Pharmacy Policy Bulletin
: Lyrica/Lyrica CR (pregabalin/pregabalin ER) – Commercial and Healthcare Reform
Number: J-0300 Category: Managed Rx Coverage
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial (1. or 2.):

1.  Rx Mgmt Performance = Patent Deterrents/Extenders + Guideline

2.  Rx Mgmt Performance = MRXC = Yes

 

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Lyrica (pregabalin IR) immediate-release capsules and oral solution
  • Lyrica CR (pregabalin ER) controlled-release tablets
FDA-Approved Indications:
  • Lyrica (pregabalin) immediate-release:
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia (PHN)
    • Adjunctive therapy for the treatment of partial onset seizures in patients 1 month of age or older
    • Fibromyalgia
    • Neuropathic pain associated with spinal cord injury
  • Lyrica CR (pregabalin extended-release):
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia (PHN)


Background:
  • Lyrica binds with high affinity to the alpha2-delta site of the voltage-gated calcium channels on presynaptic terminals within the central nervous system tissues. As a result, Lyrica modulates calcium influx, reduces calcium dependent release of pain inducing neurotransmitters including glutamate and substance P, and restores the release of norepinephrine which results in pain inhibition. Ultimately this results in inhibition of excitatory neurotransmitter releases. Additionally, Lyrica is an analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and exhibits analgesic, anxiolytic and anticonvulsant activity.
  • Peripheral neuropathy is nerve damage caused by chronic hyperglycemia. It causes numbness, loss of sensation, and pain in the feet, legs, or hands.
  • Postherpetic neuralgia is a complication of shingles effecting nerve fibers and the skin causing burning pain that lasts after the rash and blisters have disappeared.
  • Seizures occur when there is a surge in electrical activity. Partial onset seizures occurs in one area of the brain.
  • Fibromyalgia is widespread musculoskeletal pain accompanied by fatigue, sleep, memory, and mood issues. Symptoms can occur after physical trauma, surgery, infection, psychological stress, or gradually accumulate over time with no single triggering event.
  • Neuropathic pain is caused by damage or disease affecting the somatosensory nervous system. Symptoms include shooting, burning pain that may be constant or occur randomly.
  • The intent of prior authorization criteria is to ensure appropriate selection of patients for treatment according to product labeling and/or clinical studies and/or guidelines to encourage use of first line safe and effective therapies. The policy enforces neuropathic pain, which does not have to be due to spinal cord injury.
  • Prescribing Considerations:
    • Angioedema (e.g. swelling of the throat, head and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Peripheral edema may also occur.
    • Increased seizure frequency or other adverse reactions may occur if Lyrica is rapidly discontinued; therefore, gradually withdraw over a minimum of 1 week.
    • Lyrica IR and Lyrica CR share side effects such as angioedema, hypersensitivity reactions, suicadal behavior or ideation, peripheral edema, increased seizure frequency, tumorigenic potential, ophthalmological effects, creatinine kinase elevations, decreaed platelet count, PR interval prolongation, caution when using concomitantly with opioids, dizziness and somnolence, dry mouth, blurred vision, and weight gain.


Approval Criteria

 

I.      Authorization Criteria

 

A.    Lyrica (pregabalin) Immediate-Release

 

1.     Diabetic Peripheral Neuropathy

When a benefit, coverage of Lyrica (pregabalin) may be approved when all of the following criteria are met (a. through e.):

a.     The member is 18 years of age or older.

b.    The member has a diagnosis of diabetic peripheral neuropathy.

c.     The member has experienced therapeutic failure, contraindication, or intolerance to duloxetine.

d.    If the request is for brand Lyrica, the member has experienced therapeutic failure or intolerance to generic pregabalin immediate-release.

e.     If the request is for Lyrica (pregabalin) oral solution, the member has an inability to swallow capsules.

