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DRUG POLICY Simponi® Aria™ (golimumab) Policy Number: 2015D0051A Effective Date: 3/1/2015 Table of Contents Page COVERAGE RATIONALE ................................................. 1 BENEFIT CONSIDERATIONS .......................................... 2 BACKGROUND ................................................................. 2 CLINICAL EVIDENCE ....................................................... 2 U.S. FOOD AND DRUG ADMINISTRATION .................... 3 APPLICABLE CODES ....................................................... 3 REFERENCES ................................................................. 10 POLICY HISTORY/REVISION INFORMATION .............. 10 Related Medical or Drug Policies: None COV ERA GE RATI ONA LE Related Coverage Determination Guidelines: None INSTRUCTIONS FOR USE This Drug Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Summary Plan Description (SPD)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this Drug Policy. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Drug Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Drug Policy is provided for informational purposes. It does not constitute medical advice. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. COVERAGE RATIONALE Golimumab is proven and medically necessary for the treatment of rheumatoid arthritis. 1 Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self-administered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals at http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf. ® ™ Medicare does not have a National Coverage Determination (NCD) for Simponi ARIA (golimumab). Local Coverage Determinations (LCDs) do not exist at this time. (Accessed September 30, 2014) Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 1 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. BENEFIT CONSIDERATIONS Some Certificates of Coverage allow coverage of experimental/investigational/unproven treatments for life-threatening illnesses when certain conditions are met. The enrollee-specific benefit document must be consulted to make coverage decisions for this service. Some states mandate benefit coverage for offlabel use of medications for some diagnoses or under some circumstances when certain conditions are met. Where such mandates apply, they supersede language in the benefit document or in the medical or drug policy. Benefit coverage for an otherwise unproven service for the treatment of serious rare diseases may occur when certain conditions are met. See the Policy and Procedure addressing the treatment of serious rare diseases. BACKGROUND Golimumab is a human anti-tumor necrosis factor (TNF) monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to 1 chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. CLINICAL EVIDENCE The efficacy of intravenous golimumab in combination with methotrexate (MTX) was evaluated in a multicenter, double-blind, placebo-controlled, phase 3 study of patients (n=592) with active rheumatoid 2 arthritis (RA) who had been receiving MTX. All subjects had active disease defined as ≥ 6 swollen joints, ≥ 6 tender joints, C-reactive protein ≥1.0 mg/dL, rheumatoid factor positive, and/or anticyclic citrullinated protein antibody positive at screening despite MTX (15–25 mg/week). Study subjects were treatment naive to biologic tissue necrosis factor (TNF) blockers and were allowed to continue stable doses of concomitant low-dose corticosteroids (not exceeding equivalent prednisone 10 mg/day) and NSAIDs. Participants were randomized to receive intravenous golimumab 2 mg/kg (n=395) or placebo (n=197) infusions at weeks 0 and 4, and every 8 weeks thereafter through Week 100 while continuing to receive MTX. Patients in the placebo group with <10% improvement in combined swollen/tender joint counts at week 16 were allowed early escape to intravenous golimumab 2 mg/kg. By week 24, all patients were switched to golimumab and MTX, but remained blinded until week 52. The primary endpoint was American College of Rheumatology 20% (ACR20) Response at Week 14. Other measures of disease activity included the European League Against Rheumatism (EULAR) response and Health Assessment Questionnaire (HAQ). Improvements in the study group versus the placebo group were