Last Review Date: 04/04/2024

Date of Origin: 09/01/2021

Dates Reviewed: 09/2021, 04/2022, 04/2023, 09/2023, 04/2024

1. Length of Authorization

Coverage will be provided for 12 months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Saphnelo 300 mg/2 mL (150 mg/mL) single-dose vial: 1 vial every 4 weeks

B. Max Units (per dose and over time) [HCPCS Unit]:

• 300 billable units (300 mg) every 4 weeks

3. Initial Approval Criteria ¹

• Patient is at least 18 years of age; AND
• Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

Universal Criteria ¹

• Patient must not have a clinically significant active infection; AND
• Patient will not receive a live or live-attenuated vaccine concurrently with treatment; AND
• Will not be used in combination with other biologic therapies, including B-cell targeted therapies (e.g., belimumab, rituximab) or cyclophosphamide; AND
• Will be used in combination with standard therapy (e.g., anti-malarials, corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressives); AND
• Patient does not have any of the following exclusion criteria:
• Severe active central nervous system lupus
• Severe active lupus nephritis; AND

Systemic Lupus Erythematosus (SLE) † ^{1,7,9,10,14,16-19}

• Patient has a confirmed diagnosis of SLE as evidenced by all of the following:
  • • • Confirmed SLE classification criteria score ≥ 10* (Note: must include clinical and immunologic domains criteria)
      • Anti-nuclear antibody (ANA) titer of ≥ 1:80 measured via indirect immunofluorescence (IIF) on human epithelial (Hep-2) cells (or an equivalent ANA positive test) at least once; AND
• Patient has documented active disease; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool (i.e., Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K), British Isles Lupus Assessment Group-2004 (BILAG 2004), and/or Physician’s Global Assessment (PGA) score); AND
• Patient has failed to respond adequately to at least one (1) standard therapy such as anti-malarials, corticosteroids, or immunosuppressives*; AND

* Note: For patients already established on biologic therapy, trial and failure of standard therapy is not required.

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,7,19

Coverage can be renewed based on the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serious infections, malignancy, severe hypersensitivity reactions/anaphylaxis, etc.; AND
• Adequate documentation of disease stability and/or improvement as indicated by one or more of the following when compared to pre-treatment baseline:
  • Improvement in the SELENA-SLEDAI-2K; OR
  • Reduction of baseline BILAG-2004 (e.g., from A to B or from B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥2 new BILAG-2004 B or ≥1 new BILAG A); OR
  • No worsening (<0.30 points increase) in Physician’s Global Assessment (PGA) score; OR
  • Seroconverted (negative)

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J0491 – Injection, anifrolumab-fnia 1 mg; 1 billable unit = 1 mg

NDC:

• Saphnelo 300 mg/2 mL single-dose vial for injection: 00310-3040-xx

7. References

1. Saphnelo [package insert]. Wilmington, DE; AstraZeneca Pharm.; December 2023. Accessed March 2024.
2. Hannon CW, McCourt C, Lima HC, et al. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. Doi: 10.1002/14651858.CD007478.pub2.
3. Furie R, Morand EF, Askanase AD, et al. Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus. Lupus. 2021 Jul;30(8):1254-1263. Doi: 10.1177/09612033211014267. Epub 2021 May 12.
4. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. Doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.
5. Petri M, Orbai AM, Alarcón GS, et al.  Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. Doi: 10.1002/art.34473.
6. Calvo-Alén J1, Silva-Fernández L, Úcar-Angulo E, et al. SER consensus statement on the use of biologic therapy for systemic lupus erythematosus. Reumatol Clin. 2013 Sep-Oct;9(5):281-96.
7. Gordon C, Amissah-Arthur MB, Gayed M, et al. The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults. See comment in PubMed Commons belowRheumatology (Oxford). 2018 Jan 1;57(1):e1-e45. Doi: 10.1093/rheumatology/kex286.
8. NICE. Belimumab for treating active autoantibody-positive systemic lupus erythematosus: Technology Appraisal Guidance [TAG397]. https://www.nice.org.uk/guidance/ta397. Published: 22 June 2016. Accessed March 2021.
9. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum. 1999;42(9):1785–1796.
10. Lam NC, Ghetu MV, Bieniek ML. Systemic Lupus Erythematosus: Primary Care Approach to Diagnosis and Management. Am Fam Physician. 2016 Aug 15;94(4):284-94.
11. NICE. Belimumab for treating active autoantibody-positive systemic lupus erythematosus: Technology appraisal guidance [TA752]. https://www.nice.org.uk/guidance/ta752. Published: 15 December 2021. Accessed March 2023.
12. Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis 2019;78: 736–745.
13. Fanouriakis A, Tziolos N, Bertsias G, et al. Update on the diagnosis and management of systemic lupus erythematosus. Ann Rheum Dis 2021; 80:14-25. Doi:10.1136/annrheumdis-2020-218272
14. Aringer M, Costenbader K, Daikh D, et al. 2019 European League against Rheumatism/American College of rheumatology classification criteria for systemic lupus erythematosus. Arthritis Rheumatol 2019;71:1400–12.
15. Lam NC, Brown JA, Sharma R. Systemic Lupus Erythematosus: Diagnosis and Treatment. Am Fam Physician. 2023 Apr 107(4):383-395.
16. Yee CS, Cresswell L, Farewell V, Rahman A, the LS, Griffiths B et al. Numerical scoring for the BILAG-2004 index. Rheumatology (Oxford) 2010; 49(9):1665-9.
17. Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol 2002; 29(2):288-91.
18. Chessa E, Piga M, Floris A, Devilliers H, Cauli A, Arnaud L. Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties. Rheumatology (Oxford). 2020 Dec 1;59(12):3622-3632. doi: 10.1093/rheumatology/keaa383.
19. Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83:15-29. doi: 10.1136/ard-2023-224762.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A