Abstracts by keywords: Orphan drugs
The aim of the study is to precisely examine the population-normalized treatment costs of orphan drugs. For this purpose, a study examining the treatment costs of orphan drugs for the years 2005 to 2021 was already conducted in 2022. The calculations have now been validated as part of a study update using the identical population. The update enabled inflation adjustment based on the 2022 price index as well as seamless treatment costs after AMNOG assessment and price negotiations for all orphan drugs. The analysis shows that AMNOG fulfills its function as a price regulation instrument for orphan drugs as well. Since the introduction of AMNOG, the inflation-adjusted normalized treatment costs for orphan drugs have decreased both in terms of the introductory price (minus 25% of the total) and the reimbursement amount (minus 6% of the total).
03.06.2024
For drugs for the treatment of rare diseases (orphan drugs), the requirements of early benefit assessment according to Section 35a SGB V represent a particular challenge. The Institute for Quality and Efficiency in Health Care (IQWiG) concludes in working paper GA21-01 on orphan drugs, which are in the As part of a re-evaluation of a regular benefit assessment, the additional benefit of the initial benefit assessment for market access was fictitious.
02.04.2023
The abolition of the supplementary federal subsidy in 2023, which will provide an additional 14 billion euros in the coffers of statutory health insurance (GKV) in 2022 (Bundestag 2021), thus increasing the total amount to 28.5 billion euros, gave rise to a debate about the impending funding gap for statutory health insurance in 2023. The question therefore arises as to which measures are suitable to enable targeted expenditure control in the statutory health insurance. The federal government's draft law for the financial stabilization of statutory health insurance (Federal Ministry of Health 2022) lists a number of measures that are intended to realize efficiency reserves without benefit cuts amounting to around 3 billion euros for 2023. For example, the sales threshold for drugs to treat a rare disease (orphan drugs) for the benefit assessment is to be reduced to 20 million euros.