Medicare Price Negotiation: Sponsors Will Have A Say, But Likely Not Sway As Timetable Comes Into Focus
CMS details when it will release information and receive public comments in the lead-up to publishing the initial list of drugs to be negotiated this fall.
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The final guidance on the Medicare drug price negotiation program also addresses complaints that the government may violate the uncompensated ‘takings’ clause of the Fifth Amendment of the US Constitution in the way it considers remaining patents and exclusivities for negotiated drugs.
CMS should adopt the minimum price reductions under the Inflation Reduction Act for most selected drugs in the early years of the Medicare price negotiation program, PhRMA urges and recommends the agency should retain that approach in the long-term for younger drugs, those targeting an unmet medical need or those representing therapeutic advances.
Medicare Price Negotiations: Competitors’ Net Prices, Clinical Benefit Are ‘Starting Point’ For Initial Offer
CMS chose the prices of therapeutic alternatives and these competitors’ comparative benefits as the ‘foundation and starting point’ for setting an initial offer for drugs subject to negotiation, ahead of other factors Congress laid out it could consider that are more singularly focused on the specific drug at issue.