Asthma/Allergy Monoclonal Antibodies

Transcription

1 bmchp.org wellsense.org Pharmacy Policy Policy Number: Version Number: 13.0 Version Effective Date: 01/01/2017 Product Applicability All Plan Products Well Sense Health Plan New Hampshire Medicaid NH Health Protection Program Boston Medical Center HealthNet Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options Note: Disclaimer and audit information is located at the end of this document. Policy Summary The Plan will authorize coverage of Cinqair, Nucala or Xolair when appropriate criteria are met. Description of Item or Service Many traditional therapies are currently available for the treatment of asthma; however, a subset of patients with severe asthma remains uncontrolled. The quest to discover other treatment approaches in the management of asthma/allergic asthma led the introduction of monoclonal antibodies. Currently FDAapproved monoclonal antibodies for asthma include omalizumab, mepolizumab and resulizumab. Xolair (omalizumab) is a recombinant DNA-derived humanized monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. Reduction of surface-bound IgE on these cells reduces the release of mediators of the allergic response. 1 of 9

2 One indication of Xolair is for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro activity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (ICS). The National Asthma Education and Prevention Program (NAEPP) Stepwise Approach to Managing Asthma in Youths > 12 years of Age and Adults recommends that use of Xolair be considered for patients with allergies that require high dose ICS and longacting beta-agonists (Step 5) or those that require high dose ICS, long-acting beta agonists, and oral corticosteroids (Step 6). The recommended dose for Xolair in asthma is 150mg to 375mg subcutaneously every 2 or 4 weeks, depending on body weight and pretreatment serum IgE level. Xolair is also indicated in chronic idiopathic urticarial (CIU) with the same age limitation as for Asthma. Based on the results of two placebo controlled trials, Xolair dosed at 300mg significantly reduced itch severity and number of hives compared to placebo in patients who were not controlled on antihistamine therapy. The mechanism through which down-regulating IgE receptors on cells affects CIU symptoms is unknown. A stepcare approach treatment is recommended by the Joint Task Force on Practice Parameters (JTFPP)* where Xolair is reserved for refractory urticarial following the treatment failure of standard therapy, which includes high-dose H1 antagonists alone, or combined with H2 antagonist or leukotriene receptor antagonists. The recommended dose for Xolair in CIU is 150mg or 300mg subcutaneously every 4 weeks. Dosing in CIU is not dependent on body weight or serum IgE level. Common side effects include nausea, fatigue, headache, dizziness, pruritus, dermatitis, nasopharyngitis, sinusitis, pain (general, leg, arm, joint), cough and upper respiratory tract infection. Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Interleukin-5 (IL-5) is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Nucala binds to IL-5 with a dissociation constant of 100 pm, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Nucala, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils; however, the mechanism of mepolizumab action in asthma has not been definitively established. Based on the results from three trials that compared to Nucala to placebo, subjects receiving Nucala experienced significantly fewer exacerbations, fewer exacerbations requiring hospitalization and/or emergency department visit, and a longer time to the first exacerbation. In addition, subjects receiving Nucala achieved greater reduction in daily maintenance oral corticosteroid dose, while maintaining asthma control. However, treatment with Nucala did not provide significant improvements in lung function as measured by mean change from baseline forced expiratory volume in 1 second (FEV 1 ). Current practice guidelines do not have recommendations on use of Nucala use in the management of asthma. The recommended dose of Nucala is 100mg subcutaneously every 4 weeks. Common side effects include headache, injection site reaction, back pain, and weakness. 2 of 9

3 Like Nucala, Cinqair (reslizumab) is a humanized interlukin-5 antagonist monoclonal antibody (IgG1 kappa). It is indicated as add-on maintenance treatment of severe asthma in adults (18 years or older) who have an eosinophilic phenotype. It is not indicated for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus. The mechanism of action is similar to that of mepolizumab with a slight differentiation in that reslizumab binds to IL-5 with a dissociation constant of 81 pm, the significance of this difference is unknown as it pertains to the treatment of severe asthma. Approval of Cinqair was based on the results of four randomized, double-blind placebo-controlled trials in 981 patients 12 years or older for weeks. Overall, Cinqair 3mg/kg administered once every 4 weeks significantly reduced frequency of clinically significant asthma exacerbations, and increased forced expiratory volume in 1 second (FEV 1 ) from baseline compared to placebo. Majority of the patients had a blood eosinophilic count greater than or equal to 400 cells/mcl within 3 to 4 weeks of dosing at baseline. While patients aged were included in these trials, Cinqair was not approved for this age group. The most common adverse effects include musculoskeletal adverse reaction on the day of infusion, and oropharyngeal pain; other reactions reported included creatine phosphokinase (CPK) elevations, myalgia, anaphylaxis, and malignancy. At the time of this update, clinical practice guidelines for the management of asthma do not yet include recommendations for Cinqair or Nucala. Clinical evidence to support combination use of Cinqair, Nucala, or Xolair has not been established. There are also no head-to-head trials demonstrating comparative efficacy and safety between these agents. *The Joint Task Force on Practice Parameters represents the American Academy of Allergy, Asthma & Immunology, the American College of Allergy, Asthma and Immunology and the Joint Council on Allergy, Asthma and Immunology Policy Medication BMC HealthNet Plan Well Sense Health Plan MassHealth QHP NH Medicaid Cinqair X X X Nucala X X X Xolair X X X The Plan may authorize coverage of Cinqair, Nucala or Xolair for members meeting the following criteria: Prior Authorization (Duration of Approval Maximum of 6 months) A prior authorization request will be required for all prescriptions for Cinqair, Nucala or Xolair. These requests will be approved when all of the following criteria are met: 3 of 9

