CLINICAL

Overcoming Biosimilar Hesitancy

Biosimilars have the potential to significantly reduce costs for medical centers, but the adoption rate is still very low. Fortunately, there are steps that pharmacists can take to increase use of these agents.

At the end of 2019, 17% of the biologics market were accessible to biosimilars, but there was only a 20% adoption rate, noted David Crosby, PharmD, BCOP, BCPS, the pharmacy director of system infusion at Dartmouth-Hitchcock Health, in Lebanon, N.H. Including approved but not yet launched biosimilars, up to 50% of the biologics market could face competition from biosimilars, he said, citing data from IQVIA’s national sales perspectives (www.iqvia.com).

There are six major challenges to biosimilar adoption, Crosby said during a session at the ASHP 2020 Midyear Clinical Meeting and Exposition:

1. Provider comfort and experience.

There has been a fair amount of confusion among some providers about biosimilars, including unfamiliarity with development pathways, and confusion and concern because of a lack of interchangeability status. Just because biosimilars aren’t designated as interchangeable by the FDA doesn’t mean they should not be substituted for the reference product, Crosby said. “Partnering with provider section leadership to enhance education and minimize inconsistency, but also to champion biosimilar rollout, is key to success,” he said. 2. Patient education. Such efforts are often needed becausepatients may have some misunderstanding regarding biosimilars, or be concerned when transitioning from a treatment they are familiar with that may be working well. “You really want to evaluate how pharmacy can supplement and support patient education to assist in that transition to biosimilars,” Crosby said. He added that patient education can overlap with provider outreach as well, since clinicians also may harbor negative attitudes toward biosimiliars. 3. Third-party payors. Most biosimilars developed so far are used primarily in outpatient settings, where individual agents require a prior authorization and benefits investigation. Ultimately, if a payor is not going to allow a biosimilar to be used, this can delay utilization. One reason is likely rebates the insurer may be receiving for the reference product, Crosby said. “We’re seeing more payors give preference to either the reference product or a specific biosimilar, and that’s based upon the rebate they receive. It’s a trend becoming more common over time.” This is an opportunity when negotiating payor contracts to ask that biosimilars be included as an option in your formulary, he said. “You may not be successful each time, but they may be receptive since you’re really trying to identify cost savings for their beneficiaries.”

4. Financial impact on patients and

organizations. Although the cost savings resulting from biosimilar use can be substantial, the bottom-line financial impact for patients and organizations is often much less significant or clear, with third-party payors deriving the greatest benefit, Crosby said. Still, that should at least have a favorable effect on premiums over time. This also can be an opportunity for the payor contracting team. 5. Clinical considerations. Biosimilars span therapeutic areas, and their use may involve multiple specialty and subspecialty providers. “This is where most [pharmacy and therapeutics committees] will need to develop policies, procedures and guidance to ensure consistency in your clinical approach,” Crosby noted. 6. Operational consideration. Even if everyone in your organization is on board with biosimilars and what they represent, if you don’t have a well-thought-out plan to operationalize the rollout, you may struggle to be successful, he said.

Those challenges and caveats aside, biosimilars “are not a failed concept; they are in fact becoming a growing part of affordable treatment options available to payers, physicians and patients,” said Murray Aitken, IQVIA senior vice president

Savings, U.S. billions 18 19 104

2010-14 2015-19 2020-24

Cohort year

Figure. Biosimilar savings.

Source: IQVIA National Sales Perspectives, Jun 2020; IQVIA Institute, Sep 2020.

and the executive director of the IQVIA Institute for Human Data Science, in an October 2020 report (bit.ly/34xNHDf). “It is our estimate that biosimilars could reach $80 billion in aggregate sales over the next five years, including $16 to $36 billion in 2024,” with potential savings in excess of $100 billion (Figure).

Aitken cited, as an example, the recent launches of biosimilar bevacizumab, trastuzumab and rituximab, which “are set to reach nearly 60% volume share by the end of their second year on the market, significantly higher and faster than prior biosimilars,” he said. —Karen Blum

The sources reported no relevant fi nancial disclosures.

EDITORIAL BOARD

ADMINISTRATION

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AMBULATORY CARE

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ANESTHESIOLOGY/PAIN

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CARDIOLOGY

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CNS/PSYCHIATRY

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COMPLEMENTARY AND ALTERNATIVE MEDICINE

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Health Systems Tackle Addiction in Varied Settings

Pharmacists can play key roles in the team-based management of substance use disorders (SUDs) across multiple care settings, from the emergency department (ED) to acute or chronic care, according to a panel of speakers at the American College of Clinical Pharmacy (ACCP) 2020 virtual annual meeting.

