Specialty Pharmacy Continuum (March/April 2020) by McMahon Group

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Serving managed care, health-system and specialty decision makers Volume 9 • Number 2 • March/April 2020 • specialtypharmacycontinuum.com

TECHNOLOGY Novel e-tools for managing opioid use disorder ..........

Paving the Way for The Patient’s Journey

CLINICAL

COVID-19:

90-Day Refills May Strain Supply Chain

Strategies to rein in the high cost of hemophilia ............................

New therapies bring down pancreatic cancer spending ................

A PBM’s approach to managing HIV patients ................................... 8

OPERATIONS & MGMT New rules urge more surface wipe sampling for hazardous drugs ..............

POLICY

The slow embrace of biosimilars hampers savings .............

cross the country, pharmacies have been seeing a significant uptick in patients seeking to extend 30-day prescriptions to 90 days to ensure access to their medications amid the growing COVID-19 crisis. While stakeholders say they have been able to meet these requests, several indicate that it’s only a matter of time before the supply chain buckles under these new pressures. “If we have everyone going out trying to get a six-month supply of medicine, that can strain the system,” said Nicolette Louissaint, PhD, the executive director of Healthcare Ready, based in Washington. Continued on page 20

he “pa he pati tien ien entt jo jour jour urne neyy.” L ne Lo ook k at th the he ag a en end da for anyy spe da p ci cial alty lty ty pharmacy h meeting i and d yo ou’re almost l certain to see this phrase in thee title of at least one session. But what does it actually mean, and how does it affect clin nical and financial outcomes? Rebekah Anguiano, PharmD D, a clinical assistant professor of phaarmacy at the University of Illinoiis (UI) at Chicago, suggests thatt the best way to frame the patientt journey is as a series of barrierss or roadblocks along that path. “In our surveys of patients and providers, many of the roaadblocks that we have found—and this should come as no surprise—[invvolve] the insurance process, includin ng prior authorization, appeals for deniaals, copay and coinsurance burdens, and qualification q for financial assistance,” Dr. Angguiano said.

CF Patients’ Risk For Ototoxicity Underreported Las Vegas—The complex needs of patients with cystic fibrosis (CF) who are managed by specialty pharmacies just got a bit more complicated by a new study showing that these patients have a much higher risk for developing aminoglycoside-induced ototoxicity than previously thought. The researchers are urging centers to monitor patients with CF more closely for aminoglycoside-induced ototoxicity after finding high rates of the complication at their institution. After implementing a pharmacistrecommended monitoring protocol,

Co t ued on Continued o page 21

Continued on page 14

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Specialty Pharmacy Continuum • March/April 2020

TECHNOLOGY

Tech Tools for Managing Addiction Disorders Alexandria, Va.—With technology transforming industries in the United States, it’s time to apply high-tech solutions to opioid use disorder management, speakers said at the 2020 Opioid Management Summit. Addiction is heavily stigmatized, and the use of evidence-based best practices in addiction treatment programs can vary widely, said Samantha Arsenault, the vice president of national treatment quality initiatives for Shatterproof, a national nonprofit focused on reversing addiction. Her company is building a free, webbased quality measurement platform called Atlas through which patients and family members will be able to compare facilities in their area and search by criteria, such as insurance carrier. The technology also could be used by providers and facilities for quality-improvement purposes. The organization has collected claims data from 1,200 facilities in six states and is analyzing the data and working to launch the website by July. Finding quality treatment for opioid use disorder can be difficult, agreed Raj Gupta, the CEO of FLT Medical. There are some resources such as findtreatment.gov (a website from the Substance Abuse and Mental Health Services Administration) and hotlines, he said, but the solutions offered may not always equate to what patients need. “Typically, when you search for treatment, someone

gives you a list of resources and phone numbers, which puts onus on the person to find out what is relevant to them,” Mr. Gupta said. ”For people suffering from a disease, that’s unacceptable.” Some spaces in health care have found a universal solution, he noted. For heart attack, he said, everyone knows to call 911 and an ambulance will bring you to the closest emergency room for treatment. There’s never a question of who will treat you or whether they’re qualified. Mr. Gupta’s group is working with health systems, health plans and some counties to help providers and patients find treatment on demand, including which professionals or programs have current capacity to accept a particular patient. “It’s not enough to have a hotline and hopefully you find therapy,” he said. “It has to be the first time you reach out, you find a quality provider for evidence-based treatment.” The best evidence-based therapy for addiction—paying people money to remain abstinent—is not used, said David R. Gastfriend, MD, an addiction psychiatrist and a co-founder and the chief medical officer of DynamiCare Health. Based on the principles of contingency management, which

‘It’s not enough to have a hotline and hopefully you find therapy. It has to be the first time you reach out, you find a quality provider for evidence-based treatment.’ —Raj Gupta offers money to patients who would like to stop their substance use, his company offers a novel platform for individuals that reinforces their recovery from addiction and rewards healthy behaviors. Patients who enroll in the mobile app receive text messages with reminders and directions about their counseling or Alcoholics Anonymous appointments, as well as pocket-sized devices for random breath and saliva tests they self-administer via video selfie and

EDITORIAL BOARD

submit through an app. Program officers monitor patients’ attendance at treatment appointments by checking the phone GPS and provide them with a recovery coach for help. Participants receive monetary rewards for completing tasks. —Karen Blum The sources reported no relevant ﬁnancial relationships other than their stated employment.

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Specialty Pharmacy Continuum • March/April 2020

CLINICAL

Managing the High Cost of Hemophilia Treatment Miami—Hemophilia is an expensive and complex condition, but there are opportunities for payors to limit their spend by collaborating with federally supported hemophilia treatment nt centers (HTCs) and their pharmacy programs. “The gold standard of care is having a person with hemophilia go to an HTC to get their clinical care,” said Jeff Blake, the senior vice president for payor relations with the Hemophilia Alliance, during a presentation at CBI’s Specialty Therapies and Biosimilars Congress. “If that HTC has a pharmacy program, payors should allow [that] program to dispense clotting factors and other hemophilia products to their patients.” The 138 HTCs across the United States have hematologists, nurses, pharmacists, social workers, physical therapists and other professionals available for integrated comprehensive medical and pharmacy care that may include home visits, bleed management, infusion and injection training, and prescription management. HTC pharmacies are covered under the federal 340B drug discount program, and have either internal pharmacies or contracted pharmacy relationships. The Hemophilia Alliance and HTCs are working with some payors on data reporting that highlights the value of the HTC model of care, Mr. Blake said. This effort includes sharing data about how they are managing patients with bleeding episodes, capturing infusion logs and providing education to emergency departments if patients require emergency care, in addition to working together to reduce ER usage. Mr. Blake shared some case studies about how the HTCs saved money for payors. In one instance, switching just two members of a health plan from receiving clotting factors from a national commercial specialty pharmacy to an HTC pharmacy resulted in a savings of more than $1.8 million.

Future Collaborations The Hemophilia Alliance is looking into potential future collaborations with payors, too, Mr. Blake said. One is in disease management, developing a model

to pay HTCs for the integrated comprehensive care coordination that currently is not reimbursed by payors. Another is possible outcomes-based contracting for future gene therapies. One investigational gene therapy product, valoctocogene roxaparvovec (BioMarin), has been submitted to the FDA for approval, which could come later this year. In three-year follow-up results from an ongoing phase 1/2 study of patients with hemophilia A, the treatment significantly reduced annual bleeding rates and increased factor VIII activity levels, according to data presented at the 2019 Congress of the International Society on Thrombosis and Haemostasis, in Melbourne. Valoctocogene roxaparvovec is a onedose administration that is projected to cost as much as $3 million per treatment (bit.ly/386W1c1). Given that high cost, “there needs to be some type of outcomes-based reimbursement between the payor, the dispensing pharmacy and the manufacturer,” Mr. Blake said. Some health plans already have taken steps to control costs in hemophilia care, including working with HTCs. Health Alliance Plan, in Detroit, has looked at the costs of different clotting factors at specialty pharmacies and larger HTCs servicing its members, asking for comparable rates, said Vanita Pindolia, PharmD, the vice president for ambulatory clinical pharmacy programs for Henry Ford Health System/ Health Alliance Plan. Tighter drug assay management has been another key to controlling cost, Dr. Pindolia said in a telephone interview. Vials of clotting factors are bloodderived, and the number of units they contain can vary, she said. If a patient needs 30,000 units, that’s not exactly in one vial, so they might receive 29,900 units one time and 30,300 units the next time. Giving factors within 10% of the prescribed dose is accepted in the industry and is safe, but can drive up

Switching just 2 members of a health plan from receiving clotting factors from a national commercial specialty pharmacy to an HTC pharmacy resulted in

>$1.8 million savings

costs, she noted. Dr. Pindolia said her plan is asking factor providers to target use plus or minus 5%, and when possible, within 1% of the prescribed dose. “If If you’re always giving at plus 10%, that’s a lot of money going out the door that you can prevent,” she said. Additionally, she and her colleagues are managing use of long-acting life factors. The concern with the cost of factors with longer half-lives occurs when the frequency of dosing increases or the prescribed dose continues to creep up. However, in the right patients these can be cost effective. One extended-life hemophilia drug is more cost-effective than other extended–half-life products due to the ability to supply a nearexact prescribed dose at certain patient weight levels. In some patients, this can save $30,000 to $50,000 per month.

Highmark Targets Fraud Highmark, a Pittsburgh-based insurer, took its own initiative to reduce the approximately $80 million it has spent annually on care for 190 members diagnosed with hemophilia. Over the past year, the company identified and

stoppe ped multiple cases of fraud, waste o or abuse associated with prescript iption drugs used to treat hemo mophilia, including problems with overutilization and automatic ship hipping, said Ned Finn, BSPharm, the payor’s director of specialty pharmacy. As of January 2020, plan members receive their hemophilia drugs exclusively from three providers, including an HTC in western Pennsylvania, identified by Highmark as having exceptional knowledge of hemophilia and with access to all medications in the space. “It’s really critical to select providers that you’re very confident are managing these patients appropriately, helping them reduce emergency room visits and helping them manage their prophylaxis and acute needs,” Mr. Finn said by telephone. “By partnering with these organizations, we are able to obtain hemophilia drugs for our members at a competitive rate while establishing new performance guarantees and oversight protocols for providers.” —Karen Blum The sources reported no relevant ﬁnancial relationships.

