MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES `I. Requirements for Prior Authorization of Cytokine and CAM Antagonists

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1 MEDICAL ASSISTANCE HBOOK `I. Requirements for Prior Authorization of Cytokine and CAM Antagonists A. Prescriptions That Require Prior Authorization All prescriptions for Cytokine and CAM Antagonists must be prior authorized. See Preferred Drug List (PDL) for the list of preferred Cytokine and CAM Antagonists at: B. Review of Documentation for Medical Necessity In evaluating a request for prior authorization of a prescription for a Cytokine and CAM Antagonist, the determination of whether the requested prescription is medically necessary will take into account the guidelines listed in Attachments 1-10: 1. Attachment 1: Amevive 2. Attachment 2: Enbrel 3. Attachment 3: Humira 4. Attachment 4: Kineret 5. Attachment 5: Orencia 6. Attachment 6: Remicade 7. Attachment 7: Cimzia 8. Attachment 8: Actemra 9. Attachment 9: Simponi 10. Attachment 10: Stelara C. Clinical Review Process Prior authorization personnel will review the request for prior authorization and apply the clinical guidelines in the corresponding Section B. Attachment, to assess the medical necessity of the request for a prescription for a Cytokine and CAM Antagonist. If the guidelines in the corresponding Section B. Attachment are met, the reviewer will prior authorize the prescription. If the guidelines are not met, the prior authorization request will be referred to a physician reviewer for a medical necessity determination. Such a request for prior authorization will be approved when, in the professional judgment of the physician reviewer, the services are medically necessary to meet the medical needs of the recipient. D. Dose and Duration of Therapy The Department will limit authorization to the U.S. Food and Drug Administration (FDA) maximum recommended therapeutic dose for specific indications for each Cytokine and CAM Antagonist. 1

2 MEDICAL ASSISTANCE HBOOK References: 1. Amevive [package insert]. Cambridge, MA: Biogen Idec Inc.; May Anakinra [package insert]. Thousand Oaks, CA: Amgen; October Enbrel[package insert]. Thousand Oaks, CA: Immunex Corp.; March Humira[package insert]. North Chicago, IL: Abbott Laboratories; February Orencia[package insert]. Princeton, NJ:Bristol-Myers Squibb; April Raptiva[package insert]. South San Franciso, CA: Genetech, Inc.; June Remicade[package insert]. Malvern, PA: Centocor, Inc.; October Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis; American College of Rheumatology 2008 Arthritis & Rheumatism 2008; 59(6): Braun J, Davis J, Dougados M, et.al. First Update of the International ASAS Consensus Statement for the Use of Anti-Tumor Necrosis Factor Agents in Patients with Ankylosing Spondylitis; Ann Rheum Dis 2006; 65: Kyle S, Chandler D, Griffiths CEM, et. al. Guidelines for Anti-Tumor Necrosis Factor in Psoriatic Arthritis; Rheumatology 2005; 44(3): Mease PJ, Goffe BS, Diagnosis and Treatment of Psoriatic Arthritis; J AM Acad Dermatol 2005; 52(1): Hashkes PJ, Laxer RM, Medical Treatment of Juvenile Idiopathic Arthritis; JAMA 2005; 294(13): Cimzia[package insert]. Smyrna, GA: UCB, Inc; April FDA MedWatch Report: Accessed on January 26, FDA Alert: Information for Healthcare Professionals: Accessed on January 26, Cimzia[package insert]. Smyrna, GA: UCB, Inc; Nov FDA MedWatch Report: FDA Alert: Information for Healthcare Professionals: Menter A, et al. American Academy of Dermatology, Guidelines of care for the management of psoriasis and psoriatic arthritis. Section ; and Section Actemra [package insert]. South San Francisco, CA: Genetech, Inc; January Simponi [package insert]. Horsham, PA; Centocor Ortho Biotech Inc.; July Stelara [package insert]. Horsham, PA; Centocor Ortho Biotech Inc.; December

