Specialty Pharmacy Continuum - March / April 2022 by McMahon Group

Serving managed care, health-system and specialty decision makers Volume 11 • Number 2 • March/April 2022 • specialtypharmacycontinuum.com

UP FRONT

Sterile compounding a hot topic at NHIA 2022 Annual Conference ........ 4 POLICY

7 habits of highly effective surface sampling programs ........

OPERATIONS & MGMT

Will Mark Cuban score with new discount drug plan? ....

The ‘OG women’ of health-system specialty pharmacy .....

TECHNOLOGY

Are digital tools the key to gaining provider access? ..........

REVIEW ARTICLES

Management of Pumonary Arterial Hypertension See page 12.

PBM Probe Continues Despite FTC Vote Delay

SP Onc PharmDs Bolster 340B, New Med Access

By Karen Blum

he Federal Trade Commission’s February 2-2 vote that put off investigating pharmacy benefit managers (PBMs) was disappointing to some stakeholders. But the issue isn’t over: The agency opened a docket for public comment, and advocacy organizations are continuing to stress the importance of pharmacists speaking up about any abuses they have experienced. The vote signaled the FTC’s interest in addressing PBM practices, said Tom Kraus, MHS, JD, the vice president of government relations for ASHP, during the FTC hearing. “It’s disappointing that they were deadlocked and did not vote to require the PBMs to provide information,” Mr. Kraus said. “However, they have since opened an opportunity for pharmacies and hospitals to submit information directly to the FTC about their experiences, and any abuses by PBMs. So there’s at least an opportunity for some inquiry. I’m hopeful that once some of those comments are reviewed, … they will reconsider their initial vote.” On Feb. 24, the FTC posted a public docket to request information on PBM practices in areas such as contract terms, rebates, fees, pricing policies, steering methods and conflicts of interest. The request for information “will enable agency staff to study a wide array of PBM business practices and issues and will help inform the agency’s policy and enforcement work,” an FTC press release said. As of March 23, 234 comments from patients, care providers and pharmacists/pharmacies have been submitted. Continued on page 7

Pharmacists’ Role in The Management of Chronic GVHD

mbedding specialty pharmacy staff in oncology clinics can hasten patients’ receipt of new specialty medications and increase the capture rate of 340B-eligible prescriptions, according to new research. Patients received their medications more than three days faster on average after specialty pharmacists were embedded in clinics, according to a retrospective chart review by AMITA Health, in Hinsdale, Ill. Moreover, the capture rate of 340B-eligible prescriptions increased from 17.65% in 2018 (before pharmacists were embedded) to Continued on page 15

Software program streamlines process amid COVID-19

Student-Led PA Team Speeds HCV Rx Access By Karen Blum

s COVID-19 cases continue to plummet, there still are lessons to be learned about optimizing pharmacy operations amid the pandemic. A case in point: As COVID-19 forced many nonessential healthcare personnel to adapt to new hybrid or remote work schedules, the hepatitis C virus (HCV) prior authorization (PA) team at the University of Illinois Hospital and Health Sciences System realized it was time for a much-needed workflow redesign.

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Specialty Pharmacy Continuum • March/April 2022

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Volume 11 • Number 2 • March/April 2022

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Specialty Pharmacy Continuum • March/April 2022

UP FRONT

The NHIA 2022 Annual Conference Alll ar A Al arti articles ticl c es cl sb by yM Ma Marcus arc r us u A A.. B Ba Banks ank ks

USP U SP <79 <797> 97> R Revisions, evisions, IIff E Enacted, nacted, W ill Af ffect M anagementt Will Affect Management O Home Infusion Infusion Products Products Off Home

torage requirements for many products used in services will change proposed homee iinfusion nfus nf usio ion n se serv rvic ices es w illl ch il chan ange ge iiff pr prop oposed revisions to USP General Chapter <797> take effect, according to David Hughes, PharmD, who directs the home infusion service at the Yale New Haven Health System, in Connecticut. Speaking at the 2022 meeting of the National Home Infusion Association in Nashville, Tenn., Dr. Hughes detailed the potential changes. Most home infusion products would fall within “Category 2” of the proposed new USP <797> guidelines, Dr. Hughes said. Many of these products are aseptically produced, made entirely of sterile components and thus do not need to undergo sterility testing. Per the new guidelines, any compound meeting all those conditions could be stored for four days at a controlled room temperature, 10 days in a refrigerator or 45 days in a freezer. That’s a change from the 14 days in a refrigerator currently allowed for lowrisk compounds in the current USP <797> guidelines, Dr. Hughes noted. (For a USP Fact Sheet on beyonduse dating [BUD], see bit.ly/3NhR6Lc.) The current USP <797> guidelines have been in 797 guidelin effect since 2008. The public comm comment period about tthee new gguidelines closed th on March 17. o Ma In the new guidelines, USP proposes lin changing from a ch low-/medium-/ high-risk model h tto one based on ccategories of risk. Category 1 comC pounds, which p do not have to d be prepared in a b cleanroom suite, cle would have the wou shortest BUDs in the short new framework. Catfr egory 2 compounds would co carry the storage limits described above, and Category 3 compounds could have BUDs of up to 180 days. “This change was proposed to avoid inaccurately conferring a level of risk to a particular compounded sterile product [CSP] without consideration for all factors that influence the quality of that CSP,” USP leaders explained in a 2021 overview of the rationale for the new BUDs and categories. Dr. Hughes noted that, according to the new guidelines, sterility testing is required for Category 2 compounds to have a BUD longer than 45 days. For example, an aseptically processed CSP that passes sterility testing can be stored in a freezer for 60 days, and a terminally sterilized CSP that passes a sterility test can be in a freezer for up to 90 days. All Category 3 CSPs, without exception, need to undergo sterility testing to achieve that 180-day mark. Dr. Hughes said, in general, it will be best for

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Hazardous H azarrdous Drugs Drugs Lists: Lists: What Wh hat A re tthe he M ost R eliable S ources? Are Most Reliable Sources?

ne of the most important steps in handling drugs simple hazardous dr drug ugs (H ((HDs) Ds)) iss a seemingly simpl le one—knowing which drugs are in fact hazardous, according to Patricia C. Kienle, MPA, BCSCP, FASHP, the director of accreditation and medication safety for Cardinal Health. Unfortunately, it may be unclear to some practitioners where to find the most updated and reliable sources for that information.

eevery ev ery co ccontainment on nttai ainm nmeen nt sst strategy tra tr rate teggyy d detailed etai et aile ile led e in in U USP SP General SP Geen ner eral era al Chapter <800>, Ms. Kienle This wearC Ch hap apte ter <8 ter < 800 00>, >,, M s K s. iieen nlle sa ssaid. aid id. Th hiiss iincludes nclu nc lude des w we ear archemotherapy donning personal protective iing in ng ch heem mot othe herapy he raap pyy ggloves, love lo ves, s, d on o nni ningg p ning errso son naal pro pr rot oteeccti tiive vvee equipment and operating properly e uipm eq ipmen entt an d op o per erat atin at ing in ing nap rope ro perlly ve pe vvented ntted ed ccleanleaan le nsystem drug-transfer room m suite. Use Use off closed Us closed lo lo syyst stem tem em d r g-ttr ru transf an nsf sfer ferr devices deevvicces es provides p pr rov rov ovid ides an id an added adde ad dde ded d layer laayyeer of of ssafety. afet af ety. ty. Ms. Kienle offered additional Ms.. Ki Ms K en nle o f ered ff d some additi ion nal precautions for any healthcare organization that handles HDs. Such facilities faciliti ies sshould: houl ho uld: d: • assess how to reduce risk at least once a year; • have well-stocked spill kits throughout the facility in locations where HDs are handled; and • if HDs allowed in an organization’s assessment of risk are stored along with other medications, consider putting them on different shelves or in different colored bins. These simple visual cues can tell a technician or pharmacist that this drug or biologic needs special care.

Vancomycin Dosing Tweaks Needed During Home Infusion

In identifying HDs, USP <800> Hazardous Drugs – Handling in Healthcare Settings requires use of the most current version of the list of such drugs maintained by the CDC’s National Institute for Occupational Safety and Health (NIOSH). NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. That means the 2016 list, which includes drugs assessed through 2015, is many years out-of-date. In addition, Ms. Kienle emphasized, the draft revised NIOSH list does not include biologics. Only those drugs approved by the FDA’s Center for Drug Evaluation and Research will be on the revised list. “You’re going to need to make your own judgment call” about whether something is hazardous at times, Ms. Kienle said. This creates a gap concerning new drugs, investigational agents and those products provided under an FDA emergency use authorization. The NIOSH list is a list of hazards, not a risk assessment, she stressed. Each pharmacy or other healthcare site handling HDs needs to evaluate its own practices when conducting an assessment of risk. Opening, breaking, or cutting tablets or capsules is a higher risk, for example, compared with counting tablets that will be given intact. But this still leaves some decisions about level of risk in the eye of the beholder. Ms. Kienle advised getting broad input from different members of the healthcare team when making decisions about the organization’s assessment of risk. “This is a team sport,” she stressed. Some organizations have inappropriately used the Environmental Protection Agency’s list of hazardous materials. These are different issues, she noted; the NIOSH list is a concern to healthcare personnel, while the EPA list is an environmental concern. There are some drugs that are on both lists, so an organization’s waste hauler is a useful source of guidance about what is considered hazardous for disposal in different jurisdictions, Ms. Kienle said. When manipulating an antineoplastic drug in Table 1 of the current NIOSH list, organizations must follow

ntravenous vancomycin sometimes requires dosing adjustments to avoid kidney damage when people begin home-based infusions of the antibiotic after leaving a hospital or clinic, according to Cheyenne Johnson, PharmD, of Option Care Health, in Lincoln, Neb. The kidney damage may occur because some people don’t maintain adequate levels of hydration once they get home, said Dr. Johnson, who presented a study tracking vancomycin dose reduction levels throughout home infusion therapy. Of 94 total patients who received home-based vancomycin for osteomyelitis treatment, 24 required a vancomycin dose reduction within a week of beginning home infusion. This decision was based on serum creatinine lab levels that indicated potential kidney damage at the higher dose.

By the end of the second week, another 13 people needed a dose reduction, and 10 more people obtained a dose reduction after that. In total, half (47) of the study population reduced their vancomycin dose. Dr. Johnson is still analyzing the data and emphasized that under-dosing vancomycin can also be bad. Dr. Johnson said her long-term goal is to publish a decision tree to aid clinicians in making decisions about vancomycin dose reduction tailored to the clinical profiles of individual patients. The sources reported no relevant financial disclosures.