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Specialty Pharmacy Continuum • March/April 2020

CLINICAL

Pancreatic Rx Cost Falls With New Therapies San Francisco—Even as drug costs skyrocketed over the past decade, the total cost of treating pancreatic cancer, adjusted for inflation, actually has declined. For every additional $1 spent on drugs for pancreatic cancer, nondrug spending fell by $9, according to findings of a new study. The analysis, conducted by researchers at Virginia Mason Medical Center and the Center for Medicine in the Public Interest (CMPI), showed that average

Program at the Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center, in Seattle, said the findings, although preliminary, “suggest that

co-investigator Robert Goldberg, PhD, a co-founder and vice president of CMPI. He said many previous analyses are skewed by the fact that a small percentage of patients generate most of the cost. In the current study, the researchers attempted to capture statistically significant changes in spending and identify factors associated with such shifts, adjusting for inflation. The study used patient-level data from the Medical Expenditure Pan-

For every additional

A Pharmacist’s Comment

spent on drugs for pancreatic cancer, nondrug spending decreased by

‘In an era when everyone is concerned ed about the price of new cancer drugs,, no one ever asks what the value is, and lots of time value is not measured ed appropriately.’ —Robert Goldberg, PhD inflation-adjusted, per-patient spending on pancreatic cancer care decreased from $37,000 in 2009 to $10,000 in 2016, while prescription drug spending increased from $2,400 to $5,300 per person. These trends are consistent with several other studies that have examined the effect of new medicines on the total cost of care. The decline is directly related to fewer hospitalizations and emergency department visits, according to the investigators, who presented the findings at the 2020 GI Cancers Symposium (abstract 773). Lead author Vincent J. Picozzi, MD, the director of the Pancreaticobilliary

The researchers plan to determine how current medications are keeping costs down. Future studies could factor in novel oral anticancer agents, which will be less expensive to administer. The sponsor of this study, Tyme, Inc, has an experimental oral modified dysfunctional tyrosine derivative (SM88) in clinical trials for the treatment of advanced pancreatic cancer. “The development of more effective, better tolerated therapies for pancreatic cancer could lead to further decreases in the total cost of care,” Dr. Picozzi said, “and will also address the urgent patient need for additional treatment options.”

the therapeutic benefit of increasing the use of prescription drugs is so great that it is driving a decrease in the actual cost of health care.” He noted that the study period corresponds to the introduction of more effective, multiagent chemotherapies for pancreatic cancer, including albumin-bound (nab)-paclitaxel (Abraxane, Celgene).

Cost in Context “In an era when everyone is concerned about the price of new cancer drugs, no one ever asks what the value is, and lots of time value is not measured appropriately,” said study

el Survey for 1996-2017, to assess the effect of new medicines on total cost of care, including l d nontherapeutic h medid cal expenditures. The sample consisted of 80 adults with pancreatic cancer whose prescription data were available. Averages were computed for the total care costs, including prescription medicine costs for the 2009-2016 period. All expenditures were adjusted for inflation using 2012 U.S. dollars. The total cost of care for the patients reached maximums of $280,443 and $312,077 for the first and second year of care, respectively. In addition, between 1997 and 2016, inflation-adjusted firstand second-year nonmedication charges for pancreatic cancer averaged about $67,000 and $105,309, respectively. Related lost workdays or school absences declined between 2007 and 2017.

“Studies like this reiterate the importance of using real-world real-w data to improve our understanding o of the overall value of new medicationss used in the treatment of cancer,”” commented Cindy L. O’Bryant, P PharmD, a professor in the Dep partment of Clinical Pharmacyy at the University of Coloraado Skaggs School of Pharmacy and Pharmaceutical Sciences, in Aurora. “Drug pricing is offten a primary focus in the rising health care ccost discussion but is only o one part of the total cost of care.” Dr. O’Bryant noted that “advancements iin supportive care medications, such h as antiemetics and white blood cell ggrowth factors, likely also contributed to the lower cost of care for pancreeatic cancer” during the study. “The u use of more effective supportive care aagents could correlate with a reduction n in supportive care costs and treatm ment utilization as a result of fewer adveerse events,” she said. One flaw of the study Dr. O’Bryant pointed out, was itts small number of patients. In addition, dd she noted that patients were excluded if they died before the first round of data collection in the second year. “The majority of pancreatic cancer patients have metastatic disease and an average survival of approximately 1 year from the time of diagnosis. By not including these individuals,” she said, “it is difficult to elucidate the actual total cost of pancreatic cancer care.” —Caroline Helwick The study was funded by Tyme, Inc. Dr. Picozzi reported ﬁnancial relationships with AbbVie, Aduro Biotech, Amgen, Celgene, Cornerstone Pharmaceuticals, FibroGen, Gilead, Halozyme, Immunomedics, Johnson & Johnson and OncoMed. Dr. Goldberg reported a ﬁnancial relationship with Celularity.

Specialty Pharmacy Continuum • March/April 2020

CLINICAL

SP Pharms Excel at Achieving High SVR12 Rates

Clinicians can n use the Merck Adherence Estimator (bit.ly/32n0czi) to assess a patient’s risk for not complying with HCV therapy.

Las Vegas—Health-system–based specialty pharmacies can ensure that patients with hepatitis C virus (HCV) adhere to costly treatments, according to a new study. Researchers at UMass Memorial’s specialty pharmacy examined data from more than 140 patients with HCV treated with ledipasvir-sofosbuvir (Harvoni, Gilead) at their institution and found an average 98% adherence rate and a

“These types of risks are especially heightened at nonprofit health systems where there may not be a lot of capital or staff to invest in a new venture,” she said. Shields’ turnaround time can be as short as nine months before a pharmacy becomes operational, Dr. Donovan noted. Autumn Zuckerman, PharmD, the program director for health outcomes and research at Vanderbilt University Medical Center Specialty Pharmacy Services, in Nashville, Tenn., said her institution developed its own specialty pharmacy, but she agreed that not all health systems are in a position to do the same. “Starting a specialty pharmacy is a cumbersome and lengthy process that involves the development of multiple standard operating procedures, cold chain process protocols and reporting procedures,” Dr. Zuckerman said. “Consulting groups may bring the knowledge and experience of developing these tools and the specialty pharmacy practice model to help jump-start a new program.”

financial assistance for patients, if they are eligible. Specialty pharmacists perform the usual tasks of a specialty pharmacy and also telephone patients with HCV prior to treatment and then three to four times during the course of therapy depending on their risk for nonadherence. They evaluated nonadherence risk using the Merck Adherence Estimator (bit.ly/32n0czi), which asks patients to rate their confidence in the efficacy of the medication, their concern about its safety, and any financial burdens. During phone calls, pharmacists counsel patients and monitor adverse events, assess symptom control and adherence, evaluate therapy appropriateness, review any related laboratory tests, and address questions patients may have. “All recommendations and interventions can be communicated to providers in real time through the electronic medical record,” the authors said. To assess the care model’s impact, the investigators retrospectively analyzed data from 200 patients who filled a ledipasvir-sofosbuvir prescription at the medical center’s specialty pharmacy in 2017. There were 58 patients who were excluded from the final analysis because they received their medication from an external specialty pharmacy, could not be reached, were not under the care of a UMass provider, were pregnant, or were in prison. Dr. Donovan and her colleagues found that 60% (86/142) of the remaining patients returned for blood tests 12 to 36 weeks after treatment completion. Of this group, the mean proportion of days covered—a surrogate marker of adherence—was 98%, with a range of 79% to 100%. Additionally, 95.3% (82/86) achieved SVR12, the investigators found. Previous research using a

—D.W.

see SVR12 RATES, page 11

95% sustained virologic response rate 12 weeks after treatment completion (SVR12). They presented their findings at the ASHP 2019 Midyear Clinical Meeting (poster 4-011). “Our work shows the value of the

health-system specialty pharmacy model, with its high level of patient care and support,” said study co-investigator Jennifer Donovan, PharmD, the director of quality and patient outcomes at Shields Health Solutions, which manages the UMass Memorial specialty pharmacy, in Worcester. In the care model, pharmacy liaisons help providers understand patient benefits, support prior authorizations and seek

Outsourcing the Specialty Pharmacy Build

hile some health systems choose to create their own specialty pharmacies, in 2012, UMass Memorial Medical Center decided to partner with Shields Health Solutions to build and manage their hospital-owned specialty pharmacy. One reason the institution did so is the stricter regulation that specialty pharmacies face and the expertise required in medications, finance, care delivery, technology, data science, government programs, law, insurance, pharmacy benefit managers and other areas, according to Jennifer Donovan, PharmD, the director of quality and patient outcomes at Shields Health Solutions, in Worcester. “It’s very difficult for any organization to gather all of the specialty pharmacy experience it needs to be successful, so a partner that can offer all of that makes sense,” Dr. Donovan said. The partnership also minimized the financial, operational, organizational and clinical risks that UMass took on during the startup phase.

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Specialty Pharmacy Continuum • March/April 2020

CLINICAL

An Integrated PBM Approach to Managing HIV Andrea Straszewski, PharmD Director of Pharmacy

Angela Riley, MD Medical Director

Vinay Bhargava, MBA, PharmD Chief Pharmacy Officer UNITE HERE HEALTH Aurora, Illinois

mployer-sponsored health plans traditionally have partnered with pharmacy benefit managers (PBMs) to help manage their increasing pharmacy spending. Yet, as pharmacy costs have continued to increase, PBMs have continued to be virtually unregulated, leading to questions about how they function and generate revenue. The lack of drug price transparency, contracting strategies, and unpaid rebates has added to high drug costs, especially in the specialty sector.1 In addition, consolidation of the PBM market has further reduced competition and given a handful of large PBMs enhanced leveraging and negotiating power, further limiting customized services for the employer market. Employers want to manage pharmacy spending, but they also want to provide their member employees with a holistic approach to customized care and services. This has resulted in some employers ending their relationships with PBMs to help drive the development of alternatives to the traditional PBM model, some by creating their own in-house PBMs.

