Ocaliva — Blue Cross Blue Shield of New Mexico

Initial criteria

• Diagnosis of PBC confirmed by at least TWO of the following: (A) biochemical evidence of cholestasis with an alkaline phosphatase (ALP) elevation; (B) positive presence of antimitochondrial antibody (AMA) OR other PBC-specific autoantibodies (e.g., sp100, gp210) if AMA is negative; (C) histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts
• Prescriber has measured baseline ALP and total bilirubin levels prior to therapy
• ONE of the following: (A) BOTH of the following: (1) patient has tried and had an inadequate response after at least 1 year of therapy with ursodeoxycholic acid (UDCA) (defined as ALP > ULN and/or total bilirubin > ULN but < 2× ULN), AND (2) patient will continue UDCA in combination with the requested agent; OR (B) patient has intolerance or hypersensitivity to UDCA; OR (C) patient has FDA labeled contraindication to UDCA
• If another FDA labeled indication, patient age is within labeled range OR there is support for use based on age
• If the requested agent is non-preferred, ONE of the following applies: (A) request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-Insured Municipalities/Counties member; OR (B) patient currently treated and stable on requested agent; OR (C) patient had inadequate response to ONE preferred agent; OR (D) preferred agent discontinued due to lack of efficacy, diminished effect, or adverse event; OR (E) patient has intolerance/hypersensitivity to ONE preferred agent; OR (F) patient has FDA labeled contraindication to ALL preferred agents; OR (G) preferred agent expected to be ineffective or cause harm/adherence issues/comorbidity worsening/adverse reaction (chart notes required); OR (H) preferred agent not in best interest of patient based on medical necessity; OR (I) patient tried another drug in same class or mechanism as preferred agent and discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required)
• Patient does NOT have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
• Prescriber is a specialist in gastroenterology or hepatology, or has consulted with one
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Ohio-specific: if member resides in Ohio AND plan is Fully Insured or HIM Shop (SG), approval granted when (1) no FDA labeled contraindications AND (2) ONE of: (A) FDA labeled indication for requested agent and route of administration; OR (B) indication supported in compendia; OR (C) prescriber submitted TWO peer-reviewed journal articles supporting use (not case studies). Accepted compendia: DrugDex level 1, 2A, 2B; AHFS-DI supportive narrative; NCCN 1 or 2A; Clinical Pharmacology supportive narrative; Lexi-Drugs level A; or peer-reviewed medical literature

Approval duration

12 months