These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.
Simponi ARIA for infusion requires prior authorization from Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.
For all inquiries, transfer to the Medical Injectable Line (ext 26135).
Simponi ARIA is generally approved for use in patients diagnosed with moderate to severe rheumatoid arthritis when all the following criteria are met:
- Prescribed and followed by Rheumatology for Simponi ARIA
- Patient has had a trial and failure of an appropriate regimen of first-line therapy:
- DMARD therapy including concurrent use of two or three of the regimens below for at least 3 months or intolerance or a contraindication to use:
- Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly)
- Hydroxychloroquine titrated to 200-400mg daily
- Sulfasalazine titrated to 2000mg-3000mg daily
- Leflunomide 10-20mg daily
- The prescribed regimen is within the FDA-approved dosing regimen of 2 mg/kg at 0 and 4 weeks, then every 8 weeks. A current patient weight is required for all Simponi ARIA requests.
- No other biologic agent will be used concurrently to treat this indication.
- For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
- The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
- The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
- There are no alternative settings available to the patient as a result of both of the following:
- The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
- The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.
Authorizations will be provided for one year at a maximum of 15 infusions during the first year and 13 infusions in subsequent years.
Reauthorizations for biologic regimens of up to FDA-approved doses and frequencies–
Renewals will be provided annually with provider attestation that they have seen the patient within the last fourteen months and the patient is benefiting from use of the medication.
Requests for more intense (dose or interval) biologic therapy than the FDA-approved regimen –
All requests for regimens exceeding the FDA-approved regimen (including annual renewals) will require provider attestation that the off-label regimen is medically necessary.
Simponi ARIA for infusion is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate.
Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.
- Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
- Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
- Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.
If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.
Injection, golimumab, 1mg, for intravenous use (Simponi ARIA)
Simponi ARIA 50mg / 4mL solution
This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.
- Simponi ARIA Full Prescribing Information; Janssen Biotech, Inc., Horsham, PA; Revised January 2017
- Smolen JS, Landewe R, Breedveld FC et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69(6):964-975.
- Singh JA, Furst DE, Bharat A, et al., 2012 Update of the 2008 ACR Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care Research 2012:64(5):625-639