Pharma Price Negotiations and Reimbursement Hurdles in Germany

March 29, 2021

Negotiating the prices of Advanced Therapy Medicinal Products (ATMPs) is a challenging and convoluted process in Germany. The majority of these approved products are orphan drugs, meaning only a relatively small amount of long-term data are available. As a result, determining drug benefits is a tough task, along with price negotiations. The Federal Joint Committee serves as an HTA (health technology assessment) organization, similar to ICER, in assessing value.

Kuchenbecker et al. note, “The challenges for a successful way to the market for ATMPs are mainly two: the assessment of evidence by the regulator and the affordability to payers. Manufacturers should prepare for the G-BA [the Federal Joint Committee] to implement mandatory disease registries in cases of non-conclusive evidence at the time of market launch. The G-BA will be part of setting up the methods and requirements for these individual registries, and this will likely become the standard for ATMPs. ATMP price will be significantly reduced over time if a company is non-compliant in setting up a real-world registry. From the payer perspective, the use of real-world evidence data is anticipated to rise significantly. Pay-for-performance agreements linked to clinical outcomes of a drug will rise, but discounts and other specifics of the contract will most likely remain confidential.” Read more here.