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.
Journal
Applied health economics and health policy
ISSN: 1179-1896
Titre abrégé: Appl Health Econ Health Policy
Pays: New Zealand
ID NLM: 101150314
Informations de publication
Date de publication:
07 2022
07 2022
Historique:
accepted:
30
03
2022
pubmed:
10
5
2022
medline:
22
6
2022
entrez:
9
5
2022
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 35534752
doi: 10.1007/s40258-022-00731-2
pii: 10.1007/s40258-022-00731-2
doi:
Substances chimiques
Aminopyridines
0
Piperazines
0
Purines
0
Pyridines
0
Fulvestrant
22X328QOC4
Capecitabine
6804DJ8Z9U
palbociclib
G9ZF61LE7G
Paclitaxel
P88XT4IS4D
ribociclib
TK8ERE8P56
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
609-621Subventions
Organisme : Department of Health Research, India
ID : F.No.T.11011/02/2017-HR/3100291
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.
pubmed: 30207593
doi: 10.3322/caac.21492
Malvia S, Bagadi SA, Dubey US, Saxena S. Epidemiology of breast cancer in Indian women. Asia Pac J Clin Oncol. 2017;13(4):289–95.
pubmed: 28181405
doi: 10.1111/ajco.12661
India Factsheet: GLOBOCON 2020. The Global Cancer Observatory; 2021 [cited 6 Sep 2021]. Available at: https://gco.iarc.fr/today/data/factsheets/populations/356-india-fact-sheets.pdf .
Agarwal G, Ramakant P. Breast cancer care in India: the current scenario and the challenges for the future. Breast Care. 2008;3(1):21–7.
pubmed: 20824016
pmcid: 2931014
doi: 10.1159/000115288
Rajan G, Culas TB, Jayalakshmy P. Estrogen and progesterone receptor status in breast cancer: a cross-sectional study of 450 women in Kerala, South India. World J Surg Oncol. 2014;12(1):120.
pubmed: 24761803
pmcid: 4004458
doi: 10.1186/1477-7819-12-120
Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period. Cancer. 2005;104(8):1742–50.
pubmed: 16149088
doi: 10.1002/cncr.21359
Dafni U, Grimani I, Xyrafas A, Eleftheraki AG, Fountzilas G. Fifteen-year trends in metastatic breast cancer survival in Greece. Breast Cancer Res Treat. 2010;119(3):621–31.
pubmed: 19915976
doi: 10.1007/s10549-009-0630-8
Prat A, Pineda E, Adamo B, Galván P, Fernández A, Gaba L, et al. Clinical implications of the intrinsic molecular subtypes of breast cancer. Breast. 2015;24:S26-35.
pubmed: 26253814
doi: 10.1016/j.breast.2015.07.008
Gong Y, Liu Y-R, Ji P, Hu X, Shao Z-M. Impact of molecular subtypes on metastatic breast cancer patients: a SEER population-based study. Sci Rep. 2017;7:45411.
pubmed: 28345619
pmcid: 5366953
doi: 10.1038/srep45411
Rajappa S, Bajpai J, Basade M, Ganvir M, Goswami C, Murali A, et al. Practical consensus recommendations regarding the use of hormonal therapy in metastatic breast cancer. South Asian J Cancer. 2018;7(2):137–41.
pubmed: 29721481
pmcid: 5909292
doi: 10.4103/sajc.sajc_121_18
Sarin R. Consensus document for management of breast cancer. Division of Publication and Information on behalf of the Secretary DHR & DG, ICMR, New Delhi. 2016. Available at: http://cancerindia.org.in/wp-content/uploads/2017/11/Breast_Cancer.pdf .
National Cancer Grid—Breast Cancer. National Cancer Grid; 2017 [cited 25 Aug 2021]. Available at: https://tmc.gov.in/ncg/index.php/guidelines/search-by-cancer-type .
