Neighborhood Health Plan RI Myobloc Coverage

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Universal criteria: Patient is at least 18 years of age; no hypersensitivity to any botulinum toxin product; no active infection at the proposed injection site; patient evaluated for disorders that may contribute to respiratory or swallowing difficulty; not on concurrent treatment with another botulinum toxin product.

Cervical Dystonia: History of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders AND sustained head tilt OR abnormal posturing with limited neck range of motion.

Chronic Sialorrhea: History of troublesome sialorrhea for at least 3 months.

Chronic Migraine Prophylaxis: Utilizing prophylactic intervention modalities AND ≥15 headache days per month for ≥3 months AND at least five migraine attacks with migraine features AND on at least 8 days/month for ≥3 months headaches with migraine characteristics OR suspected migraines relieved by a triptan/ergot AND failure of an 8‑week trial of two oral preventive medications.

See migraine-prophylactic medication classes for examples.

Severe Primary Axillary Hyperhidrosis: Failed ≥1 month trial of a topical agent (e.g., aluminum chloride, glycopyrronium) AND either medical complications/significant functional impairment OR significant burden to activities of daily living/work/social functioning.

Continuation Therapy / Renewal

Renewal criteria

Renewal: Patient continues to meet universal and indication-specific criteria; absence of unacceptable toxicity (e.g., signs of toxin spread such as generalized weakness, dysphagia, breathing difficulties, or serious hypersensitivity); and evidence of disease response (e.g., improvement in pain and head positioning for cervical dystonia).

Documentation of ongoing benefit required for prior authorization renewal.

Renewal/Continuation Criteria

Renewal covered when ALL of the following are met

Universal renewal requirements: Patient continues to meet universal and indication-specific criteria as identified in the initial approval section; absence of unacceptable toxicity from the drug; and disease response as defined per indication.

See indication-specific nodes for response measures.

Cervical Dystonia response: Improvement in the severity and frequency of pain AND improvement of abnormal head positioning.

Upper Limb Spasticity response: Decrease in tone and/or resistance of affected areas based on a validated measuring tool (e.g., Ashworth Scale, Physician Global Assessment, Clinical Global Impression).

Chronic Migraine prophylaxis response: Significant decrease in number, frequency, and/or intensity of headaches AND improvement in function AND continued use of prophylactic intervention modalities (pharmacotherapy, behavioral therapy, physical therapy, etc.).

Concurrent administration of rimabotulinumtoxinB with any other botulinum toxin product is not permitted. Members receiving treatment with another botulinum neurotoxin (for example, abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, daxibotulinumtoxinA, etc.) are excluded from coverage under this policy while on concurrent therapy.

Renewal of therapy is excluded if the member has experienced unacceptable toxicity from rimabotulinumtoxinB. Examples include symptoms consistent with systemic toxin spread (e.g., asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties) or serious hypersensitivity reactions; presence of these findings prevents authorization renewal.

Coding & Billing

Product vial and HCPCS unit limitsmixed

Myobloc 2,500 unit/0.5 mL	1 vial per 84 days
Myobloc 5,000 unit/mL	1 vial per 84 days
Myobloc 10,000 unit/2 mL	1 vial per 84 days
Cervical Dystonia HCPCS units	100 billable units per 12 weeks (84 days)
Upper Limb Spasticity HCPCS units	150 billable units per 12 weeks (84 days)
Chronic Migraine Prophylaxis HCPCS units	100 billable units per 12 weeks (84 days)
Chronic Sialorrhea HCPCS units	50 billable units per 12 weeks (84 days)
Severe Primary Axillary Hyperhidrosis HCPCS units	100 billable units per 12 weeks (84 days)

Covered HCPCS CodesHCPCSCovered

J0587

Injection, rimabotulinumtoxinB, 100 units; 1 billable unit = 100 units

NDCsNDC

10454-0710-xx	Myobloc 2,500 unit/0.5 mL Solution for Injection
10454-0711-xx	Myobloc 5,000 unit/mL Solution for Injection
10454-0712-xx	Myobloc 10,000 unit/ 2mL Solution for Injection

Covered Diagnosis Codes (partial list shown)ICD-10Covered

G24.3	Spasmodic torticollis
G25.89	Other specified extrapyramidal and movement disorders
G35	Multiple sclerosis
G43.709	Chronic migraine without aura, not intractable, without status migrainosus

Covered Diagnosis Codes (Appendix 1)ICD-10Covered

I69.039	Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting unspecified side.
I69.051	Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant side.
I69.052	Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left dominant side.
I69.053	Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right non-dominant side.
I69.054	Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non-dominant side.
I69.059	Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting unspecified side.
I69.131	Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right dominant side.
I69.132	Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left dominant side.
I69.133	Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right non-dominant side.
I69.134	Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side.

