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

Transcription

1 This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only. Immunological Agents Biological Response Modifier-Tumor Necrosis Factor (TNF) Inhibitors: Enbrel (etanercept for subcutaneous inj) Humira (adalimumab) Remicade (infliximab for IV inj) Simponi ARIA (golimumab for IV inj) Simponi (golimumab subcutaneous inj) Cimzia (certolizumab pegol for inj kit) Biological Response Modifier-Interleukin-Inhibitors: Stelara (ustekinumab inj) Actemra (tocilizumab for IV/ SQ soln) Kineret (anakinra subcutaneous inj) Taltz (ixekizumab) Biological Response Modifier-Fusion Protein: Orencia (abatacept for IV soln/ subcutaneous inj) Miscellaneous-Monoclonal Antibodies: Rituxan (rituximab for iv inj) DMARD-Janus Kinase Inhibitor: Xeljanz (tofacitinib) Xeljanz XR (tofacitinib) COVERAGE POLICY COVERAGE POLICY Note: The provision of physician samples does not guarantee coverage under the provisions of the pharmacy benefit. All criteria below must be met in order to obtain coverage of Actemra, Cimzia, Enbrel, Humira, Kineret, Orencia, Remicade, Rituxan, Simponi, Simponi ARIA, Stelara, Taltz, Xeljanz, and Xeljanz XR Coventry Health Care, Inc. Page 1

2 For Enbrel Active non-axial psoriatic arthritis a documented failure to methotrexate, or if methotrexate is contraindicated or not tolerated, to another non-biologic DMARD Active axial psoriatic arthritis and an inadequate response to at least 2 NSAIDs Adult moderate to severe active rheumatoid arthritis Ankylosing spondylitis a documented failure of at least 2 NSAIDs (e.g. naproxen, ibuprofen, meloxicam) Behcets disease documented refractory to glucocorticoids and azathioprine Moderate to severe chronic plaque psoriasis in adults ages 18 years and older documented to be a candidate for systemic therapy or phototherapy when the following criteria are met: At least 10% body surface area (BSA) is affected by plaque psoriasis [or at least 5% BSA if psoriasis involves sensitive areas (i.e. hands, feet, face, or genitals)] or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more*; Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following, unless contraindicated: Phototherapy (PUVA, UVB with coal tar or dithranol, OR UVB standard or narrow-band); OR Systemic non-biologic DMARDs (e.g. methotrexate, acetretin, cyclosporine) Moderate to severe active juvenile rheumatoid arthritis in patients ages 2 and older Reactive arthritis a documented failure of all the following: NSAIDS, methotrexate, steroids, and sulfasalazine Etanercept (Enbrel) will not be used concomitantly with other biologic DMARDs such as adalimumab (Humira), infliximab (Remicade), abatacept (Orencia), anakinra (Kineret), or secukinumab (Cosentyx). biologic therapy OR yearly for members with risk factors** that are requesting continuation of therapy. If the screening testing for TB is positive, there must be documentation of further testing to confirm there is no active disease. If there is active disease, TB treatment must be begun before initiation of etanercept. *In exceptional circumstances (e.g. disabling acral disease), individuals with severe disease may fall outside of this definition, but may be considered for treatment. **Risk factors include: persons with close contact to people with infectious TB disease; persons who Latin America, and Russia); children less than 5 years of age who have a positive TB test; groups with high rates of TB transmission (e.g. homeless persons, injection drug users, and persons with HIV infection); persons who work or reside with people who are at an increased risk for active TB (e.g. hospitals, long-term care facilities, correctional facilities, and homeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved from Coventry Health Care, Inc. Page 2

