Page 1 of 15 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016 Developed By: Medical Criteria Committee 10/28/2015

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1 Moda Health Plan, Inc. Medical Necessity Criteria Subject: Actemra (tocilizumab) Page 1 of 15 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016 Developed By: Medical Criteria Committee 10/28/2015 Approved: Mary Engrav, MD Date: 02/24/2016 Description: Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody that is approved to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Patients with rheumatoid arthritis have elevated IL-6 concentrations both in serum and in synovial fluid. Furthermore, IL-6 concentrations correlate with disease activity and joint damage. Criteria: CWQI HCS-0096 I. Actemra (tocilizumab) is considered medically necessary for 1 or more of the following indications: a. Rheumatoid Arthritis with ALL of the following: i. Adult patient (18 years or older); ii. Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment iii. Documented moderate to severe active disease iv. Patient has had at least a three (3) month trial and failed previous therapy with one oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, Imuran, Ridaura, Plaquenil, Cuprimine, Asulfidine, Arave v. May be used alone or in combination with MTX and 1 or more of the following: 1. Patient must try and have an inadequate response, contraindication, or intolerance to at least a three (3) month trial of Enbrel AND Humira 2. Patient is continuing treatment b. Systemic Juvenile Idiopathic Arthritis (SJIA) with ALL of the following: i. Patient is over the age of 2 ii. Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment; and iii. Patient has active SJIA; and iv. Patient has had at least a three (3) month trial and failed previous therapy with one oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, Arave or glucocorticoids and

2 v. Only approved for IV formulation (will not be approved for subcutaneous (SC) formulation (Actemra 162 mg/0.9 ml pre-filled syringe). vi. May be used alone or in combination with MTX and 1 or more of the following: vii. Patient must try and have an inadequate response, contraindication, or intolerance to at least a three (3) month trial of Enbrel AND Humira viii. Patient is continuing treatment c. Polyarticular Juvenile Idiopathic Arthritis (PJIA) with ALL of the following: i. Patient is over the age of 2; and ii. Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment; and iii. Patient has active PJJIA; and iv. Patient has had at least a three (3) month trial and failed previous therapy with one oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, Arave or glucocorticoids; and v. May be used alone or in combination with MTX; and vi. Only approved for IV formulation (will NOT be approved for subcutaneous (SC) formulation (Actemra 162 mg/0.9 ml pre-filled syringe) and 1 or more of the following: 1. Patient must try and have an inadequate response, contraindication, or intolerance to at least a three (3) month trial of Enbrel AND Humira; OR 2. Patient is continuing treatment d. Castleman s Disease will be covered when ALL of the following are met: i. Actemra is used as a single agent and 1 or more of the following: 1. Unicentris disease and ALL of the following: a. Patient is HIV (-) and HSVS (-) b. Used as second line therapy c. Patient has relapsed and/or refractory disease 2. Multicentris Disease and ALL of the following: a. Used as second line or later therapy b. Patient has relapsed, refractory and/or progressive disease e. Renewal of tocilizumab will be covered if ALL of the following are met: i. Patient continues to meet above criteria; and ii. Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts; and iii. Absence of unacceptable toxicity from the drug; and iv. Ongoing monitoring for TB II. Exclusions: a. Tocilizumab (Actemra) should not be administered to patients with known hypersensitivity to Actemra b. Tocilizumab (Actemra) is not medically indicated for diagnoses not FDA approved c. All indications not described in criteria are not covered and may be considered experimental or investigational.

3 III. Dosage and Administrations: Indication Adult Rheumatoid Arthritis (IV) Adult Rheumatoid Arthritis (SC) (wt<100kg Adult Rheumatoid Arthritis (SC) (wt 100kg) Polyarticular Juvenile Idiopathic Arthritis (IV) (wt 30 kg) Polyarticular Juvenile Idiopathic Arthritis (IV) (wt < 30 kg) Systemic Juvenile Idiopathic Arthritis (IV) (wt 30 kg) Systemic Juvenile Idiopathic Arthritis (IV) (wt < 30 kg) Dose 4 mg/kg 8 mg/kg IV every 4 weeks 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response 162 mg administered subcutaneously every week 8 mg/kg IV every 4 weeks 10 mg/kg IV every 4 weeks 8 mg/kg IV every 2 weeks 12 mg/kg IV every 2 weeks Jcode: J Actemra (Genentech) 80 mg, 200 mg, 400 mg IV Injection: 1 billable unit = 1mg NDC: Actemra 80 mg/4ml vial xx (Genentech) Actemra 200mg/10ml vial xx (Genentech) Actemra 400mg/20ml vial xx (Genentech) Actemra 162mg/0.9ml pre-filled syringe xx (Genentech) IV. Dosing Limits: Quantity Limit (max daily dose) (Pharmacy Benefit): Actemra 162 mg/0.9 ml pre-filled syringe: 4 syringes every 28 days Max Units (per dose and over time) (Medical Benefit): Rheumatoid Arthritis Male: 800 billable units every 28 days Female: 800 billable units every 28 days Systemic Juvenile Idiopathic Arthritis Male: 800 billable units every 14 days Female: 800 billable units every 14 days Polyarticular Juvenile Idiopathic Arthritis Male: 800 billable units every 28 days Female: 800 billable units every 28 days

