Rituxan (rituximab) Effective Date: 10/01/2015. Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage

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1 Rituxan (rituximab) Line(s) f Business: HMO; PPO; QUEST Integratin Akamai Advantage Effective Date: 10/01/2015 POLICY A. INDICATIONS The indicatins belw including FDA-apprved indicatins and cmpendial uses are cnsidered a cvered benefit prvided that all the apprval criteria are met and the member has n exclusins t the prescribed therapy. FDA-Apprved Indicatins Nn-Hdgkin s Lymphma (NHL) Rituxan is indicated fr the treatment f patients with: Relapsed r refractry, lw-grade r fllicular, CD20-psitive, B-cell NHL as a single agent Previusly untreated fllicular, CD20-psitive, B-cell NHL in cmbinatin with first line chemtherapy and, in patients achieving a cmplete r partial respnse t Rituxan in cmbinatin with chemtherapy, as single-agent maintenance therapy Nn-prgressing (including stable disease), lw-grade, CD20-psitive, B-cell NHL, as a single agent after first-line CVP (cyclphsphamide, vincristine, and prednisne) chemtherapy Previusly untreated diffuse large B-cell, CD20-psitive NHL in cmbinatin with cyclphsphamide, dxrubicin, vincristine, and prednisne (CHOP) r ther anthracyclinebased chemtherapy regimens Chrnic Lymphcytic Leukemia (CLL) Rituxan is indicated, in cmbinatin with fludarabine and cyclphsphamide (FC), fr the treatment f patients with previusly untreated and previusly treated CD20-psitive CLL. Rheumatid Arthritis Rituxan in cmbinatin with methtrexate (MTX) is indicated fr the treatment f adult patients with mderately t severely active rheumatid arthritis wh have an inadequate respnse t ne r mre tumr necrsis factr (TNF) antagnist therapies. Wegener s Granulmatsis* (WG) and Micrscpic Plyangiitis (MPA) Rituxan, in cmbinatin with gluccrticids, is indicated fr the treatment f adult patients with WG and MPA. *Als knwn as granulmatsis with plyangiitis (GPA) Cmpendial Uses Acute lymphblastic leukemia in cmbinatin with chemtherapy Central nervus system (CNS) cancers Primary CNS lymphma Leptmeningeal metastases frm lymphmas Hdgkin s lymphma, ndular lymphcyte-predminant

2 Rituxan 2 Nn-Hdgkin s lymphma Acquired immundeficiency syndrme (AIDS)-related B-cell lymphma Burkitt lymphma, in cmbinatin with chemtherapy Castleman s disease Diffuse large B-cell lymphma, in cmbinatin with chemtherapy r as a single agent in nn-transplant candidates Hairy cell leukemia, relapsed r refractry Lymphblastic lymphma Mantle cell lymphma Marginal zne lymphmas (gastric/nn-gastric MALT, splenic marginal zne lymphma) Pst-transplant lymphprliferative disrder (PTLD) Primary cutaneus B-cell lymphma Small lymphcytic lymphma (SLL) Waldenström s macrglbulinemia/lymphplasmacytic lymphma B. REQUIRED DOCUMENTATION Fr all apprvable nclgic r hematlgic indicatins: Testing r analysis cnfirming CD20 prtein n the surface f the B-cell (if applicable) Initial therapy: current nclgy r hematlgy ntes, clinical ntes (including previus treatment histry), and any pertinent pathlgy reprts and/r imaging studies Cntinuatin therapy: dcumentatin demnstrating lack f disease prgressin n therapy C. PRESCRIBER RESTRICTION Fr all nclgic r hematlgic indicatins, Rituxan must be prescribed by an nclgist r a hematlgist. D. CRITERIA FOR INITIAL APPROVAL 1. Onclgic r Hematlgic Indicatins Fr nclgic r hematlgic disrders, the tumr must be CD20-psitive as cnfirmed by testing r analysis t identify the CD20 prtein n the surface f the B-cell. 1.1 Acute lymphblastic leukemia (ALL) Initial authrizatin f 6 mnths may be granted fr members wh are prescribed Rituxan as a cmpnent f a chemtherapy regimen. 1.2 Central nervus system (CNS) cancers Initial authrizatin f 6 mnths may be granted fr members wh are prescribed Rituxan fr any f the fllwing indicatins: a. Primary CNS lymphma b. Leptmeningeal metastases frm lymphma 1.3 Hdgkin s lymphma Initial authrizatin f 6 mnths may be granted fr members wh are prescribed Rituxan fr the treatment f ndular lymphcyte-predminant Hdgkin s lymphma.

