Specialty Pharmacy Continuum - January / February 2021 by McMahon Group

Se ee IMMUNE E GLOBULINS S REVIEW W inserted after page 12

Serving managed care, health system and specialty decision makers Volume 10 • Number 1 • January/February 2021 • specialtypharmacycontinuum.com

Now a CMS requirement

UP FRONT ExceleraRx-Shields merger bolsters health-system stake in SP market ............ 3

OPERATIONS & MGMT Telepharmacy takes hold during COVID-19 ................

CLINICAL Pharmacists have the skills to administer HIV PrEP ......

POLICY Some P4P programs may not pay off ................ Inflammatory Rx drives another strong year for specialty ..........

TECHNOLOGY ICD-10 data help streamline specialty care ...................

REVIEW ARTICLE

The Role of the Specialty Pharmacist in

Treating Cystic Fibrosis See page 12.

Home Infusion Therapy Accreditation Rolls Out A

s of Jan. 1, 2021, 21, home infusion providers are officially cially required by the Centers for Medicare re & Medicaid Services (CMS) to carry att least one accreditation to bill Medicare re Part B for home infusion therapy (HIT) HIT) services. To make that transition on a success, providers need to consider nsider a number of important factors, rs, according to three organizationss now offering the accreditation. The first is to o know that Medicare HIT accreditation reditation is not necessarily forr everyone, noted Jon Pritchett, tt, PharmD, the program director ctor overseeing pharmacy programs for the Accreditation on Commission for Health th Care (ACHC). “Some places just focus on pediatric diatric infusions, and Medicare dicare may not be a significant icant part of what they do,” he explained. “But But for organizations ns that have a heavy vy Medicare popula-tion and a lot off those medications aare ree covered, then there’s ’ a good d return on investment for this accreditation.” It’s also important to know why HIT accreditation has gained traction. Historically, CMS had not covered the cost of nursing components for administering HIT. The 21st Century Cures Act, enacted in December 2016, established a new benefit for HIT services, including nursing services; training and

An effective tool for non-340B facilities

Specialty Med Committees Drive Savings

eveloping a subcommittee to evaluate the use of specialty medications among inpatients helped pharmacists at Bryan Medical Center, in Lincoln, Neb., save nearly $650,000 in the first year alone. This financial boon came from evaluating just four medications, according to a presentation at the ASHP 2020 Midyear Clinical Meeting and Exposition. The work began with an evaluation of andexanet alfa (Andexxa, Portola) in the main Pharmacy and Therapeutics Committee, and an acknowledgment Continued on page 4

MFN Drug Price Plan Frozen By U.S. Courts

C education d i not otherwise h i covered d under d the durable medical equipment benefit; remote monitoring; and other monitoring services. In 2019, CMS set the minimum expectations for home infusion suppliers to apply for and receive reimbursement, including the requirement to be accredited by an approved accrediting organization. Many providers have already met the

ourt injunctions have put the nail in the coffin of the Trump administration’s “Most Favored Nation” interim final rule aimed at lowering prescription drug prices, but experts say this probably isn’t the last we’ll see of international drug reference pricing. The rule, which was set to take effect Jan. 1, proposed to restrict costs for the top 50 physician-administered Medicare Part B drugs—which account for almost 80% of Part B spending—to no more than the lowest price that drug manufacturers receive in other similar countries (bit. ly/3oMqlSv). Specifically, it would have replaced the existing average sales price

Continued on page 11

Continued on page 18

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Specialty Pharmacy Continuum • January/February 2021

UP FRONT

Excelera Merger Boosts Health Systems’ SP Stake The recent merger of ExceleraRx and Shields Health Solutions creates a potent new force in the specialty pharmacy arena, one with enhanced scale to compete with large, traditional specialty pharmacies for access to manufacturers’ limited distribution drugs. Specialty “Both Excelera and Shields help their clients knock down barriers to access by facilitating an easy way of collaborating with manufacturers and payors to manage specialty patients,” Troy Polan, Excelera’s acting CEO, told Specialty Pharmacy Continuum. Polan added that the merger allows more patients to be managed in integrated care environments, “where pharmacies are working deeply with [the] entire medical care team and physicians inside health systems.” Under the merger agreement, Excelera will continue to operate independently as a subsidiary of Shields, providing all of the same patient care services to its 28 health-system and hospital members, said Stephen West, Shields’ chief strategy officer. “At Shields,” he added, “the executive team will be working collaboratively with Excelera to identify new opportunities for all of our partner health systems.” The financial terms of the transaction were not disclosed.

Although specialty drugs are used by only 2% of the population, its share of spend jumped from 44.7% in 2018 to 47.7% in 2019, nearly half of all spending on prescription drugs. This was due to new therapies entering the market with few or no competing drugs to drive down prices. Source: 2019 Express Scripts Drug Trend Report.

“That allows us to implement the same things at our Traditional health system. So 52.3% when I look at Fairview now, I have 60-plus partner health systems that could be innovating in a way that I was not aware of before. Now I can learn from them.” Technology will continue to play a major role in the new partnership. Data analysis in health “is a big part of what Shields has done for clients and a core function for our team at Excelera as well,” Polan said. “Through technology,” he added, Excelera members “get to benchmark their performance against that of the network. It provides analytical evidence for the work they’re doing and the value they provide in a network of peers that have the same patient care goals.” In addition, according to the company, Excelera’s and Shields’ integrated care model has the ability to: • reduce medication copayments from hundreds, sometimes thousands, of

Figure. Percentage of total drug spend by drug type, 2019.

47.7% The combined company, encompassing more than 60 health systems and academic medical centers, now extends its reach to 700-plus hospitals that offer specialty pharmacy care services across 43 states. The new network represents almost 30% of nonprofit health care systems, based on net patient service revenues, according to the company, or $30 billion out of the current $100 billion– plus specialty pharmacy market. At Fairview Health Services, one of Excelera’s six founding organizations, Tim Affeldt, PharmD, the vice president for specialty/infusion pharmacy operations, said the merger would enhance Fairview’s ability to share information among its peers. “Health systems are doing different things to innovate within the specialty care model,” Affeldt said.

EDITORIAL BOARD

dollars to an average copay of $10; • streamline time to therapy, typically from several weeks to an average of two days; • decrease physician administrative paperwork by thousands of hours; and • improve medication adherence rates to over 90%, on average. A decade ago, hospital-operated specialty pharmacies were a rare breed. Today, 26% of all U.S. hospitals, and 89% of those with 600 or more beds, own specialty pharmacies, according to a 2020 Drug Channels report (bit.ly/3tgScNm). The sharp increase coincides with the meteoric growth of specialty drug products, which now account for nearly 50% of total drug spending, according to the 2019 Express Scripts Drug Trend Report (bit.ly/3kO36EN). The growth occurred despite the fact that only 2% of the total U.S. patient population requires the closely monitored therapy that specialty pharmacies provide. —Bruce Buckley The sources reported no relevant financial disclosures other than their stated employment.

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Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

P&T Committee Savings continued from page 1

that specialty and orphan drugs are on the rise, said Scott Persson, PharmD, BCPS, the pharmacy clinical manager at the 640-bed nonprofit hospital. “These are not going away anytime soon and are just increasing,” Persson said. He expressed concern about how the many recent pharmaceutical mergers and acquisitions would affect drug costs for his medical center, whose pharmacy is not a 340B facility. The main P&T Committee at Bryan Medical Center had limited time with physicians, so the group tried to get through as many products as possible, Persson said. However, he and his colleagues believed the newer specialty products deserved more extensive review, and also a pharmacoeconomic

with the chief nursing officer: newer medications that may need several days to infuse or require 1:1 nursepatient ratios to administer. Once the group had their approvals and input, they reached out to physician leaders through a clinical integration committee and divisional meetings in areas such as surgery, critical care, trauma and oncology to find support for the process and see who might participate. The high-cost medication subcommittee was formed, consisting of the vice president of medical affairs as the chair, as well as the chief nursing officer, chief financial officer, pharmacy director and clinical manager, five physician members, and risk management.

A corporate complianalysis and modelance officer and ethics ing to determine the committee represenproducts’ true effect on tative are available as the organization’s fisneeded. The subcomcal viability. They also mittee makes recomwanted to have provider Andexanet alfa: mendations to the main endorsement available P&T Committee, which for any controversial accepts their decisions decisions. A 2018 ASHP or makes adjustments meeting presentation C1 esterase as necessary, Persson by pharmacists at the inhibitor [Human]: said. University of Virginia Subcommittee memHealth System conbers aim to evaluate vinced him that setting new formulary requests up a subcommittee to Eculizumab: from a financial and evaluate high-cost speresource utilization cialty medications was perspective, while conthe way to go. sidering the strategic First, Persson and his direction of the medicolleagues approached Total savings: cal center, said Persson, their senior leaderwho provides members ship, including the with medication monoCEO and chief opergraphs, guidelines and ating officer to explain the pharmacy’s role in strategic plan- relevant literature a week or two before ning. They also talked to the chief their meetings. Factors they consider financial officer about high-cost, involve inclusion criteria for the drugs, low-reimbursement medications, and measurable benefit to patients served, reviewed another potential sore point labor and resource requirements for

A Trio of Savings

$400,000 $10,400

$234,800

$645,200

‘We’ve had very favorable results in avoiding unnecessary medication expenditures, improving physician engagement and enhancing our senior leadership’s perception of the pharmacy’s contribution.’ —Scott Persson, PharmD administering the medications, and cost. Cost includes billing and reimbursement, what the Centers for Medicare & Medicaid Services and commercial payors will cover, diagnosis-related group fees and related payments. Pharmacy leads the discussion by explaining the drugs and their mechanisms of action, where the products fit into therapy, and what alternatives are available. The entire team also focuses on the risks versus benefits of each medication to try to mitigate any patient safety conm cerns. The subcommittee then decides whether to t recommend that the drug be added to t the formulary and with any restrictions. restriction

specialty medication requests for patients that may come up between meetings. Developing a specialty medication committee in this way has yielded significant benefits, Persson noted. “We’ve had very favorable results in avoiding unnecessary medication expenditures, improving physician engagement and enhancing our senior leadership’s perception of the pharmacy’s contribution. Partnering with hospital administration in such initiatives creates another avenue to demonstrate how pharmacydriven collaborations generate positive outcomes, resulting in significant value to the health system.”

Meeting the COVID-19 Challenge

Danielle Griggs, PharmD, MBA, the pharmacy director of business services at the University of Virginia Health System, in Charlottesville, said she was thrilled that another medical center benefited from her 2018 ASHP meeting presentation. She helped launch a Novel Therapy Committee at her medical center in 2017. As a subcommittee of the larger P&T Committee, it reviews requested, very high-cost specialty medications such as limited-distribution specialty drugs or those that have unique procurement and reimbursement considerations, to complete a more thorough financial analysis, Griggs said in a telephone interview. The Novel Therapy Committee meets monthly when requests are received, Griggs said. Members include the chief medical officer; chief nursing officer; pharmacy representatives; representatives from finance, revenue cycle and payor contracting; and leaders within the clinical service line area where the drug is being requested. They have reviewed 12 drugs to date, saving “millions of dollars,” she said. “It’s been very successful,” Griggs said. “In addition to the important safety and efficacy conversations happening at P&T, this [subcommittee] also offered an additional venue to do some financial modeling about these high-cost therapies. In almost all cases, the recommendation is to move forward with the therapy, but we’re able to put in considerations and parameters to ensure we are using the drug in the most appropriate manner.”

Althoug the subcommittee’s efforts Although were ham hampered by the focus on the COVID-19 pandemic during COV most mos of 2020, the group still conducted evaluations of four co medications, accruing an estim mated $645,200 in cost avoidm ance. This includes estimated an savings of $400,000 from s andexanet alfa, $10,400 from a C1 esterase inhibitor [human] (Berinert, CSL Behring), and $234,800 from eculizumab (Soliris, Alexion). ecu Additional savings should be seen over time, Persson said. He offered the following advice for pharmacists looking to start similar subcommittees: Engage members. “This is critical for success,” Persson said. “You need people to really take the time to review the literature and who want to be part of the discussion.” Keep a tight rein on meetings. Keeping them as short as possible to cover key agenda items will help avoid overwhelming your volunteers. To enhance physician engagement in the evaluation process, he said, review only one medication at each meeting. Get the right people involved. Having unbiased subject matter experts is critical, as is the inclusion of key stakeholders early in the process, Persson stressed. An oncologist, for example, can help promote your message to their colleagues. Also, be sure to include financial representatives and provide them with the proper ICD-10 codes so they can pull patient data. Finally, designate a person to be responsible for developing a realtime process to evaluate nonformulary

‘Thrilled’ to Be a Model

—Karen Blum The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

Community Oncology on COVID-19 Front Lines Agility. Flexibility. A can-do attitude to adapt to the unexpected. These are some attributes community oncology practices learned during the early days of the COVID-19 pandemic—lessons that proved invaluable as the cases continued to mount. The coping strategies put renewed emphasis on the importance of responsive leadership in dealing with crises, according to panelists on a Cancer v. COVID session at the Community Oncology Alliance’s 2020 virtual conference. With many systems having to retool almost overnight to a new normal, accelerating practices into high gear was crucial as the pandemic gripped the nation, the panelists agreed. For Darryl Nunes, PharmD, the pharmacy director at Southeast Nebraska Cancer Center, in Lincoln, leadership has been the driving force in maintaining high levels of operations. “We are

to 30% drop in patient visits. But telehealth picked up the slack and now is a newly entrenched communication tool, addressing the concerns of more than 6,000 patients. “We will definitely continue with telehealth,” Chang said. “We see the benefit of how it can work. Before, our concern was that our patients, many of whom are from an older generation, might be unable to manage the new technology. But now,

and patient and staff safety were among the hot topics, she noted. To reduce exposure of patients and staff and maximize efficiencies, six clinics temporarily closed to adjust to a 20%

as we all get accustomed to working more remotely, they are more equipped.” (For a further look at telepharmacy’s growth during COVID-19, see page 8.) At New England Cancer Specialists, in Maine, the leadership team started twice-daily conference calls as it accelerated implementation of numerous operational changes in a short period, said Steven D’Amato, BScPharm, the CEO. see FRONT LINES, page 7