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Specialty Pharmacy Continuum • March/April 2022

POLICY

7 Habits of Highly Effective Surface Samplers By Gina Shaw and David Bronstein

Staff working in specialty pharmacies, home infusion clinics, health systems and other care settings that handle hazardous drugs (HDs) may think their efforts to prevent surface contamination are working. But studies and practical experience suggest that even the best prevention efforts may fall short. So, here are seven steps for ensuring your facility’s HD strategies have the best chance for success, based on interviews with two safe-handling veterans. 1. Know the data. The first step is to understand how prevalent—and hidden—surface contamination can be. In 2019, researchers from the University of North Carolina retrospectively analyzed 5,842 individual surface wipe samples from 338 pharmacies over six years. Depending on the location and surface tested, 3.94% to 25.96% of samples had high levels of HD contamination, and the researchers concluded the highest levels of contamination were in preparation areas. Repeated wipe sampling lowered overall HD contamination: 45.24% of samples detected HDs with the first wipe compared with 31.64% for subsequent wipes (Am J Health Syst Pharm 2019;76[9]:591-598). 2. Be honest about your own HD handling and surface wipe sampling efforts. The experience of Bridget Gegorski, PharmD, the medication safety officer at University Hospitals Health System, in Cleveland, is a case in point. Dr. Gegorski was convinced her health system had done an outstanding job preparing for the implementation of USP General Chapter <800>. “Particularly for [National Institute for Occupational Safety and Health] Table 1 drugs and chemotherapy, we had implemented a number of processes that significantly cut down on hazardous drug contamination,” she told Specialty Pharmacy Continuum. These steps included administrative controls, such as staff training, limiting access to areas containing HDs, good housekeeping practices, as well as engineering controls such as biological safety cabinets, proper ventilation and negative pressure rooms. But surface contamination testing told her those steps had not been sufficient. “When we conducted [follow-up] surface contamination testing, we were still getting at least low positives in the environment, in places where we wouldn’t expect it—areas where we know the operators are doing things correctly and probably are even more cautious than I am about processes, so we didn’t expect to find contamination there,” she said. “We suspected something else might be going on.” 3. Consider that chemotherapy vial contamination could be the culprit. In

fact, this was a likely explanation for why Dr. Gegorski’s team’s initial HD handling efforts fell short despite a very robust list of additional interventions, including cleaning locations with a deactivation/decontamination agent; evaluating proper use of closed system drug-transfer devices; observing work practice controls and the use of personal protective equipment (PPE); revisiting PPE donning and doffing procedures; evaluating cleaning

procedures and the cleaning and decontamination agents used; and assessing the appropriateness of cleaning frequency. “We did all that, and we were still finding positives, so we were trying to figure out where we were having particles escape,” Dr. Gegorski said. “Finally, we realized that HD particles found on the outside of vials from our wholesaler could be a significant source of contamination.” see 7 HABITS, page 6

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7 HABITS continued from page 5

Published data support that scenario. A 2020 literature review of 24 articles from 11 countries concluded that the majority of antineoplastic vials have surface contamination when they arrive (Eur J Hosp Pharm 2020;27[5]:313-314). So, University Hospitals added a new step to its HD mitigation processes. “While USP <800> does not require this, our wholesaler has consented to labeling totes that contain HDs,” Dr. Gegorski

said. “Those totes are immediately taken to a receiving area within the HD cleanroom where we store all oncology products. We don’t open the tote until we are in that area and then we wipe down all the container surfaces.” 4. Have a plan for getting buy-in, not only from leaders but also staff. This is a critical step, Dr. Gegorski said. In the case of pharmacy leadership, be prepared to address their fears over the consequences of a surface wipe contamination testing plan; they may not want you to find positives. “USP <800> says that you

should do this testing, not that you must do it,” she noted. “But if you start testing and you find positives—and you’re almost certainly going to find positives— then ‘should’ becomes ‘must.’ You have to mitigate, document your action and then retest. People may not be too keen on that, but fortunately at our institution, our leaders supported our implementation of the process. Having leadership support is key.” As for getting staff buy-in, education is vital, Dr. Gegorski said. “After our first round of sampling in December 2018, we

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realized that there was a lot of confusion and misinformation. We created education to explain the benefits of testing for HD contamination, the controls that are in place to prevent occupational exposure, how to reduce HD contamination in everyday practices, and next steps to take if a positive result is found.” A town hall, held in early 2019, offered an open forum to staff to ask questions related to HD surface sampling, she added. 5. Be smart when deciding where to test—and don’t rely on vendors for this important step. Although it might seem logical to let your third-party certifier choose sampling locations for you, that’s not a good idea, said Abby Roth, the senior director of business operations for CriticalPoint. Ms. Roth advised compounding pharmacies to conduct their own prospective risk analysis to select those locations. “Only you know where best to sample in your pharmacy, since sampling must occur in locations that, if contaminated, have a higher risk of affecting the compounded sterile preparations,” she said. “You know where your high-touch-risk and back-and-forth high-traffic areas are.” 6. Remember that sampling in the cleanroom isn’t just for HD contamination. The 2019 version of USP <797> lays out requirements for air and surface sampling programs for viable microbial contamination (bioburden) in sterile compounding facilities. “But the chapter still doesn’t go into enough detail,” Ms. Roth said. “It tells you what you need to do, but not how to clearly do it.” Fortunately, in 2020, the Controlled Environment Testing Association (CETA) updated its testing guide, CAG-009 Viable Environmental Monitoring for Sterile Compounding Facilities. The document provides best-practices recommendations to close the gaps in the chapters, Ms. Roth noted. (It is available to CETA members for $245 annually.) 7. Be ready for pushback. Ms. Gegorski reiterated the importance of addressing fears about surface contamination testing. “People are afraid of what they’ll find if they start testing, so they don’t do it,” she said. “That’s misguided. I actually think it should be required, not optional. This is an essential thing we need to do to protect our employees, to identify where we’re having problems and do focused improvement.” The sources reported no relevant financial disclosures other than their stated employment.

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Specialty Pharmacy Continuum • March/April 2022

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PBM Scrutiny Not Over continued from page 1

Carolyn Hersch, a patient from Illinois, wrote that she was out of medication she’s taken for more than five years, and that every year, Express Scripts denies coverage and requires her doctor to appeal the decision. “This wastes the doctor’s and my time,” she wrote. “Meds

telling them to fill prescriptions at a different pharmacy for reasons such as better copays, or offering a 90-day supply exclusive to that pharmacy. “The insurance companies sometimes, but not always, try to incentivize the patient by saying that their copay will

‘There’s a substantially greater understanding of the techniques that PBMs use to extract money from patients, providers, manufacturers and the government.’ —Jonathan Levitt, JD haven’t gotten any less expensive since corporation’s [sic] took over management. Doctors should manage patient care, not insurance companies.” Trenton Jenks, PharmD, BCGP, the co-owner of The Prescription Pad pharmacy and compounder in Fruitland, Idaho, wrote that he has had patients come into his pharmacy every year with letters from insurers

be better or smaller if they do this,” he wrote. “I have found that this promised incentive is also not always fulfilled and sometimes is a flat-out lie to move the business over to their own pharmacy. ... Most patients prefer their locally owned pharmacy that supports the community, … so much so that they are willing to pay higher copays to stay.”

4 Actions for Addressing PBM Hassles to know your local city council people and elected 1 Get officials. familiar with your state and federal laws. In 2 Become New Jersey, for example, any provider has the right to be in a network. Under the Medicare Part D Prescription Drug Benefit Manual, you have the right to a reasonable reimbursement rate.

Participate in pharmacy organizations. “If your local or state pharmacy association isn’t getting the job done, look to see who is doing something,” said Monique Whitney, the executive director of the nonprofit advocacy group Pharmacists United for Truth and Transparency. “Get involved and get to know others in your field.”

Don’t be afraid to pick up the phone and call your congressional representatives to register a complaint. Once three people call about the same issue, it hits their radar, Ms. Whitney said. “You could be the one who tips it over into a problem they’re going to start looking into.”

PBMs contacted for this article either declined comment or directed Specialty Pharmacy Continuum to the Pharmaceutical Care Management Association (PCMA), the national group representing PBMs. “We look forward to working with Congress and the Administration on ways to increase affordability and access to prescription drugs for all patients,” said PCMA spokesperson Greg Lopes, in an emailed statement. “Drug manufacturer price setting is the root cause of high drug costs, putting a strain on patients and forcing them to make difficult decisions about their drugs. PBMs are holding drug companies accountable by relentlessly negotiating the lowest possible cost on behalf of patients, and are driving and delivering local competition that patients are demanding.”

fees, spread pricing (charging payors more than PBMs pay a pharmacy for medication), and reimbursement rates to providers, according to Mr. Kraus and Mr. Levitt. “There’s a substantially greater understanding of the techniques that PBMs use to extract money from patients, providers, manufacturers and the government,” Mr. Levitt said. The issue is unlikely to be swept under the rug anytime soon, added Monique Whitney, the executive director of the nonprofit advocacy group Pharmacists United for Truth and Transparency. “I think we’re going to continue to see a lot of pressure and a lot of interest in what role exactly PBMs are playing in every level of pharmacy care, the cost of drugs, and patient access to drugs,” she said. The sources reported no relevant financial disclosures.

It’s Time to Speak Out ASHP will submit detailed comments to the FTC docket, which is open until April 25, Mr. Kraus said. “We really would encourage health systems and pharmacies to do the same, particularly if they have experienced some of these PBM behaviors directly.” ASHP also will continue advocating on individual issues at the federal and state level, he said, including practices such as white bagging, when PBMs and payors require certain specialty drugs to be sourced from a payor-affiliated pharmacy: “We want to make sure that federal agencies recognize how some of these behaviors impact patient care.” The FTC looks at things from a competition perspective, Mr. Kraus said. But “when PBMs selectively reimburse 340B hospitals at a lower rate to try to capture some of the value of that program, that [adversely] impacts patient care. That’s obviously something that a broader set of agencies should care about, so we’ll continue to sound the alarm about those behaviors.”

Why the Stymied Vote? The FTC’s reasoning behind the stymied vote is that the issue is complicated and too broad, said Jonathan Levitt, JD, a founding partner of the firm Frier Levitt, which has offices in New Jersey and New York City. The request for comments, however, “strongly signals their intentions and where they’re headed with respect to investigating PBMs,” Mr. Levitt said. “If you look at what they’ve asked for in their request, it’s pretty revealing. They want to know from not just consumers but all the different stakeholders,” including plan sponsors and providers. Congress, other agencies and state legislatures have ongoing legislation addressing individual aspects of reported PBM abuses such as white bagging, direct and indirect remuneration

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For patients with cGVHD æÐÌ ɖǠǡ řÐīĮ åĴÐī åðăķīÐ ďå Ĵ ăÐĮĴ ǡ Ĩīðďī ăðĊÐĮ ďå ĮřĮĴÐĉðÆ ĴìÐīĨřș ìÐăĨ ĴìÐĉǠȭǢ

