MEDICAL NECESSITY GUIDELINE

Transcription

1 PAGE: 1 of 6 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted standards of medical practice, peerreviewed medical literature, government agency/program approval status, and other indicia of medical necessity. The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits ( Benefit Plan Contract ) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control. Clinical policies are intended to be reflective of current scientific research and clinical thinking. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. Description: The intent of the criteria is to ensure that patients follow selection elements established by Centene medical policy for the use of clonazepam (Klonopin ). Generic: Clonazapam Policy Indication: Indicated in the treatment of pediatric seizure disorders.

2 MEDICAL NECESSITY GUIDELINE DEPARTMENT: Pharmacy PAGE: 2 of 6 EFFECTIVE DATE: 3/2016 RETIRED: PRODUCT TYPE: Medicaid DOCUMENT NAME: Benzodiazepine Use in REPLACES DOCUMENT: REVIEWED: 12/2017 REVISED: 12/2017 Criteria for Approval: Initiation of therapy for up to 3 months (must meet A-B) A. Prescribed by a neurologist B. Use for any of the following indications and Clonazepam is requested: 1. Diagnosis of Childhood Absence Epilepsy, Juvenile Absence Epilepsy, or Absence type seizures. a. Member has tried and failed two separate monotherapy trials of PDL agents (Valproic Acid, Ethosuximide, Lamotrogine) at 4 weeks each unless contraindication or patient demonstrates intolerance b. Member has tried and failed one combination (at least 2) of PDL agents (Valproic Acid, Ethosuximide, Lamotrogine) for 4 weeks unless contraindication or patient demonstrates intolerance c. Previous AED trials were at an adequate dose d. Dose does not exceed: i. Adolescents > 30 kg, 20mg/day in three ii. Infants/Children <10years (<30kg), mg/kg/day in three 2. Diagnosis of Myoclonic type seizures a. Member has tried and failed two separate monotherapy trials of PDL agents (Valproic Acid, levetiracetam, topiramate) at 4 weeks each unless contraindication or patient demonstrates intolerance

3 PAGE: 3 of 6 b. Member has tried and failed one combination (at least 2) of PDL agents (valproic acid, levetiracetam, topiramate) for 4 weeks unless contraindication or patient demonstrates intolerance c. Dose does not exceed i. Adolescents > 30 kg, 20mg/day in three ii. Infants/Children <10years (<30kg), mg/kg/day in three 3. Diagnosis of Juvenile Myoclonic Epilepsy a. Member has tried and failed two separate monotherapy trials of PDL agents (Valproic Acid, Lamotrogine, Levetiracetam, or Topiramate) at 4 weeks each unless contraindication or patient demonstrates intolerance b. Member has tried and failed one combination (at least 2) of PDL agents (Valproic Acid, Lamotrogine, Levetiracetam, or Topiramate) for 4 weeks unless contraindication or patient demonstrates intolerance c. Does not exceed i. Adolescents > 30 kg, 20mg/day in three ii. Infants/Children <10years (<30kg), mg/kg/day in three 4. Diagnosis of Lennox-Gastaut Syndrome a. Member has tried and failed monotherapy with Valporic Acid for 4 weeks unless contraindication or patient demonstrates intolerance b. Member has tried and failed one combination of Valproic Acid plus Lamotrogine, or Topiramate for 4

4 MEDICAL NECESSITY GUIDELINE DEPARTMENT: Pharmacy PAGE: 4 of 6 EFFECTIVE DATE: 3/2016 RETIRED: PRODUCT TYPE: Medicaid DOCUMENT NAME: Benzodiazepine Use in REPLACES DOCUMENT: REVIEWED: 12/2017 REVISED: 12/2017 weeks unless contraindication or patient demonstrates intolerance c. Dose does not exceed i. Adolescents > 30 kg, 20mg/day in three ii. Infants/Children <10years (<30kg), mg/kg/day in three Continuation of therapy for up to 6 months (must meet A-B) A. Prescribed by a neurologist B. Previously met criteria for one of the diagnosis under initiation of therapy C. Demonstrated a therapeutic response by significant reduction in seizures and not having any intolerable side effects/contraindications a. Does not exceed i. Adolescents > 30 kg, 20mg/day in three ii. Infants/Children <10years (<30kg), mg/kg/day in three

5 PAGE: 5 of 6 Background Absence type seizures or epilepsy syndromes manifest with motionless staring, behavioral arrest, automatisms, and spikes and wave discharges on EEG. Mild facial jerks and lack of post-ictal periods are common. Absence seizures last 5-10 seconds and may cluster. Myoclonic type seizures or epilepsy syndromes display characteristic rapid, lightning like jerking movements of the whole body. It can either occur on one side or both sides of the body and may involve small or larger muscle groups. Lennox-Gastaut syndrome is a pharmaco-resistant epileptic syndrome that starts in children less than 5 years old. Multiple seizure types, mental regression, and specific EEG patterns are characteristic of this childhood syndrome. Some recognized causes include: brain injuries or malformations, infections, and perinatal causes. References 1. National Institute of Health and Clinical Excellence (NICE) (2012) Epilepsies: diagnosis and management. [Online]. Available at: [Accessed on Aug ]. 2. Clinical Pharmacology. Gold Standard, Inc. Clonazepam. [Online]. Available at: [Accessed on Aug ]. 3. Schmidt D, Bourgeois B. A Risk-Benefit Assessment of Therapies for Lennox-Gastaut Syndrome. Drug Safety. 2000;22(6): doi: / Rijckevorsel K. Treatment of Lennox-Gastaut syndrome: overview and recent findings. Neuropsychiatric Disease and Treatment 2008:4(6)

6 PAGE: 6 of 6 Reviews, Revisions, and Approvals Date Approval Date New policy created 03/16 03/16 Reviewed without any changes made 12/17 POLICY AND PROCEDURE APPROVAL Pharmacy & Therapeutics Committee: Director, Pharmacy Operations: Medical Director: Approval on file Approval on file Approval on file