Policy governs prior authorization and coverage criteria for botulinum toxin products (Botox, Daxxify, Dysport, Myobloc, Xeomin) for multiple neurologic and non-neurologic indications for Mass General Brigham Health Plan members.
Key ActionObtain prior authorization and provide required documentation including prescriber specialty, diagnosis, prior treatment failures, dosing, and for reauthorization attest to clinical response.
Botox criteria for overactive bladder updated to include 'urinary urgency, with or without incontinence', 'nocturia', and 'urinary frequency' as diagnoses.
Botox migraine prophylaxis criteria updated to require 'migraine' headache frequency (not just headache frequency) and clarify concomitant CGRP inhibitor dosing and partial but incomplete response requirement.
Off-label criteria were added for trigeminal neuralgia, severe craniofacial hyperhidrosis, and escalated dosing in axillary hyperhidrosis.
Dosing and age/indication alignment updates were made for Dysport, Myobloc, and Xeomin to match package inserts.
5brand products named
manyindications listed
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
prior authauthorization required
3 moinitial auth duration
6 momigraine (with CGRP) init
12 moreauthorization duration
Coverage Criteria for Botulinum Toxins
Covered when ALL of the following are met (by indication)
Authorization may be granted when all indication‑specific criteria are met; the policy specifies specific AND/OR logic per indication.
General: Diagnosis appropriate for the requested indication; prescriber specialty or consult notes provided where specified; dose appropriate for stated indication; documentation of inadequate response/adverse reaction or contraindication to required prior therapies when specified.
Botox - Migraine Prophylaxis: 1) Diagnosis of migraine prophylaxis; 2) Prescriber is a neurologist, pain medicine/anesthesiology physician, or physical medicine/rehabilitation physician or consult notes from one are provided; 3) Documentation of migraine headache frequency > 15 days per month; 4) Physician attestation of inadequate response or adverse reaction to ONE or contraindication to ALL beta‑blockers (atenolol, metoprolol, nadolol, propranolol, timolol); 5) Physician attestation of inadequate response or adverse reaction to TWO or contraindication to ALL of: amitriptyline/nortriptyline/protriptyline, topiramate, valproic acid, venlafaxine.
Overactive bladder / Neurogenic detrusor overactivity: 1) Diagnosis of overactive bladder (including 'urinary urgency, with or without incontinence', nocturia, or urinary frequency) or neurogenic bladder dysfunction; 2) Prescriber is a urologist or consult notes are provided; 3) Paid claims or physician attestation of inadequate response/adverse reaction to required prior therapies (e.g., two anticholinergics, or anticholinergic plus mirabegron or other specified combinations); 4) Dose appropriate for stated indication and dosing interval not more frequent than every 12 weeks where specified.
Severe axillary hyperhidrosis (escalated dosing): 1) Diagnosis of severe axillary hyperhidrosis; 2) Prescriber is a dermatologist or neurologist or consult notes from such are provided; 3) Inadequate response to FDA‑approved dosing of 50 units per axilla; 4) Requested escalated dose is < 200 units per axilla.
Sialorrhea: 1) Diagnosis of sialorrhea; 2) Inadequate response or adverse reaction to TWO or contraindication to ALL of: atropine, glycopyrrolate, hyoscyamine, scopolamine, or a tricyclic antidepressant; 3) Appropriate dosing (example: 40–100 units every 3–6 months); 4) Inadequate response, adverse reaction, or contraindication to BOTH Myobloc and Xeomin where specified.
Achalasia / Esophageal dysphagia: 1) Diagnosis of achalasia/esophageal dysphagia; 2) Prescriber is a gastroenterologist or surgeon or consult notes are provided; 3) ONE of the following: failed a surgical option (e.g., pneumatic dilation, laparoscopic Heller myotomy with partial fundoplication, POEM) OR is not a surgical candidate or unwilling to undergo these procedures; 4) Initial requested dose < 100–250 units (section‑specific) and dosing interval no more frequently than every six months as specified.
Spasticity / Focal dystonias: 1) Diagnosis appropriate to the requested spasticity or focal dystonia indication (e.g., cervical dystonia, limb spasticity, blepharospasm); 2) Age requirements met where specified (pediatric age thresholds and prescriber must provide child's weight when required); 3) Dose appropriate for the stated indication.
