Background
Methods
Study design
Search strategy
Eligibility criteria
Inclusion criteria | Exclusion criteria | |
---|---|---|
Population | All women, whether healthy with or without a family history or increased clinical risk of BC, as well as those already diagnosed with BC. | Male |
Intervention | BRCA1/2 germline genetic testing and/or may include another genetic testing (i.e., pathogenic or likely pathogenic variants: BRCA1/2, PALB2, CHEK2, ATM, BARD1, RAD51c/d) | Somatic genetic testing, Single nucleotide polymorphism (SNP) |
Comparison | No genetic testing or alternative screening methods | Not Applicable |
Outcome | Costs per quality-adjusted life years (QALY), cost per life-years gained, and costs per number of cancer cases averted. | Cost analysis studies (e.g., with costs but no health outcomes) |
Study Design | Partial or full economic evaluation such as cost-benefit analysis (CBA), cost-utility analysis (CUA) or/and cost-effectiveness analysis (CEA) as well as cost-minimization analysis (CMA). Studies conducted in randomized controlled trials, case studies, observational studies, or model-based studies were included. | No publication of full-text articles or original data such as systematic literature reviews, commentaries (letters to the editors, editorials), abstracts, and expert review |
Language | English language | Other than the English language |
Local setting | Low- and middle-income countries | High-income countries |
Date of Publication | Until April 2023 | May 2023 onwards |
Study selection process and data extraction
Data synthesis
Assessment of quality of reporting
Results
Search results
Study characteristics
Author (Year) | Country (country income category) | Population description | Treatment strategy | Intervention VS comparison | Study design | Perspective | Time horizon | Cascade Testing | discount rate | Type of uncertainty analysis |
---|---|---|---|---|---|---|---|---|---|---|
Genetic testing for breast cancer only | ||||||||||
Lim et al. (2018) [30] | Malaysia (UMIC) | Hypothetical cohort of 1000 patients who aged 40 years old with newly diagnosed as early stage (Stage1/2) unilateral BC. | risk-reducing mastectomy (RRM), risk-reducing bilateral salpingo-oophorectomy (RRBSO), tamoxifen chemoprevention, combination of these or neither | BRCA testing VS No testing, performed Routine clinical surveillance only | Decision tree and Markov Model (1 year length of cycle) | payer perspective | Lifetime | No | 3% for costs and health outcomes | One way deterministic sensitivity analyses & probabilistic sensitivity analysis |
Sun et al. (2022) [32] | China (UMIC) | All BC patients VS Family History/clinical-criteria-based testing | Prophylactic mastectomy and salpingo-oophorectomy | a)BRCA1/BRCA2/PALB2 testing for all BC patients b)BRCA1/BRCA2-testing for BC patients with FH/clinical criteria c) No testing | Microsimulation model at the individual level | Societal and Payer perspectives | Lifetime | Yes | 3% for costs and health outcomes | One way deterministic sensitivity analyses & probabilistic sensitivity analysis |
Wu et al. (2023) [29] | China (UMIC) | Patients with TNBC and hormone-receptor (HR)-positive and HER2-negative BC | Standard treatment with Olaparib and RRO as an adjuvant treatment | a) Universal gBRCAtesting for all TNBC and HR-positive HER2-negative BC patients b) No gBRCA testing c) Selected gBRCA testing | A decision tree analytic model based on transitional Markov Chain (1 year length of cycle) | Payer perspectives | 20 years | No | 3% for costs and health outcomes | One way deterministic sensitivity analyses & probabilistic sensitivity analysis |
Genetic testing for breast cancer and ovarian cancer | ||||||||||
Manchanda et al. (2020) [31] | China (UMIC) & Brazil (UMIC) & India (LMIC) | Population-based screening for all women ≥ 30 years old. | RRSO, MMRI/mammography screening, chemoprevention with SERM, RRM | Population-based BRCA1/BRCA2 testing VS clinical-criteria/FH-based testing | Markov Model | Societal and Payer perspectives | Lifetime (China = 48 cycles; Brazil = 49 cycles; India = 38 cycles) | No | 3% for costs and health outcomes | One way deterministic sensitivity analyses & probabilistic sensitivity analysis |
