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Gabapentin ER (extended-release) [Horizant, Gralise] Quantity Limit Program Summary
Policy Number: PH-1040
Step Therapy will only apply to members that have a benefit including the Enhanced Step Therapy Package.
This program applies to Commercial, Blue Partner, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
07-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Gralise® (gabapentin) Extended-release tablet |
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. |
|
2 |
Horizant® (gabapentin) Extended-release tablet |
Treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults Management of postherpetic neuralgia (PHN) in adults |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Restless Legs Syndrome (RLS) |
Restless legs syndrome (RLS) is a movement disorder characterized by an urge to move the legs or arms, commonly in response to uncomfortable dysesthesia.(5) Pramipexole, ropinirole, and rotigotine transdermal system are recommended by the American Academy of Sleep Medicine (AASM) and the European Federation of Neurological Societies/European Neurological Society/European Sleep Research Society as first-line treatment for RLS.(3,4) The non-ergot dopamine agonists, pramipexole and ropinirole, are effective in the treatment of RLS and are less likely to cause side effects than other dopamine agonists (e.g., cabergoline and pergolide) and levodopa. Gabapentin and pregabalin may be useful in RLS in patients with comorbid pain.(3) The American Academy of Neurology recommends that the choice of agent for the treatment of primary RLS be based on goal of treatment and patient comorbidities. The level of evidence for use of pramipexole, rotigotine, cabergoline, gabapentin, IV ferric carboxymaltose, levodopa, and pregabalin in RLS varies depending on those goals and comorbidities.(5) |
Postherpetic Neuralgia (PHN) |
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) Both topical (capsaicin and lidocaine) and systemic treatments can be effective in the management of PHN. The anticonvulsants gabapentin and pregabalin are approved for treatment of PHN. Tricyclic antidepressants are also effective in treating PHN, but up to one-fourth of patients discontinue treatment due to adverse reactions. 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) |
Safety |
Gralise is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Horizant has no FDA labeled contraindications for use. |
REFERENCES
Number |
Reference |
1 |
Horizant prescribing information. Azurity Pharmaceuticals, Inc. August 2022. |
2 |
Gralise prescribing information Almatica Pharma LLC. March 2023. |
3 |
Aurora RN, Kristo DA, Bista SR, et. al. The Treatment of Restless Legs Syndrome and Periodic Limb Movement Disorder in Adults-An Update for 2012: Practice Parameters with an Evidence-Based Systematic Review and Meta-Analyses. An American Academy of Sleep Medicine Clinical Practice Guideline. Sleep. 2012, 35(8): 1039-1062. Available at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397811/ |
4 |
Garcia-Borreguero D, Ferini-Strambi L, Kohnen R, et. al. “European guidelines on management of restless legs syndrome: report of a joint task force by the European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society. European Journal of Neurology 2012, 19: 1385-1396. Available at: https://onlinelibrary.wiley.com/doi/full/10.1111/j.1468-1331.2012.03853.x |
5 |
Winkelman WJ, Armstrong MJ, Chaudhuri KR. Practice guideline summary: Treatment of restless legs syndrome in adults. Neurology. December 13, 2016; 87 (24). Reaffirmed October 2022. |
6 |
Johnson, RW, Rice AS. Postherpetic Neuralgia. N Engl J Med 2014;371:1526-33. Available at: https://www.nejm.org/action/showPdf?downloadfile=showPdf&doi=10.1056/NEJMcp1403062&loaded=true |
7 |
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 |
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 |
|
|||||||||
Gralise |
gabapentin (once-daily) tab |
450 MG |
30 |
Tablets |
30 |
DAYS |
Gralise dosage must be titrated up over 15 days |
1. The patient requires increased quantities of Gralise to accommodate a titration schedule. The increased quantity will be approved for 1 month only. |
|
Gralise |
gabapentin (once-daily) tab |
750 MG |
30 |
Tablets |
30 |
DAYS |
Gralise dosage must be titrated up over 15 days |
1. The patient requires increased quantities of Gralise to accommodate a titration schedule. The increased quantity will be approved for 1 month only. |
|
Gralise |
gabapentin (once-daily) tab |
900 MG |
60 |
Tablets |
30 |
DAYS |
Gralise dosage must be titrated up over 15 days |
1. The patient requires increased quantities of Gralise to accommodate a titration schedule. The increased quantity will be approved for 1 month only. |
|
Gralise |
Gabapentin (Once-Daily) Tab 300 MG |
300 MG |
30 |
Tablets |
30 |
DAYS |
Gralise dosage must be titrated up over 15 days |
1. The patient requires increased quantities of Gralise to accommodate a titration schedule. The increased quantity will be approved for 1 month only. |
|
Gralise |
Gabapentin (Once-Daily) Tab 600 MG |
600 MG |
90 |
Tablets |
30 |
DAYS |
Gralise dosage must be titrated up over 15 days |
1. The patient requires increased quantities of Gralise to accommodate a titration schedule. The increased quantity will be approved for 1 month only. |
|
Horizant |
gabapentin enacarbil tab er |
300 MG ; 600 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
ADDITIONAL QUANTITY LIMIT INFORMATION
Wildcard |
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Additional QL Information |
Targeted NDCs When Exclusions Exist |
Effective Date |
Term Date |
|
|||||||
62540030000325 |
Gralise |
gabapentin (once-daily) tab |
450 MG |
Gralise dosage must be titrated up over 15 days |
|
|
|
62540030000345 |
Gralise |
gabapentin (once-daily) tab |
750 MG |
Gralise dosage must be titrated up over 15 days |
|
|
|
62540030000360 |
Gralise |
gabapentin (once-daily) tab |
900 MG |
Gralise dosage must be titrated up over 15 days |
|
|
|
62540030000320 |
Gralise |
Gabapentin (Once-Daily) Tab 300 MG |
300 MG |
Gralise dosage must be titrated up over 15 days |
|
|
|
62540030000330 |
Gralise |
Gabapentin (Once-Daily) Tab 600 MG |
600 MG |
Gralise dosage must be titrated up over 15 days |
|
|
|
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Gralise |
gabapentin (once-daily) tab |
900 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Gralise |
gabapentin (once-daily) tab |
750 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Gralise |
gabapentin (once-daily) tab |
450 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Gralise |
Gabapentin (Once-Daily) Tab 300 MG |
300 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Gralise |
Gabapentin (Once-Daily) Tab 600 MG |
600 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Horizant |
gabapentin enacarbil tab er |
300 MG ; 600 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 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.
Commercial _ PS _ Gabapentin_ER_QL _ProgSum_ 07-01-2024