Germany’s HTA institute has used its statement on the GKV stabilisation bill to press for a tighter link between statutory health insurance spending, patient benefit and future pricing instruments.
The Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) has published its statement on the draft Statutory Health Insurance Contribution Rate Stabilisation Act (GKV-Beitragssatzstabilisierungsgesetz, GKV-BStabG), discussed separately in LiSAH’s article on the wider Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) bill. Its intervention supports the bill’s direction, but also argues for a larger role for evidence-based assessment in future expenditure control.
IQWiG welcomes the bill’s principle that statutory health insurance (gesetzliche Krankenversicherung, GKV) expenditure should stand in an appropriate relationship to patient benefit. That framing fits its own assessment remit, and the institute uses the consultation to argue that pricing and coverage policy should rely more directly on evidence of added benefit.
The statement supports the proposed removal of statutory reimbursement for homeopathic and anthroposophic medicines and services. IQWiG argues that GKV should fund only services that meet the generally accepted state of medical knowledge and reflect medical progress. It also notes that alternative medical procedures can be assessed for benefit if they are to be financed by the statutory system.
On patented medicines, IQWiG identifies the bill’s internal trade-off. The draft would abolish the 2022 rules that limited reimbursement-price negotiations under the Pharmaceuticals Market Reorganisation Act (Arzneimittelmarktneuordnungsgesetz, AMNOG) according to added benefit and comparator-treatment costs. Those rules were intended to prevent high prices where the added-benefit case was weak, but BMG has argued that their effect has not been clearly demonstrated and that fixed statutory ceilings left too little room for individual negotiation.
IQWiG recognises that removing those rules could create an additional financial burden for GKV. It therefore places weight on the proposed offsetting measures, including stronger price competition between therapeutically comparable patented medicines, price-volume rules and the new dynamic manufacturer discount.
The institute then goes beyond the bill. It argues that cost-benefit assessment could become an additional tool to support reimbursement-price negotiations. At present, such assessments are mainly reserved for failed negotiations and arbitration, and have not been used since AMNOG began. IQWiG suggests defining situations where cost-benefit assessment or expenditure-impact analysis should be mandatory.
IQWiG also criticises the bill for not addressing the orphan drug privilege. It argues that the current automatic benefit assumption does not fit the bill’s benefit-based spending principle, particularly where orphan medicines are launched in areas with existing treatment options.
The statement positions IQWiG as supportive of the bill’s move towards expenditure discipline, but not of a pricing framework based mainly on broader discounts and competition. Its preferred direction is a stronger formal link between reimbursement, demonstrated benefit and explicit assessment of value.
Source: Institute for Quality and Efficiency in Health Care, IQWiG
Links: Stellungnahme des IQWiG zum Gesetz zur Stabilisierung der Beitragssätze in der gesetzlichen Krankenversicherung (IQWiG statement on the act to stabilise contribution rates in statutory health insurance); Gesetz zur Stabilisierung der Beitragssätze in der gesetzlichen Krankenversicherung: Stellungnahme vom 20.04.2026 des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Act to stabilise contribution rates in statutory health insurance: statement of 20 April 2026 by the Institute for Quality and Efficiency in Health Care)
Date: 20 April 2026
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