The National Institute for Health and Care Excellence (NICE) has published final guidance today (Wednesday 27 June), which recommends Botox injections to prevent headaches in some adults who experience chronic migraine.

NICE recommends Botox (known chemically as botulinum toxin type A and manufactured by Allergan) as a treatment option for chronic migraine in adults:

• whose condition has not responded to taking at least three prior preventative medications
• whose condition has been appropriately managed for medication overuse

The guidance recommends that Botox injections should be stopped if the person's headaches have not improved enough after two treatment cycles, or if the person's “headache days” have reduced to fewer than 15 days a month over three consecutive months - this is because if a person's headache days have reduced to fewer than 15 a month, they will have a different type of migraine (called episodic migraine), which is not covered in Allergan's licence for Botox. Botox is licensed for adults with chronic migraine.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE said: "Chronic migraines are extremely debilitating and can significantly affect a person's quality of life. We are pleased that our committee has been able to recommend Botox as a preventative therapy for those adults whose headaches have not improved despite trying at least three other medications and whose headaches are not caused by medication overuse."

"The NHS Constitution states that patients have the legal right to receive all drugs recommended by NICE if their doctors believe they are clinically appropriate. NHS settings in England and Wales now have until September to allocate funding for the use of Botox for preventing headache in chronic migraine, as outlined in our guidance."

Ends

Notes to Editors

About the final guidance (TA260)

1. For further information about the technology appraisal of “Botulinum toxin type A for the prophylaxis of headaches associated with chronic migraine”, visit: www.nice.org.uk/TA260. Please contact the NICE press office for an embargoed copy of the guidance.

2. Botulinum toxin type A (Botox, Allergan) is a purified neurotoxin complex which produces seven neurotoxins that are structurally similar but immunologically distinct. It has neuromuscular transmitter blocking effects. The recommended reconstituted dose is 155-195 units, administered intramuscularly as 0.1 ml (5 units) injections to between 31 and 39 sites around the head and back of the neck. The recommended re-treatment schedule is every 12 weeks. The net price of a 200 unit vial is £276.40, excluding VAT. Allergan estimates that the administration cost is £73 per treatment, based on a total treatment time of less than 30 minutes; therefore, the total cost for treatment and administration of treatment per 12 week cycle, assuming no vial sharing, is expected to be £349.40. Costs may vary in different settings because of negotiated procurement discounts.

3. On the basis of the evidence submitted, NICE's committee concluded that the most likely cost effectiveness estimate was £18,900 per QALY gained. This is lower than the £20,000-£30,000 range, which NICE would typically deem to be a cost effective use of NHS resources. For further information on how NICE measures cost effectiveness, please visit: www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp

4. A chronic migraine is defined as headaches on at least 15 days per month of which at least 8 days are with migraine. Chronic migraines are believed to affect 1.6% of adults.

5. The guidance recommends that Botox injections should be stopped if the person's “headache days” have reduced to fewer than 15 days a month over three consecutive months, or if the person's headaches have not improved enough after two treatment cycles - i.e. less than a 30% reduction in “headache days” per month.

6. The NHS Constitution states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if their doctors say they are clinically appropriate. For further information about the NHS Constitution, please visit: www.nhs.uk/NHSConstitution.

7. NICE's technology appraisal applies to NHS settings in England and Wales. In April 2011, the Scottish Medicines Consortium (SMC) advised NHS Scotland not to offer botulinum toxin type A for the prophylaxis of headaches in adults with chronic migraine. For further information, visit: www.scottishmedicines.org.uk

8. No Patient Access Scheme has been proposed for this treatment and end-of-life considerations do not apply for this technology appraisal.

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.