Cerdelga — Blue Cross Blue Shield of New Mexico

Gaucher disease type 1 (GD1)

Initial criteria

Requested agent eligible for continuation of therapy AND prescriber states patient treated with requested agent within past 90 days AND at risk if therapy changed OR all the following:
Diagnosis of Gaucher disease type 1 (GD1)
ONE of: baseline glucocerebrosidase enzyme activity ≤15% of mean normal in fibroblasts, leukocytes, or other nucleated cells OR genetic analysis confirmed two pathogenic alleles in GBA gene
If FDA-labeled indication THEN age within labeling OR support for age use for requested indication
Patient does NOT have neuronopathic symptoms indicative of Gaucher disease type 2 or type 3 (e.g., bulbar signs, pyramidal signs, oculomotor apraxia, tonic-clonic seizures, myoclonic epilepsy, dementia, ataxia)
Patient has ≥1 of: anemia below lab normal; thrombocytopenia (<100000/microliter on ≥2 measurements); hepatomegaly; splenomegaly; growth failure (growth velocity below standard mean for age); evidence of bone disease with other causes ruled out
Patient is CYP2D6 EM, IM, or PM as detected by FDA-cleared test
Prescriber is specialist in patient’s diagnosis (e.g., endocrinologist, geneticist) or has consulted with specialist
Patient will NOT use in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
Patient does NOT have any FDA-labeled contraindications to requested agent

Previously approved for requested agent through plan’s prior authorization process
Patient has had clinical benefit with requested agent
Prescriber is specialist or has consulted with specialist in patient’s diagnosis area
Patient will NOT use in combination with another substrate reduction therapy agent (e.g., Opfolda, miglustat, Zavesca)
Patient does NOT have FDA-labeled contraindications

12 months