On 30 January 2019 the Federal Cabinet adopted the draft of an Act for More Safety in the Supply of Pharmaceuticals (Gesetz für mehr Sicherheit in der Arzneimittelversorgung – GSAV). The following overview lines up the changes in the distribution and pricing of pharmaceuticals for the specific treatment of clotting factors in cases of haemophilia.
The first reading of the cabinet draft in the lower house of the German Parliament (Bundestag) is scheduled to take place in April. The essential parts of the Act, which requires approval, are planned to enter into force on 1 July 2019.
Conversion of the distribution channel and the emergency supply
Pursuant to an amendment of section 47(1) sent. 1 no. 2 a) of the Medicinal Products Act (AMG), all pharmaceuticals for the specific treatment of blood clotting disorders in haemophiliacs will be routed to a uniform distribution channel via the pharmacies. It would therefore no longer be possible to deliver plasmatic and recombinant clotting factor preparations directly to physicians and hospitals as is presently the case. The only exception from the distribution channel via the pharmacies is for blood preparations obtained from human blood.
In order to secure emergency treatment of haemophiliacs, however, specialised medical facilities are to have an emergency supply of haemophilia treatment products on hand which can be dispensed to patients. In case of emergencies, these stored pharmaceuticals may be dispensed by a haemostaseologically qualified physician to patients or other healthcare facilities pursuant to section 43(3a) Medicinal Products Act in the government draft (AMG Reg-E). Likewise, it would be possible for a hospital pharmacy to organise an emergency supply and dispense it pursuant to section 11(2a) Pharmacy Act in the government draft (ApoG Reg-E.). An additional transition period until the changes in the distribution channel in the Medicinal Products Act and the Pharmacy Act enter into force of one year as of the promulgation of the Act for More Safety in the Supply of Pharmaceuticals is provided for in Article 22(3) of the government draft (GSAV-Reg-E).
Changes in pricing
Moreover, under the new section 130d German Social Security Code, Book V in the government draft (SGB V Reg-E), the pharmaceutical entrepreneurs in the Central Federal Association of the Health Insurance Funds (GKV-Spitzenverband) must notify a volume-weighted arithmetical average price as the manufacturer’s price for haemophilia treatment products within three months as of the end of the month in which the Act for More Safety in the Supply of Pharmaceuticals is promulgated. This is calculated from the prices actually agreed upon for 2017 and 2018 for direct dispensing pursuant to section 47(1) sentence 1 no. 2 a) Medicinal Products Act. Excepted from this are pharmaceuticals under the Act on the Reorganisation of the Medicinal Products Market (AMNOG) with reimbursement value.
At the same time, the social health insurance funds have to notify the prices billed, as well as the quantities involved in direct purchases, for 2017 and 2018 to the Central Federal Association of the Health Insurance Funds, which must then examine the plausibility of the sales prices notified by the manufacturers on the basis of the new regulations. If the pharmaceutical entrepreneur fails to fulfil this notification duty or if doubts exist as to the plausibility of the information given, the Central Federal Association of the Health Insurance Funds will set the manufacturer’s price, possibly after the pharmaceutical entrepreneur has submitted a statement.
The price that is ascertained is to apply 12 months after the end of the month in which the Act for More Safety in the Supply of Pharmaceuticals is promulgated. More detailed regulations will be adopted by the Central Federal Association of the Health Insurance Funds in consultation with the relevant manufacturers’ associations. The government draft does not indicate exactly what powers of codetermination the manufacturers organisations will have in this respect. Legal actions against the setting of the manufacturer’s price do not have a suspensory effect. No preliminary proceedings will be conducted.
Due to the proceedings defined by the expanded section 130d German Social Security Code, Book V for the recalculation of list prices for clotting factors, section 130a(3a) German Social Security Code, Book V determines that the manufacturer’s discount will be set pursuant to the average price level determined by the pharmaceuticals company, following the new regulations.
Special termination right for a reimbursement value agreement
Additionally, due to the new regulation of the distribution channel and the pricing of plasmatic and recombinant clotting factor preparations, a limited-term special termination right for a reimbursement value agreement or arbitral award is regulated in a new paragraph 7a of section 130b German Social Security Code, Book V. In the case of a termination, a new reimbursement value is to be agreed upon without delay.
Introduction of a new authorisation to conclude healthcare agreements with haemophilia centres
Finally, a new section 132i German Social Security Code, Book V in the government draft makes it possible for health insurance funds and haemophilia centres to conclude healthcare agreements on the treatment of haemophilia patients. These agreements are to regulate the remuneration of additional, special medical expenses for treatment and care, specifically, remuneration for:
- assistance in and monitoring of self-treatment,
- documentation pursuant to section 14 German Transfusion Act (TFG),
- notification to the German haemophilia registry (Deutsches Hämophilieregister) pursuant to section 21(1a) German Transfusion Act, as well as
- emergency care and treatment.
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