Launch of PBM Hospitality Rx (HRX) is an integrated PBM, developed to support UNITE HERE HEALTH, a Taft-Hartley selffunded health plan serving 230,000 members in the hospitality industry and their dependents. Innovation and integration with the medical side of the health plan were the key strategic pillars UNITE HERE HEALTH sought when it launched the PBM in 2015. (Its pharmacy spending had been managed by one of the larger PBMs in the industry.) HRX manages its own formulary; performs all prior authorizations (PAs); manages its pharmacy network, rebate management, and customer service; and leads UNITE HERE HEALTH’s internal pharmacy and therapeutics (P&T) committee. Although certain commodity services, such as claims processing and specialty pharmacy, have been delegated to vendors, HRX maintains overall management of all services, both in-house and delegated services. As a nonprofit provider of pharmacy benefits and services, HRX strives for lower cost and higher quality than is otherwise available in the industry, by eliminating profit-generating processes and conflicts of interest.

Figure. Program metric results. Source: UNITE HERE HEALTH.

Our unique integrated PBM model has allowed us to focus on the development of specific innovative clinical programs, facilitated by enhanced transparency of all pharmacy data through HRX. In addition, integration with the data from the medical side of our plan has allowed for better insight into all aspects of health utilization of our membership.

Targeted HIV Drugs Significantly Contribute to Spending After success with our first clinical program for chronic opioid use, HIV was selected as a condition that could best benefit from the hands-on customized integrated approach. The cost of HIV medications—the most commonly prescribed drug class in our specialty medications sector, and the second highest in total pharmacy spending—continued to rise year over year, and we did not have accurate information about how effectively members were being treated. Channel management was a challenge, with 78% of HIV medications being filled at retail pharmacies, where there were often inconsistencies in clinical management. The lack of transparency about viral loads and medication compliance, the most essential factors for monitoring

treatment success, did not allow HRX to assess treatment successes and failures. Research modeling on the effects of viral suppression among people living with HIV shows that it is the single most important strategy to reduce new infections and end the HIV epidemic in the United States.2 The key initiative was to develop an HIV program that aligned with the national initiative to end the HIV epidemic. Since the HIV care continuum in the United States was first described, stakeholders at the federal, state, and local levels have sought to identify and address gaps at each step of the continuum.3 These steps include HIV diagnosis, linkage to medical care, retention, prescription of antiretroviral therapy (ART), and viral suppression.4,5 Our mission, through an integrated PBM, was to develop an HIV program consisting of internal and external stakeholders that would provide quality care to our patients with HIV, providing access to medications; consolidating to the specialty channel for enhanced and consistent clinical management; monitoring laboratory values, specifically with collection of viral levels; and ensuring that members with a diagnosis of HIV were

taking ART. The ultimate goal was to help meet the “undetectable = untransmittable” goal of the Ending the HIV Epidemic: A Plan for America initiative.6 It is critical to have the right medication available at the right time for the right patient with HIV.7 Although some payors are limiting HIV therapies on their formularies to manage cost, our approach was to include all medications with no restrictions and implement a more collaborative PA approach with physicians to help drive appropriate treatment regimens. Therefore, the HRX formulary decision approved by the internal P&T committee was to not exclude any medications to treat HIV. Before 2019, HRX members with HIV were able to fill their medications at either retail or specialty pharmacies. Beginning January 1, 2019, HIV was designated as a specialty condition. Our new specialty provider had a center of excellence dedicated to managing HIV patients with individualized therapy management and clinical support focused on monthly engagement with members. Areas of focus for member engagement included disease education, appropriate dosing and administration of medication regimens, adherence support, and emotional well-being surveys. Efforts to transition to the new specialty provider used a multidisciplinary team approach that involved the specialty pharmacy provider, HRX team, and health navigators working collaboratively to educate members who were not familiar with filling their HIV medications through a specialty pharmacy. The shift to the new specialty pharmacy provider was completed at the end of April 2019. This led to increased transparency related to member compliance and well-being and see MANAGING HIV, page 10

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Specialty Pharmacy Continuum • March/April 2020

CLINICAL

MANAGING HIV continued from page 8

an increase in viral load measurements. Baseline metrics obtained by our new specialty provider included viral loads for only 23% of our HIV population, of which only 20% of these were undetectable. This raised concerns and motivated us to ensure our efforts would improve clinical outcomes for our HIV members. Thus, the program established goal metrics to be completed by the end of 2019 that included collection

of viral loads on 90% of members, with a goal of 80% undetectable; 90% adherence rates on medications; and investigating 50% of members with an HIV diagnosis who were not on ART and starting them on therapy. The approach for collecting viral loads for members consisted of a unique collaboration with providers through the PA process and use of the medical laboratory database available for the health plan. HRX called on physicians to provide viral loads through an enhancement of our PA process to help reach the goal

of ending the HIV epidemic in the United States. A communication plan was developed that included faxes and telephone outreach by the HRX team to provider offices to collect lab results, explain program goals, and answer any questions. In addition, the HRX team used the medical database available to the plan to obtain viral load levels for members. After 6 months, we were able to obtain viral loads for 80% of our HIV members on ART, just shy of our 90% goal. The viral levels collected showed that 93% of members had undetectable levels, which surpassed our

O UR TEST, Y O U R C U R E . . .

goal of 80% undetectable—only 6 months into our program. By the end of 2019, adherence was reported to be 95% for all HIV members on ART, surpassing our goal of 90% (Figure). The program also included a review of medical claims, which identified 52 members with a diagnosis of HIV who were not taking ART according to pharmacy claims. Providers who diagnosed the member revealed that some members had an incorrect diagnosis and some were planning to be treated with only nonoccupational post-exposure prophylaxis. Health navigators contacted the rest and, through generalized questions that did not identify the member as HIV-positive, found that the majority of them were receiving medications through assistance programs or through their spouse’s insurance. By the end of 2019, navigators had investigated 44% of the members in this category, which was just under our goal of 50%. An integrated PBM approach to managing HIV has multiple benefits, providing transparency and new insights into our HIV population and quality care to patients through access to medications; consolidating coverage to the specialty channel for enhanced, consistent clinical management; facilitating effective laboratory monitoring with collection of viral levels; and helping to ensure that members with a diagnosis of HIV are on ART. As our program continues to evolve using specialty channel management and enhanced provider partnerships, we find ourselves working together breaking down barriers to end the HIV epidemic. The authors reported no relevant ﬁnancial relationships.

References 1. Barlas M. Employers and drugstores press for PBM transparency: a Labor Department Advisory Committee has recommended changes. P T. 2015;40(3):206-208.

ENSU S U RI R I NG G A H HEALTHY EALT T HY W O OR RLD

A C C co mbi nes rob ust reagent s, analy sis and t e c h n i cal servi ce exp erti s e, t o prov ide y ou wit h div er se sol uti o n s for end o t ox in and gluc an t est ing.

2. HIV.gov. National HIV/AIDS Strategy: updated to 2020. www.hiv.gov/federal-response/ national-hiv-aids-strategy/nhas-update. Accessed February 26, 2020. 3. Gardner EM, McLees MP, Steiner JF, et al. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. 2011;52(6):793-800. 4. Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000;342(13):921-929. 5. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493-505. 6. Giroir BP. The time is now to end the HIV epidemic. Am J Public Health. 2020;110(1):22-24. 7.

w w w. a c c i u s a . c o m

• 888.395.2221

DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. AIDSinfo. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. V aidsinfo.nih.gov/ contentfiles/lvguidelines/adultandadolescentgl.pdf. Updated December 18, 2019. Accessed February 26, 2020.

Specialty Pharmacy Continuum • March/April 2020

CLINICAL

SVR12 RATES continued from page 6

medical and pharmacy claims database found an SVR12 of 89.4% among HCV patients receiving the same regimen ((Infect Dis Ther 2017;6[3]:423-433). “We are especially excited by these positive outcomes, given the high acuity of patients observed in our population,” Dr. Donovan said. The researchers said since finding that 40% of their patients did not return for blood testing, pharmacists have adjusted their practice and now continue to reach out to patients after treatment and encourage them to return to the SVR laboratory. “Since we changed our approach, the number of patients completing blood work has increased,” they noted. Pharmacists also followed up with four patients who did not achieve SVR12 and determined that their use of alcohol, illicit drugs or antacids and, in one case, HIV coinfection were associated with suboptimal efficacy. “We advised them to limit or discontinue alcohol or illicit drugs and advised them on the appropriate administration of antacids,” the researchers said. That high level of patient contact is one of the features that make health-system specialty pharmacies unique, com-

A Powerful Partnership Specialty Pharmacy Continuum’s David Bronstein sat down with Lorrie A. Carr, MBA, the CEO of ExceleraRX, at Asembia 2019 to discuss how specialty pharmacies in health systems can join together to gain the scale needed to compete in the market.

Watch the video here: bit.ly/32eA757

evaluation,” Dr. Zuckerman said. “The close relationship between pharmacist, provider and patient in the integrated model of a health-system specialty pharmacy makes that an important outcome to address but one that might be overlooked if a patient is serviced through a non–health-system specialty pharmacy.” —David Wild

‘We are especially excited by these positive outcomes, given the high acuity of patients observed in our population.’ —Jennifer Donovan, PharmD Pharmacy Services, in Nashville, Tenn. “In their poster, the authors spoke about their commitment to improve patient engagement through SVR12

mented Autumn Zuckerman, PharmD, the program director for health outcomes and research at Vanderbilt University Medical Center Specialty

The sources reported no relevant ﬁnancial relationships other than their stated employment.