ROCK ON

INDICATION REZUROCK™ (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

IMPORTANT SAFETY INFORMATION Warnings and Precautions • Embryo-Fetal Toxicity: ĮÐÌ ďĊ ť ĊÌðĊæĮ ðĊ ĊðĉăĮ ĊÌ ðĴĮ ĉÐÆìĊðĮĉ ďå ÆĴðďĊș t'¢ tZ N ÆĊ ÆķĮÐ åÐĴă ìīĉ œìÐĊ administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose Adverse Reactions • }ìÐ ĉďĮĴ ÆďĉĉďĊ ȧɖ ǡǟɦȨ ÌŒÐīĮÐ īÐÆĴðďĊĮș ðĊÆăķÌðĊæ ăÅďīĴďīř ÅĊďīĉăðĴðÐĮș œÐīÐ ðĊåÐÆĴðďĊĮș ĮĴìÐĊðș ĊķĮÐș ÌðīīìÐș ÌřĮĨĊÐș Æďķæìș ÐÌÐĉș ìÐĉďīīìæÐș ÅÌďĉðĊă ĨðĊș ĉķĮÆķăďĮāÐăÐĴă ĨðĊș ìÐÌÆìÐș ĨìďĮĨìĴÐ ÌÐÆīÐĮÐÌș æĉĉ æăķĴĉřă ĴīĊĮåÐīĮÐ ðĊÆīÐĮÐÌș ăřĉĨìďÆřĴÐĮ ÌÐÆīÐĮÐÌș ĊÌ ìřĨÐīĴÐĊĮðďĊ • qÐīĉĊÐĊĴ ÌðĮÆďĊĴðĊķĴðďĊ ďå t'¢ tZ N ÌķÐ Ĵď ÌŒÐīĮÐ īÐÆĴðďĊĮ ďÆÆķīīÐÌ ðĊ Ǡǧɦ ďå ĨĴðÐĊĴĮȘ }ìÐ ÌŒÐīĮÐ īÐÆĴðďĊĮ œìðÆì īÐĮķăĴÐÌ ðĊ ĨÐīĉĊÐĊĴ ÌðĮÆďĊĴðĊķĴðďĊ ďå t'¢ tZ N ðĊ ɔ Ǣɦ ďå ĨĴðÐĊĴĮ ðĊÆăķÌÐÌ ĊķĮÐ ȧǣɦȨȘ ÌŒÐīĮÐ īÐÆĴðďĊĮ ăÐÌðĊæ Ĵď ÌďĮÐ ðĊĴÐīīķĨĴðďĊ ďÆÆķīīÐÌ ðĊ ǡǨɦ ďå ĨĴðÐĊĴĮȘ }ìÐ ÌŒÐīĮÐ īÐÆĴðďĊĮ ăÐÌðĊæ Ĵď ÌďĮÐ ðĊĴÐīīķĨĴðďĊ ðĊ ɖ ǡɦ œÐīÐ ðĊåÐÆĴðďĊĮ ȧǠǠɦȨș ÌðīīìÐ ȧǣɦȨș ĊÌ ĮĴìÐĊðș ÌřĮĨĊÐș ìÐĉďīīìæÐș ìřĨďĴÐĊĮðďĊș ăðŒÐī åķĊÆĴðďĊ ĴÐĮĴ ÅĊďīĉăș ĊķĮÐș ĨřīÐŘðș ÐÌÐĉș ĊÌ īÐĊă åðăķīÐ œðĴì ȧǡɦ ÐÆìȨ • TďĊðĴďī ĴďĴă ÅðăðīķÅðĊș ĮĨīĴĴÐ ĉðĊďĴīĊĮåÐīĮÐ ȧ w}Ȩș ĊÌ ăĊðĊÐ ĉðĊďĴīĊĮåÐīĮÐ ȧ O}Ȩ Ĵ ăÐĮĴ ĉďĊĴìăř Drug Interactions • Strong CYP3A Inducers: Coadministration of REZUROCK with strong CYP3A inducers decreases belumosudil ÐŘĨďĮķīÐș œìðÆì ĉř īÐÌķÆÐ ĴìÐ ÐŨ ÆÆř ďå t'¢ tZ NȘ AĊÆīÐĮÐ ĴìÐ ÌďĮæÐ ďå t'¢ tZ N Ĵď ǡǟǟ ĉæ ĴœðÆÐ Ìðăř when coadministered with strong CYP3A inducers • Proton Pump Inhibitors: Coadministration of REZUROCK with proton pump inhibitors decreases belumosudil ÐŘĨďĮķīÐș œìðÆì ĉř īÐÌķÆÐ ĴìÐ ÐŨ ÆÆř ďå t'¢ tZ NȘ AĊÆīÐĮÐ ĴìÐ ÌďĮæÐ ďå t'¢ tZ N Ĵď ǡǟǟ ĉæ ĴœðÆÐ Ìðăř when coadministered with proton pump inhibitors

ORRa

75% (95% CI, 63-85; P<.0001) 1,4

REZUROCK achieved clinically and statistically ĮðæĊðť ÆĊĴ ÐŨ ÆÆř with the 200-mg once-daily dose in a real-world demographic of patients with cGVHD.1

• ZĊÆÐȭÌðăř ďīă ĉÐÌðÆĴðďĊ ĴìĴ ĴīæÐĴĮ ÅďĴì ðĊŦ ĉĉĴðďĊ ĊÌ ť ÅīďĮðĮ Ĵìīďķæì ĮÐăÐÆĴðŒÐ tZ Nǡ ðĊìðÅðĴðďĊ1-3 • CR was observed in all organsș ðĊÆăķÌðĊæ ĴìďĮÐ œðĴì ť ÅīďĴðÆ ĉĊðåÐĮĴĴðďĊĮ

• There was no death or new systemic therapy initiation in 62% (95% CI, 46-74) of the responder population at 12 months1 • Clinically meaningful improvements in QOL, with CS and CNI dose reductions and discontinuations ÆìðÐŒÐÌ ðĊ ÅďĴì īÐĮĨďĊÌÐīĮ and nonresponders5 • Well tolerated1

ASSIST

™

Enroll your patients with cGVHD in Kadmon ASSIST so our ĮĨÐÆðăðĮĴĮ ÆĊ ť ĊÌ ĴìÐ ÅÐĮĴ Ĩīďæīĉ Ĵď ť Ĵ řďķī ĨĴðÐĊĴĮȸ ÆďŒÐīæÐȘ Kadmon ASSIST ðĮ ŒðăÅăÐ Monday through Friday, 8ŬƢ-8ƲƢ ET, Åř ÆăăðĊæ 1-844-KADMON1 (523-6661).

VISIT REZUROCKhcp.com TO LEARN MORE cGVHD, chronic graft-versus-host disease; CNI, calcineurin inhibitor; CR, complete response; CS, corticosteroid; FDA, US Food and Drug Administration; NIH, National Institutes of Health; ORR, overall response rate; PR, partial response; QOL, quality of life; ROCK2, rho-associated coiled-coil–containing protein kinase-2. Proportion of patients who achieved CR or PR according to the 2014 NIH cGVHD Consensus Criteria in the 200-mg once-daily arm.1

IMPORTANT SAFETY INFORMATION (cont) ĮÐ ðĊ wĨÐÆðť Æ qďĨķăĴðďĊĮ • Pregnancy: ĮÐÌ ďĊ ť ĊÌðĊæĮ åīďĉ Ċðĉă ĮĴķÌðÐĮ ĊÌ ĴìÐ ĉÐÆìĊðĮĉ ďå ÆĴðďĊș t'¢ tZ N ÆĊ ÆķĮÐ åÐĴă ìīĉ œìÐĊ administered to pregnant women. There are no available human data on REZUROCK use in pregnant women to evaluate for a drug-associated risk. Advise pregnant women and females of reproductive potential of the potential risk to the fetus • Lactation: There are no data available on the presence of belumosudil or its metabolites in human milk or the effects on ĴìÐ ÅīÐĮĴåÐÌ ÆìðăÌș ďī ĉðăā ĨīďÌķÆĴðďĊȘ ÐÆķĮÐ ďå ĴìÐ ĨďĴÐĊĴðă åďī ĮÐīðďķĮ ÌŒÐīĮÐ īÐÆĴðďĊĮ åīďĉ ÅÐăķĉďĮķÌðă ðĊ ĴìÐ ÅīÐĮĴåÐÌ ÆìðăÌș ÌŒðĮÐ ăÆĴĴðĊæ œďĉÐĊ ĊďĴ Ĵď ÅīÐĮĴåÐÐÌ ÌķīðĊæ ĴīÐĴĉÐĊĴ œðĴì t'¢ tZ N ĊÌ åďī Ĵ ăÐĮĴ ďĊÐ œÐÐā after the last dose • Pediatric Use: The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established • Geriatric Use: Zå ĴìÐ Ǡǧǥ ĨĴðÐĊĴĮ œðĴì ÆìīďĊðÆ : ># ðĊ ÆăðĊðÆă ĮĴķÌðÐĮ ďå t'¢ tZ Nș ǡǥɦ œÐīÐ ǥǤ řÐīĮ ĊÌ ďăÌÐīȘ Uď clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients • Renal and Hepatic Impairment: Treatment with REZUROCK has not been studied in patients with pre-existing severe īÐĊă ďī ìÐĨĴðÆ ðĉĨðīĉÐĊĴȘ 9ďī ĨĴðÐĊĴĮ œðĴì ĨīÐȭÐŘðĮĴðĊæ ĮÐŒÐīÐ īÐĊă ďī ìÐĨĴðÆ ðĉĨðīĉÐĊĴș ÆďĊĮðÌÐī ĴìÐ īðĮāĮ ĊÌ ĨďĴÐĊĴðă ÅÐĊÐť ĴĮ ÅÐåďīÐ ðĊðĴðĴðĊæ ĴīÐĴĉÐĊĴ œðĴì t'¢ tZ N You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call Ǡȭǧǟǟȭ9# ȭǠǟǧǧȘ ďķ ĉř ăĮď ÆďĊĴÆĴ NÌĉďĊ qìīĉÆÐķĴðÆăĮș OO ș Ĵ ǠȭǧǦǦȭǢǦǦȭǦǧǥǡ Ĵď īÐĨďīĴ ĮðÌÐ ÐååÐÆĴĮȘ References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2. Zanin-Zhorov A, Weiss JM, Nyuydzefe MS, et al. Selective oral ROCK2 inhibitor down-regulates IL-21 and IL-17 secretion in human T cells via STAT3-dependent mechanism. Proc Natl Acad Sci USA. 2014;111(47):16814-16819. doi:10.1073/pnas.1414189111 3. Flynn R, Paz K, Du J, et al. Targeted rho associated kinase 2 inhibition suppresses murine and human chronic GVHD through a Stat3-dependent mechanism. Blood. 2016;127(17):2144-2154. doi:10.1182/blood-2015-10-678706 4. #Ĵ ďĊ ť ăÐȘ NÌĉďĊ qìīĉÆÐķĴðÆăĮș OO ț ǡǟǡǠȘ 5. Cutler CS, Lee SJ, Arai S, et al. Belumosudil for chronic graft-versus-host disease (cGVHD) after 2 or more prior lines of therapy: the ROCKstar study. Blood. 2021;blood.2021012021. doi:10.1182/blood.2021012021

Please see Brief Summary of full Prescribing Information on adjacent pages.

REZUROCK™ (belumosudil) tablets, for oral use Initial U.S. Approval: 2021 BRIEF SUMMARY: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE REZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versushost disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of belumosudil to pregnant rats and rabbits during the period organogenesis caused adverse developmental outcomes including embryo-fetal mortality and malformations at maternal exposures (AUC) less than those in patients at the recommended dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose [see Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1) in the full prescribing information]. 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice. Chronic Graft versus Host Disease In two clinical trials (Study KD025-213 and Study KD025-208), 83 adult patients with chronic GVHD were treated with REZUROCK 200 mg once daily [see Clinical Studies (14.1) in the full prescribing information]. The median duration of treatment was 9.2 months (range 0.5 to 44.7 months). Fatal adverse reaction was reported in one patient with severe nausea, vomiting, diarrhea and multi-organ failure. Permanent discontinuation of REZUROCK due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of REZUROCK in > 3% of patients included nausea (4%). Adverse reactions leading to dose interruption occurred in 29% of patients. The adverse reactions leading to dose interruption in ≥ 2% were infections (11%), diarrhea (4%), and asthenia, dyspnea, hemorrhage, hypotension, liver function test abnormal, nausea, pyrexia, edema, and renal failure with (2% each). The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension. Table 2 summarizes the nonlaboratory adverse reactions. Table 2: Nonlaboratory Adverse Reactions in ≥ 10% Patients with Chronic GVHD Treated with REZUROCK REZUROCK 200 mg once daily (N=83) Adverse Reaction

Table 3 summarizes the laboratory abnormalities in REZUROCK. Table 3: Selected Laboratory Abnormalities in Patients with Chronic GVHD Treated with REZUROCK REZUROCK 200 mg once daily

Parameter

Grade 0-1 Baseline

Grade 2-4 Max Post

Grade 3-4 Max Post

(N)

(%)

Chemistry Phosphate Decreased

Gamma Glutamyl Transferase Increased

Calcium Decreased

Alkaline Phosphatase Increased

Potassium Increased

Alanine Aminotransferase Increased

Creatinine Increased

Lymphocytes Decreased

Hemoglobin Decreased

Platelets Decreased

Neutrophil Count Decreased

Hematology

7 DRUG INTERACTIONS 7.1 Effect of Other Drugs on REZUROCK Strong CYP3A Inducers Coadministration of REZUROCK with strong CYP3A inducers decreases belumosudil exposure [see Clinical Pharmacology (12.3) in the full prescribing information], which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK when coadministered with strong CYP3A inducers [see Dosage and Administration (2.3) in the full prescribing information].

