Germany approves legislation to improve cell & gene therapy availability
The German Parliament has approved legislation that could help accelerate patient access to cell and gene therapies by addressing a bureaucratic barrier that delayed their availability in hospitals.
The parliament advocated for an increase in the number of NUB inquiries that can take place each year. NUB inquiries are used by hospitals to gain short term reimbursement for innovative treatment and diagnostic methods, supplementing the standard Diagnosis Related Group (DRG) system. Traditionally, hospitals have only been able to make one NUB inquiry each year for Advanced Therapy Medicinal Products (ATMPs). The complexity of ATMPs means that they are usually administered in hospitals where physician services and associated care must also be reimbursed. Any extra payments then require negotiations between hospitals and insurance funds. The limit of one inquiry can make advanced therapies inaccessible to patients, even if those treatments have gained regulatory approval.
New legislation now means that NUB inquiries will be able to occur twice a year for ATMPs and be made before market authorisation of a therapy.
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 authorisation of the therapies. In this case, the NUB agreement would take effect on the date of the product’s market authorisation.
The Alliance for Regenerative Medicine advocated for the change in legislation alongside its member organisation and the Association for German University Hospitals (VUD).
"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 is now set to go to the Bundesrat, which represents the governments of the federal German states, and could be voted on by the end of June.