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delivering more prescriptions through mail carriers and conducting more clinical conversations over the phone,” Nunes said. Patients call when they arrive at the center, so staff can bring their prescriptions to their cars for curbside pickup. Consistent disinfection of counters and surfaces and requiring anyone entering the facility to wear a mask are important aspects of day-to-day operations. Fluid communication with patients through the webpage, Facebook and signage around the building, as well as phone calls is part of the rigorous regime, he noted. Melody Chang, RPh, MBA, the director of pharmacy operations at Florida Cancer Specialists, in Fort Myers, noted that the pandemic underscored the importance of rigorous oversight of pharmacy operations at the 100 community oncology practices in her group. Early on, Florida was not as hard hit by the pandemic as some other regions. In addition, the system has emergency protocols to handle the annual threat of hurricanes, so their urgent response capability was not overly stressed initially, Chang said. Still, to prepare, communications with leadership ramped up dramatically, from a once-weekly teleconference to daily teleconferences to brainstorm the myriad emergency issues raised by the pandemic. Supplies, physicians’ concerns,

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Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

COVID-19 Hasn’t Squeezed IG Supplies—Yet Significant anticipated shortages of immune globulin (IG) as a result of fewer plasma donations during the COVID-19 pandemic have yet to occur, but experts say it’s likely these scarcities have only been delayed by a corresponding decreased demand for IG during the past several months. “As of the beginning of February, we haven’t experienced any supply issues,” said Bhavesh Shah, MD, the senior director of specialty pharmacy strategy and market access and hematology-oncology pharmacy at Boston Medical Center. Given the length of the manufacturing process for IG, Shah said he would have expected any shortages resulting from declining plasma donation levels due to the pandemic, which first hit the United States in March 2020, to start becoming noticeable by November or December. “This has not happened yet, which could be because patients concerned about going out and possibly being exposed to the virus were extending their doses to every eight weeks, for example, when they were supposed to get IG every four weeks,” he said. “Of course, the numbers of newly diagnosed patients were down, because the diagnoses for IG indications like PID [primary immunodeficiency] and CIDP [chronic inflammatory demyelinating polyneuropathy] need to be made in person, utilizing bone marrow biopsy, neurologic testing and other resources that cannot be done via telehealth. So, there has been a lower volume of patients getting new starts of IG.” Shah said he remains watchful, however. “Hospitals are now overwhelmed in many areas of the country, so you’re likely getting even more reduced levels of plasma donations. Since things were not as locked down over the summer, there were probably more patients with conditions like CIDP and PID getting diagnosed or resuming treatment schedules they had missed, so we may see supply issues in six to nine months. I wouldn’t discount the potential for COVID-19–related shortages until we’ve made it through the spring.”

What About ASHP List? In a Jan. 21 update, ASHP’s drug shortage database did list several brands and concentrations of IG products in short supply. But Erin Fox, PharmD, the senior director of drug information and support services at University of Utah Health, which provides data for ASHP’s reporting, said the shortages are not causing problems for patients. “The main issue is that you may not be able to get the exact product you want right now or in the exact amount, but there is certainly product available,” Fox said. “Gammagard liquid from Takeda is the most difficult. But patients aren’t going without.”

IG stakeholder groups are also keeping an eye on plasma collection and other factors that could affect IG supplies. On Nov. 4, 2020, the Plasma Protein Therapeutics Association (PPTA), which represents more than 860 human plasma collection centers in the United States and Europe, issued a statement warning of an urgent need for plasma donation. “Reports vary, but plasma collectors experienced significant declines in collections due, in part, to the impacts of social distancing measures and other mobility restrictions caused by the COVID-19 pandemic,” the statement said. “Considering the complex manufacturing of plasma-derived therapies can take [up] to 12 months, any decline in plasma donations could impact patients’ ability to access [IG therapy]. This sharp decline in plasma collections could cause more significant challenges in the months to come.” In December, PPTA hosted a roundtable featuring representatives of patient advocacy groups, physicians, thought leaders and representatives from the FDA’s Center for Biologics Evaluation and Research (CDER), at which they noted continued significant declines in plasma collections. Distributors are also concerned. “A top IG manufacturer told me recently that they think it looks like our U.S. supplies will be OK through the end of January, but what things look like thereafter is still to be determined. It’s a very dynamic situation,” said Patrick Schmidt, the CEO of FFF Enterprises, a national wholesaler of plasma products. Schmidt said donations at plasma centers in Texas’ Rio Grande Valley were particularly hard hit during COVID-19 surges in 2020. For example, by midMay, he noted, donations in that region were down by about 62% compared with the same period in 2019, based on feedback he received from IG manufacturers. Donations nationwide were down by about 51% for that period, Schmidt said. He added that “there was a bit of a resurgence in donations over the summer when cases were down, but now we’re in a much more difficult time and donations will likely decline again.” Clinicians caring for patients requiring IG agree with Fox—shortages have not yet affected their patients, but they believe that may be due to the fact that, just as plasma donors have avoided donation centers during COVID-19–related quarantines, some patients have missed

‘Plasma collection is down, but there has been a corresponding decrease in the use of IG products during the pandemic.’ —Eric Tichy, PharmD doses during the pandemic. “Plasma collection is down, but there has been a corresponding decrease in the use of IG products during the pandemic,” said Eric Tichy, PharmD, MBA, the vice chair of supply chain management at Mayo Clinic, in Rochester, Minn. “When people miss these doses, they don’t get additional doses later on. They just get missed. So far, we are in a pretty good position from an IG inventory standpoint.” But that could change, because other factors might drive up usage of plasma products, Tichy noted. In addition to the development of convalescent plasma treatments for COVID-19, Tichy said he wonders about new indications for IG in the treatment of the disease’s longterm neurologic effects. “For example, the Kawasaki-like disease in children,” he noted. “If data were to emerge showing that IG treatments helped with that, it could further increase the use of IG.”

Ensuring Rational Use In the meantime, Shah urged prescribers and pharmacies to continue rigorous utilization management of IG, particularly given that the demand for these products continues to increase with new indications, the aging of the population, and more diagnoses of primary immunodeficiencies and neurologic conditions (Am J Manag Care 2019;25[6 suppl]:S105-S111). “It’s important to ensure that the indication for which you are using IG has appropriate evidence behind it,” he said. To that end, he directed clinicians to a 2017 review by a work group at the American Academy of Allergy, Asthma and Immunology (AAAAI). The review summarizes the evidence for both subcutaneous IG and IVIG indications (J Allergy

Clin Immunol 2017;139[35]:S1-S46). The AAAAI also offers principles for the effective use of IG for patients with PID.

Conservation Tips Shah offered some additional IG conservation tips: Don’t hoard! That will only make matters worse. “There’s going to be some cannibalization of supply as people recall their difficulties with previous shortages,” Shah said. “I’ve heard rumblings that home infusion providers and specialty pharmacies are buying up supplies of plasma products.” Evaluate IG use more stringently. “We know that ideal body weight [IBW] is just as effective as actual body weight for IG dosing,” he said. “If we were to use IBW for everyone in the country, that would decrease consumption by 20%, or 20 million grams of IG.” Be careful about off-label use. For many immunodeficiencies, IG is the primary treatment option, and there are few viable alternatives. To preserve supplies for these patients, consider other treatments for conditions in which IG is used off-label. “For example, in the setting of polymyositis and dermatomyositis, there are other immune modulators that can be used,” Shah said. Consider extended dosing. “We have a traditional mindset where IG has to be given every four weeks,” Shah said. “For some indications, we can extend that to every six to eight weeks, or even every two to three months. These decisions need to be made on a case-by-case basis.” —Gina Shaw The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

FRONT LINES continued from page 5

As communication became vital to keep patients aware of how the health care system was responding to patients’ concerns, telemedicine took on a significant and urgent role. In an all-hands-on-deck strategy, his team ramped up a telehealth program in four days and showed how agile systems can be under duress, D’Amato said. Communication also was a key tactic at Oncology Consultants, in Houston, where Alti Rahman, MHA, MBA, the practice administrator, discovered that dealing with the differences between people’s perceptions and objective truth was an ongoing challenge. “It is a matter of leadership being comfortable with anxiety, doing our job to get to the truth and to the action we need to keep our staff safe and patients healthy,” Rahman said. Telemedicine also helped Northwest Medical Specialties, in Washington, cope with the COVID-19 crisis, according to its medical director Sibel Blau, MD. “It has been amazing from a physician’s perspective. It provided us with great patient care in ways we never thought of. We had the tools and technology, but never had tapped into it.” For Blau, the leap is like “using the telegraph in the old days and email now for communication. I can’t imagine not having telemedicine going forward.”

Uncover Deficiencies As helpful as telemedicine has become, sometimes glaring deficiencies surface in the most unexpected ways. An experience with a cancer patient in her mid-60s with longstanding diabetes shone a light on some of the deficiencies of telemedicine at East Syracuse, N.Y.based Hematology/Oncology Associates of CNY. After an intermediate visit with the nurse practitioner, Anthony Scalzo, MD, president, had a telemedicine appointment with the patient. He asked her how she was feeling and tolerating the medication he had prescribed, and he reminded her that the drug could affect bone density, he recounted. “I advised her to keep up the calcium and vitamin D and not to forget weight-bearing exercise,” such as walking. “‘But, Dr. Scalzo,’ she responded, ‘I don’t have any legs,’” he recounted. After recovering from acute embarrassment, Scalzo said he learned a significant disadvantage of telemedicine: It doesn’t allow a full view of the patient. “Not seeing the entire patient and not getting the physical sense of the patient, things … can slip through the cracks,” he said. Going forward, health care providers must put into practice the hard-learned lessons—from addressing safety concerns to ensuring an even higher level of preparedness to fine-tuning a newfound

ubiquitous, Rahman predicted. “The new normal will depend on what researchers learn about COVID-19,” he said. “There is still —Melody Chang, RPh, MBA more to understand about different safety measures. The digital aspects of ways we’re reliance on telemedicine, the panel communicating with patients will be increasingly important. There will have experts agreed. Safety protocols will become an to be new business models that will issue as telemedicine becomes more come out of this—good and bad—that

‘We will definitely continue with telehealth. We see the benefit of how it can work.’

we will have to see how they affect communities of patients.” In the future, he said, health care providers must continue to adapt and have a clear direction of where they are going. Toward that end, Rahman said, “being honest where mistakes were made has brought the practice together and that has been an important lesson here.” —Sharon Donovan The sources reported no relevant financial disclosures.

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Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

Virtual SP Care Gains Traction During COVID-19 Going virtual during the COVID-19 pandemic has not diminished the ability of health-system specialty pharmacies to meet their patients’ medication needs and provide quality care, according to the experience of several large centers. In fact, telemedicine has helped the facilities improve communication among clinical pharmacy specialists, patients and providers. The flexibility of telemedicine, and “the convenience of providing patients with education while they are at home has facilitated greater contact between pharmacists and specialty patients,” Diane Kim, PharmD, a clinical pharmacy specialist at Penn Presbyterian Medical Center (PPMC), in Philadelphia, said during a presentation at the ASHP 2020 Midyear Clinical Meeting and Exhibition.

Moving Offsite But Still Engaged Kim said there are four specialty pharmacies located at PPMC specialty clinics. Pharmacists there do everything from confirming the appropriateness of a specialty drug to ensuring medication access, providing medication counseling, monitoring adherence and identifying drugdisease and drug–drug interactions.

“Remote EHR access is our primary means of documentation both between pharmacists and with providers, so having access to the EHR has been key to a seamless transition to telemedicine,” Kim said, adding that pharmacists have also been using the EHR to see scheduled appointments and respond to clinical questions from providers, or to provide patient education. According to Kim, the switch to telemedicine has not limited specialty pharmacy operations. She and her colleagues found new specialty prescriptions increased by 12% between February and July 2020, compared with the six months before. Kim said this increase was likely due to a higher specialty prescription capture rate from PPMC physicians, which itself was a result of a “strong relationship between

‘[Injection training] was a particularly tough challenge in the beginning, when strict restrictions were in place at the hospital and clinics and pharmacists worked fully remotely, or in many cases patients were fearful of coming into the clinic or hospital.’ —Diane Kim, PharmD Like so many others around the country, the health system’s pharmacists moved offsite in March 2020. Since then, they have been using PPMC-issued mobile phones and laptops to remotely access the electronic health record (EHR) (EPIC), Kim said. Pharmacists also use these devices to call patients, access video conferencing platforms that are compliant with the Health Insurance Portability and Accountability Act of 1996, and participate in collaborative team meetings, she said.

pharmacists and clinic providers, consistent communication with the clinics during these unprecedented times and thorough patient education for new medications as well as medication reconciliations, which specialty patients and providers find valuable.” Medication refill rates have remained unchanged thanks to an established workflow that includes specialty pharmacy patient outreach phone calls and courier-delivered medications, Kim noted. “Essentially, the only services that

have been impacted ted are the face-to-face injection njection training, along with h a shift to telephonic medication dication counseling and medication reconciliation.” n.” She acknowledged thatt some patients find it diffiicult to learn injection n techniques virtually, ly, because they “justt naturally communicate and learn better face-to-face, not to mention there are distractions at home.” Kim added: “This was a particularly tough challenge hallenge in the beginning, when en strict restrictions were in place at the hospital and clinics and pharmacists worked fully remotely, or in many cases patients were fearful of coming into the clinic or hospital.” Patients who have difficulty learning injection techniques over the phone or through video conferencing are directed to online instructional videos and can speak with a caregiver at their convenience for further guidance, Kim said. However, at press time, PPMC specialty pharmacies had implemented safety protocols and were offering in-person appointments as an option, she noted.

