Radar on Specialty Pharmacy

New FDA Approvals: FDA Expands Label of Novartis’ Leqvio

July 7: The FDA broadened the label of Novartis Pharmaceuticals Corp.’s Leqvio (inclisiran) to include its use as an adjunct to diet and statin therapy to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. The agency initially approved the small interfering RNA (siRNA) therapy on Dec. 22, 2021. Dosing is 284 mg via a subcutaneous injection by a health care professional, then another dose at three months and then every six months. The drug’s list price is $3,290.63 per dose.

July 11: The FDA expanded the label of Organon’s Hadlima (adalimumab-bwwd) to include the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on July 23, 2019. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The agent is available in both low-concentration and high-concentration versions of its reference drug. The product recently launched with a wholesale acquisition cost of $1,038 for a carton of two syringes or autoinjectors.

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Conference Speaker: Specialty Pharmacy Doesn’t Exist Anymore

Employers should start thinking about their specialty drug benefit design differently, recommended an industry expert at a recent conference. That includes not only reconsidering tiering but also coverage of biosimilars, as well as disease categories that increasingly will contribute to their specialty spend.

Alex Jung, founder of Alex Jung Consulting LLC and member of the Midwest Business Group on Health's board, opened her session at the MBGH Employer Forum on Pharmacy Benefits, Specialty Drugs & Biopharma: How PBMs Control Prices & What Employers Can Do About It by explaining that she is “try[ing] to correct a lot of the things that became misaligned incentives or…business practices that have resulted in exploitation or employers and their employees.” She expressed an interest in getting public policy experts to “understand that they need to step up and put in some governance and controls so that the burden doesn’t always fall on the employer” because they have enough to deal with.

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Newer Drugs for ALL Are Hitting the U.S. Market, Potentially Meeting Unmet Need in Treatment

The FDA has approved multiple new agents for the treatment of acute lymphoblastic leukemia (ALL) — which is also known as acute lymphocytic leukemia — and recently converted an accelerated approval it had given one of them to full. However, even with all these options, respondents to a Zitter Insights survey said that unmet need exists in treating the disease.

On June 21, 2023, the FDA granted full approval to Amgen Inc.’s Blincyto (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor ALL first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. The agency first approved the CD19-directed CD3 T-cell engager on Dec. 3, 2014; the accelerated approval for MRD-positive B-cell ALL was granted on March 29, 2018.

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PSG Report Shows Double-Digit Specialty Drug Trend, but Opportunities for Savings Exist

Specialty drug trend continues to be in consistent double digits, with increases due to both spend and trend. That’s one of the findings of the 2023 Artemetrx Specialty Spend & Trend Report from the Pharmaceutical Strategies Group (PSG), an EPIC company. And with the specialty drug pipeline continuing to pump out more and more expensive agents, opportunities for savings exist through the use of biosimilars and generic specialty drugs, among other strategies.

Published July 25, the report is sponsored by Walmart Specialty Pharmacy and includes data from 2022. Findings are based on an analysis of 347 million medical claims and 133 million pharmacy claims from PSG’s Artemetrx book of business. Artemetrx is a proprietary SaaS platform developed by PSG. This is the seventh annual version of the report, which started under the Pharmacy Benefit Management Institute (PBMI) moniker. In April 202, MJH Life Sciences acquired PBMI’s trademarks, conference, website, education and membership assets, while the current and future research and analytics projects remained with PSG.

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More Efficient, Evidence-Based PA Process Could Benefit Genomic Testing

With more than 77,000 genetic tests available and new tests constantly coming to market, it can be difficult for payers and providers alike to keep track of not just what the products are but also how effective they can be. To make sure that beneficiaries are receiving appropriate testing, many payers have prior authorization (PA) in place. But as the process often can be burdensome for providers, a more evidence-based, streamlined approach to coverage could authorize necessary genomic testing with greater efficiency.

AHIP conducted a study from February through April 2022 on PA practices and received responses from 26 health plans with 122 million commercial covered lives. Along with specialty drugs, genetic testing was the only other treatment that respondents said was subject to PA 100% of the time.

