CurrentHawaii Medical Service Association (HMSA)Policy N/A

Botulinum Toxin Product Exceptions

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This policy establishes preferred botulinum toxin products for HMSA Medicare Advantage members and prior authorization exception criteria for coverage of nonpreferred products.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyBotulinum Toxin Product Exceptions

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNovember 21, 2025

Last ReviewSep 1, 2025

Next Review DateN/A

Key ActionObtain precertification and document the requested product, indication, prior treatment, and any inadequate response or adverse event for a nonpreferred-product exception request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Preferred products

3Nonpreferred products

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

Botulinum Toxin Product Exceptions

Customize your policy alerts

Sign up for all Hawaii Medical Service Association (HMSA) policy alerts

Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy establishes preferred botulinum toxin products for HMSA Medicare Advantage members and prior authorization exception criteria for coverage of nonpreferred products.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyBotulinum Toxin Product Exceptions

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNovember 21, 2025

Last ReviewSep 1, 2025

Next Review DateN/A

Key ActionObtain precertification and document the requested product, indication, prior treatment, and any inadequate response or adverse event for a nonpreferred-product exception request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Preferred products

3Nonpreferred products

4Indications requiring preferred-product trials

Nonpreferred Product Coverage Exceptions

Nonpreferred Product Exceptions

Coverage for a non-preferred product is provided when ANY of the following criteria is met. The step therapy preferred drug criteria above does not apply to any new or existing FDA-approved product that is not listed.

ANY of the following

Member has received treatment with the non-preferred product in the past 365 days.
Member has a documented inadequate response or intolerable adverse event to both of the preferred products.
For Botox requested for the treatment of blepharospasm, either of the following criteria is met
- Member is 18 years of age or older and has had a documented inadequate response or intolerable adverse event to Xeomin.
- Member is 12 years of age or older but less than 18 years of age.
Member is requesting Botox for the treatment of lower limb spasticity and has had a documented inadequate response or adverse event to Dysport.
For Botox requested for the treatment of upper limb spasticity, both of the following criteria are met
- Member is a pediatric patient 2 years of age to 17 years of age and the upper limb spasticity is caused by cerebral palsy.
- Member has had a documented inadequate response or adverse event to Dysport.
Member is requesting Myobloc for the treatment of chronic sialorrhea and has had a documented inadequate response or an intolerable adverse event to Xeomin.

Indications Requiring Preferred-Product Trial

Preferred products must be tried for the following indications according to the exception criteria. All other indications are exempt from exception criteria and are subject to drug-specific criteria.

Indications subject to preferred-product trial

Cervical dystonia in adults.
Chronic sialorrhea in adults.
Blepharospasm in members 18 years of age and older.
Spasticity.

Authorization and Documentation Requirements

Prior Authorization

Precertification and Prior Authorization Required

Precertification is required for coverage under this program. Nonpreferred products require prior authorization through the HMSA exception process; providers should use the applicable fax form available on the HMSA medical specialty drug policy website.

For Medicare Advantage members, apply the Botulinum Toxin Types A and B Local Coverage Determination (LCD L35170).

Step Therapy

Preferred-Product Step Therapy

Before requesting coverage of a nonpreferred botulinum toxin, use the preferred products when the indication is subject to step therapy. Preferred products are Dysport (abobotulinumtoxinA) and Xeomin (incobotulinumtoxinA); nonpreferred products are Botox, Daxxify, and Myobloc.

Step therapy applies to cervical dystonia in adults, chronic sialorrhea in adults, blepharospasm in members 18 years of age and older, and spasticity.
All other indications are exempt from these exception criteria and remain subject to drug-specific criteria.

Policy Scope

This policy applies to HMSA Medicare Advantage members receiving botulinum toxin products. It identifies Dysport (abobotulinumtoxinA) and Xeomin (incobotulinumtoxinA) as preferred products and establishes a prior authorization exception process for nonpreferred products, including Botox, Daxxify, and Myobloc.

The policy addresses access for conditions including cervical dystonia in adults, chronic sialorrhea in adults, blepharospasm in members 18 years of age and older, and spasticity. For these indications, coverage of a nonpreferred product generally depends on prior treatment with the applicable preferred product and documented inadequate response or adverse event, unless a listed product-, indication-, or age-specific exception applies. Other indications are subject to drug-specific criteria rather than these exception criteria.