Vanderbilt Gets a Head Start Steve Burkes, PharmD, a clinical pharmacy specialist at Vanderbilt University Medical Center’s adult endocrinology clinic, in Franklin, Tenn., said his pharmacy now provides remote patient education for many of their specialty medications. “The majority of my telemedicine visits with patients are to review new starts, and I have demos of most of our medications as well as some educational tools I use to help patients see what to expect, and to help them understand the purpose of their particular specialty medication,” Burkes said. Like Kim, he said some patients have found it difficult to learn how to use their device remotely and visit the clinic for inperson device training. Burkes said many patients now prefer

the convenience of a remote visit and his team will continue to offer telehealth as an alternative to in-person visits. Burkes’ colleague, Johnna Oleis, PharmD, a specialty pharmacist in the Vanderbilt Hemostasis-Thrombosis Clinic, said her team has been performing most of their annual comprehensive patient examinations remotely during the pandemic. Oleis has found that implementing a telemedicine-based approach has not only allowed her team to continue providing the care patients expect; it also has come with additional advantages, such as saving time. “Patients are scheduled for a twohour, in-person visit with individual members of their care team, but with telemedicine, we all get on the same 30-minute call,” Oleis explained. Through these team–patient encounters, Oleis and her colleagues realized that “providers do a lot of repeating of the same information” in their separate appointments. “In after-appointment meetings for in-person visits, we often find that a patient has given different information to different providers, so it’s been good to get the same information from the patient during the one call.” —David Wild The sources reported no relevant financial disclosures.

If you missed any recent issues of Specialty Pharmacy Continuum, visit www.specialtypharmacycontinuum.com.

Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

CDC Guidelines Are a Tool for Safer Opioid Use Alexandria, Va.—Given the well-documented scope of the opioid crisis, one would think all providers have gotten the message that less is more when it comes to opioid prescribing. But overprescribing is still happening, with one recent study showing that an average of more than 50 excess pills were given to patients following total knee replacement (J Arthroplasty 2020 Feb 5. pii: S0883-5403[20]30115-7). In another study, investigators found nearly half of patients treated with opioids during their hospital stay were discharged with prescriptions for the painkillers, many of which were in violation of current treatment guidelines (JAMA Surg 2018;153[2]:e174859). Fortunately, specialty pharmacists can help ensure more rational opioid use once these patients are back in ambulatory care settings—a goal best accomplished by looking to the CDC for assistance, speakers said at the 3rd Annual World Congress Opioid Management Summit. Available tools include a mobile app that helps promote guidelines-based pain management; tips for tapering patients off opioids in a safe and responsible manner; and reminders to precribers that they need to consider nonopioid options for pain patients when appropriate, according to the speakers.

Tech Can Help The CDC has released a mobile app (bit.ly/3b4U8yw) of its current opioid prescribing guideline, said Jigna Patel, PharmD, a critical care pharmacist at Temple University Hospital, in Philadelphia. The app highlights key actions prescribers and allied health professions such as pharmacists can take to ensure the safe use of opioids, including: • selecting appropriate opioids by assessing what types of pain patients have, and whether the pain is related to a recent procedure versus a chronic, long-term issue; • using immediate-release agents as much as possible to reduce dependence; and • employing multimodal pain approaches. This strategy can include over-the-counter analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs), or for postsurgical patients, complementary services such as occupational and physical therapy, core strengthening, and getting out of bed and walking.

Initiation and termination of opioids also are important to consider, Patel said: “Every opiate should be prescribed with a plan as to how long it will be on board, and what the plan is to take it off.” Regarding dosages, Patel recommended starting low and using combination products when available. Patient follow-up should occur at least every three months, according to the CDC. For people taking long-term opioids, she urged clinicians to think about how often to follow up to assess pain goals, and look into other modalities to help achieve those goals.

6 REASONS TO TAPER

Consider tapering to a lower opioid dosage, or tapering and discontinuing when patient:

➊

A Stepwise Approach

Requests dosage reduction

➋ Does not experience clinically meaningful improvement in pain and function (e.g., at least 30% improvement on the 3-item Pain, Enjoyment, General Activity scale)

The Stewardship Model In Philadelphia, Temple University Hospital, Thomas Jefferson University and other academic centers began working with the city’s Department of Public Health in 2018, to implement the CDC’s opioid prescribing guideline and become better stewards of how opioids and pain are managed in their own facilities, similar to what many hospitals have done for antibiotics, Patel said. The care setting determines, to some degree, the approach taken: Outpatient settings. Hospitals are educating patients undergoing elective surgeries about realistic expectations of how much pain they will have after their procedure, Patel said. They also pushed for early movement initiatives, setting movement goals, and using physical and occupational therapy. In addition, they conducted frequent follow-ups with patients to assess how they were performing activities of daily living and what types of pain they experienced. For patients needing pharmacotherapy, they relied more on nonopioid options including acetaminophen and NSAIDs when possible, or peripheral nerve blocks for those staying in the hospital overnight. Inpatient settings. The hospitals leveraged their electronic health record system to make sure that when physicians ordered medications postoperatively, the order sets had a finite number of days of therapy or number of opioidcontaining products that the patient could receive, Patel said. Teams involved went through every type of surgery with different departments to discuss what

instead of every four. If a patient is experiencing adverse events, such as withdrawal symptoms or breakthrough pain, you don’t want to prescribe another opioid; instead, just slow the taper. “Coming off of long-term opiates is a very daunting assignment for patients, especially those who were chronically treated,” Patel said. “You want to go slow, identify the right patients and really assess their goals.”

➌ Is on a dosage of 50 morphine milligram equivalents per day or more without benefit, or opioids are combined with benzodiazepines

➍ Shows signs of substance use disorder (e.g., work or family problems related to opioid use, difficulty controlling use)

➎ Experiences an overdose or other serious adverse event

➏ Shows early warning signs for overdose risk, such as confusion, sedation or slurred speech

pain relief would be appropriate in the initial postoperative period. They also set morphine equivalent doses to target, created a dashboard to identify patients prescribed opioids and to reassess them daily. They brought in complementary services such as physical and occupational therapy, when helpful. They are collecting data to publish at a later time.

Careful Drug Tapers When tapering patients off pharmacologic therapy, Patel said, try not to decrease by more than 10% of the total daily dose each month. Decrease the dose first, and once you find the lowest tolerable dose, increase the interval, such as taking medications every six hours

The CDC guideline has 12 recommendations grouped into three conceptual areas, Alisher R. Dadabayev, MD, the PACT pain lead with the VA Ann Arbor Healthcare System, in Michigan, noted during the World Congress. These areas determine when to initiate or continue opioids for chronic pain; opioid selection, dosage, duration, follow-up and discontinuation; and assessing risks and harms of opioids. Three strategies to implement the prescribing guidelines have been used in the United States, Dadabayev said: 1. Translation and communication. The CDC offers the app and pocketsized checklists that each provider can access online or print to share with patients. They cover how to manage patients safely and provide strategies for tapering opioids. 2. Education and training. The CDC has online training modules and webinars on applying the guideline. 3. Insurer interventions. Payors have begun to cover evidence-based nonpharmacologic pain therapies such as exercise and cognitive-behavioral therapy, and reimbursing providers for patient counseling and checking state prescription drug monitoring programs. Applying the above steps to opioid management is a “high-yield” strategy, “because one prescriber cannot really solve the opioid problem in his or her community, or within his or her practice,” Dadabayev said. Over four years at his medical center, he noted, adopting multimodal approaches to pain and educating primary care physicians about more judicious use of opioids have reduced the use of long-term opioids from 20% of patients to 7.5%. —Karen Blum The speakers reported no relevant financial disclosures.

Resources CDC Guideline for Prescribing Opioids for Chronic Pain

CDC Opioid Prescribing Guideline Mobile App

Tapering Long-Term Opioid Therapy in Chronic Noncancer Pain

bit.ly/2Ms39Lb

bit.ly/39AwQCv

mayocl.in/3amC4kB

Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

the standard for any accrediting body that wanted to do virtual surveys.

How will the addition of HFAP programs benefit existing ACHC customers, and vice versa?

ACHC/HFAP Merger: An Interview With President and CEO José Domingos

s of Oct. 19, 2020, the Accreditation Commission for Health Care (ACHC) and Healthcare Facilities Accreditation Program (HFAP) have merged, marking the first time that two accreditation bodies with Centers for Medicare & Medicaid Services (CMS) deeming authority have combined forces. The HFAP will operate as a brand within ACHC, and collectively the organization will be known as ACHC. Specialty Pharmacy Continuum spoke with ACHC President and CEO José Domingos about the merged company and what customers can expect in terms of service and support.

What led to the merger of ACHC and HFAP? Several years ago, I was introduced to Meg Gravesmill, the previous CEO of HFAP and now the vice president of HFAP’s programs under ACHC. Over the years, we became aware that our organizations shared a similar approach to accreditation: very educational and nonconfrontational, with a third-party review focusing on quality. I’ve always said not all accreditors are created equal. If you’re looking to simply check a box for a regulator or third-party payor, ACHC is not the right choice for you. For organizations looking to truly become better organizations, we are committed to being partners in helping them get there. It’s a journey of continuous improvement. As accreditors, although we have contact on a regular basis, we show up at an organization to survey every three years, so if you’re not committed to maintaining that quality over time, the impact of accreditation is not what it should be and not a good return on investment. We have a tremendous amount of educational resources, with regulatory teams and clinical teams all very well versed in the segments they serve. We highly encourage our providers to use us as an extension of their organization and a resource to close gaps and understand regulatory requirements. Both organizations [value collaboration], and it became clear that the way ACHC and HFAP as separate entities viewed ourselves philosophically was very similar—not just in the approach with customers but also internally with our employees. As we continue to grow, we intend to keep a very family-type atmosphere in our combined organization. This focus makes us very approachable while also making it a great place to work. Then we also found that our service lines had very little overlap, and that is ultimately how the idea to create a one-stop shop for accreditation focused on customer service and innovative thinking became appealing enough that both boards recognized that benefit and decided to support the merger. We came to the conclusion that the future of accreditation is in full service, where niche players, in my opinion, will eventually become irrelevant.

How did the process of combining the two organizations work logistically? The merger is still an ongoing process. Some aspects of the business are relatively easy to combine, like human resources, finance and information technology. But where we have individual subject matter expertise, we don’t want to mess with that, so we are not changing existing processes. ACHC is larger and has more staff and infrastructure, so we can give HFAP programs more room to breathe and grow, allowing their smaller staff to wear fewer hats and refine their focus. We’re putting together natural combinations to get efficiencies of operation, but we will not interfere with the expertise and processes to which current customers are used to dealing. We want this merger to be as nondisruptive as possible for customers and employees. ACHC is based in Cary, N.C., and HFAP in Chicago, and ultimately our intention is to consolidate for economies of scale. But we’re not going to do that at the cost of forcing employees who have experience in this space to decide between relocating to have a job and staying in a home they love but losing their job. Anybody who has an interest has been given the option to relocate, and some are taking us up on that.

Has COVID-19 posed challenges to merging? Definitely, but in fact, we were ahead of the curve in some ways. A few years ago, ACHC created an innovation team. We couldn’t have possibly foreseen this exact situation, but I asked the team to conceptualize what accreditation would look like 10 years from now, and one of the things I used as an example, that seemed far-fetched at the time, was whether or not virtual surveys would make sense. Could we literally drop a “robot” into a facility, maybe an iPad or a camera with a stand? That’s how the organization would know they were getting a survey that day, for those that need to be unannounced. They send us a floor plan and we tell them to take the iPad and turn left here, open that closet, open that door and so on. Because of our brainstorming around this concept, we were ahead of the curve in being prepared with a virtual survey process. It unfortunately came to fruition in a way no one would have wanted. We shared our process with CMS in early April, and they accepted and adopted our virtual survey process as

Ultimately, we think that having a full-service accreditation is where the future is going. Given that health care has seen so much consolidation, many systems, partnerships and even individual provider entities need multiple accreditations. To have a single body that offers a full spectrum of solutions with a simple process will reduce duplication of efforts by customers, streamlining the amount of effort and work they need to put in when they need multiple accreditations. Staff members working for providers who are tasked with regulatory compliance will focus less on trying to crosswalk what they do and more on how they demonstrate delivery of safe, high-quality care for patients. A lot of the suite of what HFAP brings in is very complementary to what we’re already doing at ACHC. For example, a few years ago, Michigan added a requirement for sterile compounding facilities to become accredited. Ours was the first accreditation approved in that process. For most large hospitals, it’s not an issue to take on another accreditation; they have the bandwidth for it. But that’s a challenge for small rural critical access hospitals, who may only treat one patient per week who needs this type of compounding. We wanted to service these customers, but have it make financial sense for them and cover our costs in doing so. HFAP offers an accreditation for critical access hospitals, so by combining our services, we can bring them a fullservice, real-world solution that is very cost-effective.

Why is CMS deeming authority such a valuable component? First, it’s historic. Second, it’s important because while one might think it produces less choice for providers, we think it’s actually the opposite. In the past, there have been very few accrediting organizations covering the entire continuum of care. Now there’s a new option with ACHC. As an organization that leads with education and collaboration, one of our main goals is to maintain the ability to be nimble and meet the needs of health care organizations. Having another full-service accreditor in the space provides options, and competition makes everyone better. We also just released a telehealth distinction in addition to our virtual survey process, to provide those types of services for rural health and critical access hospitals. If you’re limited on resources locally, you’re able to use this distinction to tap into other expertise that may not be local to you. We intend to keep introducing these innovative approaches to the industry.

