Botulinum toxin policy compare for off-label indications

[chantell.reagan]

As a follow-up to our comparison of on-label uses for botulinum toxins, below is the analysis and discussion of non-cosmetic off-label uses.

Of note, the following published evidence-based reviews/guidelines cover most common of these uses of botulinum toxin:

•Non-cervical dystonias and related movement disorders – the American Academy of Neurology published guidance on the use of botulinum toxin in movement disorders in 2008 (summary and full guidance) and practice parameters on the therapies for essential tremor in 2005)
•Spasticity disorders - the American Academy of Neurology published guidance on the use of botulinum toxin in spasticity in adults and children with cerebral palsy in 2008 (summary and full guidance)
•Non-axillary hyperhidrosis, urologic dysfunction, headache/pain - the American Academy of Neurology published guidance on the use of botulinum toxin in autonomic disorders and pain in 2008 (summary and full guidance)
•Esophageal achalasia – the Society for Surgery of the Alimentary Tract published patient care guidelines on esophageal achalasia in 2006 and a comprehensive review on this topic was published by Lake and Wong in Alimentary Pharmacology & Therapeutics in 2006
•Chronic anal fissure - the American Society of Colon and Rectal Surgeons published practice parameters for the management of anal fissures

In an analysis of 11 plans, we evaluated criteria for the most popular off-label uses of Botox and Myobloc. The following are our key findings:

•Although all plans provide covered for at least one type of focal dystonia (at least for Botox), only 2 of 11 plans explicitly list essential tremor as a covered condition
•All plans provide coverage for limb spasticity at least for Botox (including multiple sclerosis, cerebral palsy, spastic paraplegia/hemiplegia after stroke)
•6 of 11 plans explicitly list drooling (or a certain type of drooling) as a covered condition and 3 of them require that the condition is refractory to pharmacotherapy
•6 of 11 plans explicitly list detrusor overactivity as a covered condition and 2 of them require failure of anticholinergic therapy
•Though botulinum toxin type A is in clinical trials for treatment of BPH, no plans are providing coverage at this time
•5 of 11 plans cover botulinum toxin for headache/migraine (after failure prophylactic therapy) while 5 other plans consider it to be experimental treatment
•All plans cover botulinum toxin for esophageal achalasia and/or chronic anal fissure; 9 of 11 plans require failure of or contraindication to surgical therapy for esophageal achalasia and 5 of 11 plans require failure of conservative nonsurgical therapy for chronic anal fissure

To view the full tabulated analysis, you must login first (if you haven't registered yet, please click here, registration is free). After you have logged-in, please scroll down and click on the attached PDF file at the bottom of this page. (Note: please zoom to 200% for full-size chart).

Additional sources:

Allergan annual report 2008: (see full link in the attached tabulated analysis)

Aetna Clinical Policy Bulletin: Botulinum toxins: (see full link in the attached tabulated analysis)

Cigna Pharmacy Coverage Policy: Botulinum Toxin Type A and B: (see full link in the attached tabulated analysis)

Excellus Drug Policy: Botulinum toxins: (see full link in the attached tabulated analysis)

Highmark Medical Policy: Botulinum toxin: (see full link in the attached tabulated analysis)

BlueCross BlueShield of Florida Medical Policies: (see full link in the attached tabulated analysis)

BlueCross BlueShield of Illinois Medical policy: (see full link in the attached tabulated analysis)

BCBS Mississippi Botulinum toxin policy and Hyperhidrosis policy: (see full link in the attached tabulated analysis)

Oxford (United) Botulinum toxin policy: (see full link in the attached tabulated analysis)

Premera BlueCross Corporate Medical Policy: Botulinum toxin and Hyperhidrosis policies: (see full link in the attached tabulated analysis)

Priority Health Botulinum toxin medical policy and Hyperhidrosis medical policy: (see full link in the attached tabulated analysis)

Regence Botulinum toxin A and B policies: (see full link in the attached tabulated analysis)