Reimbursement in Regenerative Medicine/stem cell therapy

At the Clinic for Cardiac Surgery, the treatment with stem cells in the case of heart diseases is handled as an innovative therapy according to the DRG-reimbursement system by means of a flat charge. Hence, already now patients have the chance to benefit from stem cell therapy.

Most new therapies in regenerative medicine – including stem cell preparations – can be classified as “Advanced Therapy Medicina Products” (ATMP). With the new ATMP-regulation coming into effect in January 2009, these products require a central approval procedure – unless they fall under the special regulation of the “hospital exemption” ( Regulatory). As approved products (from 2012 all products will need approval) they will be directly available for patients, i.e., application of these products will be reimbursed by the compulsory health insurance funds.

After completion of the clinical Phase III study, the RTC plans to apply for approval of the cardiac stem cell therapy which was developed at RTC over the past years. After approval will be granted, costs for the therapy will generally be covered by the compulsory health insurance funds.

However, for medicines for novel therapies, which fall under the special rules of the regulation (“hospital exemption”) as well as for products, which do not (yet) require approval, a reimbursement by the compulsory health insurance funds cannot be guaranteed. For those innovative medicines, individual applications for reimbursement will need to be sent to the corresponding insurance fund, supported by suitable documents and studies.

In the next few years, the RTC-team will consider reimbursement procedures for innovations in the field of stem cell therapy and regenerative medicine in detail in the frame of the joint research project “Added value in regenerative medicine – a pilot project for the reduction of translation obstacles”. The overall aim of these efforts will be to make the introduction of new therapies safe and transparent for all parties involved.

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Reimbursement for medicines which require approval

After approval or authorisation a drug may immediately be placed on the market. Whether this will also mean that it is available to all patients will depend on whether its use will also be reimbursed by the compulsory health insurance funds. Contrary to the well developed harmonisation of the European Laws for medicines, reimbursement issues are treated separately by each nation. In Germany, corresponding issues are regulated in the “Sozialgesetzbuch V” (SGB V).

According to this, members of the compulsory health insurance funds are entitled to be supplied with approved medicines. Those need to be sufficient, appropriate, and economical. Whether a novel medicine is included in the so called “Leistungskatalog” (= list of available services and medicines) is decided by the Gemeinsame Bundesausschuss (G-BA). In order to evaluate new medicines, the G-BA may ask the Institute for Quality and Efficiency in Health Care (IQWIG) to conduct a cost-benefit analysis. This includes the comparison of the new medicine with alternative drugs or therapies under the consideration of its added therapeutical value and its costs.

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Reimbursement of innovations

The Reimbursement of medical innovations, which have not yet received market approval, is typically elaborate and often not very transparent. In general, such innovations are also evaluated according on the basis of its economics/profitability. Applications for reimbursement are considered by the health insurance funds, either by physicians employed by the funds or by specialists of the „Medizinischen Dienstes der Kassen“ (MDK). In single cases, the G-BA could also be involved in the decision.

For the evaluation it matters whether the product is to be applied in the clinical or ambulant sector.
In the clinical sector, permission is granted subject to prohibition. There is the possibility, that the new medicine or therapy is accepted as a “NUB- (Neue Untersuchungs- und Behandlungsmethoden – new examination and treatment methods)”-application to G-BA or to the  Institute for the Hospital Remuneration System (InEK GmbH) as “Diagnosis Related Groups” (DRG). In the frame of the DRG-compensation system, each clinical therapy case is compensated for on the basis of a flat charge. The associations of the compulsory as well as private health insurance funds have decided that DRG-applications are handled by InEK GmbH. In cases where applications are declined, there are compensation possibilities based on contracts, model projects, or on a private basis.

In the ambulant sector, prohibition is granted subject to permission. Here, the question is whether the service is included in the  EBM (Einheitlicher Bewertungsmaßstab der Kassenärztlichen Bundesvereinigung). If not, there may be alternative possibilities, e.g., model projects.

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