The U.K.'s National Institute for Health and Care Excellence said that Bayer AG and Loxo Oncology Inc.'s cancer treatment Vitrakvi is too costly for routine funding from the National Health Service.
In a draft decision published Jan. 17, NICE said it will not recommend the treatment, clearing the way for Roche Holding AG's Rozlytrek, or entrectinib, to become the first histology-independent treatment cleared by the regulatory body, subject to marketing approval.
Histology-independent treatments target all solid tumors with certain genetic mutations regardless of their location in the body.
Vitrakvi, or larotrectinib, is also a histology independent treatment that targets solid tumors with a neurotrophic tyrosine receptor kinase, or NTRK, gene fusion. NTRK genes, which are related to the production of tropomyosin receptor kinase, or TRK proteins, can fuse with other genes to generate signals that can drive the growth of certain tumors.
Loxo Oncology and Bayer agreed to develop and commercialize Vitrakvi in 2017. The drug is approved in the U.S. and Europe to treat patients whose disease has spread to other parts of the body, cannot be removed surgically or has progressed even after using currently available therapies.
NICE calculated that a 30-day supply of Vitrakvi costs £15,000, or almost twice the price of Rozlytrek, which costs about $17,050 per month.
In its assessment, the review committee noted that Vitrakvi has shown in clinical trials that tumors with NTRK gene fusions shrink in response to the drug. However, it is difficult to know how well the medicine works, because the trials did not compare the drug with other treatments. Also, there is little or no evidence about whether the therapy works well for every type of NTRK fusion-positive tumor.
Meindert Boysen, director of the center for health technology evaluation at NICE, said clinical evidence is based on extremely small sample sizes and more data is needed, e.g., through the Cancer Drugs Fund.
NTRK gene fusions occur in less than 1% of solid common tumors such as lung, colorectal and breast cancers, according to NICE. However, NTRK fusion is prevalent in more than 90% of some rare tumor types.
About 600 to 700 patients have solid tumors with NTRK gene fusions and only a fraction of these patients will be eligible for histology-independent treatments within the first year after they are available on the NHS, according to NICE estimates.
NHS national director of specialized commissioning John Stewart said if Bayer reconsiders the price of Vitrakvi, the agency is open for further discussion. Meanwhile, the NHS will continue dialogue with Roche on a commercial deal for Rozlytrek.
The NICE decision is open for comments until Feb. 6.
On the same day, Germany's Institute for Quality and Efficiency in Health Care stated that the data on Vitrakvi provided by Bayer is not clear enough about the benefits of the drug, Reuters reported.
The agency, which evaluates new drugs and advises on the costs that will be paid by German health services, reportedly noted that clinical trials did not include a group of patients who did not receive Vitrakvi as a point of comparison.