Biosimilar/Brand Patent Settlements Need US Antitrust Review, PBM Says
Federal Trade Commission and Department of Justice should be able to scrutinize settlements between biologic reference product sponsors and biosimilar developers, Express Scripts says; PBM's policy proposals for coming year include safe harbor for certain value-based reimbursement arrangements, and mandatory electronic prescribing and dispensing limits for opioids.
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Pharma firms might avoid paying for national opioid prescription monitoring database because state systems already talk to each other, although current operations still need some upgrades.
PhRMA suggests that treating biosimilars like generics in some cases could lead to confusion and may have little impact on cost sharing for beneficiaries.
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.