3 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 1: Amevive In evaluating a request for prior authorization of Amevive, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a. Has a diagnosis of chronic moderate to severe Plaque Psoriasis b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, gastroenterologist, rheumatologist, etc) d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Amevive g. Has a documented history of therapeutic failure, contraindication or intolerance to the preferred Cytokine and CAM Antagonists approved for this indication h. Has a body surface area (BSA) i. Of 10% or more that is affected; ii. Involvement of < 10% in critical areas (palms, soles, genitals or face) that interferes with daily activities 2

4 MEDICAL ASSISTANCE HBOOK i. Has a documented history of therapeutic failure of a three (3) or more month trial of one of the following photochemotherapies a documented history of intolerance or contraindication to: i. Psoralens (methoxsalen, trioxsalen) with UVA light (PUVA) ii. UVB light with coal tar or dithranol j. Has a documented history of therapeutic failure, contraindication, or intolerance of oral systemic therapy (methotrexate, cyclosporine, Soriatane) k. Does not have a history of receiving Amevive therapy for a duration of 12 months l. Has CD4 positive T lymphocyte counts 250 cells/mcl 2. Dose and Duration of Therapy The Department will limit authorization of a prescription for Amevive to no more than 2 treatment cycles per year. 3

5 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 2: Enbrel - In evaluating a request for prior authorization of Enbrel, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a. Has a diagnosis of moderate to severe active Rheumatoid Arthritis and is 18 years of age or older b. Has a diagnosis of Juvenile Idiopathic Arthritis (JIA) and is 2 through 17 years of age c. Was prescribed the medication by a specialist (i.e. dermatologist, d. d) Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Enbrel g. Has a documented history of therapeutic failure of a three (3) or more month trial of or documented contraindication or intolerance to: i. Methotrexate ii. An alternate disease-modifying anti-rheumatic drug (DMARD*) 4

6 MEDICAL ASSISTANCE HBOOK 3. Whether the recipient: a. Has a diagnosis of Ankylosing Spondylitis, other Spondyloarthropathies a diagnosis of active Psoriatic Arthritis 1) For Axial Disease: (i) A documented history of therapeutic failure of a six (6) week trial of two (2) Non-Steroidal Anti-Inflammatory drugs (NSAIDs) (ii) A documented contraindication or intolerance to NSAIDs 2) For Peripheral Disease: (i) A documented history of therapeutic failure of a six (6) week trial of two (2) NSAIDs a. A documented history of therapeutic failure of a three (3) or more month trial of methotrexate an alternate DMARD b. A documented contraindication or intolerance to NSAIDs, methotrexate or an alternate DMARD. b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Enbrel 4. Whether the recipient: 5

7 MEDICAL ASSISTANCE HBOOK a. Has a diagnosis of chronic moderate to severe Plaque Psoriasis b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Enbrel g. Has a body surface area (BSA) 1) Of 10% or more that is affected; 2) Involvement of < 10% in critical areas (palms, soles, genitals or face) that interferes with daily activities h. Has a history of therapeutic failure of a three (3) or more month trial of one of the following photochemotherapies a documented history of intolerance or contraindication to: i. Psoralens (methoxsalen, trioxsalen) with UVA light (PUVA) ii. UVB light with coal tar or dithranol 6

8 MEDICAL ASSISTANCE HBOOK i. History of therapeutic failure of a trial of oral systemic therapy (Methotrexate, Cyclosporine, Soriatane) j. Documented contraindication or intolerance of oral systemic therapy (Methotrexate, Cyclosporine, Soriatane) 7

9 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 3: Humira - In evaluating a request for prior authorization of Humira, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a. Has a diagnosis of Crohn s Disease which has remained active despite treatment with one or more of the following therapies: 1) Aminosalicylates 2) Corticosteroids 3) Immunomodulators b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Humira 2. Whether the recipient: a. Has a diagnosis of moderate to severe active Rheumatoid Arthritis and is 18 years of age or older 8

