CurrentmhnPolicy CP.PHAR.233

Clinical Policy: RimabotulinumtoxinB (Myobloc)

Policy defines medical necessity criteria, initial and continued approval, dosing limits, exclusions, and coding implications for rimabotulinumtoxinB (Myobloc) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

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PolicyClinical Policy: RimabotulinumtoxinB (Myobloc)

Policy CodePolicy CP.PHAR.233

Change TypeStep therapy bypass added for IL HIM; other administrative updates

Effective DateJul 1, 2016

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

Revised Commercial approval duration to '6 months or to member's renewal date, whichever is longer' for injectables.

Treatment plan requirement wording changed to detailing number of Units per indication and treatment session.

Per 2Q2023 review, for cervical dystonia replaced Xeomin redirection with Botox to co-prefer with Dysport.

2FDA Approved Indications

3Approval Sections

J0587Primary HCPCS Code

Coverage Summary

Coverage stance: Covered with criteria for FDA-approved indications — cervical dystonia and chronic sialorrhea — aligned to FDA labeling. Policy applies across lines of business: Commercial, HIM, and Medicaid. Scope: policy defines medical necessity criteria for initial and continued approval, dosing and per-session/per-gland limits, exclusions (including non‑FDA indications and cosmetic uses), coding implications (HCPCS J0587), and administrative requirements (prior authorization with a treatment plan) for rimabotulinumtoxinB (Myobloc).

Initial Therapy Criteria

Initial Approval Criteria - Cervical Dystonia (focal dystonia)

Must meet ALL:

ALL of the following

Diagnosis of CD
Prescribed by or in consultation with a neurologist, orthopedist, or physiatrist
Age ≥ 18 years
Member is experiencing involuntary contractions of the neck and shoulder muscles (e.g., splenius capitis, sternocleidomastoid, levator scapulae, scalene, trapezius, semispinalis capitis) resulting in abnormal postures or movements of the neck, shoulders, or head
Contractions are causing pain and functional impairment
Step therapy
- Failure of Botox and Dysport
- Unless clinically significant adverse effects are experienced or both are contraindicated
Myobloc is not prescribed concurrently with other botulinum toxin products
Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks
Treatment plan provided detailing number of Units per indication and treatment session
Dose does not exceed 5,000 Units per treatment session<= 5,000 Units/session

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Initial Approval Criteria - Cervical Dystonia (focal dystonia)

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Initial Approval Criteria - Chronic Sialorrhea

Must meet ALL:

ALL of the following

Underlying cause (a or b)
- Underlying neurologic disorder (e.g., Parkinson disease, atypical parkinsonism, stroke, traumatic brain injury, cerebral palsy, amyotrophic lateral sclerosis)
- Craniofacial abnormality (e.g., Goldenhar syndrome)
Prescribed by or in consultation with a neurologist or physiatrist
Age ≥ 18 years
Failure of at least one anticholinergic drug (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated

Initial Approval Criteria - Other diagnoses/indications

Must meet ONE of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the applicable no coverage criteria or non-formulary policy for the relevant line of business (see policy references)
If requested use is not listed under section III and the label-change criterion does not apply, refer to the off-label use policy for the relevant line of business

Continuation Therapy Criteria

Continued Approval - Cervical Dystonia

Must meet ALL:

ALL of the following

Continuation eligibility
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Myobloc is not prescribed concurrently with other botulinum toxin products
Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks
Treatment plan provided detailing number of Units per indication and treatment session
If request is for a dose increase, new dose does not exceed 10,000 Units per treatment session<= 10,000 Units/session (if dose increase)

Continued Approval - Chronic Sialorrhea

Must meet ALL:

ALL of the following

Continuation eligibility
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Myobloc is not prescribed concurrently with other botulinum toxin products

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

ALL of the following

Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)
Cosmetic treatment of hyperfunctional wrinkles of the upper face including glabellar frown lines, deep forehead wrinkles and periorbital wrinkles (crow's feet)
Same-visit treatment of multiple indications

Provider Actions

Prior Authorization

Prior authorization required with treatment plan

Prior authorization required. Treatment plan must be provided detailing number of Units per indication and number of Units per treatment session. Include HCPCS code J0587 (Injection, rimabotulinumtoxinB, 100 units) on requests as applicable.

