Subject:
Abatacept (Orencia)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Abatacept (Orencia) is the first selective co-stimulation modulator. It works by binding to CD80 and CD86, thereby blocking CD28 and inhibiting the signal necessary for full activation of T lymphocytes, which are involved in the pathogenesis of rheumatoid arthritis (RA). This mechanism of action differs from other biologics such as the TNF-α blockers, etanercept (Enbrel), infliximab (Remicade), adalimumb (Humira), and interleukin-1 (IL-1) receptor antagonists, anakinra (Kineret). These agents work later in the immune response cascade, meanwhile abatacept (Orencia) has effects earlier in the cascade.
On December 23, 2005, the FDA approved Orencia (abatacept) for reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Orencia may be used as monotherapy or concomitantly with disease-modifying anti-rheumatic agents (DMARDs) other than tumor necrosis factor (TNF) antagonists. Orencia (abatacept) should not be administered concomitantly with TNF antagonists and anakinra, due to an increase in infections.
In April 2008, Orencia received FDA approval for Juvenile Idiopathic Arthritis for patients 6 to 17 years old. The approval is based on the AWAKEN (Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment) trial, which evaluated the efficacy and safety of abatacept (Orencia) in patients six to 17 years of age with moderately to severely active polyarticular JIA who had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate or TNF antagonists.
On July 2011, in addition to the intravenous dose available, the FDA approved a subcutaneous dose of Orencia (abatacept) for adult RA. Administration should be following a single IV loading dose, unless otherwise unable to tolerate, which weekly injections of subcutaneous Orencia can be started.
In July 2017, Orencia received FDA approval for active psoriatic arthritis for adults. The approval is based on two randomized, double-blind, placebo-controlled studies, which evaluated the efficacy and safety in abatacept (Orencia) in adult patients with disease duration of more than seven years. Patients had active Psoriatic Arthritis (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Abatacept (Orencia) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
I. Please refer to a separate policy on Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) under the Drug Section.
II. Prior to initiation of abatacept (Orencia), members must meet ALL of the following criteria:
- Member has been tested for latent tuberculosis (TB) AND if positive the patient has begun therapy for latent TB; AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g. rheumatologist) or has consulted with a specialist in the area of the patient’s diagnosis AND
- If a subcutaneous form of the drug is requested, the requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
· Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
· Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
· Member has acute mental status/cognitive changes or physical impairment due to another condition; or
· Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
· Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
· Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver
III. Abatacept (Orencia) is medically necessary for active moderate to severe Rheumatoid Arthritis (RA) in adults when all of the following criteria are met:
A. Member has tried and failed at least a 3 month trial of ONE conventional agent such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine or has an intolerance or contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) OR
B. Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of RA
[INFORMATIONAL NOTE: The ACR 2015 recommendations on use of biological DMARDs in RA patients are based on duration, severity and prior exposure to non-biologic DMARDs.
In order to assess if a patient is a candidate for biologic DMARD therapy, RA disease activity should be measured as per the tests below:
Table 2. Disease activity cutoffs for each American College of Rheumatology-recommended disease activity measure* |
Disease activity measure | Scale | Remission | Low/Minimal | Moderate | High/severe |
| Patient-driven composite tools |
PAS | 0-10 | 0.00-0.25 | 0.26-3.70 | 3.71 to <8.0 | 8.00-10.00 |
PAS-II | 0-10 | 0.00-0.25 | 0.26-3.70 | 3.71 to <8.0 | 8.00-10.00 |
RAPID-3 | 0-10 | 0-1.0 | >1.0 to 2.0 | >2.0 to 4.0 | >4.0 to 10 |
| Patient and provider composite tool |
CDAI | 0-76 | ≤2.8 | >2.8 to 10.0 | >10.0 to 22.0 | >22.0 |
| Patient, provider, and laboratory composite tools |
DAS28 (ESR or CRP) | 0-9.4 | <2.6 | ≥2.6 to <3.2 | ≥3.2 to ≤5.1 | >5.1 |
SDAI | 0-86 | ≤3.3 | >3.3 to ≤11.0 | >11.0 to ≤26 | >26 |