1–10 of 59

1/6

HCPCS unit limits per 12 weeks

Cervical dystonia100 billable units per 12 weeks (84 days)

Upper limb spasticity150 billable units per 12 weeks (84 days)

Chronic migraine prophylaxis100 billable units per 12 weeks (84 days)

Chronic sialorrhea50 billable units per 12 weeks (84 days)

Severe primary axillary hyperhidrosis100 billable units per 12 weeks (84 days)

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial use. Patient must be ≥ 18 years and meet universal and indication-specific criteria. Universal criteria include no hypersensitivity to any botulinum toxin product, no active infection at the proposed injection site, evaluation for disorders contributing to respiratory or swallowing difficulty, and not receiving concurrent treatment with another botulinum toxin product.

Patient age ≥ 18 years
No hypersensitivity to botulinum toxin products
No active infection at proposed injection site
Evaluated for disorders affecting respiration/swallowing
Not on concurrent botulinum toxin therapy

Prior Authorization

Authorization Renewal Requirements

Renewal requires documentation that the patient continues to meet the universal and indication-specific criteria and that there is absence of unacceptable toxicity (e.g., signs of systemic toxin spread such as generalized muscle weakness, dysphagia, respiratory difficulties, serious hypersensitivity reactions). Renewal must also include documentation of disease response (e.g., improvement in severity/frequency of symptoms, functional benefit) as applicable to the indication.

Background

RimabotulinumtoxinB (brand name Myobloc) is a botulinum neurotoxin type B formulation administered by intramuscular or intradermal injection for several movement and secretory disorders. The product is used for indications addressed in this policy, including cervical dystonia, upper limb spasticity, chronic migraine prophylaxis, chronic sialorrhea, and severe primary axillary hyperhidrosis; dosing and re-treatment intervals are defined in the Dosage/Administration section.

Definitions

Chronic migraine definition

Headache frequency15 or more headache days per month for at least 3 months

Migraine attacksAt least five attacks with features consistent with migraine

Migraine features thresholdMigraine characteristics present on at least 8 days per month for at least 3 months or responsiveness to triptan/ergot

Unacceptable toxicity examples

Toxin spread symptomsAsthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties

Serious hypersensitivityAnaphylaxis or other serious allergic reactions to the drug

Initial Therapy Criteria

Initial Therapy

Initial coverage requires meeting universal criteria plus indication-specific criteria and prior therapy trials where specified.

Initial therapy nodes: Patient ≥18 years AND meets universal safety criteria AND meets the specific diagnostic and failed-therapy requirements for the intended indication (see respective indication nodes: cervical dystonia, upper limb spasticity, chronic migraine prophylaxis, chronic sialorrhea, severe primary axillary hyperhidrosis).

Prior trials: ≥1 month topical agent failure for axillary hyperhidrosis; two 8‑week oral preventive medication failures for chronic migraine prophylaxis.

Continuation / Renewal Criteria

Renewal

Renewal is allowed when benefit and safety are demonstrated

Renewal nodes: Continuation requires continued meeting of universal and indication-specific criteria, absence of unacceptable toxicity (including systemic toxin spread or serious hypersensitivity), and documented clinical improvement per indication.

Documentation should reference the indication-specific response measures listed in the policy.

Continuation Therapy

Continuation/renewal dosing and safety

Continuation conditions: Patient continues to meet criteria and shows clinical response without unacceptable toxicity; re-treatment intervals and per‑indication maximum doses must be observed.

See dosing: Cervical dystonia re‑treatment 2,500–10,000 units every 12–16 weeks; Upper limb spasticity up to 15,000 units every 12 weeks; Chronic migraine up to 8,250 units every 12 weeks; Chronic sialorrhea recommended 1,500–3,500 units every 12 weeks; Severe primary axillary hyperhidrosis maximum 3,500 (up to 4,000 per axilla noted) every 12 weeks.

Step Therapy Requirements

Step	Requirement	Details
1	Documented trial and failure required prior to Myobloc	Severe primary axillary hyperhidrosis: failed ≥1 month trial of a topical agent (e.g., aluminum chloride, glycopyrronium). Chronic migraine prophylaxis: failed an 8‑week trial of any two oral preventive medications (examples include antidepressants, beta blockers, ACEi/ARBs, anti‑epileptics, calcium channel blockers).

Quantity Limits & Supply

Myobloc (rimabotulinumtoxinB) vials

Vial quantity1 vial per prescription fill

PresentationsMyobloc 2,500 unit/0.5 mL; 5,000 unit/mL; 10,000 unit/2 mL

Medicaid pharmacy limit1 fill per 84 days

Myobloc (HCPCS units)

Per‑indication billable units range50–150 billable units per 12 weeks depending on indication (see specific limits)

Typical lower limit50 billable units per 12 weeks (chronic sialorrhea)

Typical upper limit

Site of Care / Benefit Scope

Note

Pharmacy coverage limited to Medicaid; medical scope for Commercial/MMP

Medication will only be covered on the Pharmacy Benefit for Medicaid members; for Commercial and MMP plans the medical benefit scope applies as specified.

Medicaid: Pharmacy Benefit ONLY coverage for Myobloc.
Commercial and Medicare‑Medicaid Plan (MMP): medical benefit scope.

OpenPayer

Myobloc (rimabotulinumtoxinB) coverage