The URMC Approach

The ED is a critical access point for health care and, in the past decade, has become more widely used by people with SUDs, said Nicole Acquisto, PharmD, BCCCP, an emergency medicine clinical pharmacy specialist at the University of Rochester Medical Center (URMC), in New York. “After an injury, hospitalization or ED visit, there seems to be this teachable moment for those that have a [SUD], ” Acquisto said.

The SBIRT (Screening, Brief Intervention and Referral to Treatment) tool (www.samhsa.gov/sbirt) can help identify patients who use opioids and other substances at risky levels, she said. It helps establish rapport and screen patients, elicit the patient’s thoughts about making a change, enhance motivation and assess their readiness for change, and negotiate a plan and provide resources for treatment.

In cases of suspected OUD, clinicians assess where patients fall on the Clinical Opiate Withdrawal Scale (COWS) before initiating medications for OUD, such as buprenorphine-naloxone, Acquisto noted.

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A policy released in September 2020 by the American College of Emergency Physicians recommends opioid withdrawal treatment be initiated in the ED with buprenorphine or methadone (Ann Emerg Med 2020;76[3]:e13-e39).

Emergency department treatment guidelines, she added, aim to link patients with OUD to medication-assisted treatment (MAT). Patients who experience an overdose also are linked to care, and those experiencing withdrawal receive treatment for their symptoms in the most clinically appropriate setting. A policy released in September 2020 recommends opioid withdrawal treatment be initiated in the ED with buprenorphine or methadone (Ann Emerg Med 2020;76[3]:e13-e39).

At URMC, the ED provides supportive medications for withdrawal symptoms such as pain, anxiety and nausea. Patients who have an appropriate COWS score can be given 2 mg of buprenorphine as a test dose, with another 8 mg given 30 minutes later. Then they may be prescribed buprenorphine twice daily, or given a 16-mg dose for a longer duration of action and linked to local substance use programs. A primary care group at a local community hospital in the area sees patients within 72 hours after being started on MAT in the ED.

Pharmacists with specialized training play an integral role in many of these interventions, Aquisto noted, adding that she and a clinical toxicology pharmacy specialist helped to develop standardized recommendations for treating OUD patients. They also developed ED and organization-wide guidelines on opioid withdrawal, and developed an order set to assist with ED buprenorphine orders and prescribing.

Both Acquisto and her clinical toxicology pharmacist colleague have also audited an “X” waiver training class, which the Drug Enforcement Administration mandates be taken before a physician can prescribe buprenorphine to a patient with OUD. They also worked with physicians in toxicology and addiction medicine on the development of their MAT guidelines and materials, order sets, patient education handouts for buprenorphine and resources to be given in the ED to help with linkage to care. “We have used these materials to train our EM [emergency medicine] pharmacists as well as other pharmacists in various practice settings in our department on MAT initiation and buprenorphine, and then on the flip side, how to manage pain in patients coming in to the ED with acute pain and on buprenorphine,” she said.

A Bridge to Community Care

In the acute care setting, transitional bridge clinics helps stabilize patients with active opioid addiction and help them assimilate into community-based treatment programs, said Alyssa Peckham, PharmD, an advanced practice pharmacist with Massachusetts General Hospital, in Boston. The goal of such clinics is to reduce barriers so patients have more access to treatment, Peckham said during the ACCP meeting. They work on engagement, trying to ensure patients return for additional care rather than fitting them into a predetermined set of requirements. Clinics are designed to provide rapid access, offering a mix of scheduled and walk-in appointments.

Unlike other programs, the clinics have a model of harm reduction, not abstinence. “While abstinence is always an excellent goal, it’s not always what patients want at that moment,” Peckham said. “We have to accept the fact that drug use is going to occur and that we want to allow patients to be safe and enhance wellness during that time.”

Massachusetts General Hospital has operated a transitional bridge clinic since 2016, featuring a board-certified psychiatric pharmacist (Peckham) and other multidisciplinary team members. In a study reviewing the clinic’s first two years, personnel saw 800 patients for at least one visit, half of which were walkins. The median time to remain engaged in the clinic was 73 days, although 25% of patients remained in care for more than a year. In surveys, patients reported liking the flexibility and immediate access to care, the harm reduction model, relationships with a nonjudgmental provider and the availability of peers (J Subst Abuse Treat 2019;107:1-7).

