A Shortcut to Medical Device Reimbursement in Germany - Physician Office

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Your innovative medical device is better for patients and for their healthcare systems. It will shortly be certified with the CE Mark, but those German payers (aka, sickness funds) require much more ‘evidence’ in order to reimburse it, that it would take a few more years (and a lot of money) to actually commercialize it.

However, there’s a shortcut. Following a recent change in German law, German sickness funds may now be able to provide funding for a ‘controlled study‘, during which the required ‘evidence’ could be gathered, at their expense.

This article, “A Shortcut to Medical Device Reimbursement in Germany - Experimental Coverage in the Physician’s Office”, explains this new option in plain English.

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A Shortcut to Medical Device Reimbursement in Germany - Physician Office

  1. 1. www.mediclever.comUK: 27 Old Gloucester St.,London WC1N 3AX: uk@mediclever.com: +44.208.099.7435US: 616 Corporate Way, Suite 2-4683,Valley Cottage, NY 10989: us@mediclever.com: +1.845.570.2910Israel: 6 Te’ena St.,Modiin 71799: il@mediclever.com: +972.50.837.1711A SHORTCUT TO MEDICAL DEVICEA SHORTCUT TO MEDICAL DEVICEA SHORTCUT TO MEDICAL DEVICEA SHORTCUT TO MEDICAL DEVICEREIMBURSEMENT IN GERMANYREIMBURSEMENT IN GERMANYREIMBURSEMENT IN GERMANYREIMBURSEMENT IN GERMANYExperimental Coverage in the Physician’s OfficeOver the last 7 years, we have provided consulting services to more than 100different medical device startups. Some of which have planned to obtain the CEMark for their product relatively quickly and prepared to launch it in Germany.The problem was getting those German Sickness Funds (Payers) to pay for it –and fast.In one of our previous articles (http://www.mediclever.com/resources/5.pdf), wediscussed a possible reimbursement shortcut for medical devices that are beingused in the hospital inpatient setting. We present in this article a relatively newoption of securing interim reimbursement for devices that are also being usedoutside the hospital – in the physician’s office setting.1. The ProblemAccording to German law, innovative procedures and devices, utilized in thephysician’s office setting, are not reimbursed, unless they have been officiallyapproved following a positive reimbursement determination by the federal jointcommittee (G-BA).Unfortunately, an innovative procedure or devicewill not be issued a positive reimbursementdetermination from the G-BA unless it is in wideuse in Germany, has been thoroughly tested andcomes with rigorous data demonstrating its value.Obviously, prior to obtaining reimbursement itwould be very difficult to obtain this criteria, andtherefore innovative procedures and devices maynever obtain reimbursement, which make a cycleunable to fulfill. Another Catch-22…2. The SolutionAccording to the recently enacted law for the Restructuring of the StatutoryHealth Insurance (GKV-Versorgungsstrukturgesetz), instead of denyingreimbursement from procedures or devices that do not yet fulfill the requiredthreshold, the G-BA can now decide to provide funding for a ‘controlled study‘,during which time the above threshold may be achieved.
  2. 2. A Shortcut to Medical Device Reimbursement in Germany Page 2/4Experimental Coverage in the Physician’s Officewww.mediclever.comUK: 27 Old Gloucester St.,London WC1N 3AX: uk@mediclever.com: +44.208.099.7435US: 616 Corporate Way, Suite 2-4683,Valley Cottage, NY 10989: us@mediclever.com: +1.845.570.2910Israel: 6 Te’ena St.,Modiin 71799: il@mediclever.com: +972.50.837.1711Funding for such a ‘controlled study‘ may be granted to new medical diagnosticand treatment methods which present a potential for providing a better diagnosticand treatment method, compared with the current alternatives.The proposed process is currently under review by the German Ministry of Healthand the effective date for the program will only be finalized once it is published inthe Federal Gazette.3. The Processa. ApplicationA manufacturer of a medical device, utilized for the provision ofa new medical diagnostic or treatment procedure, may applyfor a ‘controlled study’ from the G-BA.The application includes the following 6 sections:Section I - Administrative Information:Name and address of applicant and contact person.Section II – Summary:Description of the suggested new medical diagnostic or treatmentmethod, relevant indication, target population, expected diffusion inthe German market and expected benefits.Section III – Information on Medical Product:Product description and technical instructions, comparableproducts, regulatory status and available clinical data.Section IV – Potential:The application should demonstrate by "meaningful documents" such as publishedarticles of randomized controlled studies, the potential of the new medical diagnostic ortreatment method as a treatment alternative.Section V – Key Elements of Proposed Study:This optional section describes the type of the suggested study, relevant population,required sample size, appropriate comparative intervention, endpoints, duration andestimated costs.Section VI - Sponsorship and Completeness of ApplicationThe application itself is free of charge, however, in this section the applicant also signsa letter of intent, indicating its willingness to assume its fair share of the costs, such asthe overhead costs associated with the ‘controlled study’, while the Sickness Fundspay for the provision of the medical procedure.a. Application- Manufacturer/Supplierb. InitialAssessment- G-BAc. Study Plan- ScientificInstituted. Re-Assessment- G-BA
