The National Institute for Health and Care Excellence announced that Enhertu will become available through the NHS in England for patients with incurable HER2-low advanced breast cancer, marking a significant shift following previous rejection of the treatment.
Approximately 1,000 women per year will be eligible to receive the drug under the new recommendation. Clinical trial data demonstrated that Enhertu extended median progression-free survival from 5.1 months to 9.9 months compared with conventional chemotherapy. Median overall survival reached 23.4 months for patients using the drug, compared with 16.8 months for those receiving standard treatment.
The decision follows extended negotiations between the regulators, NHS England, and the drug’s manufacturers, AstraZeneca and Daiichi Sankyo. A prior rejection occurred in July 2024 when the medication was deemed too costly relative to its benefits. The breakthrough came after the spending threshold for individual patient treatments was raised to £35,000 annually, up from a previous £30,000 ceiling, providing additional flexibility for cost-benefit assessments.
Enhertu has been accessible in Scotland since December 2023 and is available across 27 European countries. Campaign efforts by patient advocacy organizations, medical specialists, and affected individuals contributed to renewed discussions that ultimately produced what regulators described as a commercial solution. Government officials, including former health secretary Wes Streeting, participated in behind-the-scenes negotiations to facilitate the drug’s availability.
Health officials characterized the development as providing patients additional time with family and access to targeted treatment that delivers chemotherapy directly to cancer cells. Ministers in Wales and Northern Ireland are expected to adopt the recommendation and implement similar access provisions.
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