Health Net Myobloc Coverage & Prior Auth

Coverage and Medical Necessity Criteria

Initial Therapy — Cervical Dystonia

Covered when ALL of the following are met

Cervical Dystonia initial: 1. Diagnosis of cervical dystonia (CD); 2. Prescribed by or in consultation with a neurologist, orthopedist, or physiatrist; 3. Age ≥ 18 years; 4. Member is experiencing involuntary contractions of 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; 5. Contractions are causing pain and functional impairment; 6. Failure of Botox and Dysport unless clinically significant adverse effects are experienced or both are contraindicated; 7. 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; 9. Treatment plan provided detailing number of Units per indication and treatment session; 10. Dose does not exceed 5,000 Units per treatment session.see individual node text

Approval duration varies by line of business.

Initial Therapy — Chronic Sialorrhea

Covered when ALL of the following are met

Chronic Sialorrhea initial: 1. Diagnosis of chronic sialorrhea for at least the last three months due to an underlying neurologic disorder (e.g., Parkinson disease, atypical parkinsonism, stroke, traumatic brain injury, cerebral palsy, amyotrophic lateral sclerosis) or a craniofacial abnormality (e.g., Goldenhar syndrome); 2. Prescribed by or in consultation with a neurologist or physiatrist; 3. Age ≥ 18 years; 4. Failure of at least one anticholinergic drug unless clinically significant adverse effects are experienced or all are contraindicated; 5. Failure of Xeomin unless contraindicated or clinically significant adverse effects are experienced; 6. 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; 8. Treatment plan provided detailing number of Units per indication and treatment session; 9. Dose does not exceed 1,500 Units per parotid gland, 250 Units per submandibular gland, and 3,500 Units per treatment session.see individual node text

Approval duration varies by line of business.

Continuation Therapy — Cervical Dystonia

Covered when ALL of the following are met

Cervical Dystonia continuation: 1. Member currently receiving medication via Centene benefit or member has previously met initial approval criteria, or is enrolled under applicable continuity of care provisions; 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, new dose does not exceed 10,000 Units per treatment session.see individual node text

Approval duration varies by line of business.

Continuation Therapy — Chronic Sialorrhea

Covered when ALL of the following are met

Chronic Sialorrhea continuation: 1. Member currently receiving medication via Centene benefit or member has previously met initial approval criteria, or is enrolled under applicable continuity of care provisions; 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, and 3,500 Units per treatment session.see individual node text

Approval duration varies by line of business.

Other/Off-label indications

If requested use is not listed

Other uses: 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 the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see policy references); 2. If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

See referenced policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53.

Dosing and product interchangeability

Dosing limits and product interchangeability statements (used to determine appropriate dosing and billing):

Cervical dystonia dosing: Initial dose: Up to 5,000 Units IM divided among affected muscles every 12 weeks; Subsequent dose: Up to 10,000 Units IM; Maximum Dose = 10,000 Units per 12 weeks.see text

From dosing regimen and maximum dose for CD.

Chronic sialorrhea dosing: 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 = 3,500 Units per 12 weeks.see text

From dosing regimen and maximum dose for chronic sialorrhea.

Product interchangeability: Potency Units of Myobloc are not interchangeable with other botulinum toxin product preparations (e.g., Dysport, Botox, Xeomin).

Non-FDA approved uses that are not specifically addressed in this policy are excluded from coverage unless there is adequate documentation of efficacy and safety consistent with the applicable off‑label use policy. Refer to policy CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid when submitting requests for off‑label indications.

Coding listed in this policy is provided for informational purposes only and does not by itself determine coverage. Inclusion or exclusion of procedure or billing codes in this document does not guarantee payment; providers must consult current professional coding guidance and applicable plan documents prior to claim submission.

Requests for botulinum toxin for purely cosmetic upper‑face indications (for example, glabellar frown lines, deep forehead wrinkles, and periorbital "crow's feet") are not authorized. Additionally, the policy does not permit treating multiple different indications during the same visit; each same‑visit multi‑indication treatment is excluded.

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (office chart notes, lab results, consults, treatment plan, and any other clinical information) to demonstrate that the member meets all applicable approval criteria before Myobloc (rimabotulinumtoxinB) will be authorized.

Prior authorization required for initial and continued therapy requests
Prescriptions must be by or in consultation with required specialist(s) per indication (see criteria)

Note

Prior Authorization and Administrative Notes

Administrative notes: approval durations and program-level changes may vary by line of business. Check member’s plan-specific criteria, continuity of care addenda, and state-specific requirements. For Illinois HIM (Health Insurance Marketplace) requests, step therapy requirements for certain indications do not apply per IL HB 5395. Coding references in this policy are informational only; inclusion or exclusion of codes does not guarantee coverage — confirm current coding guidance prior to claim submission.

State/plan-specific differences may affect step therapy, approval duration, and continuity of care (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)

Dosing Limits, Units, and Codes

Policy identifiermixed

CP.PHAR.233

Policy reference number (document identifier)

HCPCS Codes referencedHCPCS

J0587

Injection, rimabotulinumtoxinB, 100 units

Maximum dose per 12 weeks (Cervical Dystonia)

Maximum dose per 12 weeks (Cervical Dystonia)10,000 Units per 12 weeks

Source dosing contextMaximum Dose = 10,000 Units/12 weeks (subsequent dose up to 10,000 Units IM)

Relevant regimenDivided among affected muscles every 12 weeks

Initial dose per session (Cervical Dystonia)

Initial dose per session (Cervical Dystonia)Up to 5,000 Units IM divided among affected muscles every 12 weeks

Session limitDose does not exceed 5,000 Units per treatment session (initial criteria)

Clinical Background and Definitions

RimabotulinumtoxinB (Myobloc) is a neuromuscular blocking agent that acts by inhibiting the release of acetylcholine at the neuromuscular junction. The product is FDA‑approved for adults with cervical dystonia to reduce severity of abnormal head position and neck pain, and for adults with chronic sialorrhea. Clinical references including the Myobloc Prescribing Information and peer‑reviewed studies are cited in the policy to support safety and efficacy statements.

Cervical dystonia (CD) — definition and clinical features

DefinitionCervical dystonia (CD): involuntary contractions of neck/shoulder muscles resulting in abnormal postures or movements and associated pain/functional impairment

Typical affected musclesExamples include splenius capitis, sternocleidomastoid, levator scapulae, scalene, trapezius, semispinalis capitis

Eligibility contextDiagnosis of CD is required for coverage; prescriber must be neurologist, orthopedist, or physiatrist

Product unit interchangeability

OpenPayer

RimabotulinumtoxinB (Myobloc) coverage

Coverage and Medical Necessity Criteria

Prior Authorization, Documentation, and Provider Responsibilities

Dosing Limits, Units, and Codes

Clinical Background and Definitions