WHA

Coverage of Drugs for Off-Label or Non-FDA Approved Indications

Indications for Prior Authorization

Criteria

Administrative (Initial Authorization)

Length of Approval: 1 Year(s)
For diagnosis of Drugs used for an off-label indication or non-FDA approved indication

  • Requests will be reviewed on a case-by-case by a clinical pharmacist
    • AND
  • The drug is approved by the FDA
    • AND
  • The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition or a chronic and seriously debilitating condition
    • AND
  • The drug is medically necessary to treat the condition
    • AND
  • Documented history of failure, intolerance, or contraindication to standard, conventional therapies to treat or manage the disease or condition, where available
    • AND
  • The drug has been recognized for treatment of that condition by one of the following:
    • The American Hospital Formulary Service (AHFS) Drug Information
      • OR
    • One of the following compendia as part of an anticancer chemotherapeutic regimen:
      • The Elsevier Gold Standard's Clinical Pharmacology
      • The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium
      • DRUGDEX System by Micromedex
      OR
    • Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal

  • Guideline ID
    GL-162186

  • Formulary
    Custom

  • Effective date
    Dec 20, 2024

  • P&T approval date

P & T Revisions

1970-01-01, 2024-11-04

  1. CA Assembly Bill No. 830. An act to amend Sections 1367.21 and 1370.4 of the Health and Safety Code, to amend Sections 10123.195 and 10145.3 of the Insurance Code, and the amend Sections 14105.43 and 14133.2 of the Welfare and Institutions Code, relating to drugs and devices. Available at: http://info.sen.ca.gov/pub/09-10/bill/asm/ab_0801-0850/ab_830_bill_20091011_chaptered.pdf Accessed November 11, 2009.
  1. Authorization will be defaulted to 12 months as defined by the criteria.
  • 2024-11-04: New Program