dedicated to this unique market. With deep roots and years of experience in the institutional space, the Amneal team provides dedicated service to its customers. Further, the company’s online customer portal enables customers to view product details, place and track orders, monitor payables, and view invoices 24/7.

cGMP Facilities Of the company’s manufacturing facilities, two are dedicated to sterile products. Both are fully integrated with manufacturing and packaging in-house. Amneal is proud to report that the most recent FDA inspections of its parenteral facilities yielded no Form 483s. For many years, Amneal’s family of plants have built and maintained a solid reputation for successful inspections.

Quality Culture Throughout its tremendous growth, Amneal has never lost sight of its commitment to quality and customer service. Its patients, customers, physicians and pharmacists trust Amneal to deliver quality pharmaceuticals that are safe and effective, and the company takes that to heart. Its quality culture is one of the core pillars of its success. Amneal team members across all functional areas work to consistently meet or exceed quality, industry and global regulatory standards. Key performance indicators validate the company’s efforts and ensure continual improvement. Employees explain that it’s just one more way “We make healthy possible.” Learn more about Amneal online at amneal.com.

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Associates of Cape Cod, Inc. Your Endotoxin Experts! Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a proud global leader in endotoxin and (1Æ3)-ß-D-glucans detection products and services for more than 45 years. ACC pioneered LAL testing methodology and was the first FDA-licensed company to manufacture LAL reagents; ACC has grown to be an internationally recognized leader in endotoxin detection. With a dedication to quality, ACC is certified to I.S. EN ISO 13485:2016 and ISO 13485:2016. The company is FDA-inspected and operates Drug Enforcement Administration (DEA)-licensed and Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories. Our endotoxin detection reagents, instruments and software are

used within the pharmaceutical, medical device, biotechnology, compounding pharmacy and dialysis industries for quality control, product release and research. Our reagents are FDA-licensed and can be used for testing in compliance with USP, European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) bacterial endotoxin test chapters, and our software is compliant with 21 CFR Part 11. ACC also operates a contract test services (CTS) laboratory that has specialized in testing for endotoxin and glucan con-

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tamination for over 40 years. Our CTS laboratory is compliant with Current Good Manufacturing Practice, ISO-registered and DEA-licensed, and is capable of handling all controlled drug substances except those included in Schedule I. All testing services can be performed to FDA, USP, EP and/or JP regulatory guidelines. In addition to routine testing, our CTS laboratory will customize endotoxin testing, troubleshoot difficult samples, develop and/or transfer LAL test methods, design and produce custom depyrogenation controls for oven validation, and perform low

AT A GLANCE 124 Bernard E. Saint Jean Drive East Falmouth, MA 02536 Phone: (888) 395-ACC1 (2221) or (508) 540-3444 Fax: (508) 540-8680 Email: custservice@acciusa.com Website: www.acciusa.com

endotoxin recovery studies/protocols. ACC also offers a clinical diagnostic product line and operates a CLIA-certified laboratory specializing in (1→3)-ß-D-glucans analysis to support the diagnosis of invasive fungal disease.

Corporate Profiles 2021

Fagron Sterile Services US DEA- & FDA-Registered 503B Outsourcing, Committed Medication Supply

AT A GLANCE Fagron Sterile Services US 8710 East 34th Street N Wichita, KS 67226 Phone: (877) 405-8066 (toll-free) Email: info@fagronsterile.com Website: fagronsterile.com Twitter: @fagronsterile

Founded in 1990, Fagron is the world’s leading pharmaceutical company dedicated to personalizing medicine. Serving 60 countries and over 200,000 customers worldwide, Fagron has an unwavering dedication to quality, customer service and supporting a reliable pharmaceutical supply chain.

A Brief History

In 2010, Fagron entered the North American market. As part of the only vertically integrated pharmaceutical company dedicated to sterile 503B outsourcing, our facilities drive pharmaceutical solutions across the continuum of care. Fagron recognized the opportunity to serve you and your patients better by acquiring JCB Laboratories. JCB was at the forefront of shaping industry standards in sterile preparations for nearly two decades and was one of the first 503Bs in the country to register with the FDA. In 2019, JCB Laboratories and Fagron Sterile Services synchronized branding to serve customers better and became Fagron Sterile Services US (FSS). FSS offers specialized pharmaceutical outsourcing solutions to acute care hospitals, ambulatory surgery centers and physician offices—putting you and your patients first. The company offers: • IDN agreements within all major GPOs • Unique state-of-the-art facilities with independent ISO 5 aseptic processing environments and industry-leading automation • A shared belief in the need to improve safety and efficiency for 503B FDA-registered outsourcing facilities.

Visit FSS’ State-of-the-Art 503B Facilities FSS has two DEA- & FDA-registered 503B outsourcing facilities located in Wichita, Kan. Its facilities are designed to ensure unilateral

Good Laboratory Practices, and strives to achieve the highest-quality standards within the industry. • 100% of batches are tested for sterility, particulate matter, potency • State-of-the-art environmental monitoring • Multiple vapor-phase hydrogen peroxide isolators for sterility testing • Industry-leading automation

Product Overview • • • • • • •

Operating room (OR) anesthesia Sterile topical anesthesia Ophthalmics Controlled substances Corticosteroids Urology (mitoMYcin Bladder) Dialysis

Ready-to-Use OR Syringes Time and accuracy matter in the OR, which is why every OR syringe from FSS is tested for stability, potency and sterility. ilit No syringe is released from quarantine until all testing is complete and approved by the FSS quality team. All OR syringes are clearly labeled while adhering to ASTM, Drug Quality and Security Act (DQSA), and Institute for Safe Medication Practices medication and anesthesia labeling standards. This includes TALLman lettering, presentation specifications, barcodes, expiration dating and room temperature storage requirements. FSS offers multiple presentations of the most commonly used anesthesia syringes.

OR Anesthesia Solutions FSS OR anesthesia line includes ready-to-administer syringes and IV bags. Presentations include some of the most commonly used medications and are continually expanding to meet customer needs.

Ophthalmics FSS is recognized as the industry standard for ophthalmic compounding. Ophthalmic compounding is one of the cornerstones of DQSA because of the need for high-concentration, small-volume compounded sterile preparations. FSS delivers a reliable supply of high-quality ophthalmic solutions including a revolutionary siliconefree Avastin® presentation, the first of its kind from a 503B outsourcing provider.

Committed Supply

movement of product and people and comply with cGMP guidance. • 16 ISO 5–classified aseptic processing environments • Industry-leading automation • Advanced environmental monitoring • Stringent testing on every batch • In-house lab testing capabilities for both stability and sterility Your patient’s safety is important to us, so quality must be a top priority for 503Bs. FSS is dedicated to the safety of the customers and patients they serve. Each cGMP cleanroom is equipped with independent HVAC systems and is fitted with industry-leading automation and depyrogenation technology. All lots are stringently tested, and no product is released before all testing is documented and complete.

FSS is committed to delivering a 503B solution you can rely on. That is why the company drew a line in the sand and developed a Committed Supply Program. You can always talk directly to a knowledgeable FSS staff member or pharmacist who will handle your requests quickly and accurately. Set up an account to access our mobile-friendly web shop (fagronsterile.com) and conveniently place an order 24/7, enjoying quick access to full order history, chart of accounts and invoices, batch details, shipment tracking, environmental monitoring reports, centralized purchasing and more. Find the latest news, product information and updates online at fagronsterile.com, or follow FSS on LinkedIn and Twitter @fagronsterile.

Trusted High-Quality Medications Over 7,300 health care facilities trust FSS to deliver a reliable supply of high-quality medications to support patient care. FSS complies with all FDA regulations, cGMP, Good Distribution Practices and current

Corporate Profiles 2021

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ICU Medical At ICU Medical, our focus is on bringing you intuitive, patientcentric infusion therapy products and services that provide meaningful clinical differentiation, consistent innovation and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time clinicians spend with patients. The unsafe handling of hazardous drugs used to treat many forms of cancer poses a significant health hazard to health care workers and patients. In response to these risks, ICU Medical has developed oncology systems—closed system drug-transfer devices (CSTDs), automated compounding systems, smart infusion pumps and safety software—that work together to cost-effectively help you safely and more efficiently prepare and deliver medications to patients.

