Patent Settlements and Medicare Negotiation: What Leverage Does Pharma Have To ‘Game’ Price Reform?

Brand drug companies might be able to use patent settlements with generic and biosimilar makers to get out of the drug price negotiations that will be created under the US legislation nearing enactment, but sponsors could run into regulatory and antitrust obstacles.

ron wyden inflation reduction act debate
Senate Finance Committee Chair Ron Wyden Speaks About The Inflation Reduction Act Ahead Of Its Passage 7 August • Source: CSPAN

Brand name drug manufacturers may be able to steer their products clear of selection for Medicare drug price negotiation under legislation that is expected to soon become law in the US by entering in to patent settlements that allow “limited” generic or biosimilar entry, experts say.

Democrats still need the House to pass and President Biden to sign the Inflation Reduction Act into law, but with the Senate’s passage of the bill 7 August – the biggest hurdle to enactment – the focus has shifted to how the industry might cope with the most dramatic changes to the US drug reimbursement landscape since the creation of Medicare Part D

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