Market Access & Reimbursement

Real-world evidence and patient involvement can help developers shore up evidence from single arm trials for EU-wide joint clinical assessments.

The statement, which is part of a final rule on the 340B administrative dispute resolution process, could facilitate manufacturer efforts to seek repayments from hospitals in such cases.

The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.

Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.

Great Ormond Street Hospital is piloting a new approach to gene therapy delivery in which it will submit a marketing authorization application to the UK regulator for a lentiviral gene therapy used to treat ADA-SCID, a rare disease.

A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.

Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.

Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.

New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.

China’s public payer perceives innovative drugs in a different way from that of the country’s top drug regulator, a former senior healthcare security official with knowledge of the matter reveals. The posture has unnerved pharma companies, which have been hit by sharp price discounts.

Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.

A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.

While the EU Health Technology Assessment Regulation could reduce divergence in reimbursement decisions made across member states, many national-level HTA hurdles and challenges will remain, market access experts from EFPIA say.

Insurance plans put on notice that CMS is concerned about restrictions on drugs with negotiated prices, but it’s not clear what the agency can or will do about it.

As it stands, drugmakers will have just 90 days to prepare their dossiers for EU-wide joint clinical assessments under the new Health Technology Assessment Regulation. Market access experts from EFPIA tell the Pink Sheet that this short deadline could delay patient access to complex medicines, such as innovative cancer drugs.

The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.