Policy not applicable to Medicare Advantage (LOB exclusion)

This policy does not apply to the Medicare Advantage line of business; prior authorization requirements in this policy do not apply to Medicare Advantage members.

Exclusion — non‑FDA muscle groups and pediatric <2 years

Requests for treatment of muscle groups not specified in FDA-approved labeling, and requests for treatment of upper or lower limb spasticity in pediatric patients under 2 years of age, will be denied as not medically necessary.

Excluded prophylactic migraine and non‑axillary hyperhidrosis

Botulinum toxin use for prophylaxis of episodic migraine (≤14 headache days/month) and for hyperhidrosis at body areas other than the axillae will be denied as not medically necessary.

Diagnoses designated unproven / not medically necessary

The policy lists diagnoses that are considered unproven and not medically necessary for all botulinum toxin formulations; requests for these diagnoses will be excluded unless the provider supplies supporting literature meeting the Off‑Label Use policy.

Denial triggers — dosing, documentation, and MDRP exclusions

Requests may be denied if dosing or frequency exceed established parameters, if clinical documentation of benefit or prior trials is not provided, or if the manufacturer does not participate in the Medicaid Drug Rebate Program for Medicaid Managed Care/HARP.

• Denial risk for dosing/frequency exceeding FDA/compendia limits or policy caps
• Denial risk when required clinical documentation (progress notes, prior treatment history, diagnostic testing) is missing
• Medicaid Managed Care/HARP: products from non‑MDRP manufacturers will not be covered

Prior authorization is required for listed botulinum toxins

Prior authorization is required per this policy for Botox, Dysport, Xeomin, Daxxify and Myobloc when administered under the medical benefit for the listed lines of business; follow indication‑specific PA criteria in the policy.

• PA applies to Medicaid (MMC/HARP), Child Health Plus (CHP), and D‑SNP for all listed products.
• For Commercial/Essential/Exchange: Dysport, Myobloc and Daxxify require PA; Botox and Xeomin do not require PA for these commercial lines.

PA requires diagnosis, age and specialty criteria

Prior authorization requests must meet indication‑specific criteria including confirmed diagnosis, applicable age, and prescriber specialty or consultation as specified by the indication.

• Provider must submit number of units per session, total dose per visit, and anticipated injection frequency.
• Specialist involvement required per indication (e.g., neurologist, urologist, dermatologist, ophthalmologist).

PA required — meet indication‑specific criteria

Prior authorization is required and conditioned on meeting the indication‑specific initial criteria (diagnosis, age, specialty prescriber/consultation, prior therapy failures where indicated, and dosing limits).

• Chronic migraine: age ≥18, prior failure of two preventive oral medications from two classes; dose ≤200 units/session; injections ≥12 weeks apart.
• Neurogenic detrusor overactivity (pediatric): age 5–17, failed 3‑month oxybutynin trial; dosing and retreat intervals specified.

PA requires diagnosis, age, specialty, and prior therapy documentation

Prior authorization submissions must include the documented diagnosis, patient age, prescriber specialty or consultation, evidence of prior therapy failure when required, and the number of units to be used per session with total dose and anticipated injection frequency.

PA required for indicated uses (example: sialorrhea)

Prior authorization is required for indicated uses such as sialorrhea where criteria include symptom duration (≥3 months), minimum age (≥2 years), specialist involvement, and failure of an adequate anticholinergic trial.

• Provider must submit units per session, total dose per visit, and anticipated injection frequency.
• Sialorrhea dosing must not exceed 100 units and retreat interval is 16 weeks.

Prior authorization requirement per policy

This policy sets prior authorization requirements for the listed botulinum toxin products when administered under the medical benefit; follow the PA rules in the policy and applicable contract/benefit language.

Prior authorization governance and contract dependence

The document is a pharmacy management drug policy; prior authorization governance and utilization management are contract dependent and aligned with plan and regulatory requirements.

• Utilization management requirements are contract dependent; refer to specific contract/benefit language.
• Policies will be updated to maintain compliance with state and federal regulations.

Step requirement: trial of Botox AND Xeomin before Dysport/Myobloc/Daxxify

For Commercial/Essential/Exchange new starts of Dysport, Myobloc, or Daxxify, the member must have had an adequate trial of BOTH Botox and Xeomin before coverage will be authorized.

Trial of oral spasticity agents required (baclofen, tizanidine, or dantrolene)

For upper and lower limb spasticity, provider must document trial and failure of an age‑appropriate course of baclofen, tizanidine, or dantrolene unless contraindicated or not clinically appropriate.

Step therapy: prior trials/failures required per indication

Policy requires documentation of failure, intolerance, or contraindication to specified prior therapies before approval where indicated (e.g., multiple oral preventives for chronic migraine; anticholinergics for bladder indications; topical aluminum chloride for hyperhidrosis).

