ModifiedBlue Cross Blue Shield - MassachusettsPolicy 006

Botulinum toxin agents (formulary, indications, prior authorization)

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BCBSMA policy governing prior authorization, formulary status, and medical necessity criteria for botulinum toxin products for Commercial members (including HMO, POS, PPO and indemnity) and related pharmacy operations.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyBotulinum toxin agents (formulary, indications, prior authorization)

Policy CodePolicy 006

Change TypeFormulary update (NFNC) + coding clarifications

Effective Date7/2024

Next Review Date

Key ActionSubmit prior authorization requests using the Massachusetts Standard Form (eForm or Form #434) and document trials of preferred toxins (Botox and Dysport) when requesting non-formulary agents.

SourceLink

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ModifiedBlue Cross Blue Shield - MassachusettsPolicy 006

Botulinum toxin agents (formulary, indications, prior authorization)

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Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyBotulinum toxin agents (formulary, indications, prior authorization)

Policy CodePolicy 006

Change TypeFormulary update (NFNC) + coding clarifications

Effective Date7/2024

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Updated to make Xeomin, Myobloc and Daxxify non formulary non-covered (NFNC).

Updated to remove Pregnancy as a reason for denial.

Clarified coding information.

6 monthsInitial approval duration (many indications)

2Required trials before NF coverage

4FDA‑approved agents referenced

5Products referenced

7/2024Most recent policy action

multipleGuideline/regulatory sources cited

Coverage & Medical Necessity Criteria

On-label / FDA-approved indications

Covered when ALL of the following are met (per indication groups below):

Cervical dystonia (spasmodic torticollis) with sustained head tilt or abnormal neck posturing AND history of recurrent involuntary contraction of one or more neck muscles (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical muscles).

Dystonia causing functional impairment: Dystonia resulting in functional impairment or pain, including oromandibular dystonia (Meige syndrome), laryngeal dystonia (adductor spasmodic dysphonia), idiopathic torsion dystonia, or symptomatic (acquired) torsion dystonia.

Spasticity and related conditions: Treatment of upper- and lower-limb spasticity and spastic conditions related to cerebral palsy, stroke, acquired spinal cord or brain injury, hereditary spastic paraparesis, spastic hemiplegia, neuromyelitis optica, multiple sclerosis, or Schilder disease.

Overactive bladder: Adults with urgency, frequency, or urge urinary incontinence who have had an inadequate response to or are intolerant of an anticholinergic medication.

Neurogenic detrusor overactivity: Urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults with inadequate response or intolerance to an anticholinergic medication.

Chronic migraine prophylaxis (initial): Age ≥ 18; prescribed by a neurologist, ophthalmologist, or board-certified headache medicine specialist; meets ICHD diagnostic criteria for chronic migraine; AND at least a 3-month trial with inadequate response, adverse reaction, or contraindication to ≥ 2 different classes of preventive medications (e.g., beta-blockers, antidepressants, antihypertensives, calcium channel blockers, anticonvulsants).Initial approval 6 months

Axillary/palmar hyperhidrosis: Age ≥ 18 with diagnosis of severe primary axillary or palmar hyperhidrosis inadequately managed with topical agents (e.g., aluminum chloride).

Blepharospasm associated with dystonia or facial nerve (VII) disorders, including hemifacial spasm.

Strabismus: Treatment of strabismus or misalignment of the eyes (e.g., esotropia, exotropia, hypertropia, hypotropia).

Chronic sialorrhea associated with ALS, atypical parkinsonian disorders, cerebral palsy, Parkinson disease, stroke, or traumatic brain injury; excessive salivation for ≥ 3 months; refractory to at least 2 months of continuous treatment with ≥ 1 oral pharmacotherapy (e.g., anticholinergics).

Off-label medically necessary indications

Covered when ALL of the following are met (per listed off-label indications):

Esophageal achalasia: Treatment of esophageal achalasia for individuals who have not responded to dilation therapy or who are considered poor surgical candidates.

Chronic anal fissure: Treatment of chronic anal fissure in individuals with history of failure, contraindication, or intolerance to at least one conventional therapy (topical nitrates or topical calcium channel blockers such as diltiazem or nifedipine).

Post-pull-through Hirschsprung obstructive symptoms: Treatment of obstructive symptoms in individuals with Hirschsprung disease following a pull-through operation.

