CurrentCentenePolicy CP PHAR.149

Baclofen (Gablofen, Lioresal Intrathecal, Fleqsuvy, Lyvispah, Ozobax, Ozobax DS)

Clinical policy governing medical necessity criteria, initial and continued therapy requirements, dosing limits, contraindications, and product availability for intrathecal and oral baclofen formulations across Centene lines of business (Commercial, HIM, Medicaid). Includes coding implications and prior review history.

Policy Summary

PayerCentene

PolicyBaclofen (Gablofen, Lioresal Intrathecal, Fleqsuvy, Lyvispah, Ozobax, Ozobax DS)

Policy CodePolicy CP PHAR.149

Change TypeAdded formulations; revised oral solution requirement

Effective DateDec 1, 2015

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

Added Ozobax DS formulation to policy.

Removed requirement for compounded baclofen oral solution or baclofen crushed/split tablets and added requirement for generic baclofen oral solution.

Gablofen/Lioresal requirement for oral baclofen revised to 'Documentation supports inability to use' language.

Added newly FDA approved Lyvispah oral granules and Fleqsuvy oral suspension to policy.

Updated product availability, contraindications and boxed warnings per PI.

2Administration routes covered (intrathecal, oral)

80 mg/dayOral maximum dose

100 mcgIntrathecal screening upper bolus

Minimum age for oral formulations (Fleqsuvy/Lyvispah/Ozobax)

Coverage Summary

Policy scope: This clinical policy governs medical necessity criteria, initial and continued therapy requirements, dosing limits, contraindications, product availability, and coding implications for both intrathecal and oral baclofen formulations across Centene lines of business (Commercial, HIM, Medicaid). Coverage stance: covered_with_criteria. Routes and formulations covered include intrathecal products Gablofen and Lioresal Intrathecal (screening trials required prior to pump implantation and specified bolus escalation up to 100 mcg), and oral products including Fleqsuvy, Lyvispah, Ozobax, and Ozobax DS with an oral maximum dose threshold of 80 mg/day.

Quick facts — policy thresholds

Intrathecal screening bolus (policy-specified)Initial 50 mcg (25 mcg for very small patient); may escalate to 75 mcg then 100 mcg at 24-hour intervals; response required to 100 mcg maximum for candidate selection

Oral maximum daily doseDose does not exceed 80 mg per day for Fleqsuvy, Lyvispah, Ozobax/Ozobax DS

Minimum age for oral formulationsAge ≥ 12 years for Fleqsuvy, Lyvispah, Ozobax/Ozobax DS

Intrathecal screening upper bolus (stat)100 mcg — patients who do not respond to 100 mcg should not be considered candidates for implanted pump chronic infusion

Initial Approval Criteria — Intrathecal Baclofen (Gablofen, Lioresal Intrathecal)

Initial Approval Criteria - Intrathecal Baclofen (Gablofen, Lioresal Intrathecal)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of severe spasticity of cerebral or spinal cord origin (e.g., due to spinal cord injury, multiple sclerosis, hypoxic-ischemic encephalopathy, cerebral palsy, TBI)
Prescriber specialty
- Prescribed by or in consultation with a neurologist, orthopedist, physiatrist, or physical medicine and rehabilitation specialist
If spasticity is due to traumatic brain injury (TBI), at least 1 year has passed since the injury

Initial Approval Criteria — Oral Baclofen Formulations (Fleqsuvy, Lyvispah, Ozobax, Ozobax DS)

Initial Approval Criteria - Oral Baclofen Formulations (Fleqsuvy, Lyvispah, Ozobax, Ozobax DS)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of severe spasticity of multiple sclerosis or due to spinal cord injury/spinal cord diseases
Prescribed by or in consultation with a neurologist, orthopedist, physiatrist, or physical medicine and rehabilitation specialist
Age ≥ 12 years
Failure of conventional therapies (unless contraindicated or clinically significant adverse effects)

Other Diagnoses / Off-label Coverage

Other Diagnoses/Indications

Coverage for other uses must meet ONE of the following:

ANY of the following

For drugs on formulary/PDL: refer to no coverage criteria policy for the line of business (CP.CPA.190 commercial; HIM.PA.33 marketplace; CP.PMN.255 Medicaid)
For drugs NOT on formulary/PDL: refer to non-formulary policy for the line of business (CP.CPA.190 commercial; HIM.PA.103 marketplace; CP.PMN.16 Medicaid)
If requested use not listed under section III and criterion 1 above does not apply: refer to off-label use policy (CP.CPA.09 commercial; HIM.PA.154 marketplace; CP.PMN.53 Medicaid)

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Continuation Therapy

Continued Therapy

Covered when ONE of the following is met and applicable criteria are satisfied:

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title": "Continued Therapy"}

ref b4_0

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization requirement

Requests require review against policy criteria. Document the prescriber specialty (neurologist, orthopedist, physiatrist, or physical medicine and rehabilitation specialist) and failure of or contraindication to conventional therapies (e.g., benzodiazepines, dantrolene, tizanidine) as part of the prior authorization submission.

Prescriber specialty must be documented
Failure of or contraindication to conventional therapies must be documented

Documentation Required

Submit supporting documentation

Provider must submit supporting clinical documentation with the request, such as office chart notes, laboratory results, or other clinical information demonstrating that the member meets all approval criteria.

Applicable Codes

HCPCS / J-codes referencedHCPCS

J0475
J0476

Clinical Evidence & References

References reviewed: Lioresal Intrathecal Prescribing Information (Aug 2022); Gablofen Prescribing Information (Oct 2020); Ozobax Prescribing Information (2020); Lyvispah Prescribing Information (Apr 2023); Ozobax DS Prescribing Information (Sep 2023); Fleqsuvy Prescribing Information (Feb 2023). These references were accessed July–August 2024 per the policy reference list.

