Instead of the 35% minimum discount mandated by the bill, “it just needs to be 42%. For starters, small molecule drugs would become eligible for negotiation at 13 years, which could mean $6bn less in savings because price controls on some drugs would be delayed for several years, he said during a media briefing hosted by the venture capital advocacy organization Incubate on 3 August.īut “in exchange, you can make up for it by simply mandating that get a deeper discount,” Kolchinsky continued. Kolchinsky believes his ask is a modest change that can be fashioned in a way that is budget neutral. The plan has prompted furious lobbying for and against the bill in recent weeks and the nine-year timeline for negotiating small molecule drugs has emerged as a key issue. Does that mean the end of the generic drug era? That may sound extreme, but it is a logical response to the incentives in the bill. Lilly’s view of the impact of the pending US drug pricing reform legislation is that it will require rethinking of all its small molecule development programs. No More Generics? Implications Of The US Pricing Bill By Michael McCaughan (Also see " Pricing Reform Advocates Poised For ‘Rearguard Action’ By Industry If Legislation Prevails" - Pink Sheet, 21 Jul, 2022.) The negotiation process and other drug pricing reforms are part of a broader bill known as the Inflation Reduction Act that leaders in the Senate are hoping to move to the floor for a vote in the coming days. (Also see " Medicare Price ‘Negotiation’ Would Have Stymied Verzenio Advance In Early Cancer – Lilly’s Ricks" - Pink Sheet, 27 Jul, 2022.) Under the price “negotiation” process established by the bill, biologics would be eligible for negotiation 13 years following approval but small molecule drugs would be eligible after nine years, which investors and pharma stakeholders believe is too short a period in which to expect a reasonable return on investment. There is a budget-neutral fix that could be applied to the Senate drug pricing reform legislation that would avoid significantly undercutting the investment potential of small molecule drugs for cancer and diseases of aging if lawmakers would only pay attention, according to RA Capital Management managing partner Peter Kolchinsky. EU Biosimilar Filings, Opinions & Approvals.Drug Review Pathways & Approval Standards.
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