To ask the Secretary of State for Health how many recommendations the National Commissioning Group has made on national funding for ultra-orphan therapies; whether his Department may overturn any decisions made by the National Specialised Commissioning Group on the funding of ultra orphan therapies; and if he will make a statement. (216766)

The National Commissioning Group (NCG) met in June and made a recommendation to the National Specialised Commissioning Group (NSCG) that the service for patients with paroxysmal nocturnal haemoglobinuria met their criteria for national commissioning. This application includes treatment of the condition with a newly licensed ultra-orphan drug, eculizumab. The NSCG will make recommendations about additions to the national commissioning portfolio at its meeting in July.

Ministers carefully consider the advice of the NCG and the NSCG and make final decisions about any proposed changes to the national specialised commissioning portfolio.

To ask the Secretary of State for Health (1) what systems his Department has in place to prevent geographical variations in prescribing of novel and unique drug therapies for rare disorders which are not appraised by the National Institute of Health and Clinical Excellence; and if he will make a statement; (216767)

In December 2006, the Government re-issued Good Practice Guidance on Managing the Introduction of New Healthcare Interventions and links to NICE Technology Appraisal Guidance to the local national health service, which states that funding for treatments should not be withheld simply because guidance from the national Institute for Health and Clinical Excellence (NICE) is unavailable but that decisions should be made on the basis of the available evidence. The Guidance also suggests alternative sources of information for NHS organisations to consult in the absence of NICE guidance. Copies of the guidance have already been placed in the Library.

The draft NHS constitution makes clear the patient's right to expect local decisions on funding for drugs for which NICE guidance is not available to be made rationally following proper consideration of the evidence. Where the local NHS decides not to fund a treatment, the patient and clinician can expect an explanation. To underpin this, the Government will require primary care trusts to put in place clear and transparent arrangements both for local decision-making on funding of new drugs and for considering exceptional funding requests, and to publish information on those arrangements.

NICE has already appraised a number of orphan drugs but a separate appraisal system for ultra-orphan drugs has not been established. This position is kept under review in the context of other developments relating to the Government's policy on new drugs.

To ask the Secretary of State for Health by what procedures and under what authority specialist commissioning groups assess funding for ultra-orphan therapies; and if he will make a statement. (216769)

specialised commissioning groups (SCGs) are joint-committees of primary care trusts (PCTs) and draw their authority to commission healthcare services from that of their constituent PCTs. The responsibility for considering the funding of new drugs or treatments rests with individual PCTs and SCGs. Commissioners must balance local pressures and priorities for existing services and new developments, taking account of the available evidence of cost and clinical effectiveness.