Required prior therapy failures for off‑label indications

For off‑label indications specified in the policy, prior failure of conservative or pharmacologic therapies (e.g., topical nitroglycerin/calcium channel blocker for anal fissure) must be documented prior to approval.

Sialorrhea requires anticholinergic trial prior to approval

For sialorrhea, provider must document failure of an adequate anticholinergic trial (examples: glycopyrrolate, trihexyphenidyl, scopolamine, atropine, amitriptyline) prior to approval.

Recertification may require trial of more cost‑effective alternatives

Recertification reviews may require trials of more cost‑effective alternatives (e.g., generics, biosimilars) as they become available; requested dosing must align with FDA‑approved or guideline‑supported off‑label dosing.

AHS consensus referenced for migraine step therapy context

The American Headache Society consensus statement is referenced and may inform stepwise treatment considerations when integrating new migraine therapies, which is relevant to chronic migraine step therapy decisions.

Submit diagnosis, age, specialty, functional impairment, and dosing details

Provider must submit diagnosis, patient age, consultation/prescriber specialty, description of functional impairment, number of units per treatment session, total dose per visit, and anticipated injection frequency for each PA request.

Documentation: positive response, units, frequency, and cumulative dosing

For initial requests and recertification the provider must document positive response when applicable and submit units per session, total dose per visit, and anticipated injection frequency; recertification must also document time since last injection and three‑month cumulative units.

Documentation must include diagnosis, dosing, frequency, and prior therapy history

Initial and recertification requests must include diagnosis, units per session, total dose per visit, anticipated frequency, and evidence of prior therapies/trials as specified for the indication.

CGRP combination: document prior partial response and ongoing headache burden

When botulinum toxin is used concurrently with injectable CGRP antagonists, submit documentation of prior monotherapy partial response and ongoing headache burden requiring combination therapy.

Required documentation: prior response, unit counts, frequency, and cumulative units

Provider must submit documentation supporting a positive response to prior treatment (when applicable), the number of units to be used in each treatment session, total dose per visit, anticipated frequency of injections, and for recertification confirm time since last injection and three‑month cumulative units.

Recertification requires documentation of positive response and unit counts

Recertification requests must document a positive response to treatment and include the number of units per session and total dose per visit; for many indications ensure the three‑month cumulative units remain within policy limits.

Submit supporting clinical documentation (progress notes, prior history, tests)

Clinical documentation must be submitted for each request (initial and recertification) including progress notes, prior treatment history, diagnostic testing, labs, imaging, and other objective or subjective measures of benefit.

Include product labeling / FDA product information as supporting references

Cite and use product labeling and FDA product information (BOTOX, DYSPORT, XEOMIN, DAXXIFY) as reference sources for administration, indications, and safety when preparing PA documentation.

Lack of required prior authorization may lead to denial

If prior authorization is required for the member's line of business and no PA is obtained, the request may be denied; lack of required PA is actionable per the policy.

Scope‑based denials: non‑FDA muscle groups or pediatric <2

Requests for treatment of muscle groups not specified in FDA labeling or for pediatric patients under 2 years for spasticity will be denied as not medically necessary.

Episodic migraine prophylaxis excluded

Requests for prophylaxis of episodic migraine (≤14 headache days/month) will be denied as not medically necessary.

Hyperhidrosis outside axillae excluded

Requests for hyperhidrosis treatment for any body area other than axillae will be denied as not medically necessary.

Denial triggers: excessive dosing/frequency or insufficient documentation

Requests exceeding per‑treatment‑session or three‑month cumulative unit limits, or lacking sufficient documentation of prior positive response or appropriate interval since last injection, may be denied.

Excluded indications: cosmetic and unproven diagnoses

Cosmetic indications and diagnoses listed as unproven/not medically necessary are excluded and will not be authorized unless the provider supplies supporting literature per the Off‑Label Use policy.

Denial triggers: manufacturer participation, dosing/frequency, or missing documentation

Requests may be denied if dosing or frequency exceed established parameters, if the manufacturer does not participate in the Medicaid Drug Rebate Program for Medicaid Managed Care/HARP, or if clinical documentation is not provided to demonstrate medical necessity.

Specialist involvement required per indication

Prescriptions must be by or in consultation with the relevant specialist for the indication (examples include neurologist, orthopedist, physiatrist, pain specialist, urologist, dermatologist, or ophthalmologist) when specified in the indication criteria.

Administration by HCP and medical‑benefit coverage

Botulinum toxin drugs are administered by a healthcare professional in settings such as office, infusion center, hospital outpatient, or home (if clinically appropriate) and are covered under the medical benefit unless contract/benefit language specifies otherwise.

Product information references required as supporting sources

Include product labeling and FDA product information (BOTOX, DYSPORT, XEOMIN, DAXXIFY) as references to support the PA request and documentation of dosing, administration technique, and safety information.