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In Preliminary Recommendation, UK's NICE Backs Oncotype DX in Subset of Breast Cancer Patients

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Originally published Feb. 19.

UK's National Institute for Health and Clinical Excellence has issued a preliminary recommendation that the National Health Service provide breast cancer recurrence assessment by Genomic Health's Oncotype DX test for a subset of women with estrogen receptor-positive, lymph node-negative, early-stage breast cancer.

NICE, which calculates the cost effectiveness of healthcare interventions and advises whether NHS should pay for them, recommended testing with Oncotype DX if the woman is at "intermediate risk" based on standard clinical measures, if the physician is uncertain as to whether to prescribe chemotherapy, and if "the manufacturer provides [testing] to NHS organizations at the price offered through the confidential arrangement agreed with NICE."

NICE last year conducted an initial analysis on the cost effectiveness of testing patients using Oncotype DX and other recurrence tests (PGx Reporter 2/8/2012). For that first analysis, NICE used a £2,580 ($3,996) price tag for Oncotype DX and came up with an incremental cost effectiveness ratio of £26,940 ($41,730) per quality-adjusted life year gained.

NICE considers a medical intervention to be cost effective when its incremental cost-effectiveness ratio falls below £20,000 ($30,980) per quality-adjusted life year gained.

For the latest analysis, NICE applied an undisclosed "revised price" for Oncotype DX that Genomic Health negotiated with the agency. In gauging the cost effectiveness of providing the test, NICE noted that its diagnostics advisory committee agreed "that the access proposal appeared workable and efficient, and did not appear to constitute an excessive administrative burden on the NHS."

When considered for all women with estrogen receptor-postive, lymph node-negative, HER2-negative early stage breast cancer, "Oncotype DX was associated with an incremental cost of £2,575 ($3,989) and incremental QALYs of 0.1 yielding an ICER of £26,940 ($41,730) per QALY gained," NICE states in its draft recommendation. When NICE further narrowed the population to those deemed to be at "intermediate risk" by clinical assessments, Oncotype DX had an incremental cost of £2,095 ($3,245) and incremental QALYs of 0.23, resulting in an ICER of £9,007 ($13,952) per QALY gained.

In a research note, analyst William Quirk of investment firm Piper Jaffray estimated that the UK represents a $48 million market for Oncotype DX among ER-positive, node-negative, early-stage breast cancer patients. Quirk viewed it as a positive for Genomic Health that NICE did not recommend competing breast cancer recurrence tests, mainly Agendia's MammaPrint.

Specifically, NICE only recommends MammaPrint, IHC4 (developed by Royal Marsden Hospital and Queen Mary University, London), and Mammostrat (developed by GE's Clarient) for research use in estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer patients, in order "to collect evidence about potentially important clinical outcomes and to determine the ability of the tests to predict the benefit of chemotherapy." NICE further states in its preliminary recommendations that these tests are "not … for general use in these people because of uncertainty about their overall clinical benefit and consequently their cost effectiveness."

NICE reviewers analyzed the data submitted by the test manufacturers and deemed Oncotype DX to be "the furthest along the validation pathway" in terms of clinical validity and the correlation between the test's recurrence score and disease-free survival or overall survival. The assessment group has indicated that "prospective confirmation of the clinical utility of Oncotype DX" is needed.

In reviewing data for MammaPrint, however, NICE was not swayed that the use of the test improved long-term outcomes, since most of these investigations were done on small cohorts. "In terms of clinical utility, the previous reviews identified one prospective study demonstrating that MammaPrint had an impact on clinical decision-making," NICE stated in its recommendations, referring to the RASTER study. "However, follow-up was not long enough to provide evidence of its effect on clinical endpoints such as distant metastasis-free survival or its utility in predicting treatment benefit." NICE reviewers have suggested that Agendia submit data from randomized controlled trials.

Furthermore, in assessing the cost-effectiveness of using MammaPrint to determine whether early-stage breast cancer patients (estrogen receptor-positive, lymph node-negative, HER2-negative) who are at intermediate risk of recurrence by standard measures should receive chemotherapy, NICE found that the proportion of patients receiving chemotherapy increased compared to current practice. "Current practice was associated with mean costs of between £8,281 ($12,827) and £8,872 ($13,743) and mean QALYs of between 12.81 and 13.07," NICE wrote. "MammaPrint was associated with mean costs of between £12,278 ($19,018) and £14,014 ($21,708) and mean QALYs of between 12.99 and 13.73. The ICER for MammaPrint was estimated to be between £6,053 ($9,376) and £29,569 ($45,802) per QALY gained."

The NICE reviewers didn't identify any studies on the analytical validity or any prospective studies on clinical outcomes involving IHC4 and Mammostrat. Although NICE found IHC4 to save costs compared to current practice, the agency couldn't recommend the test based on available evidence.

Stakeholders can comment on this draft recommendation until March 11.

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