This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only.

Transcription

1 This Cverage Plicy applies t Individual Health Insurance Marketplace benefit plans nly. Immunlgical Agents Bilgical Respnse Mdifier-Tumr Necrsis Factr (TNF) Inhibitrs: Enbrel (etanercept fr subcutaneus inj) Humira (adalimumab) Remicade (infliximab fr IV inj) Simpni ARIA (glimumab fr IV inj) Simpni (glimumab subcutaneus inj) Cimzia (certlizumab pegl fr inj kit) Bilgical Respnse Mdifier-Interleukin-Inhibitrs: Stelara (ustekinumab inj) Actemra (tcilizumab fr IV/ SQ sln) Kineret (anakinra subcutaneus inj) Bilgical Respnse Mdifier-Fusin Prtein: Orencia (abatacept fr IV sln/ subcutaneus inj) Miscellaneus-Mnclnal Antibdies: Rituxan (rituximab fr iv inj) DMARD-Janus Kinase Inhibitr: Xeljanz (tfacitinib) Xeljanz XR (tfacitinib) COVERAGE POLICY COVERAGE POLICY Nte: The prvisin f physician samples des nt guarantee cverage under the prvisins f the pharmacy benefit. All criteria belw must be met in rder t btain cverage f Actemra, Cimzia, Enbrel, Humira, Kineret, Orencia, Remicade, Rituxan, Simpni, Simpni ARIA, Stelara, Xeljanz, and Xeljanz XR Fr Enbrel Active nn-axial psriatic arthritis a dcumented failure t methtrexate, r if methtrexate is cntraindicated r nt tlerated, t anther nn-bilgic diseasemdifying anti-rheumatic drug (DMARD) Active axial psriatic arthritis and an inadequate respnse t 2 r mre NSAIDs Adult Mderate t Severe Active Rheumatid Arthritis Cventry Health Care, Inc. Page 1

2 Ankylsing spndylitis a dcumented failure f tw r mre nn-steridal anti-inflammatry drugs (NSAID) (e.g. naprxen, ibuprfen, melxicam) Behcet s Disease dcumented refractry t gluccrticids and azathiprine Chrnic Mderate t Severe Plaque psriasis in adults aged 18 years and lder dcumented t be a candidate fr systemic therapy r phttherapy when the fllwing selectin criteria are met: 10 % r mre bdy surface area is affected by plaque psriasis (r 5 percent r mre f bdy surface area if psriasis invlves sensitive areas (hands, feet, face, r genitals)) r member has a Psriasis Area and Severity Index (PASI) scre f 10 r mre Member has failed t adequately respnd t r is intlerant t a 3-mnth trial f either f the fllwing, (unless cntraindicated) 1. One f the fllwing phttherapies: Psralens (methxsalen, trixsalen) with UVA light (PUVA) UVB with cal tar r dithranl UVB (standard r narrw-band) 2. systemic nn-bilgic DMARDs (e.g., methtrexate, acetretin, r cyclsprine) Juvenile Mderate t Severe Active Rheumatid Arthritis in patients ages 2 and lder Reactive Arthritis a dcumented failure f all the fllwing: NSAIDS, methtrexate, sterids, and sulfasalazine A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease. If there is active disease, TB treatment must be begun befre initiatin f etanercept. *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Fr Humira Active Crhn s disease in persns 6 years f age r lder, where active Crhn's disease is manifested by ne r mre f the fllwing signs and symptms, when Cventry Health Care, Inc. Page 2

