Voclosporin (Lupkynis) Form

Voclosporin (Lupkynis™) is a calcineurin inhibitor. FDA Approved Indication(s)
Lupkynis is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitation(s) of use: Safety and efficacy of Lupkynis have not been established in combination with cyclophosphamide. Use of Lupkynis is not recommended in this situation. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Lupkynis is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Lupus Nephritis (must meet all):

1. Diagnosis of LN with kidney biopsy confirming one of the following (a, b, or c): a. LN class III (focal); b. LN class IV (diffuse segmental or global); c. LN class V (membranous);
2. Prescribed by or in consultation with a nephrologist or rheumatologist;
   3. Age ≥ 18 years;
   4. Member has a confirmed diagnosis of systemic lupus erythematosus;
   5. Evidence of one of the following (a or b):
      a. Urine protein/creatinine ratio (UPCR) ≥ 1.5 mg/mg; b. UPCR ≥ 2 mg/mg and LN Class V;
3. Prescribed in combination with a background immunosuppressive therapy (e.g., mycophenolate, azathioprine) and a systemic corticosteroid (e.g., prednisone);

4. Dose does not exceed 47.4 mg (6 capsules) per day. Approval duration: 6 months Page 1 of 6

   CLINICAL POLICY Voclosporin B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Lupus Nephritis (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
8. Member is responding positively to therapy as evidenced by one of the following (a, b, or c):
   a. Reduced level of proteinuria measured by UPCR ≤ 0.5 mg/mg from baseline with low dose steroids (e.g., prednisone); b. No reduction from baseline in eGFR of greater than 20% with low dose steroids (e.g., prednisone); c. eGFR ≥ 60 ml/min/1.73 m2 with low dose steroids (e.g., prednisone);
9. Prescribed in combination with a background immunosuppressive therapy (e.g., mycophenolate, azathioprine) and a systemic corticosteroid (e.g., prednisone);
10. One of the following (a or b): a. Member has had ≤ 12 months of Lupkynis therapy; b. Both (i and ii): i. Member has completed > 12 months of Lupkynis therapy;
    ii. Provider attests that the benefit of continuation of therapy exceeds the risk in light of the member’s treatment response and risk of worsening nephrotoxicity;

11. If request is for a dose increase, new dose does not exceed 47.4 mg (6 capsules) per day. Approval duration: 6 months Page 2 of 6

    CLINICAL POLICY Voclosporin B. Other diagnoses/indications (must meet 1 or 2):

12. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

13. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key eGFR: estimated glomerular filtration rate FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    Not applicable LN: lupus nephritis UPCR: urine protein/creatinine ratio Appendix C: Contraindications/Boxed Warnings
    • Contraindication(s):
    o Patients concomitantly using strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) o Known serious or severe hypersensitivity reaction to Lupkynis or any of its excipients • Boxed warning(s): malignancies and serious infection V. Dosage and Administration
    Indication LN Dosing Regimen 23.7 mg PO BID Maximum Dose 47.4 mg/day VI. Product Availability
    Capsule: 7.9 mg
    Page 3 of 6

    CLINICAL POLICY Voclosporin VII.