3 For Humira Active Crohns disease in members ages 6 years and older that has remained active (i.e. symptoms of abdominal pain, arthritis, bleeding, diarrhea, internal fistulae, intestinal obstruction, megacolon, perianal disease, spondylitis, or weight loss) despite treatment with either 6-mercaptopurine, azathioprine, or corticosteroids Active non-axial psoriatic arthritis a documented failure to methotrexate, or if methotrexate is contraindicated or not tolerated, to another non-biologic DMARD Active axial psoriatic arthritis and an inadequate response to at least two NSAIDs Adult moderate to severe active rheumatoid arthritis as monotherapy or in combination with methotrexate or other non-biologic DMARDs Ankylosing spondylitis a documented failure of at least two NSAIDs (e.g. naproxen, ibuprofen, meloxicam) Moderate to severe chronic plaque psoriasis in adults ages 18 years and older documented to be a candidate for systemic therapy or phototherapy when the following criteria are met: At least 10% body surface area (BSA) is affected by plaque psoriasis [or at least 5% BSA if psoriasis involves sensitive areas (i.e. hands, feet, face, or genitals)] or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more*; Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following, unless contraindicated: Phototherapy (PUVA, UVB with coal tar or dithranol, OR UVB standard or narrow-band); OR Systemic non-biologic DMARDs (e.g. methotrexate, acetretin, cyclosporine) Moderate to severe active polyarticular juvenile idiopathic arthritis (juvenile rheumatoid arthritis) in members ages 2 years and older Moderate to severe active ulcerative colitis (UC) in adults ages 18 years and older who meet either of the following criteria: Member is hospitalized with fulminant UC (i.e. persons with severe UC who have more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia); OR Member has moderate or severe active UC and meets all of the following criteria: Member is refractory to or requires continuous immunosuppression with corticosteroids (e.g. methylprednisolone, prednisone) at a dose equivalent to prednisone 40 to 60 mg/day for 30 days for oral therapy or 7 to 10 days for IV therapy; Member is refractory to or has a contraindication to 5-aminosalicylic acid agents (e.g. balsalazide, mesalamine, sulfasalazine); Member is refractory to or has a contraindication to immunosuppressants (e.g. azathioprine, 6-mercaptopurine) Pyoderma gangrenosum when first-line therapies (e.g. systemic glucocorticoids and/or systemic cyclosporine) have failed Coventry Health Care, Inc. Page 3

4 Refractory Behçet's uveitis Noninfectious uveitis refractory or intolerant to corticosteroids and immunosuppressive drugs (e.g. azathioprine, cyclosporine, or methotrexate), unless contraindicated Extraintestinal manifestations of Crohn's disease (e.g. arthritis, oral aphthous ulcers, episcleritis, erythema nodosum) in members 6 years of age and older that have remained active despite treatment with 6-mercaptopurine, azathioprine, or corticosteroids Moderate to severe hidradenitis suppurativa (Hurley Stage II or Hurley Stage III) in persons who have had an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of hidradenitis suppurativa, unless contraindicated. biologic therapy OR yearly for members with risk factors** that are requesting disease, TB treatment must be begun before initiation of adalimumab. *In exceptional circumstances (e.g. disabling acral disease), individuals with severe disease may fall outside of this definition, but may be considered for treatment. **Risk factors include: persons with close contact to people with infectious TB disease; persons who For Remicade Active Crohn's disease that has remained active despite treatment with either a nonbiologic DMARD (e.g. leflunomide), immunosuppressant (e.g. 6-mercaptopurine, azathioprine), 5-aminosalicylic acid (e.g. mesalamine, olsalazine), or corticosteroid (e.g. prednisone, hydrocortisone, methylprednisolone). Active non-axial psoriatic arthritis a documented failure to methotrexate, or if methotrexate is contraindicated or not tolerated, to another non-biologic DMARD Active axial psoriatic arthritis and an inadequate response to 2 or more NSAIDs Adult moderate to severe active rheumatoid arthritis Coventry Health Care, Inc. Page 4