LifeCare PCA™ infusion systems help you accurately document infusion administration through our IV-EHR Interoperability solution, and our LifeCare PCA is the only patient-controlled analgesia pump with IV-EHR capabilities.

Improve Efficiencies and Maximize Profitability

AT A GLANCE 951 Calle Amanecer San Clemente, CA 92673 Phone: (800) 824-7890 Website: www.icumed.com

With the ICU Medical MedNet™ complete IV-EHR interoperability solution, you can automatically program your Plum 360 infusion system with medication orders—direct from the pharmacy—helping to reduce medication errors and setup time. The system also sends

Streamline the Preparation Process With Automated Compounding The Diana™ compounding workflow system is the first and only system to combine both automated compounding and IV workflow technologies with wireless pharmacist notification to let you remotely verify each preparation on a handheld tablet display without having to gown up and enter the cleanroom. With its integrated high-definition cameras, you can visualize the workflow for faster, more accurate high-volume compounding, while our closed system components help you comply with U.S. Pharmacopeial Convention (USP) General Chapter <800>. Unlike automated technologies that require huge investments and do not fit within existing workflows, Diana’s compounding module fits in as small as a three-foot hood, so you can cost-effectively incorporate automation without reconfiguring your cleanroom.

Maintain a Closed System From Pharmacy Through Administration With ICU Medical’s ChemoLock™ or ChemoClave™ CSTD components at every connection point, we help minimize drug exposure and comply with USP <800> CSTD safe handling guidelines during reconstitution and compounding. The ChemoLock CSTD helps speed up preparation times by eliminating the need to assemble multiple components, and it snaps together with an audible click, ensuring a safe and secure connection. Both CSTDs are designed to prevent the escape of hazardous drug or vapor concentrations, block the transfer of environmental contaminants into the system, and eliminate the risk for needlestick injuries. During administration, the Plum 360™ infusion pump’s closed system air management allows automated back priming to remove air from the line without disconnection, helping you maintain a closed system throughout drug delivery.

Track Preparation Data and Streamline The Flow of Information With Diana, you can automatically record each order preparation for easy reporting and archiving for traceability. Our Plum 360 and

With the Diana compounding workflow system’s integrated high-definition cameras, you can visualize the workflow for faster, more accurate high-volume compounding, while closed system components help you comply with USP <800> guidelines and keep your pharmacists and technicians safe from exposure.

all infusion information back to the patient’s electronic health record, improving accurate documentation of start and stop times and creating additional revenue capture opportunities, even on secondary administrations. The unique delivery system of the 2018, 2019 and 2020 Best in KLAS Plum 360 allows for concurrent delivery of compatible medications at independent rates from a single pump, which can help reduce chair time. In addition, the cassette technology for Plum 360 can trap up to 1 mL of air before alarming, reducing air-in-line alarms for more efficient delivery. Our ChemoClave luer-based CSTDs connect directly to the Plum 360 dedicated administration sets, eliminating the need to assemble multiple components and increasing drug delivery efficiencies. You can even offset implementation costs and reduce packaging waste with the option to order commonly used CSTD components in multipacks.

Focused and Committed to Helping You Deliver Excellence in Infusion Therapy From Preparation To Administration Bringing new and innovative technologies to oncology pharmacists, technicians and nurses is at the core of who we are. We are committed to providing safe, cost-effective and easy-to-use solutions that maximize workflow efficiency, helping to keep clinicians and patients safe from exposure to hazardous drugs. Contact us today to learn how we can help you improve your IV medication safe handling practices by calling (800) 824-7890 or visiting www.icumed.com.

The 2018-2020 Best in KLAS Plum 360 features smart pump programming capabilities, helping you reduce infusion setup time while improving safety.

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Corporate Profiles 2021

International Medical Industries, Inc. AT A GLANCE 2981 Gateway Drive Pompano Beach, FL 33069 Phone: (800) 344-2884 Email: sales@imiweb.com Website: www.imiweb.com

Increase pharmacy productivity and safety with innovative and economical devices designed to protect your compounded sterile preparations.

caps combined with the cost of other tamper-evident methods, the Prep-Lock Tamper Evident Syringe Cap offers extraordinary value. More importantly, it makes a clear statement about how seriously your facility takes drug safety.

Company Background

Prep-Lock Tamper Evident Caps—For Oral Syringes (Non-Sterile)

For over 50 years, International Medical Industries has worked closely with pharmacists and compounding professionals to create innovative sterile products that meet very specialized needs. A prime example is the Prep-Lock™ Tamper Evident Syringe Cap technology. The Prep-Lock product family has become the tamper evidence standard among hospital pharmacies and outsource compounders everywhere. IMI remains at the forefront of developing new products specifically designed for the compounding industry. In addition, IMI has established long-standing partnerships with some of the biggest names in health care. Through these partnerships and directly, IMI is delivering the kind of high quality and high-value products that pharmacy operations demand. All IMI products are manufactured in the United States under the strictest quality standards at our FDAregistered, ISO 13485–certified facility.

Concerns over drug diversion continue to be a catalyst for enhanced drug security programs. Securing oral syringes with Tamper Evident Caps provides benefits that extend beyond diversion mitigation. When Oral Syringe Medication is required, dosing accuracy is often a particular concern. Unlike standard oral tip caps that can easily dislodge and fall off, the Prep-Lock™ Tamper Evident Cap provides a secure, tamper-evident, leak-free closure, to oral syringes. Once applied to the syringe, removal or reinstallation is not possible without clear evidence of access. Administration of oral medications presents unique challenges; that’s why IMI’s Oral Tamper Evident Caps now feature a retained indicator ring for improved control over disposable components. Tamper Evident Caps help ensure that medications arrive to patients uncompromised, increase pharmacist and practitioner confidence, and advance patient safety.

Prep-Lock Tamper Evident Caps—Now Available For CADD Medication Cassettes (Sterile) The newest member of the Prep-Lock Tamper Evident Cap family provides protection for CADD Medication Cassettes. The male luer lock connector allows for quick installation on the cassette’s female tubing connector. The Prep-Lock Tamper Evident Cap for CADD Medication Cassettes offers the same proven features that have made the IV syringe version the number one choice for securing CSPs.

Additional Product Lines

Product Overview Prep-Lock Tamper Evident Caps— For Luer Lock IV Syringes (Sterile) Compounded sterile preparations (CSPs) are at their greatest risk when they leave the custody of your pharmacy. The Prep-Lock Tamper Evident Cap greatly reduces the risk of your CSP being compromised either accidentally or intentionally. It ensures that product integrity is maintained from the time the CSP leaves the sterile hood until it is administered by an authorized clinician. If you partner with a compounding outsourcer, chances are you are already familiar with the Prep-Lock Tamper Evident Cap that is widely used by all the top 503B compounders. You can easily incorporate the use of this cap into your in-house preparations, which will provide standardization of all syringes throughout your hospital. As a result, your clinicians will not need training for administering syringes with multiple tamper evident methods. Installation of the Prep-Lock Tamper Evident IV Syringe Cap in your compounding operation is highly efficient. Each sterile tray of 10 caps offers a unique “keyed” feature allowing the pharmacist the ability to quickly install the cap with a simple twist of the syringe. This helps to reduce the risk of touch contamination and enhances aseptic technique. Best of all, you save time when compounding several syringes at once. Administering a syringe is very easy for the clinician. Simply pull off the outer sleeve of the tamper evident cap, unscrew the remaining luer lock cap and discard. Clinicians appreciate not having to deal with sticky tamper evident tape or frustrating shrink wrap. A choice of three different colored caps and two outer sleeve styles allows the pharmacy the ability to color-code either specific drug classes or processes. When you consider the cost of ordinary syringe

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IMI offers a variety of sterile devices designed for the compounding pharmacist: • Prep-Seal™ Sterile Luer Lock Caps and Plugs • Prep-Fill™ Sterile Luer Lock Connectors • Rx-Vent™ Sterile Venting Needles • Rx-Tract™ Sterile Aspirating Needles

Product Distribution Contact IMI today and request FREE product samples for evaluation. IMI products are available direct or through one of our valued distribution partners. Visit us at www.imiweb.com or call (800) 344-2884.

