Tolvaptan for treating autosomal dominant polycystic kidney disease

5 Implementation

5.1 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.

5.2 The Welsh Assembly Minister for Health and Social Services has 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 3 months of the guidance being published.

5.3 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 ADPKD and the doctor responsible for their care thinks that tolvaptan is the right treatment, it should be available for use, in line with NICE's recommendations.

5.4 The Department of Health and Otsuka Pharmaceuticals have agreed that tolvaptan will be available to the NHS with a patient access scheme which makes it available with a discount. The size of the discount is commercial in confidence. It is the responsibility of the company to communicate details of the discount to the relevant NHS organisations. Any enquiries from NHS organisations about the patient access scheme should be directed to mtolvaptan.ADPKD.PASinfo@otsuka.co.uk.

5.5 NICE has developed tools to help organisations put this guidance into practice (listed below):