| *PAS= Patient Activity Scale; RAPID-3= Routine Assessment of Patient Index Data with 3 measures; CDAI= Clinical Disease Activity Index; DAS28= Disease Activity Score with 28-joint counts; ESR= erythrocyte sedimentation rate; CRP= C-reactive protein; SDAI= Simplified Disease Activity Index |
Algorithm 1 - Once RA disease severity has been measured, they can be stratified in different treatments algorithms depending on the duration of the disease:
- Patients with Early RA (disease duration <6 months)
- Low disease activity or remission
- DMARD monotherapy is recommended
- DMARD monotherapy is recommended for those who are DMARD naïve
- If there is continued disease activity with DMARD therapy, consider combination of traditional DMARDs and TNF inhibitor or non TNF biologics
- Patients with established RA (disease duration ≥6 months or meeting the 1987 ACR RA classification criteria)
· 1987 ACR RA classification criteria:
· Morning stiffness
· Arthritis of 3 or more joint areas
· Arthritis of hand joints
· Symmetric arthritis
· Rheumatoid nodules
· Serum rheumatoid factor
· Radiographic changes
· Consider DMARD monotherapy for all patients of low, moderate, or high disease activity who are DMARD naïve
· For patients who do not respond adequately on DMARD monotherapy, consider combination therapy of traditional DMARD, or TNF inhibitor with or without MTX, or non TNF biologic with or without MTX, or tafacitinib with or without MTX
· If patients continue to have moderate or high disease activity, consider switching to a different agent within the drug class of TNF inhibitors, or non TNF biologics (with or without MTX) or tafacitinib with or without MTX
IV. Abatacept (Orencia) is medically necessary for moderately to severely active polyarticular Juvenile Idiopathic Arthritis (PJIA) in pediatric patients when the following criteria has been met:
· For intravenous formulation; member must be 6 years of age or older; OR
- For subcutaneous formulation; member must be 2 years of age or older; AND
- Member has tried and had an inadequate response to ONE conventional agent (i.e., azathioprine, cyclosporine, intra-articular glucocorticoids, methotrexate, leflunomide, sulfasalazine, NSAIDs, COX-2 [celecoxib]) used in the treatment of PJIA for at least 3-months or has an intolerance, FDA labeled contraindication or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, leflunomide) used in the treatment of PJIA; OR
- Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of PJIA
V. Abatacept (Orencia) is medical necessary for moderately to severely active Psoriatic arthritis (PsA) when the following criteria has been met:
- Member 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
- Member 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
- Member has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months OR member has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) OR
- Member's medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported by compendia for the treatment of PsA
VI. When medical necessity criteria are met, abatacept (Orencia) will be approved based on FDA recommended dosing as follows for 12 months:
A. For adult rheumatoid arthritis:
- Intravenous dose:
- If the member weighs <60 kg, a dose of 500 mg given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- If the member weighs 60 to 100 kg, a dose of 750 mg given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- If the member weighs >100 kg, a dose of 1000 mg given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- Subcutaneous dose:
- 125 mg/ml once weekly with or without an intravenous loading dose.
B. For juvenile idiopathic arthritis:
- Intravenous dose:
- If the member weighs < 75 kg, a weight based dose of 10 mg/kg calculated based on the patient’s body weight at each administration should be administered. Dose is given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- If the member weighs ≥ 75 kg, the adult dosing regimen should be followed, not to exceed a maximum dose of 1000 mg. Dose is given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- Subcutaneous dose:
- Weight 10 to < 25 kg: 50 mg weekly
- Weight 25 to < 50 kg: 87.5 mg weekly
- Weight ≥ 50 kg: 125 mg weekly
C. For psoriatic arthritis:
- Intravenous dose:
- If the member weighs <60 kg, a dose of 500 mg given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- If the member weighs 60 to 100 kg, a dose of 750 mg given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- If the member weighs >100 kg, a dose of 1000 mg given at 0, 2, 4 weeks, and every 4 weeks thereafter.
- Subcutaneous dose:
- 125 mg/ml once weekly without an intravenous loading dose.
[INFORMATIONAL NOTE: As per the FDA approved package insert, Orencia should be administered as a 30-minute intravenous infusion.
As per the FDA approved package insert, prior to initiating therapy, patients should be evaluated for Hepatitis B virus (HBV) risk, and if appropriate, HBV infection should be ruled out or treatment initiated.]
