Background

Pregabalin (Lyrica™) is an analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), exhibits analgesic, anxiolytic and anticonvulsant activity.  It is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN).  It is also indicated for adjunctive treatment of adult patients with partial onset seizures and for the treatment of fibromyalgia.  It is not indicated as monotherapy for partial onset seizures.  Unlike other medications used for these indications, pregabalin is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.  Pregabalin is the first drug approved for use in the treatment of fibromyalgia.

The literature does not support the use of pregabalin for the treatment of generalized anxiety disorder and will not be covered to treat this condition.

Approval Criteria:  When a benefit, coverage for pregabalin will be approved if members meet one of the following criteria:

1. The member has at least one claim for a medication used for the treatment of diabetes within the last year, OR
2. There is a claim for one antiviral medication used for the treatment of herpes zoster infection in the members' pharmacy profile within the last year, OR
3. There are claims for two antiepileptic drugs (AED) in the members' pharmacy profile within the last year, OR
4. There are claims for two tricyclic antidepressants (TCA) in the members' pharmacy profile within the last year, OR
5. There are claims for one AED and one TCA in the members' pharmacy profile within the last year.

Members who meet the criteria as outlined above will receive automatic authorization at the pharmacy without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required.

Members who do not meet this above criteria will require prior authorization.  One of the following criteria would then need to be documented.

1. The member has a documented diagnosis of DPN, OR
2. The member has a documented diagnosis of PHN, OR
3. The member has a documented diagnosis of seizures: AND has tried and failed two AED, OR
4. The member has a documented diagnosis of unspecified neuropathic pain: AND has failed two other medications in the following classes: AED or TCA. OR
5. The member has a documented diagnosis of fibromyalgia as determined by clinical notes including, but not limited to, confirmation of widespread bilateral pain both above and below the waist for > 3 months duration AND the presence of at least 11 of 18 specific tender points AND documented fibromyalgia-related symptoms (e.g. fatigue, sleep disturbance, neurologic symptoms, and/or exercise intolerance). AND
6. The member has a documented trial and failure of at least two additional agents used to treat fibromyalgia (e.g. tricyclic agents, cyclobenzaprine, SSRIs), one of which must be a tricyclic agent or cyclobenzaprine.

 

References:

1. Lyrica® (pregabalin) prescribing information. Pfizer Global Pharmaceuticals. Parsippany, NJ. July 2005.
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. Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA 2004 Nov 17;292(19): 2388-95.
10. Buckhardt CS, et al. Guideline for the management of fibromyalgia syndrome pain in adults and children. Glenview (IL): American Pain Society (APS); 2005. 109 p. (Clinical practice guideline; no. 4).
11. Wolfe F, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia: Report of the Multicenter Criteria Committee. Arthritis and Rheumatism. 1990;33(2): 160-72.
12. Crofford LJ, et al. Pregabalin for the treatment of fibromyalgia syndrome. Arthritis and Rheumatism. 2005;52(4): 1264-73.
13. Calandre EP, Morillas-Arques P, Rodriguez-Lopez CM, Rico-Villademoros F, Hidalgo J. Pregabalin augmentation of quetiapine therapy in the treatment of fibromyalgia: an open-label, prospective trial. Pharmacopsychiatry. Mar 2007;40(2): 68-71.