OBJECTIVES

The Tunisian National Authority for Assessment and Accreditation has published in 2018 its first HTA report, aimed at informing the national payer on the effectiveness and cost-effectiveness of trastuzumab, the first agent targeting HER2 positive breast cancer, representing its biggest budgetary expenditure since 2008.

METHODS

A systematic litterature review of recent clinical practice guidelines on management of breast cancer was performed to extract best available evidence on effectiveness and risks related to trastuzumab. The recommendations of the Tunisian Society of Oncology were compared with SIGN and NICE guidelines. A benchmark of ex-factory prices of trastuzumab in different countries was carried out along with a survey among INAHTA members to collect prices’ information, reimbursement and treatment management modalities. To determine the cost effectiveness of trastuzumab at the 2018 selling price, an adaptation of a Latin American cost-effectiveness study was conducted, followed by a sensitivity analysis and the estimation of the cost effectiveness price.

RESULTS

Trastuzumab significantly improves DFS and OS compared to chemotherapy alone, however it increases the risk of congestive heart failure. According to the benchmark, the 2018 ex-factory price of trastuzumab in Tunisia remains higher than most of high income countries. From the ministry of health’s perspective, the ICER of trastuzumab was 49 670,67 USD/QALY, representing 4,5 times the 3 GDPPC/QALY threshold suggested by WHO. From the national payer’s perspective, the ICER was 75 386,18 USD/QALY, representing 6,8 times the threshold. Probabilistic sensitivity analysis showed 0 % probability of trastuzumab being cost-effective considering the same threshold. A discount of 78% on trastuzumab’s acquisition price is required to reach cost-effectiveness threshold. These results provided a set of recommendations for the payer and informed the negociation of the biosimilar’s price.

CONCLUSIONS

This first INEAS HTA report clearly illustrates the central role of HTA at informing decision-makers in terms of price negotiations and reimbursement decisions.