belimumab (Benlysta) coverage and prior authorization policy
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Defines Aloha Care coverage, prior authorization, dosing, initiation and renewal criteria, exclusions, and administration/site rules for belimumab (Benlysta) for members across applicable benefits (medical for IV, pharmacy for SC). Affects providers prescribing or administering Benlysta and pharmacy/medical benefit reviewers.
No material clinical or coverage changes in this revision.
Coverage and Clinical Criteria
Coverage Criteria
Approval is contingent on diagnosis-specific and treatment-response criteria. Separate initial and renewal criteria exist for SLE and lupus nephritis.
ALL of the following
ALL of the following
- Diagnosis of Class III, IV, or V lupus nephritis with active or chronic lesions confirmed by renal biopsy
ALL of the following
- IV formulation: member is 5 years of age or older; Subcutaneous formulation: member is 18 years of age or older
ALL of the following
- Medication prescribed by or in consultation with a nephrologist or rheumatologist
ALL of the following
- Disease remains active while on corticosteroids, antimalarials, or immunosuppressants (alone or combination) for at least the last 30 days
ALL of the following
- Urinary protein to creatinine ratio greater than or equal to 1
ALL of the following
- Used in combination with standard therapy (eg corticosteroids, antimalarials, and/or immunosuppressants) and not with other biologics or IV cyclophosphamide
ALL of the following
- Not used in combination with voclosporin (Lupkynis) or anifrolumab-fnia (Saphnelo)
ALL of the following
ALL of the following
- Diagnosis of Class III, IV, or V lupus nephritis confirmed by renal biopsy
ALL of the following
- IV formulation: member is 5 years of age or older; Subcutaneous formulation: member is 18 years of age or older
ALL of the following
- Prescribed by or in consultation with a nephrologist or rheumatologist
ALL of the following
- Continued use in combination with standard therapy and not with other biologics or IV cyclophosphamide
ALL of the following
- Member has responded to Benlysta (examples: improvement in organ dysfunction, reduction in flares, steroid dose reduction, decreased anti-dsDNA, improved complement levels C3/C4)
ALL of the following
ALL of the following
- Diagnosis of SLE defined as positive ANA titer >= 1:80 or anti-dsDNA >= 30 IU/mL
ALL of the following
- Documentation of active disease: SELENA-SLEDAI score >= 6 while on current treatment regimen
ALL of the following
- IV formulation: member is 5 years of age or older; Subcutaneous formulation: member is 18 years of age or older
ALL of the following
- Prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist
ALL of the following
- Used in combination with standard therapy (eg corticosteroids, antimalarials, and/or immunosuppressants) and not with other biologics or IV cyclophosphamide
ALL of the following
- Not used in combination with voclosporin (Lupkynis) or anifrolumab-fnia (Saphnelo)
ALL of the following
ALL of the following
- Diagnosis of SLE
ALL of the following
- Prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist
ALL of the following
- IV formulation: member is 5 years of age or older; Subcutaneous formulation: member is 18 years of age or older
ALL of the following
- Continued use with standard therapy (no other biologics or IV cyclophosphamide)
ALL of the following
- Clinical response to Benlysta (examples: reduction in flares, steroid reduction, decreased anti-dsDNA, improved C3/C4, or organ-specific improvement)
ALL of the following
- Not used in combination with voclosporin (Lupkynis) or anifrolumab-fnia (Saphnelo)
Exclusions
Exclusions and conditions not covered
Initial Therapy Requirements
Initial therapy
Initial therapy dosing and age rules
Continuation / Renewal Criteria
Continuation therapy
Continuation/renewal rules
Coding and Billing Examples
| J0490 | Injection, belimumab, 10 mg (Benlysta) |
| 200 mg SC | Benlysta 200 mg/ml prefilled autoinjector/syringe |
| M32.10 | Systemic lupus erythematosus |
Prior Authorization, Billing and Medicare Notes
Prior authorization and approval durations (SC and IV)
Prior authorization is required for belimumab for both subcutaneous (SC) and intravenous (IV) formulations. Initial approvals are authorized for 6 months; renewals are authorized for 12 months. IV administration is billed on the medical benefit while SC is handled via the pharmacy benefit.
- PA required for both SC and IV formulations.
- Initial approval duration: 6 months.
- Renewal approval duration: 12 months.
- IV billed on the medical (medical benefit); SC via pharmacy benefit.
Medicare Part B: LCD/NCD/LCA review and 90-day transition
For Benlysta IV (Medicare Part B), review and apply the most current LCD, NCD, or LCA applicable to the Hawaii region. New Medicare members have a 90-day transition period during which existing active courses of treatment are covered and Coverage and Step Therapy do not apply; after 90 days, Coverage and Step Therapy criteria must be met for continued coverage.
- Check CMS Medicare Coverage Database for the applicable LCD/NCD/LCA for Hawaii: https://www.cms.gov/medicare-coverage-database/search.aspx.
- 90-day transition: active courses of treatment are exempt from Coverage and Step Therapy for the first 90 days of enrollment; afterwards standard criteria apply.
Quantity Limits and Product Details
Administration Site and Benefit Assignment
Infusion center: IV on medical benefit; SC via pharmacy
Benlysta IV (vials) must be processed and billed on the medical benefit; subcutaneous formulations are handled through the pharmacy benefit. Medicare Part B coverage notes (LCD/NCD/LCA) apply to IV infusions — verify local Medicare guidance for Hawaii.
- IV infusion (Benlysta vials) processed on the medical benefit.
- SC administration billed via pharmacy.
- Confirm Medicare Part B applicability via LCD/NCD/LCA for Hawaii.
Home administration: SC billed as pharmacy; quantity limits apply
Subcutaneous Benlysta administered at home is documented and billed as a pharmacy benefit; quantity limits and documentation requirements for the SC product apply (see quantity limits and coverage criteria).
- SC administration is a pharmacy benefit.
- Quantity limit: Benlysta 200 mg/ml prefilled autoinjector/syringe — 4 injections per 28 days.
- Ensure required documentation per coverage criteria is submitted with PA requests.
Approval Duration Definitions
Step Therapy / Transition Rules
| Population | Step therapy | Notes / transition |
|---|---|---|
| Medicare Part B members | No step therapy required | Follow applicable LCD/NCD/LCA for Hawaii; step therapy does not apply per policy language for Medicare Part B IV treatment |
| New Medicare members (first 90 days of enrollment) | Step therapy and Coverage criteria do not apply during 90-day transition | If member is currently on an active course of the requested treatment (including out-of-network), coverage and step therapy are not enforced during transition; after 90 days, standard criteria apply |
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