Lyrica. Lyrica, Lyrica CR (pregabalin) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Page: 1 of 7 Last Review Date: March 16, 2018 Description, CR (pregabalin) Background is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, management of post-herpetic neuralgia, management of fibromyalgia, management of neuropathic pain associated with spinal cord injury, and adjunctive therapy for adults with partial onset seizures. CR is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and management of post-herpetic neuralgia. and CR are structural derivatives of the inhibitory neurotransmitter gammaaminobutyric acid (GABA), although it does not bind directly to GABA A, GABA B or benzodiazepine receptors (1-2). Regulatory Status FDA-approved indication: is indicated for: (1) 3. Adjunctive therapy for adult patients with partial onset seizures 4. Fibromyalgia 5. Neuropathic pain associated with spinal cord injury CR is indicated for: (2)

2 Subject: Page: 2 of 7 Limitation of Use: (2) Efficacy of CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. and CR are controlled substances due to their potential for euphoric effects, abuse and dependence. Patients should be monitored for angioedema, ocular conditions, increased seizure frequency, increased suicidal thoughts or behavior, peripheral edema, creatinine kinase elevations, decreased platelet count, dizziness and somnolence. When discontinuing and CR, the dose should be gradually tapered over a minimum of one week to minimize the potential of increased seizure frequency in patients with seizure disorders. Dosing regimens of and CR are specific to the indication and require dose adjustment for renal impairment (1-2). The safety and effectiveness of and CR in pediatric patients have not been established (1-2). Related policies Gabapentin, Savella Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. may be considered medically necessary in patients that are 18 years of age and older with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, fibromyalgia, and neuropathic pain associated with spinal cord injury or adjunctive therapy for adult patients with partial onset seizures and if the conditions indicated below are met. CR may be considered medically necessary in patients that are 18 years of age and older with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia and CR are considered investigational in patients that are less than 18 year of age and for all other indications. Prior-Approval Requirements

3 Subject: Page: 3 of 7 Age 18 years of age or older Diagnoses Patient must have ONE of the following: CR 3. Neuropathic pain associated with spinal cord injury 4. Fibromyalgia 5. Partial onset seizures a. Used in combination with other first line anti-epileptic medications AND the following for : 1. Physician agrees to taper patient s dose to the recommended maximum FDA daily dose: a. Patients taking 2000 mg or more daily will be required to taper to 1000 mg daily b. Patients taking less than 2000 mg daily will be required to taper to 600 mg daily Prior Approval Renewal Requirements Age 18 years of age or older Diagnoses Patient must have ONE of the following: CR

4 Subject: Page: 4 of 7 Policy Guidelines 3. Neuropathic pain associated with spinal cord injury 4. Fibromyalgia 5. Partial onset seizures a. Used in combination with other first line anti-epileptic medications AND the following for : 1. Physician agrees to taper patient s dose to the recommended maximum FDA daily dose: a. Patients will be required to taper to 600 mg daily Pre - PA Allowance Age 18 years of age or older Quantity 25mg, 50mg, 75mg, 100mg 540 dosage units per 90 days OR 360 dosage units per 90 days OR 270 dosage units per 90 days OR 225mg, 300mg 180 dosage units per 90 days OR 20mg/mL solution 2700mL per 90 days Maximum daily limit of any combination: 600mg **Utilizing the highest strengths available to achieve the dosage is recommended to minimize dosing errors and improve compliance CR 82.5 mg, 165 mg 360 dosage units per 90 days OR 330mg 180 dosage units per 90 days Maximum daily limit of any combination: 660mg **Utilizing the highest strengths available to achieve the dosage is recommended to minimize dosing errors and improve compliance Prior - Approval Limits

5 Subject: Page: 5 of 7 Quantity CR 82,5 mg, 165 mg, 330 mg Pre-PA allows for the FDA recommended maximum dosage 2000mg or more daily dose 25mg 50mg 75mg 100mg 225mg 300mg 20mg/ml 7200ml per 90 days Maximum daily limit of any combination: 2400mg Less than 2000mg daily dose 25mg 50mg 75mg 100mg 225mg 300mg 540 dosage units per 90 days OR 20mg/ml 5400ml per 90 days Maximum daily limit of any combination: 1800mg Duration 6 months

6 Subject: Page: 6 of 7 Prior Approval Renewal Limits Quantity CR 82,5 mg, 165 mg, 330 mg 25mg 50mg 75mg 100mg 225mg 300mg 20mg/ml Pre-PA allows for the FDA recommended maximum dosage 540 dosage units per 90 days OR 5400ml per 90 days Maximum daily limit of any combination: 1800mg Duration 6 months (One renewal only for patients with an initial daily dose of 2000mg or above) Rationale Summary is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, management of post-herpetic neuralgia, management of fibromyalgia, management of neuropathic pain associated with spinal cord injury, and adjunctive therapy for adults with partial onset seizures. CR is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and management of post-herpetic neuralgia. and CR are controlled substances due to its potential for euphoric effects, abuse and dependence. When discontinuing and CR, the dose should be gradually tapered over a minimum of one week. Dosing regimens of and CR are specific to

7 Subject: Page: 7 of 7 the indication and require dose adjustment for renal impairment. The safety and effectiveness of and CR in pediatric patients have not been established (1-2). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of and CR while maintaining optimal therapeutic outcomes. References 1. [package insert]. New York, NY: Pfizer Pharmaceuticals, Inc.; December CR [package insert]. New York, NY: Pfizer Pharmaceuticals, Inc.; October Policy History Date May 2017 June 2017 December 2017 March 2018 Action Addition to PA Annual review Addition of CR Annual review Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on March 16, 2018 and is effective on April 1, 2018.