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Prior Authorization Protocol

LYRICAR (pregabalin)


HNMC

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia (PHN)
    • Adjunctive therapy for adult patients with partial onset seizures
    • Fibromyalgia
    • Neuropathic pain associated with spinal cord injury
  2. Health Net Approved Indications and Usage Guidelines:
    Diabetic peripheral neuropathy
    • Diagnosis of diabetic peripheral neuropathy
    Postherpetic neuralgia (shingles or herpes zoster)
    • Diagnosis of postherpetic neuralgia
    AND
    • Failure or clinically significant adverse effects to gabapentin
    Epilepsy
    • Adjunctive treatment of seizures in adults with epilepsy

    Fibromyalgia
    • Diagnosis of fibromyalgia
    Neuropathic pain associated with spinal cord injury
    • Diagnosis of pain associated with spinal cord injury
    Generalized Anxiety Disorder
    • Diagnosis of Generalized Anxiety Disorder
    AND
    • Failure or clinically significant adverse effects to TWO of the following alternatives: escitalopram, paroxetine, venlafaxine ER, duloxetine, or buspirone.
  3. Coverage is Not Authorized For:
    • Dental Pain, osteoarthritis, social phobia
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:

    • The following agents are FDA-approved for generalized anxiety disorder: escitalopram, paroxetine, venlafaxine ER, duloxetine, buspirone, and alprazolam.
    • Several of the neuropathic pain studies excluded patients who failed to respond to previous therapy with gabapentin at doses of 1200 mg or more per day.
    • Duloxetine is FDA approved for diabetic peripheral neuropathy and gabapentin and lidocaine 5% patches are FDA approved for postherpetic neuralgia.
    • Class III recommendation in Micromedex for the following: dental pain, osteoarthritis, social phobia.
    • Class IIb recommendation in Micromedex for Generalized Anxiety Disorder is supported by 5 randomized, double blind, placebo controlled studies. It is also considered a second line agent by the Canadian Psychiatric Association.
    • Study NCT00313820 compared Lyrica to placebo in the treatment of centrally mediated neuropathic pain due to stroke. The results of the study showed no difference in pain reduction between the placebo group and the Lyrica group (p=0.578). Study NCT00407745 compared Lyrica to placebo in treatment of patients with nerve pain due to spinal cord injury. Daily average reduction in pain score and weekly change in pain score were both positively affected by Lyrica (p=0.0032 and 0.0066 respectively). Spinal cord injury was defined as being traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas).
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    duloxetine (CymbaltaR)

    Diabetic peripheral neuropathy or Fibromyalgia:
    60 mg/day PO QD

    60 mg/day

    gabapentin (NeurontinR)

    1200 mg/day PO in divided TID

    3600 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Lyrica

    For all FDA approved indications,
    begin dosing at 150 mg/day PO
    Epilepsy and shingles (post herpetic neuralgia):
    BID or TID dosing with max of 600 mg/day PO
    Diabetic peripheral neuropathy:
    TID dosing with max of 300 mg/day PO
    Fibromyalgia:
    BID dosing with max of 450 mg/day PO
    Generalized Anxiety Disorder:
    up to 200 mg TID PO
    Treatment of neuropathic pain associated with spinal cord injury:
    BID dosing with max of 600 mg/day PO

    Length of Benefit

  7. Product Availability:
    Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
    Oral Solution: 20 mg/mL
  8. References:
    1. Lyrica [Prescribing Information] New York, NY: Pfizer Inc; December 2013.
    2. Mack, A. Examination of the Evidence for Off-Label Use of Gabapentin. JMCP. Nov/Dec 2003;Vol 9:No.6:559-568.
    3. Backonja M, MD and Glanzman R, MD. Gabapentin dosing for neuropathic pain: Evidence from randomized, placebo-controlled clinical trials. Clin Ther. 2003; 25(1); 81-104.
    4. Sabatowski R, Galvez R, Cherry DA, et al. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomized, placebo-controlled clinical trial. Pain. 2004;109:26-35.
    5. Rosenstock J, Tuchman M, LaMoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110:628-638.
    6. Lesser H, Sharma U, LaMoreaux L, et al. Pregabalin relieves symptoms of painful diabetic neuropathy. Neurology. 2004;63(1):2104-2110.
    7. Frampton JE and Scott LJ. Pregabalin in the treatment of painful diabetic peripheral neuropathy. Drugs. 2004;64(24):2813-2820.
    8. French JA, Kugler AR, Robbins JL, et al. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology. 2003;60(10):1631-1637.
    9. Arroyo S, Anhut H, Kugler AR, et al. Pregabalin add-on treatment: a randomized, double-blind, placebo-controlled, dose-response study in adults with partial seizures. Epilepsia. 2004;45(1):20-27.
    10. Health Net, Inc. Position Statement: Anticonvulsant off-label use. Clinical Pharmacy Advisory Committee. Approved by Health Net National Pharmacy and Therapeutics Committee, first quarter 2005.
    11. Dubinsky RM, Kabbani H, El-Chami Z, et al. Practice parameter: treatment of postherpetic neuralgia. An evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Am Acad Neur. 2004;63:959-965.
    12. Spruce MC, Potter J, Coppini DV. The pathogenesis and management of painful diabetic neuropathy: a review. Diabet Med. 2003;20(2):88-98.
    13. Feltner DE, Crockatt JG, Dubovsky SJ, et al: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study Of Pregabalin In Patients With Generalized Anxiety Disorder. J Clin Psychopharmacol. 2003; 23(3):240-249.
    14. Rickels K, Pollack MH, Feltner DE, Et Al: Pregabalin For Treatment Of Generalized Anxiety Disorder: A 4-Week, Multicenter, Double-Blind, Placebo-Controlled Trial Of Pregabalin And Alprazolam. Arch Gen Psychiatry. 2005; 62(9):1022-1030.
    15. Montgomery SA; Tobias K; Zornberg GL; Kasper S; Pande AC. Efficacy And Safety Of Pregabalin In The Treatment Of Generalized Anxiety Disorder: A 6-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison Of Pregabalin And Venlafaxine. J Clin Psychiatry. 2006:67: 771-782.
    16. Pohl RB; Feltner DE; Fieve RR; Pande AC. Efficacy Of Pregabalin In The Treatment Of Generalized Anxiety Disorder: Double-Blind, Placebo-Controlled Comparison Of Bid Versus Tid Dosing. J Clin Psychopharmacol. 2005;25:151-158.
    17. Pande AC, et al. Pregabalin in generalized anxiety disorder: a placebo-controlled trial. Am J Psychiatry. 2003;160:533-540.
    18. Canadian Psychiatric Association. Clinical practice guidelines management of anxiety disorders: Generalized Anxiety Disorder. Can J Psychiatry. 2006;51(suppl2):51S-55S.
    19. Lyrica. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 26, 2015.
    20. FDA/CEDR resources page. Food and Drug Administration Web site. Available at http://www.fda.gov/cder/approval/index.htm. Accessed May 26, 2015.
    21. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 26, 2015.
    22. American College of Rheumatology. Diagnostic Criteria for Fibromyalgia 2010. Available at: http://www.rheumatology.org/practice/clinical/classification/fibromyalgia/2010_preliminary_diagnostic_criteria.pdf. Accessed June 21, 2013.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.