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In Final Guidance, UK's NICE Recommends Genomic Health's Oncotype DX at Undisclosed Price


UK's National Institute for Health and Care Excellence has recommended Genomic Health's Oncotype DX as a tool to help doctors decide whether a woman with a specific type of breast cancer should be treated with chemotherapy.

According to NICE's appraisal, Oncotype DX is recommended to help a doctor reach a more definitive assessment of a woman's risk of breast cancer recurrence after she is found to be at intermediate risk (those with a Nottingham Prognostic Index score above 3.4) for disease recurrence using standard assessment tools. The woman should also have ER-positive, lymph node-negative, HER2-negative breast cancer.

"The manufacturer provides Oncotype DX to [National Health Service] organizations according to the confidential arrangement agreed with NICE," the agency states in its final guidance issued this week.

NICE, which calculates the cost effectiveness of healthcare interventions and advises whether NHS should pay for them, considers a drug, test, or strategy to be cost effective when it falls within the range of £20,000 to £30,000 per QALY gained.

When NICE considered recommending Oncotype DX to all women with early-stage, ER-negative, node-negative, HER2-negative disease, the test didn't meet the agency's threshold for cost-effectiveness, at £91,300 per quality-adjusted life year gained for a 30 percent risk reduction from chemotherapy and £64,900 QALY gained for a 40 percent risk reduction from chemotherapy.

For this calculation, NICE considered the list price of the test, which is not stated in the final guidance. In its preliminary assessment, NICE used around a $4,000 price tag for Oncotype DX.

After the agency's initial finding, Genomic Health proposed a "revised price" to NICE, making Oncotype DX available to NHS at an undisclosed amount for women deemed to be at intermediate risk of recurrence based on standard methods. At this reduced price, analysis by NICE's external assessment group showed that using Oncotype DX compared to standard practice imparted a £22,600 per QALY gained, if the test was prognostic but not predictive in intermediate risk patients. "[T]he ICER could be significantly lower if Oncotype DX was shown to predict the benefit of chemotherapy by robust evidence from future research," NICE wrote.

The institute has recommended Genomic Health collect additional data showing that Oncotype DX impacts clinical decision making in England and further backing the test's ability to predict chemotherapy benefit. "As part of the adoption of Oncotype DX by the NHS, the Committee encourages the collection of clinical utility and any other useful data by the health system, potentially by a multicenter audit," NICE wrote in its decision.

Financial analysts have previously estimated that in the UK Oncotype DX could be a 21,000-patient market opportunity for Genomic Health.

The recommendation backing Oncotype DX comes as part of a broader appraisal NICE performed on a number of gene expression profiling and immunohistochemistry tests for guiding chemotherapy decisions in early-stage breast cancer. The final guidance is essentially the same as its preliminary decision issued earlier this year (PGx Reporter 2/20/2013).

The other tests appraised by NICE included Agendia's MammaPrint, IHC4 developed by Royal Marsden Hospital and Queen Mary University, London, and Mammostrat developed by GE's Clarient. NICE recommended these three tests for research use in women with early-stage, ER-positive, node-negative, HER2-negative breast cancer.

The institute would like developers of these tests to collect additional data to gauge whether the diagnostics improve patients' outcomes and accurately predict whether they will benefit from chemotherapy. "The tests are not recommended for general use in these people because of uncertainty about their overall clinical benefit and consequently their cost effectiveness," NICE said.