Natural Thyroid Products - PA, NF

Indications for Prior Authorization

Amerithroid (thyroid), Armour Thyroid (thyroid, porcine), EvexiTHROID (thyroid), Niva Thyroid (thyroid, porcine), NP Thyroid (thyroid), RenThyroid (levothyroxine and liothyronine), Thyroid (thyroid)
  • For diagnosis of Hypothyroidism
    Indicated for use as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism.

  • For diagnosis of Euthyroid Goiters
    Indicated for use as pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter.

  • For diagnosis of Thyroid Cancer
    Indicated for use as pituitary TSH suppressants, in the management of thyroid cancer.

  • For diagnosis of Disclaimer:
    This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

Criteria

Amerithroid, Armour Thyroid, EvexiTHROID, Niva Thyroid, NP Thyroid, RenThyroid, Thyroid

Prior Authorization/Non-Formulary (Initial Authorization)

Length of Approval: 6 Month(s)

  • Submission of medical records (e.g., chart notes) confirming one of the following:
    • Diagnosis of one of the following:
      • Hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis
      • Thyroid cancer
      OR
    • Requested drug will be used for the treatment or prevention of euthyroid goiters (e.g., thyroid nodules, Hashimoto's)
    AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming patient has tried and failed or has an intolerance to all of the following formulary alternatives:
    • Generic levothyroxine sodium tablet
    • Euthyrox (levothyroxine sodium)
    • Levo-T (levothyroxine sodium)
    • Levoxyl (levothyroxine sodium)
    • Unithroid (levothyroxine sodium)
Amerithroid, Armour Thyroid, EvexiTHROID, Niva Thyroid, NP Thyroid, RenThyroid, Thyroid

Prior Authorization/Non-Formulary (Reauthorization)

Length of Approval: 6 Month(s)

  • Submission of medical records (e.g., chart notes) confirming one of the following:
    • Diagnosis of one of the following:
      • Hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis
      • Thyroid cancer
      OR
    • Requested drug is being used for the treatment or prevention of euthyroid goiters (e.g., thyroid nodules, Hashimoto's)
    AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming patient has tried and failed or has an intolerance to all of the following formulary alternatives:
    • Generic levothyroxine sodium tablet
    • Euthyrox (levothyroxine sodium)
    • Levo-T (levothyroxine sodium)
    • Levoxyl (levothyroxine sodium)
    • Unithroid (levothyroxine sodium)
    AND
  • Submission of medical records (e.g., chart notes) confirming one of the following:
    • If being used for hypothyroidism (except transient hypothyroidism during the recovery phase of subacute thyroiditis) or euthyroid goiters, patient demonstrates positive clinical response to therapy
    • OR
    • If being used for thyroid cancer, patient does not show evidence of progressive disease
P & T Revisions

2026-10-09, 2026-10-08, 2026-09-10, 2026-08-24, 2026-04-21, 2025-12-04, 2024-10-24, 2024-07-25, 2024-04-02, 2024-03-06, 2023-12-22, 2023-11-27, 2023-11-01, 2023-09-15, 2022-11-02, 2022-08-23, 2022-07-22, 2022-07-18, 2022-01-11, 2021-11-03, 2021-09-28, 2021-05-26, 2021-05-21, 2021-05-05, 2021-03-01, 2021-01-04, 2020-12-31, 2020-11-16, 2020-02-25, 2019-11-01

  1. NP Thyroid Prescribing Information. Acella Pharmaceuticals, LLC. Alpharetta, GA. December 2025.
  2. Amerithroid Prescribing Information. Oliva Therapeutics, LLC. Ridgewood, NJ. January 2025.
  3. Armour Thyroid Prescribing Information. Allergan, Inc. North Chicago, IL. March 2024.
  4. EvexiTHROID Prescribing Information. Trifluent Pharma, LLC. San Antonio, TX. May 2025.
  5. Niva Thyroid Prescribing Information. Nivagen Pharmaceuticals, Inc. Sacramento, CA. March 2023.
  6. RenThyroid Prescribing Information. Genus Lifesciences. Allentown, PA. September 2024.
  7. Thyroid Prescribing Information. ANI Pharmaceuticals, Inc. Baudette, MN. February 2025.

  • 2026-10-09: Updated guideline to mirror PA criteria to NF criteria.
  • 2026-10-08: Updated guideline to mirror PA criteria to NF criteria.
  • 2026-09-10: New NF program
  • 2026-08-24: Update to add reauthorization criteria for a non-formulary or excluded drug (non-contraceptives). Existing criteria will remain in place as initial authorization criteria. Submission of medical records will be added to diagnosis.
  • 2026-04-21: Update to contraceptive drug criteria to no longer specify 'FDA'- approved conditions. Approved conditions are listed in notes section. For NF drugs, formatting update to move diagnosis to beginning of criteria. Criteria update to require up to 5 formulary alternatives where available.
  • 2025-12-04: Annual Review, no changes.
  • 2024-10-24: Annual review, no changes.
  • 2024-07-25: Update criteria to clarify intent. Add operational note to clarify OTC requirement.
  • 2024-04-02: Updated operational note for non-formulary or excluded drug. No changes to clinical criteria.
  • 2024-03-06: Criteria update.
  • 2023-12-22: No changes to intent. Added operational note for non-formulary or excluded drug criteria. Removed Non-Preferred Non-Formulary or Excluded Medication criteria and move to its own stand alone guideline.
  • 2023-11-27: Updated Non-Formulary or Excluded drug criteria to reorder criteria. No changes to clinical intent. Removed Auvi-Q as target drug.
  • 2023-11-01: Annual review: No updates required.
  • 2023-09-15: Updated program. Added criteria for Non-Preferred Non-Formulary or Excluded drugs to this guideline to consolidate.
  • 2022-11-02: Annual review: No updates required.
  • 2022-08-23: Update background
  • 2022-07-22: Create contraceptive specific criteria that allows for approval upon medical necessity.
  • 2022-07-18: Update Guideline.
  • 2022-01-11: Annual review: No updates required.
  • 2021-11-03: Annual review: No updates required.
  • 2021-09-28: Renamed guideline to 'Administrative Non-Formulary & Excluded Drug Exceptions Process' to differentiate from drug-specific non-formulary/excluded guidelines.
  • 2021-05-26: Renamed guideline to 'Administrative Non-Formulary & Excluded Drug Exceptions Process' to differentiate from drug-specific non-formulary/excluded guidelines.
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-05: Removed Non-Form Non-Preferred criteria from NF admin guideline per PA team request.
  • 2021-03-01: Removed Aplenzin as target, moved to Non-Formulary Drugs of Clinical Concern
  • 2021-01-04: Updated Formulary alternatives table
  • 2020-12-31: Added targets to Non-Form Non-Preferred criteria for 1.1.21 eff date and updated alternative table in background section.
  • 2020-11-16: Attached Non-Form Non-Preferred criteria to NF admin guideline per PA team request to facilitate proper NF reviews.
  • 2020-02-25: Added keywords "non", "non-form", and "non-formulary" to criteria section per PA request.
  • 2019-11-01: Updated to add criteria for when there are only OTC equivalents.