Specialty Pharmacy Continuum - November / December 2021 by McMahon Group

Serving managed care, health-system and specialty decision makers Volume 10 • Number 6 • November/December 2021 • specialtypharmacycontinuum.com

‘No good solutions’ for the patient

CLINICAL Promising regimens for hepatitis delta variant ....

Drug testing gap another COVID-19 casualty? ................................

PrEP regimens deemed essential for ending HIV ....................

From interchangeables to injectables, a year of firsts in new drug approvals ............................

Pharma Grapples With Best Price Accumulator

New Survey Finds Biosimilars Have Wide Acceptance Aurora, Colo.—Nearly two-thirds of managed care stakeholders polled in a recent survey said they are covering some biosimilar products, with most of them reporting “meaningful” cost savings from the formulary strategy. The survey findings underscore that biosimilars are finally coming into their own, and with their use, helping to conserve scarce health care dollars, according to presenters at the AMCP Nexus 2021 meeting. “When biosimilars first entered the market, there were a lot of unknowns,” said Tasmina Hydery, PharmD, MBA, BCGP, the assistant director of integrated technology solutions at Continued on page 30

POLICY 340B, PAPs come to the rescue during pandemic ............................

OPERATIONS & MGMT

For health systems, many paths to specialty success ............ 36 Pharmacists manage the revenue cycle for home infusion ............

As Managed Care Beat Goes On, How to Keep Up

he Centers for Medicare & Medicaid Services (CMS) has been busy on the copay front, with several of the agency’s recent decisions sions affecting how copay programs influence the he cost of medications. But three main stakeholders with skin in n the game—patients, providers and manufacactures—are expressing concern about the unintended consequences of these actions. CMS’s MS’s “best price copay” and copay accumulator policies ies seem to be at the center of the debate, based on sessions sions at InformaConnect’s 2021 annual Coupon & Copay Conference. Nearly 70% of respondents in a September t b 2021 survey off pharmaceutical manufacturers and other stakeholders, for example, conducted by Informa Engage, reported that they were moderately (53%) or very (16%) concerned that CMS’s best price copay ruling negatively affect their company, reported

he managed care market is in constant flux, so health-system pharmacy leaders need to be nimble and work with their managed care teams to maintain a competitive strategy, speakers said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually. Megamergers are a big reason for the constant change, with payors such as UnitedHealth Group joining forces with or acquiring pharmacy benefit managers and pharmacies, said Paul Spencer, MBA, the vice president of managed care and revenue cycle services for Froedtert Health, in Milwaukee. “I don’t see this

Continued on page 27

Continued on page 34

The stories behind the market players Special advertising section begins on page 15.

Corporate Profiles

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Specialty Pharmacy Continuum • November/December 2021

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Volume 10 • Number 6 • November/December 2021

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Specialty Pharmacy Continuum • November/December 2021

CLINICAL

Hepatitis D Pipeline Looks Promising Interim results from a new phase 3 trial support the safety and efficacy of monotherapy with bulevirtide (Hepcludex, Gilead) in patients who have chronic infection with the hepatitis delta virus (HDV). Coupled with recent data on oral HDV regimens, the pipeline for treating this rare, challenging form of hepatitis looks promising. The interim phase 3 study, an international, multicenter investigation, concluded that treatment with bulevirtide for 24 weeks was associated with significant decreases in viral RNA and improvements in biochemical disease activity. The researchers said the findings confirm the August 2020 conditional approval by the European Commission of bulevirtide. The first-in-class entry inhibitor has received a breakthrough therapy designation from the FDA in the United States. Bulevirtide is a peptide derived from the hepatitis B surface antigen (HBsAg). “In previous phase 2 trials [MYR202/ MYR203], we showed that if you inject hepatitis D patients with this peptide [daily] with different doses, you get a linear decline in HDV RNA over time, which reflects a loss of infected cells,” said Heiner Wedemeyer, MD, the chair of the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical Hospital, in Germany. The current study was a 24-week analysis of the MYR301 trial, which comprised 150 patients (57% men; mean age, 41.8 years) coinfected with hepatitis B virus (HBV) and HDV. Participants in the trial were randomized to one of three groups: no antiviral treatment for 48 weeks followed by 10 mg daily of bulevirtide for 96 weeks (control arm A; n=51), 2 mg daily of bulevirtide (arm B; n=49), or 10 mg daily of bulevirtide (arm C; n=50). Patients in arms B and C received the drug for 144 weeks, with a treatmentfree follow-up of 96 weeks. The primary end point of the trial was a combined response of undetectable HDV RNA or HDV RNA reduction of at least 210 IU/mL and normalization of alanine aminotransferase (ALT) at week 48. Secondary end points included undetectable HDV RNA, a fall in HDV RNA of at least 210 IU/mL, normalization of ALT and a reduction in HBsAg of at least 110 IU/mL. In a presentation at the 2021 International Liver Congress (abstract LBP-2730), Dr. Wedemeyer reported that after 24 weeks, none of the patients in the control group (arm A) achieved a combined virologic and biochemical response, whereas 36.7% of patients in arm B and 28.0% of those in arm C did so

(P<0.0001). Similar results were observed for HDV RNA, which fell by at least 210 IU/mL between baseline and week 24 in 3.8% of patients in arm A, 55.1% in arm B and 68% in arm C (P<0.0001). At week 24, normalization of ALT was achieved by 53.1% of patients in arm B and 38% in arm C, compared with 5.9% in arm A (P<0.0001). The level of HBsAg did not show relevant declines in all but one patient at week 24. “The important message is that the findings of the phase 2 trials were exactly confirmed,” Dr. Wedemeyer said. Safety analyses found that treatmentrelated adverse events were much more common in patients who received the study drug. “As was expected, bile acids

increased because bulevirtide’s mode of action blocks a bile salt transporter,” Dr. Wedemeyer said. “But there were no unexpected serious adverse events.” The researchers acknowledged that only a small proportion of patients had completely undetectable HDV RNA, but they were encouraged by the results. “This confirms that we can use the drug in a real-world setting,” Dr. Wedemeyer said. “These are exciting times for hepatitis delta patients.” Tobias Böttler, MD, an attending physician at the University Hospital Freiburg, in Germany, commented that bulevirtide has the potential to make a significant difference in managing patients with active hepatitis delta infection. “We still need to learn a lot with regard to dosing, treatment duration and possible combination therapies, [because] some data suggest that combination with interferon is even more potent,” he said. “It appears to be well tolerated with little side effects, based on the data we currently have. Going forward, we might ht even

Hepatitis D: FAQs Q: What are some of the key distinguishing features off the h h hepatitis i i D virus (HDV) and its associated illness? A: HDV is known as a “satellite virus,” because it can only infect people who are also infected by the hepatitis B virus (HBV). HDV infection can be acute or lead to chronic, long-term illness. The infection can be acquired either simultaneously with HBV as a coinfection, or as a superinfection in people who are already chronically infected with HBV.

Q: What is the difference between HBV/HDV coinfection and HDV superinfection? A: HBV/HDV coinfection occurs when a person simultaneously becomes infected with both HBV and HDV, whereas HDV superinfection occurs when a person who is already chronically infected with HBV acquires HDV. Although acute HBV/HDV coinfections can resolve, HDV superinfection can lead to rapid progression of the already present HBV infection, resulting in liver cirrhosis and liver failure. These outcomes occur within five to 10 years in 70% to 80% of affected people and within one to two years in 15% with chronic HBV/HDV infection.

Q: How common is hepatitis D in the United States? A: HDV infection is uncommon in the United States; most U.S. cases occur among people who migrate or travel here from countries where HDV is endemic. Because hepatitis D is not a nationally notifiable condition, the actual number of hepatitis D cases in the United States is unknown.

Q: Where is hepatitis D most common? A: Hepatitis D is most common in Eastern Europe, Southern Europe, the Mediterranean region, the Middle East, West and Central Africa, East Asia, and the Amazon Basin in South America.

be able to use the drug in hepatitis B– monoinfected patients, but that requires a lot more data from clinical trials.”

Oral Formulation Option For patients and providers who prefer orally administered therapy, another investigational agent, lonafarnib (Zokinvy, Eiger Biopharmaceuticals), may be an option if it succeeds in its pipeline journey. Lonafarnib is a late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in the modification of proteins through a process called prenylation. The FDA approved the drug in 2020, to reduce the risk for death from Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients 1 year of age and older. Lonafarnib has been evaluated in several clinical trials for the treatment of HDV, either as monotherapy or in combination with pegylated interferon alfa-2a (PEG IFN-alfa-2a) or ritonavir. In a proof-ofconcept study that explored optimal treatment regimens, the addition of ritonavir to ti a twice-daily oral lonafarnib regimen of lo 100 mg yielded optimal antiviral responses, with sigantivira nificantly fewer gastrointestieffects than lonafarnib nal side ef monotherapy (Hepatology monothe 2018;67[4]:1224-1236).The 2018;67[ GI side effects likely reduced G are due to ritonavir’s ability to inhibit lonafarnib metabolism, allowing for higher concentrations of the farnesyl transferase inhibitor to build up in the liver and systemic circulation, the researchers noted. In 2018, the FDA granted lonafarnib breakthrough therapy designation for the treatment of HDV infection. The drug currently is being investigated in D-LIVR, a global phase 3 trial evaluating an all-oral arm of lonafarnib boosted with ritonavir. The trial also includes a combination arm of ritonavir boosted with ritonavir plus PEG IFN-alfa-2a. Each arm is to be compared with a placebo arm in HDV-infected patients (ClinicalTrials.gov identifier: NCT03719313). The estimated study completion date is April 1, 2023, according to the ClinicalTrials. gov listing. —Michael Vlessides, David Bronstein

Q: Are there different genotypes of HDV, and where do they circulate? A: Eight different HDV genotypes can be found around the world, all of which share the same transmission routes and risk groups. HDV genotype 1 circulates mainly in North America, Europe, the Middle East, and North Africa. Genotypes 2 and 4 can be found in East Asia. Genotype 3 is found exclusively in the Amazon Basin in South America. Genotypes 5, 6, 7 and 8 are found in West and Central Africa. Source: CDC (bit.ly/3jOmrI2).

Dr. Böttler reported that he served on an advisory committee for Gilead Sciences. Dr. Wedemeyer reported financial relationships with Abbott, AbbVie, Altimmune, Biotest, Bristol Myers Squibb, BTG, Dicerna, Gilead, Janssen, Merck/MSD, MYR GmbH, Novartis, Roche, Siemens and Transgene.

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Specialty Pharmacy Continuum • November/December 2021

CLINICAL

Drug Testing Gap Spurs a Different COVID Crisis In addition to the millions of lives claimed by COVID-19, another group of victims has emerged: the users and abusers of prescription and illicit drugs alike, who—as a potential result of decreased drug testing during the pandemic—have seen their overdose rates skyrocket. In a presentation during the 2021 virtual annual meeting of the American Academy of Pain Medicine, Jeffrey Gudin, MD, a faculty member in the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami Miller School of Medicine, discussed this worsening crisis within the pandemic, along with strategies for mitigating its effects. “When the stay-in-place orders were enacted in March 2020, the AMA [American Medical Association] and CDC recommended that certain nonessential medical services be paused or halted,” Dr. Gudin said. “Unfortunately, drug testing fell into that category. But prescriptions didn’t stop, patients in pain didn’t stop, and drug abuse on the streets didn’t stop. So, we decided to compare our data from a period prior to COVID-19 to what happened during the first six or eight weeks of the pandemic.” To do so, Dr. Gudin and his colleagues used de-identified drug monitoring test results from patients tested at a large national laboratory (Quest Diagnostics) between Jan. 1, 2019, and May 16, 2020. Only those specimens with clinicianprovided prescribed drug information were included; this information indicates whether the prescribed drugs specified by the ordering provider—as well as other drugs—are detected in a specimen. The researchers compared results from Jan. 1, 2019, to March 14, 2020 (control) with those from March 15 to May 16, 2020 (during COVID-19). Positivity for unprescribed drugs was defined as the presence of a positive result for unprescribed or illicit drugs on urine drug testing. Similarly, drug misuse was defined as unprescribed drug positivity and/or noncompliance, such as the absence of a prescribed drug or the presence of an unprescribed or illicit drug. More than 800,000 drug tests were performed during the baseline control period, compared with almost 50,000 during the pandemic. Not surprisingly, clinical drug monitoring declined rapidly during the COVID-19 period. “I was amazed how much clinical drug monitoring declined rapidly during the pandemic, yet the most startling finding was how much the pandemic worsened the overdose and fentanyl abuse crisis,” Dr. Gudin said in an interview. Indeed, positivity for unprescribed fentanyl increased by 35% during the

pandemic compared with baseline (P<0.01). This finding, Dr. Gudin said, was more pronounced among men (5.7% baseline positivity, 8.6% COVID-19) than women (3.2% and 3.7%, respectively). Of note, the study also found that combinations of unprescribed fentanyl in patients who tested positive for other drugs also increased significantly in a number of cases. “This suggests that people are using dangerous drug

combinations whether they know it or not, as our street drugs are often laced with these synthetic opioids, such as fentanyl,” Dr. Gudin said. “Our study supports other recent findings that during times of crisis, drug misuse goes up,” he added. “So, although I understand the need to protect health care workers from COVID-19 exposure, it seemed like a bad time to recommend a pause in drug testing.” Given these increases in illicit drug use, the researchers recommended that clinicians reestablish opioid risk management strategies, including inperson visits, querying prescription drug monitoring programs (PDMPs) and interval drug testing. “Health care providers need to know

that now is the time to tighten the reins when treating those at risk, rather than continuing blindly from a risk management standpoint,” Dr. Gudin said. “With that in mind, every patient needs to have their PDMP checked, and every patient needs to continue to undergo drug testing, especially if they’re higherrisk patients,” he continued. “As we get back to face-to-face office visits, I think it will a bit easier to put our fingers on the pulse, figuratively and literally, to get a good handle on what’s going on in somebody’s life rather than an abbreviated telemedicine visit.”

