Landmark pay-for-performance contract agreed in Germany

The Gesellschaft für Wirtschaftlichkeit und Qualität für Krankenkassen (GWQ) has announced it has reached a deal to supply Zolgensma through a pay-for-performance model.

The news follows recent successful negotiations by GWQ to supply Kymriah through a pay-for-performance model, showing GWQ’s willingness to ensure patients can have access to high-cost medicines. Such deals remain uncommon in Germany, and both manufacturers and patient groups will be encouraged that there are payers willing to explore these modes of access.

GWQ and AveXis have been able to agree that two patient-relevant outcomes will be used to determine success of the drug, and if success is not achieved the manufacturer will fund up to 100% of the treatment.

Read the full press release from GWQ below.

GWQ Press Release: AveXis and GWQ have concluded the contract for the pay-for-performance reimbursement of Zolgensma.

GWQ ServicePlus AG and AveXis Inc. (a subsidiary of Novartis AG) have concluded a contract for gene therapy, Zolgensma with a performance-based reimbursement model. The contract starts after EMA-approval of Zolgensma, so there is no interaction with the existing compassionate use programme. Unlike previous contracts with similar innovative reimbursement models, two relevant parameters such as patient-relevant outcome parameters have been taken into account. In the event of a contract, AveXis assumes the risk of repaying in some cases up to 100% of the drug costs in phases.

Zolgensma received a ‘Positive Opinion’ from the CHMP (Committee for Medicinal Products for Human Use) from the European Medicines Agency as a gene therapy for the treatment of spinal muscular atrophy (SMA). This rare genetic disease affects approximately 1 in every 10,000 children, of which around 80 are born every year in Germany. Around 60% of those patients go onto develop the most severe form of the disease, SMA type 1. Owing to this genetic deficiency, the patient lacks the SMN1 gene that is necessary to produce the survival motor neurone (SMN) protein. This deficiency leads to progressive muscle weakness and paralysis, while those with untreated SMA type 1, 9 out of 10 children will either require permanent ventilation or will die before two years of age.

Zolgensma is administered intravenously as a single dose therapy and is able to replace the missing or nonworking SMN1 gene with a new gene to produce SMN protein that is necessary for muscle development in the whole body.

The health insurance funds and AveXis have undertaken joint financial responsibility for this innovative therapy and would like the costs of therapy adjusted to the benefits in real everyday care. Following approval gaining quick access for SMA patients to Zolgensma will be a top priority so that best possible outcome can be achieved through therapy.

GWQ ServicePlus AG is a health insurance company founded by service providers. It sees itself as a community of medium-sized health insurance funds with the aim of developing innovative solutions to improve the efficiency and quality of care for 50 sick funds with 9 million clients.

Queries on this story may be referred to Dr. Barthold Deiters, Head of Pharmaceuticals at GWQ.

Read the original press release on the GWQ website here.

Translation by MAP BioPharma

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Published 17. April 2020 in News, News Germany, Press Release