10 MEDICAL ASSISTANCE HBOOK b. Has a diagnosis of Juvenile Idiopathic Arthritis (JIA) and is 4 through 17 years of age c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Humira g. Has a documented history of therapeutic failure of a three (3) or more month trial of or a documented contraindication or intolerance to: i. Methotrexate ii. An alternate disease-modifying anti-rheumatic drug (DMARD*) 3. Whether the recipient: a. Has a diagnosis of Ankylosing Spondylitis, or other Spondyloarthropathies, a diagnosis of active Psoriatic Arthritis 1) For Axial Disease: (i) A documented history of therapeutic failure of a six (6) week trial of two (2) Non-Steroidal Anti-Inflammatory drugs (NSAIDs) (ii) A documented contraindication or intolerance to NSAIDs 2) For Peripheral Disease: (i) A documented history of therapeutic failure of a six (6) week trial of two (2) NSAIDs 9

11 MEDICAL ASSISTANCE HBOOK (ii) A documented history of therapeutic failure of a three (3) or more month trial of methotrexate an alternate DMARD (iii) A documented contraindication or intolerance to NSAIDs, methotrexate, or an alternate DMARD b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Humira 4. Whether the recipient: a. Has a diagnosis of chronic moderate to severe Plaque Psoriasis b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, 10

12 MEDICAL ASSISTANCE HBOOK d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Humira g. Has a body surface area (BSA) i. Of 10% or more that is affected; ii. Involvement of < 10% in critical areas (palms, soles, genitals or face) that interferes with daily activities h. Has a history of therapeutic failure of a three (3) or more month trial of one of the following photochemotherapies a documented history of intolerance or contraindication to: i. Psoralens (methoxsalen, trioxsalen) with UVA light (PUVA) ii. UVB light with coal tar or dithranol i. History of therapeutic failure of a trial of oral systemic therapy (Methotrexate, Cyclosporine, Soriatane) j. Documented contraindication or intolerance of oral systemic therapy (Methotrexate, Cyclosporine, Soriatane) 11

13 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 4: Kineret- In evaluating a request for prior authorization of Kineret, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a. Has a diagnosis of moderate to severe active Rheumatoid Arthritis b. Is 18 year of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Kineret g. Has a documented history of therapeutic failure of a three (3) or more month trial of or documented contraindication or intolerance to: i. Methotrexate ii. An alternate disease-modifying anti-rheumatic drug (DMARD*) h. Has a documented history of therapeutic failure, contraindication, or intolerance to the preferred Cytokine and CAM Antagonists approved for this indication. 12

14 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 5: Orencia- In evaluating a request for prior authorization of Orencia, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a) Has a diagnosis of moderate to severe active Rheumatoid Arthritis and is 18 years of age or older b) Has a diagnosis of Juvenile Idiopathic Arthritis (JIA) and is 6 through 17 years of age c) Was prescribed the medication by a specialist (i.e. dermatologist, d) Is not taking any other Cytokine and CAM Antagonist e) Was evaluated for active or latent tuberculosis infection by documented test f) If under 21 years of age, Is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Orencia g) Has a documented history of therapeutic failure of a three (3) or more month trial of or documented contraindication, or intolerance to: 1) Methotrexate 2) An alternate disease-modifying anti-rheumatic drug (DMARD*) 3) The Preferred Cytokine and CAM Antagonists approved for this indication 13

15 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 6: Remicade- In evaluating a request for prior authorization of Remicade, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a) Has a diagnosis of Crohn s Disease which has remained active despite treatment with one or more of the following therapies has a documented history of a contraindication or intolerance to: i. Aminosalicylates ii. Corticosteroids iii. Immunomodulators iv. The preferred Cytokine and CAM Antagonists approved for this indication b) Is 6 years of age or older c) Was prescribed the medication by a specialist (i.e. dermatologist, d) Is not taking any other Cytokine and CAM Antagonist e) Was evaluated for active or latent tuberculosis infection by documented test f) If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Remicade 2. Whether the recipient: a) Has a diagnosis of Rheumatoid Arthritis 14