Another Risk Management Gap: Opioid Use After Hospitalization

f hospitalized patients who filled one or more opioid prescriptions within three months after discharge, roughly 15% had an opioid-related emergency department visit, a hospital readmission or death within one year of original discharge, a new study has found. The ad hoc cohort study (JAMA Netw Open 2021;4[5]:e218782) included 1,511 patients without a history of methadone or buprenorphine use who were enrolled in a randomized trial of medication reconciliation at McGill University Health Centre, in Montreal, between October 2014 and November 2016. Patients were followed for 12 months after discharge. Of patients with at least one post-discharge filled opioid script, 15.9% (n=41) had an opioid-related emergency department visit, a hospital readmission or death. Patients also had a 2.56-fold increased risk for opioid-related adverse events related to a cumulative use duration of more than 90 days compared with one to 30 days. Furthermore, there was a 3.51-fold increased risk with a mean daily dose higher than 90 morphine milligram equivalent (MME) versus 90 MME or lower. The results underscore that more frequent clinical vigilance and better pain treatment strategies are needed for patients taking opioids, according to study senior author Siyana Kurteva, BSc, a PhD candidate at McGill. “Policies to reduce extended opioid duration and its associated risk of potentially avoidable adverse health care events also need to be adopted,” Ms. Kurteva said. Charles E. Argoff, MD, the director of the Comprehensive Pain Center and director of the pain management fellowship at Albany Medical Center, in New York, said the results of the study are consistent in general with other reported findings. In addition, the CDC guideline for chronic opioid therapy notes “the increased likelihood of adverse effects with higher doses; hence the reason why there is a recommendation about MME dosing.” What is missing from the analysis, though, is the benefit that the study population derived from opioids, Dr. Argoff noted. “This omission is a serious weakness of the study. The analysis fails to inform a prescriber on how to optimize the benefit of opioid therapy while minimizing the harm.”

What About Nonopioid Pain Relief? Other pain experts suggest that rather than optimizing opioid therapy, a safer approach would be to maximize nonopioid pain modalities, particularly in surgical settings, which pose a high risk for opioid misuse and abuse after discharge. Numerous opioid-free analgesic options are available, and they have changed little in recent years, noted Eugene R. Viscusi, MD, a professor of anesthesiology at Thomas Jefferson University, in Philadelphia, and the immediate past president of the American Society of Regional Anesthesia and Pain Medicine. In the preoperative period, they include 400 mg of celecoxib or other nonsteroidal anti-inflammatory drugs, 1 to 2 g of acetaminophen, and/or 75 to 150 mg of pregabalin or 600 to 1,200 mg of gabapentin. Intraoperative nonopioid approaches include use of regional anesthesia, epidural analgesia and truncal blocks. Wound infiltration with local anesthetic also can play an important intraoperative role, he noted.

A Pharmacist’s Perspective Jeffrey Fudin, PharmD, was not surprised by the findings. “It was a mistake to think that drug testing is a nonessential item,” commented Dr. Fudin, the CEO and founder of Remitigate Therapeutics, in Delmar, N.Y. “Comparatively, it would not be acceptable to adjust diabetic medications or anticoagulant therapies without proper blood work. Why would we treat such a fragile and isolated population any differently? “Perhaps, on the one hand, regulators felt they were helping to lessen the burden on chronic pain patients, and that’s commendable,” he said. “Nevertheless, the poor outcome here should have been predictable.” Dr. Fudin offered suggestions for future similar situations. “Moving forward, it would be smart to include a team of pain experts on the government pandemic team to help government agencies develop pandemic policies regarding drug testing,” he said. Those policies “should be based on validated tools that stratify risk for drug abuse and misuse, rather than having a blanket rule that these are nonessential for all patients.” —Michael Vlessides

—Bob Kronemyer and Mike Vlessides

Dr. Kurteva reported no relevant financial relationships. Dr. Viscusi reported financial relationships with Esteve, Heron Therapeutics, Innocoll Pharmaceuticals, Merck, Salix Pharmaceuticals and Trevena Inc.

Dr. Fudin reported no relevant financial disclosures. Dr. Gudin reported a financial relationship with Quest Diagnostics, which offers drug monitoring services.

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Specialty Pharmacy Continuum • November/December 2021

CLINICAL

The Persistence of PrEP: Essential for Ending HIV By Milena Murray, PharmD, MSc, BCIDP, AAHIVP

pproximately 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. However, of the 1.2 million Americans eligible for PrEP, only an estimated 70,000 had an active prescription for PrEP as of the end of 2017.1 In 2019, FTC–tenofovir alafenamide (FTC/TAF; Descovy, Gilead) was approved as a second PrEP therapy option. The PrEP continuum of care includes awareness of risk, uptake of therapy, and adherence and retention in care.2 Barriers to adherence and retention in care include forgetfulness, competing priorities, safety concerns, stigma, and lack of a supportive social network.3 It is well known that PrEP adherence is directly related to efficacy.4 Thus, a barrier that should be addressed is the ability to remain on PrEP after initiation, referred to as PrEP persistence. PrEP persistence also is defined as the length of time a person continues to refill PrEP prescriptions without an interruption of more than 30 days.5 Initiation of PrEP may be a poor measure because PrEP discontinuation at 1 month is as high as 45%,6 with a patient’s type of insurance a potential confounder. A study of 11,807 people with commercial insurance and 647 with Medicaid, for example, revealed a significant disparity in PrEP persistence.5 People with commercial insurance remained on PrEP for a median of 13.7 months (95% CI, 13.3-14.1 months) compared with 6.8 months (95% CI, 6.1-7.6 months) among those on Medicaid. After adjustment for covariates, female sex (hazard ratio [HR], 1.81; 95% CI, 1.6-2.1) and younger age (18-24 years: HR, 2.4; 95% CI, 2.1-2.7) were predictors of nonpersistence.5 A separate study of 300 people also showed that age affected PrEP persistence.7 Of the participants, 178 (59%) were 30 years of age or older, 287 (96%) were men, and 178 (59%) identified as men who have sex with men (MSM). After 12 months, only 44% of participants were persistent with PrEP, and only 34% attended quarterly follow-up visits.

Understanding Changes Use Some people may stop PrEP for appropriate reasons, such as no longer being at high risk for HIV acquisition, but many discontinue due to structural issues. A study of 25 people taking PrEP and 18 providers of PrEP care identified several reasons for the PrEP discontinuation,8 including side effects and lack of perceived risk. In addition, a lack of housing caused 1 person to stop therapy. From

a provider perspective, there is often a focus on short-term clinical visits rather than long-term PrEP persistence. An analysis of 103 MSM taking PrEP found that 18% attended clinic appointments less often than the 3-month interval recommended by guidelines.9 The emergent reported barrier to PrEP adherence was insurance (39%), specifically the need for prior authorization and mail-order pharmacy mandates. In addition, systemic barriers to medical care were reported, such as poor availability of appointments.9 Removal of these appointmentand insurance-related barriers may help with PrEP persistence. A systematic review of experiences with PrEP use in cisgender men in the United States revealed interventions such as telehealth and pharmacist-prescribed approaches to PrEP distribution might reduce barriers to PrEP uptake and persistence.10 However, structural interventions were not likely to alleviate barriers in underserved communities. Of interest, a study of approximately 1,000 participants taking PrEP reported that out-ofpocket costs for medication and clinic visits were not barriers to PrEP persistence. In this study, the average quarterly out-of-pocket cost was $34 (median, $5; interquartile range, $0-$25), and those with commercial insurance had higher costs than those without insurance.11 The authors noted that the costs were absolute and not analyzed relative to income, which may have led to a different interpretation of the data. The introduction of 2-1-1 PrEP dosing, sometimes called “on-demand PrEP,” provided an option for people who don’t want to take medication every day.12 A study of 140 men who had used the 2-1-1 dosing strategy reported high adherence to the double dose before sexual encounters. However, barriers to using this dosing strategy, such as stigma, cost, and unplanned sexual encounters, were reported.12 It should be noted that this PrEP dosing strategy is only recommended by the International Antiretroviral Society-USA for the MSM population.13 People taking PrEP may also discontinue therapy due to a low perceived risk for HIV acquisition.14 This may occur without consultation with a health care provider. Data at the 6- to 12-month mark indicate discontinuations occur even though there is an ongoing risk for HIV acquisition.8 In a study of 112 Black ciswomen, PrEP persistence was 18%, with an average of 8.1 months on therapy.15 This small percentage was mainly attributed to a low perception of risk by participants and health care providers. Perceived and ongoing risk should be

discussed at the initiation of therapy to avoid inappropriate discontinuation.14 Although PrEP persistence is an important topic, there will be people for whom it is appropriate to discontinue therapy. It should be noted that major and international guidelines provide differing recommendations on the duration of oral therapy after the last exposure if PrEP discontinuation is desired.14 Length of therapy should be considered based on the type of exposure, and it varies from 2 to 28 days.14 PrEP specialized services, navigation, LGBTQIA+ competent providers, and accessible clinic locations may reduce barriers to PrEP persistence. In addition, a comprehensive approach should be used; referrals for substance use, housing, and mental health services should be provided if appropriate.9 Other strategies that should be considered include 90-day prescriptions, drop-in clinic visits, and standing orders for laboratory testing. “Same-day” PrEP is also an emerging strategy to avoid delays in PrEP initiation.16 Data suggest that discontinuation with this strategy occurs at the same rate as standard prescribing practices. Understanding barriers to the initiation and persistence of PrEP is a critical factor to ending the HIV epidemic. Data on people with specific characteristics continue to expand. New PrEP options will also provide more opportunities for diverse populations. Targeted interventions based on the available data should be implemented to increase PrEP persistence.

5. Huang YA, Tao G, Smith DK, et al. Persistence with human immunodeficiency virus preexposure prophylaxis in the United States, 2012-2017. Clin Infect Dis. 2021;72(3):379-385. 6. Stankevitz K, Grant H, Lloyd J, et al. Oral preexposure prophylaxis continuation, measurement and reporting. AIDS. 2020; 34(12):1801-1811. 7.

Keyes J, Crouse EC, DeJesus E, et al. Determinants of pre-exposure prophylaxis (PrEP) persistence in a high-risk population in central Florida. J Investig Med. 2021;69(2):397-401.

8. Laborde ND, Kinley PM, Spinelli M, et al. Understanding PrEP persistence: provider and patient perspectives. AIDS Behav. 2020;24(9):2509-2519. 9. D’Angelo AB, Lopez-Rios J, Flynn AWP, et al. Insurance- and medical provider-related barriers and facilitators to staying on PrEP: results from a qualitative study. Transl Behav Med. 2021;11(2):573-581. 10. Edeza A, Karina Santamaria E, Valente PK, et al. Experienced barriers to adherence to pre-exposure prophylaxis for HIV prevention among MSM: a systematic review and metaethnography of qualitative studies. AIDS Care. 2021;33(6):697-705. 11. Furukawa NW, Schneider JA, Coleman ME, et al. Out-of-pocket costs and HIV pre-exposure prophylaxis persistence in a US multicity demonstration project. Health Serv Res. 2020;55(4):524-530. 12. Camp C, Saberi P. Facilitators and barriers of 2-1-1 HIV pre-exposure prophylaxis. PLoS One. 2021;16(5):e0251917. 13. Saag MS, Gandhi RT, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 recommendations of the International Antiviral Society–USA panel. JAMA. 2020;324(16):1651-1669. 14. Rutstein SE, Smith DK, Dalal S, et al. Initiation, discontinuation, and restarting HIV pre-exposure prophylaxis: ongoing implementation strategies. Lancet HIV. 2020;7(10):e721-e730.

1. Beymer MR, Holloway IW, Pulsipher C, et al. Current and future PrEP medications and modalities: on-demand, injectables, and topicals. Curr HIV/AIDS Rep. 2019;16(4):349-358.

15. Pyra M, Johnson AK, Devlin S, et al. HIV pre-exposure prophylaxis use and persistence among black ciswomen: “Women need to protect themselves, period.” J Racial Ethn Health Disparities. 2021 Mar 17: 1-10. doi: 10.1007/s40615-021-01020-9

2. Nunn AS, Brinkley-Rubinstein L, Oldenburg CE, et al. Defining the HIV pre-exposure prophylaxis care continuum. AIDS. 2017;31(5):731-734.

16. Rowan SE, Patel RR, Schneider JA, et al. Same-day prescribing of daily oral pre-exposure prophylaxis for HIV prevention. Lancet HIV. 2021;8(2):e114-e120.

References

3. Clement ME, Kofron R, Landovitz RJ. Long-acting injectable cabotegravir for the prevention of HIV infection. Curr Opin HIV AIDS. 2020;15(1):19-26. 4. Koss CA, Liu AY, Castillo-Mancilla J, et al. Similar tenofovir hair concentrations in men and women after directly observed dosing of tenofovir disoproxil fumarate/ emtricitabine: implications for preexposure prophylaxis adherence monitoring. AIDS. 2018;32(15):2189-2194.

Dr. Murray reported being a speaker for Merck and on the advisory board for Theratechnologies and ViiV Healthcare.

About the Author Milena Murray, PharmD, MSc, BCIDP, AAHIVP, is an associate professor, College of Pharmacy, Midwestern University, in Downers Grove, Illinois.

Specialty Pharmacy Continuum • November/December 2021

CLINICAL

Specialty spending ekes out a win over traditional meds

2021 New Drug Approvals: A Year of Firsts Aurora, Colo.—Two of the most notable new drug approvals in 2021 were not technically new; they were new indications, but they should have a significant effect on the specialty market. Two biosimilars became the first interchangeable biologics approved by the FDA. Just more than one year after it was approved, insulin glargine-yfgn (Semglee, Viatris/Biocon Biologics) was granted interchangeable status with its reference product Lantus (Sanofi) in July 2021. It can be automatically substituted with the reference product by a pharmacist, similar to the substitutions made for traditional generics. On Oct. 20, Express Scripts listed insulin glargine-yfgn as a preferred insulin on its National Preferred Formulary, due to take effect in January 2022. “Semglee currently costs about half as much as Lantus,” explained Aimee Tharaldson, PharmD, at the 2021 AMCP Nexus meeting. “This could save clients $20 million next year due to this decision,” added Dr. Tharaldson, a senior clinical pharmacist of Emerging Therapeutics at Express Scripts. The second biosimilar to be designated as interchangeable is adalimumabadbm (Cyltezo, Boehringer Ingelheim), a biosimilar to Humira (AbbVie). Adalimumab-adbm, which was originally approved in August 2017, was made interchangeable on Oct. 18. Unlike insulin glargine-yfgn, however, adalimumabadbm will not launch immediately due to patent settlement agreements with AbbVie. It will launch in 2023, along with five other biosimilars to adalimumab, but only adalimumab-adbm has interchangeability at this point. Another biosimilar approved this year, ranibizumab-nuna (Byooviz, Samsung Bioepis/Biogen), a biosimilar to Lucentis (Genentech), is the first ophthalmic biosimilar. The anti–vascular endothelial growth factor therapy was approved to treat several eye conditions, including neovascular age-related macular degeneration, the leading cause of blindness in those 65 years of age and older. Bevacizumab (Biothera), a biosimilar to Avastin (Genentech) for several cancer types, and another adalimumab biosimilar by Coherus were expecting approvals before the end of the year. “So far, FDA has approved 31 biosimilars to 11 biologics. And 21 biosimilars to 8 biologics are currently available on the market,” Dr. Tharaldson explained. “These biosimilars have combined sales of about $4 billion.” Specialty spending, which has been creeping up each year, has overtaken the traditional drug spend, Dr. Tharaldson

noted. “Fifty-one percent of per member per year drug spend under the pharmacy benefit is for specialty drugs,” she said, but only about 2% of the patients covered take specialty medications.