Off‑label (anal stenosis, chronic constipation, encopresis and others listed): 1) Diagnosis confirmed for the listed off‑label condition; 2) Prescriber is a gastroenterologist or surgeon or consult notes from such are provided; 3) Inadequate response or adverse reaction to required prior therapies (condition‑specific; e.g., laxatives, dietary/behavioral interventions) as specified in the criteria.
Off-Label Indications — Required ALL elements
Covered when ALL of the following are met for each listed off‑label indication
Anal fissures: 1) Diagnosis of anal fissures; 2) Prescriber is a gastroenterologist or surgeon or consult notes from a gastroenterologist or surgeon are provided; 3) Inadequate response or adverse reaction to ONE or contraindication to BOTH topical nifedipine and topical nitroglycerin.
Gastroparesis: 1) Diagnosis of gastroparesis; 2) Prescriber is a gastroenterologist or surgeon or consult notes from a gastroenterologist or surgeon are provided; 3) Inadequate response, adverse reaction, or contraindication to metoclopramide; 4) Inadequate response or adverse reaction to ONE or contraindication to ALL antiemetics.
Anal stenosis / chronic constipation / encopresis: 1) Diagnosis of anal stenosis, chronic constipation, or encopresis; 2) Prescriber is a gastroenterologist or surgeon or consult notes are provided; 3) Inadequate response or adverse reaction to TWO or contraindication to ALL laxatives; 4) Inadequate response to dietary changes and/or behavior modification (e.g., biofeedback) as specified.
Indication and documentation: 1) Individual drug PA criteria for each agent must be met first where applicable; 2) Diagnosis of migraine prophylaxis (chronic migraine) with documentation of migraine frequency (policy requires migraine headache frequency > 15 days/month for Botox indications); 3) Partial, but incomplete, response to a CGRP inhibitor when used concomitantly (physician attestation); 4) Appropriate dosing and schedule for both agents; 5) Resubmission/reauthorization must document positive response to therapy and improvement in headache days per month.
Authorization duration: 1) Initial authorization for migraine prophylaxis when used in combination with a CGRP inhibitor is granted for 6 months; 2) Reauthorizations thereafter are granted for 12 months.
Prior therapy requirements: 1) Documentation of prior inadequate response or adverse reaction to required oral preventive agents as specified in the Botox migraine criteria (see general migraine criteria for required beta‑blocker and other agent trials when applicable).
Requests for botulinum toxin use in indications or doses not specifically listed in the policy will be considered on a case‑by‑case basis. Such requests require a documented risk‑benefit assessment and evidence that conventional or first‑line therapies were attempted and failed or were contraindicated. For members who are new to the plan and currently receiving the requested medication, authorization may also be reviewed individually to determine appropriateness of continued therapy.
Botulinum toxin products are not covered when used for cosmetic purposes. Examples of cosmetic uses that will be denied include treatment of facial rhytids, frown lines, glabellar wrinkling, horizontal neck rhytids, hyperfunctional facial lines, mid and lower face and neck rejuvenation, platysmal bands, rejuvenation of the periorbital region, and lateral canthal lines (crow’s feet).
The Plan explicitly excludes cosmetic indications for Botox, Dysport, Myobloc, and Xeomin. In addition, the policy notes a specific exclusion related to Dysport: requests for 300 units for glabellar lines are not covered. All other off‑label uses and any doses that exceed the limits specified in the policy will be reviewed on a case‑by‑case basis with a required risk‑benefit assessment prior to approval.
onabotulinumtoxinA — product referenced with adult/pediatric max doses
Dysport
abobotulinumtoxinA — product referenced with adult/pediatric max doses
Myobloc
rimabotulinumtoxinB — product referenced with adult/pediatric max doses
Xeomin
incobotulinumtoxinA — product referenced with adult/pediatric max doses
Daxxify
Daxxify product added to criteria
inv-08: Dose limits / frequency (examples and timing limits)
Bladder indications frequencyNot more frequently than every 12 weeks for overactive bladder and neurogenic detrusor overactivity.
Axillary hyperhidrosis escalationRequested escalated dose must be < 200 units per axilla after inadequate response to FDA‑approved 50 units per axilla.
Achalasia initial dosingInitial requested dose generally < 100–250 units, with specific surgical candidacy considerations noted.
Sialorrhea dosing intervalAppropriate dosing typically 40–100 units every 3–6 months for sialorrhea.
Pain syndromes total dose capsCertain pain indications reference total dose caps (examples: myofascial pain syndrome up to 200 units; myofascial pelvic pain up to 300 units).