VII. Continued therapy with abatacept (Orencia) will be considered medically necessary annually when the following criteria are met:
- Patient continues to meet initial review criteria; AND
- Member has shown clinical improvement in signs and symptoms compared to baseline with the requested agent (i.e. slowing of disease progression or decrease in symptom severity and/or frequency; AND
- Absence of unacceptable toxicity from the drug (e.g.: serious infection, severe nausea, anaphylaxis reactions) AND
- If a subcutaneous form of the drug is requested, the requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
· Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
· Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
· Member has acute mental status/cognitive changes or physical impairment due to another condition; or
· Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
· Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
· Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver
VIII. Abatacept (Orencia) is considered medically necessary for the off-label indications that are 2A or better recommendations on National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - Abatacept. Available at: https://www.nccn.org/professionals/drug_compendium/content/
IX. The combined use of abatacept (Orencia) and a TNF, IL-1 inhibitor, or non-biologic agent such as apremilast, infliximab, etanercept or anakinra, increases the risk of adverse events and has no additional benefit in efficacy; therefore, combination use is not medically necessary.
X. Other uses of abatacept (Orencia) are considered investigational including, but not limited to, prevention of RA, treatment of early RA, systemic lupus erythematosus (SLE), lupus nephritis, chronic graft versus host disease, Sjogren’s syndrome, Giant Cell Arteritis, Takayasu’s Arteritis, sarcoidosis, Wegener’s Granulomatosis, multiple sclerosis, ANCA-associated vasculitis, ulcerative colitis, Crohn’s, ankylosing spondylitis, atopic asthma, scleroderma, type 1 diabetes mellitus, gout, adult onset-Still’s disease, refractory cases of juvenile idiopathic arthritis-associated uveitis, chronic graft versus host disease, Sjogren’s syndrome, or psoriasis, IgG4-related disease, or HLA A29 uveitis.
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this drug. Therefore, Medicare Advantage will follow the Horizon Policy for Abatacept (Orencia) given intravenously.
Abatacept (Orencia) given Subcutaneous
Per Local Coverage Article A53127 Self-Administered Drug Exclusion List, Medicare covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Therefore, Medicare Advantage Products will cover Abatacept (Orencia) given subcutaneous ONLY when administered by a licensed medical provider as part of a physician service.
For members with a Medicare drug plan (Part D) Abatacept (Orencia) given subcutaneous may be covered under that plan.
**Note: Bullet 1 of the policy section referring to Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) does not apply for Medicare Advantage Products.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Abatacept (Orencia)
Orencia (Abatacept)
References:
1. Orencia (abatacept) product information. Bristol-Myers Squibb Company. Princeton, NJ. June 2020.
2. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for Rheumatoid Arthritis Refractory to Tumor Necrosis Factor alpha Inhibition. N Engl J Med 2005;353:1114-23.
3. Kremer JM, et al. Abatacept improves American College of Rheumatology responses and Disease Activity Score 28 remission rates in both recent-onset and more established rheumatoid arthritis: results from the AIM trial [presentation 1494]. Annual meeting of the American College of Rheumatology; November 13-17 2005; San Diego, Calif.
4. Moreland LW, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double-blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum 2002;46:1470.
5. Combe B, et al. Safety and patient-reported outcomes associated with abatacept in the treatment of rheumatoid arthritis patients receiving background disease modifying anti-rheumatic drugs (DMARDs): the ASSURE trial [presentation 1918]. Annual meeting of the American College of Rheumatology; November 13-17 2005; San Diego, Calif.
6. Kremer JM, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:2003.
7. Bristol-Myers Squibb Company Press Release. New Phase III Efficacy Data on Investigational Biologic Abatacept Presented at EULAR Meeting. 2005 Jun 9 [cited 2006 Apr 4]. Available from: URL: http://www.bms.com/news/press/data/pf_press_release_5658.html
8. ClinicalTrials.gov. Trial List for Abatacept. 2020. Available from: URL: http://www.clinicaltrials.gov/ct/search?term=abatacept. Accessed August 25, 2020.
9. American College of Rheumatology. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis 2002 update. Arthritis & Rheumatism. 2002 Feb;46(2):328-347.
10. Abatacept (Orencia) for Rheumatoid Arthritis. The Medical Letter on Drugs and Therapeutics. 2006 Feb 27;48(1229):17-8.
11. Micromedex. Abatacept (Orencia). Available at https://www-micromedexsolutions-com. Accessed August 24, 2020.
12. Ruperto N, Giannini EH, Quartier P et al. Re-establishment of clinical benefit from Abatacept in patients with Juvenile Idiopathic Arthritis in whom Abatacept, a co-stimulation modulator, had been withdrawn for up to 6 months and then reintroduced. [poster presentation SAT0026] EULAR: June 13-16 200; Barcelona, Spain.
