Changing landscape of hereditary breast and ovarian cancer germline genetic testing in Australia

Petelin, Lara; James, Paul; Trainer, Alison H.

doi:10.1111/imj.14058

Cited by 7 publications

(11 citation statements)

References 10 publications

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“…Code-stacking (i.e., use of multiple codes, which are commonly based on the performed laboratory procedures), was applied to reimburse the Mammostrat ® and eXagenBC TM tests, as well as molecular pathology tests in the USA [ 95 , 113 ]. Unit fees were applied to reimburse BRCA1/2 tests in Australia [ 89 ] and codes were usually used to reimburse companion diagnostics in France [ 91 , 109 ]. Molecular diagnostic tests were also reimbursed by incorporating them into existing DRG- and locally and nationally negotiated tariff-based payments (e.g., in EU5 countries: Germany, France, Spain, Italy and UK) [ 14 , 115 , 121 , 123 , 125 , 140 , 142 ], or diagnostic costs were covered by state and hospital budgets or pharmaceutical companies [ 140 ].…”

Section: Resultsmentioning

confidence: 99%

Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

Koleva-Kolarova

Buchanan

Vellekoop

et al. 2022

Appl Health Econ Health Policy

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Background The number of healthcare interventions described as ‘personalised medicine’ (PM) is increasing rapidly. As healthcare systems struggle to decide whether to fund PM innovations, it is unclear what models for financing and reimbursement are appropriate to apply in this context. Objective To review financing and reimbursement models for PM, summarise their key characteristics, and describe whether they can influence the development and uptake of PM. Methods A literature review was conducted in Medline, Embase, Web of Science, and Econlit to identify studies published in English between 2009 and 2021, and reviews published before 2009. Grey literature was identified through Google Scholar, Google and subject-specific webpages. Articles that described financing and reimbursement of PM, and financing of non-PM were included. Data were extracted and synthesised narratively to report on the models, as well as facilitators, incentives, barriers and disincentives that could influence PM development and uptake. Results One hundred and fifty-three papers were included. Research and development of PM was financed through both public and private sources and reimbursed largely through traditional models such as single fees, Diagnosis-Related Groups, and bundled payments. Financial-based reimbursement, including rebates and price-volume agreements, was mainly applied to targeted therapies. Performance-based reimbursement was identified mainly for gene and targeted therapies, and some companion diagnostics. Gene therapy manufacturers offered outcome-based rebates for treatment failure for interventions including Luxturna ® , Kymriah ® , Yescarta ® , Zynteglo ®, Zolgensma ® and Strimvelis ® , and coverage with evidence development for Kymriah ® and Yescarta ® . Targeted testing with OncotypeDX ® was granted value-based reimbursement through initial coverage with evidence development. The main barriers and disincentives to PM financing and reimbursement were the lack of strong links between stakeholders and the lack of demonstrable benefit and value of PM. Conclusions Public-private financing agreements and performance-based reimbursement models could help facilitate the development and uptake of PM interventions with proven clinical benefit. Supplementary Information The online version contains supplementary material available at 10.1007/s40258-021-00714-9.

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Section: Resultsmentioning

confidence: 99%

Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

Koleva-Kolarova

Buchanan

Vellekoop

et al. 2022

Appl Health Econ Health Policy

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“…This decentralisation of funding also led to a shift of oversight of testing from FCS to cancer treatment specialists. A potential concern of purely treatment‐focused testing is the loss of intergenerational communication and ongoing follow‐up traditionally fostered by the FCS 4 . An alternate approach initiated was “mainstreaming” 4 .…”

Section: Introductionmentioning

confidence: 99%

“…Standard practice in many hospitals had been for cancer patients potentially eligible for genetic testing to be referred to Familial Cancer Services (FCS) for further assessment and to facilitate testing. 4 Recent development of polyadenosine diphosphate ribose polymerase inhibitors (PARP-I) significantly altered the treatment paradigm. Multiple studies evaluating PARP-I have increasingly shown survival benefit for BRCA1/2 carriers in both advanced and relapsed settings [5][6][7] with overall survival benefit demonstrated in the relapse setting.…”

Section: Introductionmentioning

confidence: 99%

“…Historically, genetic testing enabled cascade testing and risk‐reducing procedures for both affected individuals and BRCA1/2 carrier family members. Standard practice in many hospitals had been for cancer patients potentially eligible for genetic testing to be referred to Familial Cancer Services (FCS) for further assessment and to facilitate testing 4 . Recent development of polyadenosine diphosphate ribose polymerase inhibitors (PARP‐I) significantly altered the treatment paradigm.…”