observed by week 2. At week 14, significantly (p<0.001) larger proportions of golimumab plus MTX than placebo plus MTX patients achieved ACR20 response (59% vs 25%, respectively; treatment difference, 95% CI, 25.9% to 41.4%). Additionally, a greater proportion of patients in the study group achieved an ACR50 at week 24 (35% vs 13%; treatment difference, 95% CI, 15.5% to 28.4%). A disease activity score of good/moderate (EULAR) response (81% vs 40%) and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125) were seen. Similar proportions of patients receiving golimumab plus MTX and placebo plus MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab plus MTX (4.1%) than placebo plus MTX (2%) patients at week 24. Professional Societies The 2012 Update of the 2008 American College of Rheumatology (ACR) recommendations includes golimumab as part of the anti-TNF biologic class along with adalimumab, etanercept, infliximab, and 4 certolizumab pegol. The update says the following regarding the treatment of rheumatoid arthritis (RA): • In patients with early RA (disease duration < 6 months), the panel recommends the use of an antiTNF biologic with or without methotrexate in patients who have high disease activity with poor prognostic features. Infliximab is the only exception and the recommendation is to use it in combination with methotrexate, but not as monotherapy. • In patients with established RA (disease duration greater than or equal to 6 months or meeting the 1987 ACR classification criteria): o If a patient has moderate or high disease activity after 3 months of methotrexate monotherapy or DMARD combination therapy, as an alternative to the DMARD Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 2 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. o o o o o recommendation just noted above, the panel recommends adding or switching to an anti-TNF biologic, abatacept, or rituximab. If after 3 months of intensified DMARD combination therapy or after a second DMARD, a patient still has moderate or high disease activity, add or switch to an anti-TNF biologic. If a patient still has moderate or high disease activity after 3 months of anti-TNF biologic therapy and this is due to a lack or loss of benefit, switching to another anti-TNF biologic or a non-TNF biologic is recommended. If a patient still has moderate or high disease activity after 6 months of a non-TNF biologic and the failure is due to a lack or loss of benefit, switch to another non-TNF biologic or an anti-TNF biologic. If a patient has high disease activity after failing an anti-TNF biologic because of a serious adverse event, switch to a non-TNF biologic. If a patient has moderate or high disease activity after failing an anti-TNF biologic because of a nonserious adverse event, switch to another anti-TNF biologic or a non-TNF biologic. If a patient has moderate or high disease activity after failing a non-TNF biologic because of an adverse event (serious or nonserious), switch to another non-TNF biologic or an anti-TNF biologic. U.S. FOOD AND DRUG ADMINISTRATION (FDA) Simponi Aria, in combination with methotrexate, is indicated for the treatment of adult patients with 1 moderately to severely active rheumatoid arthritis (RA). APPLICABLE CODES The [Current Procedural Terminology (CPT), HCPCS and/or ICD-9] codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document. HCPCS Code J1602 ICD-9 Code 714.0 714.1 714.2 Description Injection, golimumab, 1 mg, for intravenous use Description Rheumatoid arthritis Felty’s Syndrome Other rheumatoid arthritis, with visceral or systemic involvement ICD-10 Codes (Preview Draft) * In preparation for the transition from ICD-9 to ICD-10 medical coding on October 1, 2015 , a sample listing of the ICD-10 CM and/or ICD-10 PCS codes associated with this policy has been provided below for your reference. This list of codes may not be all inclusive and will be updated to reflect any applicable revisions to the ICD-10 code set and/or clinical guidelines outlined in this policy. *The effective date for ICD-10 code set implementation is subject to change. ICD-10 Diagnosis Code (Effective 10/1/15) M05.00 M05.011 M05.012 M05.019 M05.021 M05.022 M05.029 M05.031 M05.032 M05.039 Description Felty's syndrome, unspecified site Felty's