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ph-1121

Baclofen Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1121

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
04-01-2024

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Fleqsuvy® (baclofen) Oral suspension*	Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscle rigidity May also be of some value in patients with spinal cord injuries and other spinal cord diseases Limitations of Use: Fleqsuvy is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.	*generic available	6
LYVISPAH® (baclofen) Oral granules	Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity May also be of some value in patients with spinal cord injuries and other spinal cord diseases Limitations of Use: LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.		7
OZOBAX® OZOBAX® DS (baclofen) Oral solution	Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscle rigidity May also be of some value in patients with spinal cord injuries and other spinal cord diseases Limitations of Use: OZOBAX/OZOBAX DS is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.		1,8

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Multiple Sclerosis	Multiple sclerosis (MS) is a disorder of the central nervous system (CNS) characterized by demyelization, inflammation, and degenerative changes. Most people with MS experience relapses and remissions of neurological symptoms, particularly early in the disease, and clinical events are usually associated with areas of CNS inflammation. Gradual worsening or progression, with or without subsequent acute attacks of inflammation or radiological activity, may take place early, but usually becomes more prominent over time. While traditionally viewed as a disease solely of CNS white matter, more advanced imaging techniques have demonstrated significant early and ongoing CNS gray matter damage as well.(2) Those diagnosed with MS may have many fluctuating and disabling symptoms (including, but not limited to, fatigue, impaired mobility, mood and cognitive changes, pain and other sensory problems, visual disturbances, and elimination dysfunction), resulting in a significant impact on quality of life for patients and their families. There are currently four major types of MS: clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).(2) Spasticity from the upper motor neuron syndrome (a complex of signs and symptoms that can be associated with exaggerated reflexes, autonomic hyperreflexia, dystonia, contractures, paresis, lack of dexterity, and fatigability, in addition to spasticity) can result from a variety of conditions affecting the cortex or spinal cord. Some of the more common conditions associated with spasticity include multiple sclerosis, spinal cord injury, traumatic brain injury, cerebral palsy, and post-stroke syndrome. In many patients with these conditions, spasticity can be disabling and painful, with a marked effect on functional ability and quality of life. Baclofen, dantrolene, and tizanidine are approved for the treatment of spasticity related to multiple sclerosis. Other medications used to treat spasticity with multiple sclerosis include benzodiazepines, clonidine, and gabapentin.(3) There is evidence that baclofen, tizanidine, and dantrolene are effective compared to placebo in patients with spasticity related to multiple sclerosis. Baclofen and tizanidine are roughly equivalent for efficacy in patients with spasticity. The overall rate of adverse effects between baclofen and tizanidine is similar, tizanidine causes more dry mouth and baclofen more weakness.(3)
Spinal Cord Injury	A spinal cord injury (SCI) is a traumatic event that results in a disturbance to normal sensory, motor, or autonomic function and can significantly impair a patient's quality of life, functional status, and social independence. Motor vehicle accidents are the primary cause of SCI, followed by falls in the elderly population.(9) Immobility and spasticity contribute to muscle contractures after SCI. Preventive management is extremely important and should begin immediately after an SCI and continue for long-term. Preventative management includes positioning, range-of-motion exercises, and splinting.(5) Baclofen, dantrolene, pregabalin and tizanidine are approved for spasticity with spinal cord injuries. Methylprednisolone can be used for SCI but the Congress of Neurological Surgeons states there is insufficient evidence to make a recommendation.(4)
Efficacy	The efficacy of Fleqsuvy (baclofen), LYVISPAH (baclofen), and OZOBAX/OZOBAX DS (baclofen) is based on bioavailability studies in healthy adults comparing baclofen oral tablets to Fleqsuvy, LYVISPAH, or OZOBAX/OZOBAX DS.(1,6,7,8)
Safety	Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when discontinuing, unless the clinical situation justifies a rapid withdrawal.(1,6,7,8) Fleqsuvy, LYVISPAH, and OZOBAX/OZOBAX DS are contraindicated in patients with hypersensitivity to baclofen.(1,6,7,8)

