Novartis CAR-T Patient Assistance Program Could Set Template For Other One-Time Treatments

Mar 26 2021

• By Sarah Karlin-Smith

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HHS gives kickback exemption for program to provide Kymriah for free to certain eligible patients regardless of insurance provider. Treatment’s one-time use as a last resort therapy were key to the US government’s advisory opinion reasoning.

Novartis will be able to provide Kymriah for free to some qualified patients.

Novartis AG will be able to make its Kymriah CAR-T cancer treatment available free of charge to certain US patients without worrying about running afoul of the US federal anti-kickback statue, including the civil monetary penalty provision for beneficiary inducement, according to a new advisory opinion from the Health and Human Services Office of Inspector General.

The opinion released on 24 March could have implications for other companies looking to increase access to high-cost, one-time treatments...

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