Taiwan NHIA requires contracts for high-cost gene therapy patients

Taiwan's National Health Insurance Administration (NHIA) has introduced a new requirement for patients receiving extremely expensive gene therapies to sign administrative contracts. This measure aims to ensure the efficacy of high-cost treatments and collect long-term clinical data.

The policy specifically targets two gene therapies: Zolgensma, used for spinal muscular atrophy at approximately 49 million TWD per dose, and Upstaza, used for AADC deficiency at approximately 99.99 million TWD per dose. Under these contracts, patients must commit to regular follow-up visits for at least ten years to monitor treatment outcomes.

For Upstaza, patients must return for evaluations every three months during the first year, followed by visits every six months. Zolgensma patients are required to undergo evaluations every four months. The NHIA will also use this data to evaluate future payment conditions and coverage.

If disputes arise regarding the fulfillment of these contractual obligations, such as failure to attend scheduled follow-ups, the cases will be adjudicated by the Taipei High Administrative Court. The NHIA noted that while this mechanism is being implemented for these specific drugs, the application of similar requirements for other high-cost medications will be determined by expert committees on a case-by-case basis.