Benefit assessment of established drugs permitted

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Novartis must accept evaluation of established medicines

The benefits can also be checked for already established medicinal products. The benefit assessment of medicines on the market by the Federal Joint Committee (G-BA) is legal in its existing form, according to the current ruling by the Berlin-Brandenburg State Social Court. Here, the pharmaceutical company Novartis Pharma GmbH had filed a lawsuit against the G-BA's review of the drug group of gliptins (certain diabetes drugs).

With its decision, the State Social Court confirmed the benefit assessment of already established medicines carried out by the G-BA and dismissed Novartis' action (file number: L 7 KA 112/12 KL). The two diabetes medicines of the pharmaceutical company now have to face the planned benefit assessment without Novartis Pharma GmbH being able to appeal against them in isolation in the form of an objection or an action for avoidance. However, the pharmaceutical company "still has the option to file a lawsuit after an arbitration decision has been completed," said the impartial chairman of the G-BA and chairman of the responsible pharmaceutical subcommittee, Josef Hecken, in a press release after the verdict. The state social court “made a decision that ensures that benefit assessment procedures can be carried out properly,” continued Hecken.

Benefit assessment for new drug registrations since 2011 Standard Since 2011, the assessment of the additional benefit has been intended for all new drug registrations on the German market. This is to ensure that only medication that actually improves the patient's situation is reimbursed accordingly by the health insurance companies. While the pharmaceutical companies were still able to determine the prices of their medicines themselves until 2010, since the introduction of the benefit assessment, the assumption of costs by the health insurance companies has been made dependent on the additional benefit of new drugs. Already established drugs initially enjoyed some form of inventory protection, but the G-BA ordered a retrospective review for six groups of active ingredients. An approach that has caused massive concern in the pharmaceutical industry and so Novartis Pharma GmbH tried to prevent the subsequent benefit assessment of its diabetes medicines Galvus and Eucreas by means of a lawsuit before the regional social court.

Legally extending the benefit assessment to established medicinal products Now that the legality of the procedure has been confirmed by the Berlin-Brandenburg State Social Court, the benefit assessment for the diabetes medicinal products is to be completed as planned. A decision is expected by the end of the year, on the basis of which the price negotiations can finally take place. Overall, the benefit assessment of medicinal products is a very successful model, with the help of which considerable sums can be saved in the health care system without impairing the quality of treatment. In addition, pharmaceutical companies can continue to charge a higher price for new drugs with real added benefits, not least to cover the costs of research and development. An extension of the benefit assessment to certain medicinal products that were approved before 2011 seems only logical. However, the Association of Research-Based Pharmaceutical Manufacturers (vfa) continued to express considerable doubts about the usefulness of such an expansion on the existing market. The pharmaceutical industry's monetary interests are also likely to play a role here, as they could miss out on a billion dollar business if the established medicines do not confirm their benefits. (fp)

Picture: Dr. Klaus-Uwe Gerhardt, Pixelio

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