What changes can organizations that have been accredited with one or the other group expect? All the relationships we and HFAP had with organizations will remain intact; no additional processes are required for those customers. We want to be seen as an extension of our customers’ organizations and a resource for them to understand and interpret what requirements are being imposed on them. What does change is the depth and breadth of resources we will be able to offer from an education, expertise and engagement standpoint. These will be growing, which means more opportunity for them. I would suggest that ACHC is second to none as far as customer service and being a resource to our customers. ■

Specialty Pharmacy Continuum • January/February 2021

OPERATIONS & MANAGEMENT

Accreditation at Home continued from page 1

HIT accreditation deadline. ACHC, for example, accredited about 250 HIT suppliers before the Jan. 1 deadline, Pritchett noted. “Most of these have been current customers of ours, home health agencies or infusion pharmacies who are already carrying other accreditations of ours,” he said. “We put these services together so that a company can have one organization that accredits all their needs.” It’s easy to confuse the multiple accreditation programs, Pritchett added. The ACHC has had an infusion pharmacy accreditation for some time, covering the pharmacy side of the provision of home infusion products—what a pharmacy needs to bill Medicare Part B for covered drugs, supplies and equipment. “It also digs into the quality assurance controls found in U.S. Pharmacopeia Chapter <797>,” he said. “We have also had an accreditation program for infusion nursing for a number of years, covering the part of the patient care journey when a nurse is administering the medication in the home. This new Medicare HIT accreditation is very similar to the infusion nursing piece.” The ACHC’s HIT accreditation standards include sections covering organization and administration, program/ service operations, fiscal management, human resource management, provision of care and record management, quality outcomes/performance improvement, and risk management: infection and safety control. As for how long it takes to get accredited, that depends on the client, Pritchett said. “Anybody doing a new service with us works with an account advisor who walks them through the accreditation process and helps them set a ‘date of readiness’ when they feel they will be in compliance with our standards,” he said. “Once that is in place, we can typically survey them within 90 days, and then our accreditation decision is awarded. If somebody called us today and said they were ready to be seen right now, they could be accredited as soon as 30 days. But there’s always a range.”

URAC’s Approach URAC has accredited 10 pharmacy organizations as HIT providers to date, according to Heather Bonome, PharmD, URAC’s director of pharmacy. “When we launched this program, we decided that it would be designed and offered

these patients. But if we are surveying a pharmacy’s whole patient population and they are noncompliant with a commercial member, that could impact their whole accreditation and ability to bill CMS. So these are the same standards but two separate accreditations and two separate reviews.”

NABP The National Association of Boards of Pharmacy (NABP) began accreditation of home infusion providers for Medicare HIT services in March 2020, and had accredited two organizations by Jan. 1. “We focus on three key areas for these multiskilled professionals,” said Lemrey “Al” Carter, PharmD, NABP’s executive director/secretary. “These include pharmacy operations, security of supply chain, and the safety and sterility of compounding and administration. These are the areas where you have the most fluctuation, so we focus on making sure that

for home infusion pharmacies. Home health agencies can also bill for this benefit, but we decided our focus would be on pharmacies, because we have so much expertise in the pharmacy space. The new Medicare HIT services benefit is really about the education, the in-home services, the support, assessment and monitoring that pharmacies do when they dispense the medication.” The URAC HIT accreditation sections include risk management, consumer protections and empowerment, operations and infrastructure, performance monitoring and improvement, practice management, practice standards, guidelines and protocols, consumer safety, and complete care services. At the same time, URAC also launched a separate companion program. “Our Medicare HIT supplier accreditation is the one that is CMS deemed,” Bonome explained. “When organizations are pursuing that accreditation, they can also pursue a separate infusion pharmacy accreditation. It has the exact same set of standards, but they are two different accreditations, because most infusion pharmacies are not only providing care to the Medicare Part B patients that would qualify for the new reimbursement. A lot of commercial plans want a general infusion pharmacy accreditation similar to what we see in the specialty pharmacy space, because there are so many additional clinical services involved for

their entire pharmacy operation is intact, that they have an enhanced patient care model, and that their supply chain is secure.” Sections of the HIT standards specifically cover general requirements, sterile compounding, plan of care, initial assessment, professional services/ongoing assessment and national standards.

Are We There Yet? To date, Carter said, NABP’s accreditation process has been taking approximately six to nine months, depending on how much information the pharmacy or home health agency has in order. “The process for those that do have everything in order could ultimately be 90 days or less, but it’s been taking longer because of COVID-19 challenges and because this particular accreditation is so new right now.” So far, the most challenging aspect of accreditation for most applicants, Carter said, has simply been the painstaking element of gathering policies and procedures. “That is always the piece that takes the most time.” —Gina Shaw The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • January/February 2021

CLINICAL

The Role of the Specialty Pharmacist in

Treating Cystic Fibrosis NISHITA HIRA, PHARMD, CSP Clinical Program Manager, Specialty Pharmacy AllianceRx Walgreens Prime Orlando, Florida

ystic fibrosis (CF)—once considered a disease destined to result in childhood mortality—has seen median age of survival jump into the 40s

with the advent of new and more effective therapies.1

These historic advances in the treatment of CF over the last decade have enabled patients to not only live longer but to do so with improved quality of life. Coordination of care and complex treatment regimens can make disease management challenging and overwhelming for patients with CF and their caregivers. Specialty pharmacists can play a vital role in supporting patients and caregivers in the management of CF treatment regimens. By educating patients and caregivers about therapies and addressing patient-reported issues, specialty pharmacists can have a positive impact on adherence and quality of life.

Overview of CF Incidence and Diagnosis CF is a life-threatening, rare genetic disease that manifests itself primarily in the lungs and digestive system.2,3 The disease affects roughly 30,000 people in the United States, and about 80,000 worldwide.4 It is most prevalent in white infants, occurring in about 1 in 2,500 to 3,500 newborns.2 To develop CF, an individual must inherit a copy of the defective gene from each parent. 3 If an individual inherits only 1 copy of the defective gene, they are a carrier but do not have CF.3 Diagnosing an infant with CF is a 2-part process, beginning with newborn screening and followed by a confirmatory sweat test if initial testing is positive. 4 With newborn screening requirements in place in all 50 states since 2010, most infants are diagnosed

by 2 years of age.3,4 Approximately 1,000 new cases of CF are diagnosed each year.3

disease presentation, patients also may experience symptoms related to other body systems.2,3

Pathophysiology and Presentation

CF Treatment Regimens

A defect in the CF transmembrane conductance regulator (CFTR) gene causes an abnormality in CFTR proteins, which subsequently causes CF.3 Under normal conditions, CFTR proteins are responsible for the transport of chloride ions in and out of cells. 2 The chloride ions allow water to flow freely within the tissues, thus keeping mucus thin and fluid. 2 In patients with CF, defective CFTR proteins disrupt the flow of chloride and water in and out of the cells, resulting in unusually thick and sticky mucus that coats the lungs and pancreas as well as other organs in the body.2,3 In the lungs, this thick and sticky mucus can restrict breathing and provides a favorable medium for bacterial growth, leading to chronic lung infections and irreversible lung damage.2,3 In the pancreas, this thick and sticky mucus leads to an insufficient production of digestive enzymes, resulting in inadequate digestion and absorption of nutrients and fatsoluble vitamins; this, in turn, leads to poor weight gain.2,5 Additional CF symptoms include coughing, inflammation, nasal polyps, abdominal pain, and oily stools.2,4 Although patients may experience similar signs and symptoms of CF, each patient’s disease presentation and progression differs, even among siblings. In addition, although respiratory and digestive symptoms account for most of the

Treatment regimens are multifaceted and include oral, inhaled, and nebulized medications; airway clearance techniques (ACTs); a nutrition and fitness plan; and numerous supportive medications.6 The number of medications in a CF patient’s treatment regimen, requirements related to the order in which patients must take their therapies, and the length of time required to administer these therapies all contribute to a heavy therapy burden. Specialty pharmacists can work with patients to ease some of this burden. Providing education about medication administration and potential adverse events, along with ongoing counseling on how to manage adherence or other barriers to therapy, may help patients become more comfortable with their daily medication routine. Additional pharmacist support related to nebulizer use and ACTs, along with nutritional guidance, also may be of benefit to many patients. Standard Medications And Therapies The standard of care for most patients with CF includes a regimen of inhaled mucolytics, inhaled antibiotics, pancreatic enzymes, and ACTs.4,6 Cystic Fibrosis Foundation (CFF) guidelines recommend use of these medications and therapies for all patients with CF who meet the clinical criteria.1,7 Collectively, these treatments target the respiratory

and digestive symptoms associated with CF. MUCOLYTICS Mucolytic agents, also known as mucus thinners, help to thin the thick, sticky mucus in the lungs of patients with CF.8 Mucolytic therapy typically is performed first, before ACTs and inhaled antibiotics.8 Hypertonic saline and dornase alfa (Pulmozyme, Genentech) are 2 types of nebulized mucolytics that work in different ways to thin out mucus.8 Hypertonic saline is a salt solution; once it is inhaled into the airways, water is drawn in, which subsequently thins out the mucus, allowing it to be coughed out.8 In contrast, dornase alfa is an enzyme that adheres to the DNA in sputum and reduces its viscosity, allowing it to be coughed out more easily.8,9 Mucolytic agents have been shown to improve lung function and reduce the incidence of lung infections.8 ACTS Once the mucus has thinned, ACTs can be used to get mucus out of the lungs. The process involves vibration or percussion on the chest to dislodge the thinned mucus from the walls of the airways, followed by forceful coughing or huffing to expectorate mucus from the lungs.10 This crucial step not only helps to maintain lung function but also allows subsequent inhaled antibiotic medication to reach bacteria deep in the lungs.10 Various types of ACTs include active cycles of breathing, airway oscillating devices, autogenic drainage, chest physical therapy, high-frequency chest wall

Specialty Pharmacy Continuum • January/February 2021

CLINICAL

oscillating vests, and positive expiratory devices.10 The decision of which ACT should be performed should be made by the patient and caregiver, considering lifestyle and daily routines.10

Table 1. CF Medications Treatment Category

Medication

Recommended Dosing

Common AEs

Mucolytics

Hypertonic saline

Adults and children, ages 6 y and older: Inhale (3%, 3.5%, or 7%) twice daily via nebulizer; dose varies

• Increased cough • Sore throat • Chest tightness

Dornase alfa (Pulmozyme, Genentech)

Adults and children, ages 5 y and older: Inhale 2.5 mg once daily via nebulizer (some patients may benefit from twice-daily use)

• Throat pain • Chest pain • Changes in voice

Tobramycin inhalation solution

Adults and children, ages 6 y and older: Inhale 300 mg twice daily via nebulizer in a cycle of 28 d on/28 d off

• • • • •

Cough Throat pain Increased sputum Shortness of breath Changes in voice

Tobramycin inhalation powder (TOBI Podhaler, Mylan)

Adults and children, ages 6 y and older: Inhale contents of four 28-mg capsules every 12 h via Podhaler in a cycle of 28 d on/28 d off

• • • • •

Cough Shortness of breath Throat pain Changes in voice Headache

Antibiotic (monobactam)

Aztreonam (Cayston, Gilead)

Adults and children, ages 7 y and older: Inhale 75 mg 3 times daily via nebulizer in a cycle of 28 d on/28 d off

• • • •

Cough Nasal congestion Shortness of breath Throat pain

CFTR modulators

Ivacaftor (Kalydeco, Vertex)

Adults and children, ages 6 y and older: One 150-mg tablet every 12 h Pediatric, ages 6 mo to <6 y: 5 to <7 kg: One 25-mg granules packet every 12 h 7 to <14 kg: One 50-mg granules packet every 12 h ≥14 kg: One 75-mg granules packet every 12 h

• Headache • Throat pain • Upper respiratory tract infection • Nasal congestion • Abdominal pain • Rash • Nausea

Lumacaftor-ivacaftor (Orkambi, Vertex)

Adults and children, ages 12 y and older: Two lumacaftor 200-mg/ivacaftor 125-mg tablets every 12 h Children, ages 6 through 11 y: Two lumacaftor 100-mg/ivacaftor 125-mg tablets every 12 h Children, ages 2 through 5 y: <14 kg: One lumacaftor 100-mg/ivacaftor 125-mg granules packet every 12 h ≥14 kg: One lumacaftor 150-mg/ivacaftor 188-mg granules packet every 12 h

• • • • •

Tezacaftor-ivacaftor and ivacaftor (Symdeko, Vertex)

Adults and children, ages 12 y and older: One tezacaftor 100-mg/ivacaftor 150-mg tablet in the morning, one ivacaftor 150-mg tablet in the evening Children, ages 6 through 11 y: <30 kg: One tezacaftor 50-mg/ivacaftor 75-mg tablet in the morning, one ivacaftor 75-mg tablet in the evening ≥30 kg: One tezacaftor 100-mg/ivacaftor 150-mg tablet in the morning, one ivacaftor 150-mg tablet in the evening

• • • •

Elexacaftor-tezacaftorivacaftor and ivacaftor (Trikafta, Vertex)

Adults and children, ages 12 y and older: Two tablets (each containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg) in the morning and one ivacaftor 150-mg tablet in the evening

• Headache • Upper respiratory tract infection • Abdominal pain • Diarrhea • Rash • Nasal congestion

Pancrelipase

Adults and children: Dosing may vary; taken before meals and snacks Infants up to 12 mo: Dosing may vary; given prior to each feeding

• • • • •

Inhaled Antibiotics Chronic bacterial infections and inflammation in the lungs are the hallmark symptoms of CF and can lead to scarring and permanent lung damage.4,11 Most often, it is this progressive decline in respiratory function that is the leading cause of morbidity.11 Thus, long-term inhaled antibiotics are an essential component of CF regimens.11 Inhaled antibiotics are used after ACTs, when the lungs are clear of as much mucus as possible, to maximize medication delivery directly to the lungs and therapeutic effects.11 Tobramycin and aztreonam—the 2 mainstays of antibiotic therapy— target Pseudomonas aeruginosa, one of the most common pathogens to colonize the lungs.4 The cyclic dosing schedule of these 2 drugs is unique. The thought behind cyclic administration is to minimize the incidence of antibiotic resistance that may occur with the use of continuous antibiotic therapy.11 As with all antibiotic therapy, adherence to the treatment regimen is crucial to improve respiratory symptoms and avoid worsening lung function.