Prior Authorization, Documentation, and Submission Requirements
Prior Authorization
Prior Authorization Required
Prior authorization is required for botulinum toxin products except when obtained as samples or via manufacturer patient assistance programs. New-to-plan members currently receiving treatment may have authorization reviewed on a case-by-case basis; include supporting documentation (see documentation callouts).
Authorization required for botulinum toxin products
New-to-plan treatment reviewed case-by-case; samples and manufacturer assistance program supplies excluded
Step Therapy
Step Therapy / Prior Treatment Requirements
Step therapy and prior treatment requirements vary by indication. For labeled and off‑label indications, prescribers must document prior trials and inadequate response or contraindications as specified below. Pay close attention to indication-specific step requirements (e.g., migraine, overactive bladder, neurogenic bladder, sialorrhea, anal fissures, gastroparesis).
Migraine prophylaxis: attestation of inadequate response or adverse reaction to one beta‑blocker (atenolol, metoprolol, nadolol, propranolol, timolol) AND to two agents among amitriptyline/nortriptyline/protriptyline, topiramate, valproic acid, venlafaxine
Clinical Background
Botulinum toxin products are used across both neurologic and non‑neurologic conditions. The policy lists indication‑specific coverage pathways for conditions such as focal dystonias and spasticity, chronic migraine prophylaxis (including pathways when given with a CGRP inhibitor), sialorrhea, hyperhidrosis (including escalated axillary dosing), bladder dysfunction, and selected gastrointestinal indications (e.g., achalasia, anal fissures, gastroparesis). For many indications the policy requires appropriate prescriber specialty or consult notes, documentation of inadequate response or intolerance to specified prior therapies, and adherence to dosing and frequency limits; off‑label indications included in the policy require specialist involvement and prior treatment failure before authorization will be granted.
Definitions and Notes
inv-20: Off-label indications key-value summary
Anal fissures (off‑label)Requires diagnosis of anal fissures; prescriber is gastroenterologist or surgeon (or consult notes); inadequate response or adverse reaction to ONE or contraindication to BOTH topical nifedipine and topical nitroglycerin.
Gastroparesis (off‑label)Requires diagnosis of gastroparesis; prescriber is gastroenterologist or surgeon (or consult notes); inadequate response/adverse reaction/contraindication to metoclopramide and to one or all antiemetics.
Other listed off‑label usesListed off‑label indications require specialist involvement, documented inadequate response to specified prior therapies, and will be reviewed under the stated ALL‑criteria.
Unlisted off‑label usesAll other conditions and doses exceeding limits are reviewed case‑by‑case with a risk–benefit assessment and documentation of failure of conventional treatments.
Key ActionObtain prior authorization and provide required documentation including prescriber specialty, diagnosis, prior treatment failures, dosing, and for reauthorization attest to clinical response.
1) Diagnosis of trigeminal neuralgia; 2) Prescriber is a neurologist or physical medicine/rehabilitation physician or consult notes from a specialist are provided; 3) Inadequate response or adverse reaction to TWO or contraindication to ALL of the following: baclofen, carbamazepine, gabapentin, lamotrigine, tizanidine, oxcarbazepine, topiramate (as listed).
inv-09: Maximum Approvable Doses (examples per product)
Botox (onabotulinumtoxinA) — adult maxUp to 840 units (adults).
Botox — pediatric maxUp to 25 units/kg or a max total dose of up to 600 units (pediatrics).
Dysport (abobotulinumtoxinA) — adult maxUp to 1,500 units (adults).
Dysport — pediatric maxUp to 25 units/kg or a max total dose of up to 1,000 units (pediatrics).
Myobloc (rimabotulinumtoxinB) — adult and pediatric maxAdults: up to 25,000 units; Pediatrics: up to 400 units/kg or a max total dose of 10,000 units.
Xeomin (incobotulinumtoxinA) — adult maxUp to 840 units (adults).