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McKesson Medical-Surgical Access, reliability, support. Count on McKesson. With the acquisition of Medical Specialties Distributors LLC, in 2018, McKesson Medical-Surgical now offers the industry’s largest portfolio when it comes to infusion therapy, including pharmaceuticals, infusion devices, equipment and patient care supplies. All this is backed by a dependable supply chain and a team that feels like they’re part of your own. With the infusion therapy market growing by leaps and bounds, having a distributor you can trust is essential to keeping your business moving forward. Count on McKesson to help you get the job done.

• 99.9% order accuracy to ensure your patients always get their deliveries on time

Solutions to help support your business performance:

AT A GLANCE 9954 Mayland Drive Richmond, VA 23233 Phone: (855) 571-2100 Website: mms.mckesson.com

• Competitive pricing that works for your business • Customized patient home delivery that saves you time and money on packing, shipping and inventory • Biomedical services including equipment rentals, sales and management services for one of the industry’s largest inventory of infusion devices, enteral feeding pumps, respiratory ventilators and more.

Technology that makes your job easier: McKesson VerbalCare™—Our patient communication app connects you with your patients, supporting therapy adherence, simplifying resupply orders and driving administrative savings. McKesson OneTrack™—Our web-based asset management tool helps you lower operational costs, improve inventory management, and maximize equipment up-time.

The services you need from a team you can trust: • Dedicated Account Managers to help with your day-to-day needs • Customer service reps to deliver speedy resolution • Technology experts to assist with training and implementation

Product selection and a coast-to-coast distribution network you can depend on:

To learn more about our full line of infusion therapy solutions, start by visiting us online at mms.mckesson.com/home-infusion-therapy.

• The industry’s largest portfolio of pharmaceuticals, infusion devices and supplies from a single distributor • Next-day delivery to 95% of the United States to get patients what they need, fast

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Corporate Profiles 2021

Medi-Dose/EPS AT A GLANCE 70 Industrial Drive Ivyland, PA 18974 Phone: (800) 523-8966 Fax: (800) 323-8966 Email: info@medidose.com Website: www.medidose.com

Products • Medi-Dose® (Solid) and TampAlerT® (Liquid) Oral Unit-Dose Packaging • Medi-Cup® PLUS packaging for extended beyond-use dating • MILT® by Medi-Dose unit-dose and barcoding software • LiquiDose® labeling, IV additive and filtration products • Nultraviolet® ultraviolet light inhibitant bags • Steri-Dropper sterile ophthalmic dropper bottles • High Alert and IV Line Tracing Labels • Resealable bags, bottles, and other pharmacy supplies and disposables

For more than 40 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit-dose medications. With input from pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and barcode your inventory.

Medi-Dose began in 1971, when Milton Braverman, a former pharmaceutical company territory manager, formed his own company. Robert Braverman, president, remembers, “My dad was acutely aware of the requirements of hospital pharmacy. He saw the need for inexpensive, manual unitdose packaging allowing hospitals to convert from traditional dispensing. He developed systems to package, handle and dispense predetermined amounts of medication so they would be accessible for one regular dose.” Brightly colored Lid-Label Covers call attention to medication requiring special handling. Although familiar today, launching the idea of unit dose was a label and secure even more sizes and types of medications, huge problem the new company faced. “We were one of the pioneers, including large medications, compounded drugs, double the innovators promoting unit dose in hospitals,” Robert Braverman and triple “0” capsules, unit-of-use packaging, repackaged recalled. “Due in part to Medi-Dose’s educational efforts, pharmacists medications and suppositories. and nurses accepted the validity of unit dose.” • All Medi-Cup Blisters and Lid-Label Covers work with our MILT 4 Inexpensive, Easy and Flexible: Because of its unique Cold-Seal techSoftware, which can be used for all your barcoding and labeling nology, the Medi-Dose System is simple to use and requires no special needs. in-service training or additional space. Medi-Cup blisters are available Adapts to Your Needs: With our MILT 4 Software, you can design in 15 styles and eight sizes to accommodate the largest medications or your labels any way you want (for solids, liquids, syringes, ampules, the smallest storage spaces, and are particularly ideal for USP <800> IVs—even equipment and supplies). In addition to the ability to use medications. Ultraviolet-inhibitant blisters provide additional protecgraphics, special fonts and shapes—even logos and symbols—to tion from light. Plus, a combination of special blister plastics with better identify your medications, MILT 4 has been designed to easily aggressive tamper-evident label adhesives provides either six-month create barcodes with the information your barcode-enabled pointor one-year beyond-use dating for all your unit-dose packaging needs. of-care and barcode medication administration systems require. The Medi-Dose System offers these additional benefits: Popular 1D and 2D barcode formats can be created with National Drug • Sealed units can be left in sheets or easily torn down to individual Code numbers, beyond-use dates, lot numbers and special codes. doses. Plus, MILT 4 suggests tall man lettering options (e.g., DOPamine • Lid-Label Covers are available in 8 1/2˝ x 11˝ laser sheets of instead of DOPAMINE) for medications as recommended by the FDA 25 doses or 4˝ x 6 1/4˝ direct thermal sheets of five doses. and the Institute for Safe Medication Practices. In addition, newly • Laser Lid-Label Cover Sheets are available in a wide variety of entered and previously saved medication names are compared with colors to facilitate color coding of medications. the CDC’s “NIOSH List of Antineoplastic and Other Hazardous Drugs • Circular and Oval Blisters have been designed to fit your in Healthcare Settings.” If a match is found, the user is notified that dispensing machines and storage cabinets. this medication may potentially be hazardous to handle. • New MPB® - Multi-Purpose Blisters allow you to easily package,

To get started, all you will need is: 1. 2. 3. 4.

Medi-Cup Blisters: 15 styles to suit your packaging needs. Lid-Label Covers: Laser or Direct Thermal labels to seal the blisters. MILT 4 Software: Design and manage Lid-Label Cover printing. Fil-Form and Roll-E-ZY: Aligns Lid-Label Covers to Medi-Cup Blisters, ensuring a positive seal between labels and blisters. Inexpensive. Flexible. Tamper-Evident. If you are looking for a system to handle any or all of your unit-dose or barcoding needs, then the Medi-Dose System is the perfect fit for you!

Using our MILT 4 Software, you can label and identify all your medication, complete with graphics and a barcode.

Corporate Profiles 2021

Special Advertising Section Specialty Pharmacy Continuum

Specialty Pharmacy Continuum Specialty Pharmacy Continuum (SPC) continues to be a powerful addition to the Pharmacy Practice News editorial franchise, featuring essential clinical and business developments for managed care, health-system and specialty pharmacy decision makers. Specialty pharmacy has seen explosive, double-digit growth, with the U.S. market projected to hit $500 billion by the end of 2020—up from $200 billion in 2017 (Definitive Healthcare; bit.ly/3nbKz71). For almost a decade, SPC has been tracking this trend and its effect on patients and providers.

Clinical Topics Specialty pharmacists are a core audience for SPC. The breadth of clinical topics we frequently cover shows our dedication to meeting their information needs. Recent topics include: • Antiretroviral therapy for hepatitis C and HIV • Atopic dermatitis • Digital therapeutics • Hemophilia • Hyperkalemia • Multiple sclerosis and other inflammatory conditions • Oral chemotherapy • Orphan/rare disease therapies • Pharmacogenomics and personalized care • Pulmonary arterial hypertension

Operations & Management Clinical expertise is critical to a specialty pharmacy’s success, but delivering those services in an efficient and cost-effective manner also is important. To that end, SPC covers the following operational areas: • Contracting with payors and other managed care stakeholders • Drug pricing/utilization • Home infusion • Managing the drug spend • Navigating copay and coupon programs • Patient assistance programs • Patient engagement • Site-of-care optimization

Policy Updates State and federal health care policies, along with key practice standards organizations, continue to have a huge effect on specialty pharmacy. To help readers keep abreast of this critical area, SPC covers the following topics: • Accreditation • Biosimilars and the FDA • Health care reform • Joint Commission compliance • Legislative updates • Medicare and Medicaid coverage • REMS (Risk Evaluation and Mitigation Strategies) • Value-based care and other reimbursement topics

Meeting Coverage To ensure SPC is tracking the latest developments in specialty pharmacy, our editors and reporters attend a wide range of conferences throughout the year, including those convened by Asembia, NASP, AMCP and ASHP, among others.

