REVIEW REQUEST FOR: Mepolizumab (Nucala®) Provider Data Collection Tool Based on Medical Policy DRUG.00080 Policy Last Review Date: 02/04/2016 Request Date: Initial Request Buy and bill / Policy Effective Date: 04/01/2016 Provider Tool Effective Date: 04/01/2016 / Subsequent Request Individual’s Name: Date of Birth: / / Individual’s Phone Number: Insurance Identification Number: Primary Diagnosis: Diagnosis Code(s) (if known): Ordering Provider Name & Specialty: Individual’s Weight (lbs) (kg) Provider ID Number (if known): Office Address: Contact Name and Office Phone Number: Office Fax Number: Servicing Provider Name & Specialty (If different than Ordering Provider): Provider ID Number (if known): Office Address: Contact Name and Office Phone Number: Office Fax Number: Place of Service: Home Office Dialysis Center Outpatient Hospital Ambulatory Infusion Ambulatory Infusion Center Other: Drug Name/HCPCS Code (if known) Dose to be administered: Nucala® (mepolizumab) J3490 J3590 C9473 Other: When did the individual first start this drug? Frequency (Days, Wks, Months) / / Duration: Start Date For This Request: (Weeks) / / (mg) (other) This Medical Policy based provider data collection tool is intended to facilitate a UM medical necessity review request for the initial and continued use of mepolizumab (Nucala®) in the treatment of individuals with severe eosinophilic asthma that is not well-controlled with inhaled corticosteroids and long-acting beta-agonists. Please check all that apply to the individual. Initial Use Request is for use of Nucala® in the treatment of severe eosinophilic asthma for an initial period of 12 months Individual is 12 years of age or older Symptoms have been unsuccessfully controlled by various therapies. (If checked, indicate which of the therapies in the below listing have been attempted and were ineffective) 12 months of high-dose inhaled corticosteroid (ICS) given in combination with a minimum of 3 months of controller medication (If checked, mark any of the controller medications used from the list below) Long-acting beta2-agonist [LABA] unless the individual was intolerant of, or had a medical contraindication to this agent Leukotriene receptor antagonist [LTRA], unless the individual was intolerant of, or had a medical contraindication to this agent Theophylline, unless the individual was intolerant of, or had a medical contraindication to this agent REVIEW REQUEST FOR: Mepolizumab (Nucala®) Provider Data Collection Tool Based on Medical Policy DRUG.00080 Policy Last Review Date: 02/04/2016 Policy Effective Date: 04/05/2016 Provider Tool Effective Date: 04/05/2016 6 months of inhaled use of corticosteroids (ICS) with daily oral glucocorticoids given in combination with a minimum of 3 months of controller medication (If checked, mark any of the controller medications used from the list below) A long-acting beta2-agonist (LABA), unless the individual was intolerant of, or had a medical contraindication to these agents) A leukotriene receptor antagonist (LTRA), unless the individual was intolerant of, or had a medical contraindication to these agents Theophylline, unless the individual was intolerant of, or had a medical contraindication to these agents Individual has eosinophilia, in the absence of other potential causes, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection Individual has a blood eosinophil count greater than or equal to 150 cells/microliter* at initiation of therapy Individual has a blood eosinophil count greater than or equal to 300 cells/microliter* in the prior 12 months *NOTE: 1 microliter (ul) is equal to 1 cubic millimeter (mm3) Individual has a confirmed asthma diagnosis (If checked, mark the following clinical evidence supporting the diagnosis) A pretreatment forced expiratory volume in 1 second (FEV 1 ) less than 80% predicted FEV1 reversibility of at least 12% and 200 milliliters (ml) after albuterol (salbutamol) administration Treatment Continuation Request is for continued use of Nucala® treatment after 12 months for an individual with documented severe eosinophilic asthma Treatment with Nucala® has resulted in clinical improvement (If checked, identify the documented evidence of improvement from the list below) Decreased use of rescue medications Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids) Increase in predicted FEV1 from pretreatment baseline Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing Other uses: Nucala® will be used for: Aspirin-exacerbated respiratory disease (AERD) Atopic dermatitis Eosinophilic esophagitis Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss Syndrome) Nasal polyposis Hypereosinophillic syndromes (other than severe eosinophilic asthma) Request is for use of Nucala® to treat another condition not specified above. Please specify: (Please submit all supporting documents including labs, progress notes, imaging, etc., for review.) Page 2 of 3 REVIEW REQUEST FOR: Mepolizumab (Nucala®) Provider Data Collection Tool Based on Medical Policy DRUG.00080 Policy Last Review Date: 02/04/2016 Policy Effective Date: 04/05/2016 Provider Tool Effective Date: 04/05/2016 This request is being submitted: Pre-Claim Post–Claim. If checked, please attach the claim or indicate the claim number I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its designees may perform a routine audit and request the medical documentation to verify the accuracy of the information reported on this form. Name and Title of Provider or Provider Representative Completing Form and Attestation (Please Print)* Date *The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted. Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization management services on behalf of your health benefit plan or the administrator of your health benefit plan. Page 3 of 3
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