Spotlight on Market Access

Although the approval of Kisunla (donanemab) earlier this month was celebrated by the Alzheimer’s Association as “real progress,” the challenge of getting commercial insurers to cover the drug will likely end up tempering that excitement.

Eli Lilly’s Kisunla, which received full FDA approval on July 2, is a once-monthly, IV-infused treatment for people with early symptoms of Alzheimer’s disease, including mild cognitive impairment and mild dementia. Like the drug Leqembi (lecanemab), which received full approval last July, Kisunla aims to slow the progression of Alzheimer’s by removing amyloid plaques from the brain. (The naturally occurring protein amyloid can create plaques when clumped together, and if those plaques build up excessively in the brain, it may lead to memory and cognitive issues associated with Alzheimer's disease.)

As U.S. tensions with China rise, federal legislation is proposing limiting federal agencies’ contracting with certain biotech companies. But the efforts have the potential to affect a large swath of the U.S. biotech and pharmaceutical industries, say experts, who recommend that firms should start assessing their potential exposure in order to mitigate any impact on their operations.

On Dec. 20, 2023, Sen. Gary Peters (D-Mich.) introduced S. 3558; on Jan. 25, Rep. Mike Gallagher (R-Wis.) introduced the House version, H.R. 7085. Known as the BIOSECURE Act, the legislation would ban federal contracting with a “biotechnology company of concern,” and it specifically mentioned Chinese companies BGI (formerly known as Beijing Genomics Institute), MGI, Complete Genomics, WuXi AppTec and any of their patent companies, subsidiaries or successor of these entities. It also includes any entity that

The FDA recently took another step toward levelling the playing field between biosimilars and interchangeable biosimilars when it proposed doing away with switching studies for interchangeable products. While the draft guidance may receive some resistance, ultimately it should help provide clarity that all biosimilars are similar in their safety and efficacy, bringing these agents onto the U.S. market faster and prompting more competition among the agents, industry experts maintain.

As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

Most industry experts likely would agree that certain provisions in the Inflation Reduction Act (IRA), such as a $2,000 out-of-pocket spending cap for Medicare Part D beneficiaries and copay smoothing — known as the Medicare Prescription Payment Plan (M3P) — are no-doubt wins for patients. But other aspects of the law, particularly Medicare drug price negotiations and inflation-based rebates, have prompted disagreements over their ultimate outcomes, with some experts claiming that they will hurt drug development and will prompt more restrictive utilization management among payers. Ultimately, said pharma industry experts during a recent webinar, stakeholders should keep patient support top of mind as they navigate these changes.

Pharma manufacturers began offering patient assistance programs (PAPs) as a way to help patients afford their medications. And as list prices of drugs continue to rise, so does that assistance. Companies can take a variety of steps to make sure that their offerings are not being hamstrung due to common pitfalls and instead are truly helping patients access and remain adherent to their medicines, say industry sources. In addition, manufacturers should be keeping an eye on copay offset programs, as well as the Inflation Reduction Act (IRA), for their potential impact on PAPs.

In 2023, manufacturer-provided copay assistance in the form of coupons and debit cards offset patient costs of $23 billion, according to the IQVIA Institute for Human Data Science report titled “The Use of Medicines in the U.S. 2024: Usage and Spending Trends and Outlook to 2028. Released in April, the report also found that such assistance offset costs of $84 billon over the last five years.