GRALISE (gabapentin) oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. This Pharmacy Coverage Guideline does not apply to FEP or other states Blues Plans. Information about medications that require precertification is available at www.azblue.com/pharmacy. Some large (100+) benefit plan groups may customize certain benefits, including adding or deleting precertification requirements. All applicable benefit plan provisions apply, e.g., waiting periods, limitations, exclusions, waivers and benefit maximums. Precertification for medication(s) or product(s) indicated in this guideline requires completion of the request form in its entirety with the chart notes as documentation. All requested data must be provided. Once completed the form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) 864-3126 or emailed to Pharmacyprecert@azblue.com. Incomplete forms or forms without the chart notes will be returned. Page 1 of 7
Description: Gralise (gabapentin) is indicated for the management of postherpetic neuralgia (PHN). It is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The mechanism of action by which gabapentin exerts its analgesic action is unknown but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). Gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice. It also decreases pain related responses after peripheral inflammation, but does not alter immediate pain-related behaviors. The relevance of these animal pain models to human pain is not known. Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA), but it does not modify GABA or GABA binding; it is not converted metabolically into GABA or a GABA agonist; and it is not an inhibitor of GABA uptake or degradation. Gabapentin does not alter the cellular uptake of dopamine, noradrenaline, or serotonin. Post-herpetic neuralgia (PHN): PHN is the most frequent chronic complication of herpes zoster (shingles) infection Herpes zoster (HZ) represents a reactivation of the varicella zoster virus (VZV) The primary viral infection causes varicella (chickenpox), after which VZV becomes latent in sensory ganglia With decline in cell mediated immunity seen in elderly and in immunocompromised individuals, VZV may reactivate to cause HZ Acute HZ is characterized by a painful or aching, burning vesicular rash along dorsal root ganglia o The pain is described as electric shock-like and unbearable itching may occur with the outbreak of the rash o The thorax is the most common site that is affected o Other areas that can be affected are the trigeminal, cervical, and lumbar distributions o Acute HZ usually resolves in a few weeks but some patients experience persistent pain that can last months, years, or a lifetime There are three phases of pain associated with HZ: o Acute herpetic neuralgia pain preceding or accompanying the eruption of rash that persists up to 30 days from it onset o Subacute herpetic neuralgia pain that persists beyond healing of the rash but resolves within four months of onset o Post-herpetic neuralgia (PHN) pain that persists beyond three months or more after resolution of acute HZ The term zoster-associated pain is used to describe a continuum of pain from acute HZ to the development of PHN Page 2 of 7
Treatment: usually involves decreasing pain and improving the quality of life in patients with PHN o Tricyclic antidepressants (TCAs) amitriptyline, nortriptyline, desipramine o Gabapentinoids (gabapentin, pregabalin) used in those who cannot use a TCA Gabapentin is often used for the management of a variety of pain and neurological conditions Generic gabapentin is indicated for partial seizures and postherpetic neuralgia Gabapentin has been available since 1993 with established safety profile o Valproic acid limited data suggests effective in improving pain in some patients o Topical capsaicin, topical lidocaine may be used for mild-moderate pain and in those not wanting oral agents o Opioids cautious use, may be helpful in some patients, not recommended first line o Intrathecal glucocorticoid injections an option for patients who continue to have intractable pain o Botulinum toxin injection some evidence suggests it is effective Gralise (gabapentin) Medication class: Anticonvulsant, miscellaneous; GABA analog FDA-approved indication(s): Management of post-herpetic neuralgia (PHN) in adults Recommended Dose: 300 mg day 1, 600 mg day 2, 900 mg days 3-6, 1,200 mg days 7-10, 1,500 mg days 11-14, then 1,800 mg day 15 Maximum dosage Not stated Available Dosage Forms: 300 mg and 600 mg tablets Started pack contains 78 tablets: 9 x 300 mg and 69 x 600 mg tablets Warnings and Precautions: Doses should be adjusted in patients with reduced renal function Should not be used in patients with a creatinine clearance < 30 ml/min or patients on hemodialysis Safety and effectiveness in patients with epilepsy has not been studied Should be taken at least 2 hours following antacid administration Gabapentin should be withdrawn gradually over a minimum of 1 week or longer Gabapentin bioavailability decreases with increasing dose, it is also lower if taken on an empty stomach Gralise is an extended release formulation, the tablets swell in gastric fluid and gradually release gabapentin, it is also referred to as a gastric-retentive form It is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles Gralise (1,800 mg once daily) compared to immediate release gabapentin (600 mg TID) given with high fat meal, at steady state: Cmax was higher, Cmin was lower, and AUC was lower for Graslise (package insert) Page 3 of 7