Patel A, Tilak TVS, Gupta VG, Batra A, Mehta P, Parikh PM, et al. Dynamics of sequencing of cyclin-dependent kinase inhibitors and cost expenditure analysis in the management of metastatic hormone-receptor positive, human epidermal growth factor 2-negative advanced breast cancer. Indian J Med Paediatr Oncol. 2019;40(2):311–3.
doi: 10.4103/ijmpo.ijmpo_111_19
Slamon DJ, Neven P, Chia S, Fasching PA, Laurentiis MD, Im S-A, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514–524 [cited 3 Dec 2020]. Available at: https://www.nejm.org/doi/10.1056/NEJMoa1911149 .
Turner NC, Slamon DJ, Ro J, Bondarenko I, Im S-A, Masuda N, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379(20):1926–36.
pubmed: 30345905
doi: 10.1056/NEJMoa1810527
Sledge GW, Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875–84.
pubmed: 28580882
doi: 10.1200/JCO.2017.73.7585
Xie N, Qin T, Ren W, Yao H, Yu Y, Hong H. Efficacy and safety of cyclin-dependent kinases 4 and 6 inhibitors in HR+/HER2− advanced breast cancer. Cancer Manag Res. 2020;12:4241–50.
pubmed: 32581595
pmcid: 7280088
doi: 10.2147/CMAR.S254365
Dhankhar A, Kumari R, Bahurupi YA. Out-of-pocket, catastrophic health expenditure and distress financing on non-communicable diseases in India: a systematic review with meta-analysis. Asian Pac J Cancer Prev. 2021;22(3):671–80.
pubmed: 33773528
pmcid: 8286691
doi: 10.31557/APJCP.2021.22.3.671
Leighl NB, Nirmalakumar S, Ezeife DA, Gyawali B. An arm and a leg: the rising cost of cancer drugs and impact on access. Am Soc Clin Oncol Educ Book. 2021;41:e1-12.
doi: 10.1200/EDBK_100028
Health Benefit Package—2.0. Official Website Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, National Health Authority [cited 16 Jun 2021]. Available at: https://pmjay.gov.in/node/1128 .
Yang J, Han J, Tian M, Tian K, Liao W, Yan X. Cost-effectiveness of ribociclib for hormone receptor-positive HER2-negative advanced breast cancer. Cancer Manag Res. 2020;12:12905–13.
pubmed: 33364838
pmcid: 7751309
doi: 10.2147/CMAR.S284556
Mistry R, May JR, Suri G, Young K, Brixner D, Oderda G, et al. Cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole and letrozole monotherapy in the first-line treatment of postmenopausal women with HR+/HER2− advanced or metastatic breast cancer: a US payer perspective. J Manag Care Spec Pharm. 2018;24(6):514–23.
pubmed: 29799329
Suri G, Chandiwana D, Lee A, Mistry R. Cost-effectiveness analysis of ribociclib plus letrozole versus palbociclib plus letrozole in the United Kingdom. J Health Econ Outcomes Res. 2019;6(2):20–31.
pubmed: 32685577
pmcid: 7299496
doi: 10.36469/9725
Galve-Calvo E, González-Haba E, Gostkorzewicz J, Martínez I, Pérez-Mitru A. Cost-effectiveness analysis of ribociclib versus palbociclib in the first-line treatment of HR+/HER2− advanced or metastatic breast cancer in Spain. Clin Outcomes Res. 2018;10:773–90.
doi: 10.2147/CEOR.S178934
Health Technology Assessment in India (HTAIn)—HTAIn manual [cited 21 Nov 2020]. Available at: https://htain.icmr.org.in/index.php/documents/publications/htain-manual .
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—explanation and elaboration: a report of the ISPOR health economic evaluation publication guidelines good reporting practices task force. Value Health. 2013;16(2):231–50.
pubmed: 23538175
doi: 10.1016/j.jval.2013.02.002
Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im S-A, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465–72.
pubmed: 29860922
doi: 10.1200/JCO.2018.78.9909
Gogia A, Deo SVS, Sharma D, Thulkar S, Kumar R, Malik PS, et al. Clinicopathologic characteristics and treatment outcomes of patients with up-front metastatic breast cancer: single-center experience in India. J Glob Oncol. 2019;5:1–9.
pubmed: 30951390
doi: 10.1200/JGO.19.11000
Department of Community Medicine and School of Public Health PGIMER Chandigarh [cited 16 Aug 2021]. Available at: https://www.healtheconomics.pgisph.in/costing_web/index.php?action=Cost_data .