Successes on the Web

AT A GLANCE 545 W. 45th Street, 8th Floor New York, NY 10036 Phone: (212) 957-5300 Fax: (212) 957-7230 Website: specialtypharmacycontinuum.com

Editorial Director David Bronstein davidb@mcmahonmed.com Ext. 212

Group Publication Director Dave Kaplan dkaplan@mcmahonmed.com Ext. 912

Senior Editors Marie Rosenthal mrosenthal@mcmahonmed.com Ext. 265 Sarah Tilyou smtilyou@mcmahonmed.com Ext. 216

A central tenet of our meeting coverage is to file late-breaking news from sessions each day. Sales Account Manager We significantly expanded our capabilities in this Sarah Rezvani area in 2020, and the efforts have paid off with srezvani@mcmahonmed.com a huge surge in web traffic. In the most recent Ext. 260 2020 web metrics report for SPC, monthly average page views and unique page views were up by 124% and 136%, respectively. To ensure maximum reach for meeting content and other late-breaking news, SPC sends out twice-weekly e-newsletters. Registration for these alerts also has surged, with nearly 500 new subscribers added in 2020. SPC’s online offerings also include multimedia content, such as video interviews and podcasts with leading specialty pharmacists and managed care executives. Here are a few topics and experts we have featured: The Art of RA Management, with Katrina Cooper, PharmD, a clinical specialty pharmacist at Vanderbilt Rheumatology. Real-Time Pharmacy Benefits, with Leann McDowell, PharmD, a supervisor in Pharmacy Utilization Management at HealthPartners, in Minnesota. The Human Genome and Its Implication in Clinical Practice, with Laney Jones, PharmD, MPH, an assistant professor at Geisinger, in Blakeslee, Pa.

Be Heard! We welcome contributed articles, so if you are a clinical expert or an operational whiz, we’d like to hear from you. Send your topic ideas to davidb@mcmahonmed.com, and we will help you share your insights. Know that if we accept your article, your work will appear in the best-read publication in specialty pharmacy: According to the 2020 Readex Research study, 96% of respondents said they take action after reading an article in SPC, and 92% share issues with their decision-maker colleagues. Plus, SPC now is sent to payors, so you’ll be sharing your expertise with that key group as well.

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Corporate Profiles 2021

Visante AT A GLANCE 101 East Fifth St. #2220 St. Paul, MN 55101 Phone: (866) 388-7583 Email: solutions@visanteinc.com Website: visanteinc.com

Visante is a multidisciplinary, clinician-composed consulting firm specializing in all aspects of the business of pharmacy. We believe in moving the practice of pharmacy forward through innovative solutions that deliver lasting results. Far too often, we’ve seen pharmacy and medication management underutilized or under-resourced, resulting in a negative impact on finances and patient care. We’re in the business of reversing that. We’re in the business of advancing pharmacy.

By diagnosing and solving complex problems, we help organizations more effectively deliver optimized and compliant medication-related services. Our 60-plus consultants include experienced pharmacists, nurses, physicians, IT professionals and business experts, all working together to ensure you get the right solutions for your unique needs. No matter what your challenge is, we always know what matters most—delivering safe, high-quality, cost-effective patient care so you can continue to grow.

Comprehensive Pharmacy Assessment Optimizes Financial and Clinical Results We put our extensive experience and knowledge to work to assess your current operations and help you take your pharmacy to the next level. We have the right combination of skills to evaluate all the moving parts and recommend improvements that will help you provide better patient care while improving your bottom line. We listen and work closely with you to support your objectives, delivering a personalized pharmacy plan for optimal growth, including a complete evaluation of your current program; opportunity analysis for safety, clinical, operational and financial improvements; strategic planning support based on identified opportunities; and program enhancement design and implementation.

340B Solutions For Total Compliance And Lasting Success Visante’s independent, external audit support continues to provide transparency to your 340B processes, allowing you to recognize compliance gaps while also focusing on new opportunities within the program. Visante provides the following: internal and external audit support, on-site Health Resources and Services Administration (HRSA) audit support, and corrective action plan guidance in the event of HRSA audit findings; gap analysis and targeted recommendations, focusing on a long-term strategy in the mixed-use and contract pharmacy space to ensure program optimization; program implementation and development of internal oversight structure and maintenance; and split billing request for proposal guidance, implementation and program redesigns. Visante’s experienced team members are all Apexus 340B University graduates, many of whom have completed the Advanced 340B Operations Certificate.

Corporate Profiles 2021

Expand Your Specialty Pharmacy Services And Quality of Care A clearly defined specialty pharmacy strategy can help improve patient care and optimize your bottom line. Developing a specialty pharmacy strategy or expanding your existing services can be a complex process, but our team of experts guides you through each phase and delivers lasting return on investment. Our specialty pharmacy consulting capabilities include operational assessment and pro forma models; multiyear business and strategic plans; facility design including workflow and automation options; implementation and project management; accreditation support (Accreditation Commission for Health Care, the Center for Pharmacy Practice Accreditation and URAC); contract pharmacy strategy, if applicable; wraparound strategy to include consideration for site-of-care challenges (infusion); and home infusion and durable medical equipment strategies and business planning.

Sterile and Nonsterile Compounding Compliance That Drives Safe, High-Quality, Cost-Effective Care Safely compounded medications are essential to quality patient care. Hospitals face the challenge of optimizing care while meeting safety requirements and managing cost. We will prepare you for compliance with USP Chapters <795>, <797>, <800> and <825>. We’ll also assist you in preparing for compounding-related inspections by the Centers for Medicare & Medicaid Services, the FDA, the Drug Enforcement Administration and the Joint Commission/DNV GL Healthcare. Our consulting services include: USP <795>, <797>, <800> and <825> and gap assessment and facility design; 503A and 503B assessment, facility design and implementation support; and home infusion compounding services. When it comes to pharmacy compounding, we don’t settle for basic compliance—and you shouldn’t either. Our processes are designed to assist you and your team to be successful.

Drug Diversion Prevention Protects Your Patients And Yourself Drug diversion problems continue to escalate with opioid addiction at epidemic levels. Our program takes a comprehensive multidisciplinary approach to identify drug diversion risk points in your medication-use processes. Minimize risk through assessment of pharmacy operations, informatics, automation, nursing and perioperative processes to identify and strengthen points of vulnerability. Our drug diversion experts have real-life experience in hospitals and health systems, and understand the challenges that hospitals face today and in the future.

Special Advertising Section Specialty Pharmacy Continuum

Specialty Pharmacy Continuum • November/December 2020

CLINICAL

Meeting Unique Needs of Fertility Patients Undergoing Advanced Treatments: The Role of the Specialty Pharmacy NANCY HARRINGTON, RNC-REIN Senior Specialist, Clinical Education AllianceRx Walgreens Prime

ertility patients undergoing assisted reproductive technology (ART) require special handling and expertise at every

level. Specialty pharmacies have a unique opportunity to improve delivery of care to such patients.

Successful use of ART depends on the collaboration and coordination of professionals from varying specialties who rely on specialty pharmacies to support the complex medication protocols that are needed. In addition, specialty pharmacies can become valuable sources of empathy, compassion, and education for patients with infertility.

