WHA
 

New Drug to Market Program - PA

Indications for Prior Authorization

Criteria

Drugs included on the New Drug to Market list for which a Drug-Specific Prior Authorization Guideline is Unavailable*

Prior Authorization

Length of Approval: 6 Month(s)

  • One of the following:
    • All of the following:
      • Requested drug is FDA-approved for the condition being treated
        • AND
      • Additional requirements listed in the "Indications and Usage" sections of the prescribing information (or package insert) have been met (e.g., first line therapies have been tried and failed, any testing requirements have been met, etc.)
        • AND
      • Requested drug will be used at a dose which is within FDA recommendations
      OR
    • If requested for an off-label indication, the off-label administrative guideline criteria have been met
    AND
  • One of the following:
    • If the requested drug has a formulary alternative with the same active ingredient, both of the following:
      • Patient has experienced intolerance (e.g., allergy to excipient) with a formulary alternative that has the same active ingredient
        • AND
      • Patient has tried and failed at least 4 additional formulary alternatives within the same therapeutic class. If less than 4 formulary alternatives within the therapeutic class are available, the patient must have tried all formulary alternatives within the therapeutic class AND additional formulary alternatives to a total of four. If there are no formulary alternatives within the same therapeutic class, the patient must have failed 4 formulary alternatives or have a contraindication or intolerance to all formulary alternatives
      OR
    • If the requested drug is a fixed-dose combination product with each individual ingredients available on formulary, both of the following:
      • Patient has experienced intolerance (e.g., allergy to excipient) with the individual ingredients in the combination product
        • AND
      • Patient has tried and failed at least 4 additional formulary alternatives. If less than 4 alternatives are available, the patient must have failed or have contraindications or intolerance to all available formulary alternativeshas
      OR
    • If only over-the-counter (OTC) equivalents^ are available, patient has tried and failed or has contraindications or intolerance to 5 OTC equivalents. If less than 5 equivalents are available, the patient must have failed or have contraindications or intolerance to all available OTC equivalents [document drug(s), dose, duration of trial]
      • OR
    • If formulary alternatives are available and do not meet above scenarios, patient has tried and failed, or has contraindication or intolerance to at least 5 formulary alternatives or has contraindications or intolerance to all formulary alternatives. If less than 5 alternatives are available, the patient must have failed or have contraindications or intolerance to all available formulary alternatives
      • OR
    • No formulary alternative or OTC equivalent is available to treat the patient's condition

  • Guideline ID
    GL-633209

  • Formulary
    Premium

  • Effective date
    Jul 1, 2026

  • P&T approval date
    Feb 15, 2011

P & T Revisions

2026-06-10, 2025-12-18, 2024-10-24, 2024-03-06, 2024-02-20, 2023-11-01, 2022-11-02, 2022-09-06, 2022-08-03, 2022-01-14, 2021-11-03, 2021-09-28, 2021-05-21, 2020-10-28, 2019-10-10

  • 2026-06-10: Criteria update to require up to 5 formulary alternatives where available.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2024-10-24: Annual review, no changes.
  • 2024-03-06: Criteria update.
  • 2024-02-20: Program update to PA criteria. Removed Non-Formulary criteria from this guideline.
  • 2023-11-01: Annual review: No updates required.
  • 2022-11-02: Annual review: No updates required.
  • 2022-09-06: Updated guideline to clarify criteria applies to drugs on NDTM list for which a drug-specific PA is unavailable. Add criteria to confirm appropriate lower tier drugs or OTC agents have been tried.
  • 2022-08-03: Updated guideline to clarify criteria applies to drugs on NDTM list for which a drug-specific PA is unavailable. Add criteria to confirm appropriate lower tier drugs or OTC agents have been tried.
  • 2022-01-14: Annual review: No updates required.
  • 2021-11-03: Annual review: No updates required.
  • 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-10-28: Annual review: No updates required.
  • 2019-10-10: Annual review. No changes.