Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary

Biologic Immunomodulators Prior Authorization with Quantity Limit – (with a preferred option)

Actemra® (tocilizumab) Avsola (infliximab-axxq) Cimzia® (certolizumab pegol) Cosentyx® (secukinumab) Enbrel ® (etanercept) Entyvio (vedolizumab) Humira® (adalimumab) Ilumya™ (tildrakizumab-asmn) Inflectra (infliximab-dyyb) Kevzara® (sarilumab) Kineret® (anakinra) Olumiant® (baricitinib) Orencia® (abatacept) Remicade® (infliximab) Renflexis (infliximab-abda) Rinvoq™ (upadacitinib extended release) Siliq™ (brodalumab) Simponi® (golimumab) Simponi ARIA (golimumab) Skyrizi™ (risankizumab-rzaa) Stelara® (ustekinumab) Taltz® (ixekizumab) Tremfya® (guselkumab) Xeljanz® (tofacitinib) Xeljanz XR® (tofacitinib extended release)

Disease Step 1 Step 2 (Non- Step 3a Step 3b Step 3c State (Preferred) preferred (Non- (Non- (Non- directed to preferred preferred preferred ONE step 1 directed to directed to directed to agent) TWO step 1 TWO agents THREE step agents) from step 1 1 agents) and/or step 2) Rheumatoid Disorders Ankylosing SQ: Cosentyx, N/A SQ: Cimzia, N/A N/A Spondylitis Enbrel, Simponi, Taltz (AS) Humira Nonradiograp SQ: Cimzia, N/A SQ: Taltz N/A N/A hic Axial Cosentyx Spondyloarthr

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Divisions of Health Care Service Corporation, a Mutual Legal Reserve Company, an Independent Licensee of the Blue Cross and Blue Shield Association itis (nr- axSpA) Polyarticular SQ: Enbrel, SQ: Actemra N/A SQ: Orencia N/A Juvenile Humira, (Humira is Idiopathic Xeljanz required Step Arthritis 1 agent) (PJIA) Psoriatic SQ: Cosentyx, N/A SQ: Cimzia, N/A N/A Arthritis (PsA) Enbrel, Orencia, Humira, Simponi, Taltz Stelara, Tremfya

Oral: Otezla, Xeljanz, Xeljanz XR Rheumatoid SQ: Enbrel, SQ: Actemra Oral: N/A N/A Arthritis Humira (Humira is Olumiant required Step Oral: Rinvoq, 1 agent) SQ: Cimzia, Xeljanz, Kevzara, Xeljanz XR Kineret, Orencia, Simponi Dermatological Disorder Hidradenitis SQ: Humira N/A N/A N/A N/A Suppurativa (HS) Psoriasis (PS) SQ: Cosentyx, N/A SQ: Cimzia, N/A SQ: Taltz Enbrel, Ilumya, Siliq Humira, Skyrizi, Stelara, Tremfya

Oral: Otezla Inflammatory Bowel Disease Crohn’s SQ: Humira, SQ: Cimzia N/A N/A N/A Disease Stelara (Humira is required Step 1 agent)

Ulcerative SQ: Humira, SQ: Simponi N/A N/A N/A Colitis Stelara (Humira is required Step 1 agent)

Oral: Xeljanz, Xeljanz XR Other Uveitis SQ: Humira N/A N/A N/A N/A Indications Without Preferred Agents Required Giant Cell N/A N/A N/A N/A N/A Arteritis (GCA)

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Neonatal- Onset Multisystem Inflammatory Disease (NOMID)

Systemic Juvenile Idiopathic Arthritis (SJIA) *Note: A trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as ONE product

QUANTITY LIMITS FOR TARGET AGENTS Brand (generic) GPI Quantity Limit Multisource Code Actemra® (tocilizumab) 162 mg/0.9 mL 4 autoinjectors (3.6 6650007000D520 M, N, O, or Y autoinjector mL)/28 days 4 syringes (3.6 mL) 162 mg/0.9 mL syringe 6650007000E520 M, N, O, or Y /28 days 10 vials (40 mL)/28 80 mg/4 mL vial 66500070002030 M, N, O, or Y days 4 vials (40 mL)/28 200 mg/10 mL vial 66500070002035 M, N, O, or Y days 2 vials (40 mL)/28 400 mg/20 mL vial 66500070002040 M, N, O, or Y days Avsola (infliximab-axxq) 100 mg/20 mL vial 52505040132120 N/A M, N, O, or Y Cimzia® (certolizumab) 2 kits/28 days 2 x 200 mg vial, kit 52505020106420 (2 kits of 4 x 200 mg M, N, O, or Y vials/28 days) 2 kits/28 days 2 x 200 mg/mL 52505020106440 (2 kits of 4 M, N, O, or Y syringe, kit syringes/28 days) 6 X 200 mg/mL 1 starter kit (3)/180 52505020106460 M, N, O, or Y syringe, starter kit days CosentyxTM (secukinumab) 300 mg/ 2 mL (2 x 9025057500D530 2 pens/28 days M, N, O, or Y 150 mg/mL) pen 150 mg/mL pen 9025057500D520 1 pen/28 days M, N, O, or Y 150 mg/mL pre-filled 9025057500E520 1 syringe/28 days M, N, O, or Y syringe 300 mg/2 mL (2 x 150 mg/mL) pre-filled 9025057500E530 2 syringes/28 days M, N, O, or Y syringe Enbrel® (etanercept) 25 mg/0.5 mL single 8 vials/28 days 66290030002015 M, N, O, or Y use vial 25 mg/vial, kit 66290030002120 8 vials/28 days M, N, O, or Y