Simoes Correa-Galendi et al. (2021) [33] | Brazil (UMIC) | Healthy women aged 30 years with personal or family history of BRCA-associated cancer and meeting the clinical criteria for genetic testing according to the National Comprehensive Cancer Network (NCCN). | Intensified surveillance, risk-reducing bilateral mastectomy and bilateral salpingo-oophorectomy | BRCA1/BRCA2 testing and counselling VS no genetic testing and counselling | Markov Model | Payer perspectives | 70 years | No | 5% for costs and utilities | One way deterministic sensitivity analyses & probabilistic sensitivity analysis |
Lourencao et al. (2022) [34] | Brazil (UMIC) | Healthy women aged 30 years with personal or family history of BRCA-associated cancer and meeting the clinical criteria for genetic testing according to the National Comprehensive Cancer Network (NCCN). | Intensified surveillance, risk-reducing bilateral mastectomy, bilateral salpingo-oophorectomy, both bilateral mastectomy and bilateral salpingo-oophorectomy | BRCA1/BRCA2 testing and counselling and with surgical/non-surgical preventive options VS No genetic testing and counselling (with standard care) | Markov Model | Payer perspectives | 70 years | Yes | 5% for costs and utilities | Deterministic sensitivity analyses & probabilistic sensitivity analysis |
Summary of results from selected studies
Author (Year) | Source of cost data | International value of genetic testing (2022) USD | Source of effectiveness data | Willingness to pay threshold USD | Outcome measurement | Cost-effectiveness results, ICER* and conclusion from study |
---|---|---|---|---|---|---|
Genetic testing for breast cancer only | ||||||
Lim et al. (2018) [30] | Local Hospital | 451.5 (2016) → 509.31 (2022) | Literature Search from Other Countries | 9500 USD/QALY (1 time GDP per capita) | Incremental Costs per QALY (ICERs), Incremental Costs per LYS (ICERs) | • ICER: USD 2566/QALY; USD 918/life-year saved • Genetic testing is cost-effective compared to routine clinical surveillance as it was below WTP threshold. |
Sun et al. (2022) [32] | Sampling database of the Chinese Urban Basic Medical Insurance | 367 (2019) → 390.36 (2022) | Lifetime Tables from each country were obtained from the World Health Organization (WHO) and published literatures. | 10,262 USD/QALY (1 time GDP per capita) | Incremental Costs per QALY (ICERs), Incremental Costs per LYG (ICERs) | • Multigene testing for all BC patients VS No genetic testing USD 4793/QALY, USD 4294/LYG (Societal) & USD 7729/QALY, USD 6923/LYG (payer perspective) • Unselected multigene testing to all BC patients in China is cost-effective as compared with no testing or selected testing as it was below WTP threshold |
Wu et al. (2023) [29] | Price Announcement by the Shanghai Health Minister of China | 308.6 (2021) → 314.98 (2022) | Published literatures | 31,500 USD /QALY | Primary Outcome: QALY gained & ICERs Secondary Outcome: life expectancy gained & survival outcome | • Universal gBRCA testing among TNBC patient compared with no testing and selected testing respectively, ICERs of USD 10,812/QALY and USD 11,218 /QALY • Universal testing for all HER2-negative BC patients compared with no testing and selected testing respectively, with ICERs of USD 2214/QALY & USD 2065/QALY. • Universal gBRCA testing is cost-effective as the ICER value is below the WTP threshold. |
Genetic Testing for Breast Cancer and Ovarian Cancer | ||||||
Manchanda et al. (2020) [31] | China Urban Basic Medical Insurance Database; Brazil Management System of Procedures/Medical drugs/Orthotics/Prosthetics/Special Materials (SIGTAP), the Health Price Bank (BPS), and Chamber of Regulation of the Market of Medicines (CMED); India Accredited Cancer Centre Tata Medical Centre | 200 (2016) → 225.61 (2022) | Lifetime Tables from each country were obtained from the World Health Organization (WHO); QALY values obtained from published literatures. | China: ($15,531/QALY-$46,592/QALY) Brazil: ($15,182/QALY-$45,545/QALY India: ($6574/QALY-$19,722/QALY) WTP were based on 1–3 times GDP of each country | Lifetime costs and QALYs, ICERs | • ICER China Societal: USD 26,716/LY, USD 20,379/QALY Payer: USD 34,730/LY, USD 26,492/QALY Brazil Societal: USD 17,873/LY, USD 15,318/QALY Payer: USD 27,632/LY, USD 23,683/QALY India Societal: USD 31,831/LY, USD 25,980/QALY Payer: USD 44,527/LY, USD 36,342/QALY • BRCA testing is cost-effective in both China and Brazil except India from both payer and societal perspective when compared to the WTP threshold set in the study |
