title: Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland.
abstract: The 21-gene test is a validated multi-gene diagnostic test that predicts chemotherapy (CT) benefit in oestrogen receptor positive (ER+), lymph node-negative (N0) breast cancer (BC) patients (pts). Ireland was the first public health care system to reimburse this test in Europe. Study objectives were to assess the impact of this test on decision-making and to analyse the economic impact of testing. Between October 2011 and February 2013, a national, retrospective, cross-sectional observational study of ER+, N0 BC pts tested with the 21-gene test was conducted. Surveyed breast medical oncologists, provided the assumption for the decision impact analysis that grade (G) 1 pts would not have received CT before testing and G2/3 pts would have received CT before testing. Descriptive statistical analyses were performed. 592 pts were identified; Low, intermediate and high recurrence score were identified in 53, 36 and 10 % pts, respectively. 384 (70 %) pts had G2, 129 (22 %) G3 and 76 (13 %) G1 tumours. Post testing, 345 pts (59 %) experienced a change in CT decision; 339 changed to hormone therapy alone and 6 advised to receive CT. 172 (30 %) pts received CT, 12 (3.9 %) of pts with low scores, 108 (50.9 %) of intermediate risk and 50 (90.9 %) of pts with high risk scores. Net reduction in CT use was 58 % and net savings achieved were €793,565. Since public reimbursement, the introduction of the 21-gene test has resulted in a significant reduction in chemotherapy administration and cost savings for the Irish public healthcare system.
authors.affiliation: Medical Oncology Department, St Vincent's University Hospital, Dublin 4, Ireland. smythl@mskcc.org.
authors.forename: Lillian
authors.initials: L
authors.lastname: Smyth
authors.affiliation: Medical Oncology Department, St Vincent's University Hospital, Dublin 4, Ireland.
authors.forename: Geoff
authors.initials: G
authors.lastname: Watson
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Walsh
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Kelly
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Maccon
authors.initials: M
authors.lastname: Keane
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: M John
authors.initials: MJ
authors.lastname: Kennedy
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Liam
authors.initials: L
authors.lastname: Grogan
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Bryan T
authors.initials: BT
authors.lastname: Hennessy
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Seamus
authors.initials: S
authors.lastname: O'Reilly
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Linda E
authors.initials: LE
authors.lastname: Coate
authors.affiliation: All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Miriam
authors.initials: M
authors.lastname: O'Connor
authors.affiliation: Department of Histopathology, St Vincent's Healthcare Group, Dublin 4, Ireland.
authors.forename: Cecily
authors.initials: C
authors.lastname: Quinn
authors.affiliation: Pharmerit GmbH, Berlin, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Verleger
authors.affiliation: Pharmerit GmbH, Berlin, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Schoeman
authors.affiliation: National Cancer Control Programme (NCCP), Dublin, Ireland.
authors.forename: Susan
authors.initials: S
authors.lastname: O'Reilly
authors.affiliation: Medical Oncology Department, St Vincent's University Hospital, Dublin 4, Ireland.|All-Ireland Co-operative Oncology Research Group, Dublin 2, Ireland.
authors.forename: Janice M
authors.initials: JM
authors.lastname: Walshe
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000235:genetics* / Q000628:therapy; D000066491:Clinical Decision-Making; D003362:Cost-Benefit Analysis; D003430:Cross-Sectional Studies; D005260:Female; D020869:Gene Expression Profiling / Q000191:economics* / Q000379:methods*; D006801:Humans; D007494:Ireland / Q000453:epidemiology; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D011960:Receptors, Estrogen / Q000235:genetics; D012189:Retrospective Studies; D014057:Tomography, X-Ray Computed; D059467:Transcriptome; D047368:Tumor Burden
chemical_list: D011960:Receptors, Estrogen
keywords: 21-Gene test; Adjuvant chemotherapy; Breast cancer; Economic evaluation; Oncotype DX; Recurrence score