CurrentColorado Rocky Mountain Health PlansPolicy N/A

Botulinum toxin (Botox/Myobloc/Dysport/Xeomin) prior authorization

This prior authorization form defines coverage criteria for botulinum toxin products across multiple neurologic and related indications, including chronic migraine, urinary incontinence, overactive bladder, spasticity, and other listed indications for Colorado Rocky Mountain Health Plans beneficiaries.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBotulinum toxin (Botox/Myobloc/Dysport/Xeomin) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form including beneficiary and prescriber details, drug name/strength/quantity, indication, and documentation of prior medication trials and headache frequency where applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15+headache days threshold

3prophylactic drug classes required

6 daysresponse needed for continuation

365authorization duration option

Coverage Criteria for Botulinum Toxin

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Chronic Migraine (New Therapy)

Covered when ALL of the following are met for new chronic migraine therapy (BOTOX):

Chronic Migraine New Therapy: Patient has 15 or more headache days each month with headache lasting 4 or more hours; patient has tried and failed prophylactic medications from at least 3 different drug classes (e.g., beta blockers, calcium channel blockers, tricyclic antidepressants, anticonvulsants) each for at least 3 months; prescriber documents medications tried.15+ days; 3 drug classes; 3 months each

Approval up to 6 months for new therapy

Chronic Migraine (Continuation)

Covered when ALL of the following are met for continuation of chronic migraine therapy (BOTOX):

Chronic Migraine Continuation: Patient responded favorably after the first 2 injections; the average number of headache days decreased by 6 or more days from the patient's baseline headache frequency.>=6 day reduction

Approval up to 1 year for continuation

Urinary Incontinence / Detrusor Overactivity

Covered when ALL of the following are met for urinary incontinence/detrusor overactivity:

Urinary Incontinence: Patient has detrusor overactivity associated with neurologic conditions; patient tried and failed an anticholinergic medication or has a documented contraindication, intolerable side effects, or allergy to anticholinergic medications.prior anticholinergic trial or documented contraindication/intolerance

Document medication tried or reason for contraindication/intolerance

Overactive Bladder

Covered when ALL of the following are met for overactive bladder (BOTOX):

Overactive Bladder: Beneficiary tried and failed on 2 anticholinergic medications; or has a documented contraindication, intolerable side effect, or allergy to anticholinergic medications; prescriber lists medications tried.2 anticholinergics or documented contraindication/intolerance

List medications tried on the request form

Other Indications

Form lists multiple other covered indications to be documented on the request form:

Other Indications: Blepharospasm; disorders of eye movement (strabismus); spasmodic torticollis/cervical dystonia; spasticity (adult and pediatric as specified); severe axillary hyperhidrosis; sialorrhea; chronic anal fissure; esophageal achalasia when surgery not indicated; infantile cerebral palsy; hemifacial spasms; laryngeal dystonia; upper and lower limb spasticity as specified; and other listed indications. Documentation of the selected indication is required on the form.

Specific additional clinical criteria for these indications are not specified on the form; indicate the chosen diagnosis on the request form

The prior authorization form does not list any blanket or explicit exclusions. Instead, coverage is organized by selecting the specific indication from a provided list of approved uses on the request form and documenting the required supporting information for that indication.

Providers must complete the applicable indication selection and supply the documentation fields required for that indication (for example, baseline headache frequency and prior prophylactic medication trials for chronic migraine, or prior anticholinergic trials or contraindications for urinary/overactive bladder). Failure to document the required indication‑specific information may result in denial.

Key Coding and Thresholds

inv-07: Chronic migraine headache frequency — >= 15 days per month with headache lasting >= 4 hours.

Chronic migraine frequency threshold15 or more headache days per month with headaches lasting 4 or more hours

Applies toAdult beneficiaries (18 and older) for new therapy with BOTOX

Approval duration (new therapy)Up to 6 months for initial approval

inv-08: Response threshold for continuation — decrease in average headache days by >= 6 days from baseline after first two injections.

Response threshold for continuationDecrease in average headache days by 6 or more days from baseline after the first 2 injections

Documentation requiredProvider must document favorable response after first 2 injections and change in average monthly headache days

Approval duration (continuation)Up to 1 year for continuation of therapy

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization submission is required. Use the completed prior authorization form to provide beneficiary, prescriber, and drug details, and select requested length of therapy (options include up to 30, 60, 90, 120, 180, or 365 days).

