Benefit assessment of established drugs allowed

Novartis must accept evaluation of established drugs

05/16/2013

Even with already established drugs, the benefits may be reviewed. The benefit assessment of drugs on the market by the Joint Federal Committee (G-BA) is legal in the existing form, so the current judgment of the Landessozialgericht Berlin-Brandenburg. Here, the pharmaceutical company Novartis Pharma GmbH filed a lawsuit against the G-BA's review of the drug class of gliptins (certain diabetes medicines).

With its ruling, the Federal Social Court confirmed the benefit assessment of already established drugs carried out by the G-BA and dismissed the action brought by Novartis (Ref .: L 7 KA 112/12 KL). Thus, the two diabetes drugs of the pharmaceutical company must now face the planned benefit assessment, without Novartis Pharma GmbH could appeal against these isolated in the form of an objection or an action for annulment. However, the pharmaceutical company remains „the possibility to file an action following a decision by the arbitral“, said the impartial chairman of the G-BA and chairman of the competent subcommittee on pharmaceuticals, Josef Hecken, in a press release after the verdict. The state social court have „thereby making a decision that ensures that benefit assessment procedures can be properly performed“, so hedges continue.

Benefit assessment for new drug approvals since 2011 Standard
The assessment of the additional benefit has been planned since 2011 for all new registrations of medicines on the German market. In this way, it should be ensured that only medicines which actually improve the situation of the patients are reimbursed by the health insurance funds accordingly. While the pharmaceutical companies were still able to determine the prices of their medicines by the year 2010, since the introduction of the benefit assessment, the reimbursement of costs by the health insurance funds has been made dependent on the additional benefit of new preparations. Already established remedies initially enjoyed a kind of grandfathering 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 by means of an action before the National Social Court to prevent the subsequent benefit assessment of their diabetes drugs Galvus and Eucreas.

Extending the benefit assessment to established drugs lawful
Now that the legality of the procedure has been confirmed by the Landessozialgericht Berlin-Brandenburg, the benefit assessment for the diabetes preparations should be completed as planned. At the latest by the end of the year, a decision is expected on the basis of which the price negotiations can finally take place. Overall, the benefit assessment of the drugs is a thoroughly successful model that can save considerable sums of money in the healthcare sector without compromising treatment quality. In addition, pharmaceutical companies may continue to charge a higher price for new medicines with added value, not least to cover research and development costs. An extension of the benefit assessment to certain drugs already approved before 2011 seems only logical. However, the Association of Research-Based Pharmaceutical Manufacturers (vfa) continued to express significant doubts as to the relevance of such expansion to the existing market. The monetary interests of the pharmaceutical industry should also play a role here as they could avoid a billion-dollar business if the established drugs do not prove their usefulness. (Fp)

Picture: Dr. Klaus-Uwe Gerhardt, Pixelio