REFERENCES

Number	Reference
1	OZOBAX Prescribing Information. Metacel Pharmaceuticals, LLC. May 2020.
2	Multiple Sclerosis Coalition. The Use of Disease Modifying Therapies in Multiple Sclerosis: Principles and Current Evidence. A Consensus Paper by the Multiple Sclerosis Coalition. Original July 2014. Updated September 2019.
3	Chou R, Peterson K, Helfand M. Comparative Efficacy and Safety of Skeletal Muscle Relaxants for Spasticity and Musculoskeletal Conditions: A Systemic Review. Journal of Pain and Symptom Management. 2004 Aug;28(2):140-75.
4	Arnold PM, Anderson PA, Chi JH, et al. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Evaluation and Treatment of Patients with Thoracolumbar Spine Trauma: Pharmacological Treatment. Neurosurgery. 2019 Jan;84(1):E36-E38.
5	Dalyan M, Sherman A, Cardenas DD. Factors associated with contractures in acute spinal cord injury. Spinal Cord. 1998 Jun;36(6):405-8.
6	Fleqsuvy Prescribing Information. Azurity Pharmaceuticals, Inc. February 2023.
7	LYVISPAH prescribing information. Amneal Pharmaceuticals LLC. April 2023.
8	OZOBAX DS Prescribing Information. Metacel Pharmaceuticals, LLC. October 2023.
9	Fehlings MG, Tetreault LA, Wilson JR, Kwon BK, Burns AS, Martin AR, Hawryluk G, Harrop JS. (2017). A Clinical Practice Guideline for the Management of Acute Spinal Cord Injury: Introduction, Rationale, and Scope. Global spine journal, 7(3 Suppl), 84S-94S. https://doi.org/10.1177/2192568217703387

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Lyvispah	Baclofen Granules Packet	5 MG	M ; N ; O ; Y	N
Lyvispah	Baclofen Granules Packet	10 MG	M ; N ; O ; Y	N
Lyvispah	Baclofen Granules Packet	20 MG	M ; N ; O ; Y	N
Ozobax ds	baclofen oral soln	10 MG/5ML	M ; N ; O ; Y	M
Ozobax	Baclofen Oral Soln 5 MG/5ML	5 MG/5ML	M ; N ; O ; Y	M ; N
Fleqsuvy	Baclofen Susp	25 MG/5ML	M ; N ; O ; Y	O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Fleqsuvy	Baclofen Susp	25 MG/5ML	480	mLs	30	DAYS
Lyvispah	Baclofen Granules Packet	5 MG	120	Packets	30	DAYS
Lyvispah	Baclofen Granules Packet	10 MG	120	Packets	30	DAYS
Lyvispah	Baclofen Granules Packet	20 MG	120	Packets	30	DAYS
Ozobax	Baclofen Oral Soln 5 MG/5ML	5 MG/5ML	2400	mLs	30	DAYS
Ozobax ds	baclofen oral soln	10 MG/5ML	1200	mLs	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Fleqsuvy	Baclofen Susp	25 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Lyvispah	Baclofen Granules Packet	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Lyvispah	Baclofen Granules Packet	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Lyvispah	Baclofen Granules Packet	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Ozobax	Baclofen Oral Soln 5 MG/5ML	5 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Ozobax ds	baclofen oral soln	10 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Fleqsuvy	Baclofen Susp	25 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Lyvispah	Baclofen Granules Packet	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Lyvispah	Baclofen Granules Packet	5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Lyvispah	Baclofen Granules Packet	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Ozobax	Baclofen Oral Soln 5 MG/5ML	5 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series
Ozobax ds	baclofen oral soln	10 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Initial Evaluation Target Agent(s) will be approved when ALL of the following are met: ONE of the following: The patient has a diagnosis of spasticity resulting from multiple sclerosis (MS) AND BOTH of the following: The requested agent will be used for at least ONE of the following: Flexor spasms and concomitant pain OR Clonus OR Muscular rigidity AND ONE of the following: BOTH of the following: ONE of the following: The patient has an intolerance or hypersensitivity to generic baclofen tablets that is not expected to occur with the requested agent OR The patient has an FDA labeled contraindication to generic baclofen tablets that is not expected to occur with the requested agent OR The prescriber has provided information to support use of the requested agent over generic baclofen tablets AND ONE of the following: The patient has tried and had an inadequate response to another muscle relaxant (e.g., dantrolene, tizanidine) used for spasticity related to multiple sclerosis OR The patient has an intolerance or hypersensitivity to ALL muscle relaxants used for spasticity related to multiple sclerosis OR The patient has an FDA labeled contraindication to ALL muscle relaxants used for spasticity related to multiple sclerosis OR The prescriber has provided information on why the patient is unable to use a solid dosage form (e.g., difficulty swallowing tablets or capsules, feeding tube) OR The patient has a diagnosis of spasticity related to spinal cord injury or other spinal cord disease AND ONE of the following: BOTH of the following: ONE of the following: The patient has an intolerance or hypersensitivity to generic baclofen tablets that is not expected to occur with the requested agent OR The patient has an FDA labeled contraindication to generic baclofen tablets that is not expected to occur with the requested agent OR The prescriber has provided information to support use of the requested agent over generic baclofen tablets AND ONE of the following: The patient has tried and had an inadequate response another muscle relaxant (e.g., dantrolene, pregabalin, tizanidine) used for spasticity related to spinal cord injuries or other spinal diseases OR The patient has an intolerance, or hypersensitivity to ALL muscle relaxants used for spasticity related to spinal cord injuries or other spinal cord diseases OR The patient has an FDA labeled contraindication to ALL muscle relaxants used for spasticity related to spinal cord injuries or other spinal cord diseases OR The prescriber has provided information on why the patient is unable to use a solid dosage form (e.g., difficulty swallowing tablets or capsules, feeding tube) AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 6 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. Renewal Evaluation* Target Agent(s) will be approved when ALL of the following are met: The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND The patient has had clinical benefit with the requested agent (e.g., decreased spasms) AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

