Pioneering access scheme secures NICE recommendation

Friday, January 22nd, 2010

Cimzia has become the first RA treatment to receive positive guidance from NICE in more than two years due to an innovative patient access scheme.

Certolizumab pegol, or Cimzia, has been recommended for approval for the treatment of adults with severe active RA, on the condition that the patient access scheme is implemented and the drug is prescribed in accordance with NICE’s specifications.

The drug’s registered UK indication is for use in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.

In a novel move for drugs in RA, manufacturer UCB has worked with the DH to provide a clear, cost-effective alternative for people with RA through a patient access scheme.

In clinical studies, the new drug has demonstrated significant results as early as the first week of treatment, and the majority of patients have responded within the first 12 weeks. UCB and the DH have agreed a patient access scheme to ensure that treatment decisions are based on patient need rather than cost. UCB will make the new treatment available to all eligible RA patients free of charge for the first 12 weeks.

Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society, comments: “This is the first time a new NICE-recommended RA treatment has been made available in over two years – and it could make a big difference to patients’ day-to-day lives.”

“Certolizumab pegol is an important new treatment option for people with rheumatoid arthritis, and it’s exciting that it is now available on the NHS,” commented Professor Peter Taylor, investigator and Professor in Experimental Rheumatology, Imperial College London NHS Trust.

“Certolizumab pegol has been shown to rapidly improve patients’ symptoms and to significantly reduce the rate of progression of joint damage associated with rheumatoid arthritis. This fast and lasting effect is important as it quickly improves function, reduces work disability and leads to a better quality of life for patients.”

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Alzheimer’s drugs guideline remains unchanged

Friday, June 19th, 2009

Manufacturers Eisai and Pfizer have reacted angrily to NICE’s decision not to change its draft guidance on the use of Alzheimer’s drugs, despite admitting the model is faulty.

The Independent Advisory Committee concluded that, although a number of technical problems were highlighted and changes were made to the economic model, these were not enough to change the original conclusion that these treatments are not cost effective in the mild stages of the disease.

According to the pharma companies: “The new model incorporated the latest techniques for determining cost effectiveness and showed a cost saving to the NHS and society by treating mild Alzheimer’s disease patients. NICE recognised the existence of this model and the implications of its results, but chose not to incorporate them into its review of the Guidance.”

Andrew Dillon, NICE Chief Executive, said: “Alzheimer’s disease is one of the most distressing and debilitating disorders but drug treatment is not the only option for these patients. This is why we have published a clinical guideline on the management of dementia (including Alzheimer’s disease) which outlines the package of medical and social care that should be available for people with dementia and their carers.”

He added: "NICE was not asked by the Court of Appeal to carry out a new appraisal of these treatments. However, we operate a process of regularly reviewing our guidance to take into account any new evidence and as long as no appeals are received a review can start as soon as possible.”

The drugs affected by the guideline are donepezil, galantamine and rivastigmine and memantine for the treatment of Alzheimer’s disease, which continue to be recommended only for people with moderate Alzheimer’s disease.

Eisai and Pfizer have expressed their frustration that patients suffering from mild Alzheimer’s disease will “continue to be denied treatment after such a lengthy process”, but have welcomed the opportunity of working with NICE in the new review.

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