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Brand (generic) GPI Quantity Limit Multisource Code 50 mg/mL SureClick 4 autoinjectors (4 mL) 6629003000D530 M, N, O, or Y autoinjector /28 days 50 mg/mL Mini 6629003000E230 4 cartridges (4 mL) M, N, O, or Y injector cartridge /28 days 4 syringes (2.04 25 mg/0.5 mL syringe 6629003000E525 M, N, O, or Y mL)/28 days 4 syringes (4 mL)/28 50 mg/mL syringe 6629003000E530 M, N, O, or Y days Entyvio (vedolizumab) 300 mg/vial 52503080002120 1 vial/56 days M, N, O, or Y Humira® (adalimumab) 10 mg/0.1 mL syringe 6627001500F804 2 syringes/28 days M, N, O, or Y 10 mg/0.2 mL syringe 6627001500F805 2 syringes/28 days M, N, O, or Y 20 mg/0.2 mL syringe 6627001500F809 2 syringes/28 days M, N, O, or Y 20 mg/0.4 mL 6627001500F810 2 syringes/28 days M, N, O, or Y syringe, kit 6627001500F820 Pediatric Crohn’s 1 kit/180 days

Disease Starter Kit 40 NDC: M, N, O, or Y mg/0.8mL (Both 3 [1 kit (3 syringes) [00074379903 and 6 syringe pack) 1 kit (6 syringes)] 00074379906] 40 mg/0.8 mL 6627001500F820 2 syringes/28 days M, N, O, or Y syringe, kit 40/0.4 mL syringe 6627001500F830 2 syringes/28 days M, N, O, or Y Pediatric Crohn’s 6627001500F840 Disease Starter kit 1 kit (3 syringes)/180 (NDC M, N, O, or Y (80 mg/0.8 mL days 00074379902) syringe) Pediatric Crohn’s Disease Starter kit 1 kit (2 syringes)/180 (40 mg/0.4 mL and 6627001500F880 M, N, O, or Y days 80 mg/0.8 mL syringe) 6627001500F420 2 pens/28 days 40 mg/0.8 mL pen, kit (NDC M, N, O, or Y 00074433902) Psoriasis/Uveitis 6627001500F420 1 kit (4 pens)/180 Starter kit (40 mg/0.8 (NDC M, N, O, or Y days mL pen) 00074433907) Crohn’s Disease, Ulcerative Colitis, or 6627001500F420 1 kit (6 pens)/180 Hidradenitis Starter (NDC M, N, O, or Y days Kit (40 mg/0.8 mL 00074433906) pen) 40 mg/0.4 mL pen 6627001500F430 2 pens/28 days M, N, O, or Y 80 mg/0.8 mL pen 6627001500F440 (NDC 2 pens/28 days M, N, O, or Y 00074012402) 80 mg/0.8 mL pen, Crohn’s disease, 6627001500F440 1 kit (3 pens)/180 ulcerative colitis, or (NDC M, N, O, or Y days hidradenitis 00074012403) suppurativa Starter kit

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Brand (generic) GPI Quantity Limit Multisource Code 80 mg/0.8 mL pen, 6627001500F440 1 kit (4 pens)/180 Pediatric ulcerative (NDC M, N, O, or Y days colitis Starter kit 00074012404) 80 mg/0.8 mL and 40 mg/0.4 mL pen, 1 kit (3 pens)/180 6627001500F450 M, N, O, or Y Psoriasis, uveitis days Starter kit Ilumya (tildrakizumab-asmn) 100 mg/mL syringe 9025058010E520 1 syringe/84 days M, N, O, or Y Inflectra (infliximab -dyyb) 100 mg/20 mL vial 52505040202120 N/A M, N, O, or Y Kevzara (sarilumab) 2 pens (2.28 mL) /28 150 mg/1.14 mL pen 6650006000D520 M, N, O, or Y days 2 pens (2.28 mL) /28 200 mg/1.14 mL pen 6650006000D530 M, N, O, or Y days 150 mg/1.14 mL 2 syringes (2.28 mL) 6650006000E520 M, N, O, or Y syringe /28 days 200 mg/1.14 mL 2 syringes (2.28 mL) 6650006000E530 M, N, O, or Y syringe /28 days Kineret® (anakinra) 28 syringes (18.76 100 mg syringe 6626001000E520 M, N, O, or Y mL) /28 days Olumiant (baricitinib) 1 mg tablets 66603010000310 1 tablet/day M, N, O, or Y 2 mg tablets 66603010000320 1 tablet/day M, N, O, or Y Orencia® (abatacept) 4 syringes (1.6 50 mg/0.4 mL syringe 6640001000E510 M, N, O, or Y mL)/28 days 87.5 mg/ 0.7 mL 4 syringes (2.8 6640001000E515 M, N, O, or Y syringe mL)/28 days 4 syringes (4 mL)/28 125 mg/mL syringe 6640001000E520 M, N, O, or Y days 125 mg/mL ClickJect 4 autoinjectors/28 6640001000D520 M, N, O, or Y autoinjector days 250 mg vial 66400010002120 4 vials/28 days M, N, O, or Y Remicade (infliximab) 100 mg/20 mL vial 52505040002120 N/A M, N, O, or Y Renflexis (infliximab-abda) 100 mg/20 mL vial 52505040102120 N/A M, N, O, or Y Rinvoq (upadacitinib) 15 mg tablet 66603072007520 1 tablet/day M, N, O, or Y Siliq (brodalumab) 210 mg/1.5 mL 2 syringes (3 mL)/28 9025052000E520 M, N, O, or Y syringe days Simponi ARIA (golimumab) 5 vials (20 mL)/56 50 mg/4 mL vial 66270040002015 M, N, O, or Y days Simponi® (golimumab) 50 mg/0.5 mL auto- 1 auto-injector (0.5 6627004000D520 M, N, O, or Y injector mL)/28 days 1 syringe (0.5 mL)/28 50 mg/0.5 mL syringe 6627004000E520 M, N, O, or Y days

