Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 10, 2025

Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 10, 2025

The Week’s Biggest Shifts in Payer Strategy This week’s policy and access landscape was defined by a sweeping overhaul of U.S. Medicaid drug pricing and a widening push toward value-driven reimbursement models. CMS’ newly announced GENEROUS model, paired with Most Favored Nation (MFN) pricing agreements for GLP-1s, marks a structural shift that will reshape affordability … Read more

TLV Endorses Keytruda Combo for Advanced Cervical Cancer with Cost-Effectiveness Caveats

TLV Endorses Keytruda Combo for Advanced Cervical Cancer with Cost-Effectiveness Caveats

Sweden’s TLV has published its health economic assessment of Merck’s Keytruda for locally advanced cervical cancer, finding clear efficacy benefits when added to chemoradiation. However, the agency warns that cost-effectiveness hinges on price transparency and real-world survival durability.

Reimbursement Series: CMS and Europe Reimbursement Pathway Accelerates Innovation

CMS and Europe reimbursement pathway

In a transformative week for market access, the CMS and Europe reimbursement pathway expansion delivered several pivotal coverage and pricing decisions reshaping patient access across cardiovascular, hepatic, and oncology therapies. From CMS’s national determinations on breakthrough devices to European HTA approvals in rare disease and cancer, these developments underscore a growing transatlantic alignment between regulators … Read more