17 out of 25 new drugs have an additional benefit

Berlin - So far, discounts have been set for 13 new drugs as result of the drug market reform act (AMNOG). This can be seen from the figures of the one who negotiates the discounts with the manufacturing companies. The negotiating partners only called the arbitration board once - they reached an agreement twelve times in the negotiations. For the Kassenverband, this is sign that the system works: "The facts show that fair balance between the interests of the pharmaceutical industry and the health insurers on new drugs is possible through negotiation."

That AMNOG stipulates that the manufacturing companies are only allowed to set the prices for new drugs themselves for one year. After that, the prices that you negotiated with the National Association of Statutory Health Insurance Funds apply. The basis of the negotiations is an early benefit assessment by the (G-BA), which compares the new drug with so-called appropriate comparative therapy.

According to the National Association of Statutory Health Insurance Funds, the G-BA has carried out 25 early benefit assessments to date. He certified an additional benefit in 17 cases - considerable additional benefit in five cases and minor additional benefit in nine cases. In two cases, an added benefit was not quantifiable. “At first it was expected that only about every fifth new drug would have an additional benefit,” said the National Association of Statutory Health Insurance Funds. In this respect, this result is better than expected.

The (vfa) is less satisfied with the implementation of the AMNOG. "Our member companies perceive the process as one-sided and unsatisfactory," said vfa Managing Director Birgit Fischer to the German Medical Journal. "The focus of politics must not be directed solely to savings at any price, but should promote opportunities through innovations." In this respect, scientific benefit assessment must make the reality of supply binding standard, take into account the approval procedures equally and only negotiate the discounts in second procedure .

Pharmaceutical industry criticizes selection of comparator therapy Pharmaceutical associations had criticized the AMNOG procedure in particular for the fact that inexpensive generics were used for the appropriate comparator therapy and that part of the price negotiations were already anticipated in this way .

The National Association of Statutory Health Insurance Funds takes different view. On the one hand, the G-BA used seven criteria as filter when determining the comparative therapy. And profitability is only applied as the last filter. And on the other hand, the appropriate comparative therapy is not just in the cent range, as is often shown. For oncological drugs or immunosuppressants, the price is in the range of many thousands of euros.

Both the pharmaceutical and the cash register side name various aspects that they believe still need to be improved in the process. "The list of problems with the early benefit assessment is unfortunately still quite long," says Fischer. They range from the inadequate interaction between approval and early benefit assessment to the selection of comparative therapy and the classification of the additional benefit to the criteria for setting the reimbursement amount.

The National Association of Statutory Health Insurance Funds criticizes in particular that "the associations of pharmaceutical companies and the Trade delay the technical implementation since the first reimbursement amount is due ", so that no savings have become financially effective up to now". The association demands that the negotiated reimbursement amount be used as reference value, from which, for example, the manufacturer's discount, the sales surcharges for pharmacies and wholesalers or the co-payments from patients.

The pharmaceutical companies, on the other hand, want theirs for this purpose Use the selected manufacturer's selling price because, as the National Association of Statutory Health Insurance Funds puts it, “fear the price transparency ... that would come about with the publication of the agreed discounts”.