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Brand (generic) GPI Quantity Limit Multisource Code 100 mg/1 mL auto- 1 auto-injector (1 6627004000D540 M, N, O, or Y injector mL)/28 days 1 syringe (1 mL)/28 100 mg/1 mL syringe 6627004000E540 M, N, O, or Y days Skyrizi (risankizumab-rzaa) 2 x 75 mg/0.83 mL 9025057070F820 1 kit/84 days M, N, O, or Y syringe, kit Stelara (ustekinumab) 130 mg/26 mL (5 4 vials (104 mL)/180 52504070002020 M, N, O, or Y mg/mL) days 1 vial (0.5 mL)/84 45 mg/0.5 mL vial 90250585002020 M, N, O, or Y days 1 syringe (0.5 45 mg/0.5 mL syringe 9025058500E520 M, N, O, or Y mL)/84 days 1 syringe (1 mL)/56 90 mg/1 mL syringe 9025058500E540 M, N, O, or Y days Taltz (ixekizumab) 80 mg/mL 9025055400D520 1 syringe/28 days M, N, O, or Y autoinjector 80 mg/mL syringe 9025055400E520 1 syringe/28 days M, N, O, or Y Tremfya (guselkumab) 100 mg/mL pen 9025054200D220 1 pen/56 days M, N, O, or Y 100 mg/mL syringe 9025054200E520 1 syringe/56 days M, N, O, or Y Xeljanz® (tofactinib) 5 mg tablet 66603065100320 2 tablets/day M, N, O, or Y 10 mg tablet 66603065100330 224 tablets/ 365 days M, N, O, or Y 1 mg/mL oral solution 66603065102020 240 mL/30 days M, N, O, or Y Xeljanz XR® (tofactinib extended release) 11 mg tablet 66603065107530 1 tablet/day M, N, O, or Y 22 mg tablet 66603065107550 112 tablets/365 days M, N, O, or Y

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Initial Evaluation Target Agents will be approved when ALL of the following are met: 1. ONE of the following: a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR b. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR c. ALL of the following: i. The patient has an FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the requested agent and route of administration AND ii. ONE of the following: 1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR 2. The prescriber has provided information in support of using the requested agent for the patient’s age

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3. The patient has a diagnosis of moderately to severely active rheumatoid arthritis (RA) AND BOTH of the following: a. ONE of the following: i. The patient has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) for at least 3- months OR ii. The patient has tried and had an inadequate response to another conventional agent (i.e., hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA for at least 3-months OR iii. The patient has an intolerance or hypersensitivity to ONE of the following conventional agents (i.e., maximally tolerated methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA OR iv. The patient has an FDA labeled contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA OR v. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of RA AND b. If the request is for Simponi, ONE of the following: i. The patient will be taking the requested agent in combination with methotrexate OR ii. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate OR 4. The patient has a diagnosis of active psoriatic arthritis (PsA) AND ONE of the following: a. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months OR b. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA OR c. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA OR d. The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) OR HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 7 of 29

e. The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) OR f. The patient’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of PsA OR 5. The patient has a diagnosis of moderate to severe plaque psoriasis (PS) AND ONE of the following: a. The patient has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months OR b. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PS OR c. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS OR d. The patient has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) OR e. The patient has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) OR f. The patient’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of PS OR 6. The patient has a diagnosis of moderately to severely active Crohn’s disease (CD) AND ONE of the following: a. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months OR b. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD OR c. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD OR HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 8 of 29

d. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of CD OR 7. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC) AND ONE of the following: a. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3-months OR b. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC OR c. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC OR d. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of UC OR 8. The patient has a diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis AND ONE of the following: a. BOTH of the following: i. ONE of the following: 1. The patient has tried and had an inadequate response to oral corticosteroids used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis for a minimum of 2 weeks OR 2. The patient has tried and had an inadequate response to periocular or intravitreal corticosteroid injections in the treatment of non- infectious intermediate uveitis, posterior uveitis, or panuveitis OR 3. The patient has an intolerance or hypersensitivity to oral corticosteroids OR periocular or intravitreal corticosteroid injections used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR 4. The patient has an FDA labeled contraindication to BOTH oral corticosteroids and periocular/intravitreal corticosteroids AND ii. ONE of the following: 1. The patient has tried and had an inadequate response to ONE conventional systemic agent (i.e., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) used in the treatment of

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non-infectious intermediate uveitis, posterior uveitis, or panuveitis for at least 3-months OR 2. the patient has an intolerance or hypersensitivity to ONE conventional systemic agent used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR 3. The patient has an FDA labeled contraindication to ALL conventional systemic agents used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR b. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR 9. The patient has a diagnosis of giant cell arteritis (GCA) AND ONE of the following: a. The patient has tried and had an inadequate response to systemic corticosteroids (e.g., prednisone, methylprednisolone) used in the treatment of GCA for at least 7-10 days OR b. The patient has an intolerance or hypersensitivity to systemic corticosteroids used in the treatment of GCA OR c. The patient has an FDA labeled contraindication to ALL systemic corticosteroids OR d. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of GCA OR 10. The patient has a diagnosis of active ankylosing spondylitis (AS) AND ONE of the following: a. The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4- week total trial OR b. The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of AS OR c. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of AS OR d. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of AS OR

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11. The patient has a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA) AND ONE of the following: a. The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of nr-axSpA for at least a 4-week total trial OR b. The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of nr-axSpA OR c. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of nr-axSpA OR d. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of nr- axSpA OR 12. The patient has a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) AND ONE of the following: a. The patient has tried and had an inadequate response to ONE conventional agent (i.e., methotrexate, leflunomide) used in the treatment of PJIA for at least 3-months OR b. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PJIA OR c. The patient has an FDA labeled contraindication ALL of the conventional agents used in the treatment of PJIA OR d. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of PJIA OR 13. The patient has a diagnosis of active systemic juvenile idiopathic arthritis (SJIA) AND ONE of the following: a. The patient has tried and had an inadequate response to NSAIDs (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least 1-month OR b. The patient has an intolerance or hypersensitivity to NSAIDs used in the treatment of SJIA OR c. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of SJIA OR d. The patient has tried and had an inadequate response to another conventional agent (i.e., methotrexate, leflunomide, systemic corticosteroids) used in the treatment of SJIA for at least 3-months OR e. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of SJIA HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 11 of 29