Semen, oocyte, and embryo donation

wishing to preserve fertility8; • freezing of eggs or embryos for future childbearing10; • genetic disease prevention through preimplantation genetic testing, in which embryos are biopsied to detect genetic abnormalities, allowing a patient to select a nonaffected embryo for transfer9; • family building for LGBTQ patients11; and • family balancing for families who prefer to select the sex of their baby.12 The Society for Assisted Reproductive Technology (SART) reported that more than 70,000 babies were born via ART in 2018.7 SART also noted that there have been steady increases in ART cycles and egg freezing and declines in multiple births associated with ART cycles.13

Zygote intrafallopian transfer

Medications

Table. Assisted Reproductive Technologies Assisted hatching Embryo biopsy

Infertility

Embryo transfer

Infertility is a disease defined as the inability to achieve pregnancy after 12 months of regular, unprotected intercourse or due to an impairment of a person’s capacity to reproduce either as an individual or with a partner.1 It affects both men and women equally.2 Approximately 13% of women aged 15 to 49 years of age cannot get pregnant or carry a baby to term, and infertility is one of the most common diseases in people aged 20 to 45 years.3,4 Many factors can affect fertility, including age, lifestyle factors, genetics, hormone issues, ovulatory dysfunction, tubal or uterine abnormalities, and other medical problems.2 Sometimes there is no identifiable cause. Individuals diagnosed with infertility can experience distressing emotions that are commonly felt by people experiencing a significant loss. Patients might experience grief, depression, anger, frustration, a loss of self-esteem and self-confidence, and a perceived loss of control over their future.5 Studies have shown that the psychological symptoms associated with infertility are similar to those associated with other serious medical conditions, such as cancer and cardiac issues.6

Gamete and embryo cryopreservation

Advanced Treatment Options Patients who turn to ART to build their families generally have been unsuccessful using the normal route to family building, and ART might be their last option for fulfilling their dream of having a baby. For these patients, treatments such as intrauterine insemination, ovulation induction, or surgery have not resulted in viable pregnancy. Many patients seeking ART are

Gamete intrafallopian transfer Intracytoplasmic sperm injection In vitro fertilization Preimplantation genetic testing

at a difficult crossroads in their treatment that requires enormous faith in their clinical team, including their specialty pharmacy. The most common type of ART is in vitro fertilization (IVF), which involves the in vitro handling of human oocytes, sperm, or embryos for the purpose of establishing a pregnancy.1 Other procedures are listed in the Table.1 These procedures can help patients with one or more steps in conception. They also are used to facilitate third-party reproduction, which involves someone other than the intended parent(s) in the process of reproduction. This includes using donated eggs, sperm, or embryos as well as gestational carrier arrangements, in which a pregnancy is carried by someone other than an intended parent.7 Although most patients undergoing advanced therapies have been diagnosed with infertility, some turn to ART for other reasons.8,9 This expanding use of the technology includes: • fertility preservation for medical reasons, such as male and female cancer patients

The first live birth through IVF was achieved in 1978 using a natural cycle that required no medications to stimulate the ovaries.14 Inspired by this birth, Drs Georgeanna and Howard Jones developed the first IVF program in the United States.15 After overseeing 41 natural cycle procedures that did not result in pregnancy, they began administering human menopausal gonadotropin, which stimulates a patient’s ovaries to produce multiple eggs.15 In 1981, this practice resulted in the birth of Elizabeth Carr, the first IVF baby conceived using “fertility medications.”16 This unprecedented birth initiated the use of controlled ovarian stimulation (COS) as a new method to help couples achieve pregnancy.16 Improved understanding of reproductive biology, laboratory and pharmaceutical advances, and evolving strategies for IVF family building have highlighted the importance of COS to IVF outcomes.16 In the current practice of IVF, the vast majority of cycles use some form of COS to increase the number of embryos available for transfer or cryopreservation.17 COS relies on several drugs to stimulate and see FERTILITY, page 28

Specialty Pharmacy Continuum • November/December 2020

CLINICAL

FERTILITY continued from page 27

promote the growth of multiple follicles that will lead to multiple eggs for ART procedures (Figure 1). These drugs can stimulate the ovaries to make multiple eggs (ovarian stimulation), control the response of the ovaries (ovarian control), induce maturity and release of the eggs (ovulation), and prepare the uterine lining to receive a fertilized embryo (uterine support).18,19 ART medications most often are self-injectable agents with specific storage and administration instructions. There also is a great urgency related to the delivery and daily dosing of these drugs because they are given in synchronization with the menstrual cycle. They must be delivered at specific, predetermined times, and any delay can result in a canceled treatment cycle. All treatment medication protocols are individualized, and there are no set doses.19 Dosing is determined by each patient’s daily response to the agents. There can be no lapse in the regimen, and timely refills are required to maintain continuous treatment.

Fertility Order Review

One or more from each of the following categories:

Role of the Specialty Pharmacy The complexities of treatment can be stressful for patients, and they require assistance to guide them through the process.20 Aside from the complex aspects of advanced treatment, other factors that can affect a fertility patient’s challenging journey include personal, professional, and financial constraints. These factors can become additional stressors affecting treatment (Figure 2).21 Clinicians working with ART patients rely on the specialty pharmacy as a vital part of the continuum of fertility care. Specialty pharmacies bring tremendous value to infertility treatment by providing expert medication information, financial and cost-saving programs, care for special patient populations, emotional support, and compassionate care. Fertility patients benefit from expert medication guidance, including information about product usage and action, delivery and storage, common side effects, and disposal of related supplies. Information that specialty pharmacists provide about how to qualify for and access financial and cost-saving programs also is critical because a large population of fertility patients do not have insurance coverage for their treatment. AllianceRx Walgreens Prime along with Walgreens’ 10 fertility-specialized pharmacies have established dedicated teams of patient care advocates, reimbursement specialists, and pharmacy staff with expert training in the field of advanced fertility treatments. They have developed fertility education materials including medication and injection guides and educational tutorials. These interactive materials cover all aspects of fertility care, including diagnostic testing, treatment options, and medications. A specialty pharmacy team trained to support ART is available to assist patients around the clock, seven days a week. In addition, special populations, such as oncology patients looking to preserve their future fertility, can speak with specialty-trained pharmacy staff about special programs that assist with medications related to fertility preservation. Significant savings might apply for patients who qualify for these programs.

Figure 1. Types of common medications in a complete IVF cycle. GnRH, gonadotropin-releasing hormone; IVF, in vitro fertilization Based on reference 19.

Figure 2. Factors influencing advanced fertility treatment plans.

Emotional support and compassionate care are a vital part of providing specialized pharmacy care to fertility patients.17 In addition to pharmacy and clinical support, AllianceRx Walgreens Prime fertility teams provide post-dispense supportive service through the Fertility Order Review (FOR) program. Patients often are overwhelmed when their initial box of medication arrives. This program is designed to help minimize the anxiety patients might face when preparing to selfadminister fertility medications. The service gives patients direct access to a professional with fertility pharmacy experience—at no additional cost. When a patient’s first medication order arrives, a fertility health professional will provide a personalized phone consultation to assist with the following: • reviewing the contents of the fertility medication order; • explaining the purpose of each item and how each medication is to be correctly stored; • providing access to online patient infertility guides for step-by-step administration instructions, fertility education, and medication information; and • determining medication expiration dates and establishing reorder reminders to maintain an adequate supply of medication. The FOR program also includes the FOR Video Connected Care Program, which offers webbased video consultation for additional educational resources and support. This gives patients the opportunity to have face-to-face communication with a fertility health professional in any private setting of their choice (eg, home or office).

Expectations for the Specialty Pharmacy Both patients and clinicians have certain expectations when relying on a specialty pharmacy for fertility care. Patient expectations might include: • caring and respectful support, even if they are upset or angry; • expedient phone assistance without long hold times, several transfers, or multiple callbacks; • competitive pricing through maximization of insurances and/or all available discount programs/coupons; • prompt delivery of medications on or before the “needs by” date; • the option to request delivery of medication a day before needed to reduce stress; • accurate, discreetly packaged medication orders; and • access to a pharmacist 24/7. Clinician expectations might include: • an ability to trust the specialty pharmacy to take care of patient needs; • competitive pricing and availability of discount medication programs; • fast and accurate referral processing; • prompt communication related to prescription issues or questions; • thorough and succinct follow-up with clinicians that eliminates the need for multiple outreaches; and • accurately filled medication and supply orders received on or before the “needs by” date. Specialty pharmacy providers have the see FERTILITY, page 30

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CLINICAL

FERTILITY continued from page 28

extraordinary opportunity to make a significant difference in the outcome of a patient’s fertility journey. Specialty pharmacists can build positive interactions with patients by offering empathic, nonjudgmental care and understanding. Patients are extremely thankful for such knowledgeable and compassionate specialty pharmacy care.

References 1.

Zegers-Hochschild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017;108(3):393-406.

2. Practice Committee of the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2015;103(6):e44-e50.

6. Domar AD, Zuttermeister PC, Friedman R. The psychological impact of infertility: a comparison with patients with other medical conditions. J Psychosom Obstet Gynaecol. 1993;14(suppl):45-52.

