To ask the Minister of Health to detail any criteria that will determine whether a patient is granted access to Enhertu, including who will make that decision.

Trastuzumab deruxtecan (Enhertu®) is routinely available in Northern Ireland as a treatment option for individuals who meet the clinical criteria set out in the final draft guidance published by NICE on 17 September 2026, which recommended trastuzumab deruxtecan (Enhertu®) as an option for the treatment of HER2-low metastatic or unresectable breast cancer in adults.

Decisions on an individual patient's suitability for treatment are a matter for the patient's HSC clinician, in consultation with the patient and, where appropriate, their guardian or carer. The clinician will assess whether the patient meets the relevant clinical eligibility criteria and whether the treatment is appropriate having regard to the patient's individual circumstances and any other relevant clinical considerations.

In advance of final guidance publication, my Department has accepted this treatment for use within the HSC as part of the HSC Managed Entry process and will process applications from HSC clinicians through the cost-per-case (CPC) mechanism. The CPC process is a commissioning mechanism that enables individuals who meet the criteria set by the relevant NICE guidance to access treatment at the earliest possible stage by enabling my Department to gather monitoring information on the initial uptake of the treatment. The process does not introduce any additional clinical criteria or financial barriers to access; rather, it facilitates timely access to treatment from the date of publication of the relevant guidance.

When the final guidance for this treatment is issued by NICE, my Department will consider it under the usual process for NICE Technology Appraisals as per the guidance set out in circular HSC (SQSD) 12/22 which is available at:

https://www.health-ni.gov.uk/sites/default/files/publications/health/doh-hsc-sqsd-12-22.pdf