U.S. Administration Proposes Medicare Drug Negotiation Rule Changes
The Trump administration proposed altering a policy that prevents drugmakers from avoiding Medicare price negotiation by adding active ingredients to existing drugs. The change is part of an annual rule governing selection of the next 20 drugs and biologics for negotiation.
ndtv.comThe Trump administration proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs. The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation.
Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. If a company adds a second drug to one that is eligible for negotiation, the FDA considers the resulting combination drug a new product, giving it additional time before price negotiation.
The administration is now proposing to subject certain types of combination biologics to negotiation in some cases.
Warken said that drugmakers will not be exempted from cost-cutting measures, after some companies warned they may be unable to launch innovative medicines in Europe unless governments agree to pay more than they historically have. Proposed legislation in Germany will cap rapidly growing costs in the statutory health insurance system.
Warken said she realizes many drug companies are under pressure, and the planned legislation is not going to bring them any extra revenue. She maintained Germany remains an attractive location for the pharmaceutical industry thanks to reimbursement under the statutory health insurance scheme and opportunities for clinical trials.
Exempting the industry from the proposed legislation is out of the question.
