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Value-Based Contracts Getting More Safe Harbor Attention From OIG

 
• By Cathy Kelly

But so far, OIG has declined a blanket safe harbor for proposed value-based payments, saying it still wants to consider proposals case-by-case. Discussions between the office and stakeholders are continuing, Bristol-Myers Squibb's Mike Ryan says.

Business concept illustration of a businessman being guided by a hand holding a flashlight uncovering arrow sign.

Stakeholder requests for safe harbors from anti-kickback enforcement that would facilitate value-based payment arrangements are growing and involve a range of activities, such as patient adherence programs and product performance "warranties," according to reports from the US Department of Health and Human Services' Office of Inspector General (OIG).

Requests received are disclosed by the office in an appendix to its semi-annual report to Congress. The reports do not...

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Second-Most Favored Nation? CMS Clarifies Medicaid Price Benchmark In GENEROUS Model

 
• By Cathy Kelly

Demonstration could bring unprecedented transparency into international net prices, at least to CMS.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

Novo, Lilly Lower GLP-1 Prices, ‘Enabling’ Medicare, Medicaid Coverage In Obesity

 
• By Cathy Kelly

The $245 price agreed to by both firms may be in line with the maximum fair price that Medicare negotiated for Novo Nordisk’s semaglutide products.

China Takes Major Step On Commercial Insurance For Innovative Drugs But Hurdles Ahead

 
• By Xu Hu

China’s NHSA expects to release the first list of innovative drugs to be covered by commercial health insurance in early December, but implementation, payment collection and data sharing are expected to be among the main hurdles ahead.

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How Regulatory Horizon Scanning Works In The EU, UK & Switzerland

 
• By Eliza Slawther

Horizon scanning is a tool used by regulators to prepare for forthcoming medicines that might challenge existing processes. Senior figures from the European Medicines Agency, Swissmedic and the UK MHRA explain how they conduct horizon scanning activities in their respective jurisdictions.

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.