13. American Society for Reproductive Medicine. More than 74 thousand babies born from assisted reproductive technology cycles done in 2018. March 26, 2020. Accessed October 14, 2020. https://bit.ly/2H9RfCD

7. American Society for Reproductive Medicine. Third party reproduction: sperm, egg, and embryo donation and surrogacy. Revised 2017. Accessed October 14, 2020. https://bit.ly/3doOlpS

14. Steptoe PC, Edwards RG. Birth after the reimplantation of a human embryo. Lancet. 1978;2(8085):366.

8. Kim SY, Kim SK, Lee JR, et al. Toward precision medicine for preserving fertility in cancer patients: existing and emerging fertility preservation options for women. J Gynecol Oncol. 2016;27(2):e22. 9. Practice Committee of Society for Assisted Reproductive Technology, Practice Committee of American Society for Reproductive Medicine. Preimplantation genetic testing: a practice committee opinion. Fertil Steril. 2008;90(5 suppl):S136-S143. 10. American Society for Reproductive Medicine. Fact sheet. Can I freeze my eggs to use later if I am not sick? 2014. Accessed October 14, 2020. https://bit.ly/2GPHFp1

3. CDC/National Center for Health Statistics. FastStats. Infertility. Updated December 2, 2019. Accessed October 14, 2020. https://www.cdc.gov/nchs/fastats/infertility.htm 4. American Society for Reproductive Medicine. Defining infertility. Revised 2014. Accessed October 14, 2020. https://bit.ly/378btIa 5. Burns LH. Psychiatric aspects of infertility and infertility treatments. Psychiatr Clin North Am. 2007;30(4):689-716.

11. American Society for Reproductive Medicine. Fact sheet. Counseling issues to discuss with gay men and lesbians seeking assisted reproductive technology (ART). Revised 2015. Accessed October 14, 2020. https://bit.ly/3dtDdIi 12. Ethics Committee of the American Society for Reproductive Medicine. Use of reproductive technology for sex selection for nonmedical reasons. Fertil Steril. 2015;103(6):1418-1422.

15. Jones HW Jr, Jones GS, Andrews MC, et al. The program for in vitro fertilization at Norfolk. Fertil Steril. 1982;38(1):14-21. 16. Beall SA, DeCherney A. History and challenges surrounding ovarian stimulation in the treatment of infertility. Fertil Steril. 2012;97(4):795-801. 17. Van Voorhis BJ, Thomas M, Surrey ES, et al. What do consistently high-performing in vitro fertilization programs in the U.S. do? Fertil Steril. 2010;94(4):1346-1349. 18. American Society for Reproductive Medicine. Medications for inducing ovulation. Published 2016. Accessed October 14, 2020. https://bit.ly/2H2XXKL 19. Jungheim ES, Meyer MF, Broughton DE. Best practices for controlled ovarian stimulation in in vitro fertilization. Semin Reprod Med. 2015;33(2):77-82. 20. American Society for Reproductive Medicine. Fact sheet. Stress and infertility. Revised 2014. Accessed October 14, 2020. https://bit.ly/2Fy06Oi 21. Farley Ordovensky Staniec J, Webb NJ. Utilization of infertility services: how much does money matter? Health Serv Res. 2007;42(3 pt 1):971-989.

Coming in 2021: Practical Considerations for Implementation of Biosimilars in Oncology: The Pharmacist’s Role in Education BY DOUGLAS HACKNEYOS, PHARMD, BCOP Oncology Pharmacy Clinical Coordinator Department of Pharmacy UConn Health Farmington, Connecticut

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Specialty Pharmacy Continuum • November/December 2020

OPERATIONS & MANAGEMENT

Strength in numbers

Health System Coalition Seeks Bigger SP Reach Seven major health systems launched a new nonprofit coalition that will work to share specialty pharmacy best practices and advocate for their common interests. “We’ve seen there is a need for a platform that specifically addresses and is committed to the concerns of health systems’ specialty pharmacies,” said Tanya Menchi, the executive director of the new Health System Owned Specialty Pharmacy Alliance (HOSP). “That’s why they have come together.” Among HOSP members’ key concerns are providing patient choice of specialty pharmacy providers and accessing limited distribution and payor networks, according to Menchi. The viability and continuance of the 340B program is

medication adherence, reduce readmissions and lower overall healthcare costs,” Tom Scully, a general partner at Welsh, Carson, Anderson and Stowe, and the former Centers for Medicare & Medicaid Services administrator, said in a statement. “HOSP delivers a platform for the industry to firmly establish the integrated specialty model as the new industry standard.” Scully also noted that the organization was “long overdue” and “a great way to datashare ideas and expertise, discuss data based research on improved outcomes,

Pharmacy, Hartford HealthCare, Shields Health Solutions, UMass Memorial Health Care and WVU Medicine. Baystate Health is typical of the integrated health systems that make up the alliance’s eight-member core group. It serves some 800,000 patients across western New England; and, according to Gary Kerr, PharmD, MBA, the chief pharmacy officer, it treats over 30,000 patients per year through its specialty pharmacy platform. “We need more collective weight,” Kerr told Specialty Pharmacy Continuum. “We need more stories to tell. Internally, we all agree that the more outcomes we can track, report and publicize, the better off we’re going to be.”

The Skyrocketing Specialty Drug Spend In 2019, specialty drug expenditures

increased nearly 12% versus less than 1% growth for traditional pharmaceuticals. In 2020,

15% growth is expected. Source: IQVIA, Segal Consulting.

“obviously another big concern,” she told Specialty Pharmacy Continuum. The new advocacy group is taking off at a critical time for health-system specialty pharmacies, as the market for costly specialty medications continues to outpace that of traditional medicines. In 2019, for example, specialty drug expenditures increased nearly 12% versus less than 1% growth for traditional pharmaceuticals, according to Doug Long, the vice president of industry relations at IQVIA. For 2020, that number is estimated to climb even further: Segal Consulting estimated that by the end of this year, the cost trend for specialty drugs is projected to increase by 15% (bwnews.pr/3p2ba8f ). That growth, however, does not guarantee access. Indeed, patients often are forced to leave the health-system specialty pharmacy and join a preferred pharmacy to receive their medications, moving them away from the integrated patient care model offered by hospitals, according to HOSP. “Health system-owned specialty pharmacies are an important care integration strategy that helps to improve

‘We need more collective weight. We need more stories to tell. The more outcomes we can track, report and publicize, the better off we’re going to be.’ —Gary Kerr, PharmD, MBA and advocate” for the common interests of integrated specialty pharmacies.

Increased Advocacy and Focus Tim Affeldt, the vice president for Specialty/Infusion Pharmacy Operations at Fairview Health Services and a member of HOSP’s board of directors, stated that creating a trade association “dedicated to representing specialty pharmacies owned by health systems means HOSP members can focus on our unique issues and commitment to patients and their care team. This is why Fairview has been very interested in HOSP from the beginning.” Other members of the new coalition include Baystate Health, Berkshire Health Systems, CommonSpirit Specialty

Kerr cited a three-year retrospective cohort study by investigators from UMass Memorial Health Care and Shields Health Solutions, two other founding HOSP members, which suggested substantial potential savings in total medical expenditures (TME) among members of an accountable care organization (ACO) who used an integrated specialty pharmacy. The study, conducted at the UMass Memorial Medicare ACO, indicated TME savings of as much as $1,000 per month for integrated specialty pharmacy users compared with a control group of ACO patients who did not use the specialty pharmacy (JAMA Netw Open 2020;3[10]:e2018772). (Costs

were calculated on a per-member permonth basis.) That is the kind of evidence, Kerr noted, that “spreads the impact story” of integrated specialty pharmacy “beyond just capturing scripts and filling and processing the claims.”

‘Who Better Than Us?’ Like its HOSP partners, Baystate Health strives to promote the value of its specialty pharmacy services to patients with complex, rare and chronic medical conditions. “Here in Western Massachusetts, we service the ZIP codes within our immediate catchment area,” Kerr said. “Who better to service these patients than us?” Kerr questioned why some speccialty products have to be shipped “from Texas or Florida or even oth“fr parts of New England when we’re er p exceptionally well set up to service our excep patients.” He added: “We can do so much patie when we control all elements of the care model. It’s very difficult to give up control mode outside parties and rely on the airlines to ou and cconventional courier services to get product in here on a timely basis.” prod The Baystate Regional Cancer ProTh gram’s D’Amour Center for Cancer Care gram is a prime example, he said, of how shipment delays can affect patient care. shipm Patients “are scheduled on particular Patie days and at particular intervals,” Kerr noted. “Their diseases are closely moninoted tored. And to have to rely on another tored specialty pharmacy provider outside the speci state is introducing all kinds of variables that we control when we own the channel ourselves.” Kerr said Baystate had made inroads into limited drug distribution channels. “Once we jump through fiery hoops and swim flooded tunnels, we’re able to get into the network,” he said. Will an organization like HOSP help to expand entry into those networks? “That’s our core belief,” Kerr said. —Bruce Buckley The sources reported no relevant financial relationships.