More Firsts Long-Acting HIV Medication

ViiV Healthcare kicked off the year with the approval of the first long-acting HIV medication. Cabotegravir-rilpivirine injectable (CAB/RPV; Cabenuva) is an alternative to oral treatment for adults with low viral loads who are on a current stable regimen and no history of treatment failure, she explained. Dosed monthly, CAB/RPV comes as a copack with two injectable medications, ViiV’s cabotegravir and Janssen’s rilpivirine.

options, and these have been only modestly effective but highly toxic,” Brad H. Rovin, MD, the director of the Division of Nephrology at The Ohio State University Wexner Medical Center, in Columbus, and an AURORA clinical trial investigator, said in a press release announcing the approval (bit.ly/30ekHkz). “About 10% of these patients with lupus nephritis develop end-stage renal disease,” Dr. Tharaldson said. Genetic Disorders

Casimersen (Amondys 45, Sarepta Therapeutics) is the first drug approved to treat Duchenne muscular dystrophy (DMD) with a mutation amenable to exon 45 skipping. About 10,000 boys and young men have DMD, but only about

Non-small cell lung cancer (NSCLC) patients benefited from several approvals in 2021, with drugs hitting a variety of targets, including KRAS G12C, epidermal growth factor receptor exon 20 insertion mutations and METexon14 alterations. Although lung cancer rates are decreasing in the United States, 235,760 adults still are diagnosed each year, 85% of whom have NSCLC, according to the American Society of Clinical Oncology.

The approval was based on the phase 3 ATLAS and FLAIR studies that included more than 1,100 patients from 16 countries. Prior to initiating treatment, oral dosing of CAB and RPV are given to assess tolerability with therapies. The first therapy for adults with active lupus nephritis was also approved in January. Lupus nephritis, a common complication of systemic lupus erythematosus, causes irreversible kidney damage and significantly increases the risk for kidney failure, cardiac events and death. Voclosporin (Lupkynis, Aurinia), an oral therapy used with a background immunosuppressive regimen, is a calcineurin inhibitor. In the pivotal AURORA trials, patients treated with voclosporin with immunosuppressives were more than twice as likely to achieve renal response and experience a decline in the urine protein to creatinine ratio. “For years, treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic

8% have this genetic mutation, according to Dr. Tharaldson. Casimersen is an antisense oligonucleotide that skips over exon 45 to enable a partially functioning dystrophin protein. The medication is given as a weekly infusion. The new indication is based on a statistically significant increase in dystrophin production in skeletal muscle observed in patients treated with casimersen, which is reasonably likely to predict clinical benefit. Fosdenopterin (Nulibry, BridgeBio/ Origin Biosciences) is the first drug for patients with molybdenum cofactor deficiency (MoCD) type A, which affects fewer than 150 infants and young children worldwide. MoCD type A is an autosomal recessive, inborn error of metabolism caused by mutations in the molybdenum cofactor synthesis 1 gene and characterized by a deficiency in molybdenum cofactor production and enzyme activity. The lack of activity leads to a buildup of sulfite and secondary metabolites in the brain, which causes irreversible, progressive neurologic damage.

“Nulibry the off a lib allows ll h production d i missing enzyme that reduces the buildup of the harmful substances in the brain. It’s administered as a daily IV infusion,” Dr. Tharaldson said. Small studies showed improved overall survival (OS) compared with an untreated cohort. Belzutifan (Welireg, Merck), an oral hypoxia-inducible factor-2 alpha (HIF2alpha) inhibitor, is the first treatment for von Hippel-Lindau (VHL) syndrome, a rare genetic disorder that leads to the development of cancerous and noncancerous tumors. Seventy percent of people with this condition develop renal cell carcinoma, Dr. Tharaldson explained. Belzutifan reduces transcription and expression of HIF-2alpha target genes associated with cellular proliferation, angiogenesis and tumor growth. “In Study 004, nearly half of all patients with VHL-associated renal cell carcinoma, as well as the majority of patients with VHL-associated central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, who were treated with Welireg experienced a reduction of their respective tumor size,” explained Ramaprasad Srinivasan, MD, PhD, the head of the Molecular Cancer Therapeutics Section, National Cancer Institute.

Cancer Drugs Approved Non-small cell lung cancer

Non-small cell lung cancer (NSCLC) patients also benefited from several approvals. Although lung cancer rates are decreasing in the United States, 235,760 adults still are diagnosed each year, and 85% with NSCLC, according to the American Society of Clinical Oncology. • Sotorasib (Lumakras, Amgen) is the first targeted treatment for KRAS G12C mutated locally advanced or metastatic NSCLC. About 13% of NSCLC patients have this “previously elusive mutation,” according to David M. Reese, MD, the executive vice president of Research and Development at Amgen. A phase 2 study found a 37% objective response rate. • Mobocertinib (Exkivity, Takeda) is the first medication to target epidermal growth factor receptor (EGFR) exon 20 insertion mutations, and is indicated for locally advanced or metastatic see 2021 APPROVALS, page 12

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Specialty Pharmacy Continuum • November/December 2021

CLINICAL

2021 APPROVALS continued from page 10

disease. “EGFR exon 20 insertion plus NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs [tyrosine kinase inhibitors],” said Pasi A. Jänne, MD, PhD, of the Dana Farber Cancer Institute, in Boston. • Amivantamab-vmjw (Rybrevant, Janssen), an EGFR exon 20–directed and mesenchymal–epithelial transition (MET) receptor–directed antibody, was approved to treat patients with NSCLC with EGFR exon 20 insertion mutations. “This [NSCLC variant] is pretty rare,” Dr. Tharaldson said. “Only about 1% to 2% of patients with NSCLC have these exon 20 insertion mutations. It’s more common in Asian populations and is associated with lower survival rates.” • Tepotinib (Tepmetko, EMD Serono), a second oral MET inhibitor, is indicated for adults with NSCLC that has metastasized and has MET exon 14 alterations, which affects about 3% to 4% of patients with NSCLC. • Trilaciclib (Cosela, G1 Therapeutics/ Boehringer Ingelheim), a cyclindependent kinase 4 and 6 inhibitor, was approved to reduce chemotherapyinduced myelosuppression in extensive-stage small cell lung cancer. The IV infusion is given four hours before chemotherapy to reduce the duration and severity of neutropenia. Lymphomas

Lymphomas also benefited from new options in 2021. • Loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics) is the first CD19directed antibody and alkylating agent conjugate approved for diffuse large B-cell lymphoma (DLBCL) and indicated in the third-line setting. DLBCL affects about 10% of patients. • Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb [BMS]), a chimeric antigen receptor (CAR) T-cell agent, was approved for the third-line treatment of adults with relapsed/ refractory DLBCL. It is given as a one-time infusion. • Umbralisib (Ukoniq, TG Therapeutics) is an oral phosphoinositide 3-kinase delta and casein kinase 1 epsilon inhibitor approved for adults with relapsed/refractory marginal zone or follicular lymphoma. Marginal zone lymphoma is diagnosed in about 7,500 U.S. patients and follicular lymphoma in about 15,000. Both are slow-growing forms of non-Hodgkin lymphoma, Dr. Tharaldson explained. Multiple Myeloma

Two specialty medications were approved for multiple myeloma (MM),

both for relapsed/refractory disease: melphalan flufenamide (Peptaxo, Oncopeptides), a peptide–drug conjugate alkylating drug used in combination with dexamethasone, and idecabtagene vicleucel (Abecma, BMS/bluebird bio), a B-cell maturation antigen-directed CAR T-cell therapy. However, Oncopeptides is withdrawing melphalan flufenamide after results from the OCEAN study (ClinicalTrials.gov Identifier: NCT03151811) showed the OS of patients who received the injection with dexamethasone was lower than those who were treated with pomalidomide (Pomalyst, BMS) and dexamethasone, as reported in Pharmacy

phase 2/3, single-arm, open-label, multicenter, dose-confirmation study evaluating pediatric and adult patients with ALL or LBL demonstrated the achievement and maintenance of nadir serum asparaginase activity (NSAA) greater than or equal to 0.1 U/mL at 48 hours using intramuscular 25-mg/m2 doses of asparaginase erwinia-rywn. The proportion of patients maintaining NSAA of at least 0.1 U/mL at 48 hours after a dose of asparaginase erwinia-rywn was 93.6% (95% CI, 92.6%-94.6%). Asciminib (Scemblix, Novartis) was approved to treat Philadelphia chromosome–positive myeloid leukemia

‘So far, FDA has approved 31 biosimilars to 11 biologics. And 21 biosimilars to 8 biologics are currently … on the market, [with] combined sales of about $4 billion.’ —Aimee Tharaldson, PharmD Practice News (bit.ly/3oh6xHO). Collaborating with the FDA, Oncopeptides will ensure that patients who need to keep using melphalan flufenamide will have access to it. (For more information, contact OnCourse Patient Support Services at 1-844-300-6626.) “Even though there are a lot of drugs to treat MM, most patients wind up relapsing,” Dr. Tharaldson said. Advanced Renal Cell Carcinoma

The FDA approved tivozanib (Fotivda, Aveo Oncology), a new oral angiogenesis inhibitor, for third-line treatment of adults with advanced renal cell carcinoma. “About of 76,000 new cases of kidney cancer are diagnosed each year, and about 90% are renal cell carcinoma, which typically does not respond well to chemotherapy,” she explained. Cholangiocarcinoma

Infigratinib (Truseltiq, BridgeBio/ Helsinn) is an oral fibroblast growth factor 2 TKI indicated for cholangiocarcinoma that is inoperable. About 8,000 cases of cholangiocarcinoma are diagnosed each year. It’s typically difficult to diagnose, and the average survival rate is less than 10%. About 50% of cases involved an FGFR2 mutation. Leukemias

Asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals) is a new asparaginespecific enzyme product used with other chemotherapy drugs to treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) for patients 1 month of age and older. “These are rare cancer types that primarily affect children,” Dr. Tharaldson said. Clinical data from an ongoing pivotal

chronic phase (Ph+ CML-CP) previously treated with two or more TKIs, and Ph+ CML-CP with the a T315I mutation. Asciminib is the first FDAapproved CML treatment that works by binding to the ABL myristoyl pocket. Cervical cancer

Tisotumab vedotin-tftv (Tivdak, Seagen/Genmab) is an antibody inhibitor conjugate approved to treat women with recurrent or metastatic cervical cancer with progression on or after chemotherapy.

Orphan and Other Conditions Belumosudil (Rezurock, Kadmon Holdings) is an oral graft inhibitor for patients 12 years of age and older with chronic graft-versus-host disease (cGVHD), a common complication after hematopoietic stem cell transplant. In ROCKstar, a randomized, openlabel, multicenter pivotal trial of belumosudil, patients with cGVHD who had received two to five prior lines of systemic therapy achieved an overall response rate of 75% through cycle 7 on day 1 of treatment, with 6% achieving a complete response and 69% achieving a partial response. The median time to first response was 1.8 months. “Patients receiving Rezurock reported significant improvements in cGVHD symptoms, showing that not only did treatment result in organ responses, but it also made people feel better. This is so important for a chronic disease with a high symptom burden,” Stephanie Lee, MD, MPH, a professor at the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine, in Seattle, said in a Kadmon Holdings press release announcing the approval (bit.ly/3qyeH1m).

Other notable approvals include two ileal bile acid transporter inhibitors: odevixibat (Bylvay, Albireo Pharma) and maralixibat (Livmarli, Mirum). Odevixibat is indicated for the once-daily oral treatment of pruritus associated with progressive familial intrahepatic cholestasis patients 3 months of age and older. Maralixibat is approved for cholestatic pruritus caused by Alagille syndrome. Pegcetacoplan (Empaveli, Apellis Pharmaceuticals) is the first C3 complement inhibitor used to treat paroxysmal nocturnal hemoglobinuria, a rare life-threatening blood disorder affecting about 6,000 patients in the United States. The approval of pegcetacoplan is based on results from the head-to-head phase 3 PEGASUS study, which demonstrated superiority to eculizumab (Soliris, Alexion) for the change from baseline in hemoglobin level at week 16, with an adjusted mean increase of 3.84 g/dL of hemoglobin (P<0.0001). Eighty-five percent of pegcetacoplan patients were transfusion-free over 16 weeks versus 15% of those treated with eculizumab (Solirus, Alexion). Aducanumab (Aduhelm, Biogen/ Eisai), an amyloid beta–directed antibody indicated to treat Alzheimer’s disease, was probably one of the most controversial approvals (https://bit. ly/3bWL3du-PPN). “The results of clinical trials are mixed,” Dr. Tharaldson said. “Two phase 3 trials were actually stopped early because they didn’t look like they’re going to be effective. But a reanalysis of one of the studies found that those treated longer term with a higher dose responded to therapy.” Avalglucosidase alfa-ngpt (Nexviazyme, Sanofi Genzyme) is an acid alphaglucosidase (GAA) enzyme replacement therapy for people 12 months of age and older with Pompe disease, which is caused by a genetic deficiency or dysfunction of the lysosomal enzyme GAA, which results in a buildup of glycogen in muscle cells throughout the body. The accumulation of glycogen leads to irreversible damage to the muscles, including the diaphragm that supports respiratory function and skeletal muscles that affect mobility, functional endurance and breathing. About 3,500 people suffer from Pompe disease. Avalglucosidase alfa-ngpt is an enzyme replacement therapy that targets the mannose-6-phosphate receptor, which ameliorates cellular enzyme uptake and enhances glycogen clearance, improving respiratory function and walking distance. —Marie Rosenthal Dr. Tharaldson reported no relevant financial disclosures. In addition to her presentation at AMCP Nexus, company and FDA press materials were used to develop this article. This is not a comprehensive list of all specialty drugs approved in 2021.

