Market Access & Reimbursement

Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after another Capitol Hill appearance, and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed.

The US Medicare agency is creating a formal reconciliation process for new inflation rebates in Part B and Part D of the program.

The CDC’s ACIP again punted a decision on whether to make a pneumococcal vaccine available to all adults 50 and older amid concerns over cost and equity tradeoffs, as well as unknowns about the length of vaccine protection. 

Second generation combination products may become more appealing as companies navigate the complexities of the Medicare price negotiation program.

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

The House Oversight Committee held its third hearing on pharmacy benefit manager reforms in 14 months, but could not elicit an admission from executives that they are responsible for increasing drug prices.

Strong concerns about the imminent joint clinical assessments remain, but there are signs that communications between the health technology assessment coordination group and stakeholders could be improving.

Market exclusivity is the key incentive offered under the EU orphan drug framework, but pricing and regulatory problems are the main challenges for rare disease drugmakers, not the pressure from competitors, a life sciences lawyer says.

A number of diabetes drugs are also expected to be targeted in the next cycle of the price negotiation program, led by Novo Nordisk’s Ozempic.

A US House of Representatives bill to provide obesity drug coverage to a very select group of Medicare beneficiaries, passed only after Democrats debated whether the proposal is a “first step” towards broader coverage or a misstep counter to Medicare’s goals.

The latest report on the competitiveness of the UK’s life sciences sector shows that the nation “continues to underperform” on its potential in terms of the adoption of new treatments and innovation, according to industry body the ABPI.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Ixchiq, Valneva's chikungunya virus vaccine

Akebia says its price for Vafseo at about $15,500 per year, meant to reflect its potential value in dialysis as well as eventually in non-dialysis patients.

In a joint proposal with its partners, the Medicines Patent Pool explores challenges in monoclonal antibody equity in low- and middle-income countries and provides actionable solutions to increase development and manufacturing.

Experts expect litigation challenging Medicare’s definitions of single-source drug and bona fide marketing to get a boost from recent Supreme Court rulings, but overall, the IRA is likely better positioned in a post-Chevron world than older Medicare statutes.

A new act in Germany does not go far enough to address the deeply unpopular “guardrail” link between Amnog benefit assessment ratings and price negotiations, which can deter companies from launching.