Section: Introductionmentioning

confidence: 99%

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Mainstream genetic testing for high‐grade ovarian, tubal and peritoneal cancers: A tertiary referral centre experience

Srinivasa

Bowman

Titterton

et al. 2023

Aust NZ J Obst Gynaeco

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Background Fifteen percent of ovarian, tubal, and peritoneal (OTP) invasive epithelial cancers are linked to an underlying heritable pathogenic variant (PV) in the BRCA1/2 cancer susceptibility genes. Identifying a PV has management implications for an affected individual and relatives. Cancer team‐facilitated genetic testing (mainstreaming) aims to provide equitable systematic access to genetic testing for appropriate patients. Aim To evaluate a multi‐disciplinary team (MDT)‐led mainstream germline genetic testing program for OTP cancer at a tertiary referral centre. Materials and methods We conducted a retrospective review of our MDT‐led mainstream genetic testing program initiated in June 2017. We included all patients diagnosed with OTP cancer registered with the hospital gynaecological oncology MDT from program initiation to December 2020. Patients were considered eligible for testing if they were diagnosed with a high‐grade epithelial OTP AND ≤70 years, OR if >70 with a first/second degree relative with breast and/or ovarian cancer OR Jewish ancestry. Results Of 205 women diagnosed with high‐grade epithelial OTP cancer, 140 were eligible for mainstreaming. Eight‐five percent were mainstreamed, with the gynae‐oncologists facilitating 64.5% of tests. The overall PV detection rate in BRCA1/2 was 10.1% (BRCA1 n = 9, BRCA2 n = 3). The median turnaround time (TAT) was 44.5 days (range 16–118). All women with PV were referred to the Familial Cancer Service for further assessment and five (of six eligible; 83%) were subsequently treated with polyadenosine diphosphate ribose polymerase inhibitors. Cascade testing was undertaken in 75% of families with a mean of three relatives tested per proband. Conclusion Mainstreamed genetic testing is feasible, with an acceptable TAT, ensuring adequate opportunity to inform treatment decisions. Tumour testing and inclusion of moderate‐risk cancer predisposition genes in mainstreaming represent potential pathways that will require further exploration.

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“…Prior to mainstreaming, access to genetic counselling (GC) services has been through referral to genetics services. In many jurisdictions, medical specialists in oncology can now order a panel of multiple genes to assess for hereditary breast and ovarian cancer (HBOC) [ 10 ] without prior referral to genetic services. Mainstreaming assumes that oncology health professionals will take on the role of pre-test GC for GT.…”

Section: Introductionmentioning

confidence: 99%

Health system interventions to integrate genetic testing in routine oncology services: A systematic review

et al. 2021

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Background Integration of genetic testing into routine oncology care could improve access to testing. This systematic review investigated interventions and the tailored implementation strategies aimed at increasing access to genetic counselling and testing and identifying hereditary cancer in oncology. Methods The search strategy results were reported using the PRISMA statement and four electronic databases were searched. Eligible studies included routine genetic testing for breast and ovarian cancer or uptake after universal tumour screening for colorectal or endometrial cancer. The titles and abstracts were reviewed and the full text articles screened for eligibility. Data extraction was preformed using a designed template and study appraisal was assessed using an adapted Newcastle Ottawa Scale. Extracted data were mapped to Proctor’s et al outcomes and the Consolidated Framework for Implementation Research and qualitatively synthesised. Results Twenty-seven studies, published up to May 2020, met the inclusion criteria. Twenty-five studies ranged from poor (72%), fair to good (28%) quality. Most interventions identified were complex (multiple components) such as; patient or health professional education, interdisciplinary practice and a documentation or system change. Forty-eight percent of studies with complex interventions demonstrated on average a 35% increase in access to genetic counselling and a 15% increase in testing completion. Mapping of study outcomes showed that 70% and 32% of the studies aligned with either the service and client or the implementation level outcome and 96% to the process or inner setting domains of the Consolidated Framework for Implementation Research. Conclusion Existing evidence suggests that complex interventions have a potentially positive effect towards genetic counselling and testing completion rates in oncology services. Studies of sound methodological quality that explore a greater breadth of pre and post implementation outcomes and informed by theory are needed. Such research could inform future service delivery models for the integration of genetics into oncology services.

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Changing landscape of hereditary breast and ovarian cancer germline genetic testing in Australia

Cited by 7 publications

References 10 publications

Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

Mainstream genetic testing for high‐grade ovarian, tubal and peritoneal cancers: A tertiary referral centre experience

Health system interventions to integrate genetic testing in routine oncology services: A systematic review

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