mhn baclofen coverage & PA update

Coverage Criteria

Initial Approval — Gablofen or Lioresal (intrathecal)

Covered when ALL of the following are met:

Intrathecal initial criteria: 1. Diagnosis of severe spasticity of cerebral or spinal cord origin (e.g., spinal cord injury, multiple sclerosis, hypoxic-ischemic encephalopathy, cerebral palsy, TBI); 2. Prescribed by or in consultation with a neurologist, orthopedist, physiatrist, or physical medicine and rehabilitation specialist; 3. Age ≥ 4 years; 4. If spasticity is due to traumatic brain injury, > 1 year has passed since the injury; 5. Documentation supports inability to use oral baclofen therapy; 6. For Gablofen vial or Lioresal requests, member must use generic baclofen vial or ampule unless contraindicated or clinically significant adverse effects are experienced; 7. Failure of one conventional therapy (a benzodiazepine OR dantrolene OR tizanidine) unless contraindicated or clinically adverse effects are experienced (Illinois HIM requests: step therapy does not apply per IL HB 5395); 8. Baclofen will be used as either a screening trial OR for maintenance: - Screening trial (both i and ii): (i) Prescribed formulation is Gablofen 50 mcg/mL (1 mL syringe) OR Lioresal Intrathecal 50 mcg/mL (1 mL ampule); (ii) Screening bolus dose does not exceed 100 mcg and member responded positively to the screening dose as evidenced by decreased muscle tone/frequency or spasm severity; - Maintenance therapy (both i and ii): (i) Prescribed formulation is any Gablofen vial/syringe except the 1 mL syringe OR any Lioresal Intrathecal ampule except the 1 mL ampule; (ii) follow maintenance dosing and pump administration guidance.intrathecal screening ≤100 mcg

Screening approval duration: 14 days (up to 3 screening trials); Maintenance approval duration: 12 months.

Initial Approval — Fleqsuvy, Lyvispah, Ozobax/Ozobax DS (oral)

Covered when ALL of the following are met:

Oral branded initial criteria: 1. Diagnosis of severe spasticity due to multiple sclerosis or spinal cord injury/spinal cord diseases; 2. Prescribed by or in consultation with a neurologist, orthopedist, physiatrist, or physical medicine and rehabilitation specialist; 3. Age ≥ 12 years; 4. Member must use generic baclofen oral solution unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of one conventional therapy (a benzodiazepine OR dantrolene OR tizanidine) unless contraindicated or clinically adverse effects are experienced (Illinois HIM requests: step therapy does not apply per IL HB 5395); 6. Dose does not exceed 80 mg per day.max 80 mg/day

Approval duration: 12 months.

Continuation Therapy

Covered when ALL of the following are met:

Continued therapy general: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies; 2. Member is responding positively to therapy; 3. For Fleqsuvy, Lyvispah or Ozobax/Ozobax DS, member must use generic baclofen oral solution unless contraindicated or clinically significant adverse effects are experienced; 4. For Gablofen vial or Lioresal, member must use generic baclofen vial or ampule unless contraindicated or clinically adverse effects are experienced; 5. Gablofen/Lioresal-specific requirements: documented adherence with scheduled refill visits; baclofen is requested for continuance of maintenance therapy; prescribed formulation excludes the 1 mL screening syringe/ampule; 6. For Fleqsuvy/Lyvispah/Ozobax dose increases, the new dose must not exceed 80 mg per day.

Approval duration for continuation: 12 months for maintenance therapy; Gablofen/Lioresal maintenance formulations must be pump-appropriate.

Not Authorized / Off-Label

Non-FDA indications: Non–FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided in accordance with the applicable off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Refer to the specified off-label use policies for required documentation.

Fleqsuvy, Lyvispah, and Ozobax/Ozobax DS are indicated for treatment of spasticity resulting from multiple sclerosis and may also be useful for spasticity due to spinal cord injury or other spinal cord diseases. These products are not indicated for skeletal muscle spasm resulting from rheumatic disorders. (Refer to product labeling for pediatric age limits; safety and effectiveness of these branded oral formulations have not been established in patients < 12 years.)

Policy change: the prior requirement that requests for Fleqsuvy, Lyvispah, or Ozobax/Ozobax DS include use of a compounded baclofen oral solution or baclofen crushed/split tablets has been removed. The revision (effective 07.15.24; P&T approval noted) also added the Ozobax DS formulation to the policy.

