Abstract
Background
In this study, we evaluate the cost and outcomes of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) plus fulvestrant, fulvestrant alone, and conventional chemotherapy as the second-line therapy for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC) in India.
Methods
Using a Markov model, the clinical effectiveness of managing HR+, HER2− MBC in postmenopausal women with either a CDK4/6i (either ribociclib or palbociclib) and fulvestrant, fulvestrant alone, and chemotherapy (single-agent paclitaxel or capecitabine) was measured in terms of quality-adjusted life-years (QALYs). The costs were estimated from two different points of view: scenario I, as per the prevailing market prices of the drugs; and scenario II, as per the reimbursement rates set up by the publicly financed national health insurance scheme. Incremental cost per QALY gained with a given treatment option was compared against the next best alternative and was assessed for cost effectiveness using a threshold of 1-time the per capita gross domestic product (GDP) in India from a societal perspective.
Results
In scenario I, an MBC patient was found to incur a lifetime cost of Indian Rupees (₹) 2.54 million ($34,644), ₹2.53 million ($34,496), ₹512,598 ($6,984), ₹326,026 ($4,442) and ₹237,115 ($3,230) for the ribociclib and palbociclib combination arms, fulvestrant monotherapy, single-agent paclitaxel and the single-agent capecitabine treatment arms, respectively. The lifetime cost for CDK4/6i (ribociclib and palbociclib) combination therapy, fulvestrant monotherapy, paclitaxel, and capecitabine arms was estimated to be ₹1.94 million ($26,459), ₹1.92 million ($26,220), ₹315,387 ($4,296), ₹187,392 ($2,553) and ₹153,263 ($2,088), respectively, in scenario II. The mean QALYs lived per MBC patient with CDK4/6i (either ribociclib or palbociclib) combination therapy, fulvestrant, paclitaxel and capecitabine were estimated to be 1.4, 1.0, 0.9 and 0.7, respectively. None of the treatment arms are cost effective at current prices and reimbursement rates at a threshold of 1-time the per capita GDP of India. However, a 78% reduction in the current market price or a 72% reduction in the reimbursement rate of fulvestrant in the government-funded insurance program will make it a cost-effective treatment option for HR+, HER2− MBC patients in India.
Conclusion
CDK4/6i (ribociclib and palbociclib) therapy is not a cost-effective treatment option for MBC patients. A 72% reduction in the reimbursement rate for fulvestrant monotherapy will make it a cost-effective treatment option in the Indian context.
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Funding
This work was supported by the Department of Health Research, Ministry of Health and Family Welfare, Government of India, vide Grant number F.No.T.11011/02/2017-HR/3100291.
Conflict of interest
Sudeep Gupta has participated in research projects sponsored by Pfizer, Novartis, and Eli Lilly for which research funding was provided by these companies to his institution. Nidhi Gupta, Dharna Gupta, Jyoti Dixit, Nikita Mehra, Ashish Singh, Manjunath Nookala Krishnamurthy, Gaurav Jyani, Kavitha Rajsekhar, Jayachandran Perumal Kalaiyarasi, Partha Sarathi Roy, Prabhat Singh Malik, Anisha Mathew, Pankaj Malhotra, Lalit Kumar, Amal Kataki, and Shankar Prinja declare no conflicts of interest.
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The datasets generated and/or analyzed during the current study are available from the corresponding author on request.
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The code that supports the findings of this study is available from the corresponding author on request.
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The study protocol was approved by the Institutional Ethics Committee of the Post Graduate Institute of Medical Education and Research, Chandigarh, India (IEC-03/2020-1565).
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Study conception: SP, NG, DG and JD. Study design: NG, DG, SP and JD. Analysis: DG, JD, NG and SP. Writing (first draft): DG, NG and SP. Writing (review and editing): All authors.
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Gupta, N., Gupta, D., Dixit, J. et al. Cost Effectiveness of Ribociclib and Palbociclib in the Second-Line Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer in Post-Menopausal Indian Women. Appl Health Econ Health Policy 20, 609–621 (2022). https://doi.org/10.1007/s40258-022-00731-2
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DOI: https://doi.org/10.1007/s40258-022-00731-2