|
Effective Date
|
Date of Origin
|
|
1/1/2024
|
|
FDA APPROVED INDICATIONS AND DOSAGE
|
Agent(s)
|
FDA Indication(s)
|
Notes
|
Ref#
|
|
ciclopirox
Topical solution
|
The treatment of onychomycosis of the toenail or fingernail (topical treatment in immunocompetent patients with mild to moderate onychomycosis without lunula involvement, due to Trichophyton rubrum)
|
|
3
|
|
Jublia®
(efinaconazole)
Topical solution
|
The topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
|
|
13
|
|
Kerydin®
(tavaborole)
Topical solution
|
The topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes
|
Available as a generic; designated target as determined by client
|
14
|
|
Sporanox®
(itraconazole)
Capsules
Oral solution
|
The treatment of blastomycosis, histoplasmosis, aspergillosis, onychomycosis of the toenail or fingernail
The treatment of oropharyngeal and esophageal candidiasis
|
Available as a generic; designated target as determined by client
|
1
|
|
terbinafine
Tablets
|
The treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium)
|
|
2
|
|
Tolsura®
(itraconazole)
Capsules
|
The treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients:
- Blastomycosis, pulmonary and extrapulmonary
- Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis
- Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
Limitations of use: Tolsura is not indicated for the treatment of onychomycosis. Tolsura is not interchangeable or substitutable with other itraconazole products
|
|
16
|
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
|
Esophageal candidiasis and candidemia
|
Infectious Diseases Society of America (IDSA) guidelines recommend fluconazole as the first line oral therapy for esophageal candidiasis and candidemia in nonneutropenic patients. Fluconazole is also recommended for prophylaxis against esophageal candidiasis in at risk patients. For patients with fluconazole-refractory disease, guidelines recommend itraconazole or voriconazole. Voriconazole has demonstrated effectiveness for both mucosal and invasive candidiasis, but offers little advantage over fluconazole as initial therapy. Its clinical use has been primarily for step-down oral therapy in patients with infection due to C. krusei and fluconazole-resistant, voriconazole-susceptible C. glabrata.(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 ciclopirox 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)
|
|
Safety
|
Sporanox capsules, Sporanox solution and Tolsura all carry a black box warning warning against their administration for the treatment of onychomycosis in patients with evidence of ventricular dysfunction. Tolsura can cause or exacerbate congestive heart failure. If signs or symptoms of CHF occur or worsen during administration of Tolsura, reassess the benefit-risk of continuing treatment.(1,16,17)
Terbinafine carries the following contraindication:
- Individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis.
Ciclopirox carries the following contraindication:
- Contraindicated in individuals who have shown hypersensitivity to any of its components
Sporanox carries the following contraindication:
- Should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
Tolsura carries the following contraindications:
- Co-administration of certain drugs that either affect metabolism of itraconazole or whose metabolism is affected by itraconazole.
- Hypersensitivity to itraconazole
|
REFERENCES
|
Number
|
Reference
|
|
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
|
Westerberg, Dyanne, DO and Voyack, Michael DO. Onychomycosis: Current Trends in Diagnosis and Treatment. Am Fam Physician. 2013; 88 (11):762-770.
|
|
12
|
Reference no longer used.
|
|
13
|
Jublia prescribing information. Bausch Health Companies, Inc. March 2022.
|
|
14
|
Kerydin prescribing information. Pfizer Inc. August 2018.
|
|
15
|
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.
|
|
16
|
Tolsura prescribing information. Mayne Pharma. December 2018.
|
|
17
|
Sporanox oral solution prescribing information. Janssen Pharmaceuticals, Inc. March 2019.