Specialty Pharmacy Continuum • November/December 2021

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Specialty Pharmacy Continuum • November/December 2021

POLICY

Access to affordable medications a key focus

340B Program, PAPs Help Ensure SP Rx Success Actively managing participation in the federal 340B Drug Pricing Program, coupled with efforts to boost financial assistance stance and medication access, can help maximize savings and ensure nsure the overall success of specialty pharmacy services, a panel el of experts said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually. For example, when the FDA approved the pediatric cystic fibrosis medication elexacaftor-tezacaftor-ivacaftor (Trikafta, Vertex) in June, the specialty pharmacy team at Atrium Health Wake Forest Baptist, in Winston-Salem, N.C., worked with eligible patients and their families to ensure they were completing necessary lab tests and education counseling during clinic visits leading up to the approval so patients would be ready, said Regina Schomberg, PharmD, BCPS, the system director of pharmacy, retail and specialty pharmacy services. With the help of a medication access specialist, they were able to obtain prior approval for 19 patients within one week of the FDA approval, and all patients were able to have their prescriptions sent either to the hospital’s internal specialty pharmacy or another specialty pharmacy within the first week. They also were able to use 340B savings to support pharmacy staff to continue providing personalized care to this vulnerable population. Solid organ transplant patients also o can benefit from ongoing specialty pharmacy care and 340B funding.. “Financial assistance continues to bee

the largest barrier these patients ti t experience,” Dr. Schomberg said. ‘You can imagine the severity of a patient being overwhelmed with the desire to continue with their newly transplanted organ, and then also have to grapple with the need for finance assistance.” During a patient outreach call, one of her pharmacy technicians discovered that a patient had lost their job two months before, was at risk for losing insurance coverage, and had been paying out of pocket for the medication. The patient shared they were a few days from being out of medication and didn’t have the funds to pay for the new script. The pharmacy technician found a patient assistance program (PAP) and contacted the manufacturer for approval within a few days. Year to date, Dr. Schomberg and her colleagues’s work on PAPs has garnered millions of dollars of medication savings. They also use a computerized system that allows searching for

340B Market Forces 340

PAP, foundation or grant funding, and they keep track of the paperwork to assist patients. Their efforts to maximize 340B savings also have paid off. But Dr. Schomberg stressed that the program doesn’t just benefit patients; at her institution, 340B savings also are invested in staff, including two designated medication access specialists fully devoted to PAPs.

UC Davis Approach The UC Davis Health System in California also established specialty services to help solid organ transplant patients with medication access needs, said David Mitchell, PharmD, MBA, the health system’s pharmacist manager of specialty pharmacy operations. Dr. Mitchell’s team used 340B savings to hire and train staff to perform tasks such as billing Medicare B for immunosuppressants, supporting the prior authorization process and obtaining financial assistance when needed. They also established a medsto provide preto-beds delivery system sys patients before discharge. scriptions to patien Technicians also als call patients every month m nth to eensure they continue mo on therapy. o therap But those 340B savings don’t do d on magically appear, Dr. D Dr r Mitchell stressed. His specialty pharH macy has clinical m pharmacists embedp ded in clinics who make that sure tha haat orders for specialty medications me ediicati cati ca tiion ons sent to the internal on specialty pharmacy are eligible for specia iaalltty ph p harrm 340B ssavings. avviin nggss. They They Th e also are responsible for ensuring that orders patients choose to have filled at external pharmacies—or that payors mandate be sent to a specialty pharmacy—still remain in the health system’s contract pharmacy network. Clinical pharmacists also guarantee that orders are eligible for 340B savings by ensuring patients are seen within a specified time frame. It not only makes for great patient care, Dr. Mitchell said, but guarantees that patient orders are issued from a qualified encounter. He said pharmacy staff perform additional activities to optimize 340B savings, such as checking 340B

o understand the need for maximizing 340B savings, it’s m al also important to understand tthe h overall market pressures that health system–based specialty pharmacies are facing, specia noted Allison Bystriansky, MBA, a regio regional account director for Acentrus Specialty. It is expected that specialty prescription revenues will represent almost half of total prescription drug revenue by 2025, she said, citing statistics from the 2021 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers released by the Drug Channels Institute (bit. ly/2Z3flbR). In rankings from that report, she said, the top four specialty pharmacy companies, including CVS Specialty and Accredo/ Freedom Fertility, now capture 75% of the market, leaving the remaining 25% to other players such as healthsystem specialty pharmacies. With many payors engaging in vertical integration arrangements with commercial specialty pharmacies, health system–based specialty pharmacies are grappling with a number of challenges, including access to payor networks and limited distribution drugs as well as payor and pharmacy benefit manager mandates to use alternate sites of care and specialty pharmacies owned by the payors and PBMs, Ms. Bystriansky said. However, it is a strongly held belief among health systems and supported by the real-world examples (see main article) that health-system specialty pharmacies provide tangible value and better outcomes for patients that cannot be matched by commercial specialty pharmacies. Studies underway and soon to be published are focused on substantiating this claim. This includes a trend toward better patient outcomes through established relationships with providers and patients; access to electronic health records; faster therapy start times and less abandonment. —K.B.

accumulations before placing orders to maximize orders through the 340B account and minimize orders from the wholesale acquisition cost account. The 340B team also reviews orders that are not automatically qualified and manually qualifies them if initially rejected, if they meet certain criteria. —Karen Blum The sources reported no relevant financial disclosures.

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Corporate Profiles

2022 Acute Care Pharmaceuticals Amneal Associates of Cape Cod, Inc. Brightree Business Management Software for Pharmacy Central Admixture Pharmacy Services, Inc. (CAPS©) Contec© Healthcare Equashield International Medical Industries, Inc. Medi-Dose/EPS Visante

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

Acute Care Pharmaceuticals The nation’s leader in USP <797> and <800> compliant supplies specifically designed for your advanced health care environment

AT A GLANCE 12195 Dearborn Place Poway, CA 92064 Phone: (888) 909-7700 Fax: (858) 675-9380 Info@acutecareonline.com www.Pharma-Choice.com

Acute Care Pharmaceuticals has been servicing the health care industry for more than 20 years, delivering exceptional products and services to health care providers nationwide. We offer a wide range of USP Chapter <797> and <800> compliant disposPRODUCT LINE able products that are manufactured under • Pharma-Choice™ Brand the highest standards. With numerous group • Full line of USP <797> and <800> purchasing organization (GPO) and integratCompliant Supplies ed delivery network (IDN) contracts, our goal is to make your buying experience simple and easy. Our Pharma-Choice™ brand of products is stocked at AmerisourceBergen, Cardinal, McKesson and Medline, where you can receive your special discounted GPO contract pricing.

• Pharma-Choice™ Isolation Gown, Polypropylene, Knit Cuffs, Waist/Neck Ties, Yellow, Level 1 • Pharma-Choice™ Isolation Gown, Polypropylene/PE Laminated, Knit Cuffs, Waist/Neck Ties, Blue, Level 2 • Pharma-Choice™ Isolation Gown, Polypropylene, Knit Cuffs, Waist/Neck Ties, Yellow, Level 1

Stay tuned for more details about Acute Care Pharmaceuticals’ integration into Hospeco Brands Group. Customers will have an expanded breadth of lines in the Hospeco Signature Bundle of essential products.

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

• Pharma-Choice™ Isolation Gown, Polypropylene/PE Laminated, Knit Cuffs, Waist/Neck Ties, Blue, Level 2 • PHARMA-COAT™ Lab Coat Polypropylene Elastic Wrist, No Pockets, White • PHARMA-COAT KNIT WRIST™ Lab Coat Polypropylene Knit Wrists, No Pockets, White • PHARMA-CAP™ Polypropylene Bouffant Cap, White or Blue • PHARMA-SHOE COVERS™ Polypropylene Anti-Skid, Blue

PHARMA-CHOICE BRAND OF PRODUCTS INCLUDES:

GPO/IDN CONTRACTS

• PHARMA-SAT PLUS™ 70% IPA Polyester/Cellulose Low Endotoxin (Sterile and Non-Sterile) • PHARMA-SAT CANISTER™ 70% IPA Non-Sterile Polyester/ Cellulose • PHARMA-SAT PLUS™ 70% IPA, Poly/Cell, Low Endotoxin • PHARMA-WIPE™ Polyester/Cellulose (Sterile and Non-Sterile) • PHARMA-WIPE PLUS™ Non-Sterile Polyester/Cellulose, Low Endotoxin • PHARMA-POLYESTER WIPE™ 100% Polyester • PHARMA-HOL™ Sterile 70/30 Isopropanol/USP WFI (16 oz, 32 oz and gallons) • PHARMA-D SURFACE DISINFECTANT™ Sterile Quat, Virucide, Fungicide • PHARMA-SURFACE GUARD™ Chemo Spill Wiper + Neutralizing Wiper, 2-Step Kit • PHARMA-MOP COVERS™ Polyester Universal Mopping System • PHARMA-MINI MOP COVERS™ Polyester and Poly/Cell • PHARMA-SAT MOP COVERS™ 70% IPA/30% DI Pre-Saturated Poly Covers • PHARMA-TACKY MAT + FRAME™ Mat removes up to 99% of footborne contaminants • PHARMA-CHEMO MAT™ Sterile Non-Linting, Absorbent Mat with Impervious Poly Backing • PHARMA-GLOVE™ Sterile Nitrile 12”, Chemo Approved-ASTM Tested, PF • PHARMA-GLOVE CR™ Nitrile 12” Glove, Chemo Approved

• • • • • • • • • • • •

Corporate Profiles 2022

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

MARKETS SERVED • • • • • • • • •

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

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Amneal Amneal is a U.S.-based, integrated pharmaceutical company headquartered in Bridgewater, N.J. Founded nearly 20 years ago, the company now ranks among the leading providers of affordable generic and innovative specialty medicines for the United States. Amneal markets a portfolio of more than 250 generic products in nearly every dosage form and therapeutic category, and a selection of branded pharmaceutical products focused primarily on central nervous system disorders, hypothyroidism and parasitic infections. Amneal operates five manufacturing facilities in the United States as well as six abroad. A dedicated packaging plant in New Jersey and extensive distribution centers in Glasgow, Ky., round out its commercial operations.

liquids, topicals, inhalants and transdermals, along with the aforementioned injectables. A growing biosimilars program, which includes three filed products, further enhances the value of Amneal’s pipeline.

Customer Focus

AT A GLANCE 400 Crossing Blvd. Bridgewater, NJ 08807 (866) 525-7270 sales@amneal.com www.amneal.com

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

CGMP Facilities Of the company’s 11 manufacturing sites, two are dedicated to sterile products. Both are fully integrated with manufacturing and packaging in-house. Amneal is proud to report that the most recent FDA inspections of its parenteral facilities yielded no FDA Form 483s. For many years, Amneal’s family of plants have built and maintained a solid reputation for successful inspections.

Broadening Portfolio For the past few years, Amneal has enhanced its generic business by focusing on more complex formulations, broadening its portfolio of injectable medications and investing in biosimilar development. Amneal ranks among the top five U.S. generics manufacturers based on the total number of prescriptions, and, with its solid pipeline, looks to remain firmly in that elite tier. Of the abbreviated New Drug Applications that Amneal has filed with the FDA, 20% are injection dosage form. Injectables also represent nearly 50% of the company’s development pipeline. To meet the expected production requirements of its growing institutional business, Amneal expanded its parenteral facility in 2020 with the addition of a new ophthalmic line and an upgrade to a vial line. In the first three quarters of 2021, Amneal launched 14 new generic prescription products, plus five line extensions and an over-thecounter topical. Among those are generic TobraDex® (dexamethasone-tobramycin ophthalmic suspension 0.3%/0.1%), the generic for Trisenox® (arsenic trioxide, Teva) injection, generic Jadenu® Sprinkle (deferasirox, Novartis) granules and generic Decadron® (dexamethasone, Pragma) tablets.

In-house Expertise

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

Unlike many of its competitors, Amneal holds in-house expertise in both complex product development and manufacturing, which reduces its reliance on third parties and delivers better economics on high-value products. Amneal’s development capabilities span nearly all dosage forms, including complex oral solids, ophthalmics,

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Corporate Profiles 2022

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

Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1Æ3)-ß-D-glucan detection products and services for nearly 50 years. ACC pioneered limulus amebocyte lysate (LAL) testing methodology and was the first FDA-licensed company to manufacture LAL reagents. ACC has grown to be an internationally recognized leader in endotoxin detection.

Earlier this year, we were very excited to introduce another first when we launched the first and only commercially available sustainable bacterial endotoxin testing (BET) recombinant cascade reagent, PyroSmart NextGen™. PyroSmart NextGen™ is completely free of horseshoe crab blood,

and, unlike first-generation recombinant factor C (rFC) BET reagents, PyroSmart NextGen™ is the only one that uses the same LAL cascade as traditional LAL reagents, while eliminating the potential for (1Æ3)ß-D-glucans. This eliminates the need to change test methods and purchase new specialized instrumentation as required by first-generation rFC reagents. Simply put: same instrument, same preparation steps, same method. Keep your method. Make an impact! Our worldwide headquarters is located in East Falmouth, Mass. With a dedication to quality, ACC is certified to I.S. EN ISO 13485:2016 and ISO 13485:2016. The company is FDA inspected and operates Drug Enforcement Administration (DEA)-licensed and Clinical Laboratory

Corporate Profiles 2022

Improvement Amendments (CLIA)-certified laboratories. Our endotoxin detection reagents, instruments and software are used within the pharmaceutical, medical device, biotechnology, compounding pharmacy and dialysis industries for quality control, product release and research. Our reagents are FDA licensed and can be used for testing in compliance with USP, European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) BET chapters, and our software is compliant with 21 CFR Part 11. ACC also operates a Contract Test Services (CTS) laboratory that has specialized in testing for endotoxin and glucan contamination for more than 40 years. Our CTS laboratory is compliant with Current Good Manufacturing Practices, ISO registered and DEA licensed, and capable of handling all controlled drug substances except those included in Schedule I. All testing services can be performed within the FDA, USP, EP and/or JP regulatory guidelines. In addition to routine testing, our CTS laboratory will customize endotoxin testing, troubleshoot difficult samples, develop and/or

transfer LAL test methods, design and produce custom depyrogenation controls for oven validation, and perform low endotoxin recovery studies/protocols. ACC also offers a clinical diagnostic product line–Fungitell®—and operates a CLIA-certified laboratory specializing in ((1Æ3)-ß-Dglucan analysis to support the diagnosis of invasive fungal disease.