4 V. Information to be submitted with Pre-Authorization Request: a. Chart notes with documentation of diagnosis and confirmation of negative TB test. b. Laboratory reports ICD-10 Codes: ICD-10 D36.0 Benign neoplasm of lymph nodes ICD-10 Description M05.10 Rheumatoid lung disease with rheumatoid arthritis of unspecified site M Rheumatoid lung disease with rheumatoid arthritis of right shoulder M Rheumatoid lung disease with rheumatoid arthritis of left shoulder M Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder M Rheumatoid lung disease with rheumatoid arthritis of right elbow M Rheumatoid lung disease with rheumatoid arthritis of left elbow M Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow M Rheumatoid lung disease with rheumatoid arthritis of right wrist M Rheumatoid lung disease with rheumatoid arthritis of left wrist M Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist M Rheumatoid lung disease with rheumatoid arthritis of right hand M Rheumatoid lung disease with rheumatoid arthritis of left hand M Rheumatoid lung disease with rheumatoid arthritis of unspecified hand M Rheumatoid lung disease with rheumatoid arthritis of right hip M Rheumatoid lung disease with rheumatoid arthritis of left hip M Rheumatoid lung disease with rheumatoid arthritis of unspecified hip M Rheumatoid lung disease with rheumatoid arthritis of right knee M Rheumatoid lung disease with rheumatoid arthritis of left knee M Rheumatoid lung disease with rheumatoid arthritis of unspecified knee M Rheumatoid lung disease with rheumatoid arthritis of right ankle and foot M Rheumatoid lung disease with rheumatoid arthritis of left ankle and foot M Rheumatoid lung disease with rheumatoid arthritis of unspecified ankle and foot M05.19 Rheumatoid lung disease with rheumatoid arthritis of multiple sites M05.20 Rheumatoid vasculitis with rheumatoid arthritis of unspecified site M Rheumatoid vasculitis with rheumatoid arthritis of right shoulder M Rheumatoid vasculitis with rheumatoid arthritis of left shoulder M Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder

5 M Rheumatoid vasculitis with rheumatoid arthritis of right elbow M Rheumatoid vasculitis with rheumatoid arthritis of left elbow M Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow M Rheumatoid vasculitis with rheumatoid arthritis of right wrist M Rheumatoid vasculitis with rheumatoid arthritis of left wrist M Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist M Rheumatoid vasculitis with rheumatoid arthritis of right hand M Rheumatoid vasculitis with rheumatoid arthritis of left hand M Rheumatoid vasculitis with rheumatoid arthritis of unspecified hand M Rheumatoid vasculitis with rheumatoid arthritis of right hip M Rheumatoid vasculitis with rheumatoid arthritis of left hip M Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip M Rheumatoid vasculitis with rheumatoid arthritis of right knee M Rheumatoid vasculitis with rheumatoid arthritis of left knee M Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee M Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot M Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot M Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot M05.29 Rheumatoid vasculitis with rheumatoid arthritis of multiple sites M05.30 Rheumatoid heart disease with rheumatoid arthritis of unspecified site M Rheumatoid heart disease with rheumatoid arthritis of right shoulder M Rheumatoid heart disease with rheumatoid arthritis of left shoulder M Rheumatoid heart disease with rheumatoid arthritis of unspecified shoulder M Rheumatoid heart disease with rheumatoid arthritis of right elbow M Rheumatoid heart disease with rheumatoid arthritis of left elbow M Rheumatoid heart disease with rheumatoid arthritis of unspecified elbow M Rheumatoid heart disease with rheumatoid arthritis of right wrist M Rheumatoid heart disease with rheumatoid arthritis of left wrist M Rheumatoid heart disease with rheumatoid arthritis of unspecified wrist M Rheumatoid heart disease with rheumatoid arthritis of right hand M Rheumatoid heart disease with rheumatoid arthritis of left hand M Rheumatoid heart disease with rheumatoid arthritis of unspecified hand M Rheumatoid heart disease with rheumatoid arthritis of right hip M Rheumatoid heart disease with rheumatoid arthritis of left hip

