BOTOX® (Allergan's botulinum toxin type A) Given Final Guidance from the National Institute for Health and Clinical Excellence (NICE) for the Prevention of Chronic Migraine in Patients Who Have Failed Previous Treatments

News provided by

Allergan

27 Jun, 2012, 06:00 GMT

MARLOW, England, June 27, 2012 /PRNewswire/ --

Allergan announced today that the National Institute for Health and Clinical Excellence (NICE) has issued its Final Guidance giving the green light for BOTOX® (botulinum toxin type A) to be used on the NHS as prophylaxis (prevention) against headache in adults with chronic migraine*, specifically in patients who have not responded to at least three prior preventative treatments and whose condition is appropriately managed for medication overuse.[1] This means that Primary Care Trusts (PCTs) in England and Wales now have 90 days to make funding and resources available to treat patients suffering from this debilitating condition with BOTOX®. Allergan's BOTOX® is the only botulinum toxin type A to have received authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for the prevention of headache in chronic migraine.[2]

Wendy Thomas, Chief Executive of The Migraine Trust comments, "This decision is widely welcomed by the migraine community as these patients are frequently debilitated and are often poorly served by the NHS. Together with the British Association for the Study of Headache, we call on decision makers within the NHS to quickly implement the guidance for BOTOX® in order to provide access to this valuable treatment option."

Chairman of the British Associations for the Study of Headache Dr Fayyaz Ahmed said, "As the new NHS evolves, it's imperative that the commissioners and GP consortia takes into consideration the needs of patients with headache and migraine. On behalf of BASH, I welcome the decision by NICE to agree that this potentially life changing treatment can now be offered within the NHS. However, currently access to BOTOX® as a treatment option for eligible patients with chronic migraine is patchy across the country and I am hopeful that this Final Guidance will speed up commissioning of services."

Chronic migraine is a disabling condition that disrupts the lives of patients as well as their families, with many sufferers unable to work or struggling to manage household and family responsibilities.[3] Patients with chronic migraine frequently struggle to adequately control their headaches and migraine, often using many different types of pain relief and preventative medications. While there are an estimated 730,000 adults in the UK[4] with chronic migraine, only 20% of people with the condition are properly diagnosed.[5] Allergan estimates that about a third of diagnosed patients with chronic migraine have already tried three or more preventative medications and may now be eligible for treatment with BOTOX®.

Historically, treatment for chronic migraine has consisted of a combination of acute and prophylactic treatments available either over-the-counter or by prescription, such as triptans, tricyclic antidepressants, β-blockers and anti-epileptics. Current prophylactics for migraine are poorly adhered to for a variety of reasons including tolerability issues, unrealistic expectations of treatment, and dosing frequency.[6]

Heather Sim, Chief Executive from the National Migraine Centre says "It's concerning that nearly 8 in 10 patients with chronic migraine do not have a formal diagnosis, despite spending more than half of each month suffering from a headache or migraine. Patients at home struggling to manage their condition should ask their GP for an appointment with a headache specialist."

The Final Guidance reflects current best clinical care and  incorporates appropriate stopping rules. According to the Final Guidance, treatment with BOTOX® should be stopped in people whose condition is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles) or has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months.

"This Final Guidance is tremendous news for patients with chronic migraine who have tried three different types of medication to manage their condition. The evidence shows that BOTOX® can provide significant benefit to patients with chronic migraine, helping to reduce the number of days disrupted by migraine or headache while improving their quality of life", said Dr Selwyn Ho, Country Manager, Allergan UK. "It is therefore crucial that the NHS and PCTs act swiftly to ensure they can provide the necessary services to these patients."

Notes to Editor

Headache diaries

Headache diaries are valuable tools that allows patients to track the number of days disrupted with a headache or a migraine. Online diaries are available from the Migraine Trust, Migraine Action or the National Migraine Centre Clinic.

About BOTOX®

BOTOX® is a brand name. It is a prescription-only medication that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. In the UK, BOTOX® is indicated for the treatment of adult patients with:[2]

  • blepharospasm (uncontrolled blinking of the eyelids)
  • hemifacial spasm (a neuromuscular disorder characterised by unpredictable and involuntary twitching of facial muscles on one side of the face)
  • cervical dystonia (a muscle condition affecting the neck making it difficult to hold the head up straight)
  • severe axillary hyperhidrosis (excessive sweating) of the armpits
  • upper limb spasticity (wrist and hand disability associated with stroke in adults)
  • prophylactic (prevention) of headache in adult patients with chronic migraine

BOTOX® is also approved for the treatment of glabellar lines (frown lines). In addition, BOTOX® is approved for the treatment of dynamic equinus foot deformity in paediatric patients with cerebral palsy aged two years and older. Refer to the Summary of Product Characteristics for full prescribing information at http://www.medicines.org.uk/emc/medicine/112.  

About Allergan

Allergan, Inc. is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have more than 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, over-the-counter medicines and medical devices, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

Forward-Looking Statement

This press release contains "forward-looking statements", including but not limited to the statements by Selwyn Ho, Dr. Fayyaz Ahmed, Wendy Thomas, Heather Simms and other statements regarding the NICE Final Guidance, likelihood of National Health Service adoption, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding BOTOX®. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2011 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. ® and ™ Marks owned by Allergan, Inc.

References

1. National Institute for Health and Clinical Excellence. Final Guidance: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine accessible via http://www.nice.org.uk/TA260 [accessible from June 27, 2012]

2. Botox® Summary of Product Characteristics http://www.medicines.org.uk/EMC/medicine/112/SPC/BOTOX+100+Units/

3. Lipton RB. Chronic Migraine, Classification, Differential Diagnosis and Epidemiology. Headache. 2011;51(suppl2): 77S-83S.

4. National Institute for Health and Clinical Excellence. Costing Template: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine accessible via http://www.nice.org.uk/TA260 [accessible from June 27, 2012]

5. Bigal ME, et al. Chronic Migraine in the Population. Neurology. 2008;71:559-566.

6. Cady R, Schreiber C. Botulinum toxin type A as migraine preventive treatment in patients previously failing oral prophylactic treatment due to compliance issues.Headache. 2008;48:900-13

Media contacts
For any further information please contact:
Janet Kettels, Allergan : kettels_janet@allergan.com or +44(0)7738-506476
Julia Cross, CCA : j.cross@cca-uk.com or +44(0)207-632-1896