Evidence-based indication summaries

Evidence-supported indications summarized in the policy (examples provided below).

Esophageal achalasia: Botulinum toxin injections may be reasonable for patients with esophageal achalasia who have failed initial medication therapy and who are not candidates for pneumatic dilation or surgical myotomy; systematic reviews/meta-analyses show inferior long‑term remission vs dilation/myotomy but suggest benefit in select, less invasive situations and ease of endoscopic administration.

Chronic anal fissure: Meta-analyses indicate lateral internal sphincterotomy has higher healing and lower recurrence rates than botulinum toxin, but botulinum toxin is a reasonable option for patients who fail medical therapy or who are poor surgical candidates because it carries lower fecal incontinence risk.

Hirschsprung disease (postoperative obstructive symptoms): Case series (total N=135 across 5 series) report consistent short-term responses and possible durable benefit for obstructive symptoms after pull-through operations in select pediatric populations.

Primary axillary hyperhidrosis:

Use of botulinum toxin products is considered INVESTIGATIONAL for indications not specifically listed as covered or as accepted off‑label medically necessary uses in this policy. The policy provides an extensive non‑covered list that includes, but is not limited to, neurologic indications (e.g., headaches except prevention of chronic migraine, essential tremor, tinnitus, chronic motor tic disorders), urologic indications (e.g., benign prostatic hyperplasia, interstitial cystitis, detrusor sphincter dyssynergia), multiple pain syndromes (e.g., chronic low back pain, myofascial pain syndrome, lateral epicondylitis), ano‑rectal conditions (e.g., internal anal sphincter achalasia, anismus), gastroparesis, depression, facial wound healing, cosmetic wrinkle treatment, and severe gustatory hyperhidrosis.

PrabotulinumtoxinA‑xvfs (Jeuveau®) is considered out of scope for this medical policy because its FDA approval is for cosmetic use; consequently, Jeuveau is not considered in the policy’s clinical coverage determinations.

The referenced literature citations and related reference chunks do not contain additional explicit coverage exclusions beyond those listed in the policy; they serve as supporting evidence for the policy statements and indication summaries.

For any indication not specifically listed as covered (on‑label or listed off‑label medically necessary), use of botulinum toxin is considered INVESTIGATIONAL. The policy therefore treats unlisted indications as out of scope for routine coverage absent compelling supporting evidence.

For a number of clinical indications (for example, various neurologic, urologic, gastroenterologic, and pain conditions), the evidence base is limited to case series or randomized trials with methodological limitations. When studies lack rigorous comparators, standardized dosing, and adequate follow‑up, the policy concludes there is insufficient evidence to determine a net health benefit and therefore does not support routine coverage for those indications.

The reference listings and bibliography included in the policy window do not themselves state explicit 'not medically necessary' determinations; they are cited to support summaries of evidence and clinical statements elsewhere in the policy.

Billing Codes & Initial Approval

HCPCS CodesHCPCS

C9160	Injection_daxibotulinumtoxina-lanm 1 unit (DAXI)
J0585	Injection, onabotulinumtoxin A, unit (Botox)
J0586	Injection, abobotulinumtoxin A, 5 units (Dysport)
J0587	Injection, rimabotulinumtoxin B, 100 units (Myobloc)
J0588	Injection; incobotulinumtoxin A, unit (Xeomin)

HCPCS Codes for botulinum toxinsHCPCS

C9160	Injection daxibotulinumtoxina-lanm 1 unit (DAXI)
J0585	Injection, onabotulinumtoxin A, unit (Botox)
J0587	Injection, rimabotulinumtoxin B, 100 units (Myobloc)
J0586	Injection, abobotulinumtoxin A, 5 units (Dysport)
J0588	Injection; incobotulinumtoxin A, unit (Xeomin)

Initial approval duration

Initial approval duration6 months

Applies toInitial 6-month trial for chronic migraine (age >=18, prescribed by neurologist/ophthalmologist/headache specialist)

Continuation criteria referencedContinuation beyond 6 months requires migraine frequency reduced by >=7 days/month or duration reduced by >=100 hours/month

Prior Authorization, Documentation & Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for outpatient administration of botulinum toxin products for Commercial members. Providers must use the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or Form #434 to request prior authorization or formulary exception.