6 M Rheumatoid heart disease with rheumatoid arthritis of unspecified hip M Rheumatoid heart disease with rheumatoid arthritis of right knee M Rheumatoid heart disease with rheumatoid arthritis of left knee M Rheumatoid heart disease with rheumatoid arthritis of unspecified knee M Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot M Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot M Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot M05.39 Rheumatoid heart disease with rheumatoid arthritis of multiple sites M05.40 Rheumatoid myopathy with rheumatoid arthritis of unspecified site M Rheumatoid myopathy with rheumatoid arthritis of right shoulder M Rheumatoid myopathy with rheumatoid arthritis of left shoulder M Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder M Rheumatoid myopathy with rheumatoid arthritis of right elbow M Rheumatoid myopathy with rheumatoid arthritis of left elbow M Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow M Rheumatoid myopathy with rheumatoid arthritis of right wrist M Rheumatoid myopathy with rheumatoid arthritis of left wrist M Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist M Rheumatoid myopathy with rheumatoid arthritis of right hand M Rheumatoid myopathy with rheumatoid arthritis of left hand M Rheumatoid myopathy with rheumatoid arthritis of unspecified hand M Rheumatoid myopathy with rheumatoid arthritis of right hip M Rheumatoid myopathy with rheumatoid arthritis of left hip M Rheumatoid myopathy with rheumatoid arthritis of unspecified hip M Rheumatoid myopathy with rheumatoid arthritis of right knee M Rheumatoid myopathy with rheumatoid arthritis of left knee M Rheumatoid myopathy with rheumatoid arthritis of unspecified knee M Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot M Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot M Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot M05.49 Rheumatoid myopathy with rheumatoid arthritis of multiple sites M05.50 Rheumatoid myopathy with rheumatoid arthritis of unspecified sites M Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder M Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder

7 M Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder M Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow M Rheumatoid polyneuropathy with rheumatoid arthritis of left elbow M Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified elbow M Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist M Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist M Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist M Rheumatoid polyneuropathy with rheumatoid arthritis of right hand M Rheumatoid polyneuropathy with rheumatoid arthritis of left hand M Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand M Rheumatoid polyneuropathy with rheumatoid arthritis of right hip M Rheumatoid polyneuropathy with rheumatoid arthritis of left hip M Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip M Rheumatoid polyneuropathy with rheumatoid arthritis of right knee M Rheumatoid polyneuropathy with rheumatoid arthritis of left knee M Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified knee M Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot M Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot M Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot M05.59 Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites M05.60 Rheumatoid arthritis of unspecified site with of other organs and systems M Rheumatoid arthritis of right shoulder with of other organs and systems M Rheumatoid arthritis of left shoulder with of other organs and systems M Rheumatoid arthritis of unspecified shoulder with of other organs and systems M Rheumatoid arthritis of right elbow with of other organs and systems M Rheumatoid arthritis of left elbow with of other organs and systems M Rheumatoid arthritis of unspecified elbow with of other organs and systems M Rheumatoid arthritis of right wrist with of other organs and systems M Rheumatoid arthritis of left wrist with of other organs and systems M Rheumatoid arthritis of unspecified wrist with of other organs and systems M Rheumatoid arthritis of right hand with of other organs and systems M Rheumatoid arthritis of left hand with of other organs and systems M Rheumatoid arthritis of unspecified hand with of other organs and systems M Rheumatoid arthritis of right hip with of other organs and systems

8 M Rheumatoid arthritis of left hip with of other organs and systems M Rheumatoid arthritis of unspecified hip with of other organs and systems M Rheumatoid arthritis of right knee with of other organs and systems M Rheumatoid arthritis of left knee with of other organs and systems M Rheumatoid arthritis of unspecified knee with of other organs and systems M Rheumatoid arthritis of right ankle and foot with of other organs and systems M Rheumatoid arthritis of left ankle and foot with of other organs and systems M Rheumatoid arthritis of unspecified ankle and foot with of other organs and systems M05.69 Rheumatoid arthritis of multiple sites with of other organs and systems M05.70 Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems M Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems M Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems M Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems M Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems M Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems M Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems M Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems M Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems M Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems M Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems M Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems M Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems M Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems

9 M Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems M Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems M Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems M Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems M Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems M Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems M Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems M Rheumatoid arthritis with rheumatoid factor of unspecified ankle and wrist without organ or systems M05.79 Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems M05.80 Other rheumatoid arthritis with rheumatoid factor of unspecified site M Other rheumatoid arthritis with rheumatoid factor of right shoulder M Other rheumatoid arthritis with rheumatoid factor of left shoulder M Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder M Other rheumatoid arthritis with rheumatoid factor of right elbow M Other rheumatoid arthritis with rheumatoid factor of left elbow M Other rheumatoid arthritis with rheumatoid factor of unspecified elbow M Other rheumatoid arthritis with rheumatoid factor of right wrist M Other rheumatoid arthritis with rheumatoid factor of left wrist M Other rheumatoid arthritis with rheumatoid factor of unspecified wrist M Other rheumatoid arthritis with rheumatoid factor of right hand M Other rheumatoid arthritis with rheumatoid factor of left hand M Other rheumatoid arthritis with rheumatoid factor of unspecified hand M Other rheumatoid arthritis with rheumatoid factor of right hip M Other rheumatoid arthritis with rheumatoid factor of left hip M Other rheumatoid arthritis with rheumatoid factor of unspecified hip M Other rheumatoid arthritis with rheumatoid factor of right knee M Other rheumatoid arthritis with rheumatoid factor of left knee

10 M Other rheumatoid arthritis with rheumatoid factor of unspecified knee M Other rheumatoid arthritis with rheumatoid factor of right ankle and foot M Other rheumatoid arthritis with rheumatoid factor of left ankle and foot M Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot M05.89 Other rheumatoid arthritis with rheumatoid factor of multiple sites M05.9 Rheumatoid arthritis with rheumatoid factor, unspecified M06.00 Rheumatoid arthritis without rheumatoid factor, unspecified site M Rheumatoid arthritis without rheumatoid factor, unspecified shoulder M Rheumatoid arthritis without rheumatoid factor, right elbow M Rheumatoid arthritis without rheumatoid factor, left elbow M Rheumatoid arthritis without rheumatoid factor, unspecified elbow M Rheumatoid arthritis without rheumatoid factor, right wrist M Rheumatoid arthritis without rheumatoid factor, left wrist M Rheumatoid arthritis without rheumatoid factor, unspecified wrist M Rheumatoid arthritis without rheumatoid factor, right hand M Rheumatoid arthritis without rheumatoid factor, left hand M Rheumatoid arthritis without rheumatoid factor, unspecified hand M Rheumatoid arthritis without rheumatoid factor, right hip M Rheumatoid arthritis without rheumatoid factor, left hip M Rheumatoid arthritis without rheumatoid factor, unspecified hip M Rheumatoid arthritis without rheumatoid factor, right knee M Rheumatoid arthritis without rheumatoid factor, left knee M Rheumatoid arthritis without rheumatoid factor, unspecified knee M Rheumatoid arthritis without rheumatoid factor, right ankle and foot M Rheumatoid arthritis without rheumatoid factor, left ankle and foot M Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot M06.08 Rheumatoid arthritis without rheumatoid factor, vertebrae M06.09 Rheumatoid arthritis without rheumatoid factor, multiple sites M06.4 Inflammatory polyarthropathy M06.80 Other specified rheumatoid arthritis, unspecified site M Other specified rheumatoid arthritis, right shoulder M Other specified rheumatoid arthritis, left shoulder M Other specified rheumatoid arthritis, unspecified shoulder M Other specified rheumatoid arthritis, right elbow