Criteria: Criteria for initial therapy: Gralise (gabapentin) is considered medically necessary and will be approved when ALL of the following criteria are met : 1. Individual is 18 years of age or older 2. A confirmed diagnosis of post-herpetic neuralgia 3. Individual has failure, contraindication or intolerance to one tricyclic antidepressant and generic gabapentin Tricyclic antidepressants include: Amitriptyline Desipramine Nortriptyline 4. The creatinine clearance is > 30 ml/min 5. There are NO contraindications: Contraindications include: Hypersensitivity to Gabapentin Initial approval duration: 6 months Criteria for continuation of coverage (renewal request): Gralise (gabapentin) is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Individual s condition responded while on therapy Response is defined as: Pain has decreased over baseline by > 30% 2. Individual has been adherent with the medication 3. Individual has not developed any contraindications or other significant level 4 adverse drug effects that may exclude continued use Creatinine clearance is < 30 ml/min or patient is on hemodialysis Contraindications or adverse effect: Hypersensitivity reaction to gabapentin 4. There are no significant interacting drugs Renewal duration: 12 months Page 4 of 7
Resources: Gralise. Package Insert. Reference ID 3283839. Revised by manufacturer 09/2012. Accessed 10-23-2014. Gralise. Package Insert. Revised by manufacturer 12/2012. Accessed 10-14-2015. Gralise. Package Insert. Revised by manufacturer 09/2015. Accessed 10-11-2016. Johnson RW and Rice ASC. Clinical Practice. Postherpetic neuralgia. NEJM 2014;371;16:1526-1544 Attal N, Cruccu G, Baron R, et al.: European Federation of Neurological Society (EFNS) Task Force. Guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol 2010;17:1113-1123 UpToDate: Postherpetic neuralgia. Current through Sep 2017. https://www-uptodatecom.mwu.idm.oclc.org/contents/postherpeticneuralgia?source=search_result&search=postherpetic%20neuralgia&selectedtitle=1~54 Page 5 of 7
Fax completed prior authorization request form to 602-864-3126 or email to pharmacyprecert@azblue.com. Call 866-325-1794 to check the status of a request. All requested data must be provided. Incomplete forms or forms without the chart notes will be returned. Pharmacy Coverage Guidelines are available at www.azblue.com/pharmacy. Pharmacy Prior Authorization Request Form Do not copy for future use. Forms are updated frequently. REQUIRED: Office notes, labs, and medical testing relevant to the request that show medical justification are required. Member Information Member Name (first & last): Date of Birth: Gender: BCBSAZ ID#: Address: City: State: Zip Code: Prescribing Provider Information Provider Name (first & last): Specialty: NPI#: DEA#: Office Address: City: State: Zip Code: Office Contact: Office Phone: Office Fax: Dispensing Pharmacy Information Pharmacy Name: Pharmacy Phone: Pharmacy Fax: Requested Medication Information Medication Name: Strength: Dosage Form: Directions for Use: Quantity: Refills: Duration of Therapy/Use: Check if requesting brand only Check if requesting generic Check if requesting continuation of therapy (prior authorization approved by BCBSAZ expired) Turn-Around Time For Review Standard Urgent. Sign here: Exigent (requires prescriber to include a written statement) Clinical Information 1. What is the diagnosis? Please specify below. ICD-10 Code: Diagnosis Description: 2. Yes No Was this medication started on a recent hospital discharge or emergency room visit? 3. Yes No There is absence of ALL contraindications. 4. What medication(s) has the individual tried and failed for this diagnosis? Please specify below. Important note: Samples provided by the provider are not accepted as continuation of therapy or as an adequate trial and failure. Medication Name, Strength, Frequency Dates started and stopped or Approximate Duration Describe response, reason for failure, or allergy 5. Are there any supporting labs or test results? Please specify below. Date Test Value Blue Cross Blue Shield of Arizona, Mail Stop A115, P.O. Box 13466, Phoenix, AZ 85002-3466 Page 1 of 2
Pharmacy Prior Authorization Request Form 6. Is there any additional information the prescribing provider feels is important to this review? Please specify below. For example, explain the negative impact on medical condition, safety issue, reason formulary agent is not suitable to a specific medical condition, expected adverse clinical outcome from use of formulary agent, or reason different dosage form or dose is needed. Signature affirms that information given on this form is true and accurate and reflects office notes Prescribing Provider s Signature: Date: Please note: Some medications may require completion of a drug-specific request form. Incomplete forms or forms without the chart notes will be returned. Office notes, labs, and medical testing relevant to the request that show medical justification are required. Blue Cross Blue Shield of Arizona, Mail Stop A115, P.O. Box 13466, Phoenix, AZ 85002-3466 Page 2 of 2