Federal Health Minister Proposes Independent Medical Review Board
For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could lead to new opportunities for market access of their products.
The Federal Ministry of Health in Germany is seeking to reform the regional medical review boards of the SHI funds (Medizinischer Dienst der Krankenversicherung – MDK), and the medical review board of the National Association of SHI funds (Medizinischer Dienst des Spitzenverbandes der Krankenkassen – MDS). The verification of hospital bills and assessment of medical necessity, efficacy, and efficiency of inpatient treatments are amongst a range of areas under review.
Currently, these review boards are organized as working groups of the SHI funds, with questions raised as to the level of independent advice provided. A draft bill presented by the Federal Ministry of Health plans to convert the MDK/MDS into an independent body and broadens representatives on the board to include patients, consumers, physicians, and nursing professions.
The MDK/MDS undertakes case-by-case reviews procedures, which are not covered regularly by the SHI. Both groups also conduct internal SHI reviews (not published) of new treatment and diagnostic methods. Independent recommendations, which are not influenced by the financial interests of the SHI funds, could lead to fewer rejected applications for cost assumptions, and more clinical driven decisions in the NUB process.
If the proposed change becomes law, it will establish the MDK/MDS as an independent assessment body in addition to the IQWiG and IQTIG, with direct implications for reimbursement decision making. An increase in transparency of decision-making could also be expected.
Boston Healthcare has successfully guided hundreds of life science clients from around the world in commercializing their medical devices in Germany. To learn more, please contact us.
From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA evaluated a total of 166 Dossiers - 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already reimbursed, and 25 to other types of negotiations.
The field of DTx has gained traction over the last couple of years, with FDA approvals/clearances, the founding of a DTx specialty society, large-scale acquisitions of DTx firms, pharma investments in DTx, and pharma co-development deals, amongst other key developments.