Provide beneficiary full name, beneficiary ID number, date of birth, and gender
Provide prescribing provider NPI and requester contact information (name, phone, fax)
Specify drug name, strength, quantity per 30 days, and select length of therapy

Documentation Required

Chronic Migraine Documentation

For chronic migraine new therapy, document baseline headache frequency and confirm the patient has ≥15 headache days per month with headaches lasting ≥4 hours. Include a list of prophylactic medications tried, with durations.

Document baseline number of headache days per month and typical duration of headache episodes
Indicate whether the patient has ≥15 headache days/month lasting ≥4 hours — lack of documentation may lead to denial
List all prophylactic medications tried and duration of each trial

Step Therapy

Step Therapy Requirements

Step therapy for chronic migraine requires trials of prophylactic medications from at least three different drug classes (examples: beta blockers, calcium channel blockers, tricyclic antidepressants, anticonvulsants), each tried for at least 3 months. For continuation, document clinical response (decreased headache days by ≥6 days after two injections) to qualify for ongoing approval.

Initial therapy: documented trials from at least 3 different prophylactic drug classes, each ≥3 months
Continuation therapy: favorable response after first two injections and reduction in average headache days by ≥6 days from baseline

Documentation Required

Urinary / Overactive Bladder Documentation

For urinary incontinence or overactive bladder, document detrusor overactivity due to a neurologic condition when applicable and prior trials of anticholinergic medications or a documented contraindication/intolerance/allergy to anticholinergics.

State whether detrusor overactivity is present and if it is associated with a neurologic condition
For urinary incontinence: document a trial and failure of at least one anticholinergic medication (list agent(s) and duration) or document contraindication/intolerance/allergy
For overactive bladder: document trials of two anticholinergic medications (list agents) or documented contraindication/intolerance/allergy

Documentation Required

Required Form Fields

Required form fields must be completed fully. Missing beneficiary, prescriber, or drug information may delay or deny the request.

Beneficiary: last name, first name, beneficiary ID number, date of birth, gender
Prescriber: prescribing provider NPI, provider fax, requester contact name and phone/extension
Drug: requested drug name, strength, quantity per 30 days, and selected length of therapy checkbox
Prescriber signature and date (mandatory)

Denial Risk

Anticholinergic Trial

Anticholinergic trial requirements: document specific anticholinergic agents tried and durations; if anticholinergics are not appropriate, provide documented contraindication, intolerable side effects, or allergy.

List anticholinergic medication(s) tried and the duration of each trial
If anticholinergics were not tried, include clear documentation of contraindication, intolerable side effects, or allergy
Failure to document trials or contraindications may result in denial

Background and Indications

Botulinum toxin preparations are used for a broad range of neurologic and related conditions listed on the request form. The form explicitly lists multiple indications including blepharospasm, disorders of eye movement (strabismus), cervical dystonia (spasmodic torticollis), spasticity (adult and pediatric as specified), severe axillary hyperhidrosis, sialorrhea, chronic anal fissure, esophageal achalasia when surgery is not indicated, infantile cerebral palsy, hemifacial spasms, laryngeal dystonia, and upper/lower limb spasticity among others.

For each selected indication the provider must document the prescribed dosage and supporting clinical details requested on the form (for example, prior conservative management for hyperhidrosis or the specific diagnosis and prior therapies relevant to the chosen indication).

Definitions and Scope

inv-18: Chronic migraine — definition: 15+ headache days/month with headaches >=4 hours; initiation and continuation criteria summary.

Definition (chronic migraine)Patient has 15 or more headache days per month with headaches lasting 4 or more hours

Initiation criteria summaryFor new therapy: 15+ headache days/month, failed prophylactic medications from ≥3 different drug classes each for ≥3 months; list medications tried

Continuation criteria summaryPatient responded favorably after first 2 injections and average headache days decreased by ≥6 days from baseline

inv-19: Overactive bladder / urinary incontinence — includes detrusor overactivity associated with neurologic conditions; authorization requires prior anticholinergic trials or documented contraindication.

Condition scopeIncludes detrusor overactivity associated with neurologic conditions (urinary incontinence) and overactive bladder

Prior therapy requirementAuthorization requires prior trial(s) of anticholinergic medications (urinary incontinence: trial of an anticholinergic; overactive bladder: trial and failure of 2 anticholinergics)

Alternatives to trialDocumented contraindication, intolerable side effects, or allergy to anticholinergic medications may substitute for prior trial requirement