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NICE leaves the ‘the NHS door’ open despite rejecting Bayer’s Vitrakvi

Initial guidance says drug is too costly but encourages further data


The UK’s National Institute for Health and Care Excellence (NICE) says it cannot recommend Bayer’s tumour-agnostic drug Vitrakvi at its current price, but remain ‘open’ for further discussion. 

In a blow to Bayer, NICE also said in the statement that Roche’s Vitrakvi (larotrectinib) rival Rozlytrek (entrectinib) could instead become the first histology independent treatment to be made available to NHS patients.

Vitrakvi was the first out of the two to gain approval in the EU, for the treatment of adult and paediatric patients with solid tumours that display a NTRK gene fusion, which occurs in around 1% of all solid tumours.

The drug was indicated only for patients whose cancer is locally advanced, metastatic, or where surgery is likely to result in death and so have no other viable treatment options.

Rozyltrek won FDA approval in August, and is currently being reviewed for approval in the EU. Although Bayer has had a head start in the EU market, it could see its progress derailed because of Roche’s willingness to compete on price.

Simon Stevens Last June, NHS England chief executive Simon Stevens (pictured left) announced that the health service wants to fast-track tumour-agnostic drugs, like Vitrakvi and Rozlytrek. These novel treatments target specific genetic mutations found across a number of different cancer, so can be prescribed across the indication spectrum.

Stevens said that NHS England would attempt to work with industry to prepare for fast-tracking tumour-agnostic therapies by ensuring NICE “appropriately and efficiently” values these drugs.

However, in this most recent draft guidance, NICE deemed the current price of Vitrakvi too expensive to be considered for use on the NHS.

The current list price of the drug is £5,000 per 100ml vial of 20mg/ml oral solution, totalling £15,000 per 30-day supply. In its draft guidance, the NICE committee “considered that the ICER range was above what it would normally consider a plausibly cost-effective use of NHS resources if larotrectinib was considered to meet the end-of-life criteria”.

Despite this draft rejection, there is still possible hope or Bayer to reach an agreement with the institute, as NICE is keen to accelerate access to this particular class of drug.

“It is disappointing that Bayer has not yet been willing to price John Stewartlarotrectinib at a level which represents value for the NHS and the taxpayer, however, should they reconsider, the NHS’ door remains open for further discussion” said John Stewart (pictured right), NHS national director of specialised commissioning.

“In the meantime, preparation continues for the introduction of this next generation of therapies, including constructive conversations with Roche on a commercial deal for entrectinib,” he added.

Both Bayer’s and Roche’s drugs target tumours with the genetic variation known as neurotropic tyrosine receptor kinase (NTRK), which is most commonly found in rare cancers affecting children and adults.

This includes salivary tumours, secretory breast cancer, infantile fibrosarcoma and congenital mesoblastic nephroma, but the mutation is also found in low levels in more common cancers.

NICE estimates that around 600-700 people have solid tumours with NTRK gene fusion in England. It also said that a proportion of those will be eligible for one of these therapies within the first year that they become available on the NHS.

These new personalised therapies need genetic tests to determine which patients will benefit, and this fits in with NHS England's plans to roll out regular genomics testing, following its world-leading 100,000 Genomes Project. As part of the NHS Meindert Boysenlong-term plan, the health service plans to develop more sophisticated strategies to improve genomic testing in clinical practice.

This includes the creation of a new 'NHS Genomic Medicine Service' which will support the uptake of drugs like Vitrakvi and Rozlytrek, said NICE's director of the centre fo health technology evaluation Meindert Boysen (pictured left).

Article by
Lucy Parsons

17th January 2020

From: Regulatory



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