11 M Other specified rheumatoid arthritis, left elbow M Other specified rheumatoid arthritis, unspecified elbow M Other specified rheumatoid arthritis, right wrist M Other specified rheumatoid arthritis, left wrist M Other specified rheumatoid arthritis, unspecified wrist M Other specified rheumatoid arthritis, right hand M Other specified rheumatoid arthritis, left hand M Other specified rheumatoid arthritis, unspecified hand M Other specified rheumatoid arthritis, right hip M Other specified rheumatoid arthritis, left hip M Other specified rheumatoid arthritis, unspecified hip M Other specified rheumatoid arthritis, right knee M Other specified rheumatoid arthritis, left knee M Other specified rheumatoid arthritis, unspecified knee M Other specified rheumatoid arthritis, right ankle and foot M Other specified rheumatoid arthritis, left ankle and foot M Other specified rheumatoid arthritis, unspecified ankle and foot M06.88 Other specified rheumatoid arthritis, vertebrae M06.89 Other specified rheumatoid arthritis, multiple sites M06.9 Rheumatoid arthritis, unspecified M08.00 Unspecified juvenile rheumatoid arthritis of unspecified site M Unspecified juvenile rheumatoid arthritis, right shoulder M Unspecified juvenile rheumatoid arthritis, left shoulder M Unspecified juvenile rheumatoid arthritis, unspecified shoulder M Unspecified juvenile rheumatoid arthritis, right elbow M Unspecified juvenile rheumatoid arthritis, left elbow M Unspecified juvenile rheumatoid arthritis, unspecified elbow M Unspecified juvenile rheumatoid arthritis, right wrist M Unspecified juvenile rheumatoid arthritis, left wrist M Unspecified juvenile rheumatoid arthritis, unspecified wrist M Unspecified juvenile rheumatoid arthritis, right hand M Unspecified juvenile rheumatoid arthritis, left hand M Unspecified juvenile rheumatoid arthritis, unspecified hand M Unspecified juvenile rheumatoid arthritis, right hip

12 M Unspecified juvenile rheumatoid arthritis, left hip M Unspecified juvenile rheumatoid arthritis, unspecified hip M Unspecified juvenile rheumatoid arthritis, right knee M Unspecified juvenile rheumatoid arthritis, left knee M Unspecified juvenile rheumatoid arthritis, unspecified knee M Unspecified juvenile rheumatoid arthritis, right ankle and foot M Unspecified juvenile rheumatoid arthritis, left ankle and foot M Unspecified juvenile rheumatoid arthritis, unspecified ankle and foot M08.08 Unspecified juvenile rheumatoid arthritis, vertebrae M08.09 Unspecified juvenile rheumatoid arthritis, multiple sites M08.20 Juvenile rheumatoid arthritis with systemic onset, unspecified site M Juvenile rheumatoid arthritis with systemic onset, right shoulder M Juvenile rheumatoid arthritis with systemic onset, left shoulder M Juvenile rheumatoid arthritis with systemic onset, unspecified shoulder M Juvenile rheumatoid arthritis with systemic onset, right elbow M Juvenile rheumatoid arthritis with systemic onset, left elbow M Juvenile rheumatoid arthritis with systemic onset, unspecified elbow M Juvenile rheumatoid arthritis with systemic onset, right wrist M Juvenile rheumatoid arthritis with systemic onset, left wrist M Juvenile rheumatoid arthritis with systemic onset, unspecified wrist M Juvenile rheumatoid arthritis with systemic onset, right hand M Juvenile rheumatoid arthritis with systemic onset, left hand M Juvenile rheumatoid arthritis with systemic onset, unspecified hand M Juvenile rheumatoid arthritis with systemic onset, right hip M Juvenile rheumatoid arthritis with systemic onset, left hip M Juvenile rheumatoid arthritis with systemic onset, unspecified hip M Juvenile rheumatoid arthritis with systemic onset, right knee M Juvenile rheumatoid arthritis with systemic onset, left knee M Juvenile rheumatoid arthritis with systemic onset, unspecified knee M Juvenile rheumatoid arthritis with systemic onset, right ankle and foot M Juvenile rheumatoid arthritis with systemic onset, left ankle and foot M Juvenile rheumatoid arthritis with systemic onset, unspecified ankle and foot M08.28 Juvenile rheumatoid arthritis with systemic onset, vertebrae M08.29 Juvenile rheumatoid arthritis with systemic onset, multiple sites