5 Ankylosing spondylitis and other spondyloarthropathies a documented inadequate response to at least two NSAIDS (e.g. celecoxib, diclofenac, ibuprofen, indomethacin, meloxicam, naproxen, sulindac) Refractory Behcet's uveitis Severe or life-threatening enterocolitis that persists despite permanent discontinuation of nivolumab (Opdivo) and administration of systemic corticosteroids. Noninfectious uveitis refractory or intolerant to corticosteroids and immunosuppressive drugs (e.g. azathioprine, cyclosporine, or methotrexate), unless contraindicated Moderate to severe chronic plaque psoriasis in adults ages 18 years and older documented to be a candidate for systemic therapy or phototherapy when the following criteria are met: At least 10% body surface area (BSA) is affected by plaque psoriasis [or at least 5% BSA if psoriasis involves sensitive areas (i.e. hands, feet, face, or genitals)] or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more*; Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following, unless contraindicated: Phototherapy (PUVA, UVB with coal tar or dithranol, OR UVB standard or narrow-band); OR Systemic non-biologic DMARDs (e.g. methotrexate, acetretin, cyclosporine) Chronic pulmonary sarcoidosis that remains symptomatic despite treatment for at least 3 months with steroids (10 mg per day or more) immunosuppressants (e.g. azathioprine, cyclophosphamide, methotrexate) Fistulizing Crohn's disease for at least 3 months Moderate to severe active juvenile rheumatoid arthritis that has failed to respond to other TNF inhibitors (e.g. Enbrel, Humira) Refractory pyoderma gangrenosum Reactive arthritis (e.g., Reiter's syndrome) or inflammatory bowel disease arthritis (enteropathic arthritis) that has failed or is intolerant to NSAIDs, methotrexate, and sulfasalazine Moderate to severe active ulcerative colitis (UC) in members who meet either of the following criteria: Member is hospitalized with fulminant UC (i.e. persons with severe UC who have more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia); OR Member has moderate or severe active UC and meets all of the following criteria: Member is refractory to or requires continuous immunosuppression with corticosteroids (e.g. methylprednisolone, prednisone) at a dose equivalent to prednisone 40 to 60 mg/day for 30 days for oral therapy or 7 to 10 days for IV therapy; Member is refractory to or has a contraindication to 5-aminosalicylic acid agents (e.g. balsalazide, mesalamine, sulfasalazine); Member is refractory to or has a contraindication to immunosuppressants (e.g. azathioprine, 6-mercaptopurine) Coventry Health Care, Inc. Page 5

6 Moderate to severe hidradenitis suppurativa (Hurley Stage II or Hurley Stage III) in members who have had an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of hidradenitis suppurativa, unless contraindicated Infliximab (Remicade) is not being used concomitantly with other biologic DMARDs (e.g. Enbrel, Humira, Cimzia, Simponi, Orencia, Kineret, or Cosentyx) for treating the same condition. biologic therapy OR yearly for members with risk factors** that are requesting disease, TB treatment must be begun before initiation of infliximab. *In exceptional circumstances (e.g. disabling acral disease), individuals with severe disease may fall outside of this definition, but may be considered for treatment. **Risk factors include: persons with close contact to people with infectious TB disease; persons who For Simponi Active ankylosing spondylitis with evidence of inflammatory disease in members who have had an inadequate response to NSAIDS (e.g. celecoxib, diclofenac, ibuprofen, indomethacin, meloxicam, naproxen, sulindac, or valdecoxib), unless contraindicated treatment with at least two preferred alternatives (one-month trial each) indicated for ankylosing spondylitis (e.g. Enbrel, Humira, Remicade) was ineffective, not tolerated, or is contraindicated Active non-axial psoriatic arthritis a documented failure to methotrexate, or if methotrexate is contraindicated or not tolerated, to another non-biologic DMARD treatment with at least two preferred alternatives (one-month trial each) indicated for psoriatic arthritis (e.g. Enbrel, Humira, Remicade, Stelara) was ineffective, not tolerated, or is contraindicated Coventry Health Care, Inc. Page 6

7 Active axial psoriatic arthritis and an inadequate response to at least two NSAIDs treatment with at least two preferred alternatives (one-month trial each) indicated for psoriatic arthritis (e.g. Enbrel, Humira, Remicade, Stelara) was ineffective, not tolerated, or is contraindicated Adult moderate to severe active rheumatoid arthritis in combination with methotrexate treatment with at least two preferred alternatives (one-month trial each) indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Remicade, Simponi ARIA) was ineffective, not tolerated, or is contraindicated Active ulcerative colitis (UC) Member is hospitalized with fulminant (UC) (i.e., persons severe ulcerative colitis who have more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia) OR Moderate to severe active ulcerative colitis (UC) in adults ages 18 years and older who meet either of the following criteria: Member is hospitalized with fulminant UC (i.e. persons with severe UC who have more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia); OR Member has moderate or severe active UC and meets all of the following criteria: Member is refractory to or requires continuous immunosuppression with corticosteroids (e.g. methylprednisolone, prednisone) at a dose equivalent to prednisone 40 to 60 mg/day for 30 days for oral therapy or 7 to 10 days for IV therapy; Member is refractory to or has a contraindication to 5-aminosalicylic acid agents (e.g. balsalazide, mesalamine, sulfasalazine); Member is refractory to or has a contraindication to immunosuppressants (e.g. azathioprine, 6-mercaptopurine) Treatment with two preferred alternatives (one-month trial each) indicated for UC (e.g. Humira, Remicade) was ineffective, not tolerated, or is contraindicated. biologic therapy OR yearly for members with risk factors* that are requesting disease, TB treatment must be begun before initiation of golimumab. *Risk factors include: Persons with close contact to people with infectious TB disease; persons who Coventry Health Care, Inc. Page 7

8 For Simponi ARIA A documented diagnosis of moderate to severe active rheumatoid arthritis in adult members 18 years of age or older in combination with methotrexate biologic therapy OR yearly for members with risk factors* that are requesting disease, TB treatment must be begun before initiation of golimumab. *Risk factors include: persons with close contact to people with infectious TB disease; persons who For Cimzia Moderately to severely active Crohn's disease in adult members ages 18 years and older, as manifested by any of the following signs/symptoms: Abdominal pain, bleeding, diarrhea, internal fistulae, intestinal obstruction, megacolon, perianal disease, weight loss, extra-intestinal manifestations (i.e. arthritis or spondylitis); Crohn's disease has remained active despite treatment with one of the following: 6-mercaptopurine, azathioprine, or corticosteroids; Treatment with two preferred alternatives (one-month trial each) indicated for Crohn's disease (e.g. Humira, Remicade) was ineffective, not tolerated, or is contraindicated. Adult moderate to severe active rheumatoid arthritis as monotherapy or in combination with methotrexate treatment with two preferred alternatives (onemonth trial each) indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Remicade, Simponi ARIA) was ineffective, not tolerated, or is contraindicated. Active non-axial psoriatic arthritis a documented failure to methotrexate, or if methotrexate is contraindicated or not tolerated, to another non-biologic DMARD Coventry Health Care, Inc. Page 8

