German Parliament Approves Legislation to Accelerate Access to Life-Changing Cell and Gene Therapies

GERMAN PARLIAMENT APPROVES LEGISLATION TO ACCELERATE ACCESS TO LIFE-CHANGING CELL AND GENE THERAPIES

The Alliance for Regenerative Medicine advocated for reducing the “NUB gap” for advanced therapies

BRUSSELS, BELGIUM – 15 June 2021

Legislation approved by the German Parliament on 11 June would accelerate patient access to transformative cell and gene therapies by addressing a bureaucratic barrier that delayed their availability in hospitals.

The reduction of the “NUB gap” – advocated for by the Alliance for Regenerative Medicine (ARM), its member organizations, and the Association for German University Hospitals (VUD) -- would enable NUB inquiries to occur twice a year for Advanced Therapy Medicinal Products (ATMPs) instead of just once. Inquiries could also be made before market authorization of a therapy.

ATMPs and other pharmaceuticals are approved for reimbursement in Germany through the AMNOG pathway, with simplified rules for orphan drugs. But due to the complexity of ATMPs, they are usually administered in hospitals where physician services and associated care must also be reimbursed. This can be achieved through the NUB pathway to supplement the standard Diagnosis Related Group (DRG) system. Under current law, NUB inquiries can only be obtained once a year and the extra payments require negotiations between individual hospitals and insurance funds. A gene or CAR-T therapy that can durably treat or potentially cure a devastating disease could therefore be inaccessible to patients for up to a year even if that therapy has been approved via AMNOG.

The change approved by the Bundestag last week gives hospitals the opportunity to make a NUB inquiry for ATMPs to the Institute for the Hospital Remuneration System (InEK) by 31 October and by 30 April. If InEK does not reply within two months of the latter deadline, negotiations on a NUB payment can be concluded without a decision by the institute.

The law also enables hospitals to make NUB inquiries for all services provided in conjunction with the administration of new pharmaceuticals, including ATMPs, prior to market authorization of the therapies. In this case, the NUB agreement would take effect on the date of the product’s market authorization.

Other than the additional deadline and the ability to make an inquiry prior to market authorization, the NUB process remains the same. The first inquiry is made to InEK, followed by a local negotiation by the hospital if the result of the inquiry is positive.

“ARM applauds this action to reduce a bureaucratic hurdle that stood in the way of patient access to durable, and potentially curative, ATMPs,” said Paige Bischoff, ARM’s senior vice president of global public affairs. “The legislation makes it easier for German hospitals to provide life-changing cell and gene therapies to patients, many of whom have few other treatment options.”

The legislation now goes to the Bundesrat, which represents the governments of the federal German states, and could be voted on by the end of June. The NUB legislation is part of a larger health package. Without any delays in the Bundesrat, the legislation could become law in August after signature by the federal president.

Media inquiries
For more information or for media requests, please contact Stephen Majors, Director of Public Affairs for ARM, at smajors@alliancerm.org

About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs). ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives in Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing ATMPs. In its 11-year history, ARM has become the global voice of the sector, representing the interests of 390+ members worldwide and 85+ members across 15 European countries, including small and large companies, academic research institutions, major medical centres and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.