Pharmacy Prior Authorization Criteria

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*

* Drug should be reviewed using the drug-specific Prior Authorization guideline if available. If no drug-specific Prior Authorization guideline is available, proceed with the criteria above. This guideline will not apply to Non-Formulary reviews, drugs that are benefit exclusions, drugs with step therapy edits, drugs that require quantity limit review only, or drugs that are not reviewed for prior authorization by OptumRx. ^OTC equivalents refers to any covered or non-covered OTC equivalent product.

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 2 additional formulary alternatives within the same therapeutic class. If only 1 formulary alternative within the therapeutic class is available, the patient must have tried the formulary alternative within the therapeutic class AND 1 additional formulary alternative. If there are no formulary alternatives within the same therapeutic class, the patient must have failed or had contraindication or intolerance to 2 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 2 additional formulary alternatives
OR
• If only over-the-counter (OTC) equivalents^ are available, patient has tried and failed or has contraindications or intolerance to 3 OTC equivalents. If only one or only two equivalents are available, the patient must have failed or had 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 three formulary alternatives. If only one or only two formulary alternatives are available, the patient must have failed or had contraindications or intolerance to all available formulary alternatives.
OR
• No formulary alternative or OTC equivalent is available to treat the patient's condition

P & T Revisions

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

References

Revision History

• 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.