Peckham completed a year of postgraduate training in psychiatry and addiction—experience that she said helps guide her when interviewing patients and discussing modifications to treatment for any opioid, alcohol, stimulant and tobacco use disorders. The training also is a boon, she noted, when ordering lab tests, coordinating care and scheduling follow-up visits. Peckham also performs many other tasks, including leading clinical initiatives in SUDs such as microdosing of buprenorphine in the outpatient setting, conducting training and education seminars, writing protocol and guidance documents, and facilitating a four-week patient group on the neurobiology of addiction.

Collaboration at Gatton College

On the chronic care end, collaborative practice agreements also can be effective resources for patients overcoming OUD, Sarah Melton, PharmD, a professor of pharmacy practice at East Tennessee State University’s Bill Gatton College of Pharmacy, in Johnson City, noted during the ACCP meeting. Melton formerly was a clinical pharmacist with Highpower, an interdisciplinary program for OUD patients in Lebanon, Va. The program, started by Melton and her late husband, employs a physician board-certified in addiction medicine, a nurse practitioner and physician assistant, a licensed professional counselor, and peer recovery specialists, with a board-certified psychiatric pharmacist paid by Gatton College.

Professionals with Highpower use motivational enhancement therapy, a counseling approach that helps patients engage in treatment. Participants attend group counseling sessions at varying frequencies depending on their needs; they also are required to get community support through a 12-step program, or have an outside sponsor they can call if stressed. Patients receive urine drug testing and breath alcohol tests at every visit.

Melton performed a range of activities, including providing medication education about buprenorphine, dosing of buprenorphine and participation in groups. Outcomes seen, so far, include increased adherence to buprenorphine, decreased illicit use of opioids, and, thanks to a collaboration with a local OB-GYN practice, a decrease in neonatal abstinence syndrome (NAS). —Karen Blum

ESMO: When to Order Next-Gen Cancer Sequencing

In looking back on key oncology developments in 2020, clinicians should put new recommendations for using next-generation sequencing (NGS) in metastastic cancer on their short list, according to Jai Patel, PharmD, the chair of the Department of Cancer Pharmacology and Pharmacogenomics at Levine Cancer Institute, Atrium Health, in Charlotte, N.C.

Experts at the European Society for Medical Oncology (ESMO) published the new recommendations, using a rigorous methodology to identify advanced cancers with firm evidence supporting the clinical utility of NGS. They also identified cancers with insufficient data to recommend widespread and routine clinical application of this technology (Ann Oncol 2020 Aug 24. [Epub ahead of print]).

“The ESMO guidelines should help streamline the use of multigene sequencing in specific cancers where there is evidence of benefit at minimal added cost,” Patel commented.

The document was developed by a group of genomics experts who used ESMO’s Scale for Clinical Actionability of Molecular Targets (ESCAT) to classify recurrent genomic alterations of specific cancers. The scale helps assess the clinical relevance of such alterations. The experts also evaluated the strength of the evidence supporting the utility of NGS for these cancers.

Based on the strength of the evidence and the clinical relevance of mutations, the ESMO guidelines recommend routine use of tumor NGS in advanced nonsquamous non-small cell lung cancer, prostate cancer, ovarian cancer and cholangiocarcinoma. They also recommend NGS as an alternative to polymerase chain reaction in colon cancer, if it is cost-effective.

ESMO also supports routine tumor mutational burden (TMB) testing for patients with cervical cancer, well- and moderately differentiated neuroendocrine tumors, as well as salivary gland, thyroid and vulvar cancers. Such support reflects the fact that TMB-high tumors in these patients predicted their response to pembrolizumab ( Keytruda, Merck) in the KEYNOTE-158 trial ( ClinicalTrials.gov Identifier: NCT02628067). This trial is examining the effectiveness of pembrolizumab by TMB in many solid cancer types.

Although individual institutions and practitioners may decide to use multigene panels outside of the cancers specified in the ESMO guidelines, they should be aware of the “low likelihood of benefit” in those cancers, the authors noted.