All Grades (%)

Grades 3-4 (%)

Infection (pathogen not speciﬁed)a

Viral infectionb

Bacterial infectionc

Astheniad

Edemae

Pyrexia Gastrointestinal

Nauseaf

Diarrhea

Abdominal paing

Dysphagia

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action [see Clinical Pharmacology (12.1) in the full prescribing information], REZUROCK can cause fetal harm when administered to pregnant women. There are no available human data on REZUROCK use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, administration of belumosudil to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes, including alterations to growth, embryo-fetal mortality, and embryo-fetal malformations at maternal exposures (AUC) approximately ≥ 3- (rat) and ≥ 0.07 (rabbit) times the human exposure (AUC) at the recommended dose (see Animal Data). Advise pregnant women and females of reproductive potential of the potential risk to the fetus.

Dyspneah

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Coughi

Nasal congestion

Hemorrhagej

Hypertension

Musculoskeletal paink

Muscle spasm

Arthralgia

Decreased appetite

Skin and subcutaneous Rashm

Pruritusn

Infections and infestations

General disorders and administration site conditions

Respiratory, thoracic and mediastinal

Vascular

Musculoskeletal and connective tissue

Nervous system Headachel Metabolism and nutrition

includes edema peripheral, generalized edema, face edema, localized edema, edema. includes nausea, vomiting. g includes abdominal pain, abdominal pain upper, abdominal pain lower. h includes dyspnea, dyspnea exertional, apnea, orthopnea, sleep apnea syndrome. i includes cough, productive cough. j includes contusion, hematoma, epistaxis, increased tendency to bruise, conjunctival hemorrhage, hematochezia, mouth hemorrhage, catheter site hemorrhage, hematuria, hemothorax, purpura. k includes pain in extremity, back pain, flank pain, limb discomfort, musculoskeletal chest pain, neck pain, musculoskeletal pain. l includes headache, migraine. m includes rash, rash maculo-papular, rash erythematous, rash generalized, dermatitis exfoliative. n includes pruritus, pruritus generalized. f

infection with an unspecified pathogen includes acute sinusitis, device related infection, ear infection, folliculitis, gastroenteritis, gastrointestinal infection, hordeolum, infectious colitis, lung infection, skin infection, tooth infection, urinary tract infection, wound infection, upper respiratory tract infection, pneumonia, conjunctivitis, sinusitis, respiratory tract infection, bronchitis, sepsis, septic shock. b includes influenza, rhinovirus infection, gastroenteritis viral, viral upper respiratory tract infection, bronchitis viral, Epstein-Barr viremia, Epstein-Barr virus infection, parainfluenzae virus infection, Varicella zoster virus infection, viral infection. c includes cellulitis, Helicobacter infection, Staphylococcal bacteremia, catheter site cellulitis, Clostridium difficile colitis, Escherichia urinary tract infection, gastroenteritis Escherichia coli, Pseudomonas infection, urinary tract infection bacterial. d includes fatigue, asthenia, malaise.

Proton Pump Inhibitors Coadministration of REZUROCK with proton pump inhibitors decreases belumosudil exposure [see Clinical Pharmacology (12.3) in the full prescribing information], which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK when coadministered with proton pump inhibitors [see Dosage and Administration (2.3) in the full prescribing information].

Data Animal Data Embryo-fetal development studies were conducted in rats with administration of belumosudil to pregnant animals during the period of organogenesis at oral doses of 25, 50, 150, and 300 mg/kg/day in a pilot study and doses of 15, 50, and 150 mg/kg/day in a pivotal study. In the pilot study, maternal toxicity and embryofetal developmental effects were observed. Maternal toxicity (reduced body weight gain) occurred at 150 and 300 mg/kg/day doses. Increased post-implantation loss occurred at 50 and 300 mg/kg/day. Fetal-malformations were observed at ≥ 50 mg/kg/day and included absence of anus and tail, omphalocele, and dome shaped head. The exposure (AUC) at 50 mg/kg/day in rats is approximately 3 times the human exposure at the recommended dose of 200 mg. In an embryo-fetal developmental study in rabbits, pregnant animals administered oral doses of belumosudil at 50, 125, and 225 mg/kg/day during the period of organogenesis resulted in maternal toxicity and embryo-fetal developmental effects. Maternal toxicity (body weight loss and mortality) was observed at doses ≥ 125 mg/kg/day. Embryo-fetal effects were observed at doses ≥ 50 mg/kg/day and included spontaneous abortion, increased post-implantation loss, decreased percentage of live fetuses, malformations, and decreased fetal body weight. Malformations included those in the tail (short), ribs (branched, fused or deformed), sternebrae (fused), and neural arches (fused, misaligned, and deformed). The exposure (AUC) at 50 mg/kg/day in rabbits is approximately 0.07 times the human exposure at the recommended dose of 200 mg. 8.2 Lactation Risk Summary There are no data available on the presence of belumosudil or its metabolites in human milk or the effects on the breastfed child, or milk production. Because of the potential for serious adverse reactions from belumosudil in the breastfed child, advise lactating women not to breastfeed during treatment with REZUROCK and for at least one week after the last dose. 8.3 Females and Males of Reproductive Potential REZUROCK can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating treatment with REZUROCK.

Contraception Females Advise females of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose of REZUROCK. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose of REZUROCK. Infertility Females Based on findings from rats, REZUROCK may impair female fertility. The effect on fertility is reversible [see Nonclinical Toxicology (13.1) in the full prescribing information]. Males Based on findings from rats and dogs, REZUROCK may impair male fertility. The effects on fertility are reversible [see Nonclinical Toxicology (13.1) in the full prescribing information]. 8.4 Pediatric Use The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. Use of REZUROCK in this age group is supported by evidence from adequate and well-controlled studies of REZUROCK in adults with additional population pharmacokinetic data demonstrating that age and body weight had no clinically meaningful effect on the pharmacokinetics of drug substance, that the exposure of drug substance is expected to be similar between adults and pediatric patients age 12 years and older, and that the course of disease is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to pediatric patients. The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established. 8.5 Geriatric Use Of the 186 patients with chronic GVHD in clinical studies of REZUROCK, 26% were 65 years and older. No clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients. Active ingredient made in India. Distributed and marketed by: Kadmon Pharmaceuticals, LLC Warrendale, PA 15086 1-877-377-7862 REZUROCK™ is a trademark of Kadmon Pharmaceuticals, LLC. © 2021 Kadmon Pharmaceuticals, LLC, Warrendale, PA 15086. All rights reserved. KAD25000266 10/21

Specialty Pharmacy Continuum • March/April 2022

CLINICAL

Management of

Pulmonary Arterial Hypertension MELANIE RADI, PHARMD, CSP Manager, Clinical Programs AllianceRx Walgreens Prime Gibsonia, Pennsylvania

ulmonary arterial hypertension (PAH), a rare disease that falls under the larger umbrella of pulmonary hypertension (PH),1 can affect

anyone, but certain risk factors may make it more likely that someone will develop the disease.

PAH is defined as increased pulmonary arterial pressure of at least 20 mm Hg at rest.2 The arteries in the lung become narrow or blocked, making blood flow more difficult. This, in turn, increases the pulmonary arterial blood pressure, causing the right side of the heart to work harder to pump blood to the lungs. Over time, the heart muscle weakens, eventually leading to heart failure.2 PAH, 1 of the 5 categories of PH recognized by the World Health Organization (Table),3 affects approximately 30,000 people of all ages, races, and ethnic groups in the United States.4 Although PAH can affect anyone, risk factors have been identified. Sex can play a major role, with women being almost twice as likely as men to develop PAH.5 A small percentage of patients have heritable PAH, which exhibits an autosomal dominant pattern, with several gene mutations identified.3 Obesity with obstructive sleep apnea, and underlying diseases such as scleroderma and lupus, have been shown to lead to the development of PAH.4 The use of certain drugs or toxins, including methamphetamines and fenfluramine-containing appetite suppression agents, also can play a role in the development of the disease.3 It is not uncommon for diagnosis to be delayed because the symptoms can be nondescript and include chest pain, dizziness, fatigue, leg swelling, weakness, and shortness of breath during activity.1 Diagnostic tests including an echocardiogram and pulmonary function tests can help support a diagnosis of PAH, but right

cardiac catheterization is required to confirm the diagnosis. This test also will help the physician determine the severity of the disease.5 Patients with PAH exhibit an imbalance in vasodilators produced in the lungs that is caused by a malfunction of 1 of 3 key signaling pathways: the nitric oxide (NO), prostacyclinthromboxane A2, and endothelin-1 pathways.3 Nitric oxide is responsible for pulmonary vasodilation, and patients with PAH have been shown to have lower levels in their system.3 Prostacyclins are responsible for smooth muscle relaxation and vasodilation.3 Patients with PAH have reduced production of prostacyclin, as well as reduced expression of prostacyclin receptors and prostacyclin synthase.3 Endothelin-1 acts as a potent vasoconstrictor, and patients with PAH have an increased concentration in their plasma and pulmonary vascular endothelial cells. Understanding of these underlying pathways in the pathophysiology of PAH has led to the development of targeted pharmacologic treatment options.2

Table. Classification of Pulmonary Hypertension Group 1

Pulmonary arterial hypertension

Group 2

Pulmonary hypertension due to left heart disease

Group 3

Pulmonary hypertension due to lung diseases and/or hypoxia

Group 4

Chronic thromboembolic pulmonary hypertension

Group 5

Pulmonary hypertension with unclear multifactorial mechanisms

Based on reference 3.

goal of pharmacologic therapy is to reduce symptoms, improve quality of life, delay disease progression, and reduce the risk for death or the need for lung transplantation.6

resulting in increased concentrations of cGMP as well as vasodilation of the pulmonary vascular bed and relaxation of pulmonary vascular smooth muscle cells.7,8

CALCIUM CHANNEL BLOCKERS

GUANYLATE CYCLASE STIMULATORS

Calcium channel blockers promote vasodilation by inhibiting the flow of calcium into the smooth muscle. This medication class is indicated for a small group of patients who respond well to the vasodilation challenge during right heart catheterization testing.2

Riociguat (Adempas, Bayer) stimulates soluble guanylate cyclase (sGC), an enzyme that plays a role in the cardiopulmonary system and is the receptor for NO.9 Riociguat stimulates the NO-sGC-cGMP pathway, leading to increased generation of cGMP with subsequent vasodilation.9

Treatment

PHOSPHODIESTERASE TYPE 5 INHIBITOR

PROSTACYCLIN ANALOGS

Over the past decade, the treatment options for PAH have greatly expanded. The management of PAH consists of both pharmacologic and supportive therapies delivered in a practical stepwise approach. Supportive therapies include physical exercise, supplemental oxygen, and psychosocial support that can decrease the morbidity associated with PAH.2 The

Phosphodiesterase type 5 is an enzyme that degrades cyclic guanosine monophosphate (cGMP), which plays a role in regulating processes that influence vascular tone, smooth muscle proliferation, fibrosis, and inflammation and results in an impaired release of NO by the vascular endothelium.7-9 Sildenafil (Revatio, Pfizer) and tadalafil (Adcirca, Lilly) inhibit phosphodiesterase type 5,

Prostacyclin is a naturally occurring substance produced in the endothelial cells as a metabolite of arachidonic acid with potent vasodilatory activity and inhibition of platelet aggregation.3 Several different prostacyclin analogs with direct effects on vasodilation of pulmonary and systemic arterial vascular beds are available. Epoprostenol as is available only intravenously due to its extremely