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Brightree Business Management Software for Pharmacy Improve pharmacy compliance. Get paid faster. Increase productivity. At Brightree, we continually invest in new and innovative tools for post-acute providers, and pharmacy is a big part of that investment. We give pharmacists state-of-the-art tools to reduce the complexities and costs associated with managing compounded and non-compounded medications, equipment and supplies. Built on the industry’s most trusted billing and business management platform, Brightree pharmacy solution allows you to communicate with prescribers, file and find documents, and clinically monitor patients. In addition, our single, cloud-based platform offers an integrated, robust document management solution so you can scan and automatically file faxed referrals, prescriptions and other necessary documentation. Ready for the power of patient safety, efficiency, and getting paid when and what you’re due? Then you’re ready for business management software for pharmacy. We spend 100% of our time focused on out-of-hospital care, including significant investments in innovative tools to receive, fill and renew prescriptions, all while reducing errors and improving patient safety. • Patient Hub app or Citus Health integration automates patient engagement. • ePrescribe eliminates manual processes and associated errors and interfaces with Epic, Cerner, athenahealth® and SureScripts®. • Mobile Delivery eliminates lost paperwork, capturing patient signatures on mobile devices and collecting patient copays at the point of delivery.

AT A GLANCE 125 Technology Parkway Peachtree Corners, GA 30092 Phone: (888) 598-7797 Local: (678) 243-1800 Fax: (678) 775-7294 support@brightree.com www.brightree.com

• ePurchasing connects you directly with leading manufacturers, like AmerisourceBergen and McKesson Medical-Surgical, to electronically submit purchase orders and streamline your overall purchasing operations. • Brightree Business Management Software seamlessly integrates with Brightree 340B Reporter, RelayHealth Connection, and Baxter and B. Braun total parenteral nutrition (TPN) compounders.

Better Way, Better Results Whether you’re a pharmacist, nurse or biller, we offer a solution that allows you to streamline workflows, analyze data and improve results for your home infusion, ambulatory infusion and pharmacy patients. We back it up with tailored implementation and real-time support to ensure your success. From stress-free prescription filling for everything from test strips, specialty injectables, large-volume hydrations and TPN formulations, to automatic clinical alerts, oneclick printing for labels and prescription documentation, we simplify your complex job. Furthermore, with progress notes, medical history, access devices and care plans that are all easily accessible and TPN compounders already integrated, you’re able to get medications into the hands of all your patients quickly and reliably while easily monitoring your own profitability.

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Corporate Profiles 2022

Central Admixture Pharmacy Services, Inc. (CAPS®) Who we are. What we believe.

AT A GLANCE 6430 Oak Canyon, Suite 200 Irvine, CA 92618 (800) 853-6498 www.CAPSpharmacy.com

We are the nation’s largest network of outsourcing admixture pharmacies. With 22 regional 503A pharmacies and three 503B-registered outsourcing facilities, CAPS offers the convenience of both batch compounding and customized compounding for customers nationwide.

We Are Growing to Support Our Customers • While others have exited the drug compounding business, CAPS is expanding its product portfolio to help meet our customers’ needs for high-quality, safe and readily available compounded medicines. • Our ability to supply new products is supported by CAPS’ recently completed 250,000-square-foot 503B outsourcing facility in Phoenix, as well as continuing investments at our 503B facilities in Pennsylvania’s Lehigh Valley and San Diego.

Our Commitment to Quality and Safety Has Never Been More Important • CAPS has established a legacy of safety by providing hospitals and their patients with the highest-quality compounded therapies. • Our Test, Hold and Release (THR®) quality assurance program put us at the forefront of addressing patient safety. • We perform 100% batch level testing on every batch that comes from our 503B outsourcing facilities, and each distributed batch is accompanied by a Certificate of Release.

We Advocate for Strong Regulations To Protect Patients • We believe the FDA’s policy for 503B outsourcing facilities to only compound from FDA-approved, commercially available products is essential to ensuring the safe supply of compounded drugs.

• As the market leader in customized parenteral nutrition (PN) delivery, we offer PN Clinical Training Services to help you deliver patient-specific solutions. • We are committed to providing customers with programs and services that help them focus on standardization and improving patient care. • Pharmacists perform a PN double check and identify interventions to catch and correct medication errors.

When It Comes to 503A And 503B Services, Our Customers Speak Volumes

‘Being a CAPS customer enables my hospital to provide quality parenteral nutrition to our patients and allows our pharmacists to devote more of their time, skills and resources to providing other patient-specific intravenous medications. It eases the burden of continued drug shortages related to parenteral nutrition solutions.’ —M. Petrea Cober, PharmD, BCNSP Clinical Coordinator–NICU Akron Children’s Hospital Join Us • Learn more about our services, the expansion of our product portfolio and our advocacy for patient safety. • Call us or visit our website for additional information: (800) 853-6498; www.CAPSpharmacy.com

‘Patient safety and well-being have always been our highest priority—one that is shared by the hospitals we partner with. We will continue supporting policies and practices to ensure that compounded therapies are prepared to the highest standards of patient safety.’ —Tom Wilverding President, CAPS We’re Here to Help • Our experts at CAPS Consulting help hospitals, home infusion pharmacies and surgery centers navigate through the complex and changing compounding regulatory environment.

Corporate Profiles 2022

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Contec® Healthcare Contec, Inc. and its multiple business units, including Contec Healthcare, is a leading manufacturer of contamination control products for cleaning, disinfecting and decontaminating critical environments worldwide. Based in Spartanburg, S.C., Contec is dedicated to understanding and addressing the unique needs found in today’s pharmacy environment. Our products, many of which are made in the United States, include sterile alcohol, presaturated and dry cleanroom wipes, mopping systems, and disinfectants. Our ISO 9001 registration ensures customers consistent quality products from development to delivery.

Knowledgeable Representatives With more than 100 combined years of experience in supporting critical environments, our technical and sales representatives are great resources when reviewing facility protocols and the best products to meet these critical needs. Contec has developed industryleading procedures that will help you maintain a state of control.

Contec’s technical and sales representatives can help you select the correct products for your protocol.

The Contec Commitment We commit to: • Treating you as a partner first and a customer second; helping you in ways that best meet your changing needs and challenges. • Supporting those serving on the front lines of life sciences and health care systems. Our team will act with heightened urgency to meet your requirements.

AT A GLANCE P.O. Box 530 Spartanburg, SC 29304 Phone: (864) 503-8333 Toll-Free U.S., Canada, Puerto Rico: (800) 289-5762 Fax: (864) 503-8444 www.contechealthcare.com

On-site Product Training As a benefit to our customers, we assist pharmacies in the development of best practices, training and education, and documentation, all of which are required by USP standards. No one in our shared industry provides a higher level of on-site technical assistance.

Products Tailored to Your Cleanroom Contec has developed a line of products that meet the specific needs of sterile compounding pharmacies. Our cleanroom wipes, mops, disinfectants and personal protective equipment are made to keep you compliant in an ever-changing world of regulations. • Keeping innovation at the forefront of everything we do; continually reinventing and improving ourselves through an unbroken cycle of research, development, testing and feedback. • The never-ending pursuit of enhanced corporate social responsibility, informed by the belief that improving our company, our people and our shared community, deserves our best every single day. • Supporting an environment that respects diverse traditions, heritages and experiences. • Always being driven by our core values, because while profitability is necessary to drive growth, nothing is more important than maintaining our culture.

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Corporate Profiles 2022

Equashield Equashield is a leading provider of stateof-the-art closed-system transfer devices (CSTDs) for the safe handling of hazardous drugs. Dedicated to providing a simple and 2 Harbor Park Drive elegant design that is also unparalleled Port Washington, NY 11050 in safety and ease of use, Equashield has Phone: (516) 684-8200 created a family of products designed to Fax: (516) 684-8202 protect health care workers—primarily Toll-Free: (855) 378-2744 compounding pharmacists and oncology info@equashield.com nurses—from the health risks associated with exposure to hazardous drug residues and vapors when preparing and administering chemotherapy treatments.

AT A GLANCE

Equashield’s product portfolio comprises a wide array of closed syringes and adaptors for accessing vials and IV bags in the pharmacy, as well as a selection of connectors and tubing sets for nursing. It includes the EQUASHIELD® Pro automated compounding system, the first CSTD-enabled compounding robot, providing increased safety and efficiency of pharmacy workers when compounding hazardous drugs.

Equashield’s Closed-System Transfer Device: A Proven Closed System Equashield’s innovative design makes its CSTD the only system to prevent syringe plunger contamination by hazardous drugs, a major route of exposure during routine drug preparations and IV pushes. Unlike standard syringes, an Equashield CSTD can be used safely even beyond nominal capacity as the encapsulated plunger rod can never be detached from the syringe. This feature prevents the potential for spillage. It can also be used for up to 10 connections with the syringe unit without leaks or drug residues on its surfaces and without the risk for transferring environmental contaminants into the vial.

The Equashield system has been cleared by the FDA and is defined in FDA labeling as “Preventing Microbial Ingress for up to 7 Days.” It is also FDA cleared under the ONB code for “Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer Systems.” Equashield complies with the strictest regulatory requirements and passed the National Institute for Occupational Safety and Health “Alcohol Vapor Containment Performance Test.”

Corporate Profiles 2022

EQUASHIELD Pro Automated Pharmacy Compounding System Working in tandem with the Equashield CSTD, the EQUASHIELD Pro—the first CSTD-enabled automated compounding system—is also designed to prevent the escape of hazardous drug vapors and drug residues during the compounding process. The Pro closed-system robot provides an additional layer of protection to pharmacy workers; a high throughput to meet the compounding demands during peak hours; medication error prevention through proprietary dose verification and image processing systems; and a low capital acquisition cost. The Pro was designed to reimagine the automation process safely and efficiently and to operate like a factory line, with eight simultaneous workstations to complete the compounding process. Each station is an effective “expert” in its role and performs its task quickly and efficiently, shortening the length of the entire process. As the Pro utilizes CSTDs, with its syringes and vials all using uniform vial adaptors, it is able to move faster than other robots. This is because the Pro can lift up any sized vial in the same manner and also is able to verify the drug and dosage with visual verification software, as well as efficiently carry it to the next station. The Pro can be used for both high-throughput patient-specific dose preparation and batch compounding. Equipped for both tasks, it can store over 50 syringes and 70 drug vials, allowing it to produce more than 60 individual doses per hour. It also offers medication error control by using verification software for each dose and can detect any bubbles in the syringe, which could result in inaccurate dosing. The Pro’s factory-style lineup is housed in a machine that is comparable in size to standard biological safety cabinets. For more information about Equashield’s award-winning CSTDs and the EQUASHIELD Pro automated compounding system for cytotoxic drugs, and to find out how we can help keep your pharmacy teams safe when compounding hazardous drugs, contact us at info@ equashield.com.

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International Medical Industries, Inc. Innovation in Secure Drug Delivery Devoted to the Needs of the Compounding Pharmacist Founded in 1967 and exclusively devoted to the needs of the compounding pharmacist, creating products for the compounding pharmacist is the sole focus at IMI. As a result, our customers experience the quality, service and value that only a specialized partner can offer. Through our partnerships with compounding professionals, we continue to advance our devices to serve the health care community. From new product developments to customized packaging configurations, IMI’s customer-focused ethos and superior engineering capabilities allow us to be responsive to the needs of our partners and customers. Our capabilities and highly trained teams are the reasons we have remained the industry standard for tamper-evident cap technology and continue to deliver customer-focused products to enhance pharmacy productivity, safety and security. All IMI products are manufactured in the United States at our FDA-registered, ISO 13485–certified facility under the strictest quality standards.

Innovation in Secure Drug Delivery Compounded sterile preparations (CSPs) are at their greatest risk when they leave the custody of your pharmacy. The benefits of tamper-evident products to address this risk have been recognized within the standards and guidelines of multiple influential organizations, including the American Society of Health-System Pharmacists and the FDA. Tamper-evident products increase overall accountability in the chain of custody of mediations, maintain sterility, prevent leakage, ensure patients receive the full intended dose and reduce the risk for contamination. Experts agree that the use of tamper-evident products increases the confidence of pharmacists, health care workers and patients. IMI’s Prep-Lock™ Line of products provides high-value, high-quality, tamper-evident closure devices for a variety of drug delivery containers, including IV, enteral and oral syringes, medication cassettes, and IV bags.

Prep-Lock Tamper-Evident Caps for IV Syringes Hospitals that partner with an outsource compounder may already be familiar with Prep-Lock Tamper-Evident Caps for IV syringes. Over 85% of the top 503B compounding facilities trust IMI Tamper-Evident Caps to secure their preparations. Incorporating these caps for in-house preparations can provide standardization of all syringes throughout the hospital. As a result, clinicians will not need training for administering syringes with multiple tamperevident methods. Tamper-Evident Caps help to ensure the integrity of your compounds by providing a visual indication of tampering, misuse or access. Installation and administration are highly efficient. Each sterile tray of 10 includes a unique keyed feature that allows the pharmacist to install a cap with a simple twist of the syringe, helping to reduce the risk for touch contamination and enhance aseptic technique. To administer, simply pull off the outer sleeve of the tamper-evident cap and unscrew the remaining luer lock cap. Clinicians and pharmacists appreciate not having to deal with sticky tapes or frustrating shrink wrap. Tamper-Evident Caps represent a convenient and comparatively low-cost risk mitigation mechanism for pharmacies and health systems.

AT A GLANCE RFID-tagged products. Tamper-Evident Caps 2981 Gateway Drive with RFID provide a labor-reducing solution Pompano Beach, FL 33069 to incorporating RFID into your drug doses. (800) 344-2884 With a simple twist of a syringe, your CSPs sales@imiweb.com are equipped with renowned tamper-evident www.imiweb.com protection and powerful analytical automation capabilities. These two powerful technologies in combination enhance workflow efficiencies, eliminate time-consuming manual inventory control processes, provide assistance with growing regulatory demand, and supply a comprehensive strategy to prevent, detect and resolve drug diversion events. In addition, by incorporating RFID technology into IMI’s industry-leading Tamper-Evident Caps, facilities can reduce their cost of RFID implementation by up to 55% with little time-to-live and minimal staff investment, procedural changes, or capital investment.

Prep-Lock Tamper-Evident Additive Port Caps The Tamper-Evident Additive Port Cap provides remarkable protection and protocol assurance to the medication ports of Baxter, B. Braun and Fresenius Kabi IV bags. The simple one-handed installation and considerable contributions to the integrity of IV compounds have gained acclaim from pharmacists and health care professionals. “I find their products to be the best on the market in terms of the device itself, the functionality and the securement,” said Neil Colby, RPh, the director of Infusion Pharmacy Services at CDRx Infusion. These products extend the intention of USP General Chapter <797> from pharmacy to patient by providing last-mile security that strengthens pharmacist and health care provider confidence and reduces risk for contamination and diversion.

