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Effective Date
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Date of Origin
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07-01-2025
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FDA LABELED INDICATIONS AND DOSAGE
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Agent(s)
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FDA Indication(s)
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Notes
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Ref#
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Gralise®
(gabapentin)
Extended-release tablet
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Management of postherpetic neuralgia (PHN)
Important Limitation: Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
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2
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Horizant®
(gabapentin enacarbil)
Extended-release tablet
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Treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults
Management of postherpetic neuralgia (PHN) in adults
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1
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See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
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Restless Legs Syndrome (RLS)
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Restless legs syndrome (RLS) is a sleep-related movement disorder characterized by an urge to move the legs or arms when immobile, commonly in response to uncomfortable dysesthesia. To this day, there is no single biological explanation as to what the cause of RLS symptoms.(5)
The American Academy of Sleep Medicine (AASM) strongly recommends the use of gabapentin enacarbil, gabapentin, and pregabalin for the treatment of RLS. Due to augmentation, AASM recommends against the use of levodopa, pramipexole, transdermal rotigotine, ropinirole. Augmentation is the gradual worsening of RLS symptom intensity and duration when exposed to dopaminergic agents over months to years. Short-term duration of initial pivotal clinical trials of dopamine agonists for FDA approval did not demonstrate this complication. Since 2016, expert recommendations for RLS in adults has pointed towards alpha-2-delta ligand medications as first-line pharmacotherapy as an alternative to dopamine agonists after heightened awareness of dopaminergic augmentation of RLS symptoms with long term use of these medications.(5)
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Postherpetic Neuralgia (PHN)
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Postherpetic neuralgia (PHN) is the most common complication of herpes zoster. PHN is defined as pain in the dermatomal distribution that is sustained for at least 90 days after the rash. PHN is caused by nerve damage secondary to an inflammatory response induced by viral replication within a nerve. Pain-management strategies should focus on symptom control. Some patients have complete resolution of symptoms at several years while others continue medications indefinitely.(7)
The anticonvulsants gabapentin and pregabalin are FDA approved for treatment of PHN.(6) Tricyclic antidepressants (TCAs) used off-label are also effective in treating PHN, but up to one-fourth of patients discontinue treatment due to adverse reactions.(4,7) Both gabapentiniods and TCAs are unanimously recognized as first-line drugs.(4) Both topical (capsaicin and lidocaine) and systemic treatments can be effective in the management of PHN but various guidelines do not agree on efficacy in treatment of PHN.(4,7) Opioids are considered third-line treatment with two systematic reviews finding tramadol provided significant pain relief in patients with PHN.(6,7) Acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are generally considered to be ineffective for neuropathic pain.(7)
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Safety
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Gralise is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Horizant has no FDA labeled contraindications for use.
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REFERENCES
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Number
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Reference
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1
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Horizant prescribing information. Azurity Pharmaceuticals, Inc. August 2022.
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2
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Gralise prescribing information Almatica Pharma LLC. March 2023.
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3
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Reference no longer used.
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4
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Beben D, Kowalewski J, Recka K, et al. Post-herpetic neuralgia: currently available oral and topical medications in the management of pain - a review. Journal of Pre-Clinical and Clinical Research. Published online June 14, 2024. doi:10.26444/jpccr/189442
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5
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Winkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. Journal of Clinical Sleep Medicine. Published online September 26, 2024. doi:10.5664/jcsm.11390
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6
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Johnson RW, Rice ASC. Postherpetic neuralgia. New England Journal of Medicine. 2014;371(16):1526-1533. doi:10.1056/nejmcp1403062
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7
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Saguil AS, Kane S, Mercado M, et. al. Herpes Zoster and Postherpetic Neuralgia: Prevention and Management. Am Fam Physician. 2017;96(10):656-663. Available at: https://www.aafp.org/afp/2017/1115/p656.pdf
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POLICY AGENT SUMMARY QUANTITY LIMIT
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Target Brand Agent Name(s)
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Target Generic Agent Name(s)
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Strength
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QL Amount
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Dose Form
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Day Supply
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Duration
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Addtl QL Info
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Allowed Exceptions
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Targeted NDCs When Exclusions Exist
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Gralise
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gabapentin (once-daily) tab
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450 MG
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30
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Tablets
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30
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DAYS
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Gralise
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gabapentin (once-daily) tab
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750 MG
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30
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Tablets
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30
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DAYS
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Gralise
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gabapentin (once-daily) tab
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900 MG
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60
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Tablets
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30
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DAYS
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|
|
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Gralise
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Gabapentin (Once-Daily) Tab 300 MG
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300 MG
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30
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Tablets
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30
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DAYS
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|
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Gralise
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Gabapentin (Once-Daily) Tab 600 MG
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600 MG
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90
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Tablets
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30
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DAYS
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|
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Horizant
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gabapentin enacarbil tab er
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300 MG ; 600 MG
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60
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Tablets
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30
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DAYS
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CLIENT SUMMARY – QUANTITY LIMITS
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Target Brand Agent Name(s)
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Target Generic Agent Name(s)
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Strength
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Client Formulary
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Gralise
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gabapentin (once-daily) tab
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450 MG
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
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Gralise
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gabapentin (once-daily) tab
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900 MG
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
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Gralise
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gabapentin (once-daily) tab
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750 MG
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
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Gralise
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Gabapentin (Once-Daily) Tab 300 MG
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300 MG
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
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Gralise
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Gabapentin (Once-Daily) Tab 600 MG
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600 MG
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
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Horizant
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gabapentin enacarbil tab er
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300 MG ; 600 MG
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
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QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
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Module
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Clinical Criteria for Approval
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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
- The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
- BOTH of the following:
- The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
- There is support for therapy with a higher dose for the requested indication OR
- BOTH of the following:
- The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
- There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
- BOTH of the following:
- The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
- There is support for therapy with a higher dose for the requested indication
Length of Approval: up to 12 months
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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.
Commercial _ PS _ Gabapentin_ER_QL _ProgSum_ 07-01-2025
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