Antibiotics (aminoglycosides)

Pancreatic Enzymes Thick mucus found in the pancreas inhibits the release of enzymes that are required for digestion and absorption of nutrients.12 The immediate effects of this manifest as incomplete digestion of fats, protein, and starch, which results in constipation, flatulence, and pain.12 The longterm effects of poor digestive health include inadequate weight gain and a potential negative impact on lung function.12 Therefore, pancreatic enzymes, which contain small beads of varying concentrations of lipase, protease, and amylase, to aid in the digestion of fats, proteins, and carbohydrates, respectively, are included as part of CF regimens.5

Pancreatic enzyme replacement

CFTR Modulators This backbone of CF therapy has remained largely unchanged, but over the last several years, the advent of a new class of medications,

AEs, adverse events; CF, cystic fibrosis Based on references 8, 9, and 13-20.

Shortness of breath Nasal congestion Nausea Diarrhea Upper respiratory tract infection • Abnormal respiration • Rash

Headache Nausea Nasal congestion Dizziness

Vomiting Abdominal pain Abnormal feces Flatulence Frequent bowel movements

Specialty Pharmacy Continuum • January/February 2021

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CFTR modulators, is significantly altering the treatment landscape for CF (Table 1).8,9,13-20 The CFTR modulators—ivacaftor (Kalydeco, Vertex), lumacaftor-ivacaftor ( Orkambi, Vertex), tezacaftor-ivacaftor and ivacaftor (Symdeko, Vertex), and elexacaftor-tezacaftor-ivacaftor and ivacaftor (Trikafta, Vertex)—aim to correct the underlying genetic defect of CF.3 Each of these therapies targets a specific set of gene mutations, and only patients with those specific mutations are eligible for the corresponding agent.21 Although more than 1,800 mutations related to CF have been identified, the most common CFTR mutation is F508del, with approximately 85% of patients with CF having at least 1 copy of this mutation.1,3 Ivacaftor, the first of the CFTR modulators to be available, is a potentiator that works by allowing the CFTR channel to remain open longer, thus increasing the transport of chloride ions through the cell surface.3 The combination products employ the potentiator ivacaftor along with 1 or more of the correctors lumacaftor, tezacaftor, and elexacaftor. 21 The corrector

component increases the amount of CFTR protein that reaches the cell surface; therefore, the combination medications have a beneficial impact on both the function and quantity of CFTR.3 Before the approval of the copackaged product containing elexacaftortezacaftor-ivacaftor and ivacaftor, favorable clinical trial results had, in part, shaped this product to be possibly the most highly anticipated of all the CFTR modulators. The 2 correctors—elexacaftor and tezacaftor— may contribute to its increased efficacy.14 Study results showed a 13.8% increase in forced expiratory volume in the first second (FEV1) after 4 weeks of therapy in patients with 1 copy of the F508del mutation compared with those taking placebo.22 A second study showed patients with 2 copies of F508del who crossed over from the product containing the corrector tezacaftor to the one containing both tezacaftor and elexacaftor saw additional benefit after 4 weeks, with a 10% increase in FEV1.22 The impact the CFTR modulators have had on patients thus far has been profound. In 2015, with only 2 CFTR modulators available, roughly

CF Patient Case JM is a 15-year-old male adolescent with CF, diagnosed shortly after birth. Progression of CF has been moderate, with impact most notably in the lungs. JM has been hospitalized for pulmonary exacerbations requiring IV antibiotic treatment. Since beginning lumacaftorivacaftor at the age of 13, JM’s pulmonary function has improved. Approximately 3 months ago, JM’s physician switched his lumacaftor-ivacaftor to elexacaftor-tezacaftor-ivacaftor and ivacaftor based on clinical trial results and increased efficacy data for the latter combination. All other medications remained unchanged. JM’s primary caregiver is his mother. He attends a small high school and is active in sports and other extracurricular activities. With the exception of an occasional missed nebulizer treatment, JM is mostly compliant with his medication regimen. His medical and prescription history are listed in Table 2. He has the F508del/ F508del-CFTR gene mutation. Before starting elexacaftor-tezacaftor-ivacaftor and ivacaftor, his FEV1 was in the 70% to 75% range, and his alanine aminotransferase, aspartate aminotransferase, and bilirubin were within normal limits. On initial fill of elexacaftor-tezacaftor-ivacaftor and ivacaftor, an AllianceRx Walgreens Prime specialty pharmacist provided JM’s caregiver with education and counseling related to dosing and administration, what to do in the event of a missed dose, how to transition from the old medication to the new one, and

40% of the CF population was eligible for therapy.23 By the end of 2019, by which time 2 additional CFTR modulator medications had become available, that number had doubled to 80%.23 Adjunct Medications In addition to the medications listed in Table 1, patients with CF take a variety of adjunct therapies, with the regimen depending on the individual. Some of these adjunct therapies include acid suppression therapy, acute antibiotic therapy, anti-inflammatory agents, bronchodilators, corticosteroids, insulin, and vitamins. Insurance requirements or patient preference may not allow for all of a patient’s medications to be filled at the same pharmacy. However, it is important for the specialty pharmacist to be knowledgeable about a patient’s entire medication profile to be able to recognize potential drug–drug interactions and make the appropriate intervention, if necessary.

Pipeline Despite advances in CF medication therapies over the last 20 years,

Table 2. Medical and Prescription History Medical History • Asthma • Pancreatic insufficiency • Negative for CFRD and sinusitis

Prescription History • • • • • •

Tobramycin Pancrelipase Albuterol HFA Dornase alfa Beclomethasone dipropionate HFA Elexacaftor-tezacaftor-ivacaftor and ivacaftor

CFRD, cystic fibrosis–related diabetes; HFA, hydrofluoroalkane

common adverse effects, including the potential for rash. The pharmacist also confirmed whether JM had a liver function test completed before starting the medication and reviewed the recommended monitoring schedule. JM continued refilling elexacaftor-tezacaftorivacaftor and ivacaftor with no significant issues reported to the pharmacy. However, during the fourth refill outreach by AllianceRx Walgreens Prime, JM’s mom reported an unusually high number of missed doses to the patient care advocate (PCA). As part of AllianceRx Walgreens Prime’s clinical management platform

additional therapies are needed to support patients who do not have a CFTR modulator available or who no longer benefit from an existing medication. The CF pipeline is robust with phase 1 and 2 trials evaluating agents affecting CFTR function, mucociliary clearance, and inflammation, as well as anti-infective and nutritional agents.24 It is prudent for specialty pharmacists to stay abreast of medications in the pipeline and how approval of these agents may affect the care of patients with CF.

CF-Related Diabetes, Nutrition, and Fitness As the life expectancy of patients with CF increases, so too does their potential to develop comorbid conditions. Effective management of comorbidities is imperative to maintain overall health and preserve quality of life. Specialty pharmacists are well positioned to assist patients in the management of comorbidities. This begins with ensuring that a thorough and complete history of the patient’s medical conditions and associated medications and therapies is on

and through system-driven logic, the PCA was able to gather additional information about the missed doses and promptly transfer the call to a pharmacist for additional counseling. After review of patient-reported issues and through a conversation with the mom, it was determined that JM was skipping his morning doses of elexacaftor-tezacaftor-ivacaftor and ivacaftor because he did not have time to eat breakfast in addition to completing morning treatments due to a change in his morning school activities. JM’s mother also noted that he seemed to be experiencing shortness of breath in recent weeks. The pharmacist provided JM’s mother with some quick and easy breakfast ideas that worked for both her and JM’s schedule. The pharmacist also reviewed the importance of continued adherence. During the next monthly refill outreach by AllianceRx Walgreens Prime, JM’s mother reported zero missed doses and informed the PCA that the pharmacist’s breakfast suggestions were working out well for both her and JM. She also reported that JM’s episodes of shortness of breath had subsided. This case study supports the key role that a specialty pharmacy plays in the care of patients with CF. The pharmacist was able to intervene and prevent a significant lapse in therapy and potentially prevent progression of disease. Through system-generated notes, the specialty pharmacy was able to inform the patient’s CF care team of the event along with the recommended intervention. Author’s note: Information is an example and not derived from an actual patient’s file.

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record with the specialty pharmacy. Of note, CF-related diabetes is the most common comorbid condition in patients with CF, with roughly 40% to 50% of adults and 20% of children affected.4 Thick, sticky mucus in the pancreas causes scarring and, ultimately, insulin insufficiency, which leads to CF-related diabetes.25 The CFF guidelines recommend chronic insulin therapy as the treatment of choice.1 Of note, unlike patients with type 2 diabetes, patients with CF-related diabetes do not need to restrict calorie intake, although carbohydrate counting is recommended to accurately dose insulin.25 Similar to patients with type 2 diabetes, those with CF-related diabetes should engage in physical activity; in addition to the positive impact on insulin response, exercise also improves lung function.25 A discussion of CF is not complete without addressing the role and impact of both nutrition and fitness as part of the daily CF regimen. Good nutrition and maintaining a healthy weight affect pulmonary function and diabetes.26 Patients with CF typically need about twice as many calories as the average person to meet the daily energy requirements.26 For some patients, fitting in these extra calories can be time-consuming and challenging. Working with a dietitian along with having a list of go-to meal and snack ideas may be helpful.26 Similarly, the benefits of exercise for patients with CF go beyond good physical fitness.27 The CFF guidelines recommend aerobic exercise for its general benefit to health.1 In addition, both aerobic and weightbearing exercises can improve lung function, increase energy, and improve concomitant health conditions such as diabetes.27 Dealing with an already complex medication regimen, patients may sometimes lose sight of the importance of nutrition and fitness. Specialty pharmacists can reinforce the benefits of good nutrition and fitness as part of the CF treatment regimen via counseling and education along with ensuring that enzymes and vitamins are filled regularly.

Role of the Specialty Pharmacist Adherence to the daily CF medication regimen is a struggle for many patients, with overall medication adherence at just under 50%.28 Medication nonadherence has many implications including poor health outcomes, increased CF-related hospitalizations, and higher health care costs.28 Specialty pharmacists

have the ability to positively influence a patient’s adherence to their medication regimen through timely, patient-centered interventions. Patients and caregivers may feel a certain level of anxiety about new medications or other changes to their treatment regimens. Specialty pharmacists can ease some of this anxiety by engaging patients and caregivers in discussions about their medications. These conversations should go beyond standard medication counseling and include discussion about a given medication’s administration, place in therapy, potential benefits, and lab monitoring parameters. Time also should be devoted to reinforcing the benefits of nutrition and fitness and, most importantly, to addressing patient questions and concerns. Each patient’s CF journey will be unique. Patients with CF may experience periods with minimal adherence issues and other times when a higher level of support will be needed. Specialty pharmacists should direct ongoing counseling and education to the patient’s specific adherence barriers and therapy concerns, keeping in mind what may work for one patient may not work for another. Regular touch points between the patient and specialty pharmacist also allow for follow up on other CF-related health conditions and medications. At AllianceRx Walgreens Prime, a team of specialty-trained pharmacists provides comprehensive medication and condition counseling at the start of therapy and as needed. On an ongoing basis, patient care advocates (PCAs) contact patients with refill reminders. During this patient outreach, the PCA uses proprietary software to identify medication-related adverse events, adherence barriers, or worsening CF-related symptoms. Any patient with an identified issue or concern is offered consultation with a pharmacist. The pharmacist then provides prompt counseling, including management tips specific to the patient’s reported issue or concern. In addition, patient-reported issues are communicated to the patient’s CF care team as needed. This proactive patient support can minimize discontinuations or lapses in therapy and improve adherence and overall quality of life.

Conclusion Whether providing care for a patient with CF who is newly diagnosed or an established patient, specialty pharmacists play an important role in the care continuum. A

collaborative approach enables the pharmacist and patient (and caregiver) to work together to help the patient achieve the best possible outcomes from his or her medication regimen.

References 1.

