ph-1034
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Antifungal Agents - ciclopirox, efinaconazole, tavaborole Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1034

 

This prior authorization applies to Blue Partner, Commercial, GenPlus, SourceRx, and Health Insurance Marketplace formularies.

TARGET AGENTS

Jublia (efinaconazole 10% topical solution)

Kerydin (tavaborole 5% topical solution)

Penlac (ciclopirox 8% topical solution)a

a - available as a generic

PROGRAM PRIOR AUTHORIZATION AND QUANTITY LIMITS

Brand (generic)

GPI

Quantity

Multisource Code

Jublia (efinaconazole)

topical solution 10%

90154037002020

4 mL / 30 days

M, N, O, or Y

Kerydin (tavaborole)

topical solution 5%

90156080002010

4 mL / 30 days

M, N, O, or Y

Penlac (ciclopirox)

topical solution 8%a

90150030002020

6.6 mL / 30 days

M, N, O, or Y

a - available as a generic

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Jublia (efinaconazole), Kerydin (tavaborole), or Penlac (ciclopirox) will be approved when ALL of the following are met:

  1. The patient has a diagnosis of onychomycosis (tinea unguium)

AND                  

  1. The patient has ONE of the following: diabetes mellitus, peripheral vascular insufficiency, immune deficiency due to medical condition or treatment (e.g. cancer chemotherapy, HIV/AIDS, anti-rejection therapy post organ transplant), pain limiting normal activity, or secondary bacterial infection in the surrounding skin or systemic dermatosis with impaired skin integrity

AND

  1. Treatment of the patient’s onychomycosis (tinea unguium) is medically necessary and not entirely for cosmetic reasons

AND

  1. The fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture or nail biopsy)

AND

  1. The patient has ONE of the following:
    1. a treatment failure with an oral antifungal agent
    2. a contraindication to an oral antifungal agent, or
    3. the prescriber has provided information that an oral antifungal agent is not clinically appropriate

AND

  1. If the requested agent is Penlac, ciclopirox 8% topical solution; treatment will include removal of the unattached, infected nail(s) by an appropriate health care professional

AND

  1. If the requested agent is a brand agent, ONE of the following:
    1. The patient’s medication history includes use of a generic antifungal onychomycosis agent (e.g. itraconazole, terbinafine, ciclopirox) in the past 90 days

OR

    1. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL generic antifungal onychomycosis agents

AND

  1. The patient does not have any FDA labeled contraindication(s) to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose

AND

      1. The prescriber has submitted information in support of therapy with a higher dose for the requested indication

Length of approval:  12 months

FDA APPROVED INDICATIONS AND DOSAGE1-3,12-14,16

Agent

FDA Indication(s)

Dosing

Jublia®

(efinaconazole)

topical solution

Onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton

mentagrophytes

Apply to affected toenail once daily for 48 weeks

Kerydin®

(tavaborole)

topical solution

Onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Apply to affected toenail once daily for 48 weeks

Lamisil® (terbinafine)

tablets,

Onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium)

Onychomycosis - 250 mg daily

  Fingernail – treat 6 weeks

  Toenail – treat 12 weeks

Onmel®

(itraconazole)

tablets

Onychomycosis of the toenail caused by Trichophyton rubrum or T. mentagrophytes

Onychomycosis toenail-200 mg once daily for 12 weeks

Penlac®  (ciclopirox)

topical solution

Onychomycosis of the toenail or fingernail (topical treatment in immunocompetent patients with mild to moderate onychomycosis without lunula involvement, due to Trichophyton rubrum)

Apply daily to affected area

Sporanox®  (itraconazole)

capsules,

oral solution

Blastomycosis, histoplasmosis, aspergillosis, onychomycosis of the toenail or fingernail

Blastomycosis-200 mg daily (up to 400 mg daily if 200 mg not effective)

Histoplasmosis-200 mg daily (up to 400 mg daily if 200 mg not effective)

Aspergillosis-200-400 mg daily

Onychomycosis toenail-200 mg daily for 12 weeks

Onychomycosis fingernail-200 mg twice daily for 1 week, then 3 weeks off, then 200 mg twice daily for 1 more week

Tolsura™

(itraconazole)

capsules

Blastomycosis, histoplasmosis, and aspergillosis

Limitations of use:  Tolsura is not indicated for the treatment of onychomycosis.  Tolsura is not interchangeable or substitutable with other itraconazole products

Blastomycosis and histoplasmosis-130 mg to 260 mg daily

Aspergillosis-130 mg to 260 mg daily

CLINICAL RATIONALE

Esophageal candidiasis and candidemia

Infectious Diseases Society of America (IDSA) guidelines recommend an echinocandin as the first line therapy for candidemia in non neutropenic patients, with fluconazole as an alternative.  Fluconazole is first-line therapy for esophageal candidiasis.  Fluconazole is also recommended for prophylaxis against esophageal candidiasis in at risk patients. For patients with fluconazole-refractory disease, guidelines recommend itraconazole or voriconazole. Up to 80% of patients with fluconazole refractory esophageal candidiasis will respond to itraconazole.4

