MYOBLOC, RimabotulinumtoxinB Form

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 Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Myobloc is medically necessary when one of the following criteria are met:
I. Initial Approval Criteria
A. Cervical Dystonia (focal dystonia) (must meet all):

1. Diagnosis of CD;
   2. Prescribed by or in consultation with a neurologist, orthopedist, or physiatrist;
   3. Age ≥ 18 years;
   4. 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;
2. Contractions are causing pain and functional impairment;
   
   6. Failure of Botox® and Dysport®, unless clinically significant adverse effects are experienced or both are contraindicated;
3. Myobloc is not prescribed concurrently with other botulinum toxin products;
   
   8. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
4. Treatment plan provided detailing number of Units per indication and treatment session;

5. Dose does not exceed 5,000 Units per treatment session. Approval duration:
   Medicaid/HIM – 12 weeks (single treatment session) Page 1 of 8

   CLINICAL POLICY
   RimabotulinumtoxinB Commercial – 6 months or to the member’s renewal date, whichever is longer B. Chronic Sialorrhea (must meet all):

6. Diagnosis of chronic sialorrhea for at least the last three months due to one of the following (a or b): a. Underlying neurologic disorder (e.g., Parkinson disease, atypical parkinsonism, stroke, traumatic brain injury, cerebral palsy, amyotrophic lateral sclerosis); b. Craniofacial abnormality (e.g., Goldenhar syndrome);
7. Prescribed by or in consultation with a neurologist or physiatrist;
   3. Age ≥ 18 years;
   4. Failure of at least one anticholinergic drug (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated;
8. Failure of Xeomin, unless contraindicated or clinically significant adverse effects are experienced;
9. Myobloc is not prescribed concurrently with other botulinum toxin products;
   7. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
10. Treatment plan provided detailing number of Units per indication and treatment session;
11. 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 – 12 weeks (single treatment session) Commercial – 6 months or to the member’s renewal date, whichever is longer C. Other diagnoses/indications (must meet 1 or 2):
12. 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) 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, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) 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, and CP.PMN.16 for Medicaid; or
13. 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, and CP.PMN.53 for Medicaid.
    II. Continued Approval
    A. Cervical Dystonia (must meet all):

14. Member meets one of the following (a or b): Page 2 of 8

    CLINICAL POLICY
    RimabotulinumtoxinB 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;
15. Treatment plan provided detailing number of Units per indication and treatment session;
16. If request is for a dose increase, new dose does not exceed 10,000 Units per treatment session. Approval duration:
    Medicaid/HIM – 12 weeks (single treatment session) Commercial – 12 months B. Chronic Sialorrhea (must meet all):
17. 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;
18. Treatment plan provided detailing number of Units per indication and treatment session;
19. 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 – 12 weeks (single treatment session) Commercial – 12 months C. Other diagnoses/indications (1 or 2):

20. 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) 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, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 3 of 8

    CLINICAL POLICY
    RimabotulinumtoxinB CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

21. 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, 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, 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 glycopyrrolate (Glycate®) benztropine (Cogentin®) Xeomin® (incobotulinumtoxinA) Chronic Sialorrhea:
    1 mg PO TID
    Chronic Sialorrhea: 1 mg PO QD-BID Chronic Sialorrhea: Up to 30 Units IM per parotid gland, 20 Units IM per submandibular gland, and 100 Units IM per treatment session every 16 weeks. Dose Limit/ Maximum Dose 6 mg/day 3.8 mg/day 100 Units/16 weeks Dysport® (abobotulinumtoxin A) Botox® (OnabotulinumtoxinA) Cervical Dystonia: Divided among affected muscles every 12 weeks: Up to 1,000 Units IM Cervical Dystonia: Up to 50 Units IM per injection, 100 Units total in the sternocleidomastoid See dosing regimen See dosing regimens for maximum dose Page 4 of 8

    CLINICAL POLICY
    RimabotulinumtoxinB Drug Name Dosing Regimen (SCM) muscle, and 300 Units per treatment session Dose Limit/ Maximum Dose Frequency: 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): o Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation o 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 CD Divided among affected muscles every 12 weeks: • Initial dose: Up to 5,000 Units IM
    • Subsequent dose: Up to 10,000 Units IM 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. Maximum Dose 10,000 Units/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 VII.