Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Saphnelo (anifrolumab-fnia) requires prior authorization.

2)    Saphnelo is used to treat systemic lupus erythematosus (SLE).

3)    Saphnelo is a specialty medication covered under the medical benefit.

Saphnelo (anifrolumab-fnia) is considered medically necessary for members meeting the following criteria:

Systemic Lupus Erythematosus (SLE)

1)    Diagnosis of SLE; AND

2)    Prescribed by or in consultation with a rheumatologist;

3)    Age > 18 years; AND

4)    Documentation confirms that member is positive for an SLE autoantibody 9e.g., anti-nuclear antibody (ANS), anti-double-stranded DNA (anti-dsDNA), anti-Smith (anti-Sm), anti-ribonucleoprotein (anti-RNP), anti-Ro/SSA, anti-La/SSB, antiphospholipid antibody); AND

5)    Prescribed in combination with standard therapy for SLE that includes one or more of the following agents, unless all agents are contraindicated: glulcocorticoids (e.g., prednisone), antimalarial (e.g., hydroxychloroquine or chloroquine), non-biologic immunosupressants (e.g., azathioprine, methotrexate, mycophenolate);

6)    Dose does not exceed 300mg every 4 weeks.

Initial Approval Duration: 6 months

Reauthorization (Approval Duration: 6 months)

1)    Currently receiving mediation via QualChoice benefit or member has previously met initial approval criteria; AND

2)    Member is responding positively to therapy; AND

3)    Prescribed in combination with standard therapy for SLE that includes one or more of the following agents, unless all agents are contraindicated: glulcocorticoids (e.g., prednisone), antimalarial (e.g., hydroxychloroquine or chloroquine), non-biologic immunosupressants (e.g., azathioprine, methotrexate, mycophenolate).

Codes Used In This BI:

C9086            Injection, anifrolumab-fnia, 1mg (code deleted & replaced by J0491 eff 4/1/22)

J0491             Injection, anifrolumab-fnia, 1 mg

1)    Saphnelo Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021. Available at www.saphnelo.com. Accessed August 26, 2021.

2)    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;0:1–10. doi:10.1136/annrheumdis-2019-215089.

3)    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; 64:2677.

4)    Gordon C, Amissah-Arthur MB, Gayed M, et al. The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults. Rheumatology. 2018;57:e1-e45. doi:10.1093/rheumatology/kex286.

5)    Morand EF, Furie R, Tanaka Y, et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med 2020;382:211-21.

6)    Furie R, Khamashta M, Merrill JT, et al. Anifrolumab, an Anti–Interferon-a Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis & Rheumatology 2017; 69(2): 376-386.

Addendum:

Effective 01-01-2022: New Policy