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1 Grup Health Pharmacy Administratin GSE-B2N Naches Ave SW PO Bx 9009 Rentn, WA Grup Health Cperative Grup Health Optins, Inc. ghc.rg Imprtant Infrmatin February 6, 2017 Dear Prvider, New Injectable Prir Authrizatin Apprval - Meplizumab (Nucala ) Effective March 25, 2017, Meplizumab (Nucala ) will be added t the nn-medicare list f injectable drugs requiring prir authrizatin. This letter is a ntificatin f the upcming requirement that prviders must btain prir authrizatin apprval befre administering this medicatin under the medical benefit. Grup Health requires prir authrizatin fr a select grup f injectable drugs that may be administered under the medical benefit in a physician s ffice r by hme infusin. These reviews are intended t ensure cnsistent benefit adjudicatin as well as apprpriate utilizatin in accrdance with the Grup Health Pharmacy & Therapeutics Cmmittee s evidence-based criteria fr cverage. Prir Authrizatin Criteria fr Meplizumab (Nucala ): See Appendix fr inclusin and exclusin criteria details and criteria fr cntinuatin f therapy cverage. Ratinale: Efficacy: Efficacy f meplizumab was established in three pivtal randmized, placeb-cntrlled studies in patients with severe asthma. These included a 52-week exacerbatin and dse-ranging study (DREAM), a 32-week exacerbatin study (MENSA), and an OCS reductin study (SIRIUS). Patients received meplizumab r placeb as add-n drug therapy nce every fur weeks. The primary endpint fr DREAM and MENSA was the annualized rate f asthma exacerbatins. Patients receiving meplizumab had significantly fewer exacerbatins versus placeb. In SIRIUS, the primary endpint was reductin in OCS dse withut lss f asthma cntrl. Patients receiving meplizumab had greater reductins in their daily maintenance OCS dse while maintaining asthma cntrl versus placeb. Safety: The mst cmmn adverse effects with an incidence greater than r equal t 5% include headache, injectin site reactins (pain, redness, swelling, itching, r a burning feeling at the injectin site), back pain, and weakness (fatigue). The labeling warns that hypersensitivity reactins have ccurred after the administratin f meplizumab and that herpes zster infectins have ccurred in patients receiving the drug. Value: Althugh the studies demnstrated that meplizumab can reduce the number f asthma exacerbatins, there is uncertainty abut whether the benefits will persist lng-term. Additinal Infrmatin A cmplete list f ffice-administered injectable drugs requiring prir authrizatin is available n MyGrupHealth fr Cntracted Prviders at under Referrals & Clinical Review. T request prir authrizatin review, please use the Referral Request nline frm n the prvider website listed abve. Yu can als fax yur request t Review Services tll-free at

2 Thank yu fr the care yu prvide t ur members, yur patients. If yu have any questins abut this prcess, please call Review Services at Sincerely, Bruce Wilsn, MD, Chair Pharmacy & Therapeutics Cmmittee APPENDIX: INCLUSION CRITERIA: Shuld fulfill ALL f the fllwing t be eligible: Prescribing physician is an Allergist r Pulmnlgist. Patient is at least 18 years f age. Clinical diagnsis f asthma indicated by airway reversibility, hyperrespnsiveness r airway variability. Persistent airflw bstructin as indicated by: Pre-brnchdilatr frced expiratry vlume in ne secnd (FEV 1 ) <80% f the predicted value. Dcumentatin f esinphilic phentype: Bld esinphil cunt f 500 cells/mcl in the past 30 days. Uncntrlled asthma (Table 1) despite an aggressive drug therapy regimen (Table 2) including: high-dse inhaled crticsterid (ICS), plus a lng-acting beta-agnist (LABA), and requiring daily use f ral crticsterid (OCS). OR Patients wh are nt using daily OCS but wh therwise meet the abve criteria and wh have had frequent (at least tw) and/r severe exacerbatins in the past 12 mnths requiring systemic crticsterids fr >3 days can be cnsidered fr meplizumab. 2