syndrome, right shoulder Felty's syndrome, left shoulder Felty's syndrome, unspecified shoulder Felty's syndrome, right elbow Felty's syndrome, left elbow Felty's syndrome, unspecified elbow Felty's syndrome, right wrist Felty's syndrome, left wrist Felty's syndrome, unspecified wrist Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 3 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. M05.041 M05.042 M05.049 M05.051 M05.052 M05.059 M05.061 M05.062 M05.069 M05.071 M05.072 M05.079 M05.09 M05.20 M05.211 M05.212 M05.219 M05.221 M05.222 M05.229 M05.231 M05.232 M05.239 M05.241 M05.242 M05.249 M05.251 M05.252 M05.259 M05.261 M05.262 M05.269 M05.271 M05.272 M05.279 M05.29 M05.30 M05.311 M05.312 M05.319 M05.321 M05.322 M05.329 M05.331 M05.332 M05.339 M05.341 M05.342 M05.349 Felty's syndrome, right hand Felty's syndrome, left hand Felty's syndrome, unspecified hand Felty's syndrome, right hip Felty's syndrome, left hip Felty's syndrome, unspecified hip Felty's syndrome, right knee Felty's syndrome, left knee Felty's syndrome, unspecified knee Felty's syndrome, right ankle and foot Felty's syndrome, left ankle and foot Felty's syndrome, unspecified ankle and foot Felty's syndrome, multiple sites Rheumatoid vasculitis with rheumatoid arthritis of unspecified site Rheumatoid vasculitis with rheumatoid arthritis of right shoulder Rheumatoid vasculitis with rheumatoid arthritis of left shoulder Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder Rheumatoid vasculitis with rheumatoid arthritis of right elbow Rheumatoid vasculitis with rheumatoid arthritis of left elbow Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow Rheumatoid vasculitis with rheumatoid arthritis of right wrist Rheumatoid vasculitis with rheumatoid arthritis of left wrist Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist Rheumatoid vasculitis with rheumatoid arthritis of right hand Rheumatoid vasculitis with rheumatoid arthritis of left hand Rheumatoid vasculitis with rheumatoid arthritis of unspecified hand Rheumatoid vasculitis with rheumatoid arthritis of right hip Rheumatoid vasculitis with rheumatoid arthritis of left hip Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip Rheumatoid vasculitis with rheumatoid arthritis of right knee Rheumatoid vasculitis with rheumatoid arthritis of left knee Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot Rheumatoid vasculitis with rheumatoid arthritis of multiple sites Rheumatoid heart disease with rheumatoid arthritis of unspecified site Rheumatoid heart disease with rheumatoid arthritis of right shoulder Rheumatoid heart disease with rheumatoid arthritis of left shoulder Rheumatoid heart disease with rheumatoid arthritis of unspecified shoulder Rheumatoid heart disease with rheumatoid arthritis of right elbow Rheumatoid heart disease with rheumatoid arthritis of left elbow Rheumatoid heart disease with rheumatoid arthritis of unspecified elbow Rheumatoid heart disease with rheumatoid arthritis of right wrist Rheumatoid heart disease with rheumatoid arthritis of left wrist Rheumatoid heart disease with rheumatoid arthritis of unspecified wrist Rheumatoid heart disease with rheumatoid arthritis of right hand Rheumatoid heart disease with rheumatoid arthritis of left hand Rheumatoid heart disease with rheumatoid arthritis of unspecified hand Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 4 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. M05.351 M05.352 M05.359 M05.361 M05.362 M05.369 M05.371 M05.372 M05.379 M05.39 M05.40 M05.411 M05.412 M05.419 M05.421 M05.422 M05.429 M05.431 M05.432 M05.439 M05.441 M05.442 M05.449 M05.451 M05.452 M05.459 M05.461 M05.462 M05.469 M05.471 M05.472 M05.479 M05.49 M05.50 M05.511 M05.512 M05.519 M05.521 M05.522 M05.529 M05.531 M05.532 M05.539 M05.541 M05.542 Rheumatoid heart disease with rheumatoid arthritis of right hip Rheumatoid heart disease with rheumatoid arthritis of left hip Rheumatoid heart disease with rheumatoid arthritis of unspecified hip Rheumatoid heart disease with rheumatoid arthritis of right knee Rheumatoid heart disease with rheumatoid arthritis of left knee Rheumatoid heart disease with rheumatoid arthritis of unspecified knee Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot Rheumatoid heart disease with rheumatoid arthritis of multiple