Specialty Pharmacy Continuum • March/April 2022

CLINICAL

short half-life of approximately 3 minutes.10,11 Treprostinil has similar properties to epoprostenol but has a much longer half-life, which allows for multiple routes of administration.3 Treprostinil (Remodulin, United Therapeutics) is indicated for subcutaneous or IV use as a continuous infusion.12 The continuous subcutaneous route is preferred, but the drug can be administered via central IV line if the subcutaneous route is not tolerated.12 Treprostinil also is available as an inhaled formulation: Treprostinil (Tyvaso, United Therapeutics) is administered in 4 separate treatment sessions lasting 2 to 3 minutes approximately 4 hours apart, during waking hours.13 Treprostinil (Orenitram, United Therapeutics) is an oral formulation that has a titration schedule and is taken 2 to 3 times daily.14 Another agent, iloprost (Ventavis, Actelion), a synthetic analog of prostacyclin that demonstrates the same effect on pulmonary arterial vascular beds, is available as an inhaled formulation that is administered 6 to 9 times per day, no more than once every 2 hours, during waking hours.15 In November 2021, Liquidia announced that the FDA granted tentative approval for another inhalation form of treprostinil (Yutrepia), formerly LIQ861, to improve exercise ability in adults with PAH and New York Heart Association Functional class II to III symptoms. Tentative approval indicates that this inhaled product has met all regulatory standards for quality, safety,

and efficacy required for approval in the United States, but the drug cannot receive final approval until resolution of ongoing litigation with United Therapeutics.16,17 PROSTACYCLIN RECEPTOR AGONISTS Selexipag (Uptravi, Actelion), an oral prostacyclin receptor agonist that promotes vasodilation and antiproliferation, is available in an oral formulation that is taken twice daily; this agent is titrated in weekly intervals up to the highest tolerated dose.18 ENDOTHELIN RECEPTOR ANTAGONISTS Endothelin-1 and its receptors ETA and ETB facilitate vasoconstriction, fibrosis, smooth muscle proliferation, hypertrophy, and inflammation.3 Macitentan (Opsumit, Actelion), bosentan (Tracleer, Actelion), and ambrisentan (Letairis, Gilead) are endothelin receptor antagonists that inhibit the binding of endothelin-1 to both ETA and ETB receptors, resulting in vasodilation and antiproliferation.19-21

Role of the Specialty Pharmacist PAH is a complex disease requiring individualized care. Specialty pharmacists can optimize outcomes and improve the quality of life for patients with PAH by providing guidance on treatment regimens and encouraging medication adherence. At AllianceRx Walgreens Prime, specialty pharmacists educate patients, enhance compliance, and help

recommend pharmacologic treatment to fit patients’ needs. Some of the medications approved to manage PAH have special requirements related to administration. These medications that must be infused, inhaled, or taken orally can be overwhelming for a patient, especially one who was diagnosed recently. Specialty pharmacists counsel patients on managing both infused and inhaled medications to help them feel more comfortable with their therapy. Many of the oral therapies must be titrated or have Risk Evaluation and Mitigation Strategies (REMS) that must be followed. Pharmacists can educate patients to ensure they understand their titration schedules and ensure that all required REMS counseling is completed before dispensing the medication. Pharmacists also can provide education and mitigation strategies to help patients manage any adverse events that occur.

References 1.

Brown LM, Chen H, Halpern S, et al. Delay in recognition of pulmonary arterial hypertension: factors identified from REVEAL Registry. Chest. 2011;140(1):19-26.

2. Yaghi S, Novikov A, Trandafirescu T. Clinical update on pulmonary hypertension. J Investig Med. 2020;68(8):821-827. 3. Lan NSH, Massam BD, Kulkarni SS, et al. Pulmonary arterial hypertension: pathophysiology and treatment. Diseases. 2018;6(2):38. 4. Pulmonary Hypertension Association. About pulmonary hypertension. Accessed March 30, 2022. www.phassociation.org/ patients/aboutph/ 5. Memom HA, Park MH. Pulmonary arterial hypertension in women. Methodist Debakey

Cardiovasc J. 2017;13(4):224-237. 6. Hoeper MM, Bogaard HJ, Condiffe R, et al. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25 suppl):D42-D50. 7. Revatio [package insert]. Pfizer Inc; 2020. 8. Adcirca [package insert]. Eli Lilly and Company; 2020. 9. Adempas [package insert]. Bayer HealthCare; 2013. 10. Flolan [package insert]. GlaxoSmithKline; 2018. 11. Veletri [package insert]. Actelion Pharmaceuticals US, Inc; 2018. 12. Remodulin [package insert]. United Therapeutics Corp; 2021. 13. Tyvaso [package insert]. United Therapeutics Corp; 2021. 14. Orenitram [package insert]. United Therapeutics Corp; 2019. 15. Ventavis [package insert]. Actelion Pharmaceuticals US, Inc; 2021. 16. FDA grants tentative approval for Liquidia’s YUTREPIA (treprostinil) inhalation powder [press release]. Globe Newswire; Accessed March 30, 2022. https://www.benzinga. com/pressreleases/21/11/g23947803/ fda-grants-tentative-approval-for-liquidiasyutrepia-treprostinil-inhalation-powder 17. Singh V. Liquidia’s inhaled treprostinil powder scores tentative FDA approval for PAH. November 8, 2021. Accessed March 30, 2022. https://www.benzinga.com/ general/biotech/21/11/23949971/liquidiasinhaled-treprostinil-powder-scorestentative-fda-approval-for-pah 18. Uptravi [package insert]. Actelion Pharmaceuticals US, Inc; 2021. 19. Opsumit [package insert]. Actelion Pharmaceuticals US, Inc; 2021. 20. Tracleer [package insert]. Actelion Pharmaceuticals US, Inc; 2021. 21. Letairis [package insert]. Gilead Sciences, Inc; 2019.

More Clinical Reviews on the Web To access, visit www.specialtypharmacycontinuum.com and choose Section/Review Articles in the home page navigation bar.

Gene Therapy Series, Parts 1 & 2: The New Frontier of Hemophilia Treatment Hemophilia is a genetic bleeding disorder caused by absent or defective clotting factor, leading to spontaneous or excessive bleeding after injury. It is estimated that between 20,000 and 33,000 people in the United States have hemophilia. This review details the main treatment options and the role of specialty pharmacists in optimizing clinical outcomes.

Harnessing the Potential of Therapy for MM Multiple myeloma (MM), which develops in plasma cells, can result in low blood counts and weakening of the immune system. Several new treatment options are now available.

Management of Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis is a progressive, debilitating, and often fatal interstitial lung disease characterized by scarring of the lungs with unknown etiology. Early intervention and ongoing patient support can lessen the disease burden.

Cutting-Edge Issues in HIV Clinical Management The field of HIV medicine continues to be dynamic and innovative, even after 40 years since the first reports of AIDS.

The Persistence of PrEP: Essential for Ending HIV Approximately 30 years after the beginning of the HIV epidemic, emtricitabine–tenofovir disoproxil fumarate (FTC/TDF; Truvada, Gilead) was approved in 2012 as the first pre-exposure prophylaxis (PrEP) therapy. But access barriers still remain, given the fact that only an estimated 70,000 patients had an active prescription for PrEP as of the end of 2017.

Specialty Pharmacy Continuum • March/April 2022

CLINICAL

Nondrug Options for Opioids Underused A large managed care database review has yielded yet another lesson learned from COVID-19: A significant increase in opioid prescribing for pain occurred during the early phase of the pandemic, at the expense of nonpharmacologic therapies such as physical therapy and complementary medicine. By Bob Kronemyer

“Longer days of opioid prescription and more potent doses could exacerbate the opioid epidemic here in the United States,” said Byungkyu Lee, PhD, an assistant professor of sociology at Indiana University Bloomington, and lead author of the database review. Dr. Lee and his colleagues had heard anecdotal accounts of people who were unable to access nonambulatory health services during the early part of the pandemic. “We wondered if this lack of access included visits for chronic pain and suffering,” he said. “How did patients manage their pain when medical access was limited, especially for physical therapy and other treatments requiring contact? How did these conditions affect opioid prescribing?” Their study assessed weekly claims data for 24 million U.S. patients with a

diagnosis of limb, extremity, joint, back or neck pain from a nationwide commercial insurance database (Optum’s de-identified Clinformatics Data Mart database) from January 2019 to September 2020 (JAMA Network Open 2021;4[12]:e2138453). In the first three quarters of 2019 (prepandemic), 21,430,339 patients were analyzed (mean age, 48.6 years; 51.1% female; 52.2% white). In the first three quarters of 2020 (pandemic), there were 20,759,788 patients (mean age, 47.0 years; 51.5% female; 48.5% white). During the pandemic, 15.9% fewer patients received a pain diagnosis than for the same period in 2019. Patients with a pain diagnosis were 3.5% more likely to receive opioids and 6.0% less likely to receive nonpharmacologic therapy during the early pandemic in 2020 compared with 2019. Likewise,

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opioid prescriptions were 1.07 days longer and 0.96 morphine milligram equivalents more potent in the latter period. “We found that fewer people visited health professionals for pain during the early part of the pandemic, and when they did, they were much less likely to receive physical therapy and complementary medicine,” Dr. Lee said. “This was unsurprising because these treatments require person-to-person contact. What we did not anticipate, though, is that patients presenting with pain received opioids instead, and the prescriptions were longer and more potent than just before the pandemic. This raises the possibility that trends showing a reduction in opioid prescribing for pain were reversed due to the pandemic.” The CDC recommends nonpharmacologic therapy as an effective and less risky method to reduce pain than opioids, he said. “Therefore, it is critical to ensure that such services continue to be available during pandemic surges, perhaps remotely through telemedicine.” Dr. Lee noted there is no standard policy solution to the opioid crisis. “Our earlier research shows that reducing access to prescription opioids without a nonaddictive alternative such as physical therapy could be dangerous, motivating those with severe chronic pain or opioid use disorder [OUD] to switch to illicit opioids, which have a higher risk of overdose,” he said. “Harm reduction, accessible treatment for addiction and addressing stigma are all key.” More patients may have become addicted to opioids than would have been the case without the pandemic, Dr. Lee noted. “In fact, we have seen that opioid overdose deaths in the U.S. have increased dramatically during the pandemic, although future research is needed to examine the link between the increase in opioid prescriptions and the rise of opioid overdose deaths.” Vanila M. Singh, MD, a clinical associate professor of anesthesiology and pain medicine at Stanford School of Medicine,

in California, said the study “makes assumptions based on limited data. It is well established that the increase in opioid overdose deaths during the pandemic was from a rise in availability of illicit fentanyl and other illicit drugs.” The study also mixes OUD with chronic pain patients, a mistake that can lead to assumptions and stigmas connecting medically indicated opioid use for chronic pain with substance use disorder, Dr. Singh noted. “That is often an unfortunate outcome when people are talking about patients with chronic pain and opioids,” she said. Access to treatments that require an in-person presence, such as acupuncture, physical therapy, massage and nerve blocks, “were severely limited in the early days of the pandemic,” said Dr. Singh, who was not a study author. To return patients with chronic painful conditions to appropriate and clinically indicated pain treatments, including nonpharmacologic therapy, Dr. Singh strongly recommends an individualized, patientcentered care approach that looks at a risk–benefit assessment, “which is vital to ensuring best clinical outcomes rather than the ‘one-size-fits-all’ approach.” The latter strategy, she added, “does a disservice to the multitude of underlying medical conditions linked to chronic pain.” However, cost limitations exist across all treatment types. “Some patients cannot afford medications or interventions, or physical therapy or behavioral therapy, if indicated,” Dr. Singh said. Clinicians should consider what is best for a particular patient, given the underlying medical issue and other comorbidities, she stressed. “As medical care has resumed, both pharmacologic and nonpharmacologic [therapies] have resumed.” Dr. Lee reported no relevant financial disclosures. Dr. Singh serves as an independent member of the board of directors for BioDelivery Sciences International and Virpax Pharmaceuticals.

