Last week’s policy signals from Germany underscored a clear regulatory theme: access increasingly hinges on comparative evidence, not just innovation or unmet need. New assessments from the Institute for Quality and Efficiency in Health Care (IQWiG) highlighted where evidence is strong enough to support added benefit, where gaps remain despite growing treatment options. Multiple myeloma: … Read more
NICE proposes age-based CA125 testing to improve early diagnosis.
Germany adopts new STIKO vaccination recommendations, shifting meningococcal protection to adolescents and expanding shingles eligibility for high-risk adults starting in 2026.
The EU reaches a landmark deal on pharmaceutical reform, reshaping regulatory exclusivity, supply obligations, generic entry, and incentives for priority antibiotics.
CMS confirms Medicare coverage for MTF Biologics’ AmnioBand Membrane and AlloPatch Pliable under updated LCDs for diabetic foot and venous leg ulcers starting 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.
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 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 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.
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