Prep-Lock Tamper-Evident Caps Featuring RFID Radio-frequency identification (RFID) technology continues to garner adherents in hospital pharmacy systems. The technology enables real-time scanning that optimizes inventory management, efficiency and medication safety while creating quantifiable pharmaceutical supply chain benefits by providing item-level inventory visibility down to the National Drug Code and lot. Recognizing the advantages that RFID technology presents, IMI joined industry consortium DoseID to help increase interoperability, quality and performance of

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Corporate Profiles 2022

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

For more than 50 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit-dose medications. With input from pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and barcode your inventory. Medi-Dose began in 1971, when Milton Braverman, a former pharmaceutical company territory manager, formed his own company. Robert Braverman, president, remembers: “My dad was acutely aware of the requirements of hospital pharmacy. He saw the need for inexpensive, manual unit-dose packaging allowing hospitals to convert from traditional dispensing. He developed systems to package, handle and dispense predetermined amounts of medication so they would be accessible for one regular dose.” Although familiar today, launching the unit-dose packaging was a huge problem the new company faced. “We were one of the pioneers, the innovators promoting unit dose in hospitals,” Mr. Braverman recalled. “Due in part to Medi-Dose’s educational efforts, pharmacists and nurses accepted the validity of unit dose.”

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Specialty Pharmacy Continuum • November/December 2021

POLICY

Copay Consternation continued from page 1

Chris Dowd, the executive vice president for market and product development at ConnectiveRx. The ruling likely will lead many pharmaceutical manufacturers to redesign the way they offer copay assistance to patients, Mr. Dowd noted at the conference. Under the “best price” rule, a valuebased purchasing arrangement policy issued under the Trump administration, CMS requires that pharmaceutical manufacturers provide their drugs to Medicaid at the same costs as those given to commercial purchasers (go. cms.gov/3EjcHNW). Manufacturers pay rebates to state Medicaid programs that are calculated in part based on the manufacturer’s “best price.” Histori-

said Jason Zemcik, the vice president and patient affordability practice lead at TrialCard, a consultancy that offers patient prescription access and affordability services to the life sciences industry (bit.ly/3pHIynB).

CAAPs on the Rise The assumption has been that all the benefits of copay cards go to the consumer. Not necessarily, due to the rise of the so-called “copay accumulator adjustment programs” (CAAPs) adopted by many health plans in recent years. Plans with accumulator policies do not count the value of copays paid via manufacturer coupons toward the patient’s deductible. “At some point over the course of the

‘Accumulator adjustment programs deploy only after a drug has been paid for and dispensed and diverts the assistance that the manufacturer provided to the patient, against the manufacturer’s will and often without its knowledge.’

—PhRMA lawsuit

cally, cost-sharing assistance, such as copay coupons, were not included in the calculations of this best price because that assistance goes directly to patients. But a new CMS policy, issued in December 2020 with an effective date of Jan. 1, 2023, requires pharmaceutical manufacturers to “ensure” the benefit of copay assistance programs goes only to patients to maintain the exclusion from best price reporting. If a coupon’s full value doesn’t accrue to the patient, the pharmaceutical manufacturer must count it as a discount to the drug’s Medicaid price. “This places the burden on the manufacturer of ensuring that the benefits of their program go entirely to the consumer, which is very challenging due to a lack of visibility and control over how insurers account for benefits after claims adjudication,”

year, the patient learns that their copay assistance has run out but they still owe toward their deductible,” said Rachel Klein, the deputy director of the AIDS Institute, in a separate Coupon & Copay Conference session on CAAPs. Furthermore, many people do not have the choice of avoiding plans with these policies. The AIDS Institute conducted a review of all individual plans in the marketplace in 2020, and found that in 14 states, every plan had a CAAP; in 32 states, at least two-thirds of plans had CAAPs (Figure) (bit.ly/3bdfSKJ). “We don’t have the same access to information about employer-sponsored health plans that we have for individual market plans, but there is reason to believe that CAAPs have increasingly been adopted by those plans as well,” Ms. Klein said.

To complicate matters, there is very little transparency. In seven states, none of the plans made information about CAAPs available online. In May 2020, CMS finalized a Notice of Benefit and Payment Parameters for 2021, that expressly permits CAAPs. In addition, under the December 2020 CMS rule, in that scenario, copay coupons are considered a price concession to someone other than the consumer, since they lower the health plan’s cost for the drug—requiring the full coupon value to be factored into the Medicaid discounts given by the manufacturer. The Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against the new policy in May 2021. In the lawsuit against the Department of Health and Human Services, filed in the U.S. District Court for the District of Columbia, PhRMA argued that the rule directly contradicts the best price text in the Medicaid rebate program’s statute. “Manufacturer assistance to patients is not part of the ‘price’ available from the manufacturer to any best-price-eligible purchaser, with or without an accumulator adjustment program,” the lawsuit stated. “Accumulator adjustment programs deploy only after a drug has been paid for and dispensed and diverts the assistance that the manufacturer provided to the patient, against the manufacturer’s will and often without its knowledge.” Asked to comment on the various concerns raised by these policy decisions, a CMS spokesperson replied, “the agency does not speculate on future rulemaking. We encourage you to monitor the Federal Register for the 2023 Notice of Benefit and Payment Parameters, which should be released soon.”

The Next Move Manufacturers cannot wait to see if the lawsuit is successful to decide how they’re going to proceed, Mr. Zemcik said. “It will reach a point where you will have to make a determination: Are we going to change our program to be compliant, and if so, how?” he noted. “You don’t just turn a switch at the first of the year in 2023. It’s going to take a year or so to make your operational changes, so you can’t wait out the lawsuit and hope that PhRMA is successful and the whole thing goes away.” To date, Mr. Zemcik said, none of Trialcard’s client manufacturers have made defined, specific moves aimed at addressing the impact of the new policy. “It’s largely been operational information gathering, legal assessment and financial forecasting. Nobody has made a committed move in any direction yet.” Although the sting of accumulator policies can be mitigated for most patients by using alternate reimbursement methods outside the pharmacy claim, the lack of uniform requirements for health plans to disclose their accumulator policies

means this is impossible to do in all cases, Mr. Zemcik said. He added that “the ‘ensure’ standard set forth by the new rule indicates that all patients must be shielded from accumulator impact. Program reimbursement must be delivered in a way that enables the manufacturer to confidently know that the patient was the only beneficiary.” There are ways to solve this problem, but “for the patient, there are no good solutions,” he said. “No matter which way you go, it’s going to be more complicated from the patient’s perspective.” Among the possible ways manufacturers could approach the best price rule/accumulator conundrum are the following: • Reduce the offer benefit by lowering the offer value to an amount that avoids best price impact. “This has the upside of no change to the patient experience or program operations, but the downside of increased patient attrition due to lower benefits,” Mr. Zemcik said. • Offer direct-to-patient rebates. In this scenario, the patient pays for the copay out of pocket and then submits a receipt to the manufacturer to be reimbursed. “The manufacturer could offer multiple payment methods to meet patient preferences,” he said. “This requires controls to manage increased risk, and not all patients will be able to pay up front, so further risk will be involved if you are advancing funds.” Mr. Zemcik predicted that manufacturers likely will choose a combination of these approaches. Most programs have a significant cohort of patients who use far less than the annual benefit maximum, he noted. A manufacturer could reduce the copay card benefit to an amount that does not incur additional best price exposure, but would still support many patients. “Patients requiring additional benefits could pay out of pocket and then submit a receipt to receive reimbursement up to the program’s maximum, and those who cannot pay out of pocket could either be advanced funds or transitioned into patient assistance programs, depending on the manufacturer’s risk tolerance,” he said. “There is no single best solution. It will depend on the economics of your brand and how your program is set up. But the patient messaging is key: You have to prepare them for changes to their copay experience.” —Gina Shaw Ms. Klein reported that the AIDS Institute accepts funding from pharmaceutical industry sources, but the funders do not determine policy positions and the institute remains an independent voice on behalf of patients. Mr. Zemcik reported no relevant financial disclosures.

For more details on coupons and copays, see page 28.

Specialty Pharmacy Continuum • November/December 2021

POLICY

Copay Use Continues to Increase Amid Pandemic The use of manufacturer copay coupon programs continued to grow during 2020 and into 2021 amid the COVID-19 pandemic, with adoption rates as high as 80% for certain high-cost specialty medications, according to new data presented at Informa Connect’s 2021 annual Coupon & Copay Forum. “Last year, patients’ out-of-pocket exposure on prescription drugs totaled approximately $91 billion, with copay coupons offsetting $14 billion of that for a total net exposure of $77 billion,” said Chris Dowd, the executive vice president for market and product development with ConnectiveRx, citing data adapted from IQVIA’s “Use of Medicines in the United States” report issued in May 2021 (bit.ly/2ZxGxPV). Providers say these coupons are important to their patients’ care. In a September 2021 survey of more than 1,000 health care professionals in the Physicians’ Desk Reference network, which is now part of ConnectiveRx, more than 70% either “agreed” or “strongly agreed” that copay coupons encourage patients to stay on their medications. A similar percentage agreed that copay programs help them prescribe when managed care is restrictive. The perception that copay programs encourage adherence is growing, Mr. Dowd said, citing two ConnectiveRx surveys conducted in 2019 and 2020. In the copay affordability survey of 310 prescribers conducted in October 2019, 65% agreed or strongly agreed that copay coupons boost adherence; in a larger survey of 1,049 prescribers on the impact of COVID-19 on prescribing, conducted in September 2021, 70% agreed. “Physicians see these programs as going well, and they are encouraging their patients to use them,” Mr. Dowd said. Overall, about 14% of commercial claims for branded medications involve the use of copay coupons, he noted, but it varies widely by disease state. In immunology, about 80% of claims involved coupons; in multiple sclerosis, 50%; mental health, 47%; diabetes, 38%; and respiratory, 26%, according to an IQVIA analysis. The use of coupons has helped to keep patients’ actual costs for their medications under control, even as average copays have risen dramatically. “The average copay cost per

claim faced by a patient in January 2021 was 20% higher than in January 2020,” Mr. Dowd said, citing ConnectiveRx data. “That translates into an average copay of about $327 in 2021 versus $88 in January 2013. But copay programs

As of May 2020, copay accumulators are officially permitted by the Department of Health and Human Services, which in its Notice of Benefit and Payment Parameters (NBPP) for 2021 final rule, allowed health plans to implement copay accumulator programs regardless of whether a generic alternative is available. In March 2021, a bipartisan group of 50 members of Congress wrote to President Joe Biden, asking him to reverse the copay accumulator policy decision, which was enacted under the previous administration.

uptick in the mobile channel beginning in December 2020,” Mr. Dowd noted. “Between the COVID-19 pandemic and a broader embrace of mobile claims in general, there has been that steady increase, although web claims continue to have by far the highest share of claim by channel in 2021.” COVID-19 also has had a significant impact on the pharmaceutical sales model, according to a new survey from ConnectiveRx fielded in September 2021. Of companies surveyed, 73% reported that they now encourage vir-

‘We’ve … seen a more recent uptick in the mobile channel beginning in December 2020. Between the COVID-19 pandemic and a broader embrace of mobile claims in general, there has been that steady increase, although web claims continue to have by far the highest share of claim by channel in 2021.’ —Chris Dowd kept the actual out-of-pocket cost to the patient for those branded medications almost unchanged, and that helped keep them on therapy.” With payors continuing to adopt utilization management programs such as prior authorizations, high-tier classifications and formulary exclusion lists, Mr. Dowd said many manufacturers are now allowing claims with such coverage restrictions to be eligible for their copay programs. “This places the pharmaceutical company as the primary payor.”

Accumulator Programs Still an Issue But utilization of copay coupons is threatened by adoption and expansion of copay accumulator programs, a strategy developed by insurance companies and pharmacy benefit managers that stops manufacturer copay assistance coupons from counting toward a patient’s deductible and maximum out-of-pocket spending. “Approximately 80% of commercially insured beneficiaries are in plans where one of these strategies ‘could be’ place,” Mr. Dowd said. put in place,

“During a global pandemic, we should be doing everything we can to increase affordability of prescription drugs, not decrease it, and reversing the 2021 NBPP copay accumulator policy will help people save more money at the pharmacy counter. We seek to ensure that all patients can access their needed medications,” they wrote. Efforts are also underway to curb this strategy at the state level; as of fall 2021, 11 states and Puerto Rico had enacted anti-accumulator laws, with another 15 to 20 considering similar legislation. (For more details, see map on page 27.)

tual physician education detailing, 44% had bought new sales tools for physician education and 27% had reduced their number of representatives. Only 9% said they had not meaningfully changed their sales model. The need to engage with patients digitally is reflected in changes in marketing budgets. In the same survey, 59% of respondents said they had increased their budgets for digital marketing, 57% for patient engagement, 52% for virtual detailing, 48% for prescriber engagement and 20% for telehealth services.

Web-Based Programs

Companies’ top priority remains patient affordability. When asked to identify the patient trends that are most important to their company, survey respondents listed escalation of patients’ out-of-pocket burden, utilization management demand, the “patient as a consumer” and patients’ digital tool adoption as the four top trends. Out-ofpocket escalation represented the area of most concern, ranking first for 39% respondents and second for of survey re followed by utilization manage29%, follow ment, which whic ranked first for 27% of respondents and second for 37%. comes back to the same issue: “It all com out-of-pocket costs and affordability,” out-of-pock Mr. Dowd said. “Are we helping the patient to afford their medications? That’s a top priority for pharmaceutical companies today.” c —Gina Shaw

Another trend in the copay market discussed during the forum involved the growth of web-based claims. For all pharmaceutical brands that use copay cards, such claims made by the consumer have overtaken representativedelivered claims as the channel with the most volume as of early 2018, Mr. Dowd noted. That information is based on ConnectiveRx’s redemption and pharmacy data from Jan. 17 through Sept. 21. “We’ve also seen a more recent

Affordability Still Key

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

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Specialty Pharmacy Continuum • November/December 2021

POLICY

Accepting Biosimilars continued from page 1

AmerisourceBergen/Xcenda. “Will prescribers hesitate using them? Will patients hesitate taking them? Will payors even cover them? When Zarxio [filgrastim-sdnz, Sandoz] was approved in 2015—and at that time it was the only biosimilar product—I remember looking at the different formularies, even a few months after Zarxio’s launch, and many times it wasn’t listed. “Fast forward into 2021, and it’s really a different world when it comes to biosimilars,” Dr. Hydery said. “There are 31 biosimilar products that have been FDA approved, with 20 launches in a variety of therapeutic areas, including supportive care, oncology,

inflammatory diseases, insulin products and ophthalmology products.” “The biosimilar landscape is on the verge of some pretty big changes with the introduction of the pharmacy benefit biosimilars [such as biosimilars of Humira] that are anticipated in the next few years,” added Jennifer Snow, MPH, the vice president of reimbursement and policy insights at AmerisourceBergen/Xcenda. To find out how formularies were managing the changes, AmerisourceBergen/ Xcenda surveyed 51 of its managed care network advisors to see how biosimilars were being encouraged, used and covered among health plans, integrated

US Biosimilar Market Landscape

J&J, Johnson & Johnson. a Not launching in the United States

interchangeable

Adapted from “US Biosimilar Report” by AmerisourceBergen as of Sept. 17, 2021, presented at AMPC Nexus 2021.

delivery networks (IDNs) and pharmacy benefit managers (PBMs). All of the people surveyed were on the Pharmacy and Therapeutics committees for that organization, whether as a voting member, chair or medical advisor, Ms. Snow explained. About three-fourths of the respondents were pharmacy directors, and the rest were medical directors. All of them were involved with medical and pharmacy policy decisions.

