EU Finalizes Landmark Pharma Reform to Reset Access and Incentives
The EU reaches a landmark deal on pharmaceutical reform, reshaping regulatory exclusivity, supply obligations, generic entry, and incentives for priority antibiotics.
Market Access
CMS Confirms 2026 Coverage for MTF’s AmnioBand, AlloPatch
CMS confirms Medicare coverage for MTF Biologics’ AmnioBand Membrane and AlloPatch Pliable under updated LCDs for diabetic foot and venous leg ulcers starting 2026.
Netherlands Moves to Cut Mental Health Wait Times for 2026
The Dutch Healthcare Institute prioritizes group therapy and preventive mental health care to reduce long wait times under its 2026–2028 appropriate care agenda.
BioStem Lands 2026 CMS Status Quo Coverage for Skin Grafts
CMS places BioStem’s VENDAJE products in a 12-month status quo category, preserving DFU and VLU reimbursement through 2026 while evidence review continues.
ENvue’s UroShield Secures UK NHS Reimbursement
ENvue Medical’s UroShield Kit is added to the NHS Drug Tariff Part IX, enabling nationwide reimbursement and triggering early commercial orders in the UK.
CMS Reopens National TAVR Coverage Review at Edwards’ Request
CMS has accepted Edwards Lifesciences’ request to reopen the national coverage determination for TAVR, launching a review that could expand access to asymptomatic patients and ease procedural barriers by late 2026.
ICER Backs Wegovy, Zepbound Value in Obesity but Flags Access Crunch
The Institute for Clinical and Economic Review (ICER) has delivered a strong clinical and economic endorsement of today’s leading obesity drugs, while simultaneously warning that U.S. payers are unprepared for the scale of demand these therapies are likely to generate. In a final evidence report released Tuesday, ICER concluded that Novo Nordisk’s semaglutide (Wegovy, injectable … Read more
EU Greenlights Landmark Pharma Package, Overhauling Drug Rules for the First Time in 20 Years
The EU has finalized a sweeping Pharma Package deal, preserving eight years of data protection, adding new antibiotic incentives and giving member states new powers to secure medicine supply.
ICER Advances Two High-Stakes Assessments: Cytisinicline Cleared, IgAN Therapies Under Review
ICER released two notable updates this week: a final evidence report supporting cytisinicline’s role in smoking cessation and a draft review evaluating sibeprenlimab, atacicept and delayed-release budesonide for IgA nephropathy.
UK Cuts VPAG Newer-Medicine Rate to 14.5% for 2026
The UK has set the 2026 VPAG newer-medicine rebate at 14.5%, down sharply from 22.9% in 2025, reflecting slower NHS uptake and easing budget pressure. With an added 1% contribution, companies will pay 15.5% next year as talks begin to redesign the scheme for 2029 and beyond.