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ph-1040

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

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.

Horizant®

(gabapentin)

Extended-release tablet

Treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults

Management of postherpetic neuralgia (PHN) in adults

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: The requested quantity (dose) does NOT exceed the program quantity limit OR The patient requires increased quantities of Gralise to accommodate a titration schedule. The increased quantity will be approved for 1 month only 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

Module

Clinical Criteria for Approval

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 patient requires increased quantities of Gralise to accommodate a titration schedule. The increased quantity will be approved for 1 month only OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. 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
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

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