German legislature approves legislation that will expedite access to life-changing cell and gene therapies

GERMANY-The German parliament, the Bundestag, has approved a legislation that would enable patients have greater access to new transformative cell and gene therapies.

The legislation will address a bureaucratic barrier that delayed the availabilities of new and innovative drugs, medical devices and procedures (NUB) to patients.

In order to be able to integrate new examination and treatment methods into the G-DRG system, the NUB request procedure was first introduced in Germany in 2005.

For this purpose, NUB requests (InEK) would only be made once in a year with the extra payments requiring a negotiation between individual hospitals and insurance funds.

This means a gene or Chimeric Antigen Receptor-T cell (CAR-T) therapy meant to treat or potentially cure a devastating ailment could be inaccessible to patients for up to a year regardless of whether the therapy is approved via AMNOG or not.

The change that was approved by the Bundestag last allows NUB inquires to be made twice a year for the Advanced Therapy Medicinal Products (ATMPs).

The new law also makes it easier for hospitals to make a NUB inquiry for ATMPs to the institute for the Hospital Remuneration System (InEk) by the 31st of October and the 30th of April.

If a response is not received from the InEk within two months of the latter deadline, negotiations on a NUB payment can still be done without a decision by the institute.

Hospitals are also enabled through the law to make NUB inquiries for all services provided in conjunction with the administration of new pharmaceuticals, as well as ATMPs, prior to having the therapies authorized in the market.

Paige Bischoff, senior vice president of global public affairs at Alliance for Regenerative Medicine (ARM) commended the action taken by the Bundestag to reduce a bureaucratic hurdle that made it difficult for patients to access durable and potentially curative ATMPs.

“The legislation makes it easier for German hospitals to provide life-changing cell and gene therapies to patients, many of whom have fewer therapy options,” he added.

The next stage for the legislation is to take it to Bundesrat, a representative of the governments of the federal German states, where it could be voted on by the end of June.

This NUB legislation is a larger representation of the health package and could become law in August if the Bundesrat does not delay it and the president of the federal government signs it.

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