sites Rheumatoid myopathy with rheumatoid arthritis of unspecified site Rheumatoid myopathy with rheumatoid arthritis of right shoulder Rheumatoid myopathy with rheumatoid arthritis of left shoulder Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder Rheumatoid myopathy with rheumatoid arthritis of right elbow Rheumatoid myopathy with rheumatoid arthritis of left elbow Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow Rheumatoid myopathy with rheumatoid arthritis of right wrist Rheumatoid myopathy with rheumatoid arthritis of left wrist Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist Rheumatoid myopathy with rheumatoid arthritis of right hand Rheumatoid myopathy with rheumatoid arthritis of left hand Rheumatoid myopathy with rheumatoid arthritis of unspecified hand Rheumatoid myopathy with rheumatoid arthritis of right hip Rheumatoid myopathy with rheumatoid arthritis of left hip Rheumatoid myopathy with rheumatoid arthritis of unspecified hip Rheumatoid myopathy with rheumatoid arthritis of right knee Rheumatoid myopathy with rheumatoid arthritis of left knee Rheumatoid myopathy with rheumatoid arthritis of unspecified knee Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot Rheumatoid myopathy with rheumatoid arthritis of multiple sites Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow Rheumatoid polyneuropathy with rheumatoid arthritis of left elbow Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified elbow Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist Rheumatoid polyneuropathy with rheumatoid arthritis of right hand Rheumatoid polyneuropathy with rheumatoid arthritis of left hand Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 5 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. M05.549 M05.551 M05.552 M05.559 M05.561 M05.562 M05.569 M05.571 M05.572 M05.579 M05.59 M05.60 M05.611 M05.612 M05.619 M05.621 M05.622 M05.629 M05.631 M05.632 M05.639 M05.641 M05.642 M05.649 M05.651 M05.652 M05.659 M05.661 M05.662 M05.669 M05.671 Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand Rheumatoid polyneuropathy with rheumatoid arthritis of right hip Rheumatoid polyneuropathy with rheumatoid arthritis of left hip Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip Rheumatoid polyneuropathy with rheumatoid arthritis of right knee Rheumatoid polyneuropathy with rheumatoid arthritis of left knee Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified knee Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites Rheumatoid arthritis of unspecified site with involvement of other organs and systems Rheumatoid arthritis of right shoulder with involvement of other organs and systems Rheumatoid arthritis of left shoulder with involvement of other organs and systems Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems Rheumatoid arthritis of right elbow with involvement of other organs and systems Rheumatoid arthritis of left elbow with involvement of other organs and systems Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems Rheumatoid arthritis of right wrist with involvement of other organs and systems Rheumatoid arthritis of left wrist with involvement of other organs and systems Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems Rheumatoid arthritis of right hand with involvement of other organs and systems Rheumatoid arthritis of left hand with involvement of other organs and systems Rheumatoid arthritis of unspecified hand with involvement of other organs and systems Rheumatoid arthritis of right hip with involvement of other organs and systems Rheumatoid arthritis of left hip with involvement of other organs and systems Rheumatoid arthritis of unspecified hip with involvement of other organs and systems Rheumatoid arthritis of right knee with involvement of other organs and systems Rheumatoid arthritis of left knee with involvement of other organs and systems Rheumatoid arthritis of unspecified knee with involvement of other organs and systems Rheumatoid arthritis of right ankle and foot with involvement of other Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 6 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. M05.672 M05.679 M05.69 M05.70 M05.711 M05.712 M05.719 M05.721 M05.722 M05.729 M05.731 M05.732 M05.739 M05.741 M05.742 M05.749 M05.751 M05.752 M05.759 M05.761 