3 Crhn's disease has remained active despite treatment with either 6-mercaptpurine, azathiprine, r crticsterids: Abdminal pain; r Arthritis; r Bleeding; r Diarrhea; r Internal fistulae; r Intestinal bstructin; r Megacln; r Perianal disease; r Spndylitis; r Weight lss. Active nn-axial psriatic arthritis a dcumented failure t methtrexate, r if methtrexate is cntraindicated r nt tlerated, t anther nn-bilgic diseasemdifying anti-rheumatic drug (DMARD) Active axial psriatic arthritis and an inadequate respnse t 2 r mre NSAIDs Adult Mderate t Severe Active Rheumatid Arthritis as mntherapy r in cmbinatin with methtrexate r in cmbinatin with nn-bilgic diseasemdifying anti-rheumatic drugs (DMARDs) Ankylsing spndylitis a dcumented failure f tw r mre nn-steridal antiinflammatry drugs (NSAID) (e.g. naprxen, ibuprfen, melxicam) Chrnic Mderate t Severe Plaque psriasis in adults aged 18 years and lder dcumented t be a candidate fr systemic therapy r phttherapy when the fllwing selectin criteria are met: 10 % r mre bdy surface area is affected by plaque psriasis (r 5 percent r mre f bdy surface area if psriasis invlves sensitive areas (hands, feet, face, r genitals)) r member has a Psriasis Area and Severity Index (PASI) scre f 10 r mre Member has failed t adequately respnd t r is intlerant t a 3-mnth trial f either f the fllwing, (unless cntraindicated) 1. One f the fllwing phttherapies: Psralens (methxsalen, trixsalen) with UVA light (PUVA) UVB with cal tar r dithranl UVB (standard r narrw-band) 2. systemic nn-bilgic DMARDs (e.g., methtrexate, acetretin, r cyclsprine) Mderate t Severely active plyarticular juvenile idipathic arthritis (juvenile rheumatid arthritis) in persns 2 years f age and lder Active Ulcerative Clitis Member is hspitalized with fulminant ulcerative clitis (i.e., persns severe ulcerative clitis wh have mre than 10 stls per day, cntinuus bleeding, abdminal pain, and distensin, and acute, severe txic symptms including fever and anxia) OR Member has mderate t severe active ulcerative clitis and meets all f the fllwing criteria: Member is refractry t r requires cntinuus immunsuppressin with crticsterids (e.g., methylprednislne, prednisne) at a dse f prednisne 40 t 60 mg/day (r equivalent) fr 30 days fr ral therapy r 7 t 10 days fr IV therapy); and Member is refractry t r has a cntraindicatin t 5-aminsalicylic acid agents (e.g., balsalazide, mesalamine, sulfasalazine); and Member is refractry t r has a cntraindicatin t immunsuppressants (azathiprine and 6-mercaptpurine) Pyderma gangrensum when first-line therapies (e.g., systemic gluccrticids and/r systemic cyclsprine) have failed Cventry Health Care, Inc. Page 3

4 Refractry Behçet's uveitis Nninfectius uveitis refractry r intlerant t crticsterids and immunsuppressive drugs (e.g., azathiprine, cyclsprine, r methtrexate) unless cntraindicated Extraintestinal manifestatins f Crhn's disease in persns 6 years f age and lder (e.g., arthritis, ral aphthus ulcers, episcleritis, and erythema ndsum) that have remained active despite treatment with either 6-mercaptpurine, azathiprine, r crticsterids. Mderate t severe hidradenitis suppurativa (Hurley Stage II r Hurley Stage III) in persns wh have had an inadequate respnse t at least a 90 day treatment f ral antibitics fr treatment f hidradenitis suppurativa, unless cntraindicated. A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f adalimumab. *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Fr Remicade Active Crhn s Disease that has remained active despite treatment with either 6- mercaptpurine, azathiprine, r crticsterids Active nn-axial psriatic arthritis a dcumented failure t methtrexate, r if methtrexate is cntraindicated r nt tlerated, t anther nn-bilgic diseasemdifying anti-rheumatic drug (DMARD) Active axial psriatic arthritis and an inadequate respnse t 2 r mre NSAIDs Adult Mderate t Severe Active Rheumatid Arthritis Ankylsing Spndylitis and Other Spndylarthrpathies a dcumented inadequate respnse t tw r mre nn-steridal anti-inflammatry drugs (NSAIDS) (e.g., celecxib, diclfenac, ibuprfen, indmethacin, melxicam, naprxen, sulindac) Refractry Behcet's uveitis Cventry Health Care, Inc. Page 4