Lead author Fernanda Mosele, MD, a medical oncologist at Accord Medical Center, in Buenos Aires, Argentina, acknowledged that some clinicians may feel ESMO’s recommendations limit NGS to a relatively narrow group of patients. Some of the recommendations differ from “what happens in daily practice in some countries and institutions. For example, while use of tumor NGS in breast cancer is commonplace at some institutions, we do not recommend it.”

Patel, who was not involved with the guidelines, said they “somewhat coincide with how NGS is used for cancers in the U.S.” For example, in contrast to the ESMO guidelines, guidelines from the National Comprehensive Cancer Network (bit.ly/3hijMnO) recommend that U.S. clinicians perform multigene profiling for patients with lung adenocarcinoma to identify both common and rare driver mutations for which effective targeted therapies exist.

“A concerted effort by American professional associations to address the broad use of NGS across different tumor types in this country is needed,” Patel said, adding that those guidelines should account for the impact of testing on drug selection and activity as well as the cost-effectiveness of testing.

“As the cost of these diagnostics declines in the United States and data supporting their use in clinical practice increases, coverage of testing will also increase, allowing for greater availability of NGS testing in the community,” Patel added. Oncology practitioners “would greatly benefit from national efforts to streamline the use of NGS across tumor types, including recommendations for who and when to test.”

Table. Selected FDA-Approved NGS Platforms

NGS Platform (Maker)

Broad molecular profiling tests Number of Genes Tested (Cancer Type)

FoundationOne CDx (Foundation Medicine) 324

MSK-IMPACT (Memorial Sloan Kettering Cancer Center) 468

Tests focused on specific genes/cancer types

Therascreen PIK3CA RGQ PCR Kit (Qiagen) 1 (breast cancer)

BRACAnalysis CDx (Myriad Genetics) 2 (breast and ovarian cancers)

Praxis Extended RAS Panel (Illumina) 2 (CRC)

Therascreen KRAS RGQ PCR Kit (Qiagen) 1 (CRC)

Cobas EGFR Mutation Test V2 (Roche) 1 (NSCLC)

Oncomine Dx Target Test (ThermoFisher) 46 (NSCLC)

Therascreen EGFR RGQ PCR Kit (Qiagen) 1 (NSCLC)

Cobas 4800 BRAF V600 Mutation Test (Roche) 1 (melanoma)

THXID-BRAF Kit (BioMerieux) 1 (melanoma)

FoundationFocus CDxBRCA Assay (Foundation Medicine) 2 (ovarian cancer)

MyChoice CDx (Myriad Genetics) Combined assay (ovarian cancer)

Therascreen FGFR RGQ RT-PCR Kit (Qiagen) 1 (urothelial cancer)

CRC, colorectal cancer; IMPACT, Integrated Mutation Profiling of Actionable Cancer Targets; NGS, next-generation sequencing; NSCLC, non–small cell lung cancer Based on EClinicalMedicine. 2020;25(100487). doi: 10.1016/eclinm.2020.100487

A list of FDA-approved NGS platforms is provided in the Table.

Heed the Differences

Martin Gutierrez, MD, a co-chair of thoracic oncology at Hackensack Meridian Health, in New Jersey, applauded the guidelines’ authors for conducting a comprehensive evaluation of NGS use for specific tumors. However, similar to Patel, he noted differences between the American and European settings, such as TMB testing for pembrolizumab candidates. “By and large, Europeans tend to be a little more restrictive and conservative than in the United States in TMB testing,” he said. Whereas ESMO guidelines recommend testing TMB only for cervical, salivary gland, vulvar and thyroid cancers, and neuroendocrine tumors, American clinicians test TMB in any cancer for which pembrolizumab is approved, and they consider such patients with TMBhigh cancer to be good candidates for pembrolizumab.

Gutierrez said the guidelines will need to be frequently updated, given the rapid pace of approvals of novel checkpoint inhibitors and small-molecule inhibitors. “These are comprehensive guidelines,“ he said, “but the speed at which new agents are approved means guidelines will need to evolve.” —David Wild

Bumping Up COVID-19 Vax

continued from page 1

use authorization (EUA) for the vaccine.

There has been some confusion about whether pharmacies were allowed to use those extra doses, given the terms of the EUA.

“On Monday morning, I was on a call with Pfizer and heard them say that there was probably extra vaccine in the vials, and if we could get a sixth dose out of the vial, we should go ahead and do that,” said Dana Darger, RPh, the director of pharmacy for Rapid City Hospital in South Dakota, part of the Monument Health system. “We did that all day Tuesday and into Wednesday morning, but early in the afternoon we received an email from the state in big, bold letters telling us not to take additional doses out of the vials, and we had to get all that information to vaccinators. Then on Thursday morning, we got additional information from the FDA, ASHP and other organizations telling us to be frugal and use those additional doses. Then the state told us that if we could get six doses, to use six, so we’re back to that now.”