OR f. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of SJIA OR g. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of SJIA OR 14. The patient has a diagnosis of moderate to severe hidradenitis suppurative (HS) AND ONE of the following: a. The patient has tried and had an inadequate response to ONE conventional agent (i.e., oral tetracyclines [doxycycline, minocycline, tetracycline]; oral contraceptives [females only]; metformin [females only]; finasteride [females only]; spironolactone [females only]; intralesional corticosteroids [triamcinolone]; clindamycin in combination with rifampin; combination of rifampin, moxifloxacin, and metronidazole; cyclosporine, oral retinoids) used in the treatment of HS for at least 3-months OR b. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of HS OR c. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of HS OR d. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of HS OR 15. The patient has another FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the requested agent and route of administration not mentioned previously AND iii. ONE of the following (reference Step Table): 1. The requested agent’s route of administration (ROA) is intravenous (IV) OR 2. The requested agent is a Step 1 agent for the requested indication OR 3. The requested indication does NOT require any prerequisite biologic immunomodulator agents OR 4. BOTH of the following: a. ONE of the following: i. The prescriber has stated that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR ii. The prescriber has submitted documentation that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 12 of 29

used to treat an associated condition related to stage four advanced metastatic cancer [chart notes are required] AND b. The use of the requested agent is consistent with best practices for the treatment of stage four advanced, metastatic cancer, or an associated condition; supported by peer-reviewed, evidence- based literature; and approved by the United States Food and Drug Administration OR 5. ONE of the following: a. ONE of the following: i. There is documentation that the patient is currently being treated with the requested agent OR ii. BOTH of the following: 1. The patient is currently being treated with the requested agent AND 2. The patient is currently stable on the requested agent [chart notes are required] OR b. If the requested agent is a Step 2 agent for the requested indication, then ONE of the following: i. The patient has tried and had an inadequate response to ONE of the required Step 1 agents for the requested indication for at least 3-months (See Step 2) OR ii. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to ONE of the required Step 1 agents for the requested indication OR iii. The patient has an FDA labeled contraindication to ALL required Step 1 agents for the requested indication OR iv. The prescriber has provided information indicating why ALL of the required Step 1 agents are not clinically appropriate for the patient OR v. The prescriber has provided a complete list of previously tried agents for the requested indication OR c. If the requested agent is a Step 3a agent for the requested indication, then ONE of the following: i. The patient has tried and had an inadequate response to TWO of the Step 1 agents for the requested indication for at least 3-months (See Step 3a) OR ii. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of

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administration or hypersensitivity to TWO of the Step 1 agents for the requested indication OR iii. The patient has an FDA labeled contraindication to ALL of the Step 1 agents for the requested indication OR iv. BOTH of the following: 1. The prescriber has provided information indicating why ALL of the Step 1 agents are not clinically appropriate for the patient AND 2. The prescriber has provided a complete list of previously tried agents for the requested indication OR d. If the requested agent is a Step 3b agent for the requested indication, then ONE of the following: i. The patient has tried and had an inadequate response to TWO agents from Step 1 and/or Step 2 for the requested indication for at least 3-months (See Step 3b) OR ii. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to TWO agents from Step 1 and/or Step 2 for the requested indication OR iii. The patient has an FDA labeled contraindication to ALL of the Step 1 AND Step 2 agents for the requested indication OR iv. BOTH of the following: 1. The prescriber has provided information indicating why ALL of the Step 1 AND Step 2 agents are not clinically appropriate for the patient AND 2. The prescriber has provided a complete list of previously tried agents for the requested indication OR e. If the requested agent is a Step 3c agent for the requested indication, then ONE of the following: i. The patient has tried and had an inadequate response to THREE of the Step 1 agents for the requested indication for at least 3-months (See Step 3c) OR ii. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to THREE of the Step 1 agents for the requested indication OR iii. The patient has an FDA labeled contraindication to ALL of the Step 1 agents for the requested indication OR iv. BOTH of the following:

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1. The prescriber has provided information indicating why ALL of the Step 1 agents are not clinically appropriate for the patient AND 2. The prescriber has provided a complete list of previously tried agents for the requested indication OR f. The required preferred agents for the requested indication was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event (See Step 2, 3a, 3b, or 3c depending on requested agent) [chart notes are required] OR g. The patient has an FDA labeled contraindication, ALL required Step 1 and Step 2 agents (See Step 2, 3a, 3b, 3c depending on requested agent) for the requested indication [chart notes are required] OR h. The required preferred agent(s) for the requested indication is/are expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm (See Step 2, 3a, 3b, or 3c depending on requested agent) [chart notes are required] OR i. The required preferred agents for the requested indication is not in the best interest of the patient based on medical necessity (See Step 2, 3a, 3b, or 3c depending on requested agent) [chart notes are required OR j. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as the required preferred agents for the requested indication and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required]

AND iv. If Stelara 90 mg is requested, ONE of the following: 1. The patient has a diagnosis of psoriasis AND weighs >100kg OR 2. The patient has a dual diagnosis of psoriasis AND psoriatic arthritis AND the patient is >100kg OR 3. The patient has a diagnosis of Crohn’s disease or ulcerative colitis AND v. If Cosentyx 300 mg every 4 weeks is requested as maintenance dosing, ONE of the following: 1. The patient has a diagnosis of moderate to severe plaque psoriasis with or without coexistent active psoriatic arthritis OR 2. The patient has a diagnosis of active psoriatic arthritis or active ankylosing spondylitis AND has tried and had

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an inadequate response to Cosentyx 150 mg every 4 weeks for at least 3-months AND k. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for JIA, PsA, RA; gastroenterologist for CD, UC; dermatologist for PS) or has consulted with a specialist in the area of the patient’s diagnosis AND l. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent or Otezla AND m. The patient does NOT have any FDA labeled contraindications to the requested agent AND n. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB AND o. ONE of the following: a. The requested quantity (dose) does NOT exceed the program quantity limit OR b. If the requested agent is Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis, then BOTH of the following: i. The prescriber has provided information in support of therapy for the dose exceeding the quantity limit [e.g., patient has lost response to the FDA labeled maintenance dose (i.e., 5 mg twice daily or 11 mg once daily) during maintenance treatment; requires restart of induction therapy] (medical records required) AND ii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit OR c. If the requested agent is Xeljanz oral solution for a diagnosis of polyarticular course juvenile idiopathic arthritis, then ONE of the following: i. BOTH of the following: 1. The requested quantity (dose) does not exceed the maximum labeled dose (i.e., 5 mg twice daily) AND 2. The prescriber has provided information stating why the patient cannot take Xeljanz 5 mg tablets OR ii. BOTH of the following: 1. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND 2. The prescriber has provided information in support of therapy with a higher dose for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required) OR d. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following: i. The requested quantity (dose) is greater than the program quantity limit HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 16 of 29