3 Table 1: Indicatrs f Uncntrlled Asthma: 1. Tw r mre exacerbatins in the past 12 mnths requiring systemic crticsterids fr >3 days. 2. Serius exacerbatins: at least ne hspitalizatin, ICU stay r mechanical ventilatin in the past 12 mnths. 3. Asthma Cntrl Test (ACT) is cnsistently <20 Table 2: Aggressive Drug Therapy Regimens: High-dse ICS LABA OCS Fluticasne (Flvent HFA) 220 mcg: Mmetasne DPI (Asmanex) 220 mcg: 2 inh twice daily - AND- Salmeterl (Serevent Diskus) 50 mcg: 1 inh twice daily Frmterl (Fradil) 12 mcg: 1 inh twice daily Mmetasne (Asmanex HFA) 200 mcg: Cmbinatin ICS/LABA Mmetasne 200 mcg/frmterl 5 mcg (Dulera)*: Fluticasne 500 mcg/salmeterl 50 mcg (Advair Diskus): 1 inh twice daily Fluticasne 230 mcg/salmeterl 21 mcg (Advair HFA): Fluticasne 200 mcg/vilanterl 25 mcg (Bre Ellipta): 1 inh nce daily Budesnide 160 mcg/frmterl 4.5 mcg (Symbicrt): -AND- Cntinuus OCS use DPI = dry pwder inhaler; HFA = hydrfluralkane; ICS = inhaled crticsterids; LABA = lng acting beta-agnist; OCS = ral crticsterids; inh = inhalatins *Dulera preferred Crticsterid adverse effects: If a patient has been prly cntrlled ver at least ne year and is experiencing crticsterid side effects despite aggressive drug therapy (Table 2), then meplizumab may be cnsidered. Adherence: Patient shuld be at least 75% adherent t asthma drug therapies and with clinic fllw-up appintments. Drug therapy adherence shuld be at least 75% (calculated by day supply dispensed ver the ttal number f days since treatment was started). If adherence is an issue, it shuld be addressed prir t cnsidering meplizumab. Evaluatin f trigger avidance measures and cntrl f cmrbid factrs shuld be made prir t initiatin f meplizumab. Patient has uncntrlled asthma despite the fllwing: 3

4 1. Eliminating all triggers frm the hme (e.g., pets, dust mites, fds, pllen, smke, etc.) 2. Ruling ut cmrbid factrs r ther pulmnary disease (e.g., allergy, sinusitis, gastresphageal reflux disease, anxiety disrder, panic disrder, vcal crd dysfunctin, etc.) EXCLUSION CRITERIA: If ONE r mre f the criteria is met, patient is NOT eligible: Histry f hypersensitivity t meplizumab r excipients in the frmulatin. Current smkers r frmer smkers with a smking histry f 10 pack-years. Presence f a knwn pre-existing, clinically imprtant lung cnditin ther than asthma (e.g., chrnic bstructive pulmnary disease, brnchiectasis, pulmnary fibrsis, lung cancer). A current malignancy r previus histry f cancer in remissin fr less than 12 mnths prir t starting therapy. Severe r clinically significant cardivascular disease uncntrlled with standard treatment. Knwn, pre-existing, clinically significant endcrine, autimmune, metablic, neurlgical, renal, gastrintestinal, hepatic, hematlgical r any ther system abnrmalities that are uncntrlled with standard treatment. Patients with ther cnditins that culd lead t elevated esinphils such as hyperesinphilic syndrmes, including Churg-Strauss Syndrme, esinphilic esphagitis, allergic brnchpulmnary aspergillsis. Patients with knwn immundeficiency (e.g., HIV) ther than explained by being n crticsterids taken fr asthma. Patients with a knwn pre-existing parasitic infectin Treat patients with pre-existing helminth infectins befre initiating therapy with meplizumab. If patient becmes infected while receiving treatment with meplizumab and des nt respnd t anti-helminth treatment, discntinue treatment with meplizumab until infectin reslves. Patients wh received malizumab within the past 130 days r any mnclnal antibdy t treat inflammatry disease within 5 half-lives. Patients with an allergy r intlerance t a mnclnal antibdy r bilgic. Patients wh have knwn evidence f lack f adherence t cntrller medicatins and/r inability t fllw physician s recmmendatins. RELATIVE EXCLUSIONS: The clinician may use their discretin fr the fllwing: Histry f alchl/substance abuse within the past 2 years. Wmen wh are pregnant r breastfeeding (refer t prduct labeling fr further details): The data n pregnancy expsure frm the clinical trials are insufficient t infrm n drug-assciated risk. Meplizumab is expected t crss the placenta; ptential effects t the fetus may be greater in the secnd and third trimester f pregnancy. There is a pregnancy expsure registry that mnitrs pregnancy utcmes in wmen expsed t meplizumab. 4

5 Breastfeeding: It is nt knwn if meplizumab can be detected in breast milk; hwever, endgenus immune glbulin is present in small amunts. Accrding t the manufacturer, the develpmental and health benefits f breastfeeding shuld be cnsidered alng with the mther s clinical need fr meplizumab and any ptential adverse effects n the breastfed infant frm meplizumab r frm the underlying maternal cnditin. Serum IgE is less than r equal t 30 units/ml: In a subgrup analysis patients with a baseline serum IgE cncentratin less than r equal t 30 units/ml did nt have a reductin in exacerbatin frequency cmpared with placeb. Evaluatin fr Cntinuatin f Therapy Evaluate respnse after 28 weeks (prir t the 7 th dse) and then annually thereafter. Will nt be re-apprved if there is n imprvement in any f the fllwing: Exacerbatin frequency (defined as wrsening f asthma that requires increase in ICS dse r treatment with systemic crticsterids) Objective imprvement in quality f life: minimally imprtant difference f 3 pints n the Asthma Cntrl Test r 0.5 pints n the Asthma Cntrl Questinnaire. Sustained clinical imprvement frm reduced asthma symptms (such as reduced missed days frm wrk r schl) r stable asthma cntrl. 5