13 M08.3 Juvenile rheumatoid polyarthritis (seronegative) M08.40 Pauciarticular juvenile rheumatoid arthritis, unspecified site M Pauciarticular juvenile rheumatoid arthritis, right shoulder M Pauciarticular juvenile rheumatoid arthritis, left shoulder M Pauciarticular juvenile rheumatoid arthritis, unspecified shoulder M Pauciarticular juvenile rheumatoid arthritis, right elbow M Pauciarticular juvenile rheumatoid arthritis, left elbow M Pauciarticular juvenile rheumatoid arthritis, unspecified elbow M Pauciarticular juvenile rheumatoid arthritis, right wrist M Pauciarticular juvenile rheumatoid arthritis, left wrist M Pauciarticular juvenile rheumatoid arthritis, unspecified wrist M Pauciarticular juvenile rheumatoid arthritis, right hand M Pauciarticular juvenile rheumatoid arthritis, left hand M Pauciarticular juvenile rheumatoid arthritis, unspecified hand M Pauciarticular juvenile rheumatoid arthritis, right hip M Pauciarticular juvenile rheumatoid arthritis, left hip M Pauciarticular juvenile rheumatoid arthritis, unspecified hip M Pauciarticular juvenile rheumatoid arthritis, right knee M Pauciarticular juvenile rheumatoid arthritis, left knee M Pauciarticular juvenile rheumatoid arthritis, unspecified knee M Pauciarticular juvenile rheumatoid arthritis, right ankle and foot M Pauciarticular juvenile rheumatoid arthritis, left ankle and foot M Pauciarticular juvenile rheumatoid arthritis, unspecified ankle and foot M08.48 Pauciarticular juvenile rheumatoid arthritis, vertebrae M08.80 Other juvenile arthritis, unspecified site M Other juvenile arthritis, right shoulder M Other juvenile arthritis, left shoulder M Other juvenile arthritis, unspecified shoulder M Other juvenile arthritis, right elbow M Other juvenile arthritis, left elbow M Other juvenile arthritis, unspecified elbow M Other juvenile arthritis, right wrist M Other juvenile arthritis, left wrist M Other juvenile arthritis, unspecified wrist

14 M Other juvenile arthritis, right hand M Other juvenile arthritis, left hand M Other juvenile arthritis, unspecified hand M Other juvenile arthritis, right hip M Other juvenile arthritis, left hip M Other juvenile arthritis, unspecified hip M Other juvenile arthritis, right knee M Other juvenile arthritis, left knee M Other juvenile arthritis, unspecified knee M Other juvenile arthritis, right ankle and foot M Other juvenile arthritis, left ankle and foot M Other juvenile arthritis, unspecified ankle and foot M08.88 Other juvenile arthritis, other specified site M08.89 Other juvenile arthritis, multiple sites M08.90 Juvenile arthritis, unspecified, unspecified site M Juvenile arthritis, unspecified, right shoulder M Juvenile arthritis, unspecified, left shoulder M Juvenile arthritis, unspecified, unspecified shoulder M Juvenile arthritis, unspecified, right elbow M Juvenile arthritis, unspecified, left elbow M Juvenile arthritis, unspecified, unspecified elbow M Juvenile arthritis, unspecified, right wrist M Juvenile arthritis, unspecified, left wrist M Juvenile arthritis, unspecified, unspecified wrist M Juvenile arthritis, unspecified, right hand M Juvenile arthritis, unspecified, left hand M Juvenile arthritis, unspecified, unspecified hand M Juvenile arthritis, unspecified, right hip M Juvenile arthritis, unspecified, left hip M Juvenile arthritis, unspecified, unspecified hip M Juvenile arthritis, unspecified, right knee M Juvenile arthritis, unspecified, left knee M Juvenile arthritis, unspecified, unspecified knee M Juvenile arthritis, unspecified, right ankle and foot

15 M Juvenile arthritis, unspecified, left ankle and foot M Juvenile arthritis, unspecified, unspecified ankle and foot M08.98 Juvenile arthritis, unspecified, vertebrae M08.99 Juvenile arthritis, unspecified, multiple sites R59.0 Localized enlarged lymph nodes R59.1 Generalized enlarged lymph nodes R59.9 Enlarged lymph nodes, unspecified Review Date Revisions Effective Date 09/2014 New criteria adopted from ICORE guidelines 09/30/ /2015 Updated with ICD-10 codes, updated references; 10/28/2015 deleted ICD-9 codes, updated Magellan criteria 02/2016 Updated ICD-10 codes with Magellanin compliance with CMS changes 02/24/2016 References: Actemra [package insert]. South San Francisco, CA; Genentech, Inc; November Accessed November 2015 Singh JA, Furst DE, Bharat A, et al 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. Arthritis Care Res (Hoboken) May;64(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: Beukelman T, Patkar NM, Saag KG, et al American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res (Hoboken) Apr;63(4): Ringold S, Weiss PF, Beukelman T, et al update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum Oct;65(10): DeWitt EM, Kimura Y, Beukelman T, et al. Consensus treatment plans for new-onset systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken) Jul;64(7):