Prior authorization required for outpatient services for Commercial Managed Care (HMO and POS), PPO and Indemnity.
Use Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or print/fax Form #434.

Step Therapy

Step Therapy / Formulary Preference

Coverage of non-formulary / non-preferred botulinum toxin products (e.g., Xeomin, Myobloc, Daxxify) requires a prior trial and documented failure of both preferred toxins (Botox and Dysport). For non-covered medications, the member must also have had previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. A higher member cost share may apply when an exception is approved for a non-preferred or non-formulary drug.

Initial Approval Criteria

Initial therapy (chronic migraine example)

Initial approval duration and initial criteria for chronic migraine:

Chronic migraine initial: Age ≥ 18; prescribed by a neurologist, ophthalmologist, or board-certified headache medicine specialist; meets ICHD-3 diagnostic criteria for chronic migraine (headaches ≥15 days/month for >3 months with migraine features on ≥8 days/month); AND inadequate response, adverse reaction, or contraindication to at least 2 different classes of preventive medications after a ≥3-month trial.Initial approval 6 months

Initial therapy

Use in patients who have failed standard therapy or are not candidates for standard interventions:

Initial therapy considerations: Botulinum toxin injections may be considered for select patients who have failed standard medical therapy or who are poor candidates for definitive procedures; product selection should account for formulary status and required prior trials of preferred toxins (Botox and Dysport) where applicable.

Continuation / Renewal Criteria

Chronic migraine continuation

Continuation criteria for chronic migraine beyond the initial approval:

Response metric: Continuation may be authorized if EITHER of the following is met: migraine frequency reduced by ≥7 days per month from pretreatment baseline; OR migraine duration reduced by ≥100 hours per month from pretreatment baseline.

Step Therapy & Preferred Product Requirements

Step	Requirement	Products in scope / examples
1	Trial and documented failure or contraindication to BOTH preferred toxins (onabotulinumtoxinA [Botox] AND abobotulinumtoxinA [Dysport]) is required prior to coverage of a non-formulary/non-covered (NFNC) botulinum toxin.	Non-formulary/non-covered examples: daxibotulinumtoxinA (Daxxify), rimabotulinumtoxinB (Myobloc), incobotulinumtoxinA (Xeomin).

Step	Policy history / positioning	Implication for coverage
1	Policy history documents that Botox and Dysport were designated preferred products (7/2021) and that Xeomin, Myobloc and Daxxify were updated to non‑formulary non‑covered (NFNC) status (7/2024).	Preferred positioning means formulary agents (Botox, Dysport) must be tried/failed before NFNC agents will be considered; NFNC agents require prior authorization and meet step therapy requirements as described.

Site of Care & Setting

Prior Authorization

Outpatient setting requires prior authorization

Prior authorization is required for outpatient administration of botulinum toxin products for Commercial members; ensure PA is obtained when services are performed in outpatient settings.

Applies to Commercial Managed Care (HMO, POS), PPO, and Indemnity

Note

Permitted outpatient/office administration for select GI indications

Botulinum toxin injections for certain gastrointestinal indications (e.g., achalasia) can be performed during routine endoscopy or in outpatient settings as appropriate to the indication.

When performed during endoscopy, document indication and that botulinum toxin is appropriate for patients who are poor candidates for PD or myotomy

Background & Mechanism

Botulinum toxins are neurotoxins produced by Clostridium botulinum and are available in multiple FDA‑approved formulations with differing labeled indications. Products referenced in this policy include onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), rimabotulinumtoxinB (Myobloc), and daxibotulinumtoxinA (DAXXIFY). These agents are used for a variety of on‑label indications (for example, certain dystonias, spasticity, overactive bladder/neurogenic detrusor overactivity, chronic migraine prophylaxis, hyperhidrosis, blepharospasm, strabismus, and chronic sialorrhea) and selected off‑label indications addressed in the policy.