9 treatment with two preferred alternatives (one-month trial each) indicated for psoriatic arthritis (e.g. Enbrel, Humira, Remicade, Stelara) was ineffective, not tolerated, or is contraindicated. Active axial psoriatic arthritis and an inadequate response to at least two NSAIDs treatment with two preferred alternatives (one-month trial each) indicated for psoriatic arthritis (e.g. Enbrel, Humira, Remicade, Stelara) was ineffective, not tolerated, or is contraindicated. Ankylosing spondylitis a documented failure of at least two NSAIDs (e.g. naproxen, ibuprofen, meloxicam) treatment with two preferred alternatives (one-month trial each) indicated for ankylosing spondylitis (e.g. Enbrel, Humira, Remicade) was ineffective, not tolerated, or is contraindicated. biologic therapy OR yearly for members with risk factors* that are requesting disease, TB treatment must be begun before initiation of certolizumab pegol. *Risk factors include: persons with close contact to people with infectious TB disease; persons who have emigrated from areas of the world with high rates of TB (e.g., Africa, Asia, Eastern Europe, with high rates of TB transmission (e.g., homeless persons, injection drug users, and persons with (e.g., hospitals, long-term care facilities, correctional facilities, and homeless shelters). CDC For Stelara Moderate to severe chronic plaque psoriasis in adults ages 18 years and older documented to be a candidate for systemic therapy or phototherapy when the following criteria are met: At least 10% body surface area (BSA) is affected by plaque psoriasis [or at least 5% BSA if psoriasis involves sensitive areas (i.e. hands, feet, face, or genitals)] or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more*; Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following, unless contraindicated: Phototherapy (PUVA, UVB with coal tar or dithranol, OR UVB standard or narrow-band); OR Systemic non-biologic DMARDs (e.g. methotrexate, acetretin, cyclosporine) Coventry Health Care, Inc. Page 9

10 Active non-axial psoriatic arthritis a documented failure to methotrexate, or if methotrexate is contraindicated or not tolerated, to another non-biologic DMARD Active axial psoriatic arthritis and an inadequate response to at least two NSAIDs biologic therapy OR yearly for members with risk factors** that are requesting disease, TB treatment must be begun before initiation of ustekinumab. *In exceptional circumstances (e.g. disabling acral disease), individuals with severe disease may fall outside of this definition, but may be considered for treatment. **Risk factors include: persons with close contact to people with infectious TB disease; persons who For Actemra Adult moderate to severe active rheumatoid arthritis treatment with Remicade and one additional preferred alternative (one-month trial each) indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Simponi ARIA) was ineffective, not tolerated, or is contraindicated. Active systemic juvenile idiopathic arthritis and meets one of the following criteria: A documented failure of NSAID monotherapy; OR Initial symptoms include high fevers and painful polyarthritis (i.e. severe disease) Moderate to severe active polyarticular juvenile idiopathic arthritis (juvenile rheumatoid arthritis) in members ages 2 years and older treatment with two preferred alternatives (one-month trial each) indicated for polyarticular juvenile idiopathic arthritis (e.g. Enbrel, Humira) were ineffective, not tolerated, or is contraindicated. (ONLY Actemra IV formulation) Castleman's disease (CD) when one of the following criteria is met Member is using as second-line therapy as a single agent for relapsed or refractory unicentric CD and is HIV-negative and human herpesvirus-8- negative; OR Coventry Health Care, Inc. Page 10

11 Member is using as subsequent therapy as a single agent for multicentric CD that has progressed following treatment of relapsed/refractory or progressive disease biologic therapy OR yearly for members with risk factors* that are requesting disease, TB treatment must be begun before initiation of toclizumab. *Risk factors include: persons with close contact to people with infectious TB disease; persons who For Kineret Adult moderate to severe active rheumatoid arthritis as monotherapy or in combination with DMARDs other than TNF inhibitors treatment with two preferred alternatives (one-month trial each) indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Remicade, Simponi ARIA) was ineffective, not tolerated, or is contraindicated. Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and neonatalonset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological cutaneous articular (CINCA) syndrome Adult-onset Still's disease when used after failure of glucocorticoids, methotrexate, and a TNF inhibitor Active systemic onset juvenile idiopathic arthritis and meet one of the following criteria: Failed to respond to an NSAID; OR Initial symptoms included high fevers and painful polyarthritis (severe disease) Subsequent therapy as a single agent for multicentric Castleman's disease (CD) that has progressed following treatment of relapsed/refractory or progressive disease Schnitzler syndrome (characterized by chronic, nonpruritic urticaria in association with recurrent fever, bone pain, arthralgia or arthritis) with documented monoclonal immunoglobulin M (IgM) gammopathy (present in all cases) Coventry Health Care, Inc. Page 11

12 biologic therapy OR yearly for members with risk factors* that are requesting disease, TB treatment must be begun before initiation of anakinra. *Risk factors include: persons with close contact to people with infectious TB disease; persons who For Orencia I.V./Subcutaneous Adult moderate to severe active rheumatoid arthritis treatment with two preferred alternatives (one-month trial each) indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Remicade, Simponi ARIA) was ineffective, not tolerated, or is contraindicated. (Note: For Orencia IV, one preferred alterative must be Remicade) Moderate or severe active polyarticular juvenile idiopathic arthritis (juvenile rheumatoid arthritis) in pediatric patients 6 years of age; Treatment with two preferred alternatives (one-month trial each) indicated for polyarticular juvenile idiopathic arthritis (e.g. Enbrel, Humira, Remicade) was ineffective, not tolerated, or is contraindicated. (Note: For Orencia IV, one preferred alterative must be Remicade); The member meets one of the following criteria: Failed to respond to an NSAID; OR Initial symptoms included high fevers and painful poly arthritis (severe disease) biologic therapy OR yearly for members with risk factors* that are requesting disease, TB treatment must be begun before initiation of abatacept. *Risk factors include: persons with close contact to people with infectious TB disease; persons who Coventry Health Care, Inc. Page 12

13 For Rituxan Acute lymphoid leukemia (induction/consolidation therapy for Philadelphia chromosone-negative ALL for patients aged greater than or equal to 40 years); OR Anti-neutrophil cytoplasmic antibody-associated (ANCA-associated) vasculitides (Wegener granulomatosis, Churg-Strauss syndrome, microscopic polyangiitis, and pauci-immune glomerulonephritis) in persons with an inadequate response to cyclophosphamide (rituximab is used in conjunction with glucocorticoids); OR Antibody mediated rejection in heart transplant recipients, prevention of recurrence; OR Chronic lymphocytic leukemia/small lymphocytic leukemia; OR Chronic graft versus host disease (last resort treatment); OR Corticosteroid-refractory autoimmune blistering diseases (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, cicatricial pemphigoid, epidermolysis bullosa acquisita and paraneoplastic pemphigus); OR Cryoglobulinemia refractory to corticosteroids and other immunosuppressive agents; OR Multi-centric Castleman's disease (angiofollicular lymph node hyperplasia); OR Non-Hodgkin's lymphoma; OR Opsoclonus-myoclonus-ataxia associated with neuroblastoma, that is refractory to steroids, chemotherapy and intravenous immunoglobulins; OR Post-transplant lymphoproliferative disorder; OR Prophylaxis of rejection in sensitized kidney transplant recipients with donor specific antibodies; OR Refractory autoimmune hemolytic anemia; OR Relapsed or refractory hairy cell leukemia in persons who have failed at multiple (2 or more) courses of cladribine; OR Sjogren syndrome refractory to corticosteroids and other immunosuppressive agents; OR Lymphocyte-predominant Hodgkins disease; OR Treatment of neuromyelitis optica when one or more immunotherapies have failed; OR Treatment of refractory immune or idiopathic thrombocytopenic purpura, refractory thrombotic thrombocytopenic purpura; OR Waldenströms macroglobulinemia; OR In combination with methotrexate in adult members with moderately to severely active rheumatoid arthritis and meets the following criteria: Treatment (one-month trial each) with Remicade and one additional preferred alternative indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Simponi ARIA) was ineffective, not tolerated, or is contraindicated. Coventry Health Care, Inc. Page 13

