In further draft guidance published today (1 December), NICE, the healthcare guidance body, has not been able to recommend a daily capsule that could reduce relapses in some people who have a particular type of multiple sclerosis. Based on the evidence submitted by its manufacturer, offering the drug would not be cost effective for the NHS, compared with the treatments that are already available for the condition. NICE has not yet issued guidance for the NHS.

The second appraisal consultation document provisionally does not recommend fingolimod (known commercially as Gilenya and manufactured by Novartis Pharmaceuticals UK) for highly active relapsing-remitting multiple sclerosis (RRMS); a type of the condition characterised by periods when symptoms worsen and then improve. The second draft has been published following a proposed discount from Novartis (called a Patient Access Scheme) to the price of fingolimod.

NICE's independent appraisal committee has not been convinced that offering fingolimod would be a cost effective option for the NHS, even with this discount (which Novartis has asked to be kept confidential) when compared with treatments currently offered to people with highly active RRMS, such as beta interferons.

Sir Andrew Dillon, Chief Executive of NICE said: “It is important for people with multiple sclerosis to have access to different treatment options wherever possible; however these new treatments must represent value for money so that everyone can get the most out of the NHS. While Novartis submitted evidence that shows fingolimod can reduce relapses, our independent committee has not been convinced that it is a cost effective treatment option for the NHS, even with the proposed Patient Access Scheme.

“Our revised draft guidance has been published as part of a public consultation. We encourage healthcare professionals, people with multiple sclerosis and our other stakeholders to comment on our independent committee's provisional recommendation so that they can contribute to the development of this guidance.”

Those wishing to comment on NICE's draft recommendations have until Thursday 5 January 2012 to do so. NICE's independent committee will then meet again in February to review the comments received. NICE expects to publish its final guidance for the NHS in April 2012.

Until NICE issues final guidance, decisions on the funding of fingolimod should continue to be made locally by NHS bodies.

Ends

For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance (second appraisal consultation document)

1. The second appraisal consultation document follows a first draft published for consultation in August. Further information about the second appraisal consultation document of “Fingolimod for the treatment of relapsing-remitting multiple sclerosis” can be found here: ta254. Contact the press office for embargoed copies.

2. Fingolimod (Gilenya, Novartis Pharmaceuticals UK) is an oral medicine for highly active relapsing-remitting multiple sclerosis. In multiple sclerosis, white blood cells (called lymphocytes) attack the coating of the nerve cells which help messages from the brain travel to the rest of the body. As these cells are damaged, people experience symptoms such as numbness and tingling, blurred vision, mobility and balance problems, and muscle weakness and tightness. Fingolimod works by preventing the lymphocytes from attacking nerve cells in the brain and spinal cord. This is why it is called a “disease modifying” medication, but it is not a cure.

3. The recommended dosage for fingolimod is 0.5mg once a day. 28 capsules cost £1,470. This is equivalent to an annual cost of approximately £19,196 per person. In comparison, the cost of a year's use of natalizumab (Tysabri, Biogen) is £14,730 per patient. Costs may vary in different settings because of negotiated procurement discounts. For further information about NICE's appraisal of natalizumab, please visit: www.nice.org.uk/TA127.

4. Patient Access Schemes can be proposed by pharmaceutical companies during the development of NICE's technology appraisals in order to make drugs more affordable for the NHS. The manufacturer agrees these directly with the Department of Health. After the first appraisal consultation document was published, Novartis submitted a Patient Access Scheme for consideration. Novartis has requested for the size of its proposed discount for fingolimod to remain confidential.

5. Following the proposed Patient Access Scheme, the most plausible Incremental Cost Effectiveness Ratio (ICER) for fingolimod is at least £40,000 per QALY gained. Generally if a treatment costs more than £20,000-30,000 per QALY, then it is not considered to be a cost effective option for the NHS. For further information about how NICE measures cost effectiveness, please visit:www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp

6. Fingolimod is licensed for adults with RRMS who experience at least one relapse in a year despite being treated with beta interferons and adults with rapidly evolving severe RRMS who experience two or more disabling relapsed regardless of their treatment .Highly active relapsing-remitting multiple sclerosis (RRMS) is generally defined by at least one relapse in previous year while on therapy (such as with beta interferon) and at least nine T2-hyperintense lesions detected by brain MRI or at least one gadolinium-enhancing lesion. Rapidly evolving severe RRMS is generally defined by two or more disabling relapses in one year, and one or more gadolinium-enhancing lesions detected by brain MRI or a significant increase in T2 lesion load compared with a previous MRI.

7. In 2002, NICE published guidance which did not recommend the use of beta interferons or glatiramer acetate for relapsing remitting multiple sclerosis. For further information about this technology appraisal, visit: www.nice.org.uk/TA32. After this guidance was issued, the Department of Health agreed a risk sharing scheme with manufacturers, which encouraged these disease-modifying treatments to be offered to patients on the NHS under certain conditions. For further information about this patient access scheme, please contact the Department of Health press office.

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS

3. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.