Specialty Pharmacy Continuum • March/April 2022

CLINICAL

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91.80% in 2020 (after pharmacists were embedded), “resulting in cost savings to the health system that can be passed on to patients in need,” said lead study author Betty Fang, PharmD, BCACP, AMITA’s system manager of specialty pharmacy services. AMITA developed a specialty pharmacy program in late 2019 to manage specialty medications ordered by its providers. Clinical specialty pharmacists and technicians were hired and embedded within various specialty clinics, including five oncology clinics. Upon receipt of a specialty prescription, a specialty technician conducts a benefit investigation, obtains prior authorization and financial assistance, and determines the final dispensing pharmacy restrictions. Meanwhile, the specialty pharmacist reviews the order for safety, appropriateness and drug interactions, and consults with the prescribing provider as needed. Specialty pharmacists then educate the patient about proper medication use either by phone or in the clinic. If the medication is restricted to an outside pharmacy, the specialty team facilitates the prescription transfer and monitors for confirmed delivery. All interactions by the team are documented in the electronic health record (EHR). Prior to this program, the amount of time required for these processes “occupied a significant part of the nursing or ancillary staffs’ workday,” said Dr. Fang, who presented the data at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Pharmacists reviewed all oral hematology/oncology specialty prescriptions generated from three oncology clinics during two time periods: July to December 2018 and July to December 2020. Only new-to-therapy prescriptions were included in the analysis. They reviewed 762 prescriptions during the two study periods; 667 were excluded, leaving 95 for inclusion. During the 2018 study period, 34 specialty prescriptions were generated and managed by nursing and medical staff, with an average time to delivery of 11.68 days and a wide variability (SD, 9.12 days). The 2020 study included 61 specialty prescriptions managed by specialty pharmacy staff, with an average time to delivery of 7.97 days—a 31.77% decrease in time to delivery of medication. “We attributed this outcome to the specialty pharmacy staff’s expertise in pharmacy benefit structure and their dedicating time to manage and coordinate specialty prescriptions,” Dr. Fang said. She added that the team has plans to expand into other specialty clinics and use 340B savings for patients needing

financial assistance. Embedding pharmacists in oncology clinics has been piloted at other centers and makes sense, both for the sustainability of hospital specialty pharmacies and for patient satisfaction, commented Benyam Muluneh, PharmD, BCOP, an assistant professor of pharmacotherapy and experimental therapeutics at the University of North Carolina Eshelman School of Pharmacy, in Chapel Hill. A recent study from his institution found that 100% of patients enrolled in a pharmacist-led oral

chemotherapy program were satisfied with their care, compared with 75% of patients not enrolled (J Adv Pract Oncol 2021;12[2]:148-157). The program includes counseling sessions from oncology clinical pharmacist before and after receiving oral chemotherapy medication from the specialty pharmacy associated with the medical center, as well as clinical management by a clinical pharmacist. When filling prescriptions in-house, embedded pharmacists can ensure that the prescription gets to the pharmacy,

Dr. Muluneh said. If there is an issue, such as a dose being too high, “it’s very easy to resolve those in real time, and access to the [EHR] is a big part of it.” During the initiation and maintenance phases of treatment, he added, pharmacists can review medical charts, see dose changes, note whether patients were hospitalized or switching therapies, and can respond to those needs much more quickly than an external pharmacy. The sources reported no relevant financial disclosures.

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Specialty Pharmacy Continuum • March/April 2022

OPERATIONS & MANAGEMENT

Cost Plus Drug Co. stirs debate

Will Mark Cuban Disrupt Rx Ecosystem? By Gina Shaw

Generic imatinib (Gleevec, Novartis) for $17.10 per month, compared with $2,502.80 at retail? Generic memantine (Namenda XR, Allergan) for $12.90 per month, compared with $359.42 at retail? Generic esomeprazole (Nexium, Pfizer) for just $6, compared with $216.66?

These are just a few of the 27 drugs that will be discounted by $100 or more per prescription—sometimes a lot more—from billionaire Mark Cuban’s generic drug company, Mark Cuban Cost Plus Drug Co. (MCCPDC), which officially launched on Jan. 19, 2022. Mr. Cuban, the owner of the NBA’s Dallas Mavericks and star of ABC’s “Shark Tank,” is the latest entrant into a growing field of competitors seeking to disrupt the prescription drug ecosystem. Like earlier players such as GoodRx and Amazon Pharmacy, MCCPDC aims to reduce the seemingly endless increases in out-of-pocket costs that patients pay for prescription drugs. “I think this is a huge and welcome pushback against the preposterous pricing that ends up at the consumer level,” said pharmacy consultant Bonnie Kirschenbaum, BSc, MS, a member of the Specialty Pharmacy Continuum editorial advisory board. “There needs to be shock waves like these to show that we can do it differently. If they become a big enough phenomenon, maybe they will force other change in the traditional way of doing things.”

Different Approaches GoodRx, which was founded in 2011, doesn’t provide pharmacy services. Instead, it acts as a comparisonshopping service, collecting the best prices, coupons and discounts to help

consumers find the lowest-cost pharmacy for their prescriptions—both brand-name and generic drugs. It also has a prescription discount card and coupons of its own. On the other hand, Amazon Pharmacy, launched in 2020, and MCCPDC actually provide mail-order pharmacy dispensing services: Amazon Pharmacy through its own pharmacy subsidiary and MCCPDC via a partnership with Truepill, which offers pharmacy fulfillment through pharmacies accredited by URAC. Amazon Pharmacy has pharmacists on call 24/7 at its customer care number and offers either out-of-pocket payment options or insurance payments. Separately, Amazon Prime members can use the Amazon Prime Rx prescription drug benefit, which offers 40% to 80% discounts off the cash price of generic and brand-name drugs at thousands of pharmacies nationwide, including CVS, Rite Aid, Walgreens and Walmart. MCCPDC is a cash-only model that directs customers with questions to call Truepill directly through a number on their prescription bottle. “Because the company refuses to pay spread prices to third-party PBMs [pharmacy benefit managers] in order to be allowed to process insurance claims, the online pharmacy will be a cash pay venture,” the company’s launch statement said. MCCPDC also touts transparency in pricing. “Every product we sell is

priced exactly the same way: our cost plus 15%, plus the pharmacy fee, if any,” a letter from Mr. Cuban on the company’s website said. There’s also a $5 shipping cost per prescription. Mr. Cuban’s savings claims are legitimate, although they may not be quite as large as advertised when compared with what other industry disruptors are offering, said Ann Johnson, the president of industry consulting firm Pharmacy Healthcare Solutions (PHSL). “They had touted 27 different drugs where you could save more than $100 per prescription. For 25 of those drugs, I could find pricing on GoodRx, and 22 of those 25 did have a lower cost at MCCPDC, although on average it was about $27.37 less,” Ms. Johnson said. “So, I’m not sure it’s quite the delta that is being claimed, but yes, there are some additional savings there for patients.” As of early 2022, Amazon had a much larger array of available medications than MCCPDC’s 110 or so, although it does not dispense specialty drugs, Schedule II controlled substances or Risk Evaluation and Mitigation Strategy medications or suspensions. Because MCCPDC ships only through the U.S. Postal Service and other ground carriers—for now, at least—temperaturecontrolled medications are still off Mr. Cuban’s list. That includes one drug whose high out-of-pocket costs for many consumers have made recent headlines: insulin. A search on Feb. 4, 2022, found Amazon Pharmacy offering a vial of insulin lispro (Humalog, Lilly) for $43.40 and insulin aspart (Novolog, Novo Nordisk) for $148.10. On the same day, GoodRx had coupons that would bring the cost of insulin lispro down to as low as $43.43 and insulin aspart as low as $58.83, both at Walgreens. (A provision in the House of Representatives–passed Build Back Better Act would cap out-of-pocket costs for insulin at $35 per month.)

Impact on Other Pharmacies What do disruptive forces like Amazon and MCCPDC mean for other leading players in the pharmacy space? Specialty Pharmacy Continuum reached out to several major pharmacies and PBMs, including CVS, Express Scripts and Optum, and received no response or a decline to comment. Walgreens corporate spokeswoman Rebekah Pajak said the company does not comment on competitors’ activities, but stressed Walgreens’ offerings and efforts to help patients save money on medications. “To assist patients who don’t have insurance, the Walgreens Prescription Savings Club is a discount prescription

drug program offering savings of up to 80% off cash retail prices of prescriptions purchased at participating Walgreens. Savings apply to more than 8,000 brand and generic medications, including many value-priced generics available at $5, $10 and $15 price points,” Ms. Pajak said. “From September to November of 2021, Walgreens Prescription Savings Club members have saved over $125 million compared to the cash retail price on prescriptions. In addition to the Prescription Savings Club, Walgreens also accepts a number of other discount program cards. “When choosing a pharmacy, we encourage patients to select one that offers the best value based on pricing and also the services available—such as participation in government plans, 24/7 convenience and services that can accommodate immediate prescription drug needs,” she added. “It’s also important for patients to use a single pharmacy so that pharmacists can monitor their medications and avoid potential drug interactions.” That issue is definitely a concern, noted PHSL’s Ms. Johnson. “From a safety perspective, MCCPDC is only filling prescriptions for about 100 medications, and they won’t have full patient profile information,” she said. “This trend in general encourages pharmacy shopping, which means that no one pharmacy is going to have a complete look into the patient’s profile and all the medications they’re taking, which runs the risk of missing drug–drug interactions and other patient safety concerns.”

Pharmacists’ Role Diminished? Online discount pharmacies also run the risk for reducing pharmacists’ role in patient care, added Tim Kosty, PHSL co-founder. “It’s unknown in my mind how the consumer will decide. Do they care about the personal services such as medication management or the ability to get a vaccine or a test that a pharmacist provides, or do they care about the lowest price? Every consumer has to balance that cost-versus-service factor.” The sources reported no relevant financial disclosures.

More on the Web For a patient perspective on how MCCPDC might ease the economic burden of highcost cystic fibrosis drugs, see the comments of Gunnar Esiason in an expanded version of this article on www.specialtypharmacy continuum.com.

