Clinical Policy: RimabotulinumtoxinB (Myobloc) Form

# Clinical Policy: RimabotulinumtoxinB (Myobloc)
Reference Number: CP.PHAR.233  
Effective Date: 07.01.16  
Last Review Date: 05.26  
Line of Business: Commercial, HIM/ICHRA, Medicaid  

[Coding Implications](Coding Implications)  
[Revision Log](Revision Log)  

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.  

## Description  
RimabotulinumtoxinB (Myobloc®) is an acetylcholine release inhibitor and a neuromuscular blocking agent.  

## FDA Approved Indication(s)  
Myobloc is indicated for the treatment of:  
- Adults with cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD  
- Adults with chronic sialorrhea  

## Policy/Criteria  
  

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# CLINICAL POLICY  
RimabotulinumtoxinB  

## Approval duration:  
Medicaid/HIM/ICHRA – 12 months  
Commercial – 6 months or to the member’s renewal date, whichever is longer  

#### B. Chronic Sialorrhea (must meet all):  
  

## Approval duration:  
Medicaid/HIM/ICHRA – 12 months  
Commercial – 6 months or to the member’s renewal date, whichever is longer  

#### C. Other diagnoses/indications (must meet 1 or 2):  
1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):  
   a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or  
   b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or  
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line  

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# CLINICAL POLICY  
RimabotulinumtoxinB  

of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.  

### II. Continued Approval  
#### A. Cervical Dystonia (must meet all):  
  

## Approval duration:  
Medicaid/HIM/ICHRA – 12 months  
Commercial – 6 months or to the member’s renewal date, whichever is longer  

#### B. Chronic Sialorrhea (must meet all):  
1. Member meets one of the following (a or b):  
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;  
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);  
2. Member is responding positively to therapy;  
3. Myobloc is not prescribed concurrently with other botulinum toxin products;  
4. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;  
5. Treatment plan provided detailing number of Units per indication and treatment session;  
6. If request is for a dose increase, dose does not exceed 1,500 Units per parotid gland, 250 Units per submandibular gland, 3,500 Units per treatment session.  

## Approval duration:  
Medicaid/HIM/ICHRA – 12 months  
Commercial – 6 months or to the member’s renewal date, whichever is longer  

#### C. Other diagnoses/indications (1 or 2):  
1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):  

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# CLINICAL POLICY  
RimabotulinumtoxinB  

a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or  
b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or  
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.  

### III. Diagnoses/Indications for which coverage is NOT authorized:  
#### A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid;  
#### B. Cosmetic treatment of hyperfunctional wrinkles of the upper face including glabellar frown lines, deep forehead wrinkles, and periorbital wrinkles (crow’s feet);  
#### C. Same-visit treatment of multiple indications.  

### IV. Appendices/General Information  
#### Appendix A: Abbreviation/Acronym Key  
CD: cervical dystonia  
FDA: Food and Drug Administration  

#### Appendix B: Therapeutic Alternatives  
This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.  

| Drug Name | Dosing Regimen | Dose Limit/ Maximum Dose |  
|-----------|---------------|-------------------------|  
| glycopyrrolate (Glycate®) | Chronic Sialorrhea: <br>1 mg PO TID | 6 mg/day |  
| benztropine (Cogentin®) | Chronic Sialorrhea: <br>1 mg PO QD-BID | 3.8 mg/day |  
| Xeomin® <br>(incobotulinumtoxinA) | Chronic Sialorrhea: <br>Up to 30 Units IM per parotid gland, 20 Units IM per submandibular gland, and 100 Units IM per treatment session every 16 weeks. | 100 Units/16 weeks |  

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# CLINICAL POLICY  
RimabotulinumtoxinB  

| Drug Name | Dosing Regimen | Dose Limit/ Maximum Dose |  
|-----------|---------------|-------------------------|  
| Dysport® <br>(abobotulinumtoxin A) | Cervical Dystonia: <br>Divided among affected muscles every 12 weeks: Up to 1,000 Units IM | See dosing regimen |  
| Botox® <br>(OnabotulinumtoxinA) | Cervical Dystonia: <br>Up to 50 Units IM per injection, 100 Units total in the sternocleidomastoid (SCM) muscle, and 300 Units per treatment session | See dosing regimens for maximum dose <br>Frequency: <br>One treatment session every 12 weeks |  

*Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic.*  

#### Appendix C: Contraindications and Boxed Warnings  
- Contraindication(s):  
  - Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation  
  - Infection at the proposed injection site  
- Boxed warning(s): distant spread of toxin effect  

#### Appendix D: Botulinum Toxin Product Interchangeability  
- Potency Units of Myobloc are not interchangeable with other botulinum toxin product preparations (e.g., Dysport®, Botox®, Xeomin®).  

### V. Dosage and Administration  

| Indication | Dosing Regimen | Maximum Dose |  
|------------|---------------|--------------|  
| CD | Divided among affected muscles every 12 weeks: <br>• Initial dose: Up to 5,000 Units IM <br>• Subsequent dose: Up to 10,000 Units IM | 10,000 Units/12 weeks |  
| Chronic sialorrhea | Up to 1,500 Units IM per parotid gland, 250 Units IM per submandibular gland, and 3,500 Units IM per treatment session every 12 weeks. | 3,500 Units/12 weeks |  

### VI. Product Availability  
Vials: 2,500 Units/0.5 mL, 5,000 Units/1 mL, 10,000 Units/2 mL  

  

## Coding Implications  
Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.  

| HCPCS Codes | Description |  
|-------------|-------------|  
| J0587 | Injection, rimabotulinumtoxinB, 100 units |  

| Reviews, Revisions, and Approvals | Date | P&T Approval Date |  
|----------------------------------|------|-------------------|  
| Ad Hoc update: max dose for Xeomin in Appendix B updated to 300 mg for CD per PI. | 07.26.21 |  |  
| 2Q 2022 annual review: no significant changes; revised Commercial approval duration from “6 months” (or whatever it is now) to the current standard for injectables of “6 months or to member’s renewal date, whichever is longer”; removed in Section III “Ambetter, hyperhidrosis is a benefit exclusion categorized as a cosmetic service”; references reviewed and updated. | 02.01.22 | 05.22 |  

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# CLINICAL POLICY  
RimabotulinumtoxinB  

| Reviews, Revisions, and Approvals | Date | P&T Approval Date |  
|----------------------------------|------|-------------------|  
| Template changes applied to other diagnoses/indications and continued therapy section. | 10.07.22 |  |  
| 2Q 2023 annual review: Per February SDC and prior clinical guidance, for cervical dystonia replaced Xeomin redirection with Botox to co-prefer Dysport, references reviewed and updated. | 02.21.23 | 05.23 |  
| 2Q 2024 annual review: no significant changes; in continued therapy revised Commercial approval duration from "12 months" to the current standard for injectables of "6 months or to member’s renewal date, whichever is longer"; references reviewed and updated. | 01.18.24 | 05.24 |  
| 2Q 2025 annual review: no significant changes; references reviewed and updated. | 01.16.25 | 05.25 |  
| Added step therapy bypass for IL HIM per IL HB 5395. | 06.27.25 |  |  
| 2Q 2026 annual review: extended Medicaid and HIM approval durations to 12 months; references reviewed and updated. Added ICHRA line of business. | 04.24.26 | 05.26 |  

## Important Reminder  
This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.  

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.  

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan  

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# CLINICAL POLICY  
RimabotulinumtoxinB  

retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.  

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions.  

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.  

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members, and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services.  

**Note:**  
**For Medicaid members,** when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.  

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