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Specialty Pharmacy Continuum • March/April 2020

CLINICAL

Innovation Marks New Drug Approvals in 2019 and 2020 The hallmark of drug approvals in 2019 and expected approvals for 2020 is innovation. More than 40% of new drugs were for orphan diseases that had no or few treatment options. Many were first-in-class medications—truly unique drugs never seen before—according to a recent FDA report on 2019 approvals (bit.ly/3aenQ4p). In drug development, innovation can be a first-in-class medication; a technological advance, such as new delivery mechanisms or a chemical structure; new indications or formulations; or drugs that provide new treatment options that are better than existing ones (Can Fam Physician 2002;48:1413-1415, 1424-1426). “The past three years have had significant innovation with more than 150 novel drugs approved through the FDA’s Center for Drug Evaluation and Research: 2017 had 46; 2018, 59; and 2019, 48,” explained Aimee Tharaldson, PharmD, a senior consultant from Emerging Therapeutics at Express Scripts. “Almost three out of four drugs approved in 2019 were ‘structurally novel,’” said Todd Wills, the managing director of CAS, a division of the American Chemical Society. Whether it was innovative chemical scaffolding or some other bioengineering advance, innovation drove many of these approvals, Mr. Wills noted. Because technology helps level the playing field, innovation will probably be driven by smaller companies in 2020, according to Mr. Wills. “Based on our recent analysis of innovation utilizing structural frameworks, there is definitely a shift away from Big Pharma being the primary driver of innovation,” he said. “Big Pharma only discovered about one out of the three structurally novel drugs that were approved in 2019. This shift has been increasing over the past decade as Big Pharma’s strategy to build their portfolios and pipelines evolves to lean more heavily on acquisition and the sophistication of small organizations.”

Outlook for 2020 “When you look at the specialty pipeline, nearly half of the novel drugs in development are for orphan conditions,” Dr. Tharaldson said at AMCP Nexus 2019, in National Harbor, Md., adding that in 2020 about half of all spending under the pharmacy benefit is expected to be for specialty medications, but fewer than 2% of patients require specialty drugs, according to Express Scripts data. Here are some breakthrough medications to look for in 2020, according to Dr. Tharaldson and other market experts.

Latest Approvals The first drug approved this year was avapritinib (Ayvakit, Blueprint Medicines) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a plateletderived growth factor receptor-alpha ( (PDGFRA ) exon 18 mutation. Avapritinib is the first personalized therapy approved to treat a genomically defined population of patients with GIST. About 6% of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. “For the first time, we can offer these patients a highly effective treatment that targets the underlying genetic cause of their disease,” said Michael Heinrich, MD, a professor of medicine at Oregon Health & Science University, in Portland, and an investigator on the NAVIGATOR trial, which the FDA considered before granting the approval. For patients harboring a PDGFRA exon 18 mutation, the overall response (OR) rate was 84%, with 7% having a complete response (CR) and 77% having a partial response (PR). For the subgroup of patients with PDGFRA D842V mutations, the OR rate was 89%, with 8% having a CR and 82% having a PR, according to the FDA. The FDA also approved teprotumumab-trbw (Tepezza, Horizon Therapeutics) to treat adults with thyroid eye disease, a rare condition in which the muscles and fatty tissues behind the eye become inflamed, causing proptosis. Teprotumumab-trbw is a fully human monoclonal antibody that inhibits insulin-like growth factor-1. The drug is administered to patients once every three weeks for a total of eight infusions. The approval of teprotumumab-trbw came weeks before its March Prescription Drug User Fee Act (PDUFA) date. When a company submits a new drug for approval, the FDA sets a PDUFA date for when the agency will make a decision about market approval. The PDUFA dates are not made public, but some companies report them. Another rare ophthalmologic condition also might get approval this year. Inebilizumab (Viela Bio) is an infused biologic to treat neuromyelitis optica spectrum disorder that is expecting approval June 11.

Clinicians who o manage patients wih anotherr rare condition, epithelioid sarrcoma, gained a new treatment option with the first-quarter approval of tazeemetostat (Tazcerik, Epizyme), an orall first first-in-class in class small smallmolecule EZH2 in inhibitor. Epithelioid sarcoma affects about a 800 U.S. patients. “Most “ of these patients d diie within a year of of being diagnosed,,” Dr. Tharaldson said d. “It usually starts as painless lumps on n the skin of the arms an nd feet and hands.” Surgeery is the typical treatment, but the dis disease often progresses and recurrence is common. Tazemetostat’s OR rate in clinical trials was 15%. HIV

“Over 95% adherence to HIV therapy is necessary to maintain viral suppression,” so the market is being dominated by therapies that improve adherence, Dr. Tharaldson explained. The FDA declined to approve the long-acting cabotegravir-rilpivirine (ViiV Healthcare/Janssen) in December because of manufacturing concerns. ViiV said it would work with the FDA to address its concerns. Once approved, possibly later this year, cabotegravir, the novel integrase strand transfer inhibitor and rilpivirine, a non-nucleoside reverse transcriptase inhibitor, will be given as a monthly, intramuscular injection. It has demonstrated a 93% rate of viral suppression in clinical trials. ViiV also is seeking a pre-exposure prophylaxis indication for cabotegravir as monotherapy given every eight weeks. Fostemsavir (ViiV), another breakthrough therapy, is expecting approval Aug. 9. It will be the first oral HIV attachment inhibitor approved for heavily treatment-experienced patients in combination with other antiretrovirals. Phase 3 data showed that 60% of patients achieved virologic suppression with this medication. Non-Alcoholic Steatohepatitis

Many drugs are in development for non-alcoholic steatohepatitis (NASH), but only two are expecting approval in 2020. NASH, which is characterized by liver inflammation and damage caused by a buildup of fat in the liver, is the third leading cause of cirrhosis, ranking behind only hepatitis C and alcoholic liver disease. NASH is also the fastest-growing cause of liver cancer in the United States.

A LOOK

Obeticholic acid (Ocaliva, Intercept Pharmaceuticals), a farnesoid X receptor agonist already approved for primary biliary cholangitis, is scheduled for an FDA review for NASH in April. In the latest trial data, obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity but did not lead to NASH resolution ( (Lancet 2019;394:2184-2196). If approved, obeticholic acid will be assigned a unique National Drug Code and brand name. Elafibranor (Genfit), an oral peroxisome proliferator–activated receptoralpha/delta agonist, is also expecting approval for NASH this year. Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a genetic disease that presents as progressive muscle degeneration and weakness, affecting about 10,000 boys and young men in the United States. It is caused by a mutation in the DMD gene, which decreases the production of dystrophin. One drug in the pipeline for the disorder is viltolarsen (Nippon Shinyaku). On Feb. 7, the company announced that the FDA accepted its New Drug Application (NDA) seeking approval of the drug under priority review. If approved, viltolarsen will be the second drug available for patients with mutations amenable to skipping exon 53, which represents about 8% of patients with DMD. This medication is given as a once-weekly IV infusion. On Dec. 12, Sarepta’s golodirsen (Vyondys 53) became the first drug to be approved for DMD. Sarepta also is developing casimersen for patients with mutations amenable to skipping exon 45. Preliminary data have shown that casimersen is associated with an increase in dystrophin expression of about 0.9% of normal. All three DMD drugs are antisense oligonucleotides.

Specialty Pharmacy Continuum • March/April 2020

CLINICAL

AHEAD

Gene Therapies

Gene therapy is a hot area of drug development, with hemophilia being a prime example. In the United States, there are about 16,000 patients with

hemophilia A and approximately 4,000 with hemophilia B. Hemophilia A is treated with factor VIII and hemophilia B with factor IX (FIX) infusions, but up to 20% of patients with hemophilia developed inhibitors that hinder the efficacy of factors. (For more news on hemophilia, see page 4.) Two companies may be the frontrunners for getting gene therapies approved in 2020. BioMarin (valoctocogene roxaparvovec) is seeking approval for a hemophilia A indication; uniQure (etranacogene dezaparvovec) is seeking approval for hemophilia B. In December, uniQure released phase 2b data for etranacogene dezaparvovec, its investigational AAV5-based gene therapy containing a FIX-Padua variant. The open-label, single-dose, single-arm multicenter trial results in three patients with severe hemophilia (endogenous FIX activity of 1% or less) showed stable and sustained FIX activity at therapeutic levels 52 weeks after the IV infusion. “These updated data show that a single administration of etranacogene dezaparvovec has been well tolerated

now out 52 weeks and has increased FIX activity into the therapeutic range for people living with hemophilia A,” said Steven Pipe, MD, a professor of pediatrics and pathology and the pediatric medical director of the hemophilia and coagulation disorders program at the University of Michigan, in Ann Arbor, and a principal investigator of the HOPE-B clinical trial. Other Gene Therapies

Beta beglogene darolentivec (Zynteglo, bluebird bio), a beta-globin gene therapy, would be a one-time IV infusion for patients with transfusion-dependent beta thalassemia. This condition affects about 1,000 people in the United States. Patients with the condition require frequent blood transfusions, as well as chelation therapy because of iron buildup in the blood. In clinical trials, beta beglogene darolentivec reduced the need for transfusions, according to data presented at the 2019 annual meeting of the European Hematology Association, in Amsterdam. In late 2021, bluebird bio will seek an expanded indication for sickle cell disease.

