PHP43 - EVIDENCE FOR HIGH RISK CLASS MEDICAL DEVICES VERSUS NEW DRUGS IN GERMANY: WHAT’S THE DIFFERENCE?

Abstract

In 2011 an evaluation process (AMNOG) for new drugs was newly implemented in Germany. Since then the evidence requirements follow high standards and results impact reimbursement price negotiations with health insurances. More recently, in 2016, a legal norm (§137h SGBV) to evaluate new treatment and diagnostic methods (MDs) of high risk classes by the Federal Joint Committee (G-BA) was introduced. The requirements, involved stakeholders, timing and setting for these pathways is outlined and compared. Methodological guidelines from G-BA and Institute for Quality and Efficiency in Health Care (IQWiG), consultations and evaluations for MDs according to §137h and for drugs according to AMNOG were reviewed and compared. Published assessment results were analyzed according the decision criteria and possible impact on price negotiations with Statutory Health Insurance (SHI). New high risk class MDs to be used in hospital fall under §137h. Hospitals need to submit jointly with the manufacturer comparative evidence on clinical efficacy, safety, cost, epidemiology versus current methods when applying for additional compensation (NUB application). A fast track assessment by IQWiG/G-BA follows within four months resulting in benefit proven, potential benefit or no benefit compared to alternatives. The latter can lead to exclusion from reimbursement. Until now 2 treatments were assigned a potential benefit while no MD was granted a benefit. Compared to AMNOG for drugs in the outpatient sector, the required evidence for MDs seems to be similar. Whereas assessment time is shorter, manufacturer can seek advice from G-BA upfront for free and need to collaborate closely with hospitals. Similarly as drugs evaluated under AMNOG the majority of new MDs failed to be granted potential benefit as a treatment alternative and unlike might be excluded from reimbursement. Manufacturers are challenged to generate higher and ideally comparative evidence within their studies. Respective advice should be sought at an early stage.