  3. 3. A Shortcut to Medical Device Reimbursement in Germany Page 3/4Experimental Coverage in the Physician’s Officewww.mediclever.comUK: 27 Old Gloucester St.,London WC1N 3AX: uk@mediclever.com: +44.208.099.7435US: 616 Corporate Way, Suite 2-4683,Valley Cottage, NY 10989: us@mediclever.com: +1.845.570.2910Israel: 6 Te’ena St.,Modiin 71799: il@mediclever.com: +972.50.837.1711The process also allows the applicant to submit the G-BA with a written requestfor a fee-based, non-binding consultation to provide guidance on the preparationof an appropriate application. The guidance should be provided within 8 weeksfrom submission and costs between €500 and €10,000, depending on itscomplexity.The information provided during the consultation is confidential.b. Initial AssessmentWithin 3 months of submitting an application, the G-BA has todecide whether a ‘controlled study’ would be appropriate andnotify the applicant accordingly.An approval as this stage would typically require sufficientevidence, which demonstrate how the new medical diagnosticor treatment procedure presents a potential to replace currentlyavailable alternative methods which may be more expensive,more invasive, result in more side effects or feature any otherdisadvantages. In addition, it should be clear to the G-BA thatthe proposed ‘controlled study’ could generate the missingevidence in order to integrate the new medical diagnostic ortreatment procedure into the healthcare system.c. Study PlanFor the scientific monitoring and evaluation of the ‘controlledstudy’, the G-BA may commission an independent academicinstitute. The institute will be responsible for designing the‘controlled study’, which may also include required qualitycriteria.After the estimated overhead costs of running the ‘controlledstudy’ have been assessed, the applicant will need to submit adeclaration of financial support and assume the obligation toconclude a funding agreement between the applicant, the G-BA and the involved scientific institute. This agreement, signedprior to the initiation of the study, will describe who pays forwhat, how much and when.Special discounts, of up to 70% of overall costs, may begranted to small and medium size businesses (categorizedaccording to annual turnover and number of employees) and also for newmedical diagnostic or treatment procedures aimed at diagnosing or treating rarediseases.a. Application- Manufacturer/Supplierb. InitialAssessment- G-BAc. Study Plan- ScientificInstituted. Re-Assessment- G-BAa. Application- Manufacturer/Supplierb. InitialAssessment- G-BAc. Study Plan- ScientificInstituted. Re-Assessment- G-BA
  4. 4. A Shortcut to Medical Device Reimbursement in Germany Page 4/4Experimental Coverage in the Physician’s Officewww.mediclever.comUK: 27 Old Gloucester St.,London WC1N 3AX: uk@mediclever.com: +44.208.099.7435US: 616 Corporate Way, Suite 2-4683,Valley Cottage, NY 10989: us@mediclever.com: +1.845.570.2910Israel: 6 Te’ena St.,Modiin 71799: il@mediclever.com: +972.50.837.1711d. Re-AssessmentFollowing a successful ‘controlled study’, the G-BA may decideto provide reimbursement for the new medical diagnostic ortreatment method. The average duration of the administrativeprocess is estimated at 29 months (excluding the time period ofthe ‘controlled study’). This may appear a long time, however itallows the company to validate its technology and provide theevidence to prove it using external resources. The generatedevidence may also be used when approaching other markets,outside of Germany.4. ConclusionThis recent change in the G-BA’s ability to perform more studies, instead ofrejecting an application for reimbursement, especially in the physician’s officesetting, is good news for the industry. By providing a solution to the notorious‘chicken and egg’ situation that so many companies have been struggling with,Germany positions itself as one of the most, if not the most, innovativehealthcare market worldwide.Amir Inbar, CEOMediclever Reimbursement Consultantswww.mediclever.comamir@mediclever.comAmir Inbar is the founder and CEO of Mediclever Reimbursement Consultants(www.mediclever.com), which provides end-to-end reimbursement consulting services tolife-science companies, selling pharmaceuticals and medical devices in the USA, Europeand Australia.With a chain of over 30 experts throughout the world, and with more than 130 clientsworldwide, Mediclever assumes full responsibility for the reimbursement ofpharmaceuticals and medical devices, from early strategy development to theestablishment of specific codes, payment rates and favorable coverage.Mediclever consultants have experience in preparing value dossiers and other valuecommunication tools, performing pricing and reimbursement assessments, creating toolsfor health economic modeling and developing market access strategies.c. Study Plan- ScientificInstituted. Re-Assessment- G-BA

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