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Britain’s healthcare spending watchdog has blocked the NHS from providing an advanced treatment for a late-stage form of breast cancer, blaming AstraZeneca and Japanese firm Daiichi Sankyo for being “unwilling” to offer their drug Enhertu 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 “very disappointed that we cannot 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 behind the decision, which is the first breast cancer treatment Nice has rejected in six years.
If a medicine is not recommended by Nice, it will not be available on the NHS, but medicines approved by the Medicines and Healthcare products Regulatory Agency can still be available privately.
However, under separate arrangements the drug could be publicly funded for the condition in Scotland and publicly funded in England for a small group of breast cancer patients.
Last week, AstraZeneca’s chief executive Pascal Soriot Calls on the UK government to review its drug approval policy to facilitate the development of new treatments and other medicines.
But the decision also highlights the challenge for strained healthcare systems in funding new, complex drugs. A course of Enhertu has a list price of £117,857, although the NHS can access an undisclosed discounted price.
Confirmation decision draft guidelines in March and Nice said the companies have not yet announced new prices.
Enhertu is a new type of cancer treatment called an antibody-drug conjugate that combines targeted antibodies that seek out cancer cells with a toxic compound that can kill them. It is currently used to treat late-stage cancer, but AstraZeneca has ambitions to roll it out to patients sooner.
In clinical trials, the drug has been shown to help patients live an additional five months without their condition becoming worse than chemotherapy.
Rachael Franklin, interim chief executive at Breast Cancer Now, said: “We are both saddened and angry that women’s lives will be cut short as a direct result of Nice, NHS England, Daiichi Sankyo and AstraZeneca failing to agree on a solution to make Enhertu available on the NHS in England for thousands of people with HER2-low secondary breast cancer. This is an avoidable tragedy.”
Pharma groups and cancer charities have criticised changes to Nice’s 2022 drug assessment methodology, which places a greater emphasis on drugs used for the most serious medical conditions rather than the previous focus on end-of-life treatment. Under this approach, low-HER2 metastatic breast cancer is classed as “intermediate severity”.
Companies said the new rules were already affecting cancer patients, with Soriot warning last week that many more drugs could be blocked under the changed criteria.
Daiichi Sankyo, which led the approval of Enhertu in the UK, said it was “disappointed and disagrees with the decision taken by NICE”, adding that it called on Nice to “improve the way it assesses treatments for patients in the UK”.
In Scotland, where the new rules do not apply, the drug is provided by the health service, but Wales and Northern Ireland generally follow Nice’s guidelines. AstraZeneca says the cost of the drug is covered in 17 countries across Europe.
Nice said 79 percent of cancer drugs evaluated under the new approach have been recommended, compared with 78 percent of cancer drugs evaluated under previous approaches since 2009. Nice added that evaluations of the new approaches are still ongoing.
AstraZeneca shares rose 2.4 percent after the company reported positive trial results on Monday for its treatment for chronic lymphocytic leukemia, a rare cancer of the blood and bone marrow.
