CER Daily Newsfeed

IRA Negotiation Changes: Pharma's Focus Remains On Near-Term Legislative, Regulatory Options

(2/25, Cathy Kelly, Pink Sheet) reports “...Manufacturers still hope to advance legislation removing the ‘pill penalty’ from the law, as well as changes they want included in the CMS guidance for the 2028 price implementation year...Manufacturers want the upcoming CMS guidance on the price negotiation program to change the agency's approach to aggregating drugs for the drug selection process and to create a broader exemption for orphan drugs.” Subscription Required

A Bill is Re-Introduced in Congress to Revise Provisions in Drug-Pricing

(2/25, Ed Silverman, STAT+) reports “...Once again, House lawmakers have introduced a bill to alter a key provision of the Inflation Reduction Act in response to arguments that the federal law is discouraging investment in developing so-called small molecule medicines. The legislation, known as the Ensuring Pathways to Innovative Cures Act, would allow Medicare to begin negotiating with pharmaceutical companies over the prices of small molecule medicines 13 years after they reach the market.” Subscription Required

UK: Amgen’s Blincyto Recommended by NICE for New Adult Leukaemia Indication

(2/26, Emily Kimber, PMLiVE) reports “...The health technology assessment agency has recommended in final draft guidance that the immunotherapy be used on the NHS in combination with chemotherapy to treat adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in the consolidation phase, a phase of frontline treatment for ALL which is aimed at killing any remaining leukaemia cells.” Full

UK: Harnessing Expertise to Improve Patient Access to Innovative Health Technologies

(2/25, John Spoors, NICE Blog) comments “...The Medicines and Medical Devices (MMD) Access Initiative – a collaboration across the four nations - has now been established to achieve this aim. This group consists of health service bodies that are united by a common goal to improve patient access to safe, clinically and cost-effective healthcare products. The initiative seeks to develop more aligned frameworks for the introduction of innovative health technologies, that is used consistently across UK. In addition, it will share intelligence across the four nations, to ensure that technologies reach patients in a timely manner and that there is no variation in access.” Full

Health Canada Looks At Easing Burden Involved With Running Expanded Access Trials

(2/26, Vibha Sharma, Pink Sheet) reports “...As part of efforts to modernize its clinical trials framework, the Canadian regulator is looking to better facilitate expanded access clinical trials, which allow investigational drugs to reach patients with serious conditions before they are approved.” Subscription Required