France Strengthens Cancer Access with TEVIMBRA and New 14-Day Trial Fast-Track

France Strengthens Cancer Access with TEVIMBRA and New 14-Day Trial Fast-Track

Breaking Down TEVIMBRA Access and the 14-Day Trial Pathway France has taken two decisive steps to reinforce its clinical research ecosystem and expand access to new oncology therapies. The Haute Autorité de Santé (HAS) has issued a favourable reimbursement opinion for TEVIMBRA (tislelizumab) in gastric and oesophageal cancers, while the National Agency for the Safety … Read more

CMS Sets New Medicare 2026 Rates Across Five Innovation Categories

CMS Sets New Medicare 2026 Rates Across Five Innovation Categories

What the New Medicare 2026 Rates Mean for Access and Adoption The U.S. Centers for Medicare & Medicaid Services (CMS) has delivered a rare cluster of reimbursement decisions that collectively mark one of the most significant access-defining weeks of 2025. Spanning neuromodulation, molecular diagnostics, AI imaging, autoimmune disease therapy, and oncology support care, the rulings … Read more

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.

CMS’ Medicaid drug payment model brings Trump’s MFN push

CMS' Medicaid drug payment model brings Trump's MFN push

CMS’ Medicaid drug payment model links value-based pricing and international benchmarks to lower costs and improve patient outcomes. (Editorial illustration.) US government aims to lower Medicaid drug prices and align costs with global rates under new GENEROUS model The US government has launched a sweeping initiative to reduce prescription drug costs under the Medicaid program, … Read more

Dutch Healthcare Institute Limits Early Access to Obesity Drugs Amid Cost and Evidence Concerns

Dutch Healthcare Institute Limits Early Access to Obesity Drugs Amid Cost and Evidence Concerns

The Dutch Healthcare Institute is taking a cautious, phased approach to new obesity drugs, limiting access to patients with the highest disease burden. The move reflects concerns about evidence gaps, cost-effectiveness, and the growing pressure obesity treatments could place on the national healthcare budget.

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