4 Drug Cinqair Initial Approval Criteria Documentation of the following: 1. A diagnosis of severe asthma with an eosinophil phenotype; AND 2. Member is 18 years of age or older; AND 3. The member is symptomatic, and is compliant with use of combination controller therapy (including at least a high dose of inhaled corticosteroids with either a long-acting beta agonist, leukotriene modifier or theophylline); AND 4. Lab finding that indicates blood eosinophil count greater than or equal to 400 cells/mcl at therapy initiation (within 3-4 weeks of dosing); AND 5. The source of the allergenic asthma-triggers (if known) has been removed or addressed; AND 6. Medication is prescribed by or in collaboration with a Pulmonologist, Immunologist, or Allergist; AND 7. There is a plan to contact a Health Plan Care Manager to schedule a VNA Home Environmental Assessment visit Nucala Documentation of the following: 1. A diagnosis of severe asthma with an eosinophil phenotype; AND 2. Member is 12 years of age or older; AND 3. The member is symptomatic, and is compliant with use of combination controller therapy (including at least a high dose of inhaled corticosteroids with either a long-acting beta agonist, leukotriene modifier or theophylline); AND 4. Lab finding that indicates blood eosinophil count of: a. 150 cells/mcl or greater at therapy initiation (within 6 weeks of dosing); or b. 300 cells/mcl or greater in the previous 12 months; AND 5. The source of the allergenic asthma-triggers (if known) has been removed or addressed; AND 6. Medication is prescribed by or in collaboration with a Pulmonologist, Immunologist, or Allergist; AND 4 of 9

5 Drug Initial Approval Criteria 7. There is a plan to contact a Health Plan Care Manager to schedule a VNA Home Environmental Assessment visit Xolair Documentation of the following: 1. A diagnosis of moderate to severe persistent asthma; AND 2. Member is 12 years of age or older; AND 3. The member is symptomatic, and is compliant with use of combination controller therapy (including at least a medium dose of inhaled corticosteroids with either a long-acting beta agonist, leukotriene modifier, or theophylline); AND 4. Lab documentation indicating serum IgE level: a. Between 30 IU/mL and 700 IU/ml or b. Over 700 IU/ml and 5 hospitalizations cumulating 20 inpatient days; AND 5. A positive skin test or in vitro reactivity to a perennial aeroallergen; AND 6. The source of the allergenic asthma-triggers (if known) has been removed or addressed; AND 7. Medication is prescribed by or in collaboration with a Pulmonologist, Immunologist or Allergist; AND 8. There is a plan to contact a Health Plan Care Manager to schedule a VNA Home Environmental Assessment visit; OR 1. A diagnosis of chronic idiopathic urticaria; AND 2. Member is 12 years of age or older; AND 3. Medication is prescribed by or in collaboration with a Dermatologists or Allergist; AND 4. The source of urticarial triggers and underlining causes (if known) has been removed or addressed; AND 5. An inadequate response or contraindication or persistent adverse effect to a one-month trial each of a first generation and a second generation histamine H1 antagonist at the maximum tolerable dose; AND 6. An inadequate response or contraindication or persistent adverse effect to a 5 of 9

6 Drug Initial Approval Criteria one-month trial of concurrent use of a histamine H1 antagonist with a histamine H2 antagonist or an antileukotriene. Re-authorization Criteria - (Duration of Approval Maximum of 6 months) Cinqair, Nucala or Xolair Documentation of the following: 1. Improved symptom control and/or decreased exacerbations while on Cinqair, Nucala or Xolair therapy evidenced by medical claim history or clinical progress notes documenting the improvement in symptoms and that there has not been an increase in utilization of emergency services, hospitalizations, or urgent care visits due to symptom exacerbation; or Reduction in total daily dose of oral corticosteroids from baseline or frequency of systemic corticosteroid use for asthma exacebation (Cinqair or Nucala only); AND 2. Review of prescription claims data indicate that the member has been compliant with therapy (defined as 80% of doses obtained during the previous 6 months) Quantity Limitations Apply- see Appendix A Limitations The Plan will not approve coverage of Cinqair, Nucala or Xolair in the following instances: 1. When the above criteria is not met. 2. When Nucala is used for the treatment of other eosinophilic conditions. 3. Requests for concurrent use of any one of the following: Cinqair, Nucala and Xolair Clinical Background Information and References 1. Product Information. Xolair, omalizumab. Genentech, Inc., South San Francisco, CA Barnes, Peter J. Anti-IgE Therapy in Asthma. Up to Date, accessed February 2015; available from: 3. National Asthma Education and Prevention Program Expert Panel Report 3, Guidelines for the Diagnosis and Management of Asthma. National Heart Lung and Blood Institute. NIH Publication Number October 2007, accessed February of 9

