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.
For all inquiries, transfer to the Medical Injectable Line (ext 26135).
Belimumab (Benlysta) is considered medically necessary when the following criteria are met:
- Prescribed and followed by a Rheumatologist; and,
- Use in the treatment of active, autoantibody-positive, systemic lupus erythematosus without severe active lupus nephritis or severe active central nervous system disease; and,
- Patient is currently being treated for systemic lupus erythematosus and all criteria below are met:
- A previous treatment course of hydroxychloroquine for at least six months resulting in failure or adverse event; and,
- Daily use of oral corticosteroids, unless contraindicated or previously not tolerated; and,
- No concurrent use of other biologics or intravenous cyclophosphamide.; and,
- Goals for therapy have been identified
- The prescribed regimen is within the FDA-approved dosing regimen of 10mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. A current patient weight is required for all requests; and
- 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 with a maximum of 15 infusions during the first year and 13 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.
Systemic lupus erythematosus is a chronic inflammatory disease that occurs when the immune system attacks other cells and tissues in the body resulting in inflammation and damage. The heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system are commonly involved.
Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy.
Limitations of Use: the efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations.
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, belimumab, 10 mg
Benlysta 120mg single use solution
Benlysta 400mg single use solution
CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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.
- Benlysta prescribing information. Glaxo Smith Kline, Research Triangle Park, NC. January 2017.
- FDA Summary Review. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370
Orig1s000SumR.pdf (Accessed 7/8/2011)
- Navarra SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomized, placebo-controlled, phase 3 trial. Lancet 2011; 377:721-31.
- Bertsias G, Ioannidis JPA, Boletis J, et al. EULAR recommendations for the management of systemic lupus erythrematosus. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. Ann Rhem Dis 2008;67:195-205.