AstraZeneca and Daiichi Sankyo’s Enhertu Denied NICE Recommendation for NHS Use, Prompting Calls for Review Process Reform

1. NICE Decision: The UK's National Institute for Health and Care Excellence (NICE) has decided not to recommend Enhertu, a cancer treatment developed by AstraZeneca and Daiichi Sankyo, for use in the National Health Service (NHS) due to a cost-effectiveness pricing dispute.
2. Impact on Patients: Approximately 1,000 patients in England could have benefited from Enhertu, which is the first licensed targeted treatment for HER2-low secondary breast cancer. The drug offers more time to live and delays disease progression compared to chemotherapy.
3. Pricing Issue: NICE expressed disappointment that the pharmaceutical companies did not propose a price deemed cost-effective, leading to the rejection. The companies have been invited to resubmit a more acceptable price for a rapid review process.
4. Previous Approvals: Despite this rejection, NICE has approved 79% of cancer medication appraisals under revised criteria since 2022, including 15 cancer therapies. The severity modifier, introduced in 2022, has improved access to vital medications for severe conditions.
5. Charity Response: Breast Cancer Now has criticized the decision, calling it a "dark day" for patients and urging NICE, NHS England, Daiichi Sankyo, and AstraZeneca to find a solution. The charity is appealing the decision and advocating for an urgent review of NICE's evaluation methods.
6. Regional Impact: The decision affects not only England but also Wales and Northern Ireland, which typically follow NICE recommendations. Scotland has already approved Enhertu for NHS use, creating a postcode lottery of access.
7. Future Considerations: NICE is open to reassessing Enhertu if the companies agree to a more acceptable price, with a potential decision expected in early autumn 2024. The ongoing debate highlights the need for a balanced approach between cost-effectiveness and patient access to life-extending treatments.