AND ii. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose OR the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND iii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit OR e. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following: i. The requested quantity (dose) is greater than the program quantity limit AND ii. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND iii. The prescriber has provided information in support of therapy with a higher dose for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required)

Length of approval: 12 months for all agents EXCEPT Humira (adalimumab) for ulcerative colitis (UC), Siliq for plaque psoriasis (PS), Xeljanz and Xeljanz XR for induction therapy for UC, and the agents with indications that require loading doses for new starts. For agents that require a loading dose for a new start, approve the loading dose noted in the table AND the maintenance dose for the remainder of the 12 months. Humira for UC may be approved for 12 weeks, Siliq for PS for 16 weeks, Xeljanz and Xeljanz XR for UC may be approved for 16 weeks.

**NOTE: Cosentyx for the diagnoses of AS, nr-axSpA, and PSA loading doses are not approvable.

Renewal Evaluation Target Agents will be approved when ALL of the following are met: 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (*please note Stelara renewal must be for the same strength as the initial approval) AND 2. The patient has had clinical benefit with the requested agent AND 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for JIA, PsA, RA; gastroenterologist for CD, UC; dermatologist for PS) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND 4. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent or Otezla AND 5. If Cosentyx 300 mg every 4 weeks is requested as maintenance dosing, ONE of the following: A. The patient has a diagnosis of moderate to severe plaque psoriasis with or without coexistent active psoriatic arthritis OR

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B. The patient has a diagnosis of active psoriatic arthritis or active ankylosing spondylitis AND has tried and had an inadequate response to Cosentyx 150 mg every 4 weeks for at least 3-months AND 6. The patient does NOT have any FDA labeled contraindications to the requested agent AND 7. ONE of the following: a. The requested quantity (dose) does NOT exceed the program quantity limit OR b. If the requested agent is Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis, then BOTH of the following: i. The prescriber has provided information in support of therapy for the dose exceeding the quantity limit [e.g., patient has lost response to the FDA labeled maintenance dose (i.e., 5 mg twice daily or 11 mg once daily) during maintenance treatment; requires restart of induction therapy] (medical records required) AND ii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit OR c.If the requested agent is Xeljanz oral solution for a diagnosis of polyarticular course juvenile idiopathic arthritis, then ONE of the following: iii. BOTH of the following: 1. The requested quantity (dose) does not exceed the maximum labeled dose (i.e., 5 mg twice daily) AND 2. The prescriber has provided information stating why the patient cannot take Xeljanz 5 mg tablets OR iv. BOTH of the following: 3. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND 4. The prescriber has provided information in support of therapy with a higher dose for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required) OR d. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following: i. The requested quantity (dose) is greater than the program quantity limit AND ii. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose OR the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND iii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit

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OR f. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following: i. The requested quantity (dose) is greater than the program quantity limit AND ii. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND iii. The prescriber has provided information in support of therapy with a higher dose for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required)

Length of approval: 12 months for all agents.

**NOTE: Cosentyx for the diagnoses of AS, nr-axSpA, and PSA loading doses are not approvable.

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Table 1: Agents with Loading Doses Actemra No loading doses required (tocilizumab)

subcutaneous injection Avsola AS: Initial dosing 5 mg/kg at 0, 2, and 6 weeks, then 5 mg/kg every 6 (infliximab-axxq) weeks

intravenous CD: Initial dosing 5 mg/kg at 0, 2, and 6 weeks, then 5 mg/kg every 8 infusion weeks; for adults only may increase dose to 10 mg/kg

PS, PSA, UC: Initial dosing 5 mg/kg at 0, 2, and 6 weeks, then 5 mg/kg every 8 weeks

RA: Initial dosing 3 mg/kg at 0, 2, and 6 weeks, then 3 mg/kg every 8 weeks with methotrexate; may increase dose up to 10 mg/kg or treat as often as every 4 weeks AS, nr-axSpA: Initial dose of 400 mg on day 1 and at week 2 and week 4, followed by maintenance dose of 200 mg every 2 weeks or 400 mg every 4 weeks

CD: Initial dosing of 400 mg on day 1 and at week 2 and week 4, followed Cimzia by maintenance dose of 400 mg every 4 weeks (certolizumab) PsA and RA: Initial dosing of 400 mg on day 1 and at week 2 and week 4, subcutaneous followed by maintenance dose 200 mg every two weeks or 400 mg every injection 4 weeks

PS: patients body weight ≤90 kg – initial dose of 400 mg on day 1 and at week 2 and week 4, followed by maintenance dose of 200 mg every 2 weeks may be considered PS and PS with PSA: Initial dosing of 300 mg at weeks 0, 1, 2, 3, and 4, Cosentyx followed by maintenance dose of 300 mg every 4 weeks or 150 mg every (secukinumab) 4 weeks

subcutaneous AS, PSA: Loading doses are not approvable injection

Adult PS: Initial dose 50 mg twice weekly for 3 months, then maintenance Enbrel dose 50 mg weekly (etanercept) Adult AS, PSA, RA: no loading dose required subcutaneous injection Pediatric PJIA, PS: no loading dose required

Adult AS, PSA, RA: no loading dose required

PJIA, adolescent uveitis: no loading dose required Humira

(adalimumab) Adult CD, UC: Initial dose of 160 mg on day 1, 80 mg on day 15, then

maintenance dose of 40 mg every 2 weeks starting on day 29 subcutaneous

injection Pediatric CD: • 17kg to <40kg: Initial dose of 80 mg on day 1, 40 mg on day 15, then maintenance dose of 20 mg every 2 weeks starting on day 29

