The Petition of Miss K Bazzichi and Miss E Woodward Trustee Officers of aHUSUK,

Declares that aHUS patients should be given access to Eculizumab when they need it, without delay, and not be disadvantaged by the Ministers’decision not to implement the AGNSS recommendation ahead of a review by NICE.

The Petitioners therefore request that the House of Commons issues instructions to the NHS CB to take such action, whilst waiting for NICE's decision.

And the Petitioners remain, etc.—[Presented by Sir Nick Harvey, Official Report, 14 May 2013; Vol. 563, c. 610.]

[P001176]

The Petition of Mr T Murby and Mr Finley Murby Trustee Officers of aHUSUK,

Declares that aHUS patients should be given access to Eculizumab when they need it, without delay, and not be disadvantaged by the Ministers’ decision not to implement the AGNSS recommendation ahead of a review by NICE.

The Petitioners therefore request that the House of Commons issues instructions to the NHS CB to take such action, whilst waiting for NICE’s decision.

And the Petitioners remain, etc.—[Presented by Keith Vaz, Official Report, 14 May 2013; Vol. 563, c. 610.]

[P001177]

Observations from the Secretary of State for Health, received on 7 June 2013:

The-Advisory Group for National Specialised Services (AGNSS) considered the application for eculizumab (Soliris) for the treatment of atypical Haemolytic Uremic Syndrome (aHUS) to be included as part of national commissioning arrangements. Whilst AGNSS members were convinced of the clinical effectiveness of the drug, they noted the very high costs of the drug and the increasing cost profile for the NHS, which is predicted to rise significantly.

In considering the recommendation from AGNSS, the Department took advice on AGNSS’s assessment of the cost impact and affordability of eculizumab. The Department accepted AGNSS’s advice concerning the clinical effectiveness of the drug, but felt further advice was needed on its suitability for direct commissioning taking account of its costs, benefits and affordability. As AGNSS no longer exists as a Ministerial advisory group, the Department has asked the National Institute for Health and Care Excellence (NICE) to undertake this further work as part of its new highly specialised technologies programme. NICE assumed responsibility for this work on 1 April 2013.

NHS England is developing an interim policy to enable patients to receive eculizumab while NICE undertakes its evaluation. This will mean that patients who were previously receiving eculizumab through arrangements with their primary care trust (PCT) will continue to receive the drug and any newly diagnosed patients will also be funded. NHS England has assured the Department that patients who are critically ill and who need eculizumab urgently will receive it.