Don’t Underestimate Cost Of survey participants, 35% cover all of the available biosimilars and 65% said they cover some products. Most respondents said they saw cost savings after putting them on their formularies. “Across the board, payors are seeing meaningful cost savings coming from biosimilars,” Ms. Snow said. In fact, 59%

said “biosimilars provide meaningful cost-savings” to the organization; 35% said they somewhat agree, and only 6% did not think using biosimilars resulted in meaningful cost savings. Ms. Snow questioned whether the 6% had an unreasonable expectation about how much money could be saved by using biosimilars instead of the reference products, thinking the savings would be like those seen from traditional generic medications, instead of the 20% to 30% that typically accrues from biosimilars. “We were never going to see the small-molecule savings,” she said, adding that a 20% to 30% discount—which still would be a considerable amount compared with the cost of the reference product—was “reasonable to expect.” It would probably come as no surprise that price and cost were primary drivers affecting decisions about designating a preferred product, Ms. Snow said. Lower price was listed by 94% as the primary influencer, followed by contracting arrangement at 75%, therapeutic area at 49%, number of indications a biosimilar has versus the reference product at 39%, physician demand at 24%, and time the biosimilar has been on the market at 22%. Patient demand amounted to only 4%. “Two things I find really interesting [about these rankings] are the number of indications approved for the reference products being a decision point for 39%, and then also, physician demand at 24%,” said Ms. Snow, who noted that she wrote an unpublished client report in 2007 about biosimilars, which found that physician acceptance of biosimilars was a serious consideration for payors. “Here we have it, that notion of physician demand starting to drive that preference,” she said. Negotiating contracts is an important issue. “Most carriers are doing some contracting for biosimilars. You have about 15% saying they don’t, and about 85% doing it for some. Most are not doing it for all biosimilars. They’re picking and choosing,” Ms. Snow said, adding that 10% contract with biosimilar see BIOSIMILARS, page 32

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Specialty Pharmacy Continuum • November/December 2021

POLICY

BIOSIMILARS

‘We know that long gone are the days of when FDA approval [of a biosimilar] means you have a marketed product. But that time frame is continuing to shrink.’

continued from page 30

manufacturers for all biosimilars; 75% for selected biosimilars; 14% are considering doing so; and 2% are not considering and do not plan to contract with manufacturers.

Preferred Product Class Can Be a Powerful Tool One of the best ways to encourage use and control costs is by making the biosimilars preferred products. However, just because you lead a physician to a preferred product does not mean they will prescribe it. So, how do you get them to at

—Cate Lockhart, PharmD, PhD was a good bit of buzz about finally having interchangeable biosimilars throughout the AMCP meeting and discussion about using a biosimilar off-label—that is, prescribing it for an indication that the reference product has but the biosimilar does not. An interchangeable biosimilar has all the indications of the reference product

takes it for granted that a patient who already is on treatment should stay on that treatment because it works for them,” she said.

Cost a Major Consideration Many factors drive biosimilar adoption, the survey found, from saving

reference product and still be safe and effective. Dr. Hydery said she understood that point of view, which she attributed at least in part to the increasing complexity of the biosimilars market. “We have products across a variety of specialties, and that means we now have more prescribers and more patients to educate,” she said. “There’s also more competition among the biosimilars themselves. It’s not just one reference product versus one biosimilar.” Although the uptake of biosimilars in the United States has been slow, use and its associated monetary benefits are on the upswing, added Cate Lockhart, PharmD, PhD, the executive

Biosimilar Coverage Decisions The coveragea of biosimilar over reference products: Preferred

On Par

14%

53%

Nonpreferred

33%

Based on a database of 535 coverage decisions, regarding nine available biosimilars, at 17 of the largest commercial health plans in the United States. Adapted from JAMA 2020;323(19):1972-1973.

least consider the biosimilar? The respondents found several ways: 92% require prior authorization; 73% use step edit requirements, which require a patient to fail therapy on a lower-cost product first; 55% use tiering; 45% require patient cost sharing; 33% limit quantities; and 22% have diagnostic limitations. “I don’t think it was surprising that prior authorizations were the primary utilization management tool. Cost sharing is up there. But I would combine that idea of tiering and cost sharing,” Ms. Snow said. “I was a little sad to see that the step edits ... were so high, especially when it came to the physician-administered drugs, because that gatekeeper’s already there. I would expect that we will see these trends continue when it came to the pharmacy benefit side.”

Prescribing Considerations There are only two interchangeable biosimilars approved—insulin glargine-yfgn (Semglee, Mylan), a biosimilar to Lantus and adalimumab-adbm (Cyltezo, Boehringer Ingelheim) a biosimilar to Humira (AbbVie), which is not yet available. There

and can be changed by the pharmacist rather than requiring prescriber authorization, just as a small-molecule generic can be switched. Ms. Snow said she was surprised by the number of organizations that would consider an off-label use for a biosimilar. Of the organizations, 55% said they would cover the biosimilar for the same indications as the reference product, including both the FDA and the non– FDA-approved indications; 24% said they would cover the biosimilar only for FDAapproved indications, and the reference product only for the remaining indications; 20% said they would cover only the FDA-approved indications; and 2% responded other (unspecified). No one said they would not cover a biosimilar. Almost all the respondents thought biosimilars were safe and effective for treatment for both starting naive patients (96%) and for switching a patient currently on a reference product (92%). Ms. Snow said she was pleased by the latter response. “Maybe I shouldn’t have been surprised, but so much of my work with patient groups and manufacturers

money to regulatory issues, but cost savings was the biggest one; 65% ranked it as a leading factor in the adoption of biosimilars. Interchangeability and increased regulatory clarity about laws such as the ability to substitute a reference product with a biosimilar were second and third. Other issues were scientific clarity about safety and efficacy data, and increased understanding of biosimilars by prescribers, patients and within an organization. When Cyltezo and other biosimilars of Humira—which will come under the pharmacy benefit instead of the medical benefit—start coming onto the market in 2023, there will be much interest in cost savings, Ms. Snow said. Of the survey respondents, 96% said they expect to see cost savings as the primary benefit of having biosimilars be classified as a pharmacy benefit. “So that is something that we will certainly be watching,” she said. Most of the third-party payors said they wanted to see better substitution laws and real-world evidence that the biosimilar can be substituted for the

director of the Biologics and Biosimilars Collective Intelligence Consortium. “There’s a lot of willingness and comfort in using them,” she said. One positive sign is the shortened lag time from approval to launch, which is definitely a plus. “We know that long gone are the days of when FDA approval means you have a marketed product. But that time frame is continuing to shrink,” Dr. Lockhart said. Legal and regulatory hurdles remain that impede biosimilar adoption, and different state laws can cause confusion. “There’s still a lot of work to do to navigate these,” she admitted, “but there’s a lot of hope, too. There’s a lot of people that I think are really invested in doing this because we want patients to get access to these medications.” —Marie Rosenthal The sources reported no relevant financial disclosures.

For 2021 biosimilars approvals, see page 10.

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Specialty Pharmacy Continuum • November/December 2021

OPERATIONS & MANAGEMENT

Managed Care in Flux continued from page 1

trend abating,” Mr. Spencer said, noting these companies likely will continue acquiring more assets and establishing more vertical arrangements to round out their continuum of care. Some are even referring to themselves as providers, he added. When negotiating with these companies, with their deep pockets and broad reach, “it’s important to remember that they have a scale we do not,” he stressed.

Winning Over the Patient These forces have pitted payors and providers in a contest to see who is going to emerge as the patient’s trusted advisor, and it’s not clear how it will play out, Mr. Spencer said. There is more blurring now of traditional provider– payor relationships. He cited telehealth and artificial intelligence as other trends to watch, with the technologies spurring

more interactions between patients and companies delivering or directing care. Providers have an advantage in being the legacy trusted advisory, but payors have an advantage in that they can direct where they will pay for care. The landscape is changing fast, with private equity money to fix the problem of lowering costs of drugs through mailorder companies, said Philip Brummond, PharmD, the chief pharmacy officer for Froedtert Health. Another trend is payors continuing the push to outpatient or home care as a major cost-saver. To compete in these vertically integrated spaces, pharmacy leaders need to leverage their integrated delivery models, with access to electronic medical records and patient data, Dr. Brummond said. How to use those data, how to determine what kind of therapy is needed for which patients, and how to get outcomes that

‘This is an area where partnering with your managed care team is incredibly important. If they’re going out and getting contracts, there’s some opportunity for direct contracting in this space.’ —Philip Brummond, PharmD pharmaceutical manufacturers and others expect are areas that are “incredibly important to spend time on,” he said. Highlight metrics such as the Net Promoter Score and patient testimonials, be wise in what you do versus what you outsource, and work to restore transparency by driving lower costs.

More Challenges Such strategies can help health-systems navigate the intricacies of the managed care market. But they still face a number of challenges, Dr. Brummond said. The COVID-19 pandemic created an environment of uncertainty and, at times, has

resulted in financial declines for health systems. Payment reforms continue to stress health systems, with a shift in the private–public payor mix. What’s more, an emphasis on quality of care requires health systems to achieve decreases in readmissions and length of stay as well as a range of other quality measures that are important for patients and outcomes. Dr. Brummond added that population health requires a shift in practice mentality and care delivery models, such as the rapid adoption of telehealth and virtual care. “We’ve come a long way as far as how we can interact with patients,” he said, but there is a need to become more sophisticated in how to understand data and demonstrate pharmacists’ involvement in caring for patients to demonstrate improved medication adherence and outcomes. Patients’ expectations of care are changing accordingly, especially around how they access care and what care they receive, and there continues to be local competition and increasing costs.

Target Local and Regional Networks

Data Mining and Other Keys to Partnering With PBMs

harmacy benefit managers (PBMs) have developed into powerful negotiators with vast scale and voice, speakers said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually. As such, pharmacy leaders need to work in tandem with their human resources and managed care contracting offices to avoid red flags and set boundaries. In many cases, staff in human resources offices manage the PBM relationship, and they may or may not consult an internal pharmacy expert, said Philip Brummond, PharmD, the chief pharmacy officer at Froedtert Health. Evaluating cost trends is crucial, he said, and pharmacy leaders need access to data from their health plans. If consultants are needed, the benefits and pharmacy teams should collaborate with that person to identify new PBM options. It’s helpful to use a consultant without ties to any particular PBM. It’s key that health-system pharmacy leaders ensure the health system is the boss with vendor partners, he said. Make sure you have seats at the table for vendor meetings, forums and reporting, and understand local and regional prescribing patterns to inform your decision making and program focus. Also guarantee that you have access to both medical and pharmacy data. Use a support team of players such as in-house clinicians and drug information specialists, those with industry knowledge

and expertise, specialty and home infusion services, and analytics support. Dr. Brummond noted five red flags to watch for from PBMs, and how to improve them: 1. Rebate guarantee nullification clauses/attempts to limit control. Include detailed language allowing flexibility on formulary, plan design, utilization management tools (step therapy) and other customization without penalty. 2. Narrow rebate definitions. Include all sources of pharmacy revenue and administrative/data fees (percentage of average wholesale price). 3. Claims re-bucketing. This practice, along with algorithms and exclusions defining what products are brand versus generic versus specialty, create customized core definitions of brand, specialty and generic drugs to prevent pricing charges. Review lists quarterly to guard against guarantee exclusions. 4. Hidden fees. Give yourself flexibility to implement inhouse clinical programs over the life of the contract. 5. Limited termination and auditing fees/rights/access to claims pricing data. Get reasonable out clauses, maximum audit rights and avoid exclusivity language. —Karen Blum

To mitigate risk in the vertically integrated space, health-system specialty pharmacy and home infusion services need to be included in local and regional networks with employers and self-funded plans, he said. “This is an area where partnering with your managed care team is incredibly important,” Dr. Brummond said. “If they’re going out and getting contracts, … there’s some opportunity for direct contracting in this space.” Pharmacy services have to offer an improved patient experience with outcomes to back up their work, and use electronic medical record data to make appropriate therapy decisions. Leaders have to be willing to take risks and move quickly to drive results, he said. Doubling down on strategy, there’s no time better than now to start developing a strategic vision and plan, Dr. Brummond advised. “It’s imperative to have this put together so that as organizational strategic tactics are laid out there, you’re able to incorporate the pharmacy aspects that are critical to the success of the organization within those plans,” he said. Dr. Brummond offered these additional tips: • Get buy-in and support from executive leaders to break down barriers. see IN FLUX, page 38

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Specialty Pharmacy Continuum • November/December 2021

