(2012; 714 Seiten)
Switzerland knows a two-step process for market access. First a new product needs market authorization by the SATP and second a positive reimbursement decision by the FOPH to be listed in the positive drug list (SL). After the marketing authorization has been granted by the SATP within 300 days, the pharmaceutical company submits a reimbursement application to the FOPH.
The FOPH mandates the FDC to evaluate and classify a new drug in one of five categories:
- Therapeutic breakthrough
- Therapeutic progress
- Saving compared to other drugs
- No therapeutic progress and no savings
- Not appropriate for the social health insurance
The FOPH makes the final decision on reimbursement based on the FDC recommendation. Basically, a new drug must be effective, appropriate and cost-effective to be listed in the positive list (SL). Public promotion is not allowed for SL-listed drugs. Efficacy and appropriateness are mostly based on SATP assessment; cost-effectiveness (value-for money) considers both international benchmarking with Germany, UK, Denmark, the Netherlands, France, Austria and therapeutic benchmarking (comparative effectiveness e.g. daily treatment costs). An innovation reward of up to 20% may be granted during the patent protection period.
A positive FOPH reimbursement decision gets a new drug listed in the SL within 30 days after the FDC meeting. The FOPH reevaluates pricing & reimbursement of drugs in the SL every three years and after patent expiry. In addition reevaluation also takes place in case of new indications or changed limitations.
The time frame to get reimbursement depends on the meeting schedule of the FDC. There are 5 annual FDC meetings for the time being. Normally it takes 4-5 months from reimbursement dossier application to official reimbursement status. However, if an innovative drug got SATP market authorization by the fast track approval process, an accelerated reimbursement process is in place.
In case of a projected negative reimbursement decision the FOPH informs the applicant about the designated negative decision. The applicant may then apply for reevaluation before the official reimbursement decision has been issued by the FOPH. Arguments for reevaluation could be e.g. price adjustments or additional data. A second reconsideration application is possible with new evidence.
Generics, Co-Marketing products and new forms with identical price levels get reimbursement by an abbreviated process without FDC assessment within about 7 weeks. A Generic is included in the SL if its ex-factory price is 10 to 60% lower (effective 2012) than its Swiss reference product after patent expiry and external price referencing (international benchmarking). The percentage in price decrease depends on the sales volume of the Swiss reference product. Co-payment is 10% for on-patent and economic off-patent drugs. However, co-payment is 20% for off-patent drugs with prices 20% higher than the average price of the lower third of available off-patent drugs of one particular active. This precondition is reassessed on a yearly basis (so called dynamic differentiated co-payment).
Drugs may be reimbursed outside an official indication / limitation or outside the SL under the following conditions: the drug must offer a vital benefit to treat a fatal disease if no alternative treatment is available. This kind of reimbursement needs prior approval by a health insurer; price will be negotiated and set by the health insurer.