INGELHEIM/BERLIN (dpa-AFX) – The pharmaceutical company Boehringer Ingelheim opposes the evaluation of a new drug against a rare disease and calls for more flexible tests in Germany overall. The pharmaceutical industry is often accused of paying too little attention to rare diseases, said the company’s head of Germany, Sabine Nikolaus, of the German Press Agency in Mainz. If this is done, but will be checked too rigidly. This could prevent patients suffering from rare diseases in this country from gaining access to new treatment options.
The Federal Joint Committee (GBA) had decided that it saw no additional benefit in comparison to other therapies in the Spevigo preparation developed by Boehringer for the treatment of acute flare-ups of generalized pustular psoriasis – a rare skin disease. As a result, according to Spevigo Boehringer, this Tuesday (August 29) will no longer be available in Germany. The company intends to challenge the GBA decision in court. The committee itself defended its actions on Tuesday.
The GBA is obliged to carry out a benefit assessment for newly approved medicinal products with new active ingredients after they have entered the market. It is checked whether the drug has any advantages over standard therapy. The result is the basis for deciding how much the statutory health insurance will pay for the new drug. Whether doctors prescribe a drug does not depend on the evaluation. However, the evaluation does influence the importance of a remedy in healthcare, said Nikolaus.
According to Boehringer, pustular psoriasis affects less than 300 patients in Germany. The implementation of clinical studies is correspondingly difficult, said Nikolaus. These could not provide all the parameters required by the GBA. More flexibility is needed in the assessment. “In Germany, innovations are often the victims of rigid processes and specifications.” Boehringer points out that Spevigo is approved in the USA and Europe, and in France, for example, an additional benefit has also been identified.
The GBA decision on Spevigo of July 20, 2023 states that an additional benefit has not been proven and that there are no assessable data. Nikolaus demanded that the GBA must be obliged to include available studies – even if they did not provide all the parameters of large studies. The perspective of the patient is also neglected. In addition to medical specialist societies, patient associations would have to be more involved in the benefit assessment. Germany continues to lose competitiveness overall due to “inadequate benefit assessments” of innovations.
The GBA said that all studies presented by the manufacturer were always included in the tests on the additional benefit of a new drug. “In the case of Spevigo, however, the study presented in the manufacturer’s dossier was unsuitable for deriving statements on the additional benefit,” said the impartial chairman Josef Hecken. The GBA dealt with the study in detail, but ultimately could not come to any other conclusion because the study was too short overall.
Meaningful studies are also possible with small groups of patients, that’s what the pharmaceutical industry already shown. The GBA also examines whether a drug improves the patient’s quality of life. In the specific case, the patient representative also agreed to the result of the consultation. The decision to take the drug off the market is made out of economic interests. “That is legitimate, but the reason is ultimately the lack of meaningful studies and by no means a too rigid testing practice of the Federal Joint Committee,” said Hecken.
The National Association of Statutory Health Insurance Funds, which represents the interests of the statutory health and long-term care insurance funds, also defended the benefit assessment. It should create more transparency on the additional therapeutic benefit at an early stage, “in order to ensure care that is based on quality aspects”. The association also considers an additional benefit of Spevigo to be unproven. “In a global comparison, Germany is one of the countries where the population has the earliest and most extensive access to newly approved medicines,” said spokesman Jens Ofiera. The early benefit assessment makes an important contribution to improving the quality of drug supply./chs/DP/jha