Bayer has run into difficulty with healthcare providers in England and Germany over the high cost of the German group’s new “tissue-agnostic” cancer drug Vitrakvi, which was developed together with Loxo Oncology.

Vitrakvi, also known by its generic name larotrectinib, is recommended for patients whose tumors feature a neurotrophic receptor tyrosine kinase (TRK) gene fusion. When a TRK gene fuses with another gene, this leads to increased proliferation of the tumor cells, and the drug aims to selectively block the corresponding signal pathway.

The first TRK inhibitor to come out of a drugmaker’s pipeline has been approved both by the US Food and Drug Administration (FDA) and the European Commission for patients with TRK fusion cancer across all solid tumors; however, it isn’t clear whether it will actually be reimbursed, due to the high cost.

In a 2018 filing with the US Securities and Exchange Commission, Loxo said the oral version of Vitrakvi would cost $32,800 a month before discounts. National Institute for Health and Care Excellence (NICE), which negotiates prices for the English arm of the UK’s National Health Service (NHS), said Bayer is pricing the drug in England at £15,000 for a 30-day supply, whereby the health institute said it had been offered a “commercial arrangement” if the drug was recommended.

Draft guidance published by NICE late last week said cost-effectiveness calculations for the expensive oncology medication are “very uncertain," especially as its benefit over existing treatment options is unknown.

While Bayer has presented evidence to show that Vitravki can shrink NTRK gene fusion cancers, NICE – which estimates that around 600 to 700 patients in England suffer from this form of the disease – said it is “difficult to know how well it works because it has not been compared in the trials with other treatments.” 

Germany’s cost-effectiveness agency Institute for Quality and Efficiency in Healthcare, known by its German-language acronym IQWiG, has also rejected Vitravki. As it explained, the new inhibitor was approved for cases in which the disease is locally advanced or metastatic, and there are no other satisfactory treatment options but because these cases are so rare, the approval studies do not produce sufficient data.

IQWiG pointed out that none of the three phase 1 and phase 2 studies conducted with the Bayer drug up to now has a comparator arm, which makes it very difficult to conduct an early benefit assessment.

In the US market, first-past-the-post TRK inhibitor Vitrakvi now has a rival. In August 2019, the FDA approved Roche’s Rozlytrek for the same indication. The Swiss pharma is reportedly pricing its treatment there at a discount to Vitravki.