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UK's NICE Recommends Roche's Rozlytrek for Solid Tumors With NTRK Fusions

This article has been updated to reflect the correct proposed list price for Rozlytrek.

NEW YORK – The UK's National Institute for Health Care Excellence (NICE) on Thursday published a final draft guidance recommending the histology-independent use of entrectinib (Roche's Rozlytrek) through the Cancer Drugs Fund (CDF).

The recommendation will allow adult and pediatric patients over the age of 12 with advanced NTRK fusion-positive solid tumors to receive entrectinib if they lack satisfactory treatment options. The availability through the CDF is another pathway by which patients in the National Health Service in England can get access to treatments that don't meet NICE's cost-effectiveness threshold based on current evidence.

Entrectinib is the second tumor-agnostic drug recommended for use through the CDF. In late April, NICE reversed course on a previous negative recommendation and said it would make available larotrectinib (Bayer's Vitrakvi) for patients with NTRK fusion-positive solid tumors via the CDF.

NICE's recommendations come more than a year after the US Food and Drug Administration approved larotrectinib and entrectinib based on response rates seen in small, single-arm trials. However, these same studies posed a challenge for NICE to evaluate the drugs' cost effectiveness — a calculation that is usually based on clear survival advantages. As of now, survival data for entrectinib in patients with NTRK fusion-positive tumors are immature.

"The committee noted the small patient numbers from each of the trials making up the pooled analysis, and that the trials were single arm and did not include a control group," said NICE in its recommendation.

However, NICE ultimately decided to recommend entrectinib for inclusion on the CDF, despite lacking the data it desired, since there are ongoing clinical trials where additional evidence will be generated. "The ongoing entrectinib clinical trials will provide more mature survival data for people already enrolled on the trials … which will provide further data to explore the heterogeneity in response to treatment," the committee wrote.

The drug's proposed list price is £5,160 ($6,727.47, as of the exchange rate on August 4, 2020), but Roche is providing it to the NHS at an undisclosed discounted price.

While more evidence is generated, NICE considers the price of entrectinib cost-effective in accordance with its end-of-life criteria. Even though the parameters for end-of-life criteria were not designed for histology-independent drugs, the committee recognized that most patients enrolled in entrectinib clinical trials had tumor types that result in short life expectancy (fewer than 24 months), and that the therapy would be used as a last-line option after all other NHS-commissioned treatments had been tried.

In addition to forthcoming survival data from ongoing clinical trials, the NICE committee's positive recommendation came with the expectation that the UK would soon establish a national service for genomic testing of all advanced solid tumors. Replacing all local testing with a national system would address uncertainties regarding the diagnostic pathway for NTRK fusions, which currently varies based on tumor type.

The national genomic testing service will rely on seven laboratory hubs across England to conduct next-generation sequencing at the time of diagnosis, and interpret the results in a standardized way. Until the labs are fully established, however, the committee said that patients would have access to NGS profiling after they have exhausted all NHS-commissioned treatment options.

"Today’s decision is another positive step forward for cancer care driven by genomics," Meindert Boysen, director of the Center for Health Technology Evaluation at NICE, said in a statement announcing the entrectinib recommendation. "Adults and children 12 years and older will be able to access entrectinib on the CDF while more data is collected to address any clinical uncertainties."