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Cost Effectiveness of Ribociclib in Combination with Fulvestrant for the Treatment of Postmenopausal Women with HR+/HER2− Advanced Breast Cancer Who Have Received No or Only One Prior Line of Endocrine Therapy: A Canadian Healthcare Perspective

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Abstract

Background

The MONALEESA-3 trial demonstrated the efficacy and safety of ribociclib plus fulvestrant versus placebo plus fulvestrant for patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). This analysis evaluated the cost effectiveness of ribociclib plus fulvestrant versus fulvestrant in patients with HR+/HER2− ABC from a Canadian healthcare payer perspective.

Methods

The incremental cost-effectiveness ratio (ICER), expressed as incremental costs per quality-adjusted life-year (QALY) gained for ribociclib plus fulvestrant versus fulvestrant, was estimated using a semi-Markov cohort model developed in Microsoft Excel, with states for progression-free, post-progression, and dead. A 15-year time horizon was used. Survival distributions for progression-free survival (PFS), post-progression survival (PPS), and time to discontinuation (TTD) were based on parametric survival distributions fit to data from MONALEESA-3. Health-state utilities were estimated using EQ-5D index values collected in MONALEESA-3. Direct costs of ABC treatment (medication and administration costs, follow-up and monitoring, adverse events, subsequent treatments) were based on Canadian-specific values from published sources. Costs (2019 CAN$) and QALYs were discounted at 1.5% annually.

Results

In the base case, ribociclib plus fulvestrant was estimated to result in gains of 1.19 life-years and 0.96 QALYs versus fulvestrant, at an incremental cost of $151,371. The ICER of ribociclib plus fulvestrant versus fulvestrant was $157,343 per QALY gained based on the mean of probabilistic analyses. Results were sensitive to parametric distributions used for projecting long-term TTD, PFS, and PPS.

Conclusions

For patients with HR+/HER2− ABC, ribociclib plus fulvestrant is projected to result in substantial gains in QALYs compared with fulvestrant. At its current list price, ribociclib used in combination with fulvestrant is likely to be cost effective in these patients at a threshold ICER of $157,343. These results may be useful in deliberations regarding reimbursement and access to this treatment.

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Authors and Affiliations

  1. Policy Analysis Inc. (PAI), 822 Boylston Street, Suite 206, Chestnut Hill, MA, 02467, USA

    Daniel Stellato & Thomas E. Delea

  2. Novartis Pharmaceuticals Corp., East Hanover, NJ, USA

    Marroon E. Thabane, Jinhee Park & David Chandiwana

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Correspondence to Thomas E. Delea.

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Funding

Funding for this research was provided to Policy Analysis Inc. (PAI) by Novartis.

Competing interests

Thomas E. Delea is an employee and owner of PAI. PAI received research funding from Novartis for this study, and has received research funding and consulting fees from AbbVie, Alexion, Amgen, Bristol Myers Squibb, EMD Serono, GlaxoSmithKline, Jazz Pharmaceuticals, Lilly, Merck, Merck Group, Novartis, Pfizer, Sanofi, Seattle Genetics, and Takeda for research activities unrelated to this study. Daniel Stellato is an employee of PAI. PAI received research funding from Novartis for this study and has received research funding and consulting fees from AbbVie, Alexion, Amgen, Bristol Myers Squibb, EMD Serono, GlaxoSmithKline, Jazz Pharmaceuticals, Lilly, Merck, Merck Group, Novartis, Pfizer, Sanofi, Seattle Genetics, and Takeda for research activities unrelated to this study. David Chandiwana is an employee of Novartis and owns stock and/or stock options in Novartis. Jinhee Park is an employee of Novartis and owns stock and/or stock options in Novartis. Marroon E. Thabane was an employee of Novartis at the time this study was conducted and owns stock and/or stock options in Novartis.

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The information reported in this manuscript and the supplementary material is sufficient to replicate the results of this study.

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The information reported in this manuscript is sufficient to replicate the results of the study. The model used in the manuscript includes proprietary code and is not provided.

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All authors contributed to the conception and design of the study, analysis of data, drafting of the manuscript, and providing final review and approval of the manuscript.

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Stellato, D., Thabane, M.E., Park, J. et al. Cost Effectiveness of Ribociclib in Combination with Fulvestrant for the Treatment of Postmenopausal Women with HR+/HER2− Advanced Breast Cancer Who Have Received No or Only One Prior Line of Endocrine Therapy: A Canadian Healthcare Perspective. PharmacoEconomics 39, 1045–1058 (2021). https://doi.org/10.1007/s40273-021-01027-4

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