PTC Therapeutics is seeking an indication for eladocagene exuparvovec to treat aromatic L-amino acid decarboxylase deficiency. Bluebird bio is looking for an indication for cerebral adrenoleukodystrophy for elivaldogene tavalentivec (Lenti-D). Patients receive an infusion of autologous CD34+ cells transduced with the elivaldogene tavalentivec lentiviral vector. Both would be one-time infusions. Several companies are hoping the FDA will approve gene therapies for various cancers in 2020: • aglatimagene besadenovec (Advantagene), an immunotherapy for prostate cancer; • idecabtagene vicleucel (bluebird bio/ Celgene), an immunotherapy/chimeric antigen receptor T-cell (CAR-T) therapy for multiple myeloma; • lisocabtagene maraleucel (Celgene), an immunotherapy/CAR-T therapy for lymphoma; and • nadofaragene firadenovec (Ferring), an immunotherapy for bladder cancer. —Marie Rosenthal

Feds to Push for More Biosimilar Competition

he FDA and the Federal Trade Commission (FTC) announced they will take further action to stem anticompetitive practices that are blocking biosimilars from entering the U.S. market. The practices are keeping the costs of these drugs artificially high, the regulators said. In a joint statement released in early February, the two agencies outlined steps they hope will achieve four key goals established in the FDA Biosimilar Action Plan of 2018 to support more competition in the market for biologic agents: developing public education initiatives; preventing biologic makers from restricting access to originator samples for biosimilar development; taking action against false or misleading promotional communications; and reviewing patent settlement agreements for antitrust violations. FDA Commissioner Stephen M. Hahn, MD, said greater oversight of the U.S. biologics market is necessary for increasing access to these important therapies and reducing their costs. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients,” he said in a statement. In the decade since the Affordable Care Act streamlined the regulatory pathway for biosimilars, about 25 of

these drugs have been approved by the FDA, but few have made it to market. Despite the approval of five adalimumab biosimilars, for example, AbbVie’s legal challenges have ensured none will enter the market until 2023. In contrast, adalimumab biosimilars gained 35% market share in the year after they were launched in Europe in 2018.

$7.2 Billion Price Tag for Failure Last year, Pacific Research Institute, a think tank, estimated that the failure to adopt biosimilars costs the United States $7.2 billion annually. FTC Chairman Joseph Simons said, “Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation. The FTC is committed to continuing to enforce the antitrust laws in health care markets, including those for biologics and biosimilars.” David T. Rubin, MD, the chief of gastroenterology at University of Chicago Medicine, said the agencies’ plan to address misleading medical communications is particularly important for protecting patients. “Patients are already facing the challenge of living with their disease and trying to understand their treatment options,” Dr. Rubin said. “Commercially driven messaging that is misrepresenting the

facts is certainly something we need to work hard to address.” The FDA and FTC did not call out specific bad actors, but said they will take “appropriate action” against communication that “misrepresents the safety or efficacy of biosimilars.” The FDA is also accepting comments on its draft guidance for truthful biologics advertising and promotional labeling until April 6, 2020. Although problems in the biologics market are likely to persist despite these announcements, they do signal increasing federal recognition that biologics are simply too expensive in the United States, and that

something needs to be done about it, Dr. Rubin said, adding, “It’s important to remember that the abbreviated biosimilar pathway was created to drive competition in the expensive biologics market and to bring down costs,” but they have continued to spiral beyond affordability. —Adam Leitenberger Dr. Rubin reported ﬁnancial relationships with AbbVie, Janssen, Merck, Pﬁzer, Samsung Bioepis and Takeda.

For more biosimilars news, see page 22.

Specialty Pharmacy Continuum • March/April 2020

CLINICAL

Figure. Algorithm for aminoglycoside-induced ototoxicity. NEB, nebulized; NTM, nontuberculous mycobacteria

CF Hearing Loss continued from page 1

physicians increased their use of audiograms in at-risk patients from roughly 25% to nearly 100% and found more than 55% were experiencing aminoglycoside-induced ototoxicity. That is in contrast to the rates of aminoglycoside-induced ototoxicity reported by the Cystic Fibrosis Foundation (CFF): 1.3% among pediatric patients and 2.4% among the overall CF population (on. cff.org/3c9Fp6x). The high rate of ototoxicity found at Children’s Mercy Kansas City after implementation of the algorithm is “extremely interesting” and likely reflects underreporting of the adverse event and low rates of extensive testing and monitoring at many centers, commented Matthew Miller, PharmD, a clinical specialist in infectious diseases and co-chair of antimicrobial stewardship at the University of Colorado Hospital, in Aurora. “It definitely appears to be a prudent consideration to monitor for ototoxicity for those requiring prolonged or repeated courses of aminoglycosides, including aerosolized routes of administration, and particularly if other risk factors, such as renal impairment or a family history of hearing problems, exist,” Dr. Miller said. E. Claire Elson, PharmD, a clinical pharmacy specialist in CF and pulmonology, Department of Pharmacy, at Children’s Mercy Kansas City, and her colleagues evaluated their institution’s approach to monitoring patients with CF for this complication by reviewing the medical records of 50 patients with CF treated with IV aminoglycosides

and 70 treated with inhaled aminoglycosides between 2014 and 2016. They found that only 25% had undergone an audiogram. “Most physicians at our institution were aware of the problem of aminoglycoside-induced ototoxicity at that time and were eager for a clinical tool to help them monitor and potentially minimize the impact of this adverse event,” noted Dr. Elson, who presented a study on the topic at the ASHP 2019 Midyear Clinical Meeting (poster 4-061). To create such a tool, Dr. Elson and her colleagues scoured the published literature and developed an aminoglycosideinduced ototoxicity monitoring algorithm (AIOA). The AIOA specifies monitoring intervals based on the type of aminoglycoside administered, the duration and frequency of treatment, the route of administration, and any patient and family history of hearing problems (Figure).

Pharmacists Take a Lead Role Pharmacists in the CF clinic and inpatient setting take a lead role in monitoring by identifying patients for ototoxicity screening, tracking exposure to aminoglycosides, and reviewing audiogram results, Dr. Elson said. They also recommend therapeutic drug monitoring, alternative agents when necessary and otoprotective agents for patients with ototoxicity, she explained. Pharmacist-recommended treatment decisions following a finding of ototoxicity depend on the severity of the adverse event and specific nature of the problem. “If we have alternative agents, we

may modify the inhaled/IV antibiotic regimen,” Dr. Elson said. “Otherwise if the ototoxicity is mild and there are no alternative agents, we ensure adequate hydration, appropriate monitoring of therapeutic levels and utilization of otoprotective agents.” An analysis of 49 patients treated with IV aminoglycosides during a 30-month period after implementation of the AIOA in January 2017 revealed that 98% (48/49) of patients

guideline-based practice for therapeutic monitoring of aminoglycosides in our population, so I believe this is less likely.” Dr. Elson said since publicizing her findings, several other CF centers have approached her institution to collaborate and develop a national AIOA. She is also optimistic that the CFF is developing practice guidelines that may include recommendations for audiogram monitoring in this patient population. Dr. Miller said the researchers’ “very

‘The most likely explanation as to why our ototoxicity rates are much higher than previously reported in this population is that centers may not have a standard monitoring practice.’ —E. Claire Elson, PharmD with CF receiving aminoglycosides had at least one audiogram after the protocol was established. Moreover, 56% (27/48) of audiograms uncovered hearing abnormalities, including 12 patients with distortion product otoacoustic emissions abnormalities and 15 with high-frequency hearing loss. Among 33 patients who had multiple audiograms, 45% (15/33) showed significant worsening of ototoxicity over time, Dr. Elson reported. “I think the most likely explanation as to why our ototoxicity rates are much higher than previously reported in this population is that centers may not have a standard monitoring practice,” Dr. Elson said. “Although it’s possible another reason could be the dosing strategies we use and the risk within our patient population, we’ve evaluated this and determined that we are following standard and

thorough process for monitoring aminoglycoside safety would be worth implementing for those centers that care for a significant population of patients with cystic fibrosis.” However, the algorithm could be challenging to use in routine practice at centers with low overall aminoglycoside utilization and shorter durations of use, he noted. “Testing could also be impractical or not possible in patients with critical illness who have received sedation or are mechanically ventilated,” Dr. Miller noted. “Lack of access to the necessary equipment and a noisy or distracting environment may also make it difficult to conduct inpatient audiometry testing.” —David Wild The sources reported no relevant ﬁnancial relationships.

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Specialty Pharmacy Continuum • March/April 2020

OPERATIONS & MANAGEMENT

Making a Plan for Surface Wipe Sampling London—Specialty pharmacies that have been focused on meeting new sterile compounding regulations need to know that surface wipe sampling is now a required compliance target. Although that may pose some operational challenges, it’s a fortunate development, because routine surface wipe sampling can significantly reduce contamination in facilities that compound hazardous drugs (HDs), Jerry Siegel, PharmD, a vice president with Safe Medication Management Associates, reminded attendees at the 2019 meeting of the International Society of Oncology Pharmacy Practitioners. Dr. Siegel noted that although data showing wipe sampling’s effectiveness may not be new, the evidence still needs to be heeded. He cited, as an example, a 2013 study that looked at wipe sampling monitoring done at regular intervals over a 15-month period. “The study showed that 61% of wipe samples were positive for contamination at baseline,” Dr. Siegel told attendees. “Over five cycles of testing, the monitoring group saw a 56% decrease in contamination while the control group had only a 14% decrease. Almost seven out of 10 participating pharmacies stated that they had changed or would change their work procedures as a consequence of these findings [[Ann Occup Hygg 2013;57(4):444-455].” Dr. Siegel urged all facilities where HDs are prepared and administered to develop a regular surface wipe

sampling plan, pointing to studies that show 75% of surfaces in pharmacies are contaminated with HDs (Hosp ( Pharm 2017;52[8]:551-558). “Over 20 studies have been published linking hazardous drug exposure to medical risks,” he said. “Contamination may be present and easily spread throughout your institution.” Dr. Siegel pointed to an online survey of health care workers that spotlighted multiple practices with risk for HD exposure, such as touching IV pumps or bed controls, using pens and pencils, and touching doorknobs and cabinets while wearing chemotherapy gloves (61%, 26% and 21% of workers, respectively) (CA Cancer J Clin 2006;56[6]:354-365).

Next Steps So, how should your facility be sampling and cleaning high-risk areas? USP’s current General Chapter <797> recommends microbial/viable sampling every six months, but the newly revised chapter <797> changes that requirement to every month for surface monitoring and every six months for air sampling. USP chapter <800> recommends routine wipe sampling for HDs but does not specify the timing. “I believe the best practice would

5 Questions for Vendors 1. What laboratory accreditations does the product/vendor have? They should have AIHA/ISO (International Organization for Standardization) 17025 accreditation at a minimum.