ONE of the following:
1. The patient has a diagnosis of spasticity resulting from multiple sclerosis (MS) AND BOTH of the following:
  1. The requested agent will be used for at least ONE of the following:
    1. Flexor spasms and concomitant pain OR
    2. Clonus OR
    3. Muscular rigidity AND
  2. ONE of the following:
    1. BOTH of the following:
      1. ONE of the following:
        
        The patient has an intolerance or hypersensitivity to generic baclofen tablets that is not expected to occur with the requested agent OR
        
        The patient has an FDA labeled contraindication to generic baclofen tablets that is not expected to occur with the requested agent OR
        
        The prescriber has provided information to support use of the requested agent over generic baclofen tablets AND
      2. ONE of the following:
        
        The patient has tried and had an inadequate response to another muscle relaxant (e.g., dantrolene, tizanidine) used for spasticity related to multiple sclerosis OR
        
        The patient has an intolerance or hypersensitivity to ALL muscle relaxants used for spasticity related to multiple sclerosis OR
        
        The patient has an FDA labeled contraindication to ALL muscle relaxants used for spasticity related to multiple sclerosis OR
    2. The prescriber has provided information on why the patient is unable to use a solid dosage form (e.g., difficulty swallowing tablets or capsules, feeding tube) OR
2. The patient has a diagnosis of spasticity related to spinal cord injury or other spinal cord disease AND ONE of the following:
  1. BOTH of the following:
    1. ONE of the following:
      1. The patient has an intolerance or hypersensitivity to generic baclofen tablets that is not expected to occur with the requested agent OR
      2. The patient has an FDA labeled contraindication to generic baclofen tablets that is not expected to occur with the requested agent OR
      3. The prescriber has provided information to support use of the requested agent over generic baclofen tablets AND
    2. ONE of the following:
      1. The patient has tried and had an inadequate response another muscle relaxant (e.g., dantrolene, pregabalin, tizanidine) used for spasticity related to spinal cord injuries or other spinal diseases OR
      2. The patient has an intolerance, or hypersensitivity to ALL muscle relaxants used for spasticity related to spinal cord injuries or other spinal cord diseases OR
      3. The patient has an FDA labeled contraindication to ALL muscle relaxants used for spasticity related to spinal cord injuries or other spinal cord diseases OR
  2. The prescriber has provided information on why the patient is unable to use a solid dosage form (e.g., difficulty swallowing tablets or capsules, feeding tube) AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 6 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
The patient has had clinical benefit with the requested agent (e.g., decreased spasms) AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
QL with PA	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR ALL of the following: The requested quantity (dose) is greater than the program quantity limit AND The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit Length of Approval: Initial: 6 months, Renewal:12 months

Module

Clinical Criteria for Approval

QL with PA

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) is greater than the program quantity limit AND
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

Length of Approval: Initial: 6 months, Renewal:12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment