Pharmacy Prior Authorization Criteria

Topical Antifungals - PA, NF

Indications for Prior Authorization

Ciclopirox Kit (ciclopirox)

• For diagnosis of Onychomycosis
  Indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.

Jublia (efinaconazole) topical solution

• For diagnosis of Onychomycosis of the toenails
  Indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Kerydin (tavaborole) topical solution

• For diagnosis of Onychomycosis of the toenails
  Indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Criteria

Ciclopirox Kit

Prior Authorization

Length of Approval: 48 Weeks [3, 6, A]
For diagnosis of Fingernail Onychomycosis

• Diagnosis of onychomycosis of the fingernail(s)
AND
• The patient does not have dermatophytomas or lunula (matrix) involvement
AND
• Diagnosis of fingernail onychomycosis has been confirmed by one of the following:
• Positive potassium hydroxide (KOH) preparation
• Culture
• Histology
AND
• Trial and failure (of a minimum 6-week supply), contraindication, or intolerance to oral terbinafine [B]

Ciclopirox Kit, Generic tavaborole, Jublia

Prior Authorization

Length of Approval: 48 Weeks [3, 6, A]
For diagnosis of Toenail Onychomycosis

• Diagnosis of onychomycosis of the toenail(s)
AND
• The patient does not have dermatophytomas or lunula (matrix) involvement
AND
• Diagnosis of toenail onychomycosis has been confirmed by one of the following:
• Positive potassium hydroxide (KOH) preparation
• Culture
• Histology
AND
• Patient has mild to moderate disease involving at least one target toenail
AND
• Trial and failure, contraindication (of a minimum 12-week supply), or intolerance to oral terbinafine [B]

Brand Kerydin

Prior Authorization

Length of Approval: 48 Weeks [3, 6, A]
For diagnosis of Toenail Onychomycosis

• Diagnosis of onychomycosis of the toenail(s)
AND
• The patient does not have dermatophytomas or lunula (matrix) involvement
AND
• Diagnosis of toenail onychomycosis has been confirmed by one of the following:
• Positive potassium hydroxide (KOH) preparation
• Culture
• Histology
AND
• Patient has mild to moderate disease involving at least one target toenail
AND
• Both of the following:
• Trial and failure, contraindication (of a minimum 12-week supply), or intolerance to oral terbinafine [B]
AND
• Trial and failure (of a minimum 48-week supply), contraindication, or intolerance to generic tavaborole

Jublia

Non Formulary

Length of Approval: 48 Weeks [3, 6, A]
For diagnosis of Toenail Onychomycosis

• Diagnosis of onychomycosis of the toenail(s)
AND
• The patient does not have dermatophytomas or lunula (matrix) involvement
AND
• Diagnosis of toenail onychomycosis has been confirmed by one of the following:
• Positive potassium hydroxide (KOH) preparation
• Culture
• Histology
AND
• Patient has mild to moderate disease involving at least one target toenail
AND
• Treatment is requested due to a documented medical condition and not for cosmetic purposes (e.g. patients with history of cellulitis of the lower extremity, patients with diabetes who have additional risk factors for cellulitis of lower extremity, patients who experience pain/discomfort associated with the infected nail)
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming history of failure, contraindication, or intolerance to 12 weeks of treatment with ciclopirox
OR
• Patient is 6 to 12 years of age
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming history of failure, contraindication, or intolerance to 12 weeks of treatment with ONE of the following oral antifungal agents:
• itraconazole
• terbinafine
• griseofulvin

P & T Revisions

2024-01-10, 2023-01-25, 2022-11-30, 2022-09-08, 2022-01-18, 2021-09-28, 2021-05-26, 2021-05-25, 2021-01-29, 2020-11-24, 2019-12-17

References

1. Jublia prescribing information. Bausch Health Companies Inc. Bridgewater, NJ. March 2022.
2. Kerydin prescribing information. PharmaDerm, a division of Fougera Pharmaceuticals, Inc. Melville, NY. August 2018.
3. Sigurgeirsson B, Olafsson JH, Steinsson JP, et al. Long-term effectiveness of treatment with terbinafine vs. itraconazole in onychomycosis: a 5-year blinded prospective follow-up study. Arch Dermatol. 2002;138:353-7.
4. Roberts DT, Taylor WD, Boyle J. Guidelines for treatment of onychomycosis. Br J Dermatol. 2003;148:402-410.
5. Ameen M, Lear JT, Madan V, Mohd Mustapa MF, Richardson M. British Association of Dermatologists’ guideline for the management of onychomycosis 2014. Br J Dermatol. 2014;171(5):937-58.
6. Gupta, AK, Daigle D, Paquet M. Therapies for onychomycosis a systematic review and network meta-analysis of mycological cure. J Am Podiatr Med Assoc. 2015;105(4):357-66.
7. Gupta AK, Daigle D, Foley KA. Topical therapy for toenail onychomycosis: an evidence-based review. Am J Clin Dermatol. 2014;15:489.
8. Tavaborole prescribing information. Alembic Pharmaceuticals, Inc. Bridgewater, NJ. November 2021.

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End Notes

1. Considering that toenails can take 12 to 18 months to grow out, many clinicians consider that 1 year is too short to assess clinical effectiveness. [4] Reports of long-term follow-up of treated patients have been presented, suggesting that positive mycology at 12 and 24 weeks after commencement of therapy are poor prognostic signs and may indicate a need for retreatment or for a change of drug. [5]
2. Oral terbinafine has been shown to have superior efficacy compared to topical treatments and is recommended as first-line therapy for onychomycosis. [4, 6, 7] Compared to itraconazole, terbinafine has been found to have lower long-term mycological recurrence rates and better tolerability. [4, 6]

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Revision History

• 2024-01-10: 2024 UM Annual Review. No criteria changes
• 2023-01-25: 2023 UM Annual Review. No changes to criteria. Updated references
• 2022-11-30: Annual review - consolidated Jublia NF criteria into this guideline. End-dated NF guideline. Updated references.
• 2022-09-08: Jublia for Toenail Onychomycosis - removal of step through brand Kerydin. Brand Kerydin updated to have double step through oral terbinafine and generic tavaborole
• 2022-01-18: 2022 UM Annual Review.
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-01-29: 2021 UM Annual Review.
• 2020-11-24: Added generic tavaborole to guideline. Criteria mirror its brand.
• 2019-12-17: 2020 UM Annual Review. No changes to criteria. Updated references.

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