Personalised medicine as a challenge for public pricing and reimbursement authorities – A survey among 27 European countries on the example of trastuzumab

Cost-effectiveness of trastuzumab in metastatic breast cancer: Mainly a matter of price in the EU?

“…Two different values for incremental OS (3.7 and 8.4 months) were referenced so two baseline results were calculated, although both referred to the CT mentioned above [15], in which two thirds of patients crossed over. The price of TR was much higher than that reported for Norway in a European survey [5] focused on TR pricing and reimbursement (D 928 in 2003 vs. D 645 in 2005). TR cost and OS were the most influential variables in sensitivity analysis.…”

“…After having compared the TR prices used in the FEEs with those from a EU survey [5], we realized that the Norwegian study used a much higher price and the Swedish a lower one, leading to respectively less and more favorable results. Since TR price/cost was an influential variable in the three studies that included a sensitivity analysis [23,24,26], we tried to estimate how a future TR price cut after patent expiry and biosimilars launch could affect base case results of the FEEs reviewed.…”

“…Accordingly, the large OS gain for TR was even over-estimated once the outcome was transformed to QALY. Outpatient costs (potentially an important item at this stage of life) were based on expert opinion only and the TR price was lower than that in the European survey [5] (D 609 vs. D 700). QALY gains and TR price were the most sensitive variables when conducting one-way sensitivity analyses.…”

“…Targeted therapy, aiming at maximizing clinical benefits for selected patients, poses a new challenge to health authorities by adding new tests to expensive drugs [5]. TR, like many other biological anti-cancer agents, has been judged positively for reimbursement by most public authorities in the EU.…”

An exploratory analysis of the factors leading to delays in cancer drug reimbursement in the European Union: The trastuzumab case

“…Trastuzumab is considered to be a high-cost drug, and its funding mechanism is diverse in Europe. Most Western European countries fund the drug out of their hospital budgets, whilst most Eastern European countries fund it through a third party (social security or national health systems), which could contribute to delays in reimbursement decision-making [40]. When funded through hospital budgets, the decision to allocate budget to a drug is taken locally, whereas if it is funded by a third party, the decision is discussed within a larger panel of stakeholders.…”