 

2.     Post Herpetic Neuralgia

When a benefit, coverage of Lyrica (pregabalin) may be approved when all of the following criteria are met (a. through e.):

a.     The member is 18 years of age or older.

b.    The member has a diagnosis of post-herpetic neuralgia.

c.     The member has experienced therapeutic failure, contraindication, or intolerance to gabapentin.

d.    If the request is for brand Lyrica, the member has experienced therapeutic failure or intolerance to generic pregabalin immediate-release.

e.     If the request is for Lyrica (pregabalin) oral solution, the member has an inability to swallow capsules.

 

2.     Seizure Disorder

When a benefit, coverage of Lyrica (pregabalin) may be approved when all of the following criteria are met (a. through d.):

a.     The member has a diagnosis of a seizure disorder.

b.    The member meets one (1) of the following criteria (i. or ii.):

i.     The member has experienced therapeutic failure or intolerance to two (2) anti-epilepsy medications.

ii.    All other anti-epilepsy medications are contraindicated.

c.     If the request is for brand Lyrica, the member has experienced therapeutic failure or intolerance to generic pregabalin immediate-release.

d.    If the request is for Lyrica (pregabalin) oral solution, the member has an inability to swallow capsules.

 

3.     Neuropathic Pain

When a benefit, coverage of Lyrica (pregabalin) may be approved when all of the following criteria are met (a. through e.):

a.     The member is 18 years of age or older.

b.    The member has a diagnosis of a neuropathic pain.

c.     The member meets one (1) of the following criteria (i. or ii.):

i.     The member has experienced therapeutic failure or intolerance to two (2) medications in any of the following classes (A., B., or C.):

A.    Serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g. duloxetine)

B.    Anti-epileptic drugs (e.g. gabapentin)

C.    Tricyclic antidepressants

ii.    All SNRIs, anti-epilepsy medications, and tricyclic antidepressants are contraindicated.

d.    If the request is for brand Lyrica, the member has experienced therapeutic failure or intolerance to generic pregabalin immediate-release.

e.     If the request is for Lyrica (pregabalin) oral solution, the member has an inability to swallow capsules.

 

4.     Fibromyalgia

When a benefit, coverage of Lyrica (pregabalin) may be approved when all of the following criteria are met (a. through f.):

a.     The member has a diagnosis of fibromyalgia.

b.    There is clinical documentation (i.e. chart notes) of the fibromyalgia diagnosis including all of the following (i., ii., and iii.):

i.     Widespread bilateral pain above and below the waist.

ii.    Pain duration of at least 3 months duration.

iii.   At least one (1) fibromyalgia-related symptom from the following (A. through E.):

A.    Cognitive impairment

B.    Fatigue

C.    Sleep disturbance

D.    Neurologic symptoms

E.    Exercise intolerance

c.     The member has experienced therapeutic failure, contraindication, or intolerance to duloxetine.

d.    The member meets one (1) of the following criteria (i. or ii.):

                               i.     The member has experienced therapeutic failure or intolerance to one (1) of the following products (A. through D.):

 A.    cyclobenzaprine

 B.    amitriptyline

 C.    gabapentin

 D.    tramadol

                               ii.     The member has a contraindication to all of the following products (A. through D.):

A.    cyclobenzaprine

B.    amitriptyline

C.    gabapentin

D.    tramadol

e.     If the request is for brand Lyrica, the member has experienced therapeutic failure or intolerance to generic pregabalin immediate-release.

f.      If the request is for Lyrica (pregabalin) oral solution, the member has an inability to swallow capsules.

 

B.    Lyrica CR

 

1.     Diabetic Peripheral Neuropathy

When a benefit, coverage of Lyrica CR may be approved when all of the following criteria are met (a. through d.):

a.     The member is 18 years of age or older.

b.    The member has a diagnosis of diabetic peripheral neuropathy.

c.     The member has experienced therapeutic failure, intolerance, or contraindication to duloxetine.

d.    The member has experienced therapeutic failure (i.e. return of pain between doses) or intolerance to generic pregabalin immediate-release that is not anticipated to occur with Lyrica CR.