14 For Xeljanz Rituximab will not be used concomitantly with other biologicals such as ofatumumab (Arzerra), etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), abatacept (Orencia), ustekinumab (Stelara), anakinra (Kineret), or secukinumab (Cosentyx). A documented diagnosis of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate o o o A documented confirmation that Xeljanz will not be used in combination with other biologic therapy (i.e. Enbrel, Humira) or potent immunosuppressants (i.e. azathioprine, cyclosporine) A documented negative TB test (which can include a tuberculosis skin test (PPD), an interferon-release assay (IGRA), or a chest x-ray) within 6 months of initiating a biologic therapy OR yearly for members with risk factors* that are requesting documentation of further testing to confirm there is no active disease; if there is active disease, TB treatment must be begun before initiation of tofacitinib. A documented contraindication or intolerance or allergy or inadequate response to a trial of one month each of two preferred alternatives indicated for rheumatoid arthritis such as Enbrel, Humira, Remicade, or Simponi ARIA For Taltz *Risk factors include: persons with close contact to people with infectious TB disease; persons who have emigrated from areas of the world with high rates of TB (e.g., Africa, Asia, Eastern Europe, Latin America, and Russia); children less than 5 years of age who have a positive TB test; groups with high rates of TB transmission (e.g., homeless persons, injection drug users, and persons with HIV infection); persons who work or reside with people who are at an increased risk for active TB (e.g., hospitals, long-term care facilities, correctional facilities, and homeless shelters). CDC (September 1, 2012). Basic TB Facts. Retrieved from A documented diagnosis of moderate to severe chronic plaque psoriasis in adults ages 18 and older who are candidates for systemic therapy or phototherapy; At least 10% body surface area (BSA) is affected by plaque psoriasis [or at least 5% BSA if psoriasis involves sensitive areas (i.e. hands, feet, face, or genitals)] or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more*; Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following, unless contraindicated: Phototherapy (PUVA, UVB with coal tar or dithranol, OR UVB standard or narrow-band); OR Systemic non-biologic DMARDs (e.g. methotrexate, acetretin, cyclosporine) Coventry Health Care, Inc. Page 14

15 Treatment with at least two preferred alternatives (one-month trial each) for plaque psoriasis (i.e. Enbrel, Humira, Remicade, or Stelara) was ineffective, not tolerated, or is contraindicated. Ixekizumab (Taltz) will not be used concomitantly with any other biologic DMARD such as adalimumab (Humira), infliximab (Remicade), abatacept (Orencia), anakinra (Kineret), or secukinumab (Cosentyx). biologic therapy OR yearly for members with risk factors** that are requesting disease, TB treatment must be begun before initiation of ixekizumab. *In exceptional circumstances (e.g. disabling acral disease), individuals with severe disease may fall outside of this definition, but may be considered for treatment. **Risk factors include: persons with close contact to people with infectious TB disease; persons who For Xeljanz A documented diagnosis of moderate to severe active rheumatoid arthritis; Treatment with methotrexate was ineffective or not tolerated; Treatment with at least two preferred alternatives (one-month trial each) indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Remicade, Simponi ARIA) was ineffective, not tolerated, or is contraindicated; Documentation that Xeljanz will not be used concomitantly with biologic DMARDs (e.g. Enbrel, Humira) or potent immunosuppressants (i.e. azathioprine, cyclosporine); biologic therapy OR yearly for members with risk factors* that are requesting Coventry Health Care, Inc. Page 15

16 disease, TB treatment must be begun before initiation of tofacitinib. *Risk factors include: Persons with close contact to people with infectious TB disease; persons who For Xeljanz XR A documented diagnosis of moderate to severe active rheumatoid arthritis; Treatment with methotrexate was ineffective or not tolerated; Treatment with at least two preferred alternatives (one-month trial each) indicated for rheumatoid arthritis (e.g. Enbrel, Humira, Remicade, Simponi ARIA) was ineffective, not tolerated, or is contraindicated; Documentation that Xeljanz XR will not be used concomitantly with biologic DMARDs (e.g. Enbrel, Humira) or potent immunosuppressants (i.e. azathioprine, cyclosporine); biologic therapy OR yearly for members with risk factors* that are requesting disease, TB treatment must be begun before initiation of tofacitinib ER. *Risk factors include: Persons with close contact to people with infectious TB disease; persons who Coventry Health Care, Inc. Page 16

