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U.S. Drug Rules Clear Way for Insurer Payments Based on Outcomes

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The Trump administration wants to make it easier for drugmakers and insurance companies to make pricing deals based on how well a medicine works, a change that both sides say could help lead to a more efficient health care system.

The Food and Drug Administration on Tuesday released the final version of a draft detailing how pharmaceutical companies can have conversations with payers about so-called value-based agreements. Under such arrangements, the amount an insurer covers is based on a specific outcome — such as keeping patients from being hospitalized — instead of a flat fee.

(Related: 3 New Reasons for Hope About Health Benefits Costs)

Restrictions on such conversations have made drugmakers nervous about breaking FDA rules. Current regulations limit what they’re able to discuss prior to a drug’s approval, and potential use of a medicine once it’s on the market that isn’t included in the label. The rules also apply to medical-device manufacturers.

The release of the guidelines come as Health and Human Services Secretary Alex Azar is set to testify Tuesday before a Senate committee about the blueprint President Donald Trump released last month to bring down drug prices. One of the suggestions in the document, “American Patients First,” includes testing value-based arrangements in the Medicare program, which provides health care for the elderly and disabled.

Value Deals

Value-based deals have already been struck for several treatments. They include: Merck & Co.’s diabetes medications Januvia and Janumet, Eli Lilly & Co.’s diabetes treatment Trulicity and Novartis AG’s heart-failure therapy Entresto. In the case of Entresto, insurer Cigna Corp. agreed to pay for the drug based on keeping patients out of the hospital for heart failure. Amgen Inc. has said it may pursue such deals for its migraine drug Aimovig.

The FDA regulates pharmaceutical companies’ communication to ensure it’s accurate based on the safety and efficacy data the FDA reviewed and included in a drug’s label. Sometimes payers want different economic data or information on uses of the drug that hasn’t undergone FDA review. Doctors are allowed to prescribe a treatment for any condition, not just those specified in the label.

One hurdle that hasn’t yet been addressed involves how the Centers for Medicare and Medicaid Services pays for medications for the poor under the Medicaid program. Medicaid is supposed to get the lowest price available, a calculation that could be skewed if that payment deal is based on the price an insurer pays for a patient who doesn’t respond well to a drug. The pharmaceutical industry has asked for clarification over how a value-based payment would influence the amount Medicaid pays.

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