Many medical device startups plan to obtain the CE mark for their product relatively quickly and launch in Germany. The problem has been getting those German Sickness Funds (payers) to provide reimbursement in a timely manner. However, a relatively new option is available for securing interim reimbursement for devices that are used outside the hospital in a physician’s office.
According to German law, innovative procedures and devices used in a physician office setting are not reimbursed, unless they have been officially approved following a positive determination by the federal joint committee (G-BA).
Unfortunately, the G-BA does not issue a positive determination before the procedure or device has been thoroughly tested and widely used in Germany and the manufacturer has amassed rigorous data demonstrating its value. Obviously, prior to obtaining reimbursement it would be very difficult to reach this threshold, creating a classic catch-22 situation.
According to the recently enacted law for the Restructuring of the Statutory Health Insurance (GKV-Versorgungsstrukturgesetz), instead of denying reimbursement for procedures or devices that do not yet fulfill all of the conditions required to meet the threshold, the G-BA can now decide to provide funding for a “controlled study.” Within the timeframe of the controlled study, the manufacturer may be able to reach the aforementioned threshold.
Funding for a controlled study may be granted for new medical diagnostic and treatment methods that have the potential to improve upon existing methods.
The proposed process is currently under review by the German Ministry of Health and the effective date for the programme will be finalised once it has been published in the Federal Gazette.
A manufacturer of a medical device used in a new medical diagnostic or treatment procedure may apply for a controlled study from the G-BA.
The application includes the following six sections:
- Section I – Administrative Information: name and address of applicant and contact person.
- Section II – Summary: description of the suggested new medical diagnostic or treatment method, relevant indications, target population, anticipated distribution in the German market and expected benefits.
- Section III – Information on the Medical Product: product description and technical instructions, comparable products, regulatory status and available clinical data.
- Section IV – Potential: the application should demonstrate by means of “meaningful documents,” such as published randomised controlled studies, the potential of the new medical diagnostic or treatment method as an alternative to existing methods.
- Section V – Key Elements of Proposed Study: This optional section describes the type of suggested study, relevant population, required sample size, appropriate comparative intervention, endpoints, duration and estimated costs.
- Section VI – Sponsorship and Completeness of Application: the application itself is free of charge; however, in this section the applicant also signs a letter of intent indicating a willingness to assume a fair share of the costs, such as the overhead associated with the controlled study. The Sickness Funds pay for the provision of the medical procedure.
The process also allows the applicant to submit a written request to the G-BA for a fee-based, nonbinding consultation to provide guidance on the preparation of an appropriate application. The guidance should be provided within eight weeks from submission and costs between €500 and €10,000, depending on its complexity.
The information provided during the consultation is confidential.
Within three months of submitting an application, the G-BA has to decide whether a controlled study would be appropriate and notify the applicant accordingly.
An approval at this stage typically would require evidence demonstrating the potential of the new medical diagnostic or treatment procedure to improve upon currently available methods. For example, it may reduce costs, be less invasive, have fewer potential side effects or eliminate other disadvantages of existing devices. In addition, it should be made clear to the G-BA that the proposed controlled study can generate needed evidence for integration of the new medical diagnostic or treatment procedure into the healthcare system.
For the scientific monitoring and evaluation of the controlled study, the G-BA may commission an independent academic institute. The institute will be responsible for designing the controlled study, which may also include required quality criteria.
After the estimated overhead costs of running the controlled study have been assessed, the applicant will need to submit a declaration of financial support and assume the obligation to conclude a funding agreement between the applicant, the G-BA and the involved scientific institute. This agreement, signed prior to initiation of the study, will describe who pays for what, how much and when.
Special discounts, which can amount to as much as 70% of the overall costs, may be granted to small and medium-size businesses (based on annual turnover and number of employees) and for new medical diagnostic or treatment procedures aimed at diagnosing or treating rare diseases.
Following a successful controlled study, the G-BA may decide to provide reimbursement for the new medical diagnostic or treatment method. The average duration of the administrative process is estimated at 29 months (excluding the time required for the controlled study). This may appear to be lengthy; however, it allows the company to validate its technology and provide evidence to show that it is using external resources. The generated evidence may also be used when approaching markets outside of Germany.
Beyond the chicken-and-egg dilemma
This recent change in the G-BA’s ability to perform more studies, instead of rejecting an application for reimbursement, especially for treatments or diagnostics used in a physician office setting, is good news for the medical technology industry. By providing a solution to the proverbial chicken-and-egg conundrum with which so many companies struggle, Germany has positioned itself as one of the world’s most—if not the most—innovative healthcare markets.