Zokinvy — Blue Cross Blue Shield of New Mexico
Other FDA labeled indication
Initial criteria
- ONE of the following: (A) BOTH of the following: (1) Diagnosis of Hutchinson-Gilford progeria syndrome (HGPS) AND (2) Genetic testing has confirmed a pathogenic variant in the LMNA gene that results in production of progerin (medical record required) OR (B) The patient has a processing-deficient progeroid laminopathy AND ONE of the following: (1) Genetic testing has confirmed heterozygous LMNA mutation with progerin-like protein accumulation (medical record required) OR (2) Genetic testing has confirmed homozygous or compound heterozygous ZMPSTE24 mutations (medical record required)
 - 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
 - Body surface area ≥ 0.39 m^2
 - Prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist) or has consulted with a specialist in the area of the patient’s diagnosis
 - Patient does not have any FDA labeled contraindications to the requested agent
 - For members in Ohio who are Fully Insured or HIM Shop (SG): the same contraindication criterion applies AND ONE of the following: (1) patient has another FDA labeled indication, OR (2) indication supported in compendia, OR (3) prescriber has submitted two peer-reviewed journal articles supporting requested use (excluding case studies); acceptable compendia and literature sources include DrugDex level 1, 2A, 2B; AHFS-DI; NCCN 1 or 2A; Clinical Pharmacology; LexiDrugs evidence level A; or peer-reviewed medical literature
 
Reauthorization criteria
- Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
 - Patient has had clinical benefit with the requested agent
 - Prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist) or has consulted with a specialist
 - Patient does not have any FDA labeled contraindications to the requested agent
 
Approval duration
12 months