To ask Her Majesty's Government when the Department of Health's selection criteria for referral of topics to the National Institute for Health and Clinical Excellence was last updated or amended; what were the changes made, and for what reasons; and when and how any changes were communicated to stakeholders. [HL2029]

To ask Her Majesty's Government in what circumstances the Department of Health refers ultra-orphan drugs to the National Institute for Health and Clinical Excellence for assessment; when this policy was last updated or amended; what were the changes made; and when and how any changes were communicated to stakeholders. [HL2030]

The criteria for deciding which topics should be referred to the work programme of the National Institute for Health and Clinical Excellence (NICE) were last updated in July 2006 following a three-month consultation on the proposed changes between March and June 2006. The 2006 consultation document, full details of the consultation responses and the analysis of the comments have been placed in the Library. Details of the topic selection process and criteria as implemented following the consultation are available on NICE's website at www.nice.org.uk/aboutnice/howwework/howguidance topicsarechosen/. The document has also been placed in the Library.

The referral to NICE of drugs for the treatment of very small patient populations, sometimes referred to as ultra-orphan drugs, is considered on a case-by-case basis.

The department and NICE are currently consulting on proposed revisions to the process and criteria for selecting topics for referral to NICE's technology appraisal work programme.

The consultation document is available at www.nice.org.uk/getinvolved/suggestatopic/. The document has also been placed in the Library.