Blastomycosis and histoplasmosis

Itraconazole is the recommended therapy for the treatment of chronic cavity pulmonary histoplasmosis.  Other forms of histoplasmosis are generally treated with amphotericin B.5  IDSA guidelines recommend itraconazole as the first line oral agent for the treatment of mild to moderate blastomycosis.  Itraconazole is also recommended in patients as a step down from amphotericin B for more severe cases of blastomycosis.  Fluconazole and voriconazole are considered alternatives for the treatment of blastomycosis.6

Onychomycosis (Tinea unguium)

Onychomycosis typically causes no symptoms other than an undesirable appearance of the nail. Guidelines recommend consideration of treatment if walking is uncomfortable, abnormal looking nails are causing significant psychological distress, or if the patient has diabetes, vascular disease, or a connective tissue disorder. Treatment may be necessary if the nail infection is the source of a fungal skin infection or if the person is, or may become, severely immunocompromised.11

Onychomycosis can be difficult to distinguish from other causes of nail dystrophy and because of slow nail growth (six months for fingernails and twelve months for toenails) evidence of treatment failure may not be apparent for several months or more. If the diagnosis is not confirmed and improvement does not occur, it is impossible to ascertain if treatment failure has occurred or if the initial diagnosis was incorrect. Guidelines on the treatment of fungal and candidal infections of the nail recommend laboratory confirmation and nail specimens for diagnosis before initiation of treatment.11

The British Association of Dermatologists guidelines for the management of onychomycosis recommends both itraconazole and terbinafine as first line treatments for dermatophyte onychomycosis and generally prefer terbinafine over itraconazole.15  The American Academy of Family Physicians recommends terbinafine as first-line treatment for dermatophyte onychomycosis due to its tolerability, high cure rate, and low cost. A meta-analysis showed a mycotic cure rate of 76% for the use of terbinafine for systemic treatment of onychomycosis.11 Several meta-analyses have found oral terbinafine more effective than oral itraconazole for onychomycosis.7-10  The guidelines consider  oral fluconazole as an alternative (off-label use).

Topical agents are recommended for patients who cannot take oral antifungals and in those with less than 50% of the distal nail affected and no lunular involvement. 11  Ciclopirox is considered less effective than systemic therapy, but has no systemic side effects or drug interactions.Additionally, a comparative study showed combination of ciclopirox and oral terbinafine had a higher mycotic cure rate and complete cure rate compared to terbinafine alone.11  The prescribing information for Penlac indicates it is part of a comprehensive management program that 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.3

REFERENCES

  1. Sporanox prescribing information. Janssen Pharmaceutical Companies. March 2019.
  2. Lamisil prescribing information. Novartis Pharmaceuticals Corporation. March 2019.  
  3. Penlac prescribing information. Sanofi Aventis. June 2016.
  4. Pappas PG, Kauffman CA, Andes D, et al.  Clinical practice guidelines for the management of candidiasis: 2016 Update by the Infectious Diseases Society of America.  Clin Infect Dis. 2016;62:e1-e50.
  5. Chapman SW, Dismukes WE, Proia LA, et al. Clinical practice guidelines for the management of blastomycosis: 2008 update by the Infectious Disease Society of America. Clin Infec Dis. 2009;48:503-535.
  6. Wheat LJ, Freifeld AG, Lkeiman MB, et al.  Clinical practice guidelines for the management of patients with histoplasmosis:  2007 update by the Infectious Diseases Society of America. Clin Infect Dis. 2007;45:807-25.
  7. Criber BJ et al.  Long-term efficacy of antifungals in toenail onychomycosis:  a critical review.  British Journal of Dermatology. 2001;145:446-52.
  8. Haugh M et al.  Terbinafine in fungal infections of the nails:  a meta-analysis of randomized clinical trials. British Journal of Dermatology. 2002;147:118-121.
  9. Epstein E.  How often does oral treatment of toenail onychomycosis produce a disease-free nail.  Arch Dermatol. 1999;134:1551-4.
  10. Crawford F et al. Oral treatments for toenail onychomycosis. Arch Dermatol. 2002;138:811-6.
  11. \
  12. Westerberg, Dyanne, DO and Voyack, Michael DO. Onychomycosis: Current Trends in Diagnosis and Treatment. Am Fam Physician. 2013; 88 (11):762-770.
  13. Onmel prescribing information. Sebela Pharmaceuticals. November 2012.
  14. Jublia prescribing information. Valeant Pharmaceuticals North America, LLC. September 2016.
  15. Kerydin prescribing information. Pfizer Inc. July 2018. March 2015.
  16. Ameen M, Lear JT, Madan V, Mustapa MFM, M. Richardson.  British Association of Dermatologists’ guidelines for the management of onychomycosis 2014.  Br J Dermatol 2014; 171: 937-58.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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