 

2.     Post Herpetic Neuralgia

When a benefit, coverage of Lyrica CR may be approved for post-herpetic neuralgia when all of the following criteria are met (a. through d.):

a.     The member is 18 years of age or older.

b.    The member has a diagnosis of post-herpetic neuralgia.

c.     The member has experienced therapeutic failure, intolerance, or contraindication to gabapentin.

d.    The member has experienced therapeutic failure (i.e. return of pain between doses) or intolerance to generic pregabalin immediate-release that is not anticipated to occur with Lyrica CR.

 

 

II.    For Commercial and HCR members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made based on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.


Limitations of Coverage

I.   No exceptions will be made if the sole purpose of Lyrica CR use is to increase patient adherence or convenience.

II.  Coverage of Lyrica (pregabalin) or Lyrica CR for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

III. For Commercial or HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

 


Authorization Duration
  • Commercial and HCR Plans: If approved, up to a 12 month authorization may be granted.

 


Automatic Approval Criteria

A.    Lyrica (pregabalin) immediate-release

Members who meet one (1) of the criteria as outlined below (1. through 5.) will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required.

1.     The member has at least one (1) claim for a medication used for the treatment of diabetes in the member’s prescription drug claims history within the previous 365 days.

2.     There is a claim for one (1) antiviral medication used for the treatment of herpes zoster infection and one claim for a gabapentin product in the member’s prescription drug claims history within the previous 365 days.

3.     There are claims for two (2) antiepileptic drugs (AED) in the member’s prescription drug claims history within the previous 365 days.

4.     There are claims for two (2) tricyclic antidepressants (TCA) in the member’s prescription drug claims history within the previous 365 days.

5.     There are claims for one (1) AED and one (1) TCA in the member’s prescription drug claims history within the previous 365 days.

 

B.    Lyrica CR

Members who meet all of the criteria as outlined below (1. and 2.) will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required.

1.     The member meets one (1) of the following criteria (a. or b.):

a.     The member has one (1) claim for a medication used for the treatment of diabetes and one (1) claim for generic duloxetine in the member’s prescription drug claims history within the previous 365 days.

b.    There is a claim for one (1) antiviral medication used for the treatment of herpes zoster infection and one (1) claim for a gabapentin product in the member’s prescription drug claims history within the previous 365 days.

2.     The member has at least one (1) claim for the Lyrica (pregabalin) immediate-release in the member’s prescription drug claims history within the previous 365 days.

 


Version: J-0300-016
Effective Date Begin: 04/28/2020
Effective End Begin: 06/29/2020
Original Date: 12/07/2005
Review Date: 08/07/2019


References:

  1. Lyrica (pregabalin) [package insert]. Pfizer Inc. New York, NY. May 2019.
  2. Lyrica CR (pregabalin ER) [package insert]. Pfizer Inc. New York, NY. October 2017.
  3. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: A randomized controlled trial.    2004;63:2104-2110.
  4. 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.    2004;45(1):20-27.
  5. French JA, Kugler AR, Robbins JL, et al. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures.    2003:60:1631-1637.
  6. 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 randomised, placebo-controlled clinical trial.    2004:109:26-35.
  7. Pande AC, Crockatt JG, Feltner DE, et al. Pregabalin in generalized anxiety disorder: A placebo-controlled trial.  Am J Psychiatry.  2003; 160:533-540.
  8. Namaka M, Gramlich C, Ruhlen D, et al. A treatment algorithm for neuropathic pain.  Clinical Therapeutics.  2004; 26:951-979.
  9. Finnerup NB, Otto M, McQuay HJ, et al. Algorithm for neuropathic pain treatment: An evidence based proposal.    2005; 1-17.
  10. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2018.
  11. Clinical Pharmacology. Tampa, FL: Gold Standard, Inc; 2015.
  12. Clauw, Daniel J. "Fibromyalgia: A Clinical Review." JAMA 311.15 (2014): 1547-1555.




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.