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Specialty Pharmacy Continuum • March/April 2022

OPERATIONS & MANAGEMENT

The ‘OG’ Women of Specialty Pharmacy How a cadre of visionary female leaders broke through the market’s glass ceiling By Gina Shaw

ompeting in the specialty pharmacy space is no easy task, given its intensive data reporting requirements, cold chain logistics and closeddoor payor contracts, to name just a few challenges. But if you were a female pharmacy leader eyeing market entry in the early days, there was yet another roadblock to overcome: a traditionally male-dominated business that didn’t always embrace the idea that women belonged in the specialty space. Thanks to the efforts of a cadre of visionary female leaders, those barriers are not nearly as iron-clad as in years past. Indeed, these pioneers have helped build highly successful health-system specialty pharmacies that continue to thrive both clinically and financially as a result of their efforts. But it wasn’t easy. JoAnn Stubbings, BSPharm, vividly recalls those early days of specialty pharmacy services at the University of Illinois at Chicago, where she directed specialty pharmacy for more than eight years and now serves as a clinical associate professor emerita at UIC College of Pharmacy. “It was about a decade ago, when there were really only a handful of hospitals dabbling in the specialty space. We were small,” she said. “I started with one part-time pharmacist and one prescription, and most of the other pharmacy leadership in the hospital were just like, ‘Why don’t you see what you can do with this?’ Meanwhile, the big pharmacies like CVS were going gangbusters into the specialty market.” What became known as “specialty” drugs had, in fact, long been the purview of hospitals and health systems. “Much of the prescription volume of the first specialty drugs originated out of the health systems. These were novel drug therapies used to manage complex, high-risk patients, such as transplant patients, cancer patients, people with multiple sclerosis and HIV and hemophilia,” said Rebekah Anguiano, PharmD, a clinical pharmacist and clinical assistant professor at UIC, whom Ms. Stubbings wooed from CVS Caremark in 2012, to help her establish UIC’s specialty pharmacy. However, hospitals and health systems were “asleep at the wheel” in the 1990s and early 2000s, Ms. Stubbings explained, as large traditional, mailorder pharmacies were building massive

specialty businesses. “While specialty pharmacy was growing, hospitals were shutting down their external pharmacies because they didn’t see any profit in dispensing generic drugs,” she said. “But they weren’t paying attention to what was really going on as new original treatments came to market for diseases like hepatitis C [HCV], multiple sclerosis and Crohn’s disease.” Even then, these specialty drugs were very expensive—a concern for some health systems, which “weren’t excited to take that cost burden on at the time,” Dr. Anguiano said. “Also, these medications are complicated; they’re hard to get reimbursed; and many have cold chain shipping requirements, not to mention so many layers of medication management.” Another challenge: “In general, the prescription volume was low,” Dr. Anguiano said. “Unfortunately, this resulted in specialty prescriptions being channeled to outside big specialty pharmacies, and health systems were initially shut out of the specialty niche.” Then a few early trailblazers, including Ms. Stubbings, Dr. Anguiano and a cadre of female leaders at other institutions saw the potential. “It made no sense not to adopt specialty in the health system,” said Ms. Stubbings, whose program had generated $60 million in annual revenue when she retired in 2020. “The patient is there, the doctors are there, the clinical trials are there. You’ve got everything packaged together beautifully, but you can’t dispense the drugs they need? That’s nonsensical.”

Seeing the Future One of the first to call attention to the importance of specialty pharmacy for hospitals was Rita Shane, PharmD, the vice president and chief pharmacy officer at Cedars-Sinai Medical Center, in Los Angeles. In 2006, she convened a panel on specialty pharmacy at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. “It had become clear to me that the future of chronic disease management was going to include biologics, that specialty pharmacy would be really important and health-system pharmacy was very well positioned to provide those services,” she said. After the ASHP meeting, Dr. Shane published an article in the American Journal of Health-System Pharmacy (2007;64[22]:2382-2385) arguing that health-system pharmacy leaders should take ownership of specialty, including clinical guidelines, patient management, the revenue cycle and changing reimbursement models, and contracting. Dr. Shane met with the executive

leadership at Cedars-Sinai and pointed out that the institution had a growing number of patients who required specialty services. “In addition to the obvious oncology population, we had a large rare disease population and many patients with inflammatory bowel disease,” she said. “While some early adopters understood the need—solidorgan transplant [clinicians], in particular, really recognized early the quality we brought to the table—it was a challenge early on to convey why we were investing in this. Our specialty pharmacy finally opened in 2014, and although there was initial concern about the costs of building the program, the value of the program to our patients and its focus on quality and safety became evident.” Some health systems partnered with larger outside specialty pharmacies, such as Shields or Diplomat, to build their services, but Cedars-Sinai did not. “We used Diplomat for our on-call service at one point, but other than that we insourced everything and built it all ourselves. In health systems, we have clinical pharmacists who have access to the electronic health record [EHR] along with the knowledge, skills and expertise to do comprehensive medication management,” Dr. Shane said. “In other settings, they may have accredited specialty pharmacists, but they don’t necessarily have our level of clinical expertise along with access to the [EHR] to determine that, for example, a drug that was started won’t be effective based on new biomarker data.”

Origin Stories Debbie Duckworth, PharmD, the senior director of specialty pharmacy and infusion services at the University of Kentucky (UK), is another pioneer of health-system specialty pharmacy. Dr. Duckworth had spent more than two decades as the owner of her own pharmacy, the Medicine Shoppe, in Harrodsburg. “I partnered with the only other female pharmacist in the county at the time. We were both young mothers working predominantly for men, and we figured we could do this together, and it would give us some flexibility and allow us to attend to the needs of our families.” After she and her colleague decided to sell the business in 2010, Dr. Duckworth

Left to right: Rebekah Anguiano, PharmD (seated), pharmacy technician Elba Sertuche, Nehrin Khamo, PharmD, and JoAnn Stubbings, BSPharm.

took on the position of helping to expand UK’s new retail pharmacy footprint. “We tasked a pharmacy fellow with the job of exploring and understanding whether or not UK should develop our own specialty pharmacy,” she said. “He came back and said yes, so he became the first director of specialty pharmacy.” However, after the first six months, the new specialty pharmacy team was on the verge of collapse. “They were coming to my office in tears, saying if something didn’t change, they’d quit,” Dr. Duckworth said. “We pulled our data and realized that this team had exceeded our five-year business model for specialty in less than six months. We hadn’t had time to build the necessary infrastructure underneath them. No wonder they were ready to quit. Because I had had experience in owning my own store and having gone through accreditation processes, leaders felt it made sense for me to take over specialty pharmacy, which I did in March of 2015.” The specialty pharmacy team moved into a 5,000-square-foot space in UK’s Albert B. Chandler Hospital building— “which sounded like a huge space at the time,” Dr. Duckworth said. “By August 2015, we were 20 team members strong and passed URAC accreditation with flying colors.” Today, UK’s specialty pharmacy occupies 30,000 square feet in South Lexington, about 15 minutes from the main campus. In addition, the pharmacy’s contribution to the hospital’s revenue budget grew from about $17 million in 2016 to $53 million in 2021, Dr. Duckworth said.

Specialty Pharmacy Continuum • March/April 2022

OPERATIONS & MANAGEMENT

‘I Don’t Really Know What That Means’ Kimberly Harrison, PharmD, received her pharmacy education at one of the other early health systems to establish a beachhead in specialty pharmacy, the University of Wisconsin-Madison, where she also completed what was then a brand-new two-year residency in medication systems and operations. “It was focused on developing pharmacy managers and keeping that expertise in the operations area,” Dr. Harrison said. After completing that program in 2012, she relocated to the University of Washington (UW), in Seattle. “They were looking for a pharmacist who could devote time to projects as they came up across the health system,” she recalled. “I focused on two things: one was standardizing the 340B [Drug Pricing] program and the other was specialty pharmacy. When they told me they were interested in specialty pharmacy, I said, ‘I don’t really know what that means, so I’ll do some research.’” After consulting with specialty pharmacists at her alma mater for guidance, Dr. Harrison started building UW’s specialty pharmacy by developing a small call center staffed by two pharmacy technicians supporting prior authorizations (PAs). “We were originally focused on the GI [gastroenterology] clinic, trying to give those patients options for fulfilling their prescriptions with us.” That was in 2014, when the FDA approved the first direct-acting antiviral therapy for HCV—a combination of simeprevir (Olysio, Janssen) and sofosbuvir (Sovaldi, Gilead)—revolutionizing treatment of that disease. “We then expanded our specialty pharmacy efforts into our hepatology clinic, and split one pharmacist between those two,” Dr. Harrison said. “The providers encouraged their patients to fill their prescriptions, showing them the benefits.” The revenue from gastrointestinal and HCV medications “justified us getting a third technician,” she added. “We worked with the Epic [EHR] team to build tools for pharmacists in the specialty clinics to document their work and enable us to get access to medications.” By the time the program expanded to include rheumatology, specialty pharmacy had taken over most of Dr. Harrison’s time. “I focused on getting feedback from patients as well,” she said. “If they had experience at other specialty pharmacies, what did they like or dislike? Our techs also took extra time with each patient to help figure out what we could do differently. For example, we learned early on that they wanted mail order and the ability to receive cold chain medications at home, so we added that capability.” In 2015, with enough revenue to justify bringing on a full-time specialty pharmacy manager, Dr. Harrison hired

Michael Alwan, PharmD. When he was promoted to a director of pharmacy position a year later, Dr. Harrison recruited Erica Diamantides, PharmD, who still manages the program today.

HIV a Trigger for Specialty Care Like Dr. Anguiano, Laura Rang, PharmD, got her start in specialty at CVS. “I went to pharmacy school during the HIV/AIDS pandemic; when I first graduated, that was one of my first experiences with specialty. There was such a stigma associated with those

medications that we created a special pharmacy at CVS just for people with HIV,” she recalled. “I spent several years serving HIV patients who were marginalized and discriminated against, and who needed complex, expensive medications and would die without them. It turned out that other disease states like hepatitis C, oncology, multiple sclerosis and rheumatoid arthritis needed specialty pharmacy, too. So I ran specialty pharmacy for CVS for about seven years, between 2007 and 2015, and learned all about it.”

In 2015, Dr. Rang was recruited to help launch the new health-system specialty pharmacy at the University of Colorado Health (UCHealth), with headquarters in Aurora. “They had started filling those hepatitis C prescriptions and were making money by accident,” she said. “They realized that they needed their own specialty pharmacy.” Dr. Rang’s role was to create UCHealth’s specialty pharmacy medication access and renewal center—essentially, its PA program. “I ended up hiring see OG WOMEN, page 20

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Specialty Pharmacy Continuum • March/April 2022

OPERATIONS & MANAGEMENT

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Above (left to right) is the specialty pharmacy team at Children’s Hospital of Colorado: Leslie Ruppe, PharmD; Emma Osbern, CPhT; Melody Odom, PharmD; John Tipton, CPhT; Taj Laugan, CPhT; Jenny French, PharmD; and Laura Rang, PharmD, who launched the program.

OG WOMEN continued from page 19

10 pharmacists and 30 pharmacy technicians, and all we did was prior authorizations, coordination of benefits and manufacturer programs—all the behindthe-scenes work to ensure that these prescriptions got filled and delivered.” In June 2019, she moved to Children’s Hospital of Colorado, where she launched that hospital’s specialty pharmacy. “This one, I got to plan and build from the beginning,” she said. “We now have a brick-and-mortar pharmacy and four clinical pharmacists with subspecialty PGY-2 pediatric training. These are very hard to find, and we’ve recruited from all over the country and are still recruiting more. We also have three operational pharmacists, three technicians and two interns/students.”

