Some essential clarifications: IQWiG comments on two critiques of the efficiency frontier approach

✍ Scribed by Charalabos-Markos Dintsios; Andreas Gerber

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 64 KB
• Volume: 19
• Category: Article
• ISSN: 1057-9230
• DOI: 10.1002/hec.1657

✦ Synopsis

Owing to scarcity of space, we will confine our refutation of Brouwer and Rutten's as well as Sculpher and Claxton's commentaries on IQWiG's efficiency frontier (EF) approach to selected points.

'The approach to exclude pharmaceuticals from reimbursement beyond a uniform threshold is not in accordance with the legal situation in Germany. To the contrary, the legal mandate is to set a fair price for innovative pharmaceuticals that is consistent with their additional therapeutic benefit. Thus, access to innovations can be warranted for all patients. This requires the development of an independent approach on a scientific basis'. (Bundesministerium fu¨r Gesundheit, 2008). This, a quote from a consultation on the IQWiG approach published by the German Federal Department of Health (FDoH), makes clear that the legal situation in Germany quite differs from what the commentaries claim. They dogmatically adhere to their country-specific approaches that answer the questions posed to them in their respective settings. In Germany, however, best allocation of scarce resources is by law solely to be pursued within a therapeutic area.

We admit that until now neither we nor anybody else has explicitly explained the background in depth in an English publication, yet this is under preparation. IQWiG's assignment is one of valuebased pricing, contrary to NICE's, which does not have any influence whatsoever on pricing. At the same time, the Federal Joint Committee's (FJC) mission in this area is to balance the conflict between different interests. One may depict the conflict of interests as a triangle that stands on its tip. This tip is represented by a group of patients that need a given treatment now offered by a manufacturer. The triangle would only stand if the two other corners representing the insured who contribute to the statutory health insurance (SHI) funds and the manufacturer asking for a price are in balance. To reach this balance and to keep the system financially sustainable does not mean to construct any overarching allocation, but to look at each therapeutic indication and balance patients' and contributors' interests against the manufacturers' prices. Guiding principles are appropriateness and affordability for the overall system as laid down in social code book V. This is also very much in line with the overarching understanding of democracy in Germany. Especially in the field of health-care self-governance, this means that interests of the various groups should be balanced to resolve conflicts of interest. Taken seriously, this means that the interests of patients, contributors, and manufacturers have to reach a balance leading to appropriate, affordable, and fair prices in the sense of keeping contributions stable while all patients do get available treatments. Also, IQWiG follows social code book V, which specifically separates benefit assessment and