G-BA Chief Hecken Warns of Medication Rationing Without Price Regulation Reform

The rising costs of medications for cancer and rare diseases have prompted a call for reform in the pricing regulations governing these essential treatments. Josef Hecken, the head of the Joint Federal Committee (G-BA), which comprises representatives from health insurance funds, doctors, and hospitals, has urged the coalition partners, Union and SPD, to consider tightening these regulations during their negotiations.

Hecken has expressed concern that if the current trend of escalating costs, particularly for oncology and rare disease medications, is not addressed, society may soon face discussions about restricting prescription practices. He emphasized the importance of transparency in communicating these challenges to the public.

According to Hecken, approximately one-third of total pharmaceutical expenditures within statutory health insurance--around 18 billion euros--are allocated to these two categories, despite them accounting for only about 1.3% of all prescriptions. This significant imbalance is expected to worsen if no action is taken.

Hecken pointed out that there is a pressing need for improved mechanisms to manage the costs associated with new drugs and to assess their efficacy more effectively. The influx of new medications into the market, particularly those targeting small patient populations, often lacks the benefit of extensive clinical trials, complicating the evaluation of their actual patient benefits.

He highlighted the ethical implications of conducting clinical trials for medications that treat rare diseases, especially those that can be life-threatening to children. It is deemed unethical to withhold treatment from a control group when there are no alternative therapies available for severely ill patients.

These challenges have repercussions for the healthcare system as a whole. Hecken noted that after a medication is introduced in Germany, the additional patient benefits cannot be reliably established due to the scarcity of comprehensive data. Yet, under the current regulatory framework, prices are negotiated based on this limited evidence.

For instance, Hecken mentioned the medication Zolgensma, used for treating spinal muscular atrophy (SMA), which has treatment costs reaching up to two million euros, making it one of the most expensive medications globally. He called for mandatory accompanying studies for such treatments to track and evaluate their long-term effectiveness in patients.

Hecken advocated for a pricing model where the final price of a medication is determined only after a reliable assessment of its benefits through these so-called registry studies. Initially, a provisional price could be set, but it should be subject to revision once sufficient data on treatment outcomes is available. He emphasized that such a decision ultimately rests with policymakers.