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Draft guidance recommends Botox for preventing headaches in adults who have chronic migraine

Botox could soon become a NHS treatment option to prevent headaches in some adults who experience chronic migraine. The National Institute for Health and Care Excellence (NICE) has published final draft guidance today (Friday 11 May) which recommends the injections for the condition.

NICE has been asked to advise the NHS on whether the benefits of Botox (known chemically as botulinum toxin type A and manufactured by Allergan) for chronic migraine are value for money. In February, NICE asked Allergan to provide more information and analyses as part of a public consultation on its draft recommendations. Allergan provided this information and NICE's independent appraisal committee is now able to recommends Botox in the final draft guidance as a treatment option for chronic migraine in adults: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The draft guidance recommends that Botox injections should be stopped if the person's headaches have not improved enough after two treatment cycles, or if the person's “headache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 the 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.

“We have published our final draft guidance so that registered stakeholders can highlight any factual errors or appeal against our provisional recommendations. We have not yet issued guidance to the NHS on the use of this drug.”

Once the final guidance has been published, the NHS must allocate funding for the use of Botox as defined in the guidance within three months. This is in accordance with the NHS Constitution, which outlines what staff, patients and the public should expect from the NHS.

Registered stakeholders wishing to appeal NICE's draft recommendations have until Friday 25 May to do so. If no appeals are received, NICE hopes to publish its final guidance for the NHS in June 2012. Until final guidance is issued, NHS bodies should continue to make decisions locally on whether to fund the treatment.

Ends

Notes to Editors

About the draft guidance (final appraisal determination, FAD)

1. Further information about the FAD on “Botulinum toxin type A for the prophylaxis of headaches associated with chronic migraine”. Please contact the NICE press office for an embargoed copy of the draft 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 FAD 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. For further information about the NHS Constitution, please visit: www.nhs.uk/NHSConstitution.

7. NICE's technology appraisal will apply 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.

9. NICE is currently holding a public consultation on its draft clinical guideline on the diagnosis and management of headaches in young people and adults. The deadline for registered stakeholders to submit comments is 5pm on Thursday 7 June.

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.

This page was last updated: 10 May 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.