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NICE Draft Guidance Reverses Endorsement of Oncotype Dx to Guide Chemotherapy

NEW YORK (GenomeWeb) – A draft document published today by the UK's National Institute for Health and Care Excellence (NICE) reverses a previous endorsement for the use of Genomic Health's Oncotype Dx test in guiding chemotherapy decisions for breast cancer patients.

The report contains an assessment of various evidence on the use of commercial tumor profiling tests (including Oncotype Dx, as well as Myriad Genetics' EndoPredict, Agendia's MammaPrint, and NanoString Technologies' Prosigna) intended to update a previous guidance on the use of such tools to guide adjuvant chemotherapy decisions in the NHS in England.

The previous guidance recommended Oncotype Dx — and no other tests — as an option for guiding adjuvant chemotherapy decisions in individuals with clinically intermediate risk, estrogen receptor positive, lymph node negative, and HER2−negative early breast cancer under certain conditions.

In the new assessment, however, NICE reports that none of the assessed technologies have demonstrated themselves to offer a significant enough impact on outcomes or cost effectiveness than current practice for informing the choice to use or avoid adjuvant chemotherapy.

"There is not enough evidence to recommend the routine adoption of EndoPredict, MammaPrint, Oncotype Dx Breast Recurrence Score, Prosigna, and IHC4+C to guide adjuvant chemotherapy decisions," the resulting draft recommendation reads. "In particular, more evidence is needed to prove that these tests have a positive effect on patient outcomes. Their cost effectiveness compared with current practice is highly uncertain."

The report and recommendation draft are now open for comments until Jan. 31, after which NICE will use the documents and any comments to inform a finalized update to its guidance on the use of these tests in the UK's National Health System. The expected publication date for the finalized document is May 9, 2018.

If finalized, the assessment could impact Genomic Health's business in the UK, and has the potential to affect its larger standing as well, as financial analysts have been banking on test sales in the UK as a key driver for the firm's revenue growth.

In a note to investors today, Cowen analyst Doug Schenkel wrote, "If finalized, [the new guidance] could cause us to slightly temper expectations for what has been a key driver to [outside US] revenue growth."

He also noted that the UK has been "a key market" for Genomic Health, adding that "UK revenue was a key part of driving the double digit international revenue growth expected in 2017, as reimbursement in other Western European markets … has been slower to materialize. If this proposed guidance is finalized in its current form, we would likely have to contemplate tempering expectations for [UK] growth over the coming quarters."

The company does still boast endorsements from several international guidelines bodies, including ASCO, NCCN, St. Gallen, and ESMO, which could somewhat mediate the impact of an update to NICE's guidance.

In an email to GenomeWeb, Genomic Health wrote that it believes that the NICE draft, if finalized, "would represent a significant step back of five years in breast cancer care with more patients potentially receiving unnecessary chemotherapy," adding that it is "confident that based on stakeholder responses, patients in the UK will continue to have access to its test through the NHS."

The company has also released statements making clear that it opposes the updated assessment.  In November 2017, the firm provided a comment to NICE calling into question the appropriateness of the methods and conclusions of the report.

Released as part of the draft guidance today, Genomic Health's letter said that the company has "major concerns" that the assessment procedure used was "fundamentally flawed" and has resulted in an assessment report that is "unbalanced" and "fails properly to take account of the purpose of tumor profiling tests."

In its email, Genomic Health said that flaws in the draft analysis include the supposition that all patients are assumed to derive an equal benefit from the chemotherapy they receive.

The company also argued in its letter to NICE that the report's authors have "major conflicts of interest," and that the assessment appears to be biased in favor of certain technologies over others, though it didn't specify which technologies it believes are benefitting from this alleged bias.

In the NICE documentation, there is one competing interest reported for one of the authors — University College, London's Rob Stein reported serving as the chief investigator of the OPTIMA (Optimal Personalized Treatment of breast cancer using Multi-Parameter Analysis) trial.

Genomic Health also critiqued the transparency of the cost effectiveness analyses conducted by the NICE assessors, and some of the assumptions used in their models. Further, the company argued that the comment period provided is "wholly insufficient."