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Several Biosimilars of Humira Launched This Month With Varying WACs

As expected, early July saw the launch of multiple biosimilars of AbbVie Inc.’s Humira (adalimumab). Most of them launched with wholesale acquisition costs (WACs) just slightly less than that of the reference drug, but a few undercut that price fairly significantly.

Of the seven agents — including a branded and an unbranded version of Hyrimoz (adalimumab-adaz) from Sandoz, a division of Novartis Pharmaceuticals Corp., that will be spun off into a new publicly traded standalone company in the second half of this year — five launched with a WAC 5% off Humira’s $6,922 price tag:

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Fein: Patients Are Trapped in ‘Doom Loop of Specialty Drug Benefits’

Plan sponsors’ use of copayment accumulators, copay maximizers and alternative funding companies to keep spending on specialty drugs down has been a fairly recent trend but one that continues to pick up speed, noted longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. But as that use continues to increase, multiple questions exist around the practices and what the future holds for them.

The focus of the June 23 webinar, titled PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding, mainly affects specialty drugs, which now represent more than half of payer spending on drugs due to two main reasons, he said. The first is the specialty drug pipeline and the costly prices of those agents, while the second is the dramatic growth in generic dispensing over the past 20 years.

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New FDA Approvals: FDA Expands Label of Pfizer’s Abrilada

June 14: The FDA expanded the label of Pfizer Inc.’s Abrilada (adalimumab-afzb) to include the treatment of moderate to severe hidradenitis suppurativa in adults. The agency first approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on Nov. 15, 2019. Dosing starts with 160 mg via subcutaneous injection on day one or split over two consecutive days, then 80 mg on day 15, and then on day 29 and subsequent doses, 40 mg every week or 80 mg every other week. Drugs.com lists the price of two 40 mg/0.4 mL kits and two 40 mg/0.8 mL kits of Humira, each with two devices, as more than $7,299. Pfizer told AIS Health, a division of MMIT, that it would launch the tumor necrosis factor (TNF) inhibitor in “late third-quarter/early fourth-quarter 2023” per the settlement of patent litigation with AbbVie.

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Leqembi Treatment Infrastructure: If Medicare Pays For It, They Will Come

Eisai Co., Ltd. and its partner Biogen, Inc. crossed over the biggest barrier in their quest to commercialize Leqembi (lecanemab) now that Medicare will cover the cost of the Alzheimer’s disease drug. The next hurdles for doctors and patients will be obtaining blood tests and PET scans for confirming amyloid pathology in the brain, genetic testing to assess APOE4 status, MRIs to monitor for amyloid-related imaging abnormalities (ARIA) and infusion centers to administer the medicine — facilities that exist, but not in the numbers and locations needed to serve all of the US patients eligible for treatment.

CMS said that it will cover the cost of Leqembi on July 6, the day that the FDA converted the amyloid protofibril-targeting antibody’s accelerated approval for the treatment of mild cognitive impairment or mild dementia associated with Alzheimer’s disease (AD) into full approval. Eisai and others believe that while uptake of Leqembi will be slow as the health care system catches up with the diagnostic, monitoring and infusion requirements associated with the therapy, Medicare coverage gives providers the confidence they need to offer those services.

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With Rinvoq’s Recent Approval for Crohn’s Disease, Agent Enters Highly Competitive Class

The FDA recently expanded the indication of AbbVie Inc.’s Rinvoq (upadacitinib), making it the first oral treatment and the first Janus kinase (JAK) inhibitor for Crohn’s disease. Still, the agent is entering a highly competitive class in which manufacturer rebates play a big role. And while respondents to a Zitter Insights survey said the drug will somewhat lessen the unmet need in the treatment of the condition, they said that a moderate level of need still exists with the agent’s approval.

On May 18, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor. The agency initially approved the JAK inhibitor on Aug. 16, 2019. This is the seventh indication the drug has gotten across rheumatology, dermatology and gastroenterology.

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