OPERATIONS & MANAGEMENT

DIY, consultants, partnerships among strategies used by hospitals

Many Paths to Specialty Success Summa Health, a hospital system in Akron, Ohio, chose to enter a partnership with Trellis Rx to launch its specialty pharmacy. The University of Illinois Chicago and University of Utah Health each built their own from scratch. Texas Children’s Hospital took a middle approach, using a consultant to help plan and launch, and ran it from there on its own. Regardless of the route, specialty pharmacy is an area many hospitals want to get into to improve the specialty medication experience for their patients and gain revenue they otherwise are outsourcing to commercial entities, said Ernest R. Anderson Jr., RPh, MS, a pharmacy consultant in Brockton, Mass., who also serves as an advisor to Trellis Rx, which helps health systems build specialty pharmacy services. A major decision is whether to take a do-it-yourself approach or hire someone with expertise to help, Mr. Anderson noted. Specialty pharmacy services can play a critical role in furthering a health system’s strategy in today’s health care environment, said Jerry Buller, DPh, the chief pharmacy officer at Trellis Rx. But many health systems misunderstand or underestimate what it takes to launch a specialty pharmacy, he said. “You are effectively starting a new business. This is not just another pharmacy program,” Dr. Buller said. “You will need not only significant time and money but also functional expertise to get this new service line off the ground and scale it. To achieve the clinical and financial results you want, you have to do it right. You have to invest in building a differentiated care model to produce a measurably better experience and results. Otherwise you won’t be able to get patients’ and providers’ buy-in; you won’t be able to collect the data you need; and you ultimately won’t be able to unlock network access.” Allow plenty of time, Mr. Anderson advised. “It’s not like you flip a switch and all of a sudden you have your own specialty pharmacy service. There’s always a ramp-up phase, but a partner or consultant can help you shorten this phase and get results faster. You really have to develop relationships with physicians in your clinics to get them on board.” Additionally, he said, be aware of two major barriers: getting managed care contracts, and gaining access to drugs in limited distribution networks. “Insurance companies often have an exclusive agreement with a commercial specialty pharmacy company, and they have to be convinced to allow a new

player—namely the health system—into that space,” Mr. Anderson said. If pharmacists at the health system don’t have experience in these areas, a partner or consultant can help. As a further aid, Specialty Pharmacy Continuum interviewed pharmacists who took different roads to building specialty pharmacies.

specialty pharmacy services in April 2019, in the oncology clinic, and planned to expand from there. The model was so well received by the executive team and clinicians “that I actually had folks calling me from other clinics wanting to know when we were going to bring

The Partner Model Within months of becoming eligible to participate in the federal 340B drug discount program in 2017, Summa Health’s CEO approached pharmacy leaders about starting an in-house specialty pharmacy service. Since the health system also owned its own health plan, hospital leaders thought this might provide an opportunity to improve the continuity of care while creating a new revenue stream, said John Feucht II, MBA, RPh, the vice president of pharmacy services. ant to get into the specialty pharmacy business? Jerry Buller, DPh, the chief pharmacy After exploring several officer at Trellis Rx, recommended asking these five questions to determine the best path for your health system when going it on your own versus hiring a partner or consultant: options, they moved forward 1. Is specialty pharmacy a core competency for your organization? with Trellis Rx. The compa2. Is your organization able and willing to make the up-front investments required to ny’s model for integrating and build a differentiated service? providing staff under Summa’s 3. How many specialty patients does your health system have who would quality for brand and its ability to ramp specialty pharmacy services? up things quickly made it a 4. How long will it take you to scale? clear choice, Mr. Feucht said. 5. What are the risks if you fail (clinical, financial or experiential)? “It’s probably one of the best Next, if you’re looking for a partner, determine what type of arrangement will best decisions that I’ve ever made support your goals, Mr. Buller said, who suggested five key questions for making that in my career.” determination: Trellis Rx implementation 1. What care model will a partner help you to establish—a remote, call center model experts engaged health system in which pharmacists operate via telephone, away from the clinic? Or an embedded stakeholders, including the model wherein pharmacists work alongside physicians and nurses as part of clinicC-suite, and pharmacy, finance based treatment teams? and IT departments to create 2. How much ownership will the partner give you? launch plans, establish medica3. How much risk will a partner take on? tion ordering and mail-order 4. What measures of success has the partner achieved before in terms of financial and capabilities, and integrate clinical outcomes, patient and provider satisfaction, payor contracting access, and so specialty pharmacy software on, and what will the partner commit to? If the partner has multiple customers, are with Summa’s EHR. Trellis Rx these results consistent? also worked with clinicians to 5. What work and expense are they going to leave or pass on to you? establish workflows and embed Additional factors to consider include the following: pharmacists and liaisons into Real estate. Summa Health’s specialty pharmacy expanded so much that it maxed out care teams to support patients. the retail pharmacy space and will be relocating later this year to a larger space. Scope. Providing specialty pharmacy services to all medical clinics requires a lot of coorToday, Trellis Rx handles all dination and time, and you need to be ready before you open the door. Pick one or two day-to-day operations and areas to start with, and get everything fine-tuned before expanding. manages growth and quality Buy-in. Find good champions from your clinics, such as a clinic pharmacist, medical initiatives, such as accreditadirector or providers, to support your cause. tion and drug manufacturer Resources. ASHP and other associations have forums available to ask questions and and payor contracting. share best practices. —K.B. Summa Health launched

What to Consider When Developing a Specialty Pharmacy

Specialty Pharmacy Continuum • November/December 2021

OPERATIONS & MANAGEMENT

specialty pharmacy services to them,” Mr. Feucht said. They expanded to 23 clinics by the end of their first year and now are in 27 clinics. Trellis Rx secured access for Summa Health to numerous limited distribution drugs including Pfizer’s oncology and cardiology portfolios, Mr. Feucht said, as well as three payor networks. He cited other measures of success, such as achieving a 93% proportion of days covered in the first six months of 2021. Additionally, 94% of patients with HIV supported by the specialty pharmacy have achieved viral suppression, and patient and provider satisfaction scores were each 94% in a recent survey. Overall the pharmacy helped drive a 14% reduction in

drug cost for SummaCare, the health system’s employee health plan.

The DIY Model At the University of Utah Health, Matthew Rim, PharmD was working on projects such as centralizing prior authorizations and establishing a pharmacy benefit manager for the employee health plan. This was around 2013, when specialty pharmacies were gaining traction. With challenges coordinating services for then-new hepatitis C therapies such as ledipasvir/sofosbuvir (Harvoni, Gilead), Dr. Rim and his colleagues realized they needed better infrastructure to support patients and process prescriptions. They, too, decided to enter the specialty pharmacy realm. Dr. Rim’s team started with a gap analysis to see what resources they needed to add. They also reached out to other colleagues who had both retail and specialty pharmacies for advice about budgets and services. They visited some sites to observe, and took advantage of national forums such as ASHPs’ meetings to exchange ideas. The group realized they needed to build a 24/7 call center. They also embedded a pharmacy contract manager in the managed care group to work on payor contracts, and assigned an administrative staff person to gain and maintain access to limited distribution drugs. They set up a management team, pursued accreditation and researched

‘One of the benefits of DIY is that it will allow you to leverage internal expertise. Having a core group of pharmacy staff who can maintain and develop operations gives organizations flexibilities and expertise to expand their services.’ —Matthew Rim, PharmD cold-chain packaging for temperaturesensitive products. Overall, it took about two years to have everything ready, said Dr. Rim, who is now the associate director of specialty pharmacy services at The University of Illinois Chicago (which built its own specialty pharmacy in 2012). Then, within three years, they had maxed out their space due to all of the new specialty medications coming to market. The hospital built a new mail-order pharmacy center to keep up with demand. At UIC, due to the success of the specialty pharmacy build-out, the organization was able to gain access to 17 limited distribution FDA-approved drugs in fiscal year 2021 alone, Dr. Rim said. UIC was one of the first academic medical centers to achieve and maintain dual specialty pharmacy accreditations (URAC and ACHC) since 2016. While maintaining a patient satisfaction rate of 95%, UIC’s specialty pharmacy services more than doubled their patient volume and annual revenue over the past five years, he said. “One of the benefits of DIY is that it will allow you to leverage internal expertise,” Dr. Rim said. “Having a core group of pharmacy staff who can maintain and develop operations gives organizations flexibilities and expertise to expand their services.”

The Consultant Model In 2016, Texas Children’s Hospital built a specialty pharmacy. The medical center already had a small retail pharmacy serving mainly Medicaid patients, said Jeffrey Wagner, PharmD, MPH, RPh, BCPS, the assistant vice president for pharmacy, respiratory care and ECMO services. Then, he and his colleagues saw some data cited in an Institute for Safe Medication Practices (ISMP) workbook demonstrating that the average outpatient pharmacy has a 15% to 35% error rate for pediatric medications (J Pediatr 2005;147[6]:761-767). “That’s pretty alarming,” Dr. Wagner said. “We knew that if we could mimic what we do on the inpatient side, the safety and quality we provide would be that much better.” The health system engaged a consultant firm, North Highland, to help prepare, starting with focus groups for

families from each of the four planned pilot locations for the specialty pharmacy: rheumatology, hematology/oncology, endocrinology and pulmonary medicine. It was important to the pharmacy that prescriptions were filled in-house. In addition, there was a feeling among some staff that projected specialty pharmacy revenue was too good to be true, Dr. Wagner said. Having a consultant with experience helped staff feel more confident it could actually be true. The consultant also served as a sales team, pitching the service to providers and helping to place pharmacists in specialty clinics, Dr. Wagner said. While patients had a choice of specialty pharmacies to use, many opted for Texas Children’s. The consultant also helped with payor and market access

and set the specialty pharmacy on a path to accreditation. “The reason we engaged a consultant is if we were going to do it ourselves, we would probably roll out a clinic once every month or two,” Dr. Wagner said. “With our consultant engaged, we went live every two weeks and had 13 clinics established by the middle of 2017.” The pharmacy now has a presence in every specialty clinic at the main campus and the health system’s two community hospitals, covering 15 specialty care service lines, Dr. Wagner said. The pharmacy processes more than 10,000 prescriptions per month, and the team has grown from none to 68 full-time employees. Internal metrics show that patients’ average time to start therapy after receiving a prescription is 0.21 day using their specialty pharmacy versus 4.05 days using external pharmacies. “It was a significant investment for the system, but the quality and outcomes we’ve achieved through our process we’re very proud of,” Dr. Wagner said. —Karen Blum The sources reported no relevant financial disclosures other than their stated employment.

Specialty Pharmacy Continuum • November/December 2021

OPERATIONS & MANAGEMENT

Getting pharmacists involved key to success

What Health Systems Are Doing in Home Infusion Home infusion care providers have been seeing increased competition from health systems. That may not be surprising, given the depth of expertise-sharing at a recent pharmacy leadership meeting. At the 2021 ASHP Conference for Pharmacy Leaders, held virtually, Nancy Palamara, PharmD, the vice president for diagnostics and therapeutics at Holy Name Medical Center, in Teaneck, N.J., shared several strategies that healthsystems are using to succeed in this competitive market. One key strategy is to align infusion care services under pharmacist leadership, Dr. Palamara noted. Although this can be done at any health system, no matter how large or small, there may still be a lack of awareness that such a model can be implemented, at least based on an informal poll of session attendees. Dr. Palamara asked attendees as to who at their institution has operational oversight of the outpatient infusion center and all of its staff. The most common response was a nurse manager (35%), followed by a nonclinical manager (15%), pharmacist (4%) and physician (2%); 31% of respondents said oversight was handled by a mix of those roles, while 13% did not know. “This tells us that pharmacists are not very often the ones in charge of infusion center,” she said. “We need to make the case that pharmacy is well suited to manage infusion therapy departments or office-based outpatient infusion centers. Pharmacy must ensure that hospital leaders have a full understanding of infusion services, the outpatient infusion revenue cycle and the impact of clinical factors.” She cited her own institution’s experience as an example. “Our infusion

IN FLUX continued from page 34

Help the leaders understand the value of pharmacy as it relates to o managing costs and improving qualityy outcomes. • Align the pharmacy team around your strategy. You’re not going to be able to get everyone, but at least incorporate key individuals. • Evaluate where your team’s m’s time is spent, and what actions ti and outcomes are being achieved. • Make sure the pharmacy executive has influence at the executive table.

services had long been integrated with the cancer center, and the cancer center director always oversaw the infusion space,” she said. “Over 25 years, that director often reported to the chief nursing officer or the chief medical officer, depending on the individual’s background.” But more recently, the institution’s leadership recognized that infusion therapy needed to be a department in its own right, since about 25% of its services were unrelated to oncology, including neurology, immunology, rheumatology and other infusion categories such as a dedicated migraine program. “We spend close to $65 million annually supporting outpatient infusion services,” Dr. Palamara said. “Because we are a community hospital and do not do heart transplants and other services that produce a high inpatient drug spend, our outpatient drugs, primarily infusion, now represent about 92% of our drug spend.” When the new department was created with Dr. Palamara as its director, it was the first time that Holy Name had a pharmacist in charge. “It’s so important that pharmacy oversees your infusion revenue cycle all the way back to prior authorization,” she said. “It’s a tough battle to go back if things have been messed up in prior authorization and try to get that reversed, so we fought to get into the drug denial space.” Educating financial professionals about the clinical side of outpatient infusion proved very valuable, she said. “For example, most of our drugs now

‘It’s so important that pharmacy oversees your infusion revenue cycle all the way back to prior authorization. It’s a tough battle to go back if things have been messed up … and try to get that reversed, so we fought to get into the drug denial space.’ —Nancy Palamara, PharmD use weight-based dosing, where your case volume does not directly equal your expense. For a CT of the neck without contrast, your technician time is approximately the same and your scanner time and expense is approximately the same. But that’s not the case with an infused drug. “I had one of our clinical pharmacy specialists put together a presentation to show our accountant with actual patient cases. One month, we had four patients infused with trastuzumab, and

all were over 100 kilos. The previous month, we only had two patients who were over 100 kilos,” Dr. Palamara said. “That produced a significant difference in expenses month over month, and they need to understand that. Having the manager overseeing the pharmacy revenue cycle be a pharmacist has proven to be huge benefit.” —Gina Shaw Dr. Palamara reported no relevant financial disclosures.

Are Your Services Worthy?

5 Tips for Striking at the Right Time The smartest managed care strategy can fail if pharmacy leaders don’t recognize when it is time to put those strategies in play. To strike at the right time, be sure to: 1. Learn about the market players and dynamics. 2. Understand your capabilities. 3. Identify subject matter experts for different areas of focus. 4. When needed, engage consultants or other industry experts. 5. Meet regularly with your managed care leaders to review payor policy updates related to pharmacy, offer your expertise and develop strategies for upcoming contract negotiations. Source: Philip Brummond, PharmD.

“It’s easier said than done,” Dr. Brummond said. “But more and more people around the country are [assuming]

roles that have that influence, and health systems are seeing the value that pharmacy is bringing to the overall enterprise.”

Another important piece of staying ahead—or at least keeping pace—with managed care trends is having a strategy related to partnerships, Dr. Brummond said. To that end, make sure that the clnical and other patient management services you offer will attract other health systems or for-profit entities as your partners. That creates more of an offensive than defensive strategy, he noted. It’s also important to understand the business and have the data to know where you are now and where you want to go. —Karen Blum The sources reported no relevant financial disclosures.

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Specialty Pharmacy Continuum - November / December 2021

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