16 MEDICAL ASSISTANCE HBOOK b) Is 18 years of age or older c) Has a documented history of therapeutic failure of a three (3) or more month trial of or a documented contraindication or intolerance to: i. Methotrexate ii. An alternate disease-modifying anti-rheumatic drug (DMARD*) iii. The Preferred Cytokine and CAM Antagonists approved for this indication d) Was prescribed the medication by a specialist (i.e. dermatologist, e) Is not taking any other Cytokine and CAM Antagonist f) Was evaluated for active or latent tuberculosis infection by documented test g) If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Remicade 3. Whether the recipient a) Has a diagnosis of Ankylosing Spondylitis, other Spondyloarthropathies, a diagnosis of active Psoriatic Arthritis 1) For Axial Disease: (i) A documented history of therapeutic failure of a six (6) week trial of two (2) Non-Steroidal Anti-Inflammatory drugs (NSAIDs) (ii) A documented history of therapeutic failure of the preferred Cytokine and CAM Antagonists approved for this indication 15

17 MEDICAL ASSISTANCE HBOOK (iii)a documented contraindication or intolerance to NSAIDs and the preferred Cytokine and CAM Antagonists 2) For Peripheral Disease: (i) A documented history of therapeutic failure of a six (6) week trial of two (2) NSAIDs (ii) A documented history of therapeutic failure of a three (3) or more month trial of methotrexate an alternate DMARD (iii) A documented history of therapeutic failure of the preferred Cytokine and CAM Antagonists approved for this indication (iv) A documented history of a contraindication or intolerance to NSAIDs, methotrexate, or an alternate DMARD, and the preferred Cytokine and CAM Antagonists b) Is 18 years of age or older c) Was prescribed the medication by a specialist (i.e. dermatologist, d) Is not taking any other Cytokine and CAM Antagonist e) Was evaluated for active or latent tuberculosis infection by documented test f) If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Remicade 4. Whether the recipient 16

18 MEDICAL ASSISTANCE HBOOK a) Has a diagnosis of moderate to severe Ulcerative Colitis refractory to one or more of the following standard therapies has a documented history of contraindication or intolerance to: 1) Corticosteroids 2) Aminosalicylates 3) Immunomodulators 4) The preferred Cytokine and CAM Antagonists approved for this indication b) Is 18 years of age or older c) Was prescribed the medication by a specialist (i.e. dermatologist, d) Is not taking any other Cytokine and CAM Antagonist e) Was evaluated for active or latent tuberculosis infection by documented test f) If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Remicade 5. Whether the recipient a) Has a diagnosis of chronic moderate to severe Plaque Psoriasis b) Is 18 years of age or older 17

19 MEDICAL ASSISTANCE HBOOK c) Was prescribed the medication by a specialist (i.e. dermatologist, d) Is not taking any other Cytokine and CAM Antagonist e) Was evaluated for active or latent tuberculosis infection by documented test f) If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Remicade g) Has a body surface area (BSA) 1) Of 10% or more that is affected; 2) Involvement of < 10% in critical areas (palms, soles, genitals or face) that interferes with daily activities h) Has a history of therapeutic failure of a three (3) or more month trial of one of the following photochemotherapies a documented history of intolerance or contraindication to: (1) Psoralens (methoxsalen, trioxsalen) with UVA light (PUVA) (2) UVB light with coal tar or dithranol i) Has a history of therapeutic failure of a documented contraindication or intolerance of: (1) A trial of oral systemic therapy (Methotrexate, Cyclosporine, Soriatane) (2) The Preferred Cytokine and CAM Antagonists approved for this indication 18

20 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 7: Cimzia - In evaluating a request for prior authorization of Cimzia, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a) Has a diagnosis of Crohn s Disease which has remained active despite treatment with one or more of the following therapies: i. Aminosalicylates ii. Corticosteroids iii. Immunomodulators b) Is 18 years of age or older c) Was prescribed the medication by a specialist (i.e. dermatologist, d) Is not taking any other Cytokine and CAM Antagonist e) Was evaluated for active or latent tuberculosis infection by documented test f) If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Cimzia 2. Whether the recipient: a) Has a diagnosis of Rheumatoid Arthritis 19

21 MEDICAL ASSISTANCE HBOOK b) Is 18 years of age or older c) Has a documented history of therapeutic failure of a three (3) or more month trial of or a documented contraindication or intolerance to: i. Methotrexate ii. An alternate disease-modifying anti-rheumatic drug (DMARD*) d) Was prescribed the medication by a specialist (i.e. dermatologist, e) Is not taking any other Cytokine and CAM Antagonist f) Was evaluated for active or latent tuberculosis infection by documented test g) If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Cimzia 20

