Lupkynis – NC Standard

Restricted Product(s):

• Lupkynis™ (voclosporin)

FDA Approved Use:

• Indicated in combination with background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).

Criteria for Approval of Restricted Product(s):

Initial Coverage Criteria:

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of systemic lupus erythematosus (SLE) according to American College of Rheumatology classification; AND
3. The patient has biopsy-proven active lupus nephritis Class III, IV, and/or V (medical record documentation required); AND
4. Documented baseline eGFR > 45mL/min/1.73m2; AND
5. Documented baseline blood pressure is ≤ 165/105mmHg; AND
6. The patient is not experiencing hypertensive emergency; AND
7. The patient will not be taking the requested agent in combination with Benlysta; AND
8. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., Rheumatologist, Nephrologist); AND
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 180 days (6 months)

Continuation Coverage Criteria:

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has experienced therapeutic benefit since initiation of therapy; AND
3. The patient has received less than 52 weeks of therapy total; OR
   1. The patient has achieved Complete Renal Response, defined as:
      1. UPCR of ≤0.5 mg/mg (medical record documentation required); AND
      2. eGFR ≥60 mL/min/1.73 m2 (medical record documentation required); OR
         1. No confirmed decrease from baseline in eGFR of >20% (medical record documentation required); AND
      3. Patient has not received rescue medication for LN; AND
   2. The provider has weighed the risks and benefits of continued treatment beyond one year; AND
4. The patient will not be taking the requested agent in combination with Benlysta; AND
5. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., Rheumatologist, Nephrologist); AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity limitations apply to brand and associated generic products

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

October 2023: Criteria change: Criteria review and formatting changes. Changed duration of approval to 6 months (initial) and 1 year (continuation). Added duration of approval to quantity limit exception criteria. Added management or consultation with a specialist for initial and continuation criteria.

July 2021: Criteria change: Medical record documentation required.

February 2021: Original utilization management criteria issued