Germany’s HTA Process Changes

How has the role of Access within the life science sector changed? How has this altered the capabilities needed to succeed?

In July, the Health Ministry in Germany published a draft of a new bill referred to as the Act for Financial Stability of the Public Health Insurance (GKV-FinStG). Despite strong opposition and critique raised by almost all stakeholders, the draft law was agreed upon by the Federal Cabinet on July 27th.

The main changes to the German pricing and reimbursement process are as follows:

- The shortening of the free price-setting and warranted reimbursement period from 1 year to 6 months. The final price negotiated between the manufacturer and the GKV-SV should be applied retroactively from month seven after launch onwards. Currently, the price applies from month 13 onwards.

- The orphan medicine threshold is lowered. A full early benefit assessment will be triggered for orphan drugs when annual sales exceed a €20mn threshold, instead of the current €50mn.

- An additional mandatory 20% rebate for combination products with new compounds will be applied.

- Price negotiations can now include price-volume agreements or caps on annual prescription volumes.

- The setup of a “solidarity fund” of €1 billion yearly for 2023 & 2024: Companies obtaining reimbursement within the statutory health insurance system for orphan drugs and patented medicines will have to contribute to the fund based on their sales within the system.

- The price freeze will be extended for another four years after 31 December 2022. The price freeze was introduced back in 2010 and allows only very limited, or “inflation-reflecting” reimbursement of price increases for medicines. Following the most recent extension in 2017 for another five years, the price moratorium was expected to expire in 2022.

- Penalties will be introduced for uneconomical pack sizes.

- Mandatory rebate on patent-protected drugs outside the reference pricing system will increase from 7% to 12% for one year.

- Medicines judged by the body to offer “minor” or “nonquantifiable additional benefit” would be priced in line with patent-protected comparators, those that offer “no additional benefit” would generally be priced lower, those that have “considerable” or “major additional benefit” will be exempt from these guidelines.

- The discount which manufacturers are obliged to grant to SHI funds increases from the current 7% to 19% in 2023, and then will gradually reduce again to 10% by 2026.

- The mandatory discount that pharmacies must grant SHI funds increases from €1.77 to €2.00.

- The price cap for products outside of reference price groups has been extended to the end of 2026.

- The VAT on drugs will be reduced from 19% to 7%.

🧩These changes in Germany illustrate the dynamic nature of the complex environment we work within.

At Decisive, we are here to support your team in understanding global changes and to develop bespoke launch and market access strategies to optimize patient access.

If you have any questions about any of these changes, please feel free to reach out!

Written by Carmen Neier