5 Nninfectius uveitis refractry r intlerant t crticsterids and immunsuppressive drugs (e.g., azathiprine, cyclsprine, r methtrexate) unless cntraindicated Chrnic Mderate t Severe Plaque psriasis in adults aged 18 years and lder dcumented t be a candidate fr systemic therapy r phttherapy when the fllwing selectin criteria are met: 10 % r mre bdy surface area is affected by plaque psriasis (r 5 percent r mre f bdy surface area if psriasis invlves sensitive areas (hands, feet, face, r genitals)) r member has a Psriasis Area and Severity Index (PASI) scre f 10 r mre Member has failed t adequately respnd t r is intlerant t a 3-mnth trial f either f the fllwing, (unless cntraindicated) 1. One f the fllwing phttherapies: Psralens (methxsalen, trixsalen) with UVA light (PUVA) UVB with cal tar r dithranl UVB (standard r narrw-band) 2. systemic nn-bilgic DMARDs (e.g., methtrexate, acetretin, r cyclsprine) Chrnic Pulmnary Sarcidsis that remains symptmatic despite treatment fr 3 r mre mnths with sterids (10 mg per day r mre) immunsuppressants (such as azathiprine, cyclphsphamide, r methtrexate) Fistulizing Crhn's Disease fr at least 3 mnths Juvenile Mderate t Severe Active Rheumatid Arthritis that has failed t respnd t ther TNF inhibitrs such as Enbrel r Humira Severe r life-threatening enterclitis that persists despite permanent discntinuatin f nivlumab (Opdiv) and administratin f systemic crticsterids. Refractry Pyderma Gangrensum Reactive Arthritis (e.g., Reiter's syndrme) r Inflammatry Bwel Disease Arthritis (enterpathic arthritis) wh have failed r are intlerant t NSAIDs, methtrexate, and sulfasalazine) Active Ulcerative Clitis Member is hspitalized with fulminant ulcerative clitis (i.e., persns severe ulcerative clitis wh have mre than 10 stls per day, cntinuus bleeding, abdminal pain, and distensin, and acute, severe txic symptms including fever and anxia) OR Member has mderate t severe active ulcerative clitis and meets all f the fllwing criteria: Member is refractry t r requires cntinuus immunsuppressin with crticsterids (e.g., methylprednislne, prednisne) at a dse f prednisne 40 t 60 mg/day (r equivalent) fr 30 days fr ral therapy r 7 t 10 days fr IV therapy); and Member is refractry t r has a cntraindicatin t 5-aminsalicylic acid agents (e.g., balsalazide, mesalamine, sulfasalazine); and Member is refractry t r has a cntraindicatin t immunsuppressants (azathiprine and 6-mercaptpurine) Cventry Health Care, Inc. Page 5

6 Mderate t severe hidradenitis suppurativa (Hurley Stage II r Hurley Stage III) in persns wh have had an inadequate respnse t at least a 90 day treatment f ral antibitics fr treatment f hidradenitis suppurativa, unless cntraindicated. A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease. If there is active disease, TB treatment must be begun befre initiatin f infliximab. Fr Simpni *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Active ankylsing spndylitis with evidence f inflammatry disease in members wh have had an inadequate respnse t NSAIDS (e.g., celecxib, diclfenac, ibuprfen, indmethacin, melxicam, naprxen, sulindac, r valdecxib) (unless cntraindicated) a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr active ankylsing spndylitis such as Enbrel, Humira, r Remicade Active nn-axial psriatic arthritis a dcumented failure t methtrexate, r if methtrexate is cntraindicated r nt tlerated, t anther nn-bilgic diseasemdifying anti-rheumatic drug (DMARD) a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr active psriatic arthritis such as Enbrel, Humira, Remicade, r Stelara Active axial psriatic arthritis and an inadequate respnse t 2 r mre NSAIDs a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr active psriatic arthritis such as Enbrel, Humira, Remicade, r Stelara Adult Mderate t Severe Active Rheumatid Arthritis in cmbinatin with methtrexate a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr active rheumatid arthritis such as Enbrel, Humira, Remicade, r Simpni Aria Cventry Health Care, Inc. Page 6

7 Active Ulcerative Clitis Member is hspitalized with fulminant ulcerative clitis (i.e., persns severe ulcerative clitis wh have mre than 10 stls per day, cntinuus bleeding, abdminal pain, and distensin, and acute, severe txic symptms including fever and anxia) OR Member has mderate t severe active ulcerative clitis and meets all f the fllwing criteria: Member is refractry t r requires cntinuus immunsuppressin with crticsterids (e.g., methylprednislne, prednisne) at a dse f prednisne 40 t 60 mg/day (r equivalent) fr 30 days fr ral therapy r 7 t 10 days fr IV therapy); and Member is refractry t r has a cntraindicatin t 5-aminsalicylic acid agents (e.g., balsalazide, mesalamine, sulfasalazine); and Member is refractry t r has a cntraindicatin t immunsuppressants (azathiprine and 6-mercaptpu A dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr ulcerative clitis, such as Humira and Remicade A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f glimumab. *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Fr Simpni ARIA A dcumented diagnsis f mderately-t-severely active rheumatid arthritis in adult members 18 years f age r lder in cmbinatin with methtrexate Cventry Health Care, Inc. Page 7

8 A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f glimumab Fr Cimzia *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Active Crhn s Disease that has remained active despite treatment with either 6- mercaptpurine, azathiprine, r crticsterids A dcumented Cntraindicatin r Intlerance r Allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr Crhn s Disease such as Humira and Remicade Adult Mderate t Severe Active Rheumatid Arthritis as mntherapy r in cmbinatin with methtrexate (MTX) A dcumented Cntraindicatin r Intlerance r Allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr Rheumatid Arthritis such as Enbrel, Humira, Remicade, r Simpni ARIA Active nn-axial psriatic arthritis a dcumented failure t methtrexate, r if methtrexate is cntraindicated r nt tlerated, t anther nn-bilgic diseasemdifying anti-rheumatic drug (DMARD) a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr active psriatic arthritis such as Enbrel, Humira, Remicade, r Stelara Active axial psriatic arthritis and an inadequate respnse t 2 r mre NSAIDs a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr active psriatic arthritis such as Enbrel, Humira, Remicade, r Stelara Active ankylsing spndylitis, t reduce signs and symptms, in members wh have had an inadequate respnse t 2 r mre NSAIDS (e.g., celecxib, diclfenac, ibuprfen, indmethacin, melxicam, naprxen, sulindac, r valdecxib) a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr active ankylsing spndylitis such as Enbrel, Humira, r Remicade Cventry Health Care, Inc. Page 8

9 A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease. If there is active disease, TB treatment must be begun befre initiatin f certlizumab pegl. *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Fr Stelara A dcumented diagnsis f ne f the fllwing: Chrnic Mderate t Severe Plaque psriasis in adults aged 18 years and lder dcumented t be a candidate fr systemic therapy r phttherapy when the fllwing selectin criteria are met: 10 % r mre bdy surface area is affected by plaque psriasis (r 5 percent r mre f bdy surface area if psriasis invlves sensitive areas (hands, feet, face, r genitals)) r member has a Psriasis Area and Severity Index (PASI) scre f 10 r mre Member has failed t adequately respnd t r is intlerant t a 3-mnth trial f either f the fllwing, (unless cntraindicated) 1. One f the fllwing phttherapies: Psralens (methxsalen, trixsalen) with UVA light (PUVA) UVB with cal tar r dithranl UVB (standard r narrw-band) 2. systemic nn-bilgic DMARDs (e.g., methtrexate, acetretin, r cyclsprine) Active nn-axial psriatic arthritis a dcumented failure t methtrexate, r if methtrexate is cntraindicated r nt tlerated, t anther nn-bilgic diseasemdifying anti-rheumatic drug (DMARD) Active axial psriatic arthritis and an inadequate respnse t 2 r mre NSAIDs A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a Cventry Health Care, Inc. Page 9

10 Fr Actemra bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f ustekinumab. *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Adult Mderate t Severe Active Rheumatid Arthritis A dcumented Cntraindicatin r Intlerance r Allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr Rheumatid Arthritis ne f which must include Remicade and ne frm the fllwing: Enbrel r Humira r Simpni ARIA Active systemic nset juvenile idipathic arthritis in persns 2 years f age and lder wh have nt respnded t a trial f a nn-steridal antiinflammatry drug (NSAID) alne, r whse initial symptms include high fevers and painful plyarthritis (severe disease) Mderate t severely active plyarticular juvenile idipathic arthritis (juvenile rheumatid arthritis) in persns 2 years f age and lder a dcumented cntraindicatin r intlerance r allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr plyarticular juvenile idipathic arthritis Enbrel and Humira Castleman's disease (CD) when the fllwing criteria are met: Secnd-line therapy as a single agent fr relapsed r refractry unicentric CD fr patients wh are human immundeficiency virus-negative and human herpesvirus-8-negative; r Subsequent therapy as a single agent fr multicentric CD that has prgressed fllwing treatment f relapsed/refractry r prgressive disease. A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease. If there is active disease, TB treatment must be begun befre initiatin f tclizumab. Cventry Health Care, Inc. Page 10

11 Fr Kineret *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Adult Mderate t Severe Active Rheumatid Arthritis as mntherapy r in cmbinatin with DMARDs ther than tumr necrsis factr (TNF) blcking agents A dcumented Cntraindicatin r Intlerance r Allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr Rheumatid Arthritis such as Enbrel, Humira, Remicade, r Simpni ARIA Crypyrin-assciated peridic syndrmes (CAPS) including familial cld autinflammatry syndrme (FCAS), Muckle-Wells syndrme (MWS), and Nenatal-Onset Multisystem Inflammatry Disease (NOMID), als knwn as chrnic infantile neurlgical cutaneus articular (CINCA) syndrme Adult-nset Still's disease when after failure f gluccrticids, methtrexate and a TNF-alpha inhibitr Active systemic nset juvenile idipathic arthritis, fr persns wh have failed t respnd t a nn-steridal antiinflammatry drug (NSAID), r whse initial symptms include high fevers and painful plyarthritis (severe disease) Subsequent therapy as a single agent fr multicentric Castleman's disease (CD) that has prgressed fllwing treatment f relapsed/refractry r prgressive disease. Schnitzler syndrme (characterized by chrnic, nnpruritic urticaria in assciatin with recurrent fever, bne pain, arthralgia r arthritis) with dcumented mnclnal immunglbulin M (IgM) gammpathy (present in all cases) A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f anakinra. *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are Cventry Health Care, Inc. Page 11

12 at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Fr Orencia I.V./Subcutaneus Adult Mderate t Severe Active Rheumatid Arthritis a dcumented Cntraindicatin r Intlerance r Allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr Rheumatid Arthritis (nte: fr Orencia IV, ne preferred alternative must include Remicade; and ne frm the fllwing: Enbrel, Humira, r Simpni ARIA) Mderate r Severely active plyarticular juvenile rheumatid arthritis (juvenile idipathic arthritis) in pediatric patients 6 years f age and lder wh have failed t respnd t a nn-steridal anti-inflammatry drug (NSAID), r whse initial symptms include high fevers and painful plyarthritis (severe disease) a dcumented Cntraindicatin r Intlerance r Allergy r an inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr juvenile rheumatid arthritis (nte: fr Orencia IV, ne preferred alternative must include Remicade; and ne frm the fllwing: Enbrel r Humira) A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f abatacept. *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Cventry Health Care, Inc. Page 12

13 Fr Rituxan Acute lymphid leukemia (inductin/cnslidatin therapy fr Philadelphia chrmsne-negative ALL fr patients aged greater than r equal t 40 years) Anti-neutrphil cytplasmic antibdy-assciated (ANCA-assciated) vasculitides (Wegener granulmatsis, Churg-Strauss syndrme, micrscpic plyangiitis, and pauci-immune glmerulnephritis) in persns with an inadequate respnse t cyclphsphamide Antibdy mediated rejectin in heart transplant recipients, preventin f recurrence CD20-psitive chrnic lymphcytic leukemia Fr Xeljanz Chrnic graft versus hst disease (last resrt treatment) Crticsterid-refractry autimmune blistering diseases (pemphigus vulgaris, pemphigus fliaceus, bullus pemphigid, cicatricial pemphigid, epidermlysis bullsa acquisita and paraneplastic pemphigus) Cryglbulinemia refractry t crticsterids and ther immunsuppressive agents Multi-centric Castleman's disease (angifllicular lymph nde hyperplasia) Nn-Hdgkin's lymphma Opsclnus-myclnus-ataxia assciated with neurblastma, that is refractry t sterids, chemtherapy and intravenus immunglbulins Pst-transplant lymphprliferative disrder Prphylaxis f rejectin in sensitized kidney transplant recipients with dnr specific antibdies Refractry autimmune hemlytic anemia Relapsed r refractry hairy cell leukemia in persns wh have failed at multiple (2 r mre) curses f cladribine Sjgren syndrme refractry t crticsterids and ther immunsuppressive agents Lymphcyte-predminant Hdgkins disease Treatment f neurmyelitis ptica when ne r mre immuntherapies have failed Treatment f factr inhibitrs in persns with hemphilia Treatment f refractry immune r idipathic thrmbcytpenic purpura, refractry thrmbtic thrmbcytpenic purpura Waldenström s macrglbulinemia In cmbinatin with methtrexate t reduce signs and symptms and t slw the prgressin f structural damage in adult members with mderately t severely active rheumatid arthritis a dcumented Cntraindicatin r Intlerance r Allergy r an inadequate respnse t a trial f ne mnth each f 2 r mre preferred alternatives indicated fr rheumatid arthritis ne f which must be Remicade and ne frm the fllwing: Enbrel, Humira, r Simpni ARIA A dcumented diagnsis f mderately t severely active rheumatid arthritis in patients wh have had an inadequate respnse r intlerance t methtrexate Cventry Health Care, Inc. Page 13