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• ≥40kg: 160 mg on day 1, 80 mg on day 15, then maintenance dose of 40 mg every 2 weeks starting on day 29

Pediatric UC: • weight 20 kg to <40 kg: 80 mg SC on day 1, 40 mg on days 8 and 15, then 20 mg every week or 40 mg every other week starting on day 29 • weight ≥40 kg: 160 mg SC on day 1, 80 mg on days 8 and 15, then 40 mg every week or 80 mg every other week starting on day 29

PS, Adult uveitis: Initial dose of 80 mg, then maintenance dose of 40 mg every 2 weeks starting one week after the initial dose

Adult HS: Initial dose of 160 mg day 1, 80 mg on day 15, then maintenance dose of 40 mg weekly or 80 mg every 2 weeks starting on day 29

Pediatric HS: • 30 kg to <60 kg: Initial dose of 80 mg on day 1, then maintenance dose of 40 mg every 2 weeks starting on day 8 • ≥60 kg: 160 mg on day 1, 80 mg on day 15, then maintenance dose of 40 mg weekly or 80 mg every 2 weeks starting on day 29 PS: 100 mg at weeks 1, 4 and every 12 weeks thereafter Ilumya (tildrakuzumab- asmn)

Kevzara Loading dose not required (sarilumab)

subcutaneous injection Kineret Loading dose not required (anakinra)

subcutaneous injection Olumiant Loading dose not required (baricitinib)

tablet Orencia subcutaneous formulations of Orencia do not have loading doses (abatacept)

subcutaneous injection Rinvoq Loading dose not required (upadacitinib)Oral tablet Siliq PS: Initial dose of 210 mg given at week 0, 1, and 2, followed by (brodalumab) maintenance dose of 210 mg every 2 weeks

subcutaneous injection Simponi AS, PSA, RA: no loading dose required (golimumab)

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subcutaneous UC: Initial dose of 200 mg at week 0, 100 mg at week 2, then injection maintenance dose of 100 mg every 4 weeks Skyrizi PS: 150 mg SC at weeks 0 and 4, then every 12 weeks thereafter (risankizumab- rzaa)

subcutaneous injection Adult CD or UC: Initial dose is a single IV weight-based dose, followed by maintenance dose with subcutaneous injection of 90 mg 8 weeks after initial IV dose, then every 8 weeks thereafter

Adult PS: Initial dose is weight based as noted below at day 0 and week 4, then maintenance dose every 12 weeks • ≤100 kg: 45 mg • >100 kg: 90 mg Stelara

(ustekinumab) Adolescent PS: Initial dose is weight based as noted below at day 0 and

week 4, then maintenance dose every 12 weeks subcutaneous • <60 kg: 0.75 mg/kg injection • 60-100 kg: 45 mg • >100 kg: 90 mg

PSA: Initial dose 45 mg at day 0 and week 4, then maintenance dose 45 mg every 12 weeks

PS with PSA and >100kg: 90 mg at day 0 and week 4, then maintenance dose 90 mg every 12 weeks AS: Initial dose of 160 mg at week 0, followed by 80 mg every 4 weeks

Adult PS, PS with PSA: Initial dose of 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then maintenance dose of 80 mg every 4 weeks thereafter

Taltz Pediatric (6 to <18 years) PS: starting dose given at week 0, then every 4 (ixekizumab) weeks (patients weighing 50 kg or less, doses must be prepared and administered by a health care professional; use prefilled syringe only) subcutaneous • weight >50 kg: 160 mg, then 80 mg injection • weight 25 to 50 kg: 80 mg, then 40 mg • weight <25 kg: 40 mg, then 20 mg

PSA: Initial dose of 160 mg (2 x 80 mg injections) at week 0, followed by maintenance dose 80mg every 4 weeks

nr-axSpA: no loading dose required Tremfya PS: Initial dose of 100 mg at week 0 and week 4, followed by (guselkumab) maintenance dose 100 mg every 8 weeks thereafter

subcutaneous injection Xeljanz Loading dose not required Xeljanz XR (tofacitinib)

oral tablet, oral solution HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 22 of 29

AS=Ankylosing Spondylitis, CAPS/NOMID= Cryopyrin Associated Periodic Syndrome/ Neonatal-Onset Multisystem Inflammatory Disease, CD=Crohn’s Disease, CRS = Cytokine Release Syndrome, GCA = Giant Cell Arteritis, HS= Hidradenitis Suppurativa, JIA=Juvenile Idiopathic Arthritis, PJIA=Polyarticular Juvenile Idiopathic Arthritis, PS=Psoriasis, PSA=Psoriatic Arthritis, RA=Rheumatoid Arthritis, SJIA=Systemic Juvenile Idiopathic Arthritis, UC=Ulcerative Colitis, nr- axSpA=Nonradiographic Axial Spondyloarthritis, pcJIA= Polyarticular course Juvenile Idiopathic Arthritis

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Agent FDA Labeled Contraindication(s) Actemra (tocilizumab) Known hypersensitivity to Actemra Doses >5 mg/kg in moderate to severe heart failure Previous severe hypersensitivity reaction Avsola (infliximab-axxq) to infliximab products, or known hypersensitivity to inactive components of Inflectra or to any murine proteins Serious hypersensivity reaction to Cimzia (certolizumab) certolizumab pegol or to any of the excipients Serious hypersensitivity reaction to Cosentyx (secukinumab) secukinumab or to any of the excipients Enbrel (etanercept) Sepsis Patients who have had a known serious Entyvio (vedolizumab) or severe hypersensitivity reaction to Entyvio or any of its excipients Humira (adalimumab) None Serious hypersensitivity reaction to Ilumya (tildrakizumab-asmn) tildrakizumab or to any of the excipients Known hypersensitivity to sarilumab or any Kevzara (sarilumab) of the inactive ingredients. Known hypersensitivity to E coli – derived Kineret (anakinra) proteins, Kineret, or to any component of the product Olumiant (baricitinib) None Orencia (abatacept) None Doses > 5 mg/kg in moderate to severe heart failure Previous severe hypersensitivity reaction Remicade (infliximab) to Remicade or known hypersensitivty to inactive components, or to any murine proteins Doses >5 mg/kg in moderate to severe heart failure Previous severe hypersensitivity reaction Renflexis (infliximab-abda) to infliximab products or known hypersensitivity to inactive components of Renflexis or to any murine proteins Rinvoq (upadacitinib) None Siliq (brodalumab) Crohn’s disease Simponi (golimumab) None Simponi ARIA (golimumab) None Skyrizi (risankizumab-rzaa) None Clinically significant hypersensitivity to Stelara (ustekinumab) ustekinumab or to any of the excipients Serious hypersensitivity reaction to Taltz (ixekizumab) ixekizumab or to any of the excipients Tremfya (guselkumab) None Xeljanz (tofacitinib) None Xeljanz XR (tofacitinib extended release)