Derived numeric metrics

Intrathecal screening upper bolus (numeric)100 mcg maximum screening bolus (escalation: 50 → 75 → 100 mcg)

Oral maximum daily dose (numeric)80 mg/day for Fleqsuvy, Lyvispah, Ozobax/Ozobax DS

Background

Background: Baclofen is a GABA-ergic agonist used as a muscle relaxant and antispastic agent. Intrathecal baclofen (Gablofen, Lioresal Intrathecal) is indicated for management of severe spasticity of cerebral or spinal cord origin and requires an intrathecal screening trial (initial bolus typically 50 mcg, may escalate to 75 mcg and 100 mcg at 24-hour intervals; failure to respond to 100 mcg generally excludes implanted pump candidacy). Oral baclofen formulations (Fleqsuvy suspension, Lyvispah granules, Ozobax and Ozobax DS solutions) are indicated for spasticity related to multiple sclerosis and spinal cord disease, with a typical oral maximum dose of 80 mg/day. Brand and generic examples noted in the policy include Gablofen, Lioresal Intrathecal, Fleqsuvy, Lyvispah, Ozobax, and Ozobax DS.

Definitions/glossary: TBI = traumatic brain injury; GABA = gamma-aminobutyric acid.

Revision History

11.24P&T approvalLatest

P&T approval 11.24 for 4Q 2024 annual review; added Ozobax DS formulation to policy (material).

07.15.24policy change

4Q 2024 annual review: added Ozobax DS formulation to policy (material).

2024 (per SDC review)policy change

Removed requirement for compounded baclofen oral solution or baclofen crushed/split tablets and added requirement for use of generic baclofen oral solution for Fleqsuvy, Lyvispah, Ozobax/Ozobax DS requests (material).

Policy Summary

PayerCentene

PolicyBaclofen (Gablofen, Lioresal Intrathecal, Fleqsuvy, Lyvispah, Ozobax, Ozobax DS)

Policy CodePolicy CP PHAR.149

Change TypeAdded formulations; revised oral solution requirement

Effective DateDec 1, 2015

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

On This Page

Documentation supports inability to use oral baclofen therapy

Failure of conventional therapies (unless contraindicated or clinically significant adverse effects)

Benzodiazepine (e.g., diazepam, clonazepam)
Dantrolene
Tizanidine

Intended use

Screening trial
- Prescribed formulation: Gablofen 50 mcg/mL (1 mL syringe) OR Lioresal Intrathecal 50 mcg/mL (1 mL ampule)
- Screening trial dosing per policy: initial 50 mcg (or 25 mcg for very small patient); may give 75 mcg 24 hours later and 100 mcg a further 24 hours later; response to bolus < 100 mcg demonstrates positive response (decrease in muscle tone/frequency or spasm severity)
Maintenance therapy
- Prescribed formulation: Gablofen vial/syringe except the 1 mL syringe OR Lioresal Intrathecal ampule except the 1 mL ampule
- Dose does not exceed 100 mcg (screening/maintenance references; maintenance dosing to be individualized)

title": "Initial Approval Criteria - Intrathecal Baclofen (Gablofen, Lioresal Intrathecal)"}

Benzodiazepine (e.g., diazepam, clonazepam)

Member must use generic baclofen oral solution unless contraindicated or clinically significant adverse effects are experienced

Dose does not exceed 80 mg per day

title": "Initial Approval Criteria - Oral Baclofen Formulations (Fleqsuvy, Lyvispah, Ozobax, Ozobax DS)"}

title": "Other Diagnoses/Indications"}

Office chart notes
Lab results
Other clinical information supporting criteria

Documentation Required

Oral solution requirement for certain products

For requests for Fleqsuvy, Lyvispah, or Ozobax/Ozobax DS, the member must use generic baclofen oral solution unless contraindicated or clinically significant adverse effects occur; documentation of use or contraindication to the generic oral solution must be provided with the request.

Member must use generic baclofen oral solution unless contraindicated or intolerant
Documentation required to show use of or contraindication to generic oral solution

Billing Rule

Formulation restrictions for intrathecal products

For Gablofen and Lioresal intrathecal products, the 1 mL syringe (Gablofen) and 1 mL ampule (Lioresal Intrathecal) formulations must not be used for maintenance therapy; maintenance requests must specify approved vial/ampule formulations per the policy.

Do not use 1 mL syringe (Gablofen) or 1 mL ampule (Lioresal) for maintenance
Specify required maintenance formulations per policy

Denial Risk

Screening trial nonresponse

Patients who do not demonstrate a positive response to intrathecal screening up to the 100 mcg bolus should not be considered candidates for implanted pump chronic infusion; lack of a positive screening response (to ≤100 mcg) will likely result in denial for pump therapy.

Screening escalation: 50 mcg (or 25 mcg for very small patient) → 75 mcg → 100 mcg at 24-hour intervals
No response to 100 mcg excludes candidacy for implanted pump and may lead to denial

RT4 2022 / 03.01.22policy change

RT4 updates circa 2022: added newly FDA approved Lyvispah oral granules and Fleqsuvy oral suspension to policy (material).

4Q 2021clarification

4Q 2021 annual review: Gablofen/Lioresal requirement for oral baclofen revised to 'Documentation supports inability to use' language (non-material clarification).

4Q 2022clarification

4Q 2022 annual review: updated product availability, contraindications and boxed warnings per prescribing information (non-material clarification).