Cystic Fibrosis Foundation. 2018 Patient Registry Annual Data Report. Published August 2019. Accessed January 19, 2021. https://www.cff.org/Research/ResearcherResources/Patient-Registry/2018-PatientRegistry-Annual-Data-Report.pdf

2. Medline Plus. Cystic fibrosis. Accessed January 19, 2021. https://ghr.nlm.nih.gov/ condition/cystic-fibrosis#definition 3. Pettit RS, Fellner C. CFTR modulators for the treatment of cystic fibrosis. P T. 2014;39(7):500-511. 4. Brown SD, White R, Tobin P. Keep them breathing: cystic fibrosis pathophysiology, diagnosis, and treatment. JAAPA. 2017;30(5):23-27. 5. Sabharwal S. Gastrointestinal manifestations of cystic fibrosis. Gastroenterol Hepatol (NY). 2016;12(1):43-47. 6. Agent P, Parrott H. Inhaled therapy in cystic fibrosis: agents, devices and regimens. Breathe (Sheff). 2015;11(2):110-118. 7. Prickett M, Naureckas ET. Chronic medications to maintain lung health clinical care guidelines. Cystic Fibrosis Foundation website. Published April 2013. Accessed January 19, 2021. https://www. cff.org/Care/Clinical-Care-Guidelines/ Respiratory-Clinical-Care-Guidelines/ Chronic-Medications-to-Maintain-LungHealth-Clinical-Care-Guidelines/ 8. Cystic Fibrosis Foundation. Mucus thinners. Accessed January 19, 2021. https://www. cff.org/Life-With-CF/Treatments-andTherapies/Medications/Mucus-Thinners/ 9. National Institutes of Health, National Library of Medicine. DailyMed. PULMOZYME-dornase alfa solution. Updated October 21, 2020. Accessed January 19, 2021. https://dailymed. nlm.nih.gov/dailymed/drugInfo. cfm?setid=d8c78a7e-ff99-48f3-8952643ec2ea0f86 10. Cystic Fibrosis Foundation. Airway clearance techniques (ACTs). Accessed January 19, 2021. https://www.cff.org/ Life-With-CF/Treatments-and-Therapies/ Airway-Clearance/Airway-ClearanceTechniques/ 11. Nichols DP, Durmowicz AG, Field A, et al. Developing inhaled antibiotics in cystic fibrosis: current challenges and opportunities. Ann Am Thorac Soc. 2019;16(5):534-539 12. Cystic Fibrosis Foundation. Enzymes. Accessed January 19, 2021. https://www.cff. org/Life-With-CF/Daily-Life/Fitness-andNutrition/Nutrition/Taking-Care-of-YourDigestive-System/Enzymes/ 13. National Institutes of Health, National Library of Medicine. DailyMed. TOBRAMYCIN INHALATION SOLUTION inhalant. Updated February 2, 2019. Accessed January 19, 2021. https:// dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?setid=e5bbf589-d066-c89a-c40fcbeb6f98c5b5 14. National Institutes of Health, National Library of Medicine. DailyMed. TOBI PODHALER-tobramycin capsule. Updated October 24, 2018. Accessed January 19, 2021. https://dailymed.nlm.nih.gov/ dailymed/drugInfo.cfm?setid=625a44994e46-4f5a-8d0c-d104f520d97e 15. National Institutes of Health, National

Library of Medicine. DailyMed. CAYSTONaztreonam kit. Updated November 25, 2019. Accessed January 19, 2021. https:// dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?setid=67300ca3-8c53-4ce4-8e862c03be1f9b8a 16. National Institutes of Health, National Library of Medicine. DailyMed. KALYDECOivacaftor tablet, film coated; KALYDECOivacaftor granule. Updated April 25, 2019. Accessed January 19, 2021. https:// dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?setid=0ab0c9f8-3eee-4e0f-9f3fc1e16aaffe25 17. National Institutes of Health, National Library of Medicine. DailyMed. ORKAMBIlumacaftor and ivacaftor tablet, film coated; ORKAMBI-lumacaftor and ivacaftor granule. Updated May 11, 2020. Accessed January 19, 2021. https:// dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?setid=3fc1c40e-cfac-47a1-9e1a61ead3570600 18. National Institutes of Health, National Library of Medicine. DailyMed. SYMDEKOtezacaftor and ivacaftor kit. Updated May 11, 2020. Accessed January 19, 2021. https:// dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?setid=302ae804-37db-44fd-ac2f3dbdeda9aa4b 19. National Institutes of Health, National Library of Medicine. DailyMed. TRIKAFTAelexacaftor, tezacaftor, and ivacaftor kit. Updated January 29, 2020. Accessed January 19, 2021. https://dailymed. nlm.nih.gov/dailymed/drugInfo. cfm?setid=f354423a-85c2-41c3-a9db0f3aee135d8d 20. National Institutes of Health, National Library of Medicine. DailyMed. CREONpancrelipase capsule, delayed release pellets; CREON-pancrelipase capsule, delayed release. Updated May 5, 2020. Accessed January 19, 2021. https:// dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?setid=073201aa-556d-4a70-918e84e9616fd88d 21. Cystic Fibrosis Foundation. CFTR modulator therapies. Accessed January 19, 2021. https://www.cff.org/Life-With-CF/ Treatments-and-Therapies/Medications/ CFTR-Modulator-Therapies/ 22. Vertex. Trikafta: what are the study details and results? Trikafta. Accessed January 19, 2021. https://www.trikafta.com/studyinformation 23. Cystic Fibrosis Foundation. 2019 Cystic Fibrosis Foundation Patient Registry Highlights. Accessed January 19, 2021. https://www.cff.org/Research/ResearcherResources/Patient-Registry/CysticFibrosis-Foundation-Patient-RegistryHighlights.pdf 24. Cystic Fibrosis Foundation. Drug development pipeline. Accessed January 19, 2021. https://www.cff.org/trials/pipeline 25. Cystic Fibrosis Foundation. Cystic fibrosisrelated diabetes. Accessed January 19, 2021. https://www.cff.org/Life-With-CF/ Daily-Life/Cystic-Fibrosis-RelatedDiabetes/ 26. Cystic Fibrosis Foundation. Nutritional basics. Accessed January 19, 2021. https:// www.cff.org/Life-With-CF/Daily-Life/ Fitness-and-Nutrition/Nutrition/GettingYour-Nutrients/Nutritional-Basics/ 27. Cystic Fibrosis Foundation. Why fitness matters. Accessed January 19, 2021. https:// www.cff.org/Life-With-CF/Daily-Life/ Fitness-and-Nutrition/Fitness/WhyFitness-Matters/ 28. Quittner AL, Zhang J, Marynchenko M, et al. Pulmonary medication adherence and health-care use in cystic fibrosis. Chest. 2014;146(1):142-151.

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Pharms Well Positioned to Administer HIV PrEP You don’t have to be an HIV expert to administer pre-exposure prophylaxis (PrEP) for the prevention of HIV infection in highrisk populations, said Brandon Patchett, PharmD, the senior director of pharmacy services for the Los Angeles-based AIDS Healthcare Foundation, during a session at the 2020 NASP Annual Meeting & Expo Virtual Experience. “Pharmacist-administered PrEP programs are becoming more and more common across the country,” Patchett said. In most states, pharmacists are allowed to prescribe by entering into collaborative practice agreements with medical providers. “Consistent PrEP use by high-risk individuals has been found to reduce the risk for transmitting the HIV virus to sexual partners by [up] to 100%,” Patchett said, although it does not prevent the transmission of other sexually transmitted infections (STIs) (N Engl J Med 2010;363[27]:2587-2599; Lancet 2016;387[10013]:53-60). Two regimens are approvedforPrEP:emtricitabine-tenofovir disporoxil fumarate (FTC/TDF; Truvada, Gilead) and emtricitabine-tenofovir alafenamide (FTC/TAF; Descovy, Gilead). In 2019, the CDC reported that awareness of PrEP among urban men who have sex with men (MSM) increased from 60% to 90% between 2014 and 2017, and use of PrEP in this population increased from 6% to 35% over the samee period (MMWR Morb Mortal Wkly Rep 2019; 68[27]:597-603). “That means that one-third of the MSM popula-tion in these 20 urban an areas studied [is] now ow using PrEP, which is great,” reat,” Patchett said. “However, ver we must still continue to push its awareness and use in high-risk [groups], particularly vulnerable demographic subgroups like Black and Hispanic populations.” Many pharmacies may receive a significant number of referrals for postexposure prophylaxis, using retroviral therapy as a one-time treatment for possible HIV exposure, he noted. “This offers an opportunity for the pharmacist to provide PrEP screening and counseling,” Patchett said. “We are in the ideal position to initiate successful PrEP. In general, it’s quite easy to manage.” Potential candidates for PrEP have the following risk factors: sex with a person known to have HIV; an STI within the past six months; a high number of sexual partners; a history of inconsistent or absent condom use; commercial sex work; injecting partner with HIV; and sharing injection equipment. To be clinically eligible for PrEP,

patients must meet the following screening criteria: a negative HIV test; no signs or symptoms of acute HIV infection; creatinine clearance ≥60 mL/min; and status documented for hepatitis B virus (HBV) infection and vaccination. (An abstract presented at the 2020 Conference on Retroviruses and Opportunistic Infections indicated that PrEP also protected against HBV.)

attended a continuing medical education course on HIV between March and May 2015 (PLoS One 2020;15[9]:e0238375). She described these clinicians as “highly motivated” practitioners. The study included physician assistants and nurse practitioners, but not pharmacists because at the time, pharmacists could not prescribe PrEP. Despite PrEP being a widely accepted method of preventing HIV transmission, less than 10% of the more than 1 million people vulnerable to HIV are taking it, Leech and her colleagues reported. “With a U.S. policy goal to eradicate HIV by 2030, practitioners are central to ensuring the delivery of PrEP across care settings,” Leech said. “Our findings, however, indicate that even among a subset of HIV-focused practitioners, PrEP

more effort placed on identifying risk across populations and clinical specialties,” Leech said. Patchett agreed that the PrEP treatment gap is significant—and one that pharmacists can help close. “Getting all providers competent in the provision of PrEP can increase the uptake of this therapy,” he said. “As specialty pharmacists, it’s particularly important that we strive to identify PrEP candidates.”

Keep an Eye on New Agents Many pharmacists involved with PrEP also help manage HIV-infected patients. So it’s important to keep current with the latest treatments—particularly those with breakthrough potential. One such agent is cabotegravir-rilpivirine (CAB/

‘Getting all providers competent in the provision of PrEP can increase the uptake of this therapy. As specialty pharmacists, it’s particularly important that we strive to identify PrEP candidates.’ —Brandon Patchett, PharmD

“Flexibility is the key to PrEP retention, and in addition to screening and helping start patients on therapy, pharmacists are in the therapy to help make sure ideal position pos patients are adherent to PrEP,” Patchett said. “Quarterly HIV testing and screening for STIs are advised to prevent the development of HIV acquisition resistance. You can review these results and communicate with patients via telehealth. Every effort should be made to avoid discontinuing PrEP or withholding it from a person who is at risk of acquiring HIV.”

Closing the PrEP Access Gap For pharmacists to be effective members of the PrEP team, they need to focus not only on efficacy and safety; they also should be aware of the main barriers to patients receiving the treatment—and that may include providers at their own hospitals, according to a new study by a Vanderbilt University Medical Center investigator. Led by Ashley Leech, PhD, an assistant professor of health policy at Vanderbilt, in Nashville, Tenn., the study surveyed 519 practitioners in five major U.S. cities who

prescribing is not routine.” The study found that internal medicine prescribers were 1.6 times more likely to prescribe PrEP than infectious disease practitioners, which researchers said was an indicator of how important internal and family medicine practitioners are in assessing and mitigating risk in their patients (95% CI, 0.99-2.60; P=0.0524). Long-standing confusion or disagreement between HIV and primary care practitioners over who should be responsible for prescribing this preventive medication may partly explain the slow adoption of PrEP among practitioners, Leech said. Age, years of training, and sex of the independent prescribers were also significantly associated with prescribing experience, with young doctors being 30 times more likely to prescribe PrEP than physicians who had been practicing for 20 years or more. “While a number of factors could impact PrEP prescribing, including patients’ low familiarity with the drug or practitioners’ lack of opportunity in offering PrEP, for the drug to be effective at eliminating HIV in the United States in the next 10 years, prescribing needs to increase, with

RPV; Cabenuva, ViiV Healthcare), the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. The FDA approved CAB/RPV in early January as a co-pack containing two injectable medicines—ViiV’s CAB and Janssen’s RPV—dosed once monthly. According to the FDA, the new treatment can replace current antiretroviral regimens in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either CAB or RPV. The FDA also approved a tablet form of CAB (Vocabria) for use with oral RPV (Edurant, Janssen) for shortterm treatment. In two studies leading to CAB/RPV’s approval, the combination was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period. —Gina Shaw The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • January/February 2021

POLICY

Not All Pay-for-Performance Programs Pay Off A pay-for-performance (P4P) program by a national insurance company improved evidence-based prescribing of cancer drug regimens but did not yield cost savings, according to results of a study by researchers from the University of Pennsylvania. The study assessed the efficacy of the voluntary Cancer Care Quality Program rolled out by national insurer Anthem through its subsidiary AIM Specialty Health (J Clin Oncol 2020;38[34]:4055-4063). The program paid oncologists $350 per patient per month when the physician prescribed a program-endorsed, evidence-based drug regimen.

‘Economic incentives are only a small part of the reasons that there are deficits in quality and inefficiency of health care.’ —Stephen Soumerai, ScD “In general, pay-for-performance programs have had a mixed history in health care policy,” said Justin E. Bekelman, MD, the director of the Penn Center for Cancer Care Innovation, in Philadelphia, and lead investigator on the study. “So, our motivation was to understand [how the model performed] in the largest program of its kind in the U.S. and most likely the world.” At the start of their observational study, Bekelman and his team found physicians following 402 unique regimens, although only 60 were evidencebased and program-approved. To see whether an incentive program shifted this pattern, the researchers took advantage of the gradual expansion of the program across 14 states from 2014 to 2015, comparing physician prescribing before and after the incentive program was rolled out in each area, Bekelman said. The investigators included administrative claims data from patients aged 18 years or older who had breast, colon or lung cancer and were prescribed cancer drugs by 1,867 participating oncologists between 2013 and 2017. The researchers evaluated whether a patient’s drug regimen was evidencebased according to approved pathways provided by AIM and evaluated spending over a six-month period.

The rollout of the program was associated with a 5.1% increase (95% CI, 3.0%-7.2%; P<0.001) in prescribing of evidence-based regimens, from 57.1% to 62.2% of patients.

