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England to fast-track tumour agnostic drugs like Vitrakvi – if the price is right

Simon Stevens calls for 'fair prices' from companies

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NHS England’s chief executive Simon Stevens was in Manchester this week at the NHS Confederation conference, delivering his latest vision of what lies ahead for the health service.

Among his many announcements, he told NHS managers that patient services would have to continue to evolve, and sent a message to politicians that the NHS needed more money and more hospital beds.

Any such chief executive keynote speech also needs some good news, to show the NHS isn’t just ‘firefighting’ but also moving forward and improving patient services.

Filling this slot was an announcement that NHS England wants to fast-track new ‘tumour agnostic’ drugs, which target specific genetic mutations found across a number of different cancers.

These new personalised therapies need genetic tests to determine which patients will benefit, and this very much fits in with NHS England’s plans to roll out regular genomic testing, following its world-leading 100,000 Genomes Project.

NHS England will now work with the industry to  prepare for the fast-tracking of these tumour agnostic therapies and:

· Bring together different cancer specialists to ensure all patients who could benefit from tumour agnostic drugs are identified

· Embed the tests for these genomic mutations within existing cancer pathways

· Through NICE ensure that the unique characteristics of these treatments will be "valued appropriately and efficiently".

Stevens referenced two of these novel therapies – Bayer/Loxo’s Vitrakvi (larotrectinib) and Roche’s entrectinib – even though neither of these drugs are yet approved in Europe.

Both drugs target tumours with the genetic variation known as neurotropic tyrosine receptor kinase, or NTRK, most commonly found in rare cancers affecting children and adults. These include salivary tumours, secretory breast cancer, infantile fibrosarcoma, congenital mesoblastic nephroma, but are also found in low levels in more common cancers.

NHS England estimates that around 850 patients a year could benefit from these frontrunners, but many thousands more a year are eventually expected to benefit from further tumour agnostic drugs.

The plans demonstrate just how far NHS England has come in horizon-scanning the market, with the aim of overturning a long-term problem of slow uptake for novel medicines in the NHS.

It also demonstrates, however, a new determination to take early control of pricing and market entry negotiations with pharma.

Simon Stevens said: “This exciting new breakthrough in cancer treatment is the latest example of how the NHS can lead the way in the new era of personalised cancer care."

He added that NHS patients in England were among the first in Europe to benefit from CAR-T treatment, and said he wanted the same for these new targeted therapies.

He was careful to add, however: “Preparations are underway to make sure the NHS can adopt these next generation of treatments, but manufacturers need to set fair and affordable prices so treatments can be made available to those who need them.”

Bayer/Loxo’s Vitrakvi is expected to gain CHMP recommendation in the next few months, with full marketing authorisation to likely to follow before the end of 2019. NHS England will be keen to see the arrival of Roche’s rival entrectinib, to allow greater leverage in market access negotiations.

These begin with NICE, which has begun the scoping of its appraisal of Vitrakvi.

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Lars Bruening

Lars Bruening, Bayer UK & Ireland CEO, said the announcement was potentially “a huge leap forward for both patient care and the next generation of partnership working between the innovative life science sector and the NHS.”

He added: “Tumour agnostic cancer treatments could pave the way for truly personalised care based on an individual’s genetics. We welcome NHS England, government and other partners working together as part of the Accelerated Access Collaborative to address some of the key challenges so that patients are able to receive swift access under the NHS.”

Article by
Andrew McConaghie

21st June 2019

From: Marketing

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