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England’s healthcare spending watchdog has blocked the NHS from providing an innovative treatment for a form of advanced breast cancer, blaming AstraZeneca and Japanese company Daiichi Sankyo for being “unwilling” to offer their Enhertu drug at a low enough price.
Helen Knight, director of medicines evaluation at the National Institute for Health and Care Excellence (Nice) said the organisation was “deeply disappointed that we are unable to recommend Enhertu for use in the NHS [England] for advanced HER2-low breast cancer”, a form of cancer that affects about half of late-stage patients.
Knight said cost was to blame for the decision, the first breast cancer treatment Nice has rejected in six years.
If a drug is not recommended by Nice, it cannot be made available on the NHS, but medicines approved by the Medicines and Healthcare Regulatory Agency can still be provided privately.
However, under separate arrangements, the drug can be publicly funded for the condition in Scotland, and is state financed in England for a smaller group of breast cancer patients.
Last week, AstraZeneca chief executive Pascal Soriot called for the UK government to rethink its policy on medicines approvals to facilitate the treatment and other new drugs.
But the decision also shows the challenge for stretched healthcare systems to fund complex, novel medicines. A course of treatment on Enhertu costs £117,857 at list price, although the NHS can access an undisclosed, discounted price.
The decision confirms draft guidance in March and Nice said the companies had not offered a new price.
Enhertu is a new form of cancer treatment known as an antibody drug conjugate that combines a targeted antibody capable of seeking out cancer cells with a toxic compound that can kill them. It is currently used for late-stage treatment of cancer but AstraZeneca has ambitions for its use to be rolled out earlier for patients.
In clinical trials, the drug has been shown to give patients an additional five months of life without their condition worsening, compared with chemotherapy.
Rachael Franklin, interim chief executive at Breast Cancer Now, said: “We are both devastated and angry that women’s lives will be shortened as a direct result of Nice, NHS England, Daiichi Sankyo and AstraZeneca failing to agree a solution that would make Enhertu available on the NHS in England for thousands of people with HER2-low secondary breast cancer. This was an avoidable tragedy.”
Pharmaceutical groups and cancer charities have criticised changes to Nice’s 2022 methodology to assessing medicines, which gives weight to drugs used for the most severe medical cases rather than a previous focus on end-of-life treatment. Under the methodology, HER2-low metastatic breast cancer is classed as a “medium severity” disease.
The companies have said that the new rules have hit cancer patients, with Soriot warning last week that further medicines could be blocked under the changed criteria.
Daiichi Sankyo, which has led work on the approval process for Enhertu in the UK, said it was “very disappointed by and disagrees with, the decision NICE has made”. It added it was calling on Nice to “evolve the way treatments are assessed for patients in England”.
In Scotland, where the new rules do not apply, the drug is provided by the health service but Wales and Northern Ireland typically follow Nice guidance. Costs of the drug are covered in 17 countries across Europe, according to AstraZeneca.
Nice said that 79 per cent of cancer medicines assessed under the new methodology have been recommended, compared with 78 per cent of cancer drugs carried out since 2009 under the previous methods. It added that evaluation of the new methods was ongoing.
Shares in AstraZeneca were up 2.4 per cent after the company reported positive trial results on Monday for a treatment for chronic lymphocytic leukaemia, a rare blood and bone marrow cancer.