M05.762 M05.769 M05.771 M05.772 M05.779 M05.79 M05.80 M05.811 M05.812 organs and systems Rheumatoid arthritis of left ankle and foot with involvement of other organs and systems Rheumatoid arthritis of unspecified ankle and foot with involvement of other organs and systems Rheumatoid arthritis of multiple sites with involvement of other organs and systems Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement Other rheumatoid arthritis with rheumatoid factor of unspecified site Other rheumatoid arthritis with rheumatoid factor of right shoulder Other rheumatoid arthritis with rheumatoid factor of left shoulder Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 7 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. M05.819 M05.821 M05.822 M05.829 M05.831 M05.832 M05.839 M05.841 M05.842 M05.849 M05.851 M05.852 M05.859 M05.861 M05.862 M05.869 M05.871 M05.872 M05.879 M05.89 M05.9 M06.00 M06.011 M06.012 M06.019 M06.021 M06.022 M06.029 M06.031 M06.032 M06.039 M06.041 M06.042 M06.049 M06.051 M06.052 M06.059 M06.061 M06.062 M06.069 M06.071 M06.072 M06.079 M06.08 M06.09 M06.1 M06.20 M06.211 M06.212 M06.219 M06.221 Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder Other rheumatoid arthritis with rheumatoid factor of right elbow Other rheumatoid arthritis with rheumatoid factor of left elbow Other rheumatoid arthritis with rheumatoid factor of unspecified elbow Other rheumatoid arthritis with rheumatoid factor of right wrist Other rheumatoid arthritis with rheumatoid factor of left wrist Other rheumatoid arthritis with rheumatoid factor of unspecified wrist Other rheumatoid arthritis with rheumatoid factor of right hand Other rheumatoid arthritis with rheumatoid factor of left hand Other rheumatoid arthritis with rheumatoid factor of unspecified hand Other rheumatoid arthritis with rheumatoid factor of right hip Other rheumatoid arthritis with rheumatoid factor of left hip Other rheumatoid arthritis with rheumatoid factor of unspecified hip Other rheumatoid arthritis with rheumatoid factor of right knee Other rheumatoid arthritis with rheumatoid factor of left knee Other rheumatoid arthritis with rheumatoid factor of unspecified knee Other rheumatoid arthritis with rheumatoid factor of right ankle and foot Other rheumatoid arthritis with rheumatoid factor of left ankle and foot Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot Other rheumatoid arthritis with rheumatoid factor of multiple sites Rheumatoid arthritis with rheumatoid factor, unspecified Rheumatoid arthritis without rheumatoid factor, unspecified site Rheumatoid arthritis without rheumatoid factor, right shoulder Rheumatoid arthritis without rheumatoid factor, left shoulder Rheumatoid arthritis without rheumatoid factor, unspecified shoulder Rheumatoid arthritis without rheumatoid factor, right elbow Rheumatoid arthritis without rheumatoid factor, left elbow Rheumatoid arthritis without rheumatoid factor, unspecified elbow Rheumatoid arthritis without rheumatoid factor, right wrist Rheumatoid arthritis without rheumatoid factor, left wrist Rheumatoid arthritis without rheumatoid factor, unspecified wrist Rheumatoid arthritis without rheumatoid factor, right hand Rheumatoid arthritis without rheumatoid factor, left hand Rheumatoid arthritis without rheumatoid factor, unspecified hand Rheumatoid arthritis without rheumatoid factor, right hip Rheumatoid arthritis without rheumatoid factor, left hip Rheumatoid arthritis without rheumatoid factor, unspecified hip Rheumatoid arthritis without rheumatoid factor, right knee Rheumatoid arthritis without rheumatoid factor, left knee Rheumatoid arthritis without rheumatoid factor, unspecified knee Rheumatoid arthritis without rheumatoid factor, right ankle and foot Rheumatoid arthritis without rheumatoid factor, left ankle and foot Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot Rheumatoid arthritis without rheumatoid factor, vertebrae Rheumatoid arthritis without rheumatoid factor, multiple sites Adult-onset Still's disease Rheumatoid bursitis, unspecified site Rheumatoid bursitis, right shoulder Rheumatoid bursitis, left shoulder Rheumatoid bursitis, unspecified shoulder Rheumatoid bursitis, right elbow Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 8 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. M06.222 