Product Classifications

Preferred products

Preferred product 1Dysport (abobotulinumtoxinA)

Preferred product 2Xeomin (incobotulinumtoxinA)

Program roleProducts designated by HMSA for preferential use under the exception program.

Nonpreferred products

Nonpreferred product 1Botox (onabotulinumtoxinA)

Nonpreferred product 2Daxxify (daxibotulinumtoxinA-lanm)

Nonpreferred product 3Myobloc (rimabotulinumtoxinB)

Initial Nonpreferred-Product Exception

For members new to treatment with a nonpreferred product, coverage is available when ANY of the following exception criteria is met:

Initial nonpreferred-product exception

Recent prior use: The member received the requested nonpreferred product within the past 365 days.past 365 days
Failure or intolerance of preferred products: The member has a documented inadequate response or intolerable adverse event to both Dysport and Xeomin.both preferred products
Product- and indication-specific exception:

Preferred-Product Trial Sequence

Step	Preferred product(s) to try	Requirement before nonpreferred-product coverage
1	Dysport and/or Xeomin	For cervical dystonia in adults, chronic sialorrhea in adults, blepharospasm in members 18 years of age and older, or spasticity, try the applicable preferred product or products before requesting a nonpreferred product. Document an inadequate response or adverse event; for some criteria, an intolerable adverse event is required.

Botulinum Toxin Dosing Limits

Quantity limits

Applies toAll botulinum toxin products

Potential limit basis 1FDA-approved labeling

Potential limit basis 2Accepted compendia

Potential limit basis 3Evidence-based practice guidelines

Policy languageApprovals may be subject to dosing limits.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyBotulinum Toxin Product Exceptions

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNovember 21, 2025

Last ReviewSep 1, 2025

Next Review DateN/A

Key ActionObtain precertification and document the requested product, indication, prior treatment, and any inadequate response or adverse event for a nonpreferred-product exception request.

SourceLink

On This Page

The step-therapy preferred-drug criteria do not apply to a new or existing FDA-approved product that is not listed in the policy.

Documentation Required

Exception Request Documentation

Submit clinical documentation supporting the requested nonpreferred product and the applicable exception criterion. Documentation should identify the indication, relevant member age and treatment history, and the response or adverse-event history for each required preferred product.

Document treatment with the requested nonpreferred product within the past 365 days, when applicable.
For inadequate response or intolerance criteria, document the inadequate response or intolerable adverse event to both preferred products, or to the specifically required product for the requested indication.
For Botox blepharospasm, document the member's age and the inadequate response or intolerable adverse event to Xeomin when required.
For Botox spasticity or Myobloc chronic sialorrhea, document the applicable indication, age or etiology requirements, and the required Dysport or Xeomin treatment response/adverse-event history.

Denial Risk

Exception Criteria Not Met

Coverage of a nonpreferred product may be denied when none of the listed exception criteria is satisfied or when the required clinical documentation is not provided. Requests that do not meet the preferred-product trial requirements remain subject to the applicable drug-specific criteria.

No qualifying treatment with the requested nonpreferred product within the past 365 days is documented.
No documented inadequate response or intolerable adverse event to both preferred products, or to the required preferred product for the indication, is present.
The request does not meet the indication-specific age, diagnosis, etiology, or prior-treatment requirements for Botox or Myobloc.

Step Therapy

Required Preferred-Product Trial

For the indications subject to step therapy, the provider must trial the applicable preferred product before requesting a nonpreferred product. The required preferred products are Dysport and/or Xeomin, depending on the exception criterion and indication.

Cervical dystonia in adults, chronic sialorrhea in adults, blepharospasm in members 18 years of age and older, and spasticity require preferred-product trials.
Botox for adult blepharospasm generally requires a documented inadequate response or intolerable adverse event to Xeomin; Botox for lower- or upper-limb spasticity requires the applicable documented response or adverse-event history to Dysport.
Myobloc for chronic sialorrhea requires a documented inadequate response or intolerable adverse event to Xeomin.
The preferred-product trial requirement does not apply to indications exempt from the exception criteria; those requests follow drug-specific criteria.

Coverage requirementAn approved clinical exception is required for coverage.

The member meets the applicable Botox, pediatric spasticity, or Myobloc exception described in the policy.

varies by indication and age