17 According to the manufacturers, Xeljanz, and Xeljanz XR can be dosed to a maximum daily dose as indicated below. A quantity of Xeljanz, and Xeljanz XR will be considered medically necessary, if the above criteria are met, as indicated in the table below: Drug Maximum Daily Dose Dosage Strength Quantity Limits Xeljanz 10 mg 5 mg Up to 60 tablets in 30 days Xeljanz XR 11 mg 11 mg Up to 30 tablets in 30 days AUTHORIZATION PERIOD LIMITATIONS Initial Approval: 6 months NON-COVERAGE 1. Use not approved by the FDA ; 2. The use is unapproved and not supported by the literature or evidence as an accepted off-label use. (see Off-Label Use Policy for determining accepted use ) REFERENCES 1. AHFS Drug Information with AHFSfirstReleases. ( American Society Of Health-System Pharmacists, Bethesda, MD. Updated periodically. 2. DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. 3. Drug Facts and Comparisons on-line. ( Wolters Kluwer Health, St. Louis, MO. Updated periodically. 4. PDR Electronic Library [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. 5. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59: Singh JA, Christensen R, Wells GA, et al. A network meta-analysis of randomized controlled trials of biologics for rheumatoid arthritis: a Cochrane overview. CMAJ. 2009;181(11): Zintzaras E, Dahabreh IJ, Giannouli S, Voulgarelis M, Moutsopoulos HM. Infliximab and methotrexate in the treatment of rheumatoid arthritis: a systematic review and meta-analysis of dosage regimens. Clin Ther. 2008;30(11): Venkateshan SP, Sidhu S, Malhotra S, Pandhi P. Efficacy of biologicals in the treatment of rheumatoid arthritis. A meta-analysis.pharmacology. 2009;83(1): Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24 week multicentre randomized placebo-controlled trial. Ann Rheum Dis. 2008;67: Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs. Arthris Rheum. 2008;58: Coventry Health Care, Inc. Page 17

18 11. Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti- IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study):evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis. 2009;68: Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. accessed online April May%202012%20AC&R.PDF 13. Taltz [prescribing information]. Indianapolis, IN: Eli Lilly and Company; March DRUGDEX System [internet database]. Greenwood Village, CO: Thomson Reuters (Healthcare) Inc.; Updated periodically. 15. Guidelines of care for the management of psoriasis and psoriatic arthritis. American Academy of Dermatology [cited 3/29/2016]; Retrieved from: Disclaimer: Coventry Health Care, Inc. (CHC) medical policies, technology assessments, and medical reviews (collectively CHC Policies ) are developed by CHC to provide guidance in administering plan benefits and constitute neither offers of coverage nor medical advice. Access to CHC Policies is provided for general reference purposes only and does not infer guaranteed coverage. CHC does not provide health care services or supplies. Providers are expected to exercise their independent medical judgment in rendering the most appropriate care. State and federal law, as well as benefit plan terms and conditions and CHC Policies in effect on the date that any service is rendered, including but not limited to definitions and specific inclusions/exclusions, take precedence over clinical policy and must be considered first in determining eligibility for coverage. The terms of the member's benefit plan shall determine coverage. Some benefit plans exclude coverage for services or supplies that Coventry may consider medically necessary. If there is a discrepancy between this policy and a member's benefit plan, the benefits shall govern. Coverage may also differ for CHC Medicare and/or Medicaid members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including National Coverage Determination (NCD), Local Medical Review Policies (LMRP), and/or Local Coverage Determinations (LCD). As clinical technology is continually updated, CHC policies are subject to periodic updates. Do not rely on printed versions of CHC policies as they may be outdated. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or means without the written consent of CHC. Coventry Health Care, Inc. Page 18