Drugs Addressed in this Policy

• Lyrica (pregabalin)

 FDA-Approved Indications

• Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia
• Adjunctive therapy for adult patients with partial onset seizures
• Fibromyalgia
• Neuropathic pain

Background

Pregabalin (Lyrica) is an analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and exhibits analgesic, anxiolytic and anticonvulsant activity.

 

Approval Criteria: 

I.      Diabetic Peripheral Neuropathy

When a benefit, pregabalin may be approved for diabetic peripheral neuropathy when all of the following criteria are met: (A., B., and C.,)

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

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

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

 

II.    Post Herpetic Neuralgia

When a benefit, pregabalin may be approved for post-herpetic neuralgia when all of the following criteria are met: (A., B., and C.,)

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

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

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

 

III.   Seizure Disorder

When a benefit, pregabalin may be approved for a seizure disorder when all of the following criteria are met: (A., B., and C.,)

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

B.    The member is 12 years or older.

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

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

2.     All anti-epilepsy medications are contraindicated.

 

IV.   Neuropathic Pain

When a benefit, pregabalin may be approved for neuropathic pain when all of the following criteria are met: (A., B., and C.,)

A.    The member has a diagnosis of a neuropathic pain

B.    The member is 18 years or older.

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

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

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

 

V.    Fibromyalgia

When a benefit, pregabalin may be approved for fibromyalgia when all of the following criteria are met: (A., B., C., and D.,)

A.    The member has a diagnosis of fibromyalgia.

B.    The member meets all of the following criteria (1 through 3), as supported by clinical documentation (i.e. chart notes):

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

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

3.     Documentation of at least one fibromyalgia-related symptom as follows (a through e):

a.     Cognitive impairment

b.    Fatigue

c.     Sleep disturbance

d.    Neurologic symptoms

e.     Exercise intolerance

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

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

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

a.     cyclobenzaprine

b.    amitriptyline

c.     gabapentin

d.    tramadol

2.     The member has a contraindication to all of the following products (a through d):

a.     cyclobenzaprine

b.    amitriptyline

c.     gabapentin

d.    tramadol

·         Coverage of Lyrica for disease states outside of its FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

·         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.

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

 

Automatic Approval Criteria: 

Members who meet one of the criteria as outlined above 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 claim for a medication used for the treatment of diabetes 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.  
3. There are claims for two antiepileptic drugs (AED) in the members' pharmacy profile within the last year.
4. There are claims for two tricyclic antidepressants (TCA) in the members' pharmacy profile within the last year.
5. There are claims for one AED and one TCA in the members' pharmacy profile within the last year.  

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

 

Authorization Duration

If approved, up to a lifetime authorization may be granted.

 

References:

1. Lyrica (pregabalin) prescribing information. Pfizer Global Pharmaceuticals. Parsippany, NJ. December 2016.
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. Pregabalin. In:  DRUGDEX System (electronic version). Truven Health Analyticsl Greenwood Village, Colorado, USA. Available at http://www.micromedixsolutions.com/ (Accessed: June 30, 2017).
10. Pregabalin. 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.