Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

Blepharospasm

Two Class I comparative effectiveness trials of onabotulinum toxin A with incobotulinum toxin A have provided evidence of equal efficacy between the 2 toxins.⁷ Similarly, 1 Class II comparative effectiveness trial between abobotulinumtoxin A and onabotulinum toxin A has provided evidence of equal efficacy.⁷ There are no data on the efficacy of rimabotulinum toxin B, so providers who choose to use it for this indication may need to be prepared to defend their BoNT choice in the event of a payer denial. If higher doses than those specified in the product insert are administered, the responsibility falls on providers to justify and clearly document the need in certain patient populations.

Chronic migraine

Two Class I studies comparing onabotulinumtoxin A with placebo have provided evidence of efficacy by reducing the number of headache days in patients with chronic migraine.^4,5 There have been no comparative effectiveness trials between BoNT and oral prophylactic drugs used to treat chronic migraine. Given the high costs of BoNT and the high prevalence of chronic migraine, some payers (e.g., Anthem, BCBS, Highmark) have instituted a step therapy in their treatment (e.g., oral prophylactic would have to be tried and fail before onabotulinumtoxinA could be offered as a treatment option). In such cases, it is imperative that providers clearly document compliance with step therapy criteria and obtain prior authorization before they start using onabotulinumtoxinA for treatment of chronic migraine.⁸ It is also prudent that a headache diary be maintained by the patient to show efficacy in case payers question its benefit and ultimately deny coverage. Data for other BoNT formulations in the treatment of chronic migraine did not meet inclusion criteria for the updated guidelines; before using other BoNT brands, providers should check with payers for migraine coverage.

For episodic migraine, the guideline clearly states that use of onabotulinumtoxinA is ineffective. Providers should not be surprised if payers do not cover BoNT for treatment of episodic migraine. It is important to clearly document that the patient's headache symptoms meet the International Classification of Headache Disorders definition of chronic migraine (e.g., ≥15 days per month) to prevent denials.⁹

Cervical dystonia

Based on the guideline findings, all brands of BoNT should enjoy payer coverage for the treatment of cervical dystonia. Although comparative dosing efficacies and equivalencies among different brands are not clearly established, we do not foresee any payer denials when there is a medical indication to change from 1 brand to another given the extensive evidence of efficacy of BoNTs for this indication. Additional research in this area using meta-analytical methods, such as mixed-treatment comparisons, will introduce additional data for evidence-based statements on the comparative efficacy of the BoNT brands.

Adult spasticity

Abobotulinumtoxin A and onabotulinumtoxin A have been shown to reduce upper-limb hypertonia with improvement of passive function.^10,11 OnabotulinumtoxinA was found through comparative effectiveness studies to be superior to tizanidine in improving wrist flexor tone.¹² Some payers may have a step therapy requirement or require documentation of failure of other standard medical therapies. Providers should periodically keep up with local payer policies and reimbursement changes.¹³ For reduction of lower-limb hypertonia, abobotulinumtoxinA and onabotulinumtoxinA can be offered as treatment options.^14,15

Dosing

Dosing for BoNT drugs, as listed on the product insert, may not be sufficient for patients with cervical dystonia for their initial—and especially subsequent—injections. Dosing should be based on provider experience and the patient's functional goals for initial and subsequent treatments. Payers often adopt BoNT package insert statements on maximum allowable doses and injection frequency for determination of coverage. To reduce likelihood of denials, providers should be familiar with branded product labeling parameters for dosage and intervals. Documenting responsiveness or lack of responsiveness to make dosing changes including escalation is good clinical practice and will demonstrate medical necessity, especially if doses or injection intervals fall outside the payer's allowable parameters. Payers may appreciate a written procedure note that indicates the injected sites and notes the specific dosages injected at each site. This is also good clinical practice, as it will better enable reproduction of injections at future visits.

What if my payer doesn't have a coverage policy on botulinum toxins?

Correct coding (using Current Procedural Terminology [CPT] and ICD-10-CM) is essential for successful integration of BoNT therapy into clinical practice, and it is important for providers to periodically keep up with policies and reimbursement changes.¹³ Each of the BoNT manufacturers has specialists to assist in reimbursement issues (e.g., prior authorization, billing and coding, insurance verification, local coverage policy support, claims denials and appeals). Medicare, Medicaid, and private insurances cover BoNT treatment for on- and off-label uses that are considered medically necessary. Based on a review of current payer policies and anecdotal experience, if BoNT is used for an off-label condition in which it is considered standard of care (i.e., a covered diagnosis), it will generally be approved. Although private insurance policies are generally universal, Medicare policies can vary from state to state. Providers should keep up-to-date with their state Medicare policies.

Novitas Solutions—the Part B Medicare administrative contractor for several states— announced in July 2013 that it had retired its coverage policy on BoNTs retroactively effective to January 18, 2013.¹⁶ It is also possible that some payers might not have updated their policies and in rare cases not even have a policy in place on the use of BoNT. It is imperative that providers check their patients' payer policies periodically.

With traditional Medicare, no prior authorization is needed for BoNT, and payment will occur if the procedure is covered on the state's policy and if proper linkage between ICD-10-CM code and CPT code (table) is documented. For patients with private insurance or Health Maintenance Organization Medicare/Medicaid, prior authorization for BoNT should be obtained, even for on-label indications. A letter of medical necessity should be included with the prior authorization request. Clear and consistent documentation of medical necessity and therapeutic benefit is necessary, especially in cases in which BoNT is needed long-term or should a payer audit occur.

Other considerations