The increase last fall, which was the largest in 15 years, was due in large part to the anticipated impact that Aduhelm would have on Medicare spending. Due to minimal uptake, Biogen cut Aduhelm’s price in half from the initial $56,000 to $28,200. HHS Secretary Becerra requested CMS to reevaluate the high premium cost after the substantial price cut as well as the final NCD. CMS noted that it is not feasible to readjust premiums in the middle of the year, so the change will go in effect for 2023; the exact change in premiums will be announced this fall. To read the CMS report, click here.
The three bills combined would reduce the deficit by $2.5 billion over the next decade. The largest savings would be from the Affordable Prescriptions for Patients Act (S. 1435) which enables the FTC to sue manufacturers who use product hopping to prolong their profits. The other bills, the Preserve access to Affordable Generics and Biosimilars Act (S. 1428) and the Stop STALLING Act (S. 1425), would reduce the deficit by increasing access to generic drugs. To read the full article, click here.
The event, “The Future of Pharmaceuticals: Examining the analysis of Pharmaceutical Mergers,” is the culmination of the Multilateral Pharmaceutical Merger Task Force that was created in March 2021. In addition to discussing new findings regarding pharmaceutical competition, there will be sessions to assess “whether current enforcement approaches accurately reflect marketplace conditions.” To read the full press release, click here.
The white paper makes various policy suggestions to address PBM practices, such as increasing reporting requirements and imposing a fiduciary duty onto PBMs and insurers. The policy recommendations are intended to realign incentives that historically add to PBM and plans’ profits at the expense of patients. To read the full paper, click here.
The researchers examined 38 drugs that were granted accelerated approval between 2012-2017. Of the $68 billion that CMS spent through 2020 on the included drugs, $51 billion (75%) was after the drugs had received full, standard approval. The researchers noted that over half (59%) of that spending was for drugs that used surrogate endpoints in confirmatory trials. To read the entire study, click here.
Richard Frank and his colleague at the USC-Brookings Schaeffer Initiative for Health Policy detailed how drug price controls would have little impact on R&D in a Brooking blog post. The post challenges the argument that price controls would reduce “new cures” by examining the relationship between R&D spend and supply of new drugs. The post also looks at the true cost of bringing a new drug to market, which they conclude is often inflated by manipulating drugs samples to exclude drugs that bring down the estimate. To read the full post, click here.
Rachel Sachs summarized the progress of the FDA user fee reauthorization across both chambers in a Health Affairs Forefront article. Sachs outlines the provisions included in both the House and Senate packages, including accelerated approval reforms, improving diversity in clinical trials, and increasing competition. To read the full article, click here.