M06.229 M06.231 M06.232 M06.239 M06.241 M06.242 M06.249 M06.251 M06.252 M06.259 M06.261 M06.262 M06.269 M06.271 M06.272 M06.279 M06.28 M06.29 M06.30 M06.311 M06.312 M06.319 M06.321 M06.322 M06.329 M06.331 M06.332 M06.339 M06.341 M06.342 M06.349 M06.351 M06.352 M06.359 M06.361 M06.362 M06.369 M06.371 M06.372 M06.379 M06.38 M06.39 M06.80 M06.811 M06.812 M06.819 M06.821 M06.822 M06.829 M06.831 M06.832 M06.839 M06.841 M06.842 Rheumatoid bursitis, left elbow Rheumatoid bursitis, unspecified elbow Rheumatoid bursitis, right wrist Rheumatoid bursitis, left wrist Rheumatoid bursitis, unspecified wrist Rheumatoid bursitis, right hand Rheumatoid bursitis, left hand Rheumatoid bursitis, unspecified hand Rheumatoid bursitis, right hip Rheumatoid bursitis, left hip Rheumatoid bursitis, unspecified hip Rheumatoid bursitis, right knee Rheumatoid bursitis, left knee Rheumatoid bursitis, unspecified knee Rheumatoid bursitis, right ankle and foot Rheumatoid bursitis, left ankle and foot Rheumatoid bursitis, unspecified ankle and foot Rheumatoid bursitis, vertebrae Rheumatoid bursitis, multiple sites Rheumatoid nodule, unspecified site Rheumatoid nodule, right shoulder Rheumatoid nodule, left shoulder Rheumatoid nodule, unspecified shoulder Rheumatoid nodule, right elbow Rheumatoid nodule, left elbow Rheumatoid nodule, unspecified elbow Rheumatoid nodule, right wrist Rheumatoid nodule, left wrist Rheumatoid nodule, unspecified wrist Rheumatoid nodule, right hand Rheumatoid nodule, left hand Rheumatoid nodule, unspecified hand Rheumatoid nodule, right hip Rheumatoid nodule, left hip Rheumatoid nodule, unspecified hip Rheumatoid nodule, right knee Rheumatoid nodule, left knee Rheumatoid nodule, unspecified knee Rheumatoid nodule, right ankle and foot Rheumatoid nodule, left ankle and foot Rheumatoid nodule, unspecified ankle and foot Rheumatoid nodule, vertebrae Rheumatoid nodule, multiple sites Other specified rheumatoid arthritis, unspecified site Other specified rheumatoid arthritis, right shoulder Other specified rheumatoid arthritis, left shoulder Other specified rheumatoid arthritis, unspecified shoulder Other specified rheumatoid arthritis, right elbow Other specified rheumatoid arthritis, left elbow Other specified rheumatoid arthritis, unspecified elbow Other specified rheumatoid arthritis, right wrist Other specified rheumatoid arthritis, left wrist Other specified rheumatoid arthritis, unspecified wrist Other specified rheumatoid arthritis, right hand Other specified rheumatoid arthritis, left hand Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 9 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc. M06.849 M06.851 M06.852 M06.859 M06.861 M06.862 M06.869 M06.871 M06.872 M06.879 M06.88 M06.89 M06.9 Other specified rheumatoid arthritis, unspecified hand Other specified rheumatoid arthritis, right hip Other specified rheumatoid arthritis, left hip Other specified rheumatoid arthritis, unspecified hip Other specified rheumatoid arthritis, right knee Other specified rheumatoid arthritis, left knee Other specified rheumatoid arthritis, unspecified knee Other specified rheumatoid arthritis, right ankle and foot Other specified rheumatoid arthritis, left ankle and foot Other specified rheumatoid arthritis, unspecified ankle and foot Other specified rheumatoid arthritis, vertebrae Other specified rheumatoid arthritis, multiple sites Rheumatoid arthritis, unspecified REFERENCES 1. Simponi Aria [package insert]. Horsham, PA: Janssen Biotech, Inc; February 2014. rd 2. Weinblatt ME, Bingham CO 3 , Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013 Mar;72(3):381-9. doi: 10.1136/annrheumdis-2012-201411. Epub 2012 Jun 1. ™ th 3. MCG Ambulatory Care 18 Edition. Golimumab. Available at: http://careweb.careguidelines.com/ed17/index.html Accessed December 3, 2014. 4. Singh JA, Furst DE, Bharat A, et al. 2012 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 & Research. 2012 May;64(5):625–639. DOI 10.1002/acr.2164. POLICY HISTORY/REVISION INFORMATION Date 3/1/2015 Action/Description New policy 2015D0051A. Approved by National Pharmacy & Therapeutics Committee on 11/19/2014. Simponi Aria (golimumab): Drug Policy (Effective 03/01/2015) 10 Proprietary Information of UnitedHealthcare. Copyright 2015 United HealthCare Services, Inc.
