Hepatitis C agent gets good rating

Joint Federal Committee distributes high marks for new, expensive drug for hepatitis C

07/18/2014

In evaluating the added value of the new hepatitis C drug with the active ingredient sofosbuvir, the Federal Joint Committee of Health Insurance Funds, Doctors and Clinics gave good marks for the funds after long disputes yesterday. Depending on the type of disease, the drug has a high or low added value, the highest body of the German health service judged in its meeting yesterday. The representatives of doctors, patients and clinics prevail in the vote against the health insurance company representatives, who criticized the fact that there are currently no studies that clearly show the improvement for the patients.

New remedy for hepatitis C has much less side effects
As the Drug Commission of the German medical profession had already established in advance, the new hepatitis C drug greatly improves the chances of a patient's cure compared to the previously available therapies. In addition, it should cause significantly fewer side effects and involve a shorter duration of treatment. So far, interferon-containing combination therapies that have to be used for 16 to 72 weeks are used in hepatitis C patients. However, these treatment options are associated with severe side effects, especially serious psychiatric problems such as depression. But the advantage of these older drugs: they are far cheaper than sofosbuvir.

New hepatitis C agent improves treatment success
The health insurances wanted to give the new hepatitis C drug a worse rating, because they lacked in their view, studies that clearly demonstrated the added benefit for those affected. „In this particular case, given the therapeutic efficacy achievable with the new drug, the potential for shortening the duration of therapy and avoiding the severe side effects of interferon, it is imperative for ethical reasons to conduct uncontrolled one-arm studies on sofosbuvir versus historical controls on previous interferon-containing treatment options to be taken as a basis for decision-making“, said the impartial chairman and chairman of the subcommittee on pharmaceuticals, Josef Hecken. „According to the Rules of Procedure of the Federal Joint Committee, the principle of evidence-based medicine to be used for the benefit assessment of a new active substance is that statements on the benefit ratio of the interventions to be compared are in principle based on direct comparative clinical trials of the highest quality. However, in particular case constellations, it may be justified to make an assessment decision on the basis of qualitatively appropriate documents of a lower level of evidence - the rules of procedure also provide for that. These requirements are met in the benefit assessment of sofosbuvir.“

Benefit assessment of the hepatitis C agent is the basis for price negotiations between health insurance companies and manufacturers
The benefit assessment of the Joint Federal Committee forms the basis for the negotiations between the Kassen-Spitzenverbands and the manufacturer about the price, which the health insurers later reimburse for the medicine.

The Cologne Institute for Quality and Efficiency in Health Care (IQWiG) had previously complained that the added benefit of the new hepatitis C agent was not quantifiable, „since it is unclear how often the occurrence of liver cancer can actually be avoided. "Some patients develop cirrhosis of the liver after 20 to 25 years, which significantly increases the risk of hepatocellular carcinoma, but the Federal Joint Committee did not follow the concerns of the IQWiG.