Documentation Required

Submit supporting documentation

Submit supporting documentation with the prior authorization request, including office chart notes, laboratory results, and other clinical information sufficient to demonstrate the member meets all approval criteria.

Step Therapy

Step therapy requirements for CD and sialorrhea

Step therapy requirements: For cervical dystonia (CD) there must be documented failure of Botox and Dysport unless clinically significant adverse effects or contraindications are present. For chronic sialorrhea there must be documented failure of at least one anticholinergic and failure of Xeomin unless contraindicated or clinically significant adverse effects are present. For Illinois HIM requests, step therapy requirements do not apply as of 01/01/2026 per IL HB 5395.

Billing Rule

Dose limits per approval

Dose limits: Claims exceeding the policy's dosing thresholds may be outside policy limits and could be denied. Examples of relevant thresholds include: for chronic sialorrhea — up to 1,500 Units per parotid gland, 250 Units per submandibular gland, and 3,500 Units per treatment session; for cervical dystonia — initial up to 5,000 Units per treatment session and subsequent/12-week maximum up to 10,000 Units per 12 weeks. Claims above these per-gland, per-session, or per-12-week maximums (e.g., >3,500 Units/session for sialorrhea or >10,000 Units/12 weeks for CD) are outside policy limits and may be denied.

Background

Indication summary: RimabotulinumtoxinB (Myobloc) is a neuromuscular blocking agent indicated for adults with cervical dystonia to reduce abnormal head position and neck pain, and for adults with chronic sialorrhea. The policy explicitly aligns coverage to FDA-approved indications.

Prescriber specialties: For cervical dystonia the agent must be prescribed by or in consultation with a neurologist, orthopedist, or physiatrist; for chronic sialorrhea prescriptions must be by or in consultation with a neurologist or physiatrist.

Step therapy: For cervical dystonia, failure of Botox and Dysport is required unless contraindicated or clinically significant adverse effects exist; for chronic sialorrhea, failure of at least one anticholinergic and failure of Xeomin are required unless contraindicated. Note: Illinois HIM requests bypass these step therapy requirements as of 01/01/2026 per IL HB 5395.

Dosing limits and intervals: Cervical dystonia initial dose is up to 5,000 Units per treatment session with subsequent doses up to 10,000 Units per 12 weeks. For chronic sialorrhea limits are up to 1,500 Units per parotid gland, 250 Units per submandibular gland, and 3,500 Units per treatment session. Botulinum toxin therapy (any product) must not have been administered within the prior 12 weeks before treatment.

Treatment plan and authorization: Prior authorization requires submission of a treatment plan detailing the number of Units per indication and treatment session and supporting clinical documentation. Product-specific considerations include contraindications (e.g., hypersensitivity, infection at injection site) and boxed warning for distant spread of toxin effect; potency units are not interchangeable with other botulinum toxin products. Coding: primary HCPCS code is J0587 (rimabotulinumtoxinB, 100 units).

Revision History

06.27.25policy_updateLatest

Added step therapy bypass for Illinois HIM per IL HB 5395; effective date recorded 06.27.25 and applies to Illinois HIM requests as of 01/01/2026 (material).

02.01.22annual_review

Revised Commercial approval duration to '6 months or to member's renewal date, whichever is longer' for injectables (non-material).

03.04.21annual_review

Operational wording change: treatment plan requirement wording changed to detail number of Units per indication and treatment session (non-material).

02.21.23annual_review

Therapeutic preference update in Appendix B: for cervical dystonia replaced Xeomin redirection with Botox to co-prefer with Dysport (non-material).

OpenPayer

Clinical Policy: RimabotulinumtoxinB (Myobloc)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Diagnoses / Indications Not Authorized

Applicable Codes

Provider Actions

Clinical Evidence

Background

Revision History