More on Web: Are Health Systems Really the Best? Although health systems bring a lot to the table when it comes to delivering coordinated specialty pharmacy care, are they really the best in the marketplace? SPC checked in with industry experts and competing providers for their take on the HOSP alliance. To access, visit specialtypharmacycontinuum.com for an expanded version of this article.

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Specialty Pharmacy Continuum • November/December 2020

TECHNOLOGY

Pre– and post–COVID-19, Fairview Specialty Pharmacy’s Approach

Connecting in a Virtual Era

At Fairview Specialty l Pharmacy h in Andover, d Minn., lleaders are using texting and other technology to refine patient outreach, while at the same time ensuring that its own workplace interactions are evolving in a way that ensures safety and productivity. A Go-Slow Approach On the texting front, a gradual, handson approach enabled Fairview to make a successful switch from phone-based patient outreach to text-based patient communication. One of the first and most important steps they took in implementing the text service, detailed during a session at NASP 2020, was providing staff with the opportunity to use the system themselves. Doing so meant staff had a better idea of what the service entailed and could clearly communicate expectations to patients during a welcome call, said Mel Nelson, PharmD, CPHQ, the regional operations manager at Fairview Pharmacy Services. The training process also provided staff with an opportunity to give important feedback about any missing content, she added. After this step, Fairview continued its gradual rollout approach by limiting initial texts to refill reminders, Nelson said. That was a good way to “ease our way” into text-based communication and acclimatize both patients and staff to the new system, she noted. One month after that initial rollout in July 2019, Fairview began sending ad hoc text messages, ranging from notifications of holiday shipping schedules to status updates on prior authorizations. That was followed, in November 2019, by the implementation of one-click reordering functionality and, this summer, with two-way chats that are started through a link in the text message. Today, the pharmacy’s text-based system includes 53 “patient journeys,”

ranging from the onboarding process to refill reminder processing and notifications of order delays, all of which begin with a text, according to Amanda Robinson, BBA, the access services manager at Fairview Specialty Pharmacy. The system they use (Relay Network; www.relaynetwork.com) is versatile, but Robinson cautioned that with greater complexity, “you tend to lose a little bit of that patient engagement.” Instead, she urged attendees to “start out simple and get feedback from both [call center] agents and patients, and then expand on that.” One tip that Nelson shared was to stagger outbound messages, thus avoiding floods of calls. She learned that lesson after her team sent out a simultaneous text to 8,000 Fairview patients reminding them of the pharmacy’s holiday shipping schedule, leading to a wave of responding phone calls. “Prepare your call center team and make sure [staff ] can be pulled away and you can have all hands on deck to answer calls shortly after they go out,” she advised. At the time of the presentation, Fairview Specialty Pharmacy had sent approximately 72,000 messages, but had not yet reduced the number of call center staff, as Nelson noted. While that may not sound encouraging, she noted that “we’ve shifted the work from doing phone calls to doing something with the information we’re getting [through the new system]. So, it’s helping us connect better with our patients,” Nelson said. That can mean

connecting patients late to fill with a clinician if they are la their prebecause they have not seen th scriber, for example, she noted. familiarity with A greater degree of familiar their patients has translated tto a high level of patient satisfaction at Fairview Specialty Pharmacy, with a recent internally conducted survey showing that most patients who use the system would strongly recommend it to their family and friends, Nelson added. Most importantly, pharmacies that take the kind of gradual and well-considered approach that Fairview has taken are more likely to have patients click their messages and ultimately fill their prescriptions on time. Indeed, as the text system has become more familiar to Fairview patients, the number of late fills has been “trending downward among those who click their messages,” Nelson said. “If we can get our patients to utilize that technology, that’s where we can really drive strong adherence.”

Perfect Mix of In-Person And Virtual Patient outreach isn’t the only challenge when optimizing virtual communication technologies. During a pandemic, the workplace itself has to be viewed as a constantly evolving environment. The optimal solution is a hybrid approach, with benefits accruing from working from home as well as holding virtual meetings, Nelson noted. “We’ve always struggled with the capacity of our call center, with only having a certain number of cubes, and now [remote work] allows us to send certain folks home, so even post-COVID, this could be a potential benefit for us if we can continue to have folks working at home,” she said. At Prime Therapeutics, based in the Greater Minneapolis-St. Paul area, one positive and unanticipated consequence of shifting to remote work has been an increase in productivity, said Kyle Skiermont, PharmD, the company’s senior vice president of specialty and home delivery. “Similarly, we thought a lot of employees would become ill [with COVID-19

and be absent from work], but in a lot of areas we’ve seen an increase in presenteeism,” he added. Although the company will not remain fully remote once the pandemic abates, Skiermont said there will be lasting changes in how they meet with stakeholders. “Some of this remote work has shown that we can have some successful discussion and you can move things forward successfully, and some of the inperson things will be saved for bigger projects,” he said, urging others to ask for feedback and find out what could be improved as they implement virtual and remote work protocols. “Make sure there’s a lot of a dialogue internally and with external stakeholders about what’s working.” Pfizer also is exploring the optimal combination of in-person and virtual meetings, said Lou Dallago, the company’s vice president of channel management. “Virtual is really good for fast decisions, for tactics, for things that are hot,” he said. “But from a strategy perspective, really getting in front of folks and having a chance to discuss things, talk things out [requires in-person meetings]. We’re trying to figure out as we move back to what we would hope would be a normal process, what the right mix is.”

Lesson Learned Whatever that mix ultimately looks like, the rapid shift from in-office to remote work and to virtual client and customer visits during the pandemic has taught Dallago an important lesson: The company can adapt well under exceptional circumstances. “We realized that we quickly needed to put tools in place to meet the customer where they were, whether that’s text messaging or email or website production,” he said. “Flexibility and speed brought some of those tools to the forefront to make sure we had the proper engagement with our stakeholders.” —David Wild The sources reported no relevant financial relationships.

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Specialty Pharmacy Continuum • November/December 2020

TECHNOLOGY

Data One Key to a Successful Specialty Launch H

ospitals and health systems are building and expanding their own specialty pharmacies, and with good reason, according to several veterans of specialty rollouts. Today, more than 75% of hospitals with at least 600 beds operate a specialty pharmacy, allowing them to directly prescribe patients critical medications for various chronic and often lifethreatening diseases such as multiple sclerosis, chronic hepatitis C and many cancers, according to data cited in Drug Channels (bit.ly/2GqhLbb). An in-house specialty pharmacy provides many financial and clinical advantages over external specialty pharmacies for both patients and providers, noted Stephen Davis, PharmD, the director of health system strategy for Shields Health Solutions, in Stoughton, Mass. Simply put, Davis said, “you need to have access to the drug if you want to take care of the patient.” Davis also acknowledged the significant roadblocks, and time and effort needed, to successfully launch a specialty pharmacy—especially in the face of the market’s evolving vertical

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integration. “A lot of this is going on within the specialty pharmacy marketplace,” said Davis, noting a number of consolidations, mergers and acquisitions among payors and pharmacy benefit managers (PBMs), which manage the prescription drug benefits on behalf of Medicare Part D drug plans, large employers and other payors. Breaking in can be difficult. But he and other experts shared strategies for overcoming the obstacles and obtaining commercial payor access and accessing limited distribution drugs.

