Spotlight on Market Access

With the FDA’s February 2021 approval of Bristol Myers Squibb’s Breyanzi, followed by another nod for the drugmaker’s Abecma just a few weeks later, there are now five chimeric antigen receptor T-cell (CAR-T) therapies on the market. Since they require administration at approved treatment centers, CAR-T drugs are most often covered under the medical benefit, though coverage under the pharmacy benefit isn’t unheard of. Among the most advantaged therapies are Novartis’ Kymriah, which holds covered or better status for more than 80% of all insured lives under the medical benefit, and Gilead Sciences’ Tecartus, following behind at 76%. The graphics below show how all five CAR-T therapies are covered under the pharmacy and medical benefit.

Highmark Health is a privately owned not-for-profit subsidiary of Highmark, Inc., and a Blue Cross and Blue Shield licensee for its insurance offerings in Delaware, Pennsylvania, New York and West Virginia. It also participates on those states’ Affordable Care Act exchanges. Highmark’s offerings include commercial, Medicare Advantage and Medicaid products.

As more high-cost drugs, including one-time gene therapies, come onto the market, employers are considering implementing a variety of contracting models to make sure their employees have access to these agents. However, even as innovative new approaches are being explored, employers have experienced challenges in executing them. Manufacturers can ensure their products are being covered when they understand employers’ concerns and help address those issues, suggest industry experts.

With more and more oncolytics targeting specific alterations in tumors, the area of precision oncology is developing rapidly. To help bring some insight into this market, Magellan Rx Management, a division of Magellan Health, Inc., and Trapelo Health, a wholly owned subsidiary of NeoGenomics Bioinformatics, recently unveiled a collaboration aimed at helping both providers and payers navigate this complex space and ultimately improve patient outcomes.

The pharmaceutical industry should continue to enjoy strong financial results in the next 12 to 18 months, according to a new report from Moody’s Investors Service. The credit ratings firm projects 4% to 6% growth in annual earnings before interest, taxes, depreciation and amortization over that period.

The majority of large private employers say that health benefit costs are excessive and a greater government role in providing health care coverage and containing costs would benefit their business and employees, according to a recent survey by the Purchaser Business Group on Health and the Kaiser Family Foundation. Based on the responses from key decision-makers at 302 large private employers with at least 5,000 employees, the survey found that 87% of respondents believed the cost of providing health benefits will become unsustainable in the next five to 10 years. Meanwhile, the majority of respondents said they were likely to implement cost-control practices, such as value-based benefit designs and use of an individual coverage health reimbursement arrangement (ICHRA).

The FDA on June 7 delivered its much-anticipated approval of Biogen Inc.’s Aduhelm (aducanumab-avwa), immediately stirring up a furor over its high cost, reigniting doubts about its effectiveness, and spurring speculation about how public and private payers will approach coverage for the first novel treatment approved for Alzheimer’s disease since 2003.

MMIT has launched its new Fee Scheduler solution. The product provides a simplified, self-serve workflow for payers to select appropriate pricing methodologies to reimburse medically covered pharmaceuticals. The product will replace payers’ manual processes today across dozens of fee schedules to free up internal resources, streamline the flow of fee schedules to third party vendors and provide clients with the ability to establish custom class pricing to handle biosimilars and other exceptions — all backed by RJ Health data.

The FDA on June 7 approved Biogen Inc.’s Aduhelm (aducanumab) to treat Alzheimer’s disease, the first novel therapy approved in this indication since 2003. The accelerated approval of Aduhelm was controversial as results of two Phase III trials in patients with early-stage and mild Alzheimer’s contradicted each other. There are a host of other Alzheimer’s medications on the market, all of which are covered under the pharmacy benefit. The majority of insured people under commercial and Medicaid formularies have plans that put Alzheimer’s drugs under the preferred/preferred (prior authorization and/or step therapy) tier and covered/covered (PA/ST) tiers. More than half of payer pharmacy benefit formularies do not require step therapy or prior authorization for Alzheimer’s medications.

Medicare Advantage enrollment grew just 1% during the 2021 Open Enrollment Period (OEP) that ran from January to March, compared with growth of 7% during the preceding Annual Election Period (AEP), according to AIS’s Directory of Health Plans (DHP). While the large MA insurers continued to nab the bulk of OEP signups (see infographic, p. 7), an AIS Health analysis finds that of the top 25 OEP performers, regional players followed their AEP successes with OEP gains that were impressive relative to their size.