7. März 2013

The request for previously authorized drugs to be reviewed by the German Federal Joint Committee (GBA) is legal, decided the Superior State Social Court (LSG Berlin-Brandenburg) February 28, 2013 under reference number: L 7 KA 106/12 KL ER.

The pharmaceutical company Novartis was defeated by the Federal Joint Committee (Gemeinsamen Bundesausschuss) on the question of whether this committee is authorized by law to undertake an assessment of the benefits of pharmaceuticals, pursuant to the “Arzneimittelmarkt-Neuordnungsgesetz” AMNOG (German Law for Reforming the Market for Pharmaceuticals) as well as for recently authorized pharmaceuticals.

This law went into force on January 1, 2011 and for the first time it obliges pharmaceutical companies to submit a dossier on the benefit assessment when a new product accesses the market in Germany or when new therapeutic indications are authorized. After these considerations, the Federal Joint Committee passes a resolution based on the benefit assessment, the hearings on the extent of the additional benefit, the groups of patients that come into question for treatment, the requirements made of quality-assured application and the costs of the therapy using that drug. If an additional benefit is approved, the procedure for establishing a price for the pharmaceutical is to negotiate the reimbursement price with the umbrella organization for the statutory health insurance funds (GKV-Spitzenverband). The specific pharmaceutical company then negotiates the reimbursement price for it´s pharmaceuticals.

In the worst case scenario, if the Federal Joint Committee arrives at the conclusion that the new pharmaceutical does not have any additional benefit compared to the appropriate comparator, that drug will be included to the reference price system (Festbetrag) within six months after accessing the market.

Novartis refused to fulfill it´s obligation to submit a dossier also for the recently registered substances, in this case: Sitagliptin, Vildagliptin and Saxagliptin.

The annual sale of these products is estimated up to 500 Million Euro (source: faz-online from 02/10/2013). Were the price of those substances reduced to that of the much lower reference price, Novartis estimated a price reduction up to 90 % for their drugs.

In June 2012, Novartis was asked by the Federal Joint Committee to submit a dossier based on the authorization documents and premised on all studies carried out on these pharmaceuticals, although the drug was already on the market before the law (AMNOG) came into affect. If there is a specific appropriate comparator – which was Linagliptin for them – this procedure is stipulated by law in accordance with section 35a SGB V. The Federal Joint Committee wanted to prove the pharmaceutical´s additional benefit in comparison to this medication but Novartis refused to deliver a dossier and fought against this request.

The essential question in this lawsuit was, whether the request to submit a dossier is an administrative act, which can be appealed in court or an obligation, which is commonly used to assist an assessment in the German social law system.

The court explained in it´s interim legal protection proceeding that the request doesn’t have an independent regulatory character, and has therefore no legal impact on the rights of the claimant (Novartis). Additionally, this result upholds the legislative intent, which was to avoid lawsuits during the assessment.




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