14 A dcumented cnfirmatin that Xeljanz will nt be used in cmbinatin with ther bilgic therapy (i.e. Enbrel, Humira) r ptent immunsuppressants (i.e. azathiprine, cyclsprine) A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f tfacitinib. A dcumented cntraindicatin r intlerance r allergy r inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr rheumatid arthritis such as Enbrel, Humira, Remicade, r Simpni ARIA *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Fr Xeljanz XR A dcumented diagnsis f mderately t severely active rheumatid arthritis in patients wh have had an inadequate respnse r intlerance t methtrexate A dcumented cnfirmatin that Xeljanz XR will nt be used in cmbinatin with ther bilgic therapy (i.e. Enbrel, Humira) r ptent immunsuppressants (i.e. azathiprine, cyclsprine) A dcumented negative TB test (which can include a tuberculsis skin test (PPD), an interfern-release assay (IGRA), r a chest x-ray) within 6 mnths f initiating a bilgic therapy OR yearly fr members with risk factrs* that are requesting cntinuatin f therapy. If the screening testing fr TB is psitive, there must be dcumentatin f further testing t cnfirm there is n active disease; if there is active disease, TB treatment must be begun befre initiatin f tfacitinib. A dcumented cntraindicatin r intlerance r allergy r inadequate respnse t a trial f ne mnth each f tw preferred alternatives indicated fr rheumatid arthritis such as Enbrel, Humira, Remicade, r Simpni ARIA *Risk factrs include: persns with clse cntact t peple with infectius TB disease; persns wh have emigrated frm areas f the wrld with high rates f TB (e.g., Africa, Asia, Eastern Eurpe, Latin America, and Russia); children less than 5 years f age wh have a psitive TB test; grups with high rates f TB transmissin (e.g., hmeless persns, injectin drug users, and persns with HIV infectin); persns wh wrk r reside with peple wh are at an increased risk fr active TB (e.g., hspitals, lng-term care facilities, crrectinal Cventry Health Care, Inc. Page 14

