In France, medicine prices are set by the French Healthcare Products Pricing Committee (CEPS) through negotiations with pharmaceutical industries. Sales volumes is one of the main price determinants. It may lead to major impact in the final pricing agreement in particular on a potential managed-entry agreement structure or on market shares assumptions.

OBJECTIVES

This analysis aims to evaluate the accuracy of the sales forecasts provided by the manufacturers to the CEPS when starting price negotiations.

METHODS

This retrospective study includes in- and out-patient medicines which reimbursement decision for their first indication was published in 2015 or 2016 in the Official Gazette. It excludes biosimilars, generics, medicines with new indication or new pharmaceutical form which reimbursement occurred within the 36 first months sales, medicines funded through a DRG and those which already had sales before reimbursement. The sales forecasts are extracted from the economic dossier submitted by the manufacturers, and actual sales volume from the GERS database. Descriptive statistics are used to compare the difference between the sales forecasts and the sales volume in a rolling period of 36 months.

RESULTS

Thirty-eight new medicines fulfill the inclusion criteria and thus have been included in the final analysis, among the eighty-one medicines that were reimbursed for their first indication in 2015 or 2016.

The actual sales volume are in general lower than the sales forecasts (median gap of -30,5% over three years). The median gap between the sales volume and the forecasts is -42.9 %, -41.5 % and -41.8 % for respectively the first, second and third year of marketing.

CONCLUSIONS

Inaccurate forecasts may distort medicines expenditure due to inadequate managed-entry agreements build on these data such as price volume agreements. Payers should mitigate these discrepancies and thus, favor simple discounts or ex-post mechanisms to increase health-spending predictability.