Pharmacy Prior Authorization Criteria

Thyroid Agents

Indications for Prior Authorization

Levothyroxine Sodium capsules

• For diagnosis of Hypothyroidism
  Indicated as replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Limitations of Use: Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

• For diagnosis of Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
  Indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer.

  Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with may induce hyperthyroidism.

Thyquidity (levothyroxine sodium) oral solution

• For diagnosis of Hypothyroidism
  Indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

  Limitations of Use: Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

• For diagnosis of Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
  Indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Thyquidity may induce hyperthyroidism.

Criteria

Brand Levothyroxine capsules, Brand Thyquidity oral solution

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (minimum 30 days supply) or intolerance to generic levothyroxine tablets

P & T Revisions

2024-04-11, 2024-01-06, 2023-10-23, 2023-08-31, 2023-07-26, 2023-04-18, 2023-01-20, 2022-12-20, 2022-12-20, 2022-11-21, 2022-01-26, 2021-01-26, 2021-01-05, 2020-02-07, 2019-12-12

References

1. Levothyroxine Sodium capsule Prescribing Information. Lannett Company Inc. Philadelphia, PA. November 2021.
2. Thyquidity Prescribing Information. Vertice Specialty Group. Largo, FL. February 2021.

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End Notes

1. This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. [1]

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Revision History

• 2024-04-11: update guideline
• 2024-01-06: 2024 Annual Review
• 2023-10-23: Attached Niva Thyroid to guideline.
• 2023-08-31: Updated indications section to include Adthyza
• 2023-07-26: Attached Adthyza to guideline.
• 2023-04-18: guideline update
• 2023-01-20: 2023 Annual Review
• 2022-12-20: Added Ermeza to guideline.
• 2022-12-20: Update Guideline
• 2022-11-21: update criteria
• 2022-01-26: 2022 Annual Review.
• 2021-01-26: Addition of Thyquidity oral solution as a step target. Annual review - background and reference updates.
• 2021-01-05: Added levothyroxine sodium capsules (Tirosint authorized brand alternative) as a target product.
• 2020-02-07: Annual Review. No Changes.
• 2019-12-12: Added WP thyroid and removed allowance for continuation of therapy.

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