Definitions & Guideline Sources

Dystonia / Spasticity — definitions

Dystonia (general)Abnormal or disordered muscle tonicity (eg, cervical dystonia/torticollis); includes conditions causing involuntary muscle contractions or abnormal postures)

Spasticity (subset)Velocity‑dependent increase in tonic-stretch reflexes with exaggerated tendon jerks, typically associated with central nervous system injury (common in cerebral palsy)

Clinical relevanceSpasticity described as a subset of dystonia used to define treatment populations for botulinum toxin

Chronic migraine (ICHD-3) — definition

Diagnostic threshold (ICHD-3)Headaches >=15 days per month for >3 months with migraine features on >=8 days per month

Features of migraineDuration 4–72 hours; at least two of: unilateral, pulsating, worsened by routine activity, moderate/severe intensity; associated with nausea/vomiting or photophobia/phonophobia

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyBotulinum toxin agents (formulary, indications, prior authorization)

Policy CodePolicy 006

Change TypeFormulary update (NFNC) + coding clarifications

Effective Date7/2024

Next Review Date

SourceLink

On This Page

Systematic reviews and RCTs demonstrate botulinum toxin A or B reduce sweating and improve severity scores in short- and longer-term follow-up; evidence sufficient to support net health benefit.

Other indications (neurologic, urologic, GI, pain, etc.): For many other indications (e.g., non-migraine headaches, essential tremor, tinnitus, BPH, interstitial cystitis, gastroparesis, lateral epicondylitis), the evidence is mixed or insufficient — studies often involve patients who failed standard care or where standard interventions were contraindicated; higher-quality randomized trials with standardized dosing and adequate follow-up are needed.

Step therapy: Trial and failure of both preferred toxins (Botox and Dysport) required before coverage of NFNC agents.
Policy history: Xeomin, Myobloc and Daxxify updated to NFNC status (7/2024).

Denial Risk

Denial Triggers

If the medical necessity criteria for the listed procedure/drug codes are not met, coverage will be denied for Commercial Members. Inclusion of a code in the policy is informational only and does not guarantee coverage; providers should verify member contract benefits at the time of service.

Failure to meet medical necessity criteria for listed CPT/HCPCS/ICD codes will trigger denial.
Inclusion of codes is informational and does not imply coverage or reimbursement.

Documentation Required

Clinical References & Literature

Providers may submit supporting clinical literature when requesting individual consideration for atypical patients. The policy includes references and peer-reviewed citations that may be used to support exception requests.

Provide relevant clinical literature from reputable peer‑reviewed journals when requesting an exception.
References cited in the policy may be used to support medical necessity/individual consideration requests.

Documentation Required

Exception Request Documentation

For individual consideration (exception requests) include the following documentation to facilitate review: names and strengths of formulary alternatives tried and failed (with specifics of treatment failure), clinical notes or supporting statements, clinical literature or guideline references, and any relevant prescription claims history. Submit documentation to BCBSMA Pharmacy Operations (address/phone/fax below).

List name and strength of alternatives tried and specifics of failure.
Include clinical notes, peer‑reviewed literature, and nationally recognized compendia or guideline references.
BCBSMA Pharmacy Operations Dept, 25 Technology Place, Hingham, MA 02043. Phone: 1-800-366-7778. Fax: 1-800-583-6289.

Note

Reference-Only Content

Some reference-only sections of the policy provide literature citations and background but do not establish additional prior authorization or step therapy requirements beyond those stated here. Providers should rely on the actionable prior authorization, step therapy, and documentation requirements in this section for submission guidance.

Reference sections supply supporting evidence only; they do not create new authorization or step therapy rules.
Follow the authorization and step therapy instructions in this Provider Actions section for operational requirements.

Medication overuseMedication overuse removed from ICHD-3 diagnostic criteria (now a separate category)

Botulinum toxin products referenced

onabotulinumtoxinABotox (onabotulinumtoxinA)

abobotulinumtoxinADysport (abobotulinumtoxinA)

incobotulinumtoxinAXeomin (incobotulinumtoxinA)

rimabotulinumxinBMyobloc (rimabotulinumtoxinB)

daxibotulinumtoxinADAXXIFY / daxibotulinumtoxinA (daxibotulinumtoxinA-lanm)

Guideline and regulatory sources

American Academy of Neurology (AAN)Practice guideline updates on botulinum neurotoxin for blepharospasm, cervical dystonia, spasticity, and headache

American Urological Association / Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (AUA/SUFU)Guidance referenced for management of urologic indications (eg, overactive bladder)

NICE and other systematic reviewsSystematic reviews and health technology assessments cited for hyperhidrosis and other indications

Food and Drug Administration (FDA)Regulatory approvals and product-specific information (eg, Jeuveau cosmetic approval) referenced