Building a Network

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This informal cadre of health-system specialty pharmacy pioneers came together in a more organized way around 2014, under the auspices of the University Healthcare Consortium, when then–associate vice president for specialty pharmacy Kevin Colgan, RPh, reached out to leading specialty consultant Suzette DiMascio, CHE, CMCE, CPC, the founder of CSI Specialty Group. “He told me that a lot of health systems wanted to figure out specialty, and wanted me to help develop strategies,” Ms. DiMascio said. “At that time, many CEOs and CFOs [chief financial officers] still wanted nothing to do with specialty pharmacy, because all they saw were expensive drugs and pictured it as a cost center, not a revenue center. But the leaders at the consortium got the vision; they saw the difference it could make when a hospital could care for a patient all the way through their discharge to home.” Ms. DiMascio met with Ms. Stubbings, Dr. Harrison, Dr. Rang and others. “Hospitals and health systems have traditionally been very male-oriented, and the largely female early champions of hospital specialty pharmacies were getting nowhere with the C-suite,” Ms. DiMascio said. “But gradually we started to see a change in receptivity around 2016 or 2017. We had to show them the numbers for how they could use 340B funds to successfully implement a specialty pharmacy. Leaders

like JoAnn and Kim were at the forefront of showing them that there was money on the table that they were missing out on—money they could use to fund the specialty pharmacy and help patients get better care. They had meds-to-beds programs for [high] cholesterol and diabetes and so on, but not for the most critically ill patients. Why not?” At many institutions, the real breakthrough came when the specialty pharmacy was able to demonstrate its ability to manage PAs. “That was, and continues to be, such a big burden on specialty clinics,” Dr. Anguiano said. “When we could off-load a portion of that burden and absorb it into the services we provide, with technicians and pharmacists who have specialized training in turning PAs around quickly with minimal involvement needed by the clinic, that was a huge win across the institution.” Managing access to limited distribution medications also helped the early health-system pioneers prove their worth. “It wasn’t just a revenue opportunity, but also a true patient care opportunity—to improve access, get patients started on treatment earlier, and provide better management on an ongoing basis,” Dr. Anguiano said. Throughout those early years, hundreds of phone calls fired back and forth between Illinois, Iowa, Washington, Kentucky and Wisconsin. “This was before everyone broke into getting accredited, and we were all just trying to figure it out,” Dr. Anguiano said. “JoAnn and I would be on the phone with Debbie or Kim and Laura. ‘How are you handling cold chain shipping? How are you managing your call center?’ There was a lot of collaboration, and there still is.” This collaborative approach “is one of the things that sets our model apart from traditional specialty pharmacy,” Dr. Anguiano said. “We’re not in competition with each other; we have different patient populations that are really never going to overlap. If someone has a problem they’re trying to solve, they reach out to their colleagues across the nation, formulate a solution and then share it with others. It’s a great model, and has helped to improve processes and set standards and best practices.” The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • March/April 2022

TECHNOLOGY Of 50 patients referred for PA management,

Faster HCV Rx Access

71%

continued from page 1

Adding to the complexity of the job, the medical center also was in the middle of converting to a new electronic health record (EHR) system, noted Michelle T. Martin, PharmD, a clinical pharmacist for the health system and an associate professor at the University of Illinois College of Pharmacy, both in Chicago. The PA team, staffed by pharmacy students, also had some new members. The fifth generation of the PA team (started in June 2014 to facilitate treatment access for liver clinic patients with pharmacy benefits that mandate dispensing via external pharmacies) assumed its role in September 2020, the same month as the EHR conversion. Four PA team members spent 468 hours updating team procedures and completing PAs from September 2020 through May 2021.

communication for fellow team members and clinicians. The team also used the Box folder to re-prioritize workflow to ensure timely initial delivery of medications and refill management to maintain continuity of care. The team created four additional electronic folders on the shared drive to facilitate workflow and consistency across shifts, as well as transitions between generations of team members. Contents included procedures, electronic PA submission documents, insurance contact information and HCV clinical resources, as well as a follow-up book in a calendar format to log completed tasks and assign other tasks to future dates. The PA team also created a master patient list and 16 smart text templates,

‘The clinical team benefits [from student involvement] because they can focus on clinical work as opposed to paperwork. And the student team benefits because they see the impact of how important this work is on clinical outcomes.’

met all insurancemandated requirements for PA submission and

100% received PA approval for their hepatitis C medications. PA, prior authorization Source: Michelle T. Martin, PharmD

hired a dedicated pharmacy technician to do PAs in his previous position working with HCV patients at the University of Colorado, and makes use of a centralized PA team at his current hospital. “I can’t stress the importance of how this allows us to do our job,” he said. “If we didn’t have that, it would just slow patient care so much, because a nurse, clinical pharmacist or physician would have to do this, and when you don’t spend every day doing it, the forms take forever.” HCV medications are not too complicated, Dr. Langness said, and a primary care doctor could very appropriately

prescribe HCV treatment for a patient. The biggest barriers in this clinical area are working through insurance and PAs, he said. Having dedicated PA teams led by students, technicians or other allied health professionals is especially critical during this period, he said, where primary care and other clinicians are being stretched thin. Dr. Langness reported no relevant financial disclosures. Dr. Martin reported that she has served on advisory boards and as a speaker for AbbVie and Gilead; received grant funding from Gilead and Merck; and is a minor shareholder for AbbVie, Gilead and Merck.

—Michelle T. Martin, PharmD But it was worth it: Of 50 patients referred for PA management, 71% met all insurance-mandated requirements for PA submission and 100% received PA approval for their hepatitis C medications, Dr. Martin and her team reported at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Previous generations of the PA team worked on-site at the medical center, taking turns in a cubicle across from Dr. Martin’s office, where they could easily knock on the door to get help or ask questions. With COVID-19, she said, no one was coming in. The team also was looking to get away from having to send 20-page faxes or sift through paperwork folders. They turned to the CoverMyMeds software program to streamline the PA process and took advantage of new features in their new EHR (Epic). Now, PA team members complete all shifts remotely. They submit electronic PAs through CoverMyMeds and use a protected health information Box folder—a secure cloud management system— to house necessary PA documents. Only the PA team has access to the folder. To adapt to the EHR conversion, the team proactively approached hospital information technology services and requested support for resources for delivery of PA services. The PA team created and incorporated standardized templates into Epic to streamline

including information regarding insurance and dispensing pharmacies, HCV medications and PA status updates. Clear documentation and frequent chart updates allow clinicians who work with HCV patients to quickly identify PA progress. Dr. Martin met with the team periodically to discuss progress and launch procedure updates. “It’s wonderful to have students who are motivated to learn and also to assist our patients in this manner,” Dr. Martin said. “The clinical team benefits [from student involvement] because they can focus on clinical work as opposed to paperwork. And the student team benefits because they see the impact of how important this work is on clinical outcomes.” An added win for the clinic: The students are not paid employees but earn course credit for their efforts. Good communication among team members is essential, Dr. Martin said, as are standardized procedures so everyone knows what steps to take and who to call. When using students, it’s helpful to have people from different years in school, so the matriculating students can help teach the newer ones, she added.

Of 50 patients re for PA managem

71%

met all insurance mandated requir for PA submissio

100%

received PA app for their hepatiti medications. PA, prior authorization

Another Nod to the Value of Students Jacob Langness, PharmD, BCPS, a senior clinical pharmacy specialist with Abbott Northwestern Hospital, in Minneapolis,

Source: Michelle T. Martin,

Specialty Pharmacy Continuum • March/April 2022

TECHNOLOGY

Could Automation Power Provider Status? By Karen Blum

A provider status bill submitted to Congress would permit pharmacists across multiple care sites—including specialty pharmacy—to practice at the top of their license and improve patient outcomes, a panel of pharmacists said at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. However, some barriers to widespread adoption still exist, as well as a need for automated tools to help with manual pharmacy tasks, the panelists said. The Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 2759/S. 1362)—a bipartisan bill to amend Section 1861(s)(2) of the Social Security Act to include pharmacists on the list of recognized healthcare providers in medically underserved areas—would grant pharmacists provider status under Medicare

population,” he said during the panel discussion, which was sponsored by Omnicell. (For more on the bill, go to bit.ly/3DwCYYm. For an exclusive video interview on provider status with ASHP’s Tom Kraus, MHS, JD, see bit. ly/3iO9ux4.)

Primary Care ‘Deserts’ Particularly acute is the shortage of primary care physicians (PCPs), now

MPH, BCPS, the director of pharmacy at Saint Luke’s Hospital, in Kansas City, Mo. Furthermore, it would permit pharmacists to optimize their scope of practice, improve job satisfaction, be fairly compensated and further enhance patient outcomes, Dr. Little said. Pharmacist productivity at his hospital currently is measured by hours worked divided by patient volumes, he said. “I don’t think that’s the best measure … because that doesn’t take into account what kind of patient care we’re doing.” Productivity based on billing for services provided would be more accurate and better for patients, he said. Dr. Little cited another disconnect: tying pharmacy practice to drug products. For example, some hospitals initially justified having pharmacists on hospital floors for their ability to save money through formulary compliance or preventing adverse drug reactions, because they can’t be reimbursed for the clinical services they provide. Provider

sickest patients most in need of pharmacy services. Artificial intelligence and automation may offer a solution, he noted, because the technology has the potential to help expand clinical services. Such programs could be used to help prevent highrisk patients from developing medication complications, optimize pharmacy workflows, and digitally track pharmacists’ clinical interventions and patient outcomes. However, some of these solutions do not yet exist. “Ultimately, this is a call to action, both for pharmacy and for automation technology vendors within the healthcare space,” said Dr. Fortier, who is a member of the Autonomous Pharmacy Advisory Board, a coalition of pharmacy leaders working to replace manual activities with automated processes. A paper he co-authored (Am J Health Syst Pharm 2021;78[7]:636-645) described a framework for automating more tasks so pharmacists could shift

‘Ultimately, this is a call to action, both for pharmacy and for automation technology vendors within the healthcare space.’ —Christopher Fortier, PharmD

Under a pending provider status bill, pharmacists would be reimbursed for medication therapy management, immunizations, point-of-care testing, cholesterol screening, chronic disease management and other key clinical services.

Part B, to help address a shortage of primary care physicians. Under the Act, pharmacists would be reimbursed for services, such as medication therapy management, immunizations, point-ofcare testing, cholesterol screening and chronic disease management. The bill, sponsored by Sen. Charles “Chuck” Grassley (R.-Iowa), is timely. Along with widespread clinician burnout, the United States may see a shortage of 139,000 physicians by 2033, said James Stevenson, PharmD, FASHP, FFIP, the chief clinical officer at Omnicell, citing statistics from the Association of American Medical Colleges. “To put that number in perspective, it’s one-seventh of today’s total physician

estimated at 15,000 but predicted to increase to as much as 55,000 by 2033. There are some primary care “deserts” with less than one primary care provider for every 3,500 people, Dr. Stevenson said. It’s estimated that 39%—or 1,200 of the 3,100 counties in this country—will have a primary care physician shortage, affecting 13% of the U.S. population, according to the Health Resources and Services Administration. Granting pharmacists provider status would help narrow that PCP gap, and also offer significant financial incentives for pharmacists in health systems to devote more time to higher-value, clinical and patient-focused tasks in outpatient clinical settings, said Jeff Little, PharmD,

status would allow a shift away from this obstacle, he said. “By removing the financial barriers associated with the delivery of [broader] clinical pharmacy services, we can empower the pharmacist to become affiliated with patient outcomes, rather than simply the drug itself,” Dr. Little noted. Several challenges to implementing provider status remain, said Christopher Fortier, PharmD, the chief pharmacy officer for Massachusetts General Hospital, in Boston. Among them are labor and staffing constraints. Thinking about large clinics with many providers, “this is just not going to get done the right way with one or two pharmacists,” he said. “We need a lot more ambulatory care pharmacists to really affect patient care to the degree that we all agree is needed.” Additionally, Dr. Fortier said, drug preparation and distribution systems continue to be too labor-intensive. Better automation and technology solutions are needed to relieve some of that burden so more pharmacists can assume direct patient care roles, he noted. Data management is another potential roadblock. Clinical data needed to assess patients and make decisions often are stored in disparate databases, Dr. Fortier said. Additionally, there are limited data analytics available to risk-stratify the

into direct patient care roles. Pharmacists can complete a free self-assessment and download a white paper at www. autonomouspharmacy.com.

Ways to Support H.R. 2759/S. 1362 Pharmacists can take several actions to help support efforts to pass the provider status bill, Dr. Little said, including writing letters and emails to their congressional representatives; scheduling meetings with their offices in their home state or in Washington, D.C.; and inviting them to visit their hospital to observe what pharmacists do. (Be sure to involve the hospital’s government relations staff in such efforts, he stressed.) Additionally, Dr. Little noted, insurance often is regulated at the state level; therefore, it’s important to work toward getting states to pass provider status provisions. In some states, Medicaid and even state private insurers allow provider status to compensate pharmacists for some services. Make sure to educate other pharmacists, healthcare providers and patients about the importance of provider status, he advised. The sources reported no relevant financial disclosures other than their stated employment.

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