Sotagliflozin with insulin for treating type 1 diabetes

4.1 Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication. However, the company has informed NICE that sotagliflozin is not yet available in the NHS. Therefore, the period during which the NHS in England has to comply with the recommendations has been extended to within 3 months of the commercial launch of sotagliflozin in England. This extension is made under Section 7(5b) of the Regulations.

4.2 The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final appraisal document. However, the company has informed NICE that sotagliflozin is not yet available in the NHS. Therefore, the period during which the NHS in Wales has to comply with the recommendations has been extended to within 2 months of the commercial launch of sotagliflozin in Wales.

4.3 When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has type 1 diabetes and the doctor responsible for their care thinks that sotagliflozin is the right treatment, it should be available for use, in line with NICE's recommendations.