The program was associated with a $3,339 increase in cancer drug spending (95% CI, $1,121-$5,557; P=0.003) and a $253 increase in patient out-of-pocket spending (95% CI, $100-$406; P=0.001) but no statistically significant change in total health care spending over the sixmonth study period ($2,772; 95% CI, –$181 to $5,725; P=0.07). “Our findings suggest pay-for-performance programs can effectively

increase evidence-based cancer drug prescribing but may not yield savings,” Bekelman said. Although the majority of prescribers opted in to the program, selection bias into the voluntary program is a possible limitation of this study, he added. The researchers cannot guarantee that there isn’t a significant difference between early and late adopters of see PAY TO PERFORM, page 19

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No Longer Favored? continued from page 1

plus 6% formula with a new one based on international pricing information from an index of 22 different countries. Health care organizations ranging from ASHP and the American Hospital Association (AHA) (bit.ly/3ccjgai), the American Association of Community Cancer Centers (ACCC) (bit.ly/ 2M3T07l) and the Pharmaceutical Research and Manufacturers of America (PhRMA) (onphr.ma/38LYcWa) filed suit to stop it, citing irreparable harm that would be done to providers due to a reduction in Medicaid drug expenditures of nearly $5 billion in the first year of the plan alone.

a last-minute Hail Mary by [Health and Human Services Secretary Alex] Azar and the administration to do something they promised to deliver on. But all it did was ruffle everyone’s feathers. The courts are now restraining them and Biden’s going to go to work.” Drug pricing reform and transparency are sorely needed, Zweigenhaft acknowledged. But he criticized the methods and timing. “Everyone wants transparency in drug pricing: consumers, payors, even pharmaceutical manufacturers. Pricing mechanisms are broken and the grossto-net bubble is very real. But amid a pandemic where there is so much cha-

“By cutting drug reimbursements to hospitals by an average of 65%, hospitals will have to absorb losses while drug companies are free to continue their trend of charging exorbitant prices,” the AHA said in a statement. “This will put hospitals in the terrible position of having to divert resources from other patient care simply to buy the drug therapies they need for their patients.” Such criticisms, coupled with lawsuits by the AHA and other groups claiming that CMS lacked statutory authority to issue the MFN interim final rule, have effectively placed it on hold. Indeed, days before the Biden/Harris administration took office, federal officials agreed not to appeal injunctions against the MFN rule. “It’s all on ice,” said Burt Zweigenhaft, PhD, DLitt, the founder of the Association for Value-Based Cancer Care. “It was

os, to put oncology practices in a pickle where they are going to get reimbursed at the prices of single-payor economies like Canada, Israel, Iceland and the U.K.—it was bad timing, to say the least.”

‘A Nonsensical Argument’ Ted Okon, MBA, the executive director at the Community Oncology Alliance, had even stronger words for the plan, noting that the administration’s attorneys, in response to the PhRMA suit, cited the fact that people are out of work due to the COVID-19 pandemic, and thus cannot afford their prescription medications, as a reason for pushing the rule through. “It’s a nonsensical argument,” Okon said. “This is a Medicare rule; 94% of Medicare patients have supplemental insurance. Avalere did a study saying that less than 1% of all Medicare

fee-for-service patients would see a lowering of their out-of-pocket costs as a result of this scheme,” he said (bit. ly/35YBgkL). Okon said he also takes issue with the timing of the MFN interim rule. “I am downright angry that in the middle of a COVID-19 resurgence, where record numbers of people are dying every day, the administration that has taken a laissez-faire attitude about the pandemic used it as a reason to proceed with this [proposal],” he said. Okon also criticized the MFN plan for its potential negative effects on seniors. CMS’ own actuaries, he noted, estimated that in the first year of the program (2021), 9% of seniors would “forgo access” to treatment. “They admitted that after two years, a third of Medicare seniors would

be displaced, with almost one in five forgoing treatment. That’s a cavalier attitude about something that really means death for people with cancer.” A study by the American Society of Clinical Oncology found that the model’s reimbursement cuts to four drugs commonly used to treat lung and other cancers would have a disastrous effect: namely, it would result in patients with metastatic non-small cell lung cancer losing as many as 87,556 years of life due to their loss of access to these drugs over the model’s seven-year duration (bit.ly/2Kf1ZSe). “Although the impact of this [drug pricing] policy change by itself would be devastating, it does not exist in a vacuum. It would exacerbate the struggles practices are already facing [with] multiple cuts and negative adjustments related to routine annual rules, new proposals, and the

COVID-19 pandemic,” wrote Monica M. Bertagnolli, MD, ASCO’s board chair, in comments submitted to CMS on Dec. 16. The Avalere report underscored the heavy hit that oncology would have taken under the MFN rule. Of the 50 drugs on the international pricing index list, 38 are used by oncologists and hematologists to treat cancer and blood disorders. The report also found that oncologists would see a reduction in their reimbursements of at least 6% to 7%. Still, the Trump administration was not alone in looking to models outside of the United States for drug pricing relief. Zweigenhaft pointed out that Biden, too, has cited international reference pricing as a strategy for lowering drug costs ( joebiden.com/healthcare). “They’re not complacent on the price of pharmaceuticals and cancer care,” he said. “That will be top of mind in a Biden administration. It’s true that we have to fix the drug pricing situation. It’s not sustainable economically and everyone knows it. People will feel like they dodged a bullet because, had Trump been in, the cuts would have been deeper than what the Biden administration is likely to do.” At press-time, the Biden administration chose to delay action on at least one alleged cause of increased drug prices: rebates from drug companies to pharmacy benefit managers. On Feb. 1, the admininstration announced that it would delay by a year the Jan. 1, 2022 implementation date for a Trump rule that would have placed restrictions on those rebate programs. HHS officials and some industry groups said the new date of Jan. 1, 2023 is needed because the original date would upend in-progress negotiations between PBMs, drug companies and health plans. As for the final fate of the MFN rule, “after the incoming Biden administration takes control, the ball will be in their court to pull it completely, appeal the California preliminary injunction or do nothing,” Oken said. “I don’t expect this particular most favored nation ‘experiment’ to go anywhere because it has too much baggage. However, it’s a very good bet that international drug reference pricing of some type ends up in legislation.” The Elijah E. Cummings Lower Drug Costs Now Act H.R. 3 is one example. Under the legislation, the Department of Health and Human Services would have to negotiate maximum prices for medications that are among either the 125 drugs that account for the greatest national spending or the greatest spending under the Medicare prescription drug benefit. The bill passed the House and is on the Senate’s legislative calendar. —Gina Shaw, David Bronstein The sources reported no relevant financial disclosures other than their stated employment.

Specialty Pharmacy Continuum • January/February 2021

POLICY

PAY TO PERFORM continued from page 17

the program and drug regimens, said Stephen Soumerai, ScD, a professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, in Boston, who was not involved in the study. He also noted that the study did not include patient outcomes, a crucial component of any health care program. Soumerai has studied and been critical of previous P4P programs. “Economic incentives are only a small part of the reasons that there are deficits in quality and inefficiency of health care,” he told Specialty Pharmacy Continuum.

‘In general, pay for performance has had a mixed history in the world of health care policy.’

The program was associated with a

5.1% increase in prescribing of evidence-based regimens, from

57.1% to 62.2% of patients.

Read Specialty Pharmacy Continuum Anywhere, Anytime!

—Justin E. Bekelman, MD He also cautioned that results from this P4P program could not necessarily be generalized to all P4P plans. Many such programs include penalties and incentives, he noted. Because this program only included an incentive, it is distinct from and, therefore, potentially not generalizable to other P4P models. The prescribing of new, evidencebased chemotherapy drugs already has been on the rise, he noted, making it hard for the researchers to tease apart what was the result of an existing trend. Also, the patients included in the study have commercial insurance and so presumably do not include the highest-risk groups, Soumerai said. “You can’t generalize this to the poor and sick and very elderly,” he said. “This is so important because we know it’s hard to develop these programs, and the ones that have come before this program have had real challenges with effectiveness,” Bekelman said. “What’s inspiring about this program is that it shows that P4P can be effective in increasing evidence-based drug prescribing, but it’s not enough.” —Jillian Mock Soumerai reported no relevant financial disclosures. Bekelman reported financial disclosures with CVS Health, Embedded Healthcare, North Carolina Blue Cross Blue Shield, Optum, Pfizer, UnitedHealthcare and UnitedHealth Group (Inst).

www.specialtypharmacycontinuum.com

Specialty Pharmacy Continuum • January/February 2021

POLICY

Inflammatory Conditions Help Drive Another Strong Year for Specialty Forty-eight percent of drug spending in pharmacy was for specialty medications in 2019, according to Express Scripts’ 2019 Drug Trend Report, the latest available report. Aimee Tharaldson, PharmD, a senior clinical pharmacist of Emerging Therapeutics at Express Scripts, predicted that once all of the numbers are in, specialty drugs will have outpaced traditional medications in 2020 and that trend would continue this year. Inflammatory conditions stood out in the Express Scripts report (bit. ly/3kO36EN), Tharaldson noted during the AMCP Nexus 2020 virtual meeting. “This was by far the No. 1 therapy class based on per member per year [PMPY] spending,” she said, citing two dominant contributors: adalimumab (Humira, AbbVie) and etanercept (Enbrel, Amgen). Quite a few novel competitors are expecting approval in 2021, according to Tharaldson, who highlighted specialty medications to watch for this year. Bimekizumab (UCB) is an interleukin-17A and IL-17F inhibitor expecting approval on July 22 for moderate to severe plaque psoriasis. It’s also in development for psoriatic arthritis and ankylosing spondylitis. In phase 3 trials, bimekizumab demonstrated improved efficacy compared with adalimumab, secukinumab (Cosentyx, Novartis) and ustekinumab (Stelara, Janssen Biotech). Deucravacitinib (Bristol Myers Squibb [BMS]) is a novel tyrosine kinase inhibitor that could also be approved this year for psoriasis. “This is an oral medication that, so far, seems like a really safe option,” she said. It appears more effective than apremilast (Otezla, Amgen), on par with adalimumab and ustekinumab, and less effective than the IL-17 and IL-23 inhibitors such as ixekizumab (Taltz, Lilly) and guselkumab (Tremfya, Janssen), Tharaldson noted. Another IL-23 inhibitor, mirikizumab (Lilly), is expecting approval for psoriasis this year. In a phase 3 trial released last summer, mirikizumab proved to be more effective than an IL-17 inhibitor. However, mirikizumab failed to show superiority over the other IL-23 inhibitors that are already on the market, she said. Mirikizumab also is being developed for ulcerative colitis and Crohn’s disease. “But it’s unclear how much market share is actually going to be captured in such a crowded [field],” Tharaldson said. Filgotinib is an oral Janus kinase (JAK) inhibitor previously in development for the treatment of moderate to severe rheumatoid arthritis (RA), Crohn’s disease,

ulcerative colitis, psoriatic arthritis and ankylosing spondylitis. In August, Gilead/Galapagos received a complete response letter from the FDA requesting data from two ongoing studies to assess whether filgotinib affected sperm parameters. The FDA also expressed concerns regarding the overall benefitto-risk profile of the 200-mg dose. In December, Gilead discontinued the U.S. development for RA and other inflammatory conditions. However, Gilead kept the option to continue pursuing development for Crohn’s disease and ulcerative colitis. Atopic dermatitis (AD) has a healthy pipeline that could yield five approvals in 2021. Almost 6 million children and adults in the United States have moderate to severe AD. Three JAK inhibitors could receive an additional indication for AD, but one JAK inhibitor, abrocitinib (Pfizer), could be a novel entry. Several phase 3 trials have demonstrated efficacy in treating moderate to severe AD. However, some patients have seen decreases in platelets and serious infections, which will need to be monitored if approved, Tharaldson said. Approval is expected in April. JAK inhibitors carry boxed warnings for infections, malignancy and thrombosis. “So it’s likely that the JAK inhibitors will be used in patients who don’t respond to Dupixent [dupilumab, Sanofi/Regeneron], even though they’re oral rather than subcutaneous,” she explained. One JAK inhibitor, ruxolitinib (Jakafi, Incyte), is available as an oral formulation for myelofibrosis and steroidrefractory graft-versus-host disease. But Incyte is developing a topical formulation for AD, which will likely compete with crisaborole (Eucrisa, Pfizer), a topical phosphodiesterase-4 inhibitor. The Prescription Drug User Fee Act (PDUFA) date for the first IL-13 inhibitor for AD, tralokinumab (LEO Pharma A/S), is May 9 for the treatment of adults with moderate to severe AD. It is given as a subcutaneous injection every two weeks. Three phase 3 trials have demonstrated efficacy and safety with or without concomitant use of a topical corticosteroid.

