Radar on Specialty Pharmacy

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.

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 eight agents (including a branded and an unbranded version of Hyrimoz (adalimumab-adaz) from Sandoz, a division of Novartis Pharmaceuticals Corp., which 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:

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.

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.