Drug Pricing

In its annual assessment of whether prescription drug formularies overly restrict access to select medications, the Institute for Clinical and Economic Review (ICER) gave insurers high marks. While it acknowledges that coverage policy information needs to be much more transparent, this year’s report concludes that “major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions.”

However, ICER President-Elect Sarah Emond says the nonprofit research institute is fully aware that its analysis can only do so much to examine all the myriad, complicated facets of what truly defines “fair access.” Therefore, she adds, ICER is actively working on how to make future reports more comprehensive.

On March 23, 2010, then-President Barack Obama signed the Affordable Care Act (ACA) into law, establishing the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. At the same time, the change may help promote uptake of biosimilars, bringing cost savings to the U.S. health care system, say industry sources.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

A recent survey from WTW found 38% of employer-sponsored health plans provide coverage for anti-obesity medications, while another 22% are planning on or considering covering those drugs in 2024 or 2025. Meanwhile, about two-thirds of employers that are members of WTW’s Rx Collaborative cover anti-obesity drugs, according to Cody Midlam, a director in the company’s Pharmacy Community group.

Midlam tells AIS Health, a division of MMIT, that “we’re definitely seeing the trend is leaning towards adding coverage” of the medications, which are expected to be costly for plans in the coming years. Morgan Stanley, for instance, projected in a September report that the global market for weight management medications could reach $77 billion in 2030, up from just $2.4 billion last year.

The Big Three PBMs — The Cigna Group’s Express Scripts, UnitedHealth Group’s Optum Rx and CVS Health Corp.’s Caremark — all delivered positive results during the third quarter of 2023, and in some ways helped offset underperformance for the firms’ health benefits businesses.

Wall Street analysts were generally positive about the performance of the firms’ PBM subsidiaries, but they had questions about the way each firm plans to manage the cost of glucagon-like peptide 1 (GLP-1) agonists for their clients.

The Senate Finance Committee on Nov. 8 unanimously approved legislation to block pharmacy benefit manager practices that result in higher cost-sharing for beneficiaries.

The bill does not include provisions that were included in an earlier draft that would ensure “high discount” biosimilars get favorable formulary tiering. But those policies may be added back before the bill reaches the Senate floor for a vote.

The committee is planning to combine the bill with other PBM reform legislation it approved in July which includes a policy that would de-link PBM compensation from the list price of drugs.

The state of California is facing delays in its efforts to produce low-cost insulin and is unlikely to meet its 2024 timeline, Bloomberg Law reports. Gov. Gavin Newsom (D) announced in March that the state had formed a partnership with Civica Rx to produce an insulin known as CalRx that would cost no more than $30 per 10ml vial and no more than $55 for a box of five, 3 mL pre-filled pens. However, California Health and Human Services Secretary Mark Ghaly, M.D., told Bloomberg Law the launch date would extend beyond 2024 due to unanticipated delays.

A group of 48 senators sent a letter to HHS Secretary Xavier Becerra, Dept. of Treasury Secretary Janet Yellen and Dept. of Labor Acting Secretary Julie A. Su asking for the Biden administration to require all insurers to fully cover over-the-counter (OTC) contraceptives. The politicians want the plans to cover the medications with no copays or out-of-pocket costs and without requiring a prescription. Opill, the first FDA-approved OTC birth control pill, is expected to become available early next year. The senators signing the bill included Patty Murray (D-Wash.), chair of the Senate Appropriations Committee; Bernie Sanders (I-Vt.), chair of the Senate Health, Education, Labor and Pensions Committee; and Ron Wyden (D-Ore.), chair of the Senate Finance Committee.

Major payer coverage policies across select categories often met fair access criteria for cost sharing, clinical eligibility, step therapy and provider restrictions, according to the third annual “Barriers to Fair Access” assessment published by the Institute for Clinical and Economic Review (ICER).

The analysis examined coverage policies for 18 drugs across 10 commercial formularies, eight Affordable Care Act exchange plans and the Veterans Health Administration national formulary, representing 42 million enrollees in total. ICER asked the payers for coverage policy information and leveraged the MMIT Analytics Market Access Database for additional information. (MMIT is the parent company of AIS Health, which maintains journalistic independence and did not play a role in producing the report.)

While a lot of the attention around the Inflation Reduction Act (IRA) has focused on its implications for pharma manufacturers and Medicare Part D plans, much of its focus is on patients and making sure they can access the prescription medications they need at a price they can afford. While aspects such as the out-of-pocket cap for Medicare beneficiaries and the limit on premium increases for plans are welcome developments, some uncertainties still exist around the actual implementation of the law and how patients may be affected. On Oct. 19, life sciences consulting firm Innopiphany, LLC brought together three speakers from patient-advocacy groups to discuss their hopes, concerns and what they have experienced so far.

Although PBMs are taking increasing heat for spread pricing — or charging payers more for a drug than pharmacies are reimbursed — they aren’t the only players in the drug supply chain that engage in the practice, a new study points out. And one of the study’s authors says its findings suggest that patients may be better off if generic drugs are simply removed from insurance coverage entirely.

The study, published in JAMA Health Forum on Oct. 20, examined data associated with 45 high-utilization Medicare Part D-covered generic drugs.

After years of having just one, limited option available to combat respiratory syncytial virus (RSV) in at-risk populations, the U.S. market this year has suddenly become rich with new products. Yet insurance coverage limitations and supply issues are frustrating efforts to keep elderly adults and very young babies from contracting what can be a life-threatening illness.

This May, the FDA approved both GSK’s Arexvy and Pfizer Inc.’s Abrysvo for people who are 60 and older, and in August, federal regulators approved Abrysvo for use in people who have been pregnant for 32 to 36 weeks, with the goal of protecting their infants after birth. Additionally, in July, the FDA approved Sanofi/AstraZeneca’s Beyfortus (nirsevimab-alip), a monocolonal antibody injection indicated for preventing RSV in newborns and infants born during or entering their first RSV season, and for children up to 24 months old who remain vulnerable to severe disease throughout their second RSV season.