2. How many and which hazardous drugs can you test for with a standard kit? The more hazardous drugs tested per sample, the better.

3. What resources does the company provide to help you conduct surface wipe sampling, such as video guides or training? Do the resources appear to be easy to use?

4. What is the turnaround time for reporting? 5. What is the pricing structure: Do you pay for analysis up front or do you pay upon receiving results?

be qualitative HD monitoring monthly and quantitative HD monitoring every six months,” Dr. Siegel said. “How do we know if our practices and facilities are working without monitoring? We need to protect our health care workers, our patients and our environment, and we need to make changes in a ‘timely’ fashion.” He listed multiple pharmacy and patient care areas with potential contamination that should be included in sampling plans: • the surface, airfoil or floor in front of a biological safety cabinet (BSC); • the surface and floor in front of a compounding aseptic containment isolator (CACI); • pharmacy floors; • floors in pharmacy; • pass-throughs (inside and outside, both for a CACI and from inside the pharmacy); • countertops; • equipment, storage trays and drug vials; • door handles, doorknobs and other high-touch areas; • the computer keyboard and mouse; • the nurses’ station; • the medication room; • IV bag storage areas; • the floor of the patient care area; • the restroom floor; • IV pumps and stands; and • patient chairs. One product on the market for surface

wipe sampling is the BD HD Check system, adapted from lateral flow immunoassay technology, which Dr. Siegel said is easy to learn, use and integrate into a daily system. “It provides easyto-read results in less than 10 minutes and allows corrective action to be taken immediately,” he said. Dr. Siegel described a recent experience with decontamination of an old chemotherapy pharmacy that was being deconstructed and replaced, using HD Check to detect HD residue. Methotrexate was detected in the BSC, on the floor, the door handle, and the windows of the pharmacy. It had to be cleaned and checked several times before it was determined to be free of contamination. The advantage was that there was relatively no waiting (<10 minutes) for the results. At another site, “the BSC was not routinely cleaned under the deck of the BSC, and it showed gross contamination with five different antineoplastic hazardous drugs,” he said. “After ‘triple cleaning,’ there was still residue of cyclophosphamide, and residue of three different antineoplastics was detected in the floor, floor mat and HVAC register near the BSC in the pharmacy, as determined by HPLC [high-performance liquid chromatographic] quantitative testing, which took 10 days to get rushed results.”

Other Testing Options Multiple products and testing kits are available for surface wipe sampling. p g Lowell General Hospital, p , which is presently undergoing a large pharmacy renovation to ensure cleanroom compliance with the new USP <797> and <800> chapters, began conducting a twice-yearly testing process in 2018, using an American Analytics SafeChemo sampling kit. see WIPE SAMPLING, page 18

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Specialty Pharmacy Continuum • March/April 2020

OPERATIONS & MANAGEMENT

WIPE SAMPLING continued from page 16

“It’s pretty simple,” Eric Musial, PharmD, the director of pharmacy services at Lowell General Hospital, in Massachusetts, said in a separate interview. “Each test pack can do up to 12 samples, which allows you to sample multiple locations in your high-risk areas. And when you send it into the lab, you can customize your panel. There are predetermined common hazardous drugs to test for, but if you have other agents

of concern in your institution, you can request testing for those as well.” Lowell typically tests for its three most common hazardous antineoplastics: paclitaxel, 5-fluorouracil and platinum analogs. “These are the agents that are compounded every single day and are constantly in and out of our IV room. We sample four high-risk areas for three drugs each,” Dr. Musial said. “For example, we might sample a counter, the hood and some furniture one cycle. If an area comes back clean, next time we might rotate and sample something else

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like keyboards or doorknobs. At present, we are only doing this sampling within the pharmacy, but I hope to take it a step further and conduct samples outside the pharmacy in nursing stations and chemo administration areas.” Lowell’s results have been reassuring so far. “Our techs and staff are very diligent about using CSTDs [closed system drug-transfer devices] and cleaning, and to date we have only had one small positive reading on a transport cart, while everything else has been negative. We cleaned that and came up with new procedures to prevent future contamination, such as putting down disposable absorption pads when we transport,” Dr. Musial said. As for the cost of wipe sampling, that could be perceived as a barrier. But it shouldn’t, according to Dr. Musial. “Regular wipe sampling is something that every pharmacy should be factoring into its budget and schedule if it is compounding hazardous drugs,” he said. “It is essential for the protection of the pharmacists and technicians who compound these agents and are exposed to them every single day.” —Gina Shaw Dr. Musial reported no relevant ﬁnancial relationships. Dr. Siegel reported a ﬁnancial relationship with BD.

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Specialty Pharmacy Continuum • March/April 2020

OPERATIONS & MANAGEMENT

Benchmarking Shows Its Worth in Specialty Rx I

n the struggle to gain access to limited-distribution specialty medication networks, health system specialty pharmacies are turning to benchmarking tools to demonstrate their clinical and cost-saving value to manufacturers, payors and providers. Emory Healthcare in Atlanta, and Summa Health in Akron, Ohio, benchmark their performance against peer organizations and internally to demonstrate that embedding residency-trained and board-certified pharmacists in specialty clinics can increase medication adherence, clinical outcomes, and patient and provider satisfaction scores.

2019 Benchmarking Performance at Trellis Rx And Summa Health Specialty Pharmacy Trellis Rx (includes health systems partnered with Trellis Rx for at least 6 months) • 92% average proportion of days covered • 101-point increase in average provider Net Promoter Score • 100% HCV sustained virologic response rate at 12 months • 97% prior authorizations submitted in <1 day

Summa Health Specialty Pharmacy • 93% average proportion of days covered scores across all clinics • 114-point increase in provider Net Promoter Score from –20 prelaunch to 94 • 100% HCV sustained virologic response rate at 12 months • 99% prior authorizations submitted in <1 day • 1.8-day average turnaround time on new therapy starts • 23 clinics supported within 9 months of launch

The pharmacies use quality performance metrics such as proportion of days covered (PDC) and medication possession ratio (MPR) to validate patient adherence. They employ outcome measures such as sustained virologic response after 12 weeks of therapy (SVR-12) to document the proportion of patients with hepatitis C virus who are cleared of the infection after treatment. At Summa Health, internal benchmarking studies have shown remarkable results less than a year after the health system launched its specialty pharmacy in partnership with Trellis Rx. The number of clinics supported by the specialty pharmacy program jumped from none to 23 within nine months. The PDC patient

adherence rates average 93% across all clinics. Provider satisfaction scores, measured using the Net Promoter Score, increased from –20 to 94, a 114-point turnaround. The SVR12 rate for HCV patients treated in the Summa Health infectious disease clinic stands at 100%.

Specialty Liaisons These gains result mainly from a Trellis Rx–designed care model that places advanced practice pharmacists in specialty clinics under the health system’s brand, working closely with clinicians to achieve optimal medication therapy for patients with complex and chronic diseases such as rheumatoid arthritis, multiple sclerosis and HIV infection. At Summa, five pharmacists currently work in high-volume clinics and two more are set to join the program this year, said Stuart Deal, PharmD, the vice president and general manager of Summa Health Specialty Pharmacy. “The value we provide is being part of the care team embedded next to the clinicians in those specialty pharmacy clinics,” Dr. Deal said. “The focus is on making sure we’re providing the best possible experience for our patients and providers.” Emory Healthcare Specialty Pharmacy also relies on advanced practice pharmacists to improve the quality of treatment for its specialty clinic patients. Working under a collaborative practice agreement, pharmacists can make dose adjustments, stop therapy, or adjust the frequency or strength of specialty medications, said Ryan Haumschild, PharmD, the director of pharmaceutical services at Emory University Hospital Midtown and Winship Cancer Institute, in Atlanta.

Adherence Rates Increase The specialty pharmacy collaborative practice model has achieved substantial gains since its launch in early 2016. Although Dr. Haumschild declined to disclose specific benchmark study scores because of pending publication in a pharmacy journal, he said the specialty pharmacy had attained “statistically higher” patient adherence rates, as indicated by PDC and MPR scores. “Our PDC rate is 95.5%,” he said. Time-to-treatment also improved, Dr.

Haumschild noted. “We decreased the time patients got their medication by four days. This meant patients had their necessary medications four days sooner than all external pharmacies, even with our robust clinical oversight program.” Patient’s positive evaluations of Emory’s specialty pharmacy reflected their experience with the augmented clinical services. “We’ve seen a significant rise in Press Ganey patient satisfaction survey scores,” Dr. Haumschild said.

EHR Access a Plus Like other health system–level specialty pharmacies, Summa Health and Emory Healthcare have a distinct advantage over large, national specialty pharmacies: access to their patients’ real-time care status via the electronic health record (EHR). Summa Health specialty pharmacists can also look at disease-state dashboards, which allow them to benchmark their performance across multiple clinic sites at other Trellis Rx partner sites.

“Trellis Rx’s purpose-built specialty pharmacy technology platform, Arbor, connects with health systems’ EHRs to support proactive patient management, data analytics and reporting,” Dr. Deal said. “Arbor keeps the data consistent so we can benchmark performance across health systems, even though they might be on different EHR systems.” Dr. Haumschild said: “As health systems, the best thing is that we control the [electronic medical record], and we know everything that is happening with the patient. We can actually pull out the clinical outcomes that are directly related to that patient.” That kind of information can have an impact on specialty medication distribution decisions. “We know that benchmarking data against other specialty pharmacies is important because it creates value, especially when you’re having those limited-distribution discussions,” Dr. Haumschild said. —Bruce Buckley Dr. Haumschild reported serving on an advisory board for Genentech. Dr. Deal reported no relevant ﬁnancial relationships.