Agents Contraindicated as Concomitant Therapy Actemra (tocilizumab) Avsola (infliximab-axxq) Cimzia (certolizumab) HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 24 of 29

Cosentyx (secukinumab) Enbrel (etanercept) Entyvio (vedolizumab) Humira (adalimumab) Ilumya (tildrakizumab-asmn) Inflectra (infliximab-dyyb) Kevzara (sarilumab) Kineret (anakinra) Olumiant (baricitinib) Orencia (abatacept) Otezla (apremilast) Remicade (infliximab) Renflexis (infliximab-abda) Riabni (rituximab-arrx) Rinvoq (upadacitinib) Rituxan (rituximab)a Rituxan Hycela (rituximab/hyaluronidase human)a Siliq (brodalumab) Simponi (golimumab) Simponi ARIA (golimumab) Skyrizi (risankizumab-rzaa) Stelara (ustekinumab) Taltz (ixekizumab) Tremfya (guselkumab) Truxima (rituximab-abbs)a Xeljanz (tofacitinib) Xeljanz XR (tofacitinib extended release) Tysabri (natalizumab)a Arcalyst (rilonacept)a Ilaris (canakinumab)a a – Rituxan (rituximab), Rituxan Hycela (rituximab/hyaluronidase human), Truxima (rituximab-abbs), Tysabri (natalizumab), Arcalyst (rilonacept), and Ilaris (canakinumab) are not targets in this program but will be included as a biologic immunomodulator contraindicated in the 30 day washout period.

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Biologic Immunomodulators Quantity Limit

TARGET AGENTS Actemra® (tocilizumab) Cimzia® (certolizumab pegol) Cosentyx® (secukinumab) Enbrel® (etanercept) Entyvio (vedolizumab) Humira® (adalimumab) Ilumya™ (tildrakizumab-asmn) Kevzara® (sarilumab) Kineret® (anakinra) Olumiant® (baricitinib) Orencia® (abatacept) Rinvoq™ (upadacitinib extended release) Siliq™ (brodalumab) Simponi ARIA (golimumab) Simponi® (golimumab) Skyrizi™ (risankizumab-rzaa) Stelara® (ustekinumab) Taltz® (ixekizumab) Tremfya® (guselkumab) Xeljanz® (tofacitinib) Xeljanz XR® (tofacitinib extended release)

PROGRAM QUANTITY LIMIT TARGET AGENTS – RECOMMENDED LIMITS Brand (generic) GPI Quantity Limit Actemra (tocilizumab) 162 mg/0.9 mL autoinjector 6650007000D520 4 autoinjectors (3.6 mL)/28 days 162 mg/0.9 mL syringe 6650007000E520 4 syringes (3.6 mL)/28 days 80 mg/4 mL vial 66500070002030 10 vials (40 mL)/28 days 200 mg/10 mL vial 66500070002035 4 vials (40 mL)/28 days 400 mg/20 mL vial 66500070002040 2 vials (40 mL)/28 days Cimzia (certolizumab) 2 x 200 mg vial, kit 52505020106420 2 kits/28 days 2 x 200 mg/mL syringe, kit 52505020106440 2 kits/28 days 6 X 200 mg/mL syringe, 52505020106460 1 starter kit (3)/180 days starter kit Cosentyx (secukinumab) 300 mg/2 mL (2 x 150 9025057500D530 2 pens/28 days mg/mL) pen 150 mg/mL pen 9025057500D520 1 pen/28 days 150 mg/mL syringe 9025057500E520 1 syringe/28 days 300 mg/2 mL (2 x 150 9025057500E530 2 syringes/28 days mg/mL) syringe Enbrel (etanercept) 25 mg/0.5 mL single use vial 66290030002015 8 vials/28 days 25 mg/vial, kit 66290030002120 8 vials/28 days 50 mg/mL SureClick 6629003000D530 4 autoinjectors (4 mL)/28 days autoinjector 50 mg/mL Mini injector 6629003000E230 4 cartridges (4 mL)/28 days cartridge 25 mg/0.5 mL syringe 6629003000E525 4 syringes (2.04) mL)/28 days 50 mg/mL syringe 6629003000E530 4 syringes (4 mL)/28 days Entyvio (vedolizumab) HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 26 of 29

