At the beginning of July, the Federal Council presented regulatory amendments for a new pricing system for reimbursable medicines and submitted them to the consultation process. The amendments are made necessary following a ruling by the federal court, which in December 2015 found in the last instance that a review of cost effectiveness by means of international reference pricing (IRP) alone is not permissible and must be more broadly based using therapeutic reference pricing (TRP). The latter must be considered both in the first price-setting procedure and also in regular price reviews. The federal court further found that that not only the cost effectiveness of all medicines in the Specialties List (SL) must be regularly reviewed, but also their efficacy and fitness for purpose.

With a greater focus on the benefits, innovation will be better rewarded.   © Barbara Jung

With a greater focus on the benefits, innovation will be better rewarded.  
© Barbara Jung

The regulatory amendments submitted to the consultation process by the Federal Council provide for future use and equal weighting of the IPR and the TPR both when medicines are included in the SL for the first time and in subsequent price reviews. The previous upper limit is also to be abolished. A further change is that a TPR is now to be conducted also in the price review after patent expiry.

As a result of the changes, no price review round was held in 2016.

Interpharma welcomes the changes

Interpharma welcomes the regulatory changes in principle, but requests amendments of two important points. Interpharma takes a particularly positive view of the greater weighting of the TPR and hence the reduced dependence on the IPR. Also to be welcomed is the 1:1 weighting of the IPR and the TPR and the abolition of an upper limit (IPR plus 5%). Finally, it is also right to maintain the frequency of reviews at every three years. Interpharma notes with regret, however, that purchasing parity is still not considered in pricing and that price adjustments are still only possible to the disadvantage of the pharmaceutical companies (asymmetry).