McMahon Group Performance Awards Honor the Best of the Best McMahon Group, the company that publishes this and several other medical newsmagazines, sets aside one evening annually when the company gets together to celebrate another successful year, during which we shine a spotlight on those individuals whose expertise and enthusiasm for their work are exceptional. We focus on medical news, the kind that informs physicians and other clinicians and, in the end, improves patient care. It takes many people with varied skills to publish this editorial, both in print and on our websites—not to mention other media, like podcasts. Those skills might be reportorial, editorial, copy editing, sales, client service, graphic design, production, IT, circulation and human resources, and that’s not a complete list. We at McMahon Group are very good at what we do. Still, in a given year there are those who especially stand out. The following employees were selected by their peers for their exceptional work, and, as always, we thank them.

SUPPORT PEOPLE OF THE YEAR now in his third year at the company, is an associate art director whose duties include laying out three of our publications: General Surgery News, OR Management Newss and Infectious Disease Special Edition. In addition, he creates all the advertising and promotional materials for those magazines, assists with custom media graphics work, and helps the other art directors when needed. ABRAHAM DE LA ROSA A has been with the company for 13 years and works as the facility’s custodian. Abraham’s dedication to keeping things tidy is appreciated by everyone, but his duties don’t stop there. As just one example, he also helps pack material for our many medical conventions and arranges shipment. Abraham wears many hats, and all well.

SALES ACHIEVEMENT AWARD JUSTIN KABACK, a six-year veteran at the company, was recognized for the second time for dedication and creative thinking to enhance his sales and customer service for the two publications he works on as the account manager, Anesthesiology Newss and Pain Medicine News. Justin has achieved much, as his sales are up a very impressive 65% since 2016.

EDITOR OF THE YEAR MEAGHAN LEE CALLAGHAN, beginning her third year at the company, is the associate editor of Pain Medicine Newss as well as associate editor of the Custom Media division. Her diverse duties include editing, writing, assigning, video shooting and editing, audio recording and editing, interviewing, proofreading, managing custom media projects, updating the PMN N website, and creating e-Newsletters.

SALESPERSON OF THE YEAR MATT SPOTO won this award by generating more revenue than any other salesperson in the company last year. A 13-year veteran, for most of that time he has worked on Gastroenterology & Endoscopy News, first as the account manager, then manager of publication sales, then associate publication director, and, since the beginning of 2019, its publication director.

PERSON OF THE YEAR KATHERINE REIDER, who is the editorial director of Special Projects, is this year’s winner. Katherine oversees the development of medical education supplements for the newsmagazines, and manages the development and delivery of these projects by coordinating among the sales, editorial, production, graphics and finance departments. Katherine is now in her 18th year at McMahon Group.

MCMAHON GROUP PARTNERS’ AWARD THOMAS CIRIACKS was the winner of this award, which is given to a person whose efforts have significantly advanced the company over time. Thomas was the winner of multiple awards through the years, including two person-of-the-year awards and two salesperson-of-the-year awards. His last title at the company was director of Medical Education. He eventually left the company to form his own health care marketing consultancy.

Specialty Pharmacy Continuum • March/April 2020

OPERATIONS & MANAGEMENT

continued from page 1

The CDC has suggested stockpiling “several weeks of medications and supplies,” but primarily for high-risk patients, such as those with comorbidities (bit.ly/2W65zBI).

Being Prudent With Overrides Insurers are making it easier for patients to increase their supply of medications, often by encouraging mail-order supplies of 90 days’ worth of medications or waiving early medication refill limits. But some are trying to build supply chain protections into their approach. Jennifer Luddy, a spokesperson for Cigna and Express Scripts, said the company is monitoring the situation closely, but that present conditions have not called for them to implement overrides for “refilltoo-soon” notices on 30-day prescriptions if patients try to refill or renew with more than 35% of the medication remaining. “Implementing overrides prematurely could put a strain on the supply chain and disrupt current inventories,” Ms. Luddy said. For patients using a specialty medication, she noted, “we are working with pharmacists and prescribers to evaluate individual patients’ needs and take care of them accordingly.” The company said its pharmacists can override “refill too soon” using their professional judgment as part of their normal business practice. It’s not always possible, however, to give patients 90 days’ worth of specialty medications due to the special storage, handling, distribution and administration requirements of the drug, or special dosing requirements and the need for blood work or other lab tests, Ms. Luddy said. “That is why it is more of an individual case-by-case basis.” The pharmacists at Accredo, the specialty pharmacy arm of Cigna and Express Scripts, “are working with patients and their care teams to make sure they have what they need when they need it,” she said. For nonspecialty maintenance medications, patients can obtain 90-day supplies via Express Scripts Pharmacy Home Delivery, either by asking their doctor for a new prescription or calling their pharmacist, Ms. Luddy added.

The Calm Before the Storm? The current level of COVID-19 preparedness may be the calm before the storm, noted Frank Koen, RPh, senior director of specialty pharmacy at AllianceRx Walgreens Prime. The company hasn’t seen a spike in 90-day specialty prescription requests, “but we expect to, so we are actively working with our specialty clients and specialty patients to get them what they need. We have also not seen a spike in 90-day home delivery

prescription requests but are expecting this to come, and we are prepared to handle the increased volume.” Healthcare Ready’s Dr. Louissaint, whose organization provides emergency preparedness advice to health care system operators, agreed that it makes sense for patients to obtain additional supplies of medications, but stopped short of recommending that they stockpile three to six months’ worth. One reason for that hesitation: Many people keep their medications in the bathroom, and such a high-humidity environment can affect the stability of medicines, especially over a six-month period, she noted, adding that mail order may be a more viable option. During many serious events, such as hurricanes, an extra 30-day supply of medication appeared to suffice for most patients, she added ((Am J Med d 2006;119[11]:986-992). The CDC is encouraging patients to consider emergency refills where states allow, which are typically 30 days for most medications that treat chronic conditions, Dr. Louissaint said. At press time, 12 states had declared a state of emergency over COVID-19, including Florida, which enables pharmacists to automatically issue a 30-day refill of non–Schedule II drugs without consulting a doctor or payor. “I’m seeing pharmacies are doing quite a bit of this as well,” she said. During those refill discussions, pharmacists should remind patients to stay on top of their normal refill schedules, “not waiting until they’re down to their last few pills,” Dr. Louissaint stressed. In fact, pharmacists “are in a good position” to talk to patients about how many pills they have, and should continue to incorporate this information as part of an overall preparedness message.

Testing Costs Waived Testing for COVID-19 is another effective preparedness tool—and one that the nation’s major health insurers are helping to foster. At a White House meeting on March 10, executives from UnitedHealth Group, Anthem, Cigna, Humana, and the Blue Cross/Blue Shield Association, among others, agreed to waive copays for coronavirus testing, which is expected to surge as commercial labs come online. But the copay waters were muddied when, in a televised address on March 11, President Donald Trump said insurers “have agreed to waive all copayments for coronavirus treatments.” America’s Health Insurance Plans, an industry lobbying group, quickly corrected the President with a statement noting that the waver is “for testing. Not for treatment” (bit.ly/2TYvuIV). —Alison McCook

Specialty Pharmacy Continuum • March/April 2020

OPERATIONS & MANAGEMENT

The Patient’s Journey continued from page 1

‘Patients [want] more user-friendly information available in mobile formats, apps and text messaging to improve communication and continuity of care.’

Still, a working definition of the patient medication in 2016 and 2017. In a series journey is a good place to start before of three meetings, those patients identiundergoing any repairs. The patient jour- fied key roadblocks that impeded their —Rebekah Anguiano, PharmD ney is considered to be that person’s path access to care, and specifically to spethrough managing an acute or chronic cialty drugs (AMCP 2017 Nexus Meethealth condition, from the time they start ing; poster 17). Mr. Grady noted that current data reported, you can implement services experiencing symptoms through diagCommon concerns they shared were: to address the most common barriers measures for satisfaction and outcomes in the “patient journey” are focused on nosis, treatment and follow-up/ongoing • lack of understanding or general frus- to access and adherence.” care. Throughout this journey (graphic), tration with drug formularies and the near-term goals of contractual arrangePatient Navigator Model they have contact with different segapproval process; ments. Such metrics “may [focus on] ments of the health care system requir- • anxiety with approval processes and The patient navigator model that adherence, or medication possession navigating insurance, such as hold has proven effective and enjoyed wide ratio or refill reminders. Did they get ing a degree of care coordination that times, paperwork and formulary adoption in cancer centers is begin- their prescription filled on time? Was can be a challenge, Dr. Anguiano noted. changes; ning to move to other chronic/complex the copay reduced?” he said. “While Various factors, she explained, such as manufacturer limited distribution and • distrust that mail-order services would disease states, and offers an opportu- these may be critical to managing insurance pharmacy network restrictions, nity for specialty pharmacies to play a patients’ therapy, they are limited. The get medications to them on time; can affect where and how a patient can fill • fear of losing or being denied greater role in coordinating the patient next wave of patient journey measures medication prescriptions. coverage, and the need to make journey, according to Lance Grady, the should incorporate patient-reported “Because specialty drugs are often dischanges in their lives to maintain vice president and team lead for market outcomes and other clinical outcomes pensed only through certain rtain specialty pharmacies, it’s not uncommon for patients to be requiired to use three or more pharm macies: a combination of walk k-up retail for acute mediccaAwareness/ tions, mail order fo or Seeking Recovery/ discovery of Prevention ongoing maintenancee Diagnosis Treatment expertise management a condition and wellness drugs, and one or moree and testing and self-care or conditions specialty pharmaciess for prescription speciallty medications,” she said. “More frequently in reecent years, we have had pattients report that health care provider–administered medications have to be delivered to them, and they must then bring it to the clinic for administration; and if the delivery is not insurance coverage; and access and reimbursement at Avalere data, such as social determinants of on time, they have to either miss their • lack of patient-friendly information Health. “This [approach] could be par- health and quality of life.” appointment or show up empty-handed.” and communication. ticularly effective in disease states like “Coverage and accessibility were the multiple sclerosis and autoimmune dis- Personal Relationships Still Key Pharmacists Can Help dominant themes,” Dr. Anguiano said. orders, where the touchpoints with the Although the patient journey modBurnis Breland, PharmD, an imple- “Patients are frustrated with barriers patient may be more frequent and better el, like so much else in health care, mentation manager for Acentrus Spe- like red tape and formulary issues, and coordinated when offered by specialty is necessarily data-driven, Dr. Breland cialty, the health-system specialty fear going without medications for a pharmacy as opposed to that patient’s stressed that it is dependent on permanagement solution from Apexus, variety of reasons. We’ve had patients physician,” Mr. Grady said. sonal relationships. “I was in southern agreed that “it’s a key role of the spe- receive letters saying that the drug that One “roadblock-busting” solution Georgia last week speaking with a hub cialty pharmacist to help remove or has been controlling their disease for category that patients are clamoring services pharmacy staff member, who mitigate these barriers. It can take a lot five years is no longer covered, and for for is better digital access to informa- described for me what she had just gone of expertise to do that and can be very some that has resulted in ER visits or tion and services, Dr. Anguiano noted. through in order to get a patient covered time consuming, but particularly in hospitalizations because of not receiv- “Our patient advisory board members for a particular oral cancer therapy,” the health-system setting, the specialty ing needed medications. Others tell were asking for improved use of tech- he said. “She spent hours and hours on pharmacist is often embedded in deci- us that their big concern is trying to nology,” she said. “Patients wanted the phone, going back and forth with sion making very early on in the patient balance disease control with access to more user-friendly information avail- the PBM [pharmacy benefit manager] journey and can collaborate in manag- medications and living a normal, pro- able in mobile formats, apps and text and multiple different departments of ing the care plan effectively: initiating ductive life. Many feel they can’t work messaging to improve communication the patient’s insurance company, but she finally did it. She was committed to drug therapy, working with a patient because they might lose access to dis- and continuity of care.” on managing adverse events, chang- ability or other coverage if their income “Specialty pharmacy has historically making it work. “Ultimately, that’s what a focus on the ing medications or dosages, address- changes—which is true.” been a call center–focused solution,” Mr. ing barriers to access, ensuring approUsing the lens of the patient journey Grady acknowledged. “To the degree that patient journey is about: being there at priate laboratory testing, and ongoing can help specialty pharmacies not just patient support services in specialty hubs each one of these roadblocks and helpchronic therapy management.” describe but quantify the issues facing can incorporate mobile health platforms, ing to eliminate them.” To better understand the specialty their patients—and identify what solu- direct interface through e-chat and other —Gina Shaw pharmacy patient journey, UI Health tions they can offer. “We can’t fix all the types of engagement, as well as the abilestablished a patient advisory board barriers for every patient with every ity to obtain and transmit data electroniThe sources reported no relevant ﬁnancial consisting of 17 patients who had plan,” Dr. Anguiano said. “But if you cally, they can dramatically improve the relationships other than their stated employment. been prescribed at least one specialty know what issues are most frequently patient experience.”