Gupta N, Prinja S, Patil V, Bahuguna P. Cost-effectiveness of temozolamide for treatment of glioblastoma multiforme in India. JCO Glob Oncol. 2021;7:108–17.
pubmed: 33449801
doi: 10.1200/GO.20.00288
About Pradhan Mantri Jan Arogya Yojana (PM-JAY). Official Website Ayusham Bharat Yojana, National Health Authority [cited 10 Jul 2020]. Available at: https://pmjay.gov.in/about/pmjay .
Giuliano M, Schettini F, Rognoni C, Milani M, Jerusalem G, Bachelot T, et al. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019;20(10):1360–9.
pubmed: 31494037
doi: 10.1016/S1470-2045(19)30420-6
Prinja S, Dixit J, Gupta N, Mehra N, Singh A, Krishnamurthy MN, et al. Development of National Cancer Database for Cost and Quality of Life (CaDCQoL) in India: a protocol. BMJ Open. 2021;11(7):e048513.
pubmed: 34326050
pmcid: 8323373
doi: 10.1136/bmjopen-2020-048513
Drugs, Surgical and Sutures [cited 5 Jul 2021]. Available at: http://www.rmsc.health.rajasthan.gov.in/content/raj/medical/rajasthan-medical-services-corporation-ltd-/en/Approved-Rate-Lists/DrugsRC.html# .
CGHS rate list—CGHS: Central Government Health Scheme [cited 16 Jun 2021]. Available at: https://cghs.gov.in/index1.php?lang=1&level=3&sublinkid=5948&lid=3881 .
US Dollar to Indian Rupee Spot Exchange Rates for 2021 [cited 6 Jul 2021]. Available at: https://www.exchangerates.org.uk/USD-INR-spot-exchange-rates-history-2021.html .
HLL Lifecare—Amrit Medicines [cited 3 Aug 2021]. Available at: http://www.lifecarehll.com/page/render/reference/Amrit_Medicines .
Fox-Rushby J, Cairns J. Economic evaluation. McGraw-Hill Education; 2005 [cited 8 Oct 2020]. Available at: https://mhebooklibrary.com/doi/book/10.1036/9780335225064 .
Wilson FR, Varu A, Mitra D, Cameron C, Iyer S. Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer. Breast Cancer Res Treat. 2017;166(1):167–77.
pubmed: 28752187
pmcid: 5645434
doi: 10.1007/s10549-017-4404-4
Registrar General and Census Commissioner of India. SRS BULLETIN 2014 [cited 8 Nov 2020]. Available at: https://censusindia.gov.in/vital_statistics/SRS_Bulletins/SRS%20Bulletin%20-Sepetember%202014.pdf .
Rath S, Elamarthi P, Parab P, Gulia S, Nandhana R, Mokal S, et al. Efficacy and safety of palbociclib and ribociclib in patients with estrogen and/or progesterone receptor positive, HER2 receptor negative metastatic breast cancer in routine clinical practice. PLoS ONE. 2021;16(7):e0253722.
pubmed: 34292933
pmcid: 8297817
doi: 10.1371/journal.pone.0253722
Lloyd A, Nafees B, Narewska J, Dewilde S, Watkins J. Health state utilities for metastatic breast cancer. Br J Cancer. 2006;95(6):683–90.
pubmed: 16967055
pmcid: 2360509
doi: 10.1038/sj.bjc.6603326
Cost-Effectiveness Threshold. YHEC—York Health Economics Consortium [cited 11 Dec 2020]. Available at: https://yhec.co.uk/glossary/cost-effectiveness-threshold/ .
GDP per capita (current US$)—India—Data [cited 24 Jun 2020]. Available at: https://data.worldbank.org/indicator/NY.GDP.PCAP.CD?locations=IN .
