Special Case Germany: G-BA, IQWiG, GKV

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A special case of  "Market Access" exists in Germany in the institutions "G-BA" [Joint Federal Committee - www.g-ba.de ] and the IQWiG [Institute for Quality and Efficiency In the German healthcare sector - www.iqwig.de ]. However, the GKV-Spitzenverband (www.gkv-spitzenverband.de/startseite/startseite.jsp ) is the representative body of the "Key Payers":

"The GKV-Spitzenverband is the central interest representation of the statutory health insurance funds in Germany and on a European and international level, creating the framework for intensive competition for quality and profitability in health and nursing care at the center of his actions ".

And: In its mandate, the GKV refers to the AMNOG (German Reorganization Act - Arzneimittelneuordnungsgesetz). "The focus of AMNOG on 22 December 2010 is to ensure an appropriate, high-quality and economic drug supply. The legislature has mandated the GKV-Spitzenverband to ensure that the supply of new patent-protected medicines at reasonable costs for statutory health insurance is provided. Fair, means for us that the prices of the new medicines are based on the additional benefit for the patients and not on the wishes of the companies".

The benefit assessment of medicinal products according to § 35a SGB V

Since January 1, 2011, the Joint Federal Committee (G-BA) has the legal task of carrying out an (additional) benefit assessment for all newly registered drugs with new active substances immediately after market entry (§ 35a SGB V). The result is the basis for the decision on how much the statutory health insurance pays for a new drug with a new active substance.

The order for (early) benefit evaluation was given to the G-BA through the Act on the Reorganization of the Pharmaceutical Market (AMNOG)!

The law, which entered into force with effect from January 1, 2011, obliges pharmaceutical companies to submit a dossier for the benefit of the preparation already for the launch of a new product in Germany or for the approval of new fields of application / indications.

The tasks of the G-BA according to AMNOG

The G-BA evaluates within a period of 3 months after the marketing authorization of a new medicinal product whether any added medicinal benefit is verifiable in comparison to appropriate comparative therapy.

To this end, the manufacturers shall submit a dossier to the G-BA on the basis of the approval documents and any studies on the medicinal products, which must demonstrate an additional benefit of the medicinal product compared to a pre-determined, appropriate comparative therapy. This dossier must be submitted to the G-BA (format and structure of the dossier, documents to be submitted, specifications for technical standards):

Annex II.1: Preparation and submission of a dossier for the benefit assessment according to § 35a SGB ​​V

Annex II.2: Module 1 - Dossier Presentation: Summary of the statements in the dossier

Annex II.3: Module 1 Annex - Checklist to check the formal completeness of the dossier

Appendix II.4: Module 2 - General information on the medicinal product, authorized use

Annex II.5: Module 3 - Appropriate comparative therapy, number of patients with therapeutically significant additional benefits, costs of therapy for GKV, requirements for a quality-assured application

Annex II.6: Module 4 - Medical benefits and medical add-on-benefits, patient groups with therapeutically significant additional benefits

Annex III - Submission to submit a written opinion on the benefit assessment according to § 35a SGB V

Annex V - Application for exemption from the benefit assessment in accordance with Section 35a (1a) SGB V i.V.m. Chapter 5 § 15 of the German Constitutional Court (VerfO) for the insignificance of finished medicinal products

Annex VI - Dossier for the benefit assessment in accordance with § 35a SGB V (for medicinal products comparable to pharmacological and therapeutic drugs with fixed-dose medicinal products)

Annex VI.1: Document presentation Dossier for the benefit assessment in accordance with § 35a SGB V (for medicinal products comparable to pharmacologically and therapeutically comparable drugs with fixed-dose medicinal products)

Annex VI.2: Checklist for the examination of the formal completeness of the dossier (for medicinal products comparable to pharmacological and therapeutic medicinal products with fixed-dose medicinal products)

The G-BA can commission the Institute for Quality and Efficiency in Health Care (IQWiG) or third parties with the benefit assessments.

The results of the benefit assessments are published on the Internet, and pharmaceutical entrepreneurs, associations and experts will have the opportunity to comment on the results in writing and orally.

After further 3 months, the G-BA decides on the basis of the benefit assessment and the comments received, which mainly include statements on the extent of the additional benefit, on the patient groups eligible for treatment, on requirements for quality assured use and on the treatment costs of the Medicinal product.

With this decision, which will also be published promptly, the G-BA also decides on the further pricing procedure for the new drug.

In the case of medicinal products with proven excipients, the GKV-Spitzenverband and the respective pharmaceutical company then negotiate a reimbursement amount for the statutory health insurance within 6 months as a discount to the original price determined by the company itself.

If no agreement is reached in the hearing, an arbitration committee shall fix the amount of reimbursement. The benchmark is the European price level.

If the G-BA comes to the conclusion that the new drug is effective against the appropriate comparator therapy (preferably a therapy, for endpoint studies and which has proven itself in practice) has no additional use, it will be transferred to the fixed-income system within 6 months after market launch.

If a medicinal product cannot be allocated to a fixed-income group without additional benefits, a reimbursement amount is also agreed, but the costs for the year are not higher than in the case of appropriate comparative therapy.

Bis 2016_Verfahren G-BA nach § 35 SGB V

GBA_Verfahren_bis_2016.pdf (64.6 KiB)

DGHO_2014_Frühe_Nutzenbewertung

DGHO_2014_Fruehe_Ntznebewertung.pdf (1.5 MiB)