Written questions by Davis.

Pursuant to the Answer of 2 December 2024 to Question 15729 on Down's Syndrome, when the statutory guidance under the Down Syndrome Act 2022 will be published.

Officials have been working to develop the Down Syndrome Act 2022’s statutory guidance as a priority, engaging with sector partners and relevant Government departments.We expect to issue the draft guidance for public consultation by the summer. The guidance will be published at the earliest opportunity, following the consultation.

Pursuant to the Answer of 30 July 2024 to Question 1398 on Down Syndrome Act 2022, what recent progress his Department has made on producing statutory guidance under the Down Syndrome Act 2022; and whether he plans to publish that guidance before the end of the year.

Officials are taking forward, as a priority, development of the Down Syndrome guidance, as required under the Down Syndrome Act 2022. Engagement with relevant stakeholders, including people with Down syndrome and organisations that work in support of people with Down syndrome, people with other genetic conditions, and a learning disability, or both, is taking place to inform the guidance. Most recently, a roundtable on improving life outcomes for people with Down syndrome was held on 26 November 2024.We expect to publish the draft guidance for public consultation as soon as possible in the new year.

What steps he is taking to encourage (a) the NHS, (b) Daiichi Sankyo, and (c) AstraZeneca to reach a commercial agreement that makes Enhertu available on the NHS in England.

Decisions on whether new medicines should be routinely funded by the National Health Service in England are taken by the National Institute for Health and Care Excellence (NICE) on the basis of an evaluation of a treatment’s costs and benefits. These are very difficult decisions to make, and it is important that they are made independently and on the basis of the available evidence.We know the NICE’s decision to not recommend Enhertu for use in the treatment of HER-2 low metastatic and unresectable breast cancer, has come as a blow to many women and their families. We understand that the NICE and NHS England have already sought to apply as much flexibility as they can in their considerations of Enhertu for HER2-low breast cancer and have made it clear to the companies that their pricing of the drug remains the main obstacle to access.The Government wants to see a deal reached to make Enhertu available. The NICE and NHS England remain open to considering an improved offer from the companies through the rapid review process, and we strongly encourage the companies to come back to the table.The NICE does recommend Enhertu (trastuzumab deruxtecan) in advanced breast cancer for treating HER2-positive unresectable or metastatic breast cancer after one or more anti-HER 2 treatments.