Limited Coverage Drugs – botulinum neurotoxin type A, with complexing proteins, also known as onabotulinumtoxinA (Botox®)
Generic Name |
clostridium botulinum neurotoxin type A, with complexing proteins, also known as onabotulinumtoxinA |
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Strength |
50 units/vial, 100 units/vial, 200 units/vial |
Form |
concentrate powder for solution for injection |
Special Authority Criteria |
Approval Period |
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Initial: 1 year Renewali: 1 year |
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Initial: 1 year Renewali: 1 year |
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Initial: 1 year Renewali: 1 year |
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Initial: 1 year Renewali: 1 year |
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Initial: 1 year Renewali: 1 year |
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Initial: 1 course (maximum 200 units) Renewalii: 1 year (coverage is provided for treatment with up to 200 units per course at minimum intervals of 36 weeks.) |
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Initial: 1 course (maximum 100 units) Renewalii: 1 course (coverage is provided for treatment with up to 100 units per course at minimum intervals of 12 weeks, to a maximum of 3 courses per year.) |
Special Notes
- For renewal requests, physicians must provide documentation of the patient’s functional and/or symptomatic improvement, as well as the dosage and injection schedule.
- For renewal requests for urinary indications, physicians must provide documentation indicating a ≥50% reduction in the frequency of urinary incontinence episodes from the baseline.
- Treatment failure is defined as using optimal doses of the indicated number of anticholinergic drug(s) for NDO or anticholinergic drugs and/or mirabegron for OAB, for a minimum of 4 weeks on each drug without a reduction of symptoms.
- For cases of intolerance to anticholinergics or mirabegron, specific details about the nature and severity of the intolerance must be provided.
- PharmaCare covers clostridium botulinum neurotoxin type A/onabotulinumtoxinA only for the indications stated above. Coverage cannot be provided for other indications such as migraines or hyperhidrosis.
Practitioner Exemptions
Physical medicine and rehabilitation specialists may be eligible to enter into a Collaborative Prescribing Agreement (CPA). CPAs are provided by invitation only. Special Authority will identify eligible practitioners who treat a high volume of patients that meet PharmaCare criteria for coverage.
Special Authority Request Form