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) Immediate-Release
  • Lyrica (pegabalin ER) Controlled-Release
FDA-Approved Indications:
  • Lyrica Immediate-Release is FDA approved for:
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia
    • Adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older
    • Fibromyalgia
    • Neuropathic pain
  • Lyrica Controlled-Release is FDA approved for:
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia


Background:
  • Pregabalin 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, pregabalin 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. Pregabalin, ultimately results in inhibition of excitatory neurotransmitter releases.
  • 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.


Approval Criteria

I.      Lyrica (pregabalin) Immediate-Release

A.    Diabetic Peripheral Neuropathy

When a benefit, coverage of pregabalin may be approved for diabetic peripheral neuropathy when all of the following criteria are met (1., 2., and 3.,)

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

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

3.     The member has had failure, intolerance or contraindication to duloxetine.

 

B.    Post Herpetic Neuralgia

When a benefit, coverage of pregabalin may be approved for post-herpetic neuralgia when all of the following criteria are met (1., 2., and 3.,)

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

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

3.     The member has had failure, intolerance or contraindication to gabapentin.

 

C.    Seizure Disorder

When a benefit, coverage of pregabalin may be approved for a seizure disorder when all of the following criteria are met (1., 2., and 3.,)

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

2.     The member is 4 years or older.

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

a.     The member has had therapeutic failure or intolerance to two anti-epilepsy medications.

b.    All anti-epilepsy medications are contraindicated.

 

D.    Neuropathic Pain

When a benefit, coverage of pregabalin may be approved for neuropathic pain when all of the following criteria are met (1., 2., and 3.,)

1.     The member has a diagnosis of a neuropathic pain

2.     The member is 18 years or older.

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

a.     The member has had therapeutic failure or intolerance to two anti-epilepsy medications or tricyclic antidepressants.

b.    All anti-epilepsy medications and tricyclic antidepressants are contraindicated.

 

E.    Fibromyalgia

When a benefit, coverage of pregabalin may be approved for fibromyalgia when all of the following criteria are met (1., 2., 3., and 4.,)

1.     The member has a diagnosis of fibromyalgia.

2.     The member meets all of the following criteria (a through c), as supported by clinical documentation (i.e. chart notes):

a.     Documentation of widespread bilateral pain above and below the waist.

b.    Documentation of pain duration of at least 3 months duration.

c.     Documentation of at least one fibromyalgia-related symptom as follows (i. through v.):

i.      Cognitive impairment

ii.    Fatigue

iii.   Sleep disturbance

iv.   Neurologic symptoms

v.     Exercise intolerance

3.     The member has had therapeutic failure, intolerance or contraindication to duloxetine.

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

a.     The member has had failure or intolerance to one of the following products (i. through iv.):

i.      cyclobenzaprine

ii.    amitriptyline

iii.   gabapentin

iv.   tramadol

b.    The member has a contraindication to all of the following products (i. through iv.):

i.     cyclobenzaprine

ii.    amitriptyline

iii.   gabapentin

iv.   tramadol

 

II.    Lyrica (pregabalin ER) Controlled Release

A.    Diabetic Peripheral Neuropathy

When a benefit, coverage of pregabalin ER may be approved for diabetic peripheral neuropathy when all of the following criteria are met (1., 2., 3., and 4.)

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

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

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

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

 

B.    Post Herpetic Neuralgia

When a benefit, coverage of pregabalin ER may be approved for post-herpetic neuralgia when all of the following criteria are met (1., 2., 3., and 4.)

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

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

3.     The member has had failure, intolerance or contraindication to gabapentin.

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

 

III.   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 Controlled-Release (pregabalin ER) use is to increase patient adherence or convenience.

II.    Coverage of pregabalin products 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
  • If approved, up to a lifetime authorization may be granted.


Automatic Approval Criteria

I. Lyrica (pregabalin) Immediate-Release

Members who meet one of the criteria as outlined below (A. through E.) 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.

A. The member has at least one claim for a medication used for the treatment of diabetes within the last year.

B. There is a claim for one antiviral medication used for the treatment of herpes zoster infection and one claim for a gabapentin product in the members' pharmacy profile within the last year.  

C. There are claims for two antiepileptic drugs (AED) in the members' pharmacy profile within the last year.

D. There are claims for two tricyclic antidepressants (TCA) in the members' pharmacy profile within the last year.

E. There are claims for one AED and one TCA in the members' pharmacy profile within the last year.

 

II. Lyrica (pregabalin ER) Controlled-Release

Members who meet all of the criteria as outlined below (A. and B.) 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.

A. The member meets one of the following criteria (1. or 2.):

1. The member has at least one claim for a medication used for the treatment of diabetes within the last year and one claim for generic duloxetine in the member’s pharmacy profile within the last year.

2. There is a claim for one antiviral medication used for the treatment of herpes zoster infection and one claim for a gabapentin product in the members' pharmacy profile within the last year.

B. The member has at least one claim for the Lyrica (pregabalin) Immediate-Release within the last year.

 

Members who do not meet any of the above criteria will require prior authorization.


Version: J-0300-015
Effective Date Begin: 08/02/2018
Effective End Begin: 04/27/2020
Original Date: 12/07/2005
Review Date: 08/01/2018


References:

  1. Lyrica (pregabalin) [package insert]. Pfizer Global Pharmaceuticals. Parsippany, NJ. May 2018.
  2. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: A randomized controlled trial. Neurology. 2004;63:2104-2110.
  3. 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.
  4. French JA, Kugler AR, Robbins JL, et al. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology. 2003:60:1631-1637.
  5. 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. Pain. 2004:109:26-35.
  6. Pande AC, Crockatt JG, Feltner DE, et al. Pregabalin in generalized anxiety disorder: A placebo-controlled trial. Am J Psychiatry. 2003; 160:533-540.
  7. Namaka M, Gramlich C, Ruhlen D, et al. A treatment algorithm for neuropathic pain. Clinical Therapeutics. 2004; 26:951-979.
  8. Finnerup NB, Otto M, McQuay HJ, et al. Algorithm for neuropathic pain treatment: An evidence based proposal. Pain. 2005; 1-17.
  9. In: DRUGDEX System (electronic version). Truven Health Analyticsl Greenwood Village, Colorado, USA. Available at http://www.micromedixsolutions.com/ (Accessed: June 30, 2017).
  10. Clinical Pharmacology. Tampa, FL: Gold Standard, Inc; 2015.. Accessed June 30, 2017.
  11. Clauw, Daniel J. "Fibromyalgia: A Clinical Review." JAMA 311.15 (2014): 1547-1555.
  12. Wolfe F, Clauw DJ, Fitzcharles MA, et al. The American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and Measurement of Symptom Severity. Arthritis Care & Research. 2010; 62: 600-610.
  13. Bennett, Friend R, Marcus D, et al. Criteria for the Diagnosis of Fibromyalgia: Validation of the Modified 2010 Preliminary ACR Criteria and the Development of Alternative Criteria. Arthritis Care and Research. 2014.
  14. Lyrica (pregabalin ER) Controlled-Release. prescribing information. Pfizer Global Pharmaceuticals. New York, New York. October 2017.




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.