Overactive bladder: inadequate response or adverse reaction to two anticholinergic agents (e.g., oxybutynin, tolterodine) or combinations with cholinergic agents or alpha‑blockers; prescriber must be a urologist or include urology consult notes
Neurogenic bladder: trials of anticholinergic and/or mirabegron as specified; prescriber is a urologist or include consult notes
Sialorrhea: inadequate response or adverse reaction to two agents (e.g., atropine, glycopyrrolate, hyoscyamine, scopolamine, TCAs)
Anal fissures: inadequate response or adverse reaction to topical nifedipine and topical nitroglycerin; prescriber is a gastroenterologist or surgeon
Step Therapy
Off‑Label Step Requirements
Off‑label use is allowed only when ALL off‑label criteria are met: diagnosis matches an accepted off‑label indication (e.g., anal fissures, gastroparesis, other listed off‑label conditions), prescriber specialty or consult notes are provided (typically gastroenterologist or surgeon for GI indications), and inadequate response or contraindication to conventional or specified therapies is documented. All off‑label and dose‑exceeding requests will be reviewed case‑by‑case with a documented risk‑benefit assessment and evidence that conventional treatments were tried.
Off‑label indications require specialty prescriber or consult notes (e.g., gastroenterologist/surgeon)
Document inadequate response/adverse reaction or contraindication to specified first‑line therapies for the off‑label indication
Requests exceeding dose limits or for unlabeled indications require risk‑benefit rationale and will be reviewed case‑by‑case
Documentation Required
Required Clinician Documentation
Required clinician documentation for initial and continuation authorizations: diagnosis and indication; prescriber specialty or relevant consult notes; detailed prior treatment history including specific agents tried, dates, and outcomes (inadequate response, adverse reaction, or contraindication); dosing requested and justification if outside usual limits; and for pediatric dosing include patient weight when applicable. For migraine prophylaxis with concomitant CGRP inhibitor, include documentation of partial but incomplete response to the CGRP inhibitor.
Diagnosis and indication
Prescriber specialty or consult notes (e.g., neurologist for migraine, urologist for bladder indications, gastroenterologist/surgeon for GI)
Prior medication trials with attestation of inadequate response, adverse reaction, or contraindication (list drugs/classes tried)
Dose requested and regimen; include weight for pediatric dosing
For migraine + CGRP inhibitor: documentation of partial but incomplete response to CGRP inhibitor
Documentation Required
Required Documentation for Off‑Label and Continuation Requests
For off‑label requests and continuation of therapy, submit documentation that demonstrates ongoing benefit: physician attestation of positive response to therapy (e.g., improvement in headache days per month for migraine prophylaxis when used with a CGRP inhibitor) or other clinical improvement for the treated indication. Reauthorizations require the same attestation and any updated prior‑therapy history if relevant.
Continuation requests must include physician attestation of positive clinical response
For migraine with CGRP inhibitor, document improvement in headache days per month
Off‑label continuations require continued evidence of benefit and updated risk‑benefit assessment
Note
Authorization Durations and Dose Review
Authorization durations: initial authorizations are typically granted for 3 months for the first course of therapy (migraine prophylaxis with CGRP inhibitor: 6 months). Reauthorizations: most indications — 12 months; migraine prophylaxis (with CGRP inhibitor) — 6 months as noted. Dose appropriateness will be reviewed; see Appendix for high‑dose requests and maximum approvable doses.
Reauthorizations: generally 12 months (exception durations noted above)
High‑dose or dosing outside FDA limits require Appendix documentation and will be reviewed per high‑dose criteria
Denial Risk
Cosmetic Exclusions
Cosmetic uses are excluded. The Plan will not cover botulinum toxin products for facial rhytids, frown lines, glabellar wrinkling, horizontal neck rhytids, hyperfunctional facial lines, mid and lower face and neck rejuvenation, platysmal bands, periorbital rejuvenation, or lateral canthal lines (crow's feet).
Cosmetic exclusions include glabellar lines and other facial/neck aesthetic indications
Examples: Dysport 300 units for glabellar lines is not covered
Definition — Maximum Approvable Dose (Adults)Specified maximum approvable adult doses per product (examples: Botox up to 840 units; Dysport up to 1,500 units; Myobloc up to 25,000 units; Xeomin up to 840 units).
Definition — Maximum Approvable Dose (Pediatrics)Pediatric maximum approvable doses are defined per product (examples: Botox up to 25 units/kg or max 600 units; Dysport up to 25 units/kg or max 1,000 units; Myobloc up to 400 units/kg or max 10,000 units); some pediatric requests evaluated case‑by‑case.
High‑dose review processRequests beyond FDA‑approved doses are evaluated against the Appendix maximum approvable doses and reviewed case‑by‑case as specified in policy.
Product‑specific noteXeomin pediatric dosing outside FDA‑approved use will be evaluated on a case‑by‑case basis per the Appendix guidance.