6 Stages of the Patient Journey

Specialty Pharmacy Continuum • March/April 2020

POLICY

Biosimilars’ Slow Embrace in Health Care Miami—Biosimilars offer the potential to save significant health care dollars, but their release into the marketplace and adoption by health systems and payors have been slow, according to several presentations during Informa’s 2020 Specialty Therapies and Biosimilars Congress. Some 26 biosimilars have been approved in the United States, only 14 of which are commercially available, said Ann McNamara, PharmD, the director of clinical development for Fairview Specialty Pharmacy, in Minneapolis. The others have expected release dates ranging from this year to as far out as 2023 for adalimumab (Humira, AbbVie) biosimilars and 2029 for etanercept (Enbrel, Amgen) biosimilars based on patent expirations and contract negotiations. Although the pace of FDA approvals of biosimilars is increasing, that doesn’t mean there’s market access or that patients are going to get them easily, said Cate Lockhart, PharmD, the executive director of the Biologics and Biosimilars Collective Intelligence Consortium. Dr. Lockhart moderated a panel discussion on challenges and solutions for biosimilars entering the marketplace. There are still many hurdles in place for biosimilars, she noted, including patent litigation; pay-for-delay contracts in which a biosimilar manufacturer agrees with the manufacturer of a reference product to hold off on marketing; and confusion and uncertainty around what a biosimilar is and why we should use them. “The ‘similar’ part of that term is what causes people uncertainty, when in reality it’s the ‘bio’ part of the term that is the real challenge, because it’s the fact that they are biologics that makes them so complex,” she said. Dr. Lockhart’s panel brought up several concerns that need to be addressed

before biosimilars are more readily adopted. One is the length of time before a biosimilar comes to market. “We are no longer in the days of FDA approval equals market access,” she said. “There are a lot more steps that seem to be happening these days, whether it’s intellectual property disputes or other contracting activities slowing down the launch of a product post-approval.” There also is confusion surrounding the naming of these products and their four-letter suffixes, she noted, as well as an understanding of the term “interchangeability.” Many educational efforts about the products are ongoing through different venues, which should help, Dr. Lockhart pointed out. The use of postmarketing data also could provide a means of overcoming some barriers to usage. Through the Sentinel Initiative, the FDA developed a surveillance system, primarily using administrative claims, to monitor real-world outcomes and safety of drug utilization. Dr. Lockhart’s organization is doing similar work, focusing specifically on real-world effectiveness and safety of biologics, including biosimilars. However, these data have limitations, and types of data across different sources are “still a bit disjointed,” she said.

Challenges in Health Systems There are a number of challenges with biosimilar adoption within health systems as well, said Bhavesh Shah, RPh, BCOP, the senior director of hematology/oncology and specialty pharmacy for

By 2026, widespread adoption of biosimilars could reduce direct spending on biologic drugs by up to

$150 billion

Source: Rand Health Q. 2018;7(4):3. eCollection 2018 Mar.

Boston Medical Center Health System, who presented on biosimilar adoption and barriers to success. This includes payor coverage, preference for the reference product, and provider and patient buy-in. Many hospitals do not even offer some biosimilars on their formularies because either their payors prefer a reference product or they cover both at parity, she noted. “This incentivizes providers to continue bad practice, because if you’re telling someone you can use either drug, then no provider is going to talk to their patient about changing to a less expensive equivalent therapy,” he said. Payors who prefer different biosimilars may cause the hospital to have to stock multiple products. “Skinny label” indications—when biosimilars are released without all of the same approved indications as a reference product—also affect adoption of biosimilars, Dr. Shah said. Sometimes there’s not much education about these limited approvals with providers, who may feel if it’s not FDA approved for a particular indication, then it shouldn’t be used. This

Value-Based Contracts Could Benefit

f we can get past barriers to adoption, biosimilars are well positioned to help reduce costs, which is particularly important in value-based contracts, said Jorge J. García, PharmD, the assistant vice president of the system oncology pharmacy service line at Baptist Health South Florida, in Miami. Fee-for-service is still how most providers are paid in the ambulatory setting, “but we know that’s going away,” Dr. García said at Informa’s 2020 Specialty Therapies and Biosimilars Congress, in Miami. “In the future, we anticipate payment models to be more value-based, and as we transition toward those models over time, and continue to see shifting of financial liability from payors to providers, the value proposition of biosimilars becomes more relevant.” Biosimilars come to the provider or health system at an average 25% to 35% discount from the reference product, Dr. García said, and those lower costs are passed on to the payor in the form of lower drug charges. Health systems that have their own in-house health plans can derive additional value because the benefits of a favorable acquisition cost and lower reimbursement are both kept within the same organization, he noted.

As far as factors that may boost biosimilars adoption, help may come from arrangements such as the Centers for Medicare & Medicaid Services’ new Oncology Care First plan, announced Nov. 4, which shares some principles with its first incarnation, the Oncology Care Model, including requiring practices to agree to certain financial and clinical performance benchmarks for improved care quality. But payors’ adoption of biosimilars varies widely, partly because they support different products, he noted. Sometimes payors will promote the use of the innovator product, whereas in other cases one or two of the biosimilars are given favored formulary status. “We all know payors have long used different tiers to drive specific drug utilization, but usually those determinations are based on cost-effectiveness,” Dr. García said. The problem, he noted, is when a particular payor “mandates that the most expensive product is used. That places a burden on us as providers because we have to buy the premium-cost product when there are lower-cost alternatives available.” —K.B.

also trickles back to coverage by payors, he noted, who may believe they shouldn’t cover it if it’s not FDA approved. Providers and patients are more open to using a biosimilar if they’re starting a new cycle, like short-term use of some cancer biologics, Dr. Shah noted. For more chronic use products, if someone has been on a product for 10 years, they will be less likely to switch. Improving adoption of biosimilars can be done through multiple mechanisms, including having pharmacist and hospital leader champions within health systems, providing more education to providers and patients, providing biosimilar manufacturers with access to reference product samples, or having the FDA and Securities and Exchange Commission work together to institute anticompetitive regulations, Dr. Shah said.

Generics Paved the Way Jorge J. García, PharmD, the assistant vice president of the system oncology pharmacy service line at Baptist Health South Florida, in Miami, noted that with more acceptance of the drug class, biosimilars “are very well positioned ... to provide patients with multiple options for lower-cost alternatives.” The same way generics helped reduce costs 30 years ago when they were introduced, “biosimilars [are an] opportunity to do something [like that] among biologics, the highest-cost drug category,” he said. “For a long time, we’ve been asking pharmaceutical companies to help us reduce drug costs,” Dr. García added. “The industry has delivered on this [request] by presenting us with a variety of FDA-approved biosimilar options for an array of health conditions. Now we as providers and payors have to learn how to effectively embrace biosimilars so we can benefit.” —Karen Blum The sources reported no relevant ﬁnancial relationships.

More Therapies for More Patients

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. We have a growing portfolio of biosimilars and specialty pharmaceuticals, with a focus on rare and chronic diseases. Our products and services are used to help care for critically and chronically ill patients. We leverage our 100-year history so that clinicians can deliver therapies in ways that are safe, efﬁcient, and affordable. That’s how Fresenius Kabi brings conﬁdence within reach. Visit us at Booth 410 at Asembia’s 2020 Specialty Pharmacy Summit in Las Vegas. www.fresenius-kabi.com/us