CER Daily Newsfeed

Landmark PHOENIX Study to Generate Real-World Insights to Personalize Prescribing with Genetic Testing

(7/3, Katie McCool, The Evidence Base) reports “...The trial spans a wide range of clinical specialties, including cardiology, stroke, orthopedics, psychiatry, respiratory medicine, and more, reflective of a real-world environment where patients often take several medications and have multiple comorbidities. Approximately 15% of individuals carry genetic variants that may reduce the effectiveness of a medication or increase the risk of side effects, highlighting the need for evidence to guide safer and more effective prescribing.” Full

Details On Trump’s Most Favored Nation Model To Lower Drug Prices May Never Emerge

(7/3, Joshua P. Cohen, Forbes.com) comments “...[T]he substantial differences in timing of approvals and launches of prescription drugs across countries make it hard if not impossible to create an international price index. Many recently approved branded medicines in the U.S. haven’t yet been approved in other peer countries, let alone had their price determined by a government authority.” Full

Medicare's Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

(7/2, Cathy Kelly, Pink Sheet) reports “...In the latest draft guidance for the Medicare price negotiation program, CMS suggested it could narrow the existing exemption from negotiation for combination products based on its assessment that they offer no ‘clinically meaningful difference’ than an older drug with the same active moiety. The change could mean combination drugs would be subject to the negotiation process along with older drugs with the same active moiety even if the combination is not old enough to qualify for the process.” Subscription Required

Exclusive: NICE to Remove Approval from Scores of Drugs for First Time

(7/2, Alastair McLellan, HSJ) reports “The National Institute for Health and Care Excellence will withdraw its backing for a large number of drugs and other interventions which now offer poor value for money in an unprecedented move set to be revealed in tomorrow’s 10-Year Health Plan, HSJ has learned. Such a move would end the NHS’s statutory mandate to supply the ‘retired’ medicines, treatments, medical devices and procedures. The government will also develop a ‘single national formulary’ to replace local lists of approved medicines in an attempt to further encourage clinicians to prescribe in the most cost-effective way.” Full

UK: NICE Relents on Takeda Colorectal Cancer Drug Fruzaqla

(7/3, Phil Taylor, PharmaPhorum) reports “After turning down Takeda's Fruzaqla for metastatic colorectal cancer (mCRC) in draft guidance last year, NICE has changed its mind and recommended the drug for use by the NHS in England and Wales. The final draft guidance document notes that Fruzaqla (fruquintinib) can be used as an option at third-line or later – if trifluridine-tipiracil with bevacizumab is not suitable – for adult mCRC patients. Takeda said that makes it ‘the first novel targeted treatment in almost a decade to be licensed in the UK for mCRC regardless of biomarker status.’” Full