In March, the FOPH published its evaluation of the implementation of Article 71a and b of the Ordinance on Health Insurance (KVV). The evaluation provides plenty of material for discussion. At times, the Rare Disease Interest Group has spoken out. It criticizes a certain bias in favor of health insurers and calls for greater involvement of all stakeholders in this field, for example by means of reference centers for rare diseases.
The FOPH’s evaluation should show how the implementation of Art. 71a and b KVV (new ordinance on the reimbursement of medicines not on the list of specialties) is working in practice. This was the FOPH’s response to the accusation that the new regulation was creating increasing legal inequalities/uncertainties for patients with rare diseases.
Shortcomings are acknowledged – yet the picture remains glossed over
Specifically, IG Reltene Krankheiten criticizes that the published document reflects the view of health insurers too one-sidedly. In doing so, it misses the everyday disease reality of many patients with rare diseases, but also that of medical professionals.
While the evaluation certainly shows the potential for improvement, e.g. the practicability of the implementation of the article is doubted and information deficiencies of the cost-guarantee applications are blamed for delayed clarification processes, the view remains glossed over. In fact, the majority of respondents were health insurers. If a specialist did have his say (in the so-called expert interviews), it quickly became apparent that there were major differences in perception: For example, the time taken to process a compensation request varied considerably (from five to 30 days). Moreover, the specialists emphasized that the benefit of a therapy was still assessed very differently in the cost-approval opinions (although the disease cases were comparable). Therefore, according to IG Rare Diseases, there is still a long way to go before we can speak of legal equality in access to medicines.
Situation with off-label drugs unsatisfactory
It is clear that inconsistent reimbursement for off-label therapies (a large proportion of rare disease sufferers are treated with them) can be discriminatory for patients. Depending on the manufacturer, the canton and the insurance company, such treatment may be covered in full or only in part and sometimes not at all, although the cases are comparable. An amendment to Article 71 a and b KVV is therefore necessary if access to medicines and their reimbursement are to be standardized. Neither the place of residence nor the manufacturer or insurer should play a role in the decision. This could prevent patients from having to bear the costs themselves in the future if a pharmaceutical company cannot reach an agreement with a health insurer on the price of an off-label drug.
Create equal access under the law
Since an off-label therapy is vital for the survival of patients with rare diseases in individual cases, the reimbursement decision in particular must be made carefully and with the best possible professional expertise. Ruth Humbel, a member of the National Council, had therefore already demanded in a postulate a good four years ago that reference centers for rare diseases be set up and that their specialists be given a say in the reimbursement decision. This is particularly the case if the treatment benefit can only be determined inadequately with a standardized benefit assessment model.
Source: Media release – FOPH evaluation of the implementation of Art. 71a and b KVV, March 6, 2014.
HAUSARZT PRAXIS 2014; 9(5): 51-52