Accessing Access Hospitals are uniquely positioned to provide the optimal care patients need with the addition of an in-house specialty pharmacy. Filling a prescription before a patient leaves the hospital is not only convenient, noted Davis, but it is also likely to improve health outcomes. “You’re having a pharmacist talk with you who knows you as well as anyone,” he said. “You have a hospital that knows you and knows the care you need.” In some cases, a patient who is prescribed a specialty medication may not need it due to conflicting lab values, intolerance, toxicity or nonadherence. Or they may have developed a health condition or started a new medication that contraindicates the drug—something a health system’s electronic health record (EHR), providers and pharmacists could catch in real time. “An outside specialty pharmacy wouldn’t know if the patient missed their scheduled appointment with their provider, or that they were currently admitted to the hospital or at home sick,” said Davis, noting that the pharmacy may still mail the prescription. “That’s one of the extra benefits of having a specialty pharmacy in the hospital.” Among the benefits of such engagements and touch points, he noted, is help with medication adherence (Pharmacy [Basel] 2019;7[4]:163). Insurance companies often will dictate that a prescription must go to an outside specialty pharmacy. So, a hospital-owned specialty pharmacy needs to be included in a PBM or payoraligned specialty pharmacy network to dispense prescriptions to patients who want to use their specialty pharmacy services. Securing that access requires demonstrating an ability to outperform external specialty pharmacies clinically and financially. Data analytics are critical. Meghan Swarthout, PharmD, MBA, the division director of ambulatory and care transitions pharmacy at the Johns Hopkins Health System, in Baltimore, encouraged a focus on outcomes collection,

measurement, analysis and reporting. “The data is in your EHR, and you need to be strategic,” she said. “Look at clinical outcomes and incorporate patientreported outcomes, including things like missed days at work or loss of productivity, as well as economic outcomes. “Don’t just present to payors a minimum amount of data requested,” Swarthout added. “Be proactive and anticipate their needs.” For example, payors are looking for the lowest-cost site of care for administering medications, especially infusion and injectable products. Do these administrations need to be done in a hospital clinic? Often it is less expensive and more convenient to administer medications in a patient’s home. “If we can’t control everything about drug cost, think about where else to look to save dollars,” she said. “A lot of this is about partnering with payors and not looking at payors as competition. Finding connections at the regional and local level is your best bet.”

Finding Success A viable specialty pharmacy needs access to limited distribution drugs, or medications that the manufacturer designates to a restricted number of pharmacies. Jacob Jolly, the director of strategy and market access at Vanderbilt University Medical Center, in Nashville, Tenn., shared strategies for obtaining that access. Again, it’s about showing value. “Consider your capabilities early on,” Jolly said. “They should be sufficient not only to deliver the value that your prospective partners expect but also provide you with the ability to demonstrate and communicate said value.” He noted that his pharmacy has developed a unique outcomes and

research program to optimize the care model and assess its impact. Each clinical area serviced at Vanderbilt’s integrated specialty pharmacy has at least one dedicated clinical pharmacist and one certified pharmacy technician, most of whom are embedded physically into the clinic. By implementing the integrated specialty pharmacy model, Vanderbilt has been able to reduce the time it took for patients to start therapy from 24.5 to three days (J Drug Assess 2019;8[suppl 1]:29). The program was awarded the ASHP Best Practices Award at the 2019 Midyear Clinical Meeting, in Las Vegas.

Pharmacists Help Design The Specialty Component At Johns Hopkins, the clinical pharmacists are also involved in the design and development of the specialty pharmacy medication regimen before the prescription is written. In the case of a patient with cystic fibrosis requiring inhaled antibiotics, for example, the pharmacist in the clinic will work proactively with the prescriber and patient to recommend an appropriate antibiotic with preferred coverage based on the patient’s insurance. The pharmacist will also provide patient education during the visit, and attempt to get the patient started on therapy that day. “We started upstream,” Swarthout said. “We thought about the clinical appropriateness and safety, financial considerations, quality of life, which all helps in terms of medication selection and the efficiency and coordination of care downstream.” —Lynne Peeples The sources reported no relevant financial relationships.

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Specialty Pharmacy Continuum • November/December 2020

OPINION

Health IT and Medication Management Reform Katherine Capps and Molly Ekstrand, BPharm, BCACP, AE-C

Pharmacists well understand that medication is part of the daily lives of many Americans. In fact, studies show nearly 75% of visits to physician offices and hospital outpatient clinics involve medication therapy, and almost 30% of adults take five or more medications. Unfortunately, suboptimal medication use leads to at least 275,000 deaths annually and costs more than $528 billion. Recently, our organization, The Get the Medications Right (GTMRx) Institute, in Tysons Corner, Va., released a report outlining steps for medication management reform, including a call for comprehensive medication management, or CMM. This comprehensive management is an evidence-based process of care that personalizes the approach, resulting in better care, reduced costs, and improved patient satisfaction and provider work life. The report, the GTMRx Blueprint

practice management systems developed around CMM workflows and thought processes, driving consistency of the CMM service. Within each of these categories, organizations will undergo a journey toward maturity. However, considerations in each of these categories are foundational.

Clinical Decision Support Tools (at the point of care): Access to diagnostic results, clinical notes, patient

clinical goals for each therapy. Organization and interpretation of these data in a medication-centric workflow can improve the efficiency and efficacy of clinical decision making. A medicationrelated dashboard should have the ability to support anyone on the care team, allowing them to make simple, streamlined decisions about a patient’s medication therapy. This dashboard should include objective data that help clinicians decide whether a patient needs a higher level statin, the blood pressure medicine should be increased, or pharmacogenomic data are needed to assess the safety or efficacy of the medications.

Population Health and Risk Stratification Tools: Health care resources are finite. There are certain patient populations that benefit more

the administrative burden from the point-of-care clinician.

Patient Engagement and Care Coordination Tools: Health IT should enable and facilitate the exchange of information between the patient and care team. Patients gather information in various forms that can inform clinical decisions regarding medication therapy. The tools should have the ability to integrate the digital therapeutic health information from a patient with the pharmacogenomic data that clinicians currently receive as a separate, cumbersome report. These types of information would come together in an EHR in a usable fashion. Health IT can facilitate bidirectional communication between the pharmacist, clinician and patient. Clinicians should have the ability to effectively and efficiently communicate across the continuum of care. In many cases, the patient’s care team, including the pharmacist providing comprehensive medication management, is not colocated and does not share a single EHR platform. It’s imperative that health IT has the ability to enable bidirectional, secure healthrelated data exchange to promote optimal medication use.

for Change, includes recommendations outlining how each stakeholder can get involved to improve patient care—from physicians to clinical pharmacists, health plan sponsors, providers, consumer groups, employers as health plan sponsors, and policymakers. Many things need to change, but information technology (IT) capabilities are central in the challenge for reform. Here, we outline four health IT categories to achieve medication optimization through CMM, enabling broad adoption of a systematic approach to medication use throughout the continuum of care. Software supports the

status and other clinical information allows care teams to fulfill important activities in the CMM process. This information offers insight into patients experiencing medication therapy problems, and it helps the clinicians determine whether or not the patient has achieved the clinical goals of therapy. Having the ability to evaluate actual use patterns of all medications (e.g., over the counter, supplements, prescribed drugs and biologics) also is important. This full view of information is essential for the medication expert to properly assess each medication for appropriateness, focusing on the achievement of the

from CMM services. Tools that integrate data from electronic health records (EHRs), pharmacies, health plans and other reliable sources can provide the foundation for deployment of comprehensive risk models. Risk modeling tools allow payor, provider or value-based networks to easily identify the patients who are at risk and will benefit most from CMM services. Health systems, pharmacies, payors and prescribers should also have the ability to proactively reach out and invite at-risk patients to participate in CMM services, effectively automating a process and significantly decreasing

Health IT Supporting Economic, Clinical and Humanistic Outcomes: Purpose-built software can drive consistency and demonstrate the value of CMM practice. Software ensures the capture of compliance and regulatory reporting requirements unique to CMM services. The tools should allow the team to identify medication therapy problems in a systematic way, with the ability to gather and analyze information across systems and care settings. The tools also should have the ability to track participation, offer point-of-care insight to the clinician, and, in order to efficiently identify medication therapy problems, record the defined medication care plan and steps toward resolution. CMM services can be correlated with broader changes in health status or health care utilization patterns, thus demonstrating contribution and value to the health care system. However, optimizing medication use through CMM in practice truly and wholly relies on having the right data, at the right time, at the point of care and available to the entire team.

Capps is the co-founder and executive director of the GTMRx Institute, a catalyst for change that brings critical stakeholders together, bound by the urgent need to get the medications right. Ekstrand is a distinguished fellow at GTMRx.

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