GKV-FKG Bill brings significant changes for cell & gene therapies in Germany

The Federal Ministry of Health in Germany (BMG) has recently introduced a bill which intends to reform the risk-pool RSA and open its funding mechanism for cell & gene therapies. It is also foreseen that risk-sharing contracts between the pharmaceutical industry and individual statutory health insurances (SHIs) will be subject to tighter scrutiny by the Bundesversicherungsamt (BVA). The Fair Choice of SHI-Health Insurance Law (GKV-FKG) is therefore another step to prepare the German system for the new generation of cell & gene therapies which are soon to be released in the European markets. A new risk-pool will be introduced in the RSA covering 80% of the costs of therapies which cost more than 100,000 EUR per patient per year.

Risk structure compensation pool (RSA)

SHIs have an unequal structure of insured persons: some have an above-average number of well-earning and healthy insured persons, others insure an above-average number of sick people and contributors with low incomes. Since 1994 there has been an equalisation of these risk differences between the health insurance funds, the so-called risk structure compensation in statutory health insurance (RSA).

Against the background of a free choice of health insurance funds for the insured and the simultaneous obligation of the health insurance funds not to reject anyone who is allowed to insure himself in the statutory health insurance (obligation to contract), the RSA is considered absolutely necessary in a system organised on a competitive basis in order to guarantee fair competitive conditions for the health insurance funds.

Disease selection in the RSA (morbi-RSA)

The morbidity-oriented RSA takes into account not only the characteristics of age, gender, receipt of a reduced earning capacity pension and entitlement to sickness benefit, but also the varying levels of care required by insured persons with a cost-intensive chronic or serious illness. In addition, the allocation system of the health fund will be used to compensate for the differences in the income subject to contributions between the members of the health insurance funds.

The new risk-pool of the GKV-FKG: Impact for cell & gene therapies

The risk-pool supplementing the RSA should decrease the financial burden for health insurances resulting from high-cost cases. This becomes increasingly important due to the growing number of high-priced medicines that might lead to full recovery or a long-term delay of the disease which yet are not relevant for the costs in the RSA. For this reason, the Ministry of Health intends to establish a risk-pool from which the SHIs can recoup 80% of the expenditure for each insured person in cases where treatment costs more than 100,000 EUR per year. Access to RSA funding was demanded by the SHIs mainly to fund the cell & gene therapies which are released to the German market soon. It is also foreseen that certain risk-sharing contracts between the pharmaceutical industry and individual health insurances will be subject to tighter scrutiny by the BVA which is another move of the German legislator to make its market ready for the next generation of cell & gene therapies in the pipeline.

The bill has to obtain approval by the German Bundestag and is not likely to enter into effect before the second half of 2019.

More details can be found here.

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Published 26. March 2019 in News, News Germany