300 mg/vial 52503080002120 1 vial/56 days Humira (adalimumab) 10 mg/0.1 mL syringe 6627001500F804 2 syringes/28 days 10 mg/0.2 mL syringe 6627001500F805 2 syringes/28 days 20 mg/0.2 mL syringe 6627001500F809 2 syringes/28 days 20 mg/0.4 mL syringe, kit 6627001500F810 2 syringes/28 days 6627001500F820 1 kit/180 days Pediatric Crohn’s Starter Kit NDC: 40 mg/0.8mL (Both 3 and 6 [00074379903 [1 kit (3 syringes) syringe pack) 00074379906] 1 kit (6 syringes)] 6627001500F820 40 mg/0.8 mL syringe, kit (NDC 2 syringes/28 days 00074379902) 40/0.4 mL syringe 6627001500F830 2 syringes/28 days Pediatric Crohn’s Disease Starter kit (80 mg/0.8 mL 6627001500F840 1 kit (3 syringes)/180 days syringe) Pediatric Crohn’s Disease Starter kit (40 mg/0.4 mL 6627001500F880 1 kit (2 syringes)/180 days and 80 mg/0.8 mL syringe) 6627001500F420 2 pens/28 days 40 mg/0.8 mL pen (NDC 00074433902) 6627001500F420 Psoriasis, Uveitis Starter kit (NDC 1 kit (4 pens)/180 days 40 mg/0.8 mL pen, 00074433907) Crohn’s Disease, Ulcerative 6627001500F420 Colitis, or Hidradenitis (NDC 1 kit (6 pens)/180 days Starter kit 40 mg/0.8 mL 00074433906) pen, 40 mg/0.4 mL pen 6627001500F430 2 pens/28 days 80 mg/0.8 mL pen 6627001500F440 (NDC 2 pens/28 days 00074012402) 80 mg/0.8 mL pen, Crohn’s 6627001500F440 disease, ulcerative colitis, or (NDC 1 kit (3 pens)/180 days hidradenitis suppurativa 00074012403) Starter kit 80 mg/0.8 mL pen, Pediatric 6627001500F440 ulcerative colitis Starter kit (NDC 1 kit (4 pens)/180 days 00074012404) 80 mg/0.8 mL and 40 mg/0.4 mL pen, Psoriasis, 6627001500F450 1 kit (3 pens)/180 days uveitis Starter kit Ilumya (tildrakizumab-asmn) 100 mg/mL syringe 9025058010E520 1 syringe/84 days Kevzara (sarilumab) 150 mg/1.14 mL pen 6650006000D520 2 pens (2.28 mL)/28 days 200 mg/1.14 mL pen 6650006000D530 2 pens (2.28 mL)/28 days 150 mg/1.14 mL syringe 6650006000E520 2 syringes (2.28 mL)/28 days 200 mg/1.14 mL syringe 6650006000E530 2 syringes (2.28 mL)/28 days Kineret (anakinra) 100 mg syringe 6626001000E520 28 syringes (18.76 mL)/28 days Olumiant (baricitinib) 1 mg tablets 66603010000310 1 tablet/day HCSC_CS_reg_Biologic_Immunomodulators_PAQL_ProgSum_AR0420_r0321 Page 27 of 29

2 mg tablets 66603010000320 1 tablet/day Orencia (abatacept) 50 mg/0.4 mL syringe 6640001000E510 4 syringes (1.6 mL)/28 days 87.5 mg/ 0.7 mL syringe 6640001000E515 4 syringes (2.8 mL)/28 days 125 mg/mL syringe 6640001000E520 4 syringes (4 mL)/28 days 125 mg/mL ClickJect 6640001000D520 4 autoinjectors (4 mL)/28 days autoinjector 250 mg vial 66400010002120 4 vials/28 days Rinvoq (upadacitinib) 15 mg tablet 66603072007520 1 tablet/day Siliq (brodalumab) 210 mg/1.5 mL syringe 9025052000E520 2 syringes (3 mL)/28 days Simponi ARIA (golimumab) 50 mg/4 mL vial 66270040002015 5 vials (20 mL)/56 days Simponi (golimumab) 50 mg/0.5 mL auto-injector 6627004000D520 1 auto-injector (0.5 mL)/28 days 50 mg/0.5 mL syringe 6627004000E520 1 syringe (0.5 mL)/28 days 100 mg/1 mL auto-injector 6627004000D540 1 auto-injector (1 mL)/28 days 100 mg/1 mL syringe 6627004000E540 1 syringe (1 mL)/28 days Skyrizi (risankizumab-rzaa) 2 x 75 mg/0.83 mL syringe, 9025057070F820 1 kit/84 days kit Stelara (ustekinumab) 130 mg/26 mL (5 mg/mL) 52504070002020 4 vials (104 mL)/180 days 45 mg/0.5 mL vial 90250585002020 1 vial (0.5 mL)/84 days 9025058500E520 45 mg/0.5 mL syringe 1 syringe (0.5 mL)/84 days

90 mg/1 mL syringe 9025058500E540 1 syringe (1 mL)/56 days Taltz (ixekizumab) 80 mg/mL autoinjector 9025055400D520 1 syringe/28 days 80 mg/mL syringe 9025055400E520 1 syringe/28 days Tremfya (guselkumab) 100 mg/mL pen 9025054200D220 1 pen/56 days 100 mg/mL syringe 9025054200E520 1 syringe/56 days Xeljanz (tofacitinib) 5 mg tablet 66603065100320 2 tablets/day 10 mg tablet 66603065100330 224 tablets/365 days 1 mg/mL oral solution 66603065102020 240 mL/30 days Xeljanz XR (tofacitinib extended release) 11 mg tablet 66603065107530 1 tablet/day 22 mg tablet 66603065107550 112 tablets/365 days

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Quantities above the program quantity limit for the Target Agents will be approved when ONE of the following is met: 1. If the requested agent is Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis, then BOTH of the following: i. The prescriber has provided information in support of therapy for the dose exceeding the quantity limit [e.g., patient has lost response to the FDA labeled maintenance dose (i.e., 5 mg twice daily or 11 mg once daily) during maintenance treatment; requires restart of induction therapy] (medical records required) AND

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ii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit OR 2. If the requested agent is Xeljanz oral solution for a diagnosis of polyarticular course juvenile idiopathic arthritis, then ONE of the following: i. BOTH of the following: 1. The requested quantity (dose) does not exceed the maximum labeled dose (i.e., 5 mg twice daily) AND 2. The prescriber has provided information stating why the patient cannot take Xeljanz 5 mg tablets OR ii. BOTH of the following: 1. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND 2. The prescriber has provided information in support of therapy with a higher dose for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required) OR 3. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following: i. The requested quantity (dose) is greater than the program quantity limit AND ii. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose OR the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND iii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit OR 4.If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following: i. The requested quantity (dose) is greater than the program quantity limit AND ii. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication AND iii. The prescriber has provided information in support of therapy with a higher dose for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required)

Length of Approval: 12 months or through the remainder of an existing authorization, whichever is shorter

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