Other Growth Areas Cancer

Even though most cancer spending is under the medical benefit, cancer therapy was the second-leading category

in specialty drug spending. Each year in the United States, about 1.8 million new cases of cancer are diagnosed, and more than 600,000 Americans die from the disease, although the death rate has dropped about 25% since 1991 due to reductions in smoking, earlier detection and improved treatments. The gene therapy lisocabtagene maraleucel (liso-cel, BMS) had been expecting approval in 2020 for adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies, but the company received an FDA response letter saying the agency would not meet the Nov. 16 PDUFA date, because it could not inspect a third-party manufacturing facility in Texas due to COVID-19 travel restrictions. Therefore, the FDA deferred action on the application until the inspection can be completed. “We are committed to bringing lisocel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need,” said Samit Hirawat, MD, the executive vice president and chief medical officer of global drug development at BMS. The biological license application is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 268 patients with various types of relapsed or refractory large B-cell lymphoma. The overall response rate (ORR) was 73% (95% CI, 67%-78%), and the complete response (CR) rate was 53% (95% CI, 47%-59%). There are seven other novel cancer drugs with PDUFA dates for the first half of 2021. Two are seeking an indication for refractory multiple myeloma (MM). Melphalan flufenamide (Oncopeptides) is a first-in-class aminopeptidase-targeting peptide–drug conjugate that rapidly delivers an alkalizing agent into tumor cells that is expecting approval on Feb. 28 for use with dexamethasone for adults with triple-class–refractory MM. Results of the pivotal phase 2, single-arm, multicenter HORIZON study of 157 heavily pretreated patients found an ORR of 29%, a median progression-free survival (PFS) of 4.2 months and a median overall survival (OS) of 11.6 months. Idecabtagene vicleucel (Bluebird bio/ BMS) is a chimeric antigen receptor T cell (CAR-T) therapy also seeking an indication for relapsed or refractory MM— the first CAR-T with this indication. An early-phase study demonstrated an 85% ORR. The PDUFA date is March 27. Dostarlimab (GlaxoSmithKline) is a programmed death-1 monoclonal antibody seeking approval for the second-line

treatment patients tr trea eatm tmen entt of p atie at ient ntss wi with th aadvanced dvan dv ance ced d recurrent endometrial cancer. An updated analysis of the GARNET trial showed that dostarlimab provided clinically meaningful results in women with recurrent or advanced mismatch repair–deficient (dMMR) endometrial cancer who progressed after a platinum-based regimen. The analysis included patients with dMMR endometrial cancer who had measurable disease at baseline and six months or more of follow-up by the data cutoff (n=71). Treatment with dostarlimab showed an ORR of 42% (95% CI, 31%-55%) and a disease control rate of 58% (95% CI, 45%-69%). Overall, 13% of patients had a CR and 30% of patients had a partial response. “There are limited treatment options for women with advanced or recurrent endometrial cancer, and prognosis of these patients is poor. The results observed in the GARNET trial indicate the potential of dostarlimab to offer a new treatment option for women with this challenging disease,” said Ana Oaknin, MD, the head of the Gynaecologic Cancer Program at Vall d’Hebron Institute of Oncology, in Barcelona, Spain, and primary investigator of the GARNET trial, when the results were released last April. Trilaciclib (G1 Therapeutics) is an infused cyclin-dependent kinase 4/6 inhibitor designed to preserve bone marrow and immune system function in patients with small cell lung cancer being treated with chemotherapy. In clinical trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression, infections and hospitalizations compared with patients receiving chemotherapy alone. Approval is expected by Feb. 15.

Specialty Pharmacy Continuum • January/February 2021

POLICY

Umbralisib Umbr Um bral alis isib ib is is a tyrosine tyro ty rosi sine ne kinase kin naas n asee ase inhibitor for patients with previv viously treated marginal zone lym-phoma or follicular lymphomaa (FL). Marginal zone lymphoma represents 8% of non-Hodgkin lymphoma cases, accounting for approximately 7,500 new cases per year in the United States. s.. Approximately 15,000 patients are r re diagnosed with FL each year in this h his country. Approval is expected by Feb. F 15 for marginal zone lymphomaa and June 15 for FL. If approved, tivozanib (Aveo OncolO ogy) will be the seventh vascular a ascular endothelial growth factor inhibitor hibitor available for renal cell carcinoma in i refractory patients. Although phase 3 results showed improved PFS by 1.7 months compared with sorafenib (Nexavar, Bayer), it didn’t improve OS. Tharaldson predicted that tivozanib will have a difficult time competing in a “very saturated market.” Gene Therapies

Gene therapies modify a person’s genes to treat or cure disease. Most are viral vectors for gene replacement therapies and patient-derived gene products, such as CAR-T. Human gene editing technology, such as clustered regularly interspaced short palindromic repeats, or CRISPR, may someday be used for gene therapy treatments. It is estimated that the market will be more than $16 billion per year by 2024, according to Tharaldson. More than 600 gene therapies are in U.S. clinical trials. Several are expecting approval for cancer in 2021. In addition to isocabtagene and idecabtagene, 2021

Cancer

25% Orphan Other

52%

23%

is given as a one-time intracerebral infusion. Three clinical studies demonstrated that it improved motor cognitive and language milestones in children, improving the ability to sit, walk and talk. SRP-9001 (Sarepta Therapeutics), a micro-dystrophin gene therapy, may be the first gene therapy for Duchenne muscular dystrophy (DMD) to reach the market. DMD affects about one in 3,500 male births worldwide and is typically worldw recognized between 3 and 6 years of age. It is caused by mutations in the DMD mu gene, which decrease decreas functioning muscle protein dystrophin. dystroph Gene therapy for DMD could potentialDM ly be used in a wide patient population. Current therapies target specific pi genetic mutations, such as eteplirsen (Exondys Sarepta), for patients with 51, Sarept 5 DMD mutations amenable to exon DM MD mutatio M skipping, which represents about 51 skip pping, wh p Although SRP-9001 is 14% off patients. A looking approval in 2021, Tharlookiiing for app aldson ald dson called that “optimistic.” Another DMD drug, which A iss not a gene therapy, that is eexpecting approval on Feb. 25 is casimersen, also by Sarepta. Casimersen will be the first drug approved to treat patients with mutations amep nable to exon 45 skipping, n which represents about 8% of w patients. It’s administered as a paa weekly IV infusion, and filing is weee based d on early-phase studies showing that it increased dystrophin levels. Orphan D Diseases

Specialty Drug Pipeline Most specialty drugs being developed today are for orphan diseases. An orphan disease affects fewer than 200,000 people in the United States, or is a common disease that has been ignored because it is not prevalent here.

PDUFA dates are expected for aglatimagene besadenovec (Advantagene), an immunotherapy for prostate cancer; ciltacabtagene autoleucel (Janssen), a CAR-T therapy for MM; and nadofaragene firadenovec (Ferring) for bladder cancer. Outside of cancer, eladocagene exuparvovec (PTC Therapeutics), a gene replacement therapy, is seeking an indication for aromatic L-amino acid decarboxylase deficiency, a genetic disease associated with defects in neurotransmitter synthesis that cause low muscle tone, developmental delay, movement disorders and premature death. About 100 patients have this disease in the United States. Eladocagene

Pegunigalsidase alfa (Protalix BioPegunig Therapeutics) is a long-acting enzyme h replacement therapy for Fabry disease, a rare genetic disorder that affects about 7,000 U.S. patients. Those with Fabry disease cannot make the enzyme alpha-galactosidase A, which is responsible for breaking down globotriaosylceramide, a type of fat used as a building block for the body’s cells. It can cause peripheral neuropathy and end-organ damage, primarily the kidneys. A phase 3 study found that pegunigalsidase alfa improved renal function in patients switched from the enzyme replacement therapy. The PDUFA date is April 17. Arimoclomol (Orphazyme) amplifies the production of heat shock proteins in Niemann-Pick disease type C, which is a rare storage disorder. It affects about 200 U.S. patients who cannot break down lipids, which build up in the liver, lungs, spleen and brain. Patients with the disorder eventually lose nerve function; the disease is fatal. In a phase 2/3 study, survival favored arimoclomol with a hazard ratio of 0.77 (95% CI, 0.32-1.80)

compared with routine clinical care. The PDUFA date is June 17. Vosoritide (BioMarin) is a C-type natriuretic peptide analog for the treatment of children who have achondroplasia, which is the most common form of disproportionate short stature. A phase 3 trial showed that children receiving daily vosoritide injections grew an average 0.6 inches more during the first year of treatment compared with placebo. The PDUFA date is Aug. 20.

Early 2021 Approvals By the time Specialty Pharmacy Continuum went to press, the FDA had approved four novel drugs in 2021. Tepotinib (Tepmetko, EMD Serono) is a mesenchymal–epithelial transition (MET) inhibitor that was approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), whose tumors have mutations that lead to MET exon 14 skipping—about 4% of cases of NSCLC. “It’s an aggressive type of lung cancer with poor prognosis,” Tharaldson said. Tepotinib is the first and only once-daily oral MET inhibitor for this NSCLC patient. The FDA approved cabotegravirrilpivirine (CAB/RPV; Cabenuva, ViiV Healthcare), a long-acting injection for HIV. CAB/RPV is provided as a co-pack with two injectable medicines—ViiV’s CAB and Janssen’s RPV—dosed every four weeks to replace a patient’s current antiretroviral regimen in those who are virologically suppressed on a stable regimen, with no history of treatment failure and with no known or suspected resistance to either medication. The FDA also approved an oral version of CAB (Vocabria), which is indicated for use with oral RPV (Edurant) as an oral leadin to assess tolerability of CAB before initiating the long-acting injections. It also can be used for patients who will miss a planned injection dose of CAB/RPV. The FDA also approved voclosporin (Lupkynis, Aurinia Pharmaceuticals), the first oral therapy for lupus nephritis (LN). LN causes irreversible kidney damage and significantly increases the risk for renal failure, cardiac events and death in patients with systemic lupus erythematosus (SLE). LN is the most serious and common complication of SLE. In pivotal trials, patients treated with voclosporin in combination with standard of care (SOC) were more than twice as likely to achieve renal response, and they experienced a decline in urine protein/creatinine ratio twice as fast as patients on typical SOC alone. Patients treated with voclosporin showed improved response rates in all parameters. —Marie Rosenthal The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • January/February 2021

TECHNOLOGY

Tapping Into ICD-10 Data Streamlines SP Care Specialty pharmacists at AllianceRx Walgreens Prime’s nine locations received more than a half-million data points on their chronically ill patients’ comorbidities from Inovalon DataStream since July 2020, according to the company. This robust pipeline of patient information, derived in part from the International Classification of Diseases, Tenth Revision (ICD-10), comes from numerous sources, including hospitals, physicians, laboratories and other health care silos, noted Rick Miller, MS Pharm, MBA, the vice president of clinical and professional services of AllianceRx Walgreens Prime. The data bring new levels of clinical detail, speed and timeliness to a patientprofile process that historically has saddled pharmacists, said Kate Eshelman, MD, MPh, the vice president of medical informatics at Inovalon. “The hunting down of clinical data is such a frustrating

primarily chronic diagnoses” to pharmacists, said Eshelman. He added that the software’s algorithm rules average 4.5 new diagnoses per found patient and 1.5 incremental new diagnoses if the

factor for pharmacists,” Eshelman told Specialty Pharmacy Continuum. Part of that frustration is caused by the fragmented nature of traditional pharmacy databases. “Pharmacists often obtain their data from patient questionnaires that can be incomplete and inaccurate,” Eshelman explained. “Even the most educated patients can’t fully describe their health problems. They might say they have a heart condition without stating if it’s atrial fibrillation or congestive heart failure. Patients may say they’re on metoprolol without saying why they take it.” As a result, “pharmacists often see patients on medications without always being sure why they’re on them,” Eshelman said. “DataStream gives pharmacists a much better picture of a patient’s whole health history so they can better impact their health care trajectory.”

patient has already cycled through the DataStream process. “Pharmacists’ access to actionable data, at workflow points where the data are necessary, was the cornerstone of collaborative decisions made between pharmacy and IT during development and implementation,” Miller said. He cited two instances in which the automated arrival of flagged information makes pharmacy workflow driven by patient conditions more efficient: It decreases outreach to prescribers for missing information when entering prescription orders, and it enhances patient safety when validating prescriptions and leads to a fuller personalized counseling experience. As an example, if a pharmacist could learn through DataStream that a cancer patient visited the emergency department a day earlier or shows worsening kidney function in a new lab value, a specialty pharmacist could proactively intervene, Eshelman explained. Accompanying the flagged data point that

The Value of ‘Actionable Data’ DataStream sends “only the most recent, succinct, actionable and

arrives automatically in the pharmacy queue are clinical protocols that establish what the pharmacist should do in light of the new information, and a list of questions to ask the patient, she said. DataStream also can be useful to hospital pharmacists “to ensure continuity of care within the hospital and posthospital discharge,” Eshelman added. “[Then] relevant information from the hospitalization and discharge [conveyed

‘This would be incredibly beneficial for specialty pharmacists filling prescriptions to know patients’ conditions, lab values, hospital stays and more, so they can start melding more medical information with the pharmacy side.’ —Ernie Anderson, RPh, MS

by DataStream] to specialty pharmacists allows them to reach out to ensure the patient’s transition back home is smooth.”

Automating Data “The automatic process of capturing patient conditions directly into the dispensing system is really helpful. Our pharmacists can spend more time counseling and educating patients rather than collecting information,” said Darren McLane, PharmD, the senior director of clinical programs-specialty clinical services of AllianceRx Walgreens Prime. “We can build on our relationship and care with patients outside of the medications we’re dispensing [to] holistically manage health conditions.” Looking ahead, Miller cited allergies, other prescribed medications, height, weight, lab values, clinical notes, recent hospital/emergency department visits, immunization records and disease activity scores as some of the “clinically valuable data on the horizon [in our]

multiphase, multiyear project.” Although both companies said data on patient regimen adherence and health outcomes are still months away, Miller credited “operational efficiencies and improvements [from DataStream that] allowed our staff to focus on providing a high level of patient support” amid the COVID-19 pandemic.

A Link ‘to Fill Information Gaps’ Ernie Anderson, RPh, MS, principal of Ernest R. Anderson, Jr. Consulting, in Brockton, Mass., said, “This would be incredibly beneficial for specialty pharmacists filling prescriptions to know patients’ conditions, lab values, hospital stays and more, so they can start melding more medical information with the pharmacy side. These have historically been two separate buckets. Inovalon is trying to fill information gaps by providing data to the Walgreens of the world

when specialty prescriptions go outside of health systems.” Anderson, who helps health systems develop and grow specialty pharmacies in-house via TrellisRx, in Atlanta, said health systems have data analytics on their patient health outcomes that prove the benefit of giving pharmacists easy access to accurate, complete and timely medical information. AllianceRx Walgreens Prime is the first specialty pharmacy chain in the United States to use DataStream, the newest component of Inovalon’s ScriptMed platform, which it has used for more than a decade. The chain was also the first to implement ScriptMed Cloud, and some of its team members serve on ScriptMed’s Innovation board, Miller noted. —Al Heller The sources reported no relevant financial disclosures other than their stated employment.

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