15 facilities, and hmeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved frm Accrding t the manufacturers, Xeljanz, and Xeljanz XR can be dsed t a maximum daily dse as indicated belw. A quantity f Xeljanz, and Xeljanz XR will be cnsidered medically necessary, if the abve criteria are met, as indicated in the table belw: Drug Maximum Daily Dse Dsage Strength Quantity Limits Xeljanz 10 mg 5 mg Up t 60 tablets in 30 days Xeljanz XR 11 mg 11 mg Up t 30 tablets in 30 days AUTHORIZATION PERIOD LIMITATIONS Initial Apprval: 6 mnths NON-COVERAGE 1. Use nt apprved by the FDA ; 2. The use is unapprved and nt supprted by the literature r evidence as an accepted ff-label use. (see Off-Label Use Plicy fr determining accepted use ) REFERENCES 1. AHFS Drug Infrmatin with AHFSfirstReleases. ( American Sciety Of Health-System Pharmacists, Bethesda, MD. Updated peridically. 2. DRUGDEX System [Internet database]. Greenwd Village, Cl: Thmsn Micrmedex. Updated peridically. 3. Drug Facts and Cmparisns n-line. ( Wlters Kluwer Health, St. Luis, MO. Updated peridically. 4. PDR Electrnic Library [Internet database]. Greenwd Village, Cl: Thmsn Micrmedex. Updated peridically. 5. Saag KG, Teng GG, Patkar NM, et al. American Cllege f Rheumatlgy 2008 recmmendatins fr the use f nnbilgic and bilgic disease-mdifying antirheumatic drugs in rheumatid arthritis. Arthritis Rheum. 2008;59: Singh JA, Christensen R, Wells GA, et al. A netwrk meta-analysis f randmized cntrlled trials f bilgics fr rheumatid arthritis: a Cchrane verview. CMAJ. 2009;181(11): Zintzaras E, Dahabreh IJ, Giannuli S, Vulgarelis M, Mutspuls HM. Infliximab and methtrexate in the treatment f rheumatid arthritis: a systematic review and meta-analysis f dsage regimens. Clin Ther. 2008;30(11): Venkateshan SP, Sidhu S, Malhtra S, Pandhi P. Efficacy f bilgicals in the treatment f rheumatid arthritis. A meta-analysis.pharmaclgy. 2009;83(1): Emery P, Keystne E, Tny HP, et al. IL-6 receptr inhibitin with tcilizumab imprves treatment utcmes in patients with rheumatid arthritis refractry t anti-tumur necrsis factr bilgicals: results frm a 24 week multicentre randmized placeb-cntrlled trial. Ann Rheum Dis. 2008;67: Cventry Health Care, Inc. Page 15

16 10. Genvese MC, McKay JD, Nasnv EL, et al. Interleukin-6 receptr inhibitin with tcilizumab reduces disease activity in rheumatid arthritis with inadequate respnse t disease-mdifying antirheumatic drugs. Arthris Rheum. 2008;58: Nishimt N, Miyasaka N, Yamamt K, et al. Lng-term safety and efficacy f tcilizumab, an anti- IL-6 receptr mnclnal antibdy, in mntherapy, in patients with rheumatid arthritis (the STREAM study):evidence f safety and efficacy in a 5-year extensin study. Ann Rheum Dis. 2009;68: Update f the 2008 American Cllege f Rheumatlgy Recmmendatins fr the Use f Disease-Mdifying Antirheumatic Drugs and Bilgic Agents in the Treatment f Rheumatid Arthritis. accessed nline April May%202012%20AC&R.PDF 13. Otezla [package insert]. Summit, NJ: Celgene Crpratin; March Csentyx [package insert]. East Hanver, NJ: Nvartis Crpratin January Accessed February 18th, Disclaimer: Cventry Health Care, Inc. (CHC) medical plicies, technlgy assessments, and medical reviews (cllectively CHC Plicies ) are develped by CHC t prvide guidance in administering plan benefits and cnstitute neither ffers f cverage nr medical advice. Access t CHC Plicies is prvided fr general reference purpses nly and des nt infer guaranteed cverage. CHC des nt prvide health care services r supplies. Prviders are expected t exercise their independent medical judgment in rendering the mst apprpriate care. State and federal law, as well as benefit plan terms and cnditins and CHC Plicies in effect n the date that any service is rendered, including but nt limited t definitins and specific inclusins/exclusins, take precedence ver clinical plicy and must be cnsidered first in determining eligibility fr cverage. The terms f the member's benefit plan shall determine cverage. Sme benefit plans exclude cverage fr services r supplies that Cventry may cnsider medically necessary. If there is a discrepancy between this plicy and a member's benefit plan, the benefits shall gvern. Cverage may als differ fr CHC Medicare and/r Medicaid members based n any applicable Centers fr Medicare & Medicaid Services (CMS) cverage statements including Natinal Cverage Determinatin (NCD), Lcal Medical Review Plicies (LMRP), and/r Lcal Cverage Determinatins (LCD). As clinical technlgy is cntinually updated, CHC plicies are subject t peridic updates. D nt rely n printed versins f CHC plicies as they may be utdated. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted in any frm r means withut the written cnsent f CHC. Cventry Health Care, Inc. Page 16