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Sotorasib was the first health technology from the UK’s ILAP scheme to be approved by NICE. April 2022   BACKGROUND   Launched by the UK MHRA in January 2021 with the aim to accelerate the marketing of innovative medicines, ILAP works in conjunction with the ‘innovation passport’ medicine designation of the MHRA and integrates the … Continued

A briefing from an IQWIG critical assessment of study planning – Abemaciclib in advanced breast cancer. Duration of measurement of quality of life, symptoms, and side effects data was too short for early benefit assessment.   March 2022   OBJECTIVE   European HTA results over the last 24 months show that value demonstration doesn’t stop … Continued

REFINEMENT OF CRITERIA FOR INNOVATIVENESS IN THE AUTORISATION TEMPORAIRE D’UTILISATION (ATU) SCHEME   BACKGROUND   The French law for temporary authorization for use (ATU) for early access to medicines has been active since 1992. The ATU scheme provides early access to medicines and carries several advantages when preparing launch of a new treatment: Access to … Continued

Latest bill, now with support from Sen. Joe Manchin (D-WV), would allow Medicare to negotiate prices of some drugs – drugs with highest spend   CONTEXT   In the “Build Back Better Act” bill, the 117th Congress attempted to give the U.S. government a role in drug price negotiation. That effort failed.   This week, … Continued