Radar on Specialty Pharmacy

A little more than a year after Rep. James Comer (R-Ky.), then-ranking member of the House Committee on Oversight and Reform, released a report on PBMs’ business practices and their negative impact on drug prices, patients’ health and market competition, the now-Chairman Comer revealed that he is launching an investigation into those practices. The move continues to keep pressure on the entities over some of their practices and lack of transparency amid concerns around prescription drug prices.

On March 1, Comer sent letters to senior officials at the Office of Personnel Management (OPM), Defense Health Agency (DHA) and CMS, as well as to the three largest PBMs — Cigna Corp.’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx — requesting a trove of documents and communications.

The U.S. biosimilars market is a dynamic and ever-evolving space, and a recent report shows growing acceptance of the medications among providers. Last year saw a handful of milestones related to these agents, and this year, particularly with the launches of biosimilars of AbbVie Inc.’s Humira (adalimumab), is likely to continue the trend, according to a recent report from Cardinal Health.

Titled 2023 Biosimilars Report: tracking market expansion and sustainability amidst a shifting industry, the report is based on responses to web-based surveys conducted in 2022 from both community- and hospital-based practices. Providers were from “therapeutic areas with the most potential for disruption in the year ahead.” Cardinal Health polled more than 100 rheumatologists in July and August, 125 dermatologists in September, 70 gastroenterologists in September and October, and 60 retina specialists in September and October.

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price came below the level that respondents to a Zitter Insights poll said they would consider a good value. The medication comes with both potential advantages and disadvantages for patients, providers and payers, say industry experts.

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s) (ARVs), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.

Breast cancer is the most common cancer diagnosed in American women and the most common cancer globally. Estimates show that more than 300,000 people in the U.S. are expected to be diagnosed this year alone, almost 3,000 of them men.

When the FDA first approved Genentech, Inc.’s Herceptin (trastuzumab) on Sept. 25, 1998, for the treatment of people with breast cancer whose tumors overexpress the human epidermal growth factor receptor-2 (HER2) protein, the drug offered a new targeted approach to treating the disease. In the years since, researchers have identified other subtypes of the cancer and developed newer agents indicated for specific types and stages of the disease.

Following a severe season of respiratory syncytial virus (RSV) in the U.S., several companies have revealed that they have promising vaccine candidates for various patient populations in the late-stage clinical trial pipeline. The FDA could approve some of them as early as this year, for what is estimated to be a market worth more than $10 billion. Currently, only one agent has FDA approval for RSV prevention, and one specialty pharmacy recently shared with AIS Health, a division of MMIT, how it manages that treatment and members taking it.

The CDC estimates that children younger than 5 years old account for more than 57,000 hospitalizations and about 100 to 500 deaths per year. Older adults experience approximately 177,000 hospitalizations and 14,000 deaths annually, but no FDA-approved treatments indicated for this population are available.