22 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 8: Actemra - In evaluating a request for prior authorization of Actemra, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a. Has a diagnosis of moderate to severe active Rheumatoid Arthritis b. Is 18 year of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Actemra g. For initiation, i. Does not have transaminases ALT or AST greater than 1.5 times the upper limit of normal. For renewal: ii. Did not develop elevated ALT or AST greater than 5 times the upper limit of normal during previous treatment cycle(s). 21

23 MEDICAL ASSISTANCE HBOOK h. Has a documented history of therapeutic failure of a three (3) or more month trial of or documented contraindication or intolerance to: i. Methotrexate ii. An alternate disease-modifying anti-rheumatic drug (DMARD*) i. Has a documented history of therapeutic failure of the preferred Cytokine and CAM Antagonists approved for this indication 22

24 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 9: Simponi - In evaluating a request for prior authorization of Simponi, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a. Has a diagnosis of Rheumatoid Arthritis b. Is 18 years of age or older c. Has a documented history of therapeutic failure of a three (3) or more month trial of or a documented contraindication or intolerance to: i. Methotrexate ii. An alternate disease-modifying anti-rheumatic drug (DMARD*) iii. The Preferred Cytokine and CAM Antagonists approved for this indication d. Was prescribed the medication by a specialist (i.e. dermatologist, e. Is not taking any other Cytokine and CAM Antagonist f. Was evaluated for active or latent tuberculosis infection by documented test 23

25 MEDICAL ASSISTANCE HBOOK g. If under 21 years of age, is up to date on immunizations (excluding live vaccines) in accordance with current Early and Periodic Screening Diagnosis and Treatment (EPSDT) immunization guidelines prior to initiating therapy with Simponi 2. Whether the recipient: a. Has a diagnosis of Ankylosing Spondylitis, other Spondyloarthropathies, a diagnosis of active Psoriatic Arthritis i. For Axial Disease: (a) A documented history of therapeutic failure of a six (6) week trial of two (2) Non-Steroidal Anti-Inflammatory drugs (NSAIDs) (b) A documented history of therapeutic failure of the preferred Cytokine and CAM Antagonists approved for this indication (c) A documented contraindication or intolerance to NSAIDs and the preferred Cytokine and CAM Antagonists ii. For Peripheral Disease: (a) A documented history of therapeutic failure of a six (6) week trial of two (2) NSAIDs (b) A documented history of therapeutic failure of a three (3) or more month trial of methotrexate an alternate DMARD (c) A documented history of therapeutic failure of the preferred Cytokine and CAM Antagonists approved for this indication 24

26 MEDICAL ASSISTANCE HBOOK (d) A documented history of a contraindication or intolerance to NSAIDs, methotrexate, or an alternate DMARD, and the preferred Cytokine and CAM Antagonists b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with immunization guidelines prior to initiating therapy with Simponi 25

27 MEDICAL ASSISTANCE HBOOK Requirements for Prior Authorization of Cytokine and CAM Antagonists Attachment 10: Stelara In evaluating a request for prior authorization of Stelara, the determination of whether the requested prescription is medically necessary will take into account the following: 1. Whether the recipient: a. Has a diagnosis of chronic moderate to severe Plaque Psoriasis b. Is 18 years of age or older c. Was prescribed the medication by a specialist (i.e. dermatologist, gastroenterologist, rheumatologist, etc) d. Is not taking any other Cytokine and CAM Antagonist e. Was evaluated for active or latent tuberculosis infection by documented test f. If under 21 years of age, is up to date on immunizations in accordance with current Early and Periodic Screening Diagnosis and Treatment (EPSDT) immunization guidelines prior to initiating therapy with Stelara g. Has a documented history of therapeutic failure, contraindication or intolerance to the preferred Cytokine and CAM Antagonists approved for this indication h. Has a body surface area (BSA) i. 1) Of 10% or more that is affected 26

28 MEDICAL ASSISTANCE HBOOK ii. Involvement of < 10% in critical areas (palms, soles, genitals or face) that interferes with daily activities 27

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