Simoes Correa-Galendi et al. (2021) [33] | Official Brazilian Universal Health Coverage System (SUS) database and local distributors | 1480 (2019) → 1574.22 (2022) | Several systematic literature searches in Medline and BIREME (a Latin American health database) | Not well defined | Incremental Costs per QALY (ICERs), Incremental Costs per LYG (ICERs) | • ICER: USD 12,472/QALY & USD 14,013/ LYG • Cost-effectiveness of BRCA testing is still depends on undecided cost-effectiveness threshold. The ICER is 1.04 times the GDP per capita |
Lourencao et al. (2022) [34] | Official Brazilian Universal Health Coverage System (SUS) database | 524.98 (2021)→ 535.84 (2022) | Published studies from a systematic literature search in the PubMed database | R$ 25,000/QALY (U$ 11, 563.37/QALY) Based on the lowest thresholds reported in National Commission for the Incorporation of Technologies (CONITEC) | Incremental Costs per QALY (ICERs), Incremental Costs per LYG (ICERs) | • ICER: USD 5618/QALY and USD 5188/ LYG • BRCA testing is cost-effective if the WTP is USD 11,563.37/QALY |
Genetic screening and treatment strategies (population, age, and intervention and comparison groups)
Variation in methodological approaches and data inputs
Analysis of the price of genetic testing and incremental cost-effectiveness ratios (ICERs)
Assessment of quality of selected studies
Item | CHEERS Criteria | Authors (Year) | |||||
---|---|---|---|---|---|---|---|
Lim et al. (2018) [30] | Sun et al. (2022) [32] | Wu et al. (2023) [29] | Manchanda et al. (2020) [31] | Simoes Correa-Galendi et al. (2021) [33] | Lourencao et al. (2022) [34] | ||
Title | |||||||
1 | Title | Yes | Partial | Partial | Partial | Partial | Partial |
Abstract | |||||||
2 | Abstract | Yes | Partial | Yes | Partial | Yes | Partial |
Introduction | |||||||
3 | Background and Objectives | Yes | Yes | Yes | Yes | Yes | Yes |
Methods | |||||||
4 | Health economic analysis plan | Yes | Yes | Yes | Yes | Yes | Yes |
5 | Study population | Yes | Yes | Yes | Yes | Yes | Yes |
6 | Setting and location | Yes | Yes | Yes | Yes | Yes | Yes |
7 | Comparators | Yes | Yes | Yes | Yes | Yes | Yes |
8 | Perspective | Yes | Yes | Partial | Yes | Yes | Yes |
9 | Time horizon | Partial | Partial | Partial | Yes | Yes | Yes |
10 | Discount rate | Yes | Yes | Yes | Yes | Yes | Yes |
11 | Selection of outcomes | Yes | Yes | Yes | Yes | Yes | Yes |
12 | Measurement of outcomes | Yes | Yes | Yes | Yes | Yes | Yes |
13 | Valuation of outcomes | Yes | Yes | Yes | Yes | Yes | Partial |
14 | Measurement and valuation of resources and costs | Yes | Yes | Yes | Yes | Yes | Yes |
15 | Currency, price date, and conversion | Yes | Yes | Yes | Yes | Yes | Yes |
16 | Rationale and description of model | Yes | Yes | Yes | Partial | Yes | Partial |
17 | Analytics and assumptions | Partial | Partial | Yes | Yes | Yes | Yes |
18 | Characterizing heterogeneity | Yes | Yes | No | Yes | Yes | Yes |
19 | Characterizing distributional effects | Yes | Yes | Yes | Yes | Yes | Yes |
20 | Characterizing uncertainty | Partial | Partial | Yes | Partial | Partial | Partial |
21 | Approach to engagement with patients and others affected by the study | Partial | Partial | Partial | No | No | Partial |
Results | |||||||
22 | Study parameters | Yes | Yes | Yes | Yes | Yes | Yes |
23 | Summary of main results | Yes | Yes | Yes | Yes | Yes | Yes |
24 | Effect of uncertainty | Partial | Partial | Yes | Partial | Partial | Yes |
25 | Effect of engagement with patients and others affected by the study | No | No | No | No | No | No |
Discussion | |||||||
26 | Study findings, limitations, generalizability, and current knowledge | Yes | Yes | Yes | Yes | Yes | Yes |
Other relevant information | |||||||
27 | Source of funding | Yes | Yes | Yes | Yes | Yes | Yes |
28 | Conflicts of interest | Yes | Yes | Yes | Yes | Yes | Yes |