Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in the SHI reimbursement fee scale EBM.
In the past, the inclusion of new diagnostic tests in the EBM was not transparent, with unclear timelines and requirements and manufacturers were unable to drive the process. As of July 2019, organizations of medical professional associations and medical societies at the federal level, national associations of manufacturers of diagnostic services or medical devices, as well as the stakeholders in evaluation committees are now entitled to apply at the start of the consultation to accept new medical diagnostic services to the EBM. Available scientific evidence and expectations of budget impact and economic efficiency has to be submitted to inform decision making on the medical background and technical aspects of the test. The duration of the process is up to 24 months, with a one-time possibility for an extension of 6 months.
Within 4 months after the submission, the applicant will be informed about the status of the test: whether it is already included in the EBM, if the test can undergo the inclusion process, or if the new test is regarded as a new scientific method. In this case, a formal lengthy method assessment by the G-BA would be required.
If the diagnostic test is required as a companion diagnostic (CDx) on the label of a new a drug, the CDx has be included in the fee scale when the AMNOG early benefit assessment of the drug is completed, which is 6 months after the drug approval.
This new evaluation process supports manufacturers’ strategic planning and defines the criteria and requirements for positive decision making. The novelty of this standardized process implies that experience in practice is still necessary.
BHA can guide manufacturers through the process and forms. 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.