3 Rituxan Nn-Hdgkin s lymphma (NHL) a. Initial authrizatin f 6 mnths may be granted fr members wh are prescribed Rituxan fr any f the fllwing indicatins: i. AIDS-related B-cell lymphma ii. Chrnic Lymphcytic Leukemia (CLL) / Small lymphcytic lymphma (SLL) iii. Fllicular lymphma iv. Hairy cell leukemia, relapsed r refractry v. Lymphblastic lymphma vi. Mantle cell lymphma vii. Marginal zne lymphma (splenic r MALT) viii. Pst-transplant lymphprliferative disrder (PTLD) ix. Primary cutaneus B-cell lymphma x. Castleman s disease b. Initial authrizatin f 6 mnths may be granted fr members wh are prescribed Rituxan as a cmpnent f a chemtherapy regimen fr the treatment f Burkitt lymphma. c. Initial authrizatin f 6 mnths may be granted fr members wh are prescribed Rituxan fr the treatment f diffuse large B-cell lymphma and meet either f the fllwing criteria: i. Rituxan is prescribed as a cmpnent f a chemtherapy regimen ii. Member has relapsed r refractry disease and either f the fllwing: Member is nt a candidate fr high-dse therapy with autlgus stem cell rescue. Member is a candidate fr high-dse therapy with autlgus stem cell rescue and Rituxan is prescribed as a cmpnent f a chemtherapy regimen. 1.5 Waldenström s macrglbulinemia/lymphplasmacytic lymphma (LPL) Initial authrizatin f 6 mnths may be granted fr members wh are prescribed Rituxan fr the treatment f Waldenström s macrglbulinemia/lymphplasmacytic lymphma (LPL). 2. Mderately t severely active rheumatid arthritis (RA) a. Initial authrizatin f 6 mnths may be granted t members wh meet bth f the fllwing criteria: i. Member has either f the fllwing: a) Inadequate respnse t at least a 3-mnth trial f a TNF inhibitr (e.g., Cimzia, Enbrel, Humira, Remicade, Simpni, Simpni Aria) b) Intlerance r cntraindicatin t a TNF inhibitr ii. Member is prescribed Rituxan in cmbinatin with MTX r has a cntraindicatin r intlerance t MTX. 3. Granulmatsis with Plyangiitis (GPA; Wegener s Granulmatsis) and Micrscpic Plyangiitis (MPA) Initial authrizatin f 6 mnths may be granted t members wh are prescribed Rituxan fr the treatment f GPA r MPA.

4 Rituxan 4 E. RE-AUTHORIZATION/CONTINUATION OF THERAPY Members wh have had Rituxan previusly authrized by HMSA/CVS are subject t the cntinuatin criteria belw fr apprval. Members withut previus authrizatin are required t meet criteria fr initial authrizatin in sectin D. abve. 1. Onclgic r Hematlgic indicatins Authrizatin f 6 mnths may be granted fr cntinuatin f therapy when there is n evidence f disease prgressin. 2. Rheumatid arthritis and granulmatsis with plyangiitis (Wegener s granulmatsis) and micrscpic plyangiitis Authrizatin f 12 mnths may be granted fr members wh achieve r maintain psitive clinical respnse t therapy as evidenced by lw disease activity r imprvement in signs and symptms f the cnditin. F. DOSAGE AND ADMINISTRATION Apprvals may be subject t dsing limits in accrdance with FDA-apprved labeling, accepted cmpendia, and/r evidence-based practice guidelines. G. IMPORTANT REMINDER The purpse f this Medical Plicy is t prvide a guide t cverage. This Medical Plicy is nt intended t dictate t prviders hw t practice medicine. Nthing in this Medical Plicy is intended t discurage r prhibit prviding ther medical advice r treatment deemed apprpriate by the treating physician. Benefit determinatins are subject t applicable member cntract language. T the extent there are any cnflicts between these guidelines and the cntract language, the cntract language will cntrl. This Medical Plicy has been develped thrugh cnsideratin f the medical necessity criteria under Hawaii s Patients Bill f Rights and Respnsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards f medical practice and review f medical literature and gvernment apprval status. HMSA has determined that services nt cvered under this Medical Plicy will nt be medically necessary under Hawaii law in mst cases. If a treating physician disagrees with HMSA s determinatin as t medical necessity in a given case, the physician may request that CVS/caremark recnsider the applicatin f the medical necessity criteria t the case at issue in light f any supprting dcumentatin. H. REFERENCES 1. Rituxan [package insert]. Suth San Francisc, CA: Genentech, Inc.; August The NCCN Drugs & Bilgics Cmpendium 2015 Natinal Cmprehensive Cancer Netwrk, Inc. Accessed Octber 14, Micrmedex Slutins [database nline]. Ann Arbr, MI: Truven Health Analytics Inc. Updated peridically. [available with subscriptin]. Accessed Octber 14, 2015.

5 Rituxan 5 Dcument Histry 10/01/2015 Original effective date 03/2016 Revised prescriber restrictin (added hematlgist) 11/2016 Editrial revisin (added hematlgy t nclgy/hematlgy sectins)