Botulinum toxin policy compare for on-label indications

[chantell.reagan]

Currently, there are 3 botulinum products approved for some non-cosmetic uses:

1. Botulinum toxin type A (Botox) approved for cervical dystonia (CD) to decrease the severity of abnormal head position and neck pain, severe primary axillary hyperhidrosis inadequately treated with topical products, strabismus and blepharospasm associated with dystonia
2. Botulinum toxin type B (Myobloc) approved for CD
3. AbobotulinumtoxinA (Dysport) approved for CD (will be launched in the 2H2009 by Ispen).

In addition, one other botulinum toxin type A product is in the late-phase pipeline, PurTox by J&J; it is being studied for CD/torticollis and cosmetic uses and if approved, it will compete directly with Botox in the marketplace.

Also, botulinum toxins are currently being studied in a host of musculoskeletal, neurological and other conditions including: chronic lumbar back pain, spasticity, vaginismus, painful artificial knee joint, cerebral palsy, psoriasis, alopecia, chronic pelvic pain, tennis elbow, primary myofacial pain syndrome, shoulder pain, plantar ulcers and restless leg syndrome. Of these, uses that may near FDA review within the next 12-24 months include: spastic hemiplegia after stroke, severe/chronic migraines, neurogenic overactive bladder and BPH.

Note that the American Academy of Neurology has published the following evidence-based reviews/guidelines that cover the use of botulinum toxin in these approved conditions:

o Movement disorders - summary and full guideline
o Autonomic disorders and pain - summary and full guideline

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

o Only 1 of 11 plans does not require any other criteria in addition to diagnosis for all 4 indications
o 3 of 11 plans cover both types of botulinum toxin (A and B) for all 4 indications
o Only 2 of 11 plans require failure of prior therapy for CD, strabismus, or blepharospasm, while 10 of 11 plans require failure of prior therapy for primary axillary hyperhidrosis
o 4 of 11 plans limit either product to up to 4-6 injections/year

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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)

[chantell.reagan]

In order to reinforce varying dosages, as well as to prevent medication errors, the FDA has established name changes for the 3 available products:

•Botox/Botox Cosmetic: new name: onabotulinumtoxinA; old name: botulinum toxin type A
•Dysport (Medicis Pharmaceutical Corporation): new name: abobotulinumtoxinA; old name: botulinum toxin type A (approved April 29, 2009)
•Myobloc: new name: rimabotulinumtoxinB; old name: botulinum toxin type B

Source: FDA MedWatch 8/3/09