Since the Act for restructuring the drug market in the statutory health insurance (AMNOG) came into effect on 1 January 2011, new legal requirements have applied regarding the pricing of medicinal products in the outpatient sector. The price for medicinal products is now subject to negotiations between the pharmaceutical manufacturer and the GKV-SV. In general, two different price negotiation procedures apply, depending on whether innovative medicinal products (ie, with additional benefit) are concerned.
To identify additional benefit, medicinal products with new active ingredients or new areas of application are to be assessed by the G-BA in ‘early assessment procedures’. The G-BA is authorised to delegate the assessment to the Institute for Quality and Efficiency in Healthcare or to another third party. The assessment is based on a dossier that is drafted by the pharmaceutical manufacturer. The dossier must be submitted to the G-BA before the medicinal product is placed on the market for the first time. According to section 4(1) of the Ordinance for the Assessment of the Benefit of Drugs with New Active Ingredients (AM-NutzenV), the dossier must contain the following information:
- the authorised application areas;
- the medical benefits;
- the additional medical benefit compared with the suitable comparative therapy;
- the number of patients and patient groups for which the therapeutically meaningful additional benefit exists;
- the costs for the therapy to the statutory health insurance; and
- the conditions for application in the requested quality.
If the pharmaceutical manufacturer submits no dossier to the G-BA, the additional benefit is deemed not proven. Provided that a dossier has been submitted by the pharmaceutical manufacturer, the G-BA conducts the assessment procedure within three months. As a matter of course, the G-BA notifies the result of the assessment to the pharmaceutical manufacturer, and publishes it on its website as well.
According to section 2(4) of the AM-NutzenV, the additional benefit of a medicinal product is defined as any quantitatively or qualitatively improved patient-relevant therapeutic effect, compared with the effect of a suitable comparative therapy (such as improvement of health, reduction of illness duration, extension of survival, reduction of side effects or improvement of the quality of life). A suitable comparative therapy must usually be determined based on conditions that result from the international standards of evidence-based medicine. Provided that more alternatives exist, more economical therapy should be selected, preferably a therapy with a reference price.
The price for medicinal products without additional benefits is limited to the costs of the comparative therapy, either by including the medicinal product in the reference price system, or, if the requirements for reference price system are not fulfilled, by negotiating a respective price with the GKV-SV.
The price for medicinal products with additional benefit may be determined by the pharmaceutical manufacturer for a 12-month period, beginning when the medicinal product has been placed on the market. Within this 12-month period, the reimbursement amount is to be negotiated between the pharmaceutical manufacturer and the GKV-SV. This amount applies from the 13th month onwards.
According to section 130b of SGB V, the GKV-SV and the pharmaceutical manufacturer must conclude a contractual agreement on a reimbursement amount. This contractual agreement applies to all health funds; in other words, to the statutory health insurance funds and to the private insurance funds. If no agreement is reached within six months, an arbitration board becomes involved and decides within three months. The arbitration board consists of seven members: three independent members, two members from the GKV-SV and two members from the pharmaceutical manufacturer. The applicable legal provisions provide no benchmark on how the price shall be stipulated by the arbitration board. With respect to medicinal products with additional benefit, the sales price in other European countries shall be taken into account (section 130b(4) of SGB V).
Provided that orphan drugs pursuant to Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products are concerned, the additional benefit of the authorised orphan medicinal product does not have to be proven by the pharmaceutical manufacturer. According to sentence 10, section 130b(1) of SGB V, orphan medicinal products need not prove any medical benefit or any additional medical benefit compared with the suitable comparative therapy, since this is legally acknowledged for orphan medicinal products by the marketing authorisation.
However, this privilege does not apply to orphan medicinal products with a turnover in the statutory health insurance fund above €50 billion in the past 12 months. The turnover is calculated by considering the sales price including value added tax. In this case, the G-BA may request evidence from the pharmaceutical manufacturer within three months with respect to the additional benefit of the orphan medicinal product as under the above-mentioned procedure.
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