Mathur P, Sathishkumar K, Chaturvedi M, Das P, Sudarshan KL, Santhappan S, et al. Cancer statistics, 2020: report from National Cancer Registry Programme, India. JCO Glob Oncol. 2020;6:1063–75.
pubmed: 32673076
doi: 10.1200/GO.20.00122
Ramani PA, Niharika VS, Lakhsmi BKM, Jahnavi S, Reddy GVS. Incidence of locally advanced breast cancer in women presenting to a tertiary care center. Int Surg J. 2019;6(10):3626–31.
doi: 10.18203/2349-2902.isj20194415
Desai SB, Moonim MT, Gill AK, Punia RS, Naresh KN, Chinoy RF. Hormone receptor status of breast cancer in India: a study of 798 tumours. Breast Edinb Scotl. 2000;9(5):267–70.
doi: 10.1054/brst.2000.0134
About Pradhan Mantri Jan Arogya Yojana (PM-JAY). Official Website Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, National Health Authority [cited 20 Aug 2021]. Available at: https://pmjay.gov.in/about/pmjay .
Vaikundaraja IM, Dhanushkodi M, Radhakrishnan V, Kalaiarasi JP, Mehra N, Rajan AK, et al. Fulvestrant in hormone-positive advanced breast cancer: real-world outcome. Cancer Res Stat Treat. 2020;3(2):275.
doi: 10.4103/CRST.CRST_53_20
Agrawal C, Doval D, Agarwal A, Goyal P, Baghmar S, Talwar V, et al. Real world evidence of palbociclib use in metastatic hormone positive HER negative metastatic breast cancer in Indian population. Eur J Cancer. 2020;138:S103.
doi: 10.1016/S0959-8049(20)30812-1
Prinja S, Kaur G, Malhotra P, Jyani G, Ramachandran R, Bahuguna P, et al. Cost-effectiveness of autologous stem cell treatment as compared to conventional chemotherapy for treatment of multiple myeloma in India. Indian J Hematol Blood Transfus. 2017;33(1):31–40.
pubmed: 28194053
pmcid: 5280872
doi: 10.1007/s12288-017-0776-1
Aboutorabi A, Hadian M, Ghaderi H, Salehi M, Ghiasipour M. Cost-effectiveness analysis of trastuzumab in the adjuvant treatment for early breast cancer. Glob J Health Sci. 2014;7(1):98–106.
pubmed: 25560346
pmcid: 4796396
doi: 10.5539/gjhs.v7n1p98
Stellato D, Thabane ME, Park J, Chandiwana D, Delea TE. 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. 2021;39(9):1045–58.
pubmed: 34105083
doi: 10.1007/s40273-021-01027-4
Mamiya H, Tahara RK, Tolaney SM, Choudhry NK, Najafzadeh M. Cost-effectiveness of palbociclib in hormone receptor-positive advanced breast cancer. Ann Oncol. 2017;28(8):1825–31.
pubmed: 28472324
doi: 10.1093/annonc/mdx201
Ministry of Statistics and Programme Implementation. Key indicators of social consumption in India: health. NSS 75th round. 2019. Available at: https://www.mospi.gov.in/reports-publications .
Singh MP, Chauhan AS, Rai B, Ghoshal S, Prinja S. Cost of treatment for cervical cancer in India. Asian Pac J Cancer Prev. 2020;21(9):2639–46.
pubmed: 32986363
pmcid: 7779435
doi: 10.31557/APJCP.2020.21.9.2639
Chauhan AS, Prinja S, Ghoshal S, Verma R, Oinam AS. Cost of treatment for head and neck cancer in India. PLoS ONE. 2018;13(1):e0191132.
pubmed: 29324861
pmcid: 5764364
doi: 10.1371/journal.pone.0191132
Prinja S, Bahuguna P, Duseja A, Kaur M, Chawla YK. Cost of intensive care treatment for liver disorders at tertiary care level in India. PharmacoEconomics Open. 2017;2(2):179–90.
pmcid: 5972113
doi: 10.1007/s41669-017-0041-4
Dukpa W, Teerawattananon Y, Rattanavipapong W, Srinonprasert V, Tongsri W, Kingkaew P, et al. Is diabetes and hypertension screening worthwhile in resource-limited settings? An economic evaluation based on a pilot of a package of essential non-communicable disease interventions in Bhutan. Health Policy Plan. 2015;30(8):1032–43.
pubmed: 25296642
doi: 10.1093/heapol/czu106