7 4. Early Communication about an ongoing safety review of omalizumab. FDA Postmarket Drug Safety Information for Patients and Providers. July 16, 2009, accessed February GINA Report: Global Strategy for Asthma Management and Prevention Ontario (Canada): National Institutes of Health: National Heart, Lung, and Blood Institute and The World health Organization: Global Initiative For Asthma (GINA); Accessed February Available from: 6. Jonathan A. Bernstein et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J ALLERGY CLIN IMMUNOL VOLUME 133, NUMBER. May FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events. September 26, 2014, accessed February Wenzel S. Treatment of severe asthma in adolescents and adults. Up to Date. Last update Jan 11, Accessed February 2015; available from: 9. Khan DA. Chronic urticaria: Standard management and patient education. Up to Date. Last updated Nov 05,2015. Accessed February Available from: Stokes J, Casale TB. Anti-IgE Therapy. Up to Date. Last updated Nov 17,2015. Accessed February Available from: Product Information. Nucala. GlaxoSmithKline. Research Triangle Park, NC. Nov Product Information. Cinqair. Teva Frazer, PA. May Reslizumab (Cinqair) for severe eosinophilic asthma. Med Lett Drugs Ther Jun 20;58(1497):81-2 Appendix A Quantity Limitations Medication Indication Quantity Limitation Cinqair Asthma 3 vials per 28 days (based on 70kg patient) Nucala Asthma 1 vial per 28 days Xolair Asthma 6 vials per 28 days Xolair Urticaria 2 vials per 28 days Original Approval Original Effective Date Date Policy Owner Approved by 09/12/ /12/2005 Pharmacy Services Pharmacy & Therapeutics (P&T) Committee Policy Revisions History 7 of 9

8 Policy Revisions History Review Date Summary of Revisions 8 of 9 Revision Effective Date Approved by 03/13/2008 P&T Annual Review, initial approval 07/01/2008 P&T Committee length changed to 6 months, requirement for laboratory documentation of serum IgE between 30 IU/mL and 700 IU/mL added, requirement for referral to BMCHP Care Manager for scheduling of VNA Home Environmental Assessment visit added, Compliance criteria for continuation of therapy added. 03/12/2009 P&T Annual Review, no changes 07/01/2009 P&T Committee required. 03/11/2010 P&T Annual Review, no changes 07/01/2010 P&T Committee required 03/14/2011 P&T Annual Review added the 07/01/2011 P&T Committee requirement of compliance with controllers and addressing the allergy source. 07/14/2011 Policy applied to Commercial 11/01/2011 P&T Committee 03/08/2012 P&T Annual Review, no changes 07/01/2012 P&T Committee required 08/22/2012 Policy applied to NH Medicaid 12/01/2013 P&T Committee 03/14/2013 P&T Annual Review, included Allergist as an acceptable prescriber, changed IgE criteria to be =/> 30IU/ml, and added criteria for IgE>700IU/ml 12/13/2013 Policy applied to ConnectorCare/Qualified Health Plan (QHP) 3/13/2014 P&T annual review, modified requirement of contacting BMC care manager for initial therapy. 03/12/2015 P&T Annual Review, added criteria for the indication of chronic idiopathic urticaria 03/10/2016 P&T Annual Review, title changed to include Nucala, added criteria for Nucala, added quantity limit for Nucala 07/01/ /01/2013 (NH) P&T Committee 04/01/2014 P&T Committee 07/01/2014 P&T Committee 07/01/2015 P&T Committee 07/06/2016 P&T Committee

9 Policy Revisions History and Xolair, modified continuation criteria for both drugs 09/08/2016 Policy Revision, added criteria and quantity limit for Cinqair; title changed to Asthma/Allergy Monoclonal Antibodies, minor revision to clarify requirement to address asthma triggers 01/01/2017 P&T Committee Next Review Date 03/09/2017 Other Applicable Policies Mandatory Generic Substitution Policy Quantity Limitation Policy Reference to Applicable Laws and Regulations, If Any Disclaimer Information Medical Policies are the Plan s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member s benefit document, and when appropriate, coordinates with the Member s health care Providers to consider the individual Member s health care needs. Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan Provider agreement. 9 of 9