Oscar Commercial Clinical Policy

Oscar Pregabalin Immediate-Release (Lyrica) (PG060) Form


Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



Pregabalin (Lyrica)

Pregabalin (Lyrica) is a medication that is used for several conditions such as neuropathic pain, fibromyalgia, seizures, and anxiety. For neuropathic pain, it works by reducing the calcium currents in the nervous system. Pregabalin is structurally similar to gabapentin (Neurontin) which is also used for similar conditions.

Definitions

"Neuropathic pain" is nerve pain that can result from several conditions affecting the nervous system and can present as burning, tingling, numbness, or itching.

"Fibromyalgia" is a condition presenting as widespread, chronic pain in which other symptoms can include fatigue and sleep issues.

"Pruritus" refers to an uncomfortable, itchy sensation on the skin, which can be associated with various conditions, including chronic kidney disease (uremic pruritus), malignancies, and neuropathies.

"Refractory chronic cough" is a persistent, hard-to-treat cough that remains unresponsive to standard treatment and significantly impacts quality of life.

"Vasomotor symptoms" typically refer to symptoms like hot flashes, night sweats, or other physiological responses to changing hormone levels, often seen during menopause.

Medical Necessity Criteria for Authorization

The Plan considers pregabalin medically necessary when ALL the following criteria are met for the applicable indication listed below:

For the management of fibromyalgia
  1. The member is 18 years of age or older; AND
  2. The member has a diagnosis of fibromyalgia; AND
  3. The member is unable to use, or has adequately tried and failed ALL of the following:
    • non-pharmacologic therapy (e.g., aerobic or strength exercises, mindfulness); and
    • gabapentin at the maximum tolerated dose for at least a 30 day duration; and
    • at least ONE of the following (at the maximum tolerated dose after a minimum 30 daytrial) :
      1. Serotonin and norepinephrine reuptake inhibitors (e.g., duloxetine); or
      2. Tricyclic antidepressants (e.g., amitriptyline); or
      3. cyclobenzaprine.
For the management of neuropathic pain
  1. The member is 18 years of age or older; AND
  2. The member has ONE of the following diagnoses:
    • postherpetic neuralgia (PHN); or
    • pain associated with diabetic peripheral neuropathy (DPN); or
    • pain associated with spinal cord injury; or
    • other types of neuropathic pain (e.g., central post-stroke pain, HIV-related peripheral neuropathy, cancer-related neuropathy, chronic neuropathic pain); AND
  3. The member is unable to use, or has adequately tried and failed gabapentin (at the maximum tolerated dose after a minimum 30 day trial).
For seizure disorders
  1. The requested medication is prescribed by, or in consultation with, a neurologist; AND
  2. The member has a diagnosis of focal onset (partial-onset) seizures; AND
  3. The requested medication will be used as adjunctive therapy (i.e., in combination with other anticonvulsant agents); AND
  4. The member is unable to use, or has adequately tried and failed gabapentin (at the maximum tolerated dose after a minimum 30 day trial).
For other off-label uses
  1. The member is 18 years of age or older; AND
  2. The medication is being requested for treatment of ONE of the following:
    • chronic kidney disease–associated pruritus (including chronic uremic pruritus) OR chronic neuropathic or malignancy-related pruritus (including brachioradial pruritus), AND the member is unable to use, or has tried and failed gabapentin; or
    • generalized anxiety disorder, AND the member is unable to use, or has tried and failed selective serotonin reuptake inhibitors (SSRIs) (e.g., escitalopram, paroxetine, sertraline) and serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine, venlafaxine); or
    • moderate to severe primary restless legs syndrome (RLS) with predominant evening symptoms, AND the member is unable to use, or has tried and failed dopamine agonist (e.g., bromocriptine, pramipexole, or ropinirole); or
      • refractory chronic cough in combination with speech pathology therapy, AND the member is unable to use, or has tried and failed gabapentin; or
      • social anxiety disorder, AND the member is unable to use, or has tried and failed selective serotonin reuptake inhibitors (SSRIs) (e.g., escitalopram, paroxetine, sertraline) and serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine, venlafaxine); or
      • vasomotor symptoms (e.g., hot flashes) associated with menopause, AND the member is unable to use, or has tried and failed hormonal therapy (e.g., oral estrogen, transdermal estrogen patch).

      If the above prior authorization criteria are met for the applicable indication, pregabalin will be approved for 12 months.

      Experimental or Investigational / Not Medically Necessary

      Pregabalin immediate-release for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

      References

      1. Abou-Khalil, B. W. (2022). Update on Antiseizure Medications 2022. CONTINUUM: Lifelong Learning in Neurology, 28(2), 500-535.
      2. Abrams GM, Wakasa M. Chronic complications of spinal cord injury and disease.UpToDate.com. Available at: https://www.uptodate.com/contents/chronic-complications-of-spinal-cord-injury-and-disease. Updated August 19, 2019. Accessed August 11, 2020.
      3. Allen R, Chen C, Soaita A, et al. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med. 2010;11(6):512-519. doi:10.1016/j.sleep.2010.03.003
      4. Allen RP, Chen C, Garcia-Borreguero D, et al. Comparison of pregabalin with pramipexole for restless legs syndrome. N Engl J Med. 2014;370(7):621-631. doi:10.1056/NEJMoa1303646
      5. Atıs G, Bilir Kaya B. Pregabalin treatment of three cases with brachioradial pruritus. DermatolTher. 2017;30(2). doi:10.1111/dth.12459
      6. Aurora RN, Kristo DA, Bista SR, et al; American Academy of Sleep Medicine. 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. doi:10.5665/sleep.1988
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      10. Foroutan N, Etminan A, Nikvarz N, Shojai Shahrokh Abadi M. Comparison of pregabalin with doxepin in the management of uremic pruritus: a randomized single blind clinical trial. Hemodial Int. 2017;21(1):63-71. doi:10.1111/hdi.12455
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        Treatment of unexplained chronic cough: CHEST guideline and expert panel report

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        Management of Fibromyalgia Syndrome

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        American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause

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        Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

        Katzman MA, Bleau P, Blier P, Chokka P, Kjernisted K, Van Ameringen M; Canadian Anxiety Guidelines Initiative Group on behalf of the Anxiety Disorders Association of Canada/Association Canadienne des troubles anxieux and McGill University. BMC Psychiatry. 2014;14(suppl 1):S1.

        Diagnosis and Management of Generalized Anxiety Disorder and Panic Disorder in Adults

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        Uraemic pruritus: clinical characteristics, pathophysiology and treatment

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        Gabapentin and pregabalin for the treatment of chronic pruritus

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        Menopause. 2015;22(11):1155-1172.

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        Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline

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        Pregabalin and speech pathology combination therapy for refractory chronic cough: a randomized controlled trial

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        Vestita M, Cerbone L, Calista D. Brachioradial pruritus in a 47-year-old woman treated with pregabalin. G Ital Dermatol Venereol. 2016;151(6):727-728.

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        Winkelman JW, Armstrong MJ, Allen RP, et al. Practice guideline summary: Treatment of restless legs syndrome in adults: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2016;87(24):2585-2593. doi:10.1212/WNL.0000000000003388.

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        Clinical Guideline Revision / History Information
        • Original Date: 11/05/2020
        • Reviewed/Revised: 10/14/2021, 12/01/2021, 06/23/2022, 06/29/20236