Pcn383 Cost-Effectivenes Analysis of Avelumab as Second-Line Treatment for Patients With Metastatic Merkel Cell Carcinoma in Russia

Abstract

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 costeffective 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.

A cost‐utility analysis of avelumab for metastatic Merkel cell carcinoma in Taiwan

“…Avelumab also demonstrated cost‐effectiveness in the United Kingdom 17 and Russia. 37 At a WTP threshold of £50 000 per QALY gained for end‐of‐life treatments in the United Kingdom, 39 avelumab was shown to be a cost‐effective treatment option compared with chemotherapy or BSC in treatment‐experienced and treatment‐naïve mMCC patients. 17 The base‐case ICERs were £35 274 for the treatment‐experienced population, and £39 178 for the treatment‐naïve population.…”

“… 17 In Russia, avelumab was estimated to be cost effective vs chemotherapy in treatment‐experienced mMCC patients. 37 This evidence is being assessed for the inclusion of avelumab in the Vital and Essential Drug List (VEDL) in Russia. 37 …”

“… 37 This evidence is being assessed for the inclusion of avelumab in the Vital and Essential Drug List (VEDL) in Russia. 37 …”

“…Avelumab also demonstrated cost-effectiveness in the United Kingdom 17 and Russia. 37 At a WTP threshold of £50 000 per QALY gained for end-of-life treatments in the United Kingdom, 39 avelumab was shown to be a cost-effective treatment option compared with 17 The base-case ICERs were £35 274 for the treatment-experienced population, and £39 178 for the treatmentnaïve population. 17 In Russia, avelumab was estimated to be cost effective vs chemotherapy in treatment-experienced mMCC patients.…”

“…The results of PSA are consistent with those presented in other countries. 17,37 To our knowledge, this is the first cost-utility analysis of avelumab vs traditional treatments for mMCC in Taiwan. This analysis is unique because there are limited cost-utility analyses of treatments for such treatment effect.…”