Uses that are non–FDA approved and not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety per the referenced off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Initial Therapy Criteria

Initial therapy rules — criteria differ for intrathecal versus oral branded products

Initial therapy coverage criteria differ depending on intrathecal versus oral branded product selection:

Intrathecal vs Oral differentiation: Intrathecal (Gablofen/Lioresal): criteria include diagnosis of severe spasticity of cerebral or spinal cord origin, specialist prescriber/consult, minimum age ≥4 years, TBI >1 year since injury, inability to use oral baclofen, use of generic baclofen vial/ampule where specified, failure of one conventional therapy, and required screening trial ≤100 mcg with documented positive response or maintenance formulation appropriate for pump administration. Oral branded (Fleqsuvy/Lyvispah/Ozobax/Ozobax DS): criteria include diagnosis limited to MS or spinal cord origin, specialist prescriber/consult, minimum age ≥12 years, use generic oral solution where possible, failure of one conventional therapy, and dose limit of 80 mg/day.

Illinois HIM exceptions to step therapy per IL HB 5395; PA and documentation requirements apply to both pathways.

Initial oral baclofen dosing (Fleqsuvy) — dosing guidance and titration for initiation

Oral baclofen (Fleqsuvy) dosing guidance and titration for initiation:

Oral initiation dosing:

Continuation Therapy Criteria

Continuation therapy rules — continuation approval requires meeting all continuation criteria

Continuation approval requires meeting ALL of the following continuation criteria:

Continuation nodes: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies; 2. Member is responding positively to therapy; 3. For oral branded products, member must use generic baclofen oral solution unless contraindicated or clinically significant adverse effects are experienced; 4. For Gablofen/Lioresal, member must use generic baclofen vial or ampule unless contraindicated or clinically adverse effects are experienced; 5. Gablofen/Lioresal-specific continuation requirements: adherence to scheduled refill visits; baclofen requested for continuance of maintenance therapy; prescribed formulation excludes the 1 mL screening syringe/ampule; 6. For Fleqsuvy/Lyvispah/Ozobax dose increases, new dose must not exceed 80 mg/day.

Continuation therapy for intrathecal baclofen — updated durations and requirements

Updated intrathecal continuation criteria and durations:

Gablofen/Lioresal continuation: Approval duration for continued Gablofen and Lioresal maintenance therapy is 12 months; member must use generic baclofen vial or ampule where specified; intrathecal maintenance formulations must be appropriate for chronic pump administration (prescribed formulation excludes the 1 mL screening syringe/ampule).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Requests for Fleqsuvy, Gablofen, Lioresal, Lyvispah, and Ozobax/Ozobax DS require prior authorization. The provider must document that all initial or continuation criteria are met, including diagnosis, prescriber specialty or consultation, member age, prior therapy failures or contraindications, and any product-specific requirements.

PA applies to all listed baclofen products in this policy
Provider must demonstrate criteria for initial or continued therapy are satisfied

Prior Authorization

PA Requirements for Intrathecal Baclofen

Intrathecal Baclofen (Gablofen, Lioresal) PA Requirements: For Gablofen or Lioresal requests, documentation must show severe spasticity of cerebral or spinal cord origin, prescriber is a neurologist/orthopedist/physiatrist/PM&R or consult documented, age ≥4 years, TBI-related spasticity >1 year post-injury, and inability to use oral baclofen therapy. For screening trials, prescribed formulation and dose limits apply; for maintenance therapy, specified vial/ampule restrictions apply. Approval duration for initial and continued intrathecal therapy is 12 months.

Coding and Billing

HCPCS CodesHCPCS

J0475	Injection, baclofen, 10 mg
J0476	Injection, baclofen, 50 mcg for intrathecal trial

Intrathecal screening dose maximum — ≤ 100 mcg

Intrathecal screening trial doseScreening bolus ≤ 100 mcg (positive response required prior to consideration for long‑term intrathecal therapy)

Screening observationScreening bolus is observed for 4–8 hours after administration

Screening regimenInitial 50 mcg (or 25 mcg for very small patients) with optional subsequent 75 mcg and final 100 mcg doses 24 hours apart if needed

Oral maximum daily dose — 80 mg/day

Oral maximum daily doseMaximum recommended oral baclofen dose = 80 mg/day

Titration example (Fleqsuvy)Suggested titration up to 4 mL (20 mg) TID then adjust to clinical response; total daily dose may increase to 80 mg/day

