Nucala (mepolizumab) Prior Authorization Protocol

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1 Nucala (mepolizumab) Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutic Subcommittee. Drug Requiring Prior Authorization Review: Nucala (mepolizumab) Formulary Alternative: None Criteria: A. Drug: Nucala 1. Diagnosis: Severe asthma with eosinophilic phenotype Criteria: Must meet all of the following requirements: a. Age 12 or older b. Diagnosis of severe eosinophilic asthma confirmed by 1 of the following laboratory results: i. Blood eosinophil counts greater than or equal to 150 cells/microliter at initiation of therapy. ii. Blood eosinophil counts greater than or equal to 300 cells/microliter in the prior year (365 days). b. Asthma is inadequately controlled by the following combination therapy: i. High-dose inhaled corticosteroids (ICS) given in combination with a long-acting beta2-agonist (LABA). c. Member has been compliant to the controller therapy for the past 6 months (180 days) according to refills record, and will continue the controller therapy. d. Documentation of symptomatic asthma despite regular use of therapies, as demonstrated by 1 of the following: i. Two or more asthma exacerbations in the previous year (365 days).

2 ii. Hospitalization due to asthma exacerbation. e. Pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted. Specialist: Allergist or Pulmonologist Quantity Limit: N/A Duration of Therapy: 6 months (180 days) Reauthorization Criteria: Must meet all of the following requirements: a. Recent pharmacy claim within 6 months (180 days) of request. b. Confirmed stability or no disease progression. Duration of Reauthorization: 6 months (180 days) 2. Diagnosis: Eosinophilic granulomatosis with polyangiitis Criteria: Must meet all of the following requirements: a. Age 18 or older b. Confirmed diagnosis by the all of the following: i. History or presence of asthma ii. Blood eosinophil level of 10% or an absolute eosinophil count of more than 1000 cells per cubic millimeter; OR iii. the presence of two or more criteria that are typical of eosinophilic granulomatosis with polyangiitis (i.e. histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation; neuropathy; pulmonary infiltrates; sinonasal abnormality; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; or antineutrophil cytoplasmic antibody [ANCA] positivity). c. Concurrently on a stable dose of oral corticosteroids (i.e. prednisone or prednisolone). Specialist: Allergist or Pulmonologist Quantity Limit: N/A Duration of Therapy: 6 months (180 days) Reauthorization Criteria: Must meet all of the following requirements: a. Recent pharmacy claim within 6 months (180 days) of request.

3 b. Confirmed stability or no disease progression. Duration of Reauthorization: 6 months (180 days) Clinical Justification: FDA-Approved Indications Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Eosinophilic granulomatosis with polyangiitis. Limitation of use Not indicated for treatment of other eosinophilic conditions. Not indicated for the relief of acute bronchospasm of status asthmaticus. Clinical Study: MENSA In a randomized, double-blind placebo study, 576 patients were evaluated with recurrent asthma exacerbations (history of 2 or more exacerbations in the previous year), despite high-dose regular use of inhaled (with or without systemic) glucocorticoids plus an additional controller in the previous year. Presence of eosinophilic inflammation is required, defined as blood eosinophil count 150/mcL at screening or 300/mcL at some point in the previous year. Patients were randomized to receive mepolizumab 75mg intravenously, mepolizumab 100mg subcutaneously or placebo every 4 weeks for 32 weeks. As a result, the rate of exacerbations was reduced by 47% in the intravenous mepolizumab group, 53% in the subcutaneous mepolizumab group, as compared with those receiving placebo (p <0.001 for both comparisons). Furthermore, exacerbations necessitating an emergency department visit or hospitalization were reduced by 32% in the intravenous mepolizumab group by 61% in the subcutaneous mepolizumab group. Significant improvement from baseline FEV 1 was noted, 100 ml greater in the intravenous mepolizumab group (p= 0.02), and 98mL improvement in the subcutaneous mepolizumab group (p= 0.03) in comparison to placebo, respectively. The improvement from baseline St. George s Respiratory Questionnaire (SGRQ) was 6.4 points and 7.0 points greater in the intravenous and subcutaneous mepolizumab groups, respectively, than in the placebo group (p< 0.001), and the improvement in the Asthma Control Questionnaire (ACQ-5) score was 0.42 points and 0.44 points greater in the two study group than placebo (p< 0.001), respectively. The safety profile was comparable to that of placebo.

4 Clinical Study: SIRIUS In a randomized, double-blind study, 135 patients were enrolled with severe eosinophilic asthma (300 blood eosinophils/mcl during the 12 months prior to the study entry or 150 eosinophils/mcl during the optimization phase), despite daily oral glucocorticoid treatment in addition to regular use of high-dose inhaled corticosteroids plus an additional controller(s). Patients were randomized to receive mepolizumab 100mg or placebo subcutaneously every 4 weeks for 20 weeks. As a result, the likelihood of a reduction in the glucocorticoid-dose was 2.39 times greater in the mepolizumab group than in the placebo group (p= 0.008), and the mean reduction from baseline was 50%, as compared with no reduction in the placebo group (p= 0.007). In addition, patients in the mepolizumab group despite receiving a lower glucocorticoid dose, resulted in a 32% relative reduction in the annualized rate of exacerbation (p= 0.04) and a reduction of 0.52 points with respect to asthma symptoms (p= 0.004). The safety profile of mepolizumab was similar to that of placebo. Clinical Study: EGPA In a randomized, placebo-controlled multicenter, 52 week trial, a total of 136 patients with eosinophilic granulomatosis with polyangiitis (EGPA or Churg-Strauss syndrome) were enrolled. Patients receiving 300mg of mepolizumab achieved a significantly greater accrued time in remission compared to placebo. Significantly higher proportion of subjects receiving 300mg of mepolizumab achieved remission at week 36 and week 48 compared to placebo, significantly more subjects receiving mepolizumab achieved remission within the first 24 weeks and remained in remission for the remainder of the 52 week study period compared to placebo (19% vs 1%). Cochrane Database Systematic Review 2015 Eight randomized controlled placebo studies of mepolizumab in adults and children with asthma were included in the systematic review that evaluated efficacy of mepolizumab in reducing exacerbations and improving health-related quality of life (HRQoL). The systematic review concludes that mepolizumab can lead to an improvement in health-related quality of life scores and reduce asthma exacerbation in people with severe eosinophilic asthma. Furthermore, the data review was limited by the fact that the intravenous route is not currently licensed for mepolizumab, and the evidence for the currently licensed subcutaneous route is limited to a single study in patients with severe eosinophilic asthma.

5 Guidelines from the National Asthma Education and Prevention Program: Expert Panel Report

6 References: 1. Nucala [package insert]. GlaxoSmithKline LLC, Philadelphia, PA. 12/ Bel EH, Wenzel SE, Thompson PJ, et al. N Engl J Med Sep; 371(13): Epub 2014 Sep Powell C, Milan SJ, Dwan K, et al. Cochrane Database Syst Rev. 2015; 7:CD Ortega HG, Liu MC, Pavord ID, et al. N Engl J Med Sep;371(13): National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. NIH Publication Number October Available at: Accessed on June 4, National Heart, Lung, and Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR-3). September Available at: Accessed on December 21, 2015.

7 Change Control Date Change 02/21/2018 Updated indications to include Eosinophilic granulomatosis with polyangiitis and added criteria Added clinical study for new indication: EGPA Duration changed from 12 months to 6 months