Xolremdi — Blue Cross Blue Shield of New Mexico
any FDA labeled indication
Initial criteria
- BOTH of the following:
 - A. ONE of the following:
 - 1. The patient has a diagnosis of WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome AND ALL of the following:
 - A. Genetic analysis confirms mutation in the CXC chemokine receptor 4 (CXCR4) gene [chart notes required] AND
 - B. Confirmed absolute neutrophil count (ANC) OR total white blood cell (WBC) count is ≤ 400 cells/microliter (prior to therapy with the requested agent AND during no clinical evidence of infection) AND
 - C. The prescriber has assessed baseline status (prior to therapy) of the patient's symptoms (e.g., ANC, ALC, number of infections)
 - OR 2. The patient has another FDA labeled indication for the requested agent and route of administration
 - B. If the patient has an FDA labeled indication, then ONE of the following:
 - A. The patient’s age is within FDA labeling for the requested indication OR
 - B. There is support for using the requested agent for the patient’s age for the requested indication
 - AND
 - The patient will NOT be using the requested agent in combination with any other CXCR4 antagonists (e.g., plerixafor) for the requested indication
 - AND
 - The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist, hematologist, immunologist), or has consulted with a specialist
 - AND
 - The patient does NOT have any FDA labeled contraindications to the requested agent
 - The requested agent will also be approved when ONE of the following is met:
 - 1. The request is for a BCBS NM Fully Insured or NM HIM member and ALL of the following:
 - A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
 - B. The requested indication is a rare disease AND
 - C. ONE of the following:
 - 1. The patient has another FDA labeled indication for the requested agent and route OR
 - 2. The patient has another indication supported in compendia for the requested agent and route
 - OR 2. ALL of the following:
 - A. The member resides in Ohio AND
 - B. The plan is Fully Insured or HIM Shop (SG) AND
 - C. The patient does NOT have any FDA labeled contraindications to the requested agent AND
 - D. ONE of the following:
 - 1. The patient has another FDA labeled indication for the requested agent and route OR
 - 2. The patient has another indication that is supported in compendia for the requested agent and route OR
 - 3. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals supporting the proposed use(s) as generally safe and effective
 
Reauthorization criteria
- The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
 - AND the patient has had clinical benefit with the requested agent
 - AND the patient will NOT be using the requested agent in combination with any other CXCR4 antagonists (e.g., plerixafor) for the requested indication
 - AND the prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist, hematologist, immunologist), or has consulted with a specialist
 - AND the patient does NOT have any FDA labeled contraindications to the requested agent
 
Approval duration
12 months