13. American Society of Health-Systems Pharmacists. American Hospital Formulary Service (AHFS) Drug Information 2008. [Available at: http://gateway.ut.ovid.com (accessed March 19, 2009)].
14. 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 & Rheumatism 2008 June;59(6):762-784.
15. Quartuccio L, Maset M, De Vita S. Efficacy of abatecept in a refractory case of adult-onset Still’s disease. Clin Exp Rheumatol. 2010 May –June; 28(2): 265-7.
16. ClinicalTrials.gov. A study of abatacept in patients with active ulcerative colitis. Available from: http://clinicaltrials.gov/ct2/show/NCT00410410?term=orencia&rank=3
17. ClinicalTrials.gov. Abatacept in the treatment and prevention of active systemic lupus erythematosus (SLE) flares in combination with prednisone. Available from: http://clinicaltrials.gov/ct2/show/NCT00119678?term=orencia&rank=7
18. ClinicalTrials.gov. Abatacept for treating adults with giant cell arteritis and Takayasu’s arteritis. Available from: http://clinicaltrials.gov/ct2/show/NCT00556439?term=orencia&rank=15
19. ClinicalTrials.gov. Abatacept and cyclophosphamide combination therapy for lupus nephritis. Available from: http://clinicaltrials.gov/ct2/show/NCT00774852?term=orencia&rank=22
20. ClinicalTrials.gov. Abatacept in treating adults with mild relapsing Wegener’s granulomatosis. Available from: http://clinicaltrials.gov/ct2/show/NCT00468208?term=orencia&rank=26
21. ClinicalTrials.gov. A study to evaluate the safety and efficacy of abatacept in patients with diffuse systemic sclerosis (scleroderma). Available from: http://clinicaltrials.gov/ct2/show/NCT00442611?term=orencia&rank=47
22. Kenawey N, Cleary G, Mewar D, et al. Abatacept: a potential therapy in refractory cases of juvenile idiopathic arthritis-associated uveitis. Graefes Arch Clin Exp Ophthalmol. 2011 Feb; 249(2):297-300. Epub 2010 Oct 5.
23. Altaha D, Neogi T, Silman A, et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism. 2010;62(9):2569-2581.
24. Beukelman T, Patkar N, Saag K, et al. 2011 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 and Research. 2011;63(4):465-482.
25. 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 Res (Hoboken). 2012 May;64(5):625-39.
26. Anderson J, Caplan L, Yazdany J, et al. Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology Recommendations for Use in Clinical Practice. Arthritis Care Res, 2012 May;64(5):640-47.
27. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
28. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50. doi: 10.1016/j.jaad.2008.02.039.
29. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.
30. Emery P, Burmester G, Bykerk V, et al. Evaluating drug-free remission with abatacept in early rheumatoid arthritis. Ann Rheum Dis, 2015;74:19-26.
31. Westhovens R, Robles M, Ximenes A C, et al. Clinical efficacy and safety of abatacept in methotrexate-naïve patients with early rheumatoid arthritis and poor prognostic factors. Ann Rheum Dis, 2009;68:1870-77.
32. Ringold S, Weiss PF, Beukelman T, et al. 2013 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. 2013 Oct;65(10):2499-512.
33. Mease P., Gottlieb A., Heijde H., et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase 3 study in psoriatic arthritis. Annals of the Rheumatic Diseases. 2017
34. Mease P, Genovese MC, Gladstein G. Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis & Rheumatism. 2011;63(4):939-948.
35. Singh JA, Saag KG, Bridges JR. L, et al. “2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.” Arthritis & Rheumatology, vol. 68, no. 1, 2015, pp. 1–26., doi:10.1002/art.39480.
36. Singh JA, Guyatt G, Ogdie A, et al. “2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis.” Arthritis & Rheumatology, vol. 71, no. 1, 2018, pp. 5–32., doi:10.1002/art.40726.
37. Ringold S, Angeles-Han ST, Beukelman T, et al. “2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non‐Systemic Polyarthritis, Sacroiliitis, and Enthesitis.” Arthritis Care & Research, vol. 71, no. 6, 2019, pp. 717–734., doi:10.1002/acr.23870.
38. 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 vol. 64,5 (2012): 625-39. doi:10.1002/acr.21641
39. Abatacept (Oriencia). National Comprehensive Cancer Network Compendia. 2020. Available at https://www.nccn.org/professionals/drug_compendium/content/. Accessed August 25, 2020.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
J0129
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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