During the public meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee on Dec. 17, Doran Fink, MD, PhD, the deputy director of the FDA’s Division of Vaccines and Related Products Applications, part of the Office of Vaccine Research and Review, Center for Biologics Evaluation and Research,

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was asked about the additional doses. “The instructions for the vaccine are to add 1.8 mL of diluent to the 0.45 mL of vaccine in the multidose vial,” he said. “That gets you to 2.25 mL. So with a dose volume of 0.3 mL per vaccine, it is not at all unexpected that there would be more than five doses in these vials.”

Not every institution is able to get six doses out of every vial of the vaccine, said Anna Legreid Dopp, PharmD, ASHP’s senior director of clinical guidelines and quality improvement. “Some of our members are saying that they are consistently getting six doses, while others are not because of differences in needles and syringes that they’re using.”

Darger said so far, there have been few, if any, vials from which they have been unable to squeeze a sixth dose. “There

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are 195 vials in a flat of vaccine, so that gives us 195 extra doses of ‘free’ vaccine per flat,” he said.

The University of Utah, in Salt Lake City, also has been able to get an additional dose out of almost every vial of vaccine it has received, said Erin R. Fox, PharmD, an adjunct associate professor of pharmacotherapy. “It’s a really nice surprise,” she said. “As soon as we got the OK from the FDA, we began using the extra doses, which for us was in the middle of the day on Wednesday. It’s important for the public to understand that Pfizer didn’t make a mistake, that this is very common in multidose vials. They want to ensure that everybody can at least get five doses out at the minimum.”

In a statement e-mailed to Pharmacy Practice News, a Pfizer spokesperson said the company could not provide a recommendation on the remaining amount of vaccine from each vial. But the company did offer some caveats. “Each dose must contain 0.3 mL of vaccine. After dilution, the multidose vial contains enough vaccine for at least 5 doses. The amount of vaccine remaining in the multidose vial after removal of 5 doses can vary, depending on the type of needles and syringes used,” the spokesperson said. “If the amount of vaccine remaining in the vial cannot provide a full additional dose of 0.3mL, vaccinators must discard the vial and any excess volume. Excess vaccine from multiple vials must never be pooled. We continue to closely coordinate with the FDA on this matter.”

Eric Tichy, PharmD, MBA, the vice chair of supply chain management for Mayo Clinic in Rochester, Minn., agreed that dilution strategies need to be done carefully. In doing so, “like many other hospitals, we’ve found that we can get an extra dose or two out of every vial,” Tichy said. “That was a huge bonus. It meant the equivalent of an additional 20% of vaccine for every 5-dose vaccine vial. That was very significant because for every 1,000 doses we were getting an extra 200. I was telling people that was like our Christmas miracle.”

The additional doses pose another challenge: running out of syringes. “The government is supplying us with kits of syringes and needles, and now we’re scrambling to get extra supplies to administer those extra doses, because we will run out,” Tichy said. “We wanted to buy supplies five or six months ago, but the government had pretty much bought out the whole market of vaccine syringes in anticipation of having to give hundreds of millions of doses. It’s a good problem to have, but something we will have to sort out. We’re hopeful now that the FDA has recognized [the safety of] those extra doses, we can also get the additional supplies.”

Stretching Moderna’s Vaccine

The Pfizer vaccine may not be the only one that can be boosted with creative dosing strategies. In early January, scientists at the National Institutes of Health and Moderna announced that they are analyzing data to see if they can double the supply of the company’s mRNA-1273 vaccine by cutting doses in half. NIH officials said results of the analysis should take about two months.

In an Operation Warp Speed call with reporters on Jan. 6, Health and Human Services Secretary Alex Azar offered another useful tip for hospitals seeking to maximize the impact of COVID-19 vaccination efforts: not to let too fine a focus on logistics get in the way of optimal distribution. “It’s better to vaccinate lower-priority populations than micromanage this process and leave vaccines in the freezer,” Azar said. “Faster administration can save lives right now.” —Gina Shaw, Marie Rosenthal,

The sources reported no relevant fi nancial disclosures.

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