Step Therapy

Step	Requirement	Applies to	Illinois HIM Exception
1	Failure of one conventional therapy (benzodiazepine OR dantrolene OR tizanidine) unless clinically significant adverse effects or contraindications	Initial requests for intrathecal baclofen (Gablofen, Lioresal) and oral branded baclofen (Fleqsuvy, Lyvispah, Ozobax/Ozobax DS)	Step therapy requirements do not apply for Illinois Health Insurance Marketplace (HIM) requests effective 1/1/2026 per IL HB 5395

Historical requirement	Current status	Affected products	Notes / effective change
Prior requirement that requests for some branded oral baclofen formulations use compounded baclofen oral solution or crushed/split tablets	Removed	Fleqsuvy, Lyvispah, Ozobax, Ozobax DS	Requirement removed as of 4Q2024; operational effect: prior requirement no longer enforced for these branded formulations

Quantity Limits

Intrathecal baclofen (screening) — Dose ≤100 mcg per screening trial

Screening trial limitIntrathecal screening trial dose limit = ≤ 100 mcg per screening trial

Screening approval durationScreening approval duration = 14 days (up to 3 screening trials)

Screening administration routeScreening bolus administered via spinal catheter or lumbar puncture

Oral branded baclofen (Fleqsuvy, Lyvispah, Ozobax/Ozobax DS) — 80 mg maximum

Maximum daily dose for branded oral baclofenMaximum allowed = 80 mg/day for Fleqsuvy, Lyvispah, Ozobax/Ozobax DS

Approval durationApproval duration for oral branded products = 12 months (continuation criteria apply)

Site of Care

Note

Site-of-care — intrathecal screening and chronic pump requirements

Intrathecal screening trials may be administered via spinal catheter or lumbar puncture in a hospital outpatient or specialized procedural setting; chronic intrathecal administration must be delivered using an FDA‑approved implantable pump.

Screening: single bolus test doses via spinal catheter or lumbar puncture
Chronic administration: use FDA‑approved implantable pumps (e.g., Medtronic SynchroMed II)

Note

Infusion/administration site considerations and formulation selection

Intrathecal baclofen is available in injection concentrations intended for pump administration or intrathecal trial dosing; providers should select formulations and concentrations consistent with screening (e.g., 50 mcg/mL 1 mL syringe/ampule for trial) versus maintenance use.

Screening formulation examples: Gablofen 50 mcg/mL (1 mL syringe) or Lioresal 50 mcg/mL (1 mL ampule) with dose ≤100 mcg
Maintenance formulations: any Gablofen vial/syringe or Lioresal ampule except the 1 mL screening form

Background

Baclofen is a GABA‑ergic agonist used as a muscle relaxant and antispastic agent. Intrathecal formulations (Gablofen and Lioresal Intrathecal) are intended for management of severe spasticity of cerebral or spinal cord origin and require a successful screening bolus prior to consideration of long‑term infusion via an implanted pump. Intrathecal injection presentations are available in multiple concentrations (for example, 50 mcg/1 mL and higher‑concentration ampules/syringes) and screening doses should not exceed ≤ 100 mcg for trialing. Oral branded baclofen products (Fleqsuvy, Lyvispah, Ozobax/Ozobax DS) are available in suspension or packet formulations and are dosed and titrated per labeling up to a maximum of 80 mg/day based on clinical response and tolerability.

Definitions

gamma-aminobutyric acid (GABA) definition

DefinitionGamma‑aminobutyric acid (GABA) — baclofen is a GABA‑ergic agonist

Pharmacologic classGABA‑ergic agonist; muscle relaxant and antispastic agent

Clinical roleUsed to reduce spasticity and muscle spasms in conditions such as multiple sclerosis, spinal cord injury, cerebral palsy, and TBI

traumatic brain injury (TBI) definition

DefinitionTraumatic brain injury (TBI) — policy notes that patients with TBI should wait at least one year after injury before considering long‑term intrathecal baclofen therapy

Implication for intrathecal therapyTBI‑related spasticity requires >1 year since injury prior to consideration of chronic intrathecal baclofen

OpenPayer

Baclofen (Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax/Ozobax DS) coverage

Coverage Criteria

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions and Requirements

Coding and Billing

Step Therapy

Quantity Limits

Site of Care

Background

Definitions