Tag Archives: reimbursement
A Fine Line Between Regulation and Evolution
The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Ansis Helmanis asks — is industry prepared to adapt or challenge?
On September 17, the FDA and CMS jointly issued a Federal Register (FR) notice that they were establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when [...]
Posted in FDA, Market Access, Regulatory Also tagged FDA, Market Access, market authorization, Regulatory Leave a comment
Wins and Losses from Risk-Sharing Agreements
Can you manage the external market impact?
Risk-sharing agreements – where companies contract with reimbursement or assessment authorities to guarantee a new drug’s performance, often against specific outcomes measures, in return for access to patients – are among the latest innovations in managing health care costs. Use of the tool is standard in Australia, is [...]
Posted in Europe, Global, Regulatory, Strategy, healthcare, pricing Also tagged innovative contracting, NICE, pricing, risk sharing, tranparency, value-based pricing Leave a comment

Value-Based Pricing Could Counter Innovation, Says UK Think Tank