|
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
|
Target Brand Agent(s)
|
Target Generic Agent(s)
|
Strength
|
Targeted MSC
|
Available MSC
|
Final Age Limit
|
Preferred Status
|
|
Ciclopirox, Efinaconazole, Tavaborole Prior Authorization with Quantity Limit
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
M ; N ; O ; Y
|
Y
|
|
|
|
Jublia
|
efinaconazole soln
|
10 %
|
M ; N ; O ; Y
|
N
|
|
|
|
Kerydin
|
tavaborole soln
|
5 %
|
M ; N ; O ; Y
|
O ; Y
|
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
|
Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
QL Amount
|
Dose Form
|
Day Supply
|
Duration
|
Addtl QL Info
|
Allowed Exceptions
|
Targeted NDCs When Exclusions Exist
|
|
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
6.6
|
mLs
|
30
|
DAYS
|
|
|
|
|
Jublia
|
Efinaconazole Soln 10%
|
10 %
|
4
|
mLs
|
30
|
DAYS
|
|
|
|
|
Kerydin
|
Tavaborole Soln 5%
|
5 %
|
4
|
mLs
|
30
|
DAYS
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
|
Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
Client Formulary
|
|
Ciclodan
|
ciclopirox solution
|
8 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Jublia
|
efinaconazole soln
|
10 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Kerydin
|
tavaborole soln
|
5 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
CLIENT SUMMARY – QUANTITY LIMITS
|
Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
Client Formulary
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Jublia
|
Efinaconazole Soln 10%
|
10 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Kerydin
|
Tavaborole Soln 5%
|
5 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
|
Module
|
Clinical Criteria for Approval
|
|
CiclopiroxEfinaconazoleTavaborole
|
Jublia (efinaconazole), Kerydin (tavaborole), or ciclopirox will be approved when ALL of the following are met:
- The patient has a diagnosis of onychomycosis (tinea unguium) AND
- 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
- Treatment of the patient’s onychomycosis (tinea unguium) is medically necessary and not entirely for cosmetic reasons AND
- The fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture or nail biopsy) AND
- ONE of the following:
- The patient has tried and had an inadequate response to an oral antifungal agent OR
- The patient has an intolerance or hypersensitivity to an oral antifungal agent OR
- The patient has an FDA labeled contraindication to ALL oral antifungal agents OR
- The prescriber has provided information that an oral antifungal agent is not clinically appropriate AND
- If the requested agent is ciclopirox 8% topical solution; treatment will include removal of the unattached, infected nail(s) by an appropriate health care professional AND
- If the requested agent is a brand agent, ONE of the following:
- The patient’s medication history includes use of a generic antifungal onychomycosis agent (e.g., itraconazole, terbinafine, ciclopirox) in the past 90 days OR
- The patient has an intolerance or hypersensitivity to a generic antifungal onychomycosis agent OR
- The patient has an FDA labeled contraindication to ALL generic antifungal onychomycosis agents AND
- The patient does NOT have any FDA labeled contraindications to the requested agent
Length of Approval: 12 months
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
|
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
|
Module
|
Clinical Criteria for Approval
|
|
CiclopiroxEfinaconazoleTavaborole
|
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
- The requested quantity (dose) does NOT exceed than the program quantity limit OR
- ALL of the following:
- The requested quantity (dose) exceeds the program quantity limit AND
- The requested quantity (dose) does NOT exceed the maximum FDA labeled dose AND
- The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
- ALL of the following:
- The requested quantity (dose) exceeds the program quantity limit AND
- The requested quantity (dose) exceeds the maximum FDA labeled dose AND
- The prescriber has submitted information in support of therapy with a higher dose for the requested indication
Length of Approval: 12 months
|
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 Blue Cross and Blue Shield of Alabama’s 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.
|
Effective Date
|
Date of Origin
|
|
1/1/2024
|
|
FDA APPROVED INDICATIONS AND DOSAGE
|
Agent(s)
|
FDA Indication(s)
|
Notes
|
Ref#
|
|
ciclopirox
Topical solution
|
The treatment of onychomycosis of the toenail or fingernail (topical treatment in immunocompetent patients with mild to moderate onychomycosis without lunula involvement, due to Trichophyton rubrum)
|
|
3
|
|
Jublia®
(efinaconazole)
Topical solution
|
The topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
|
|
13
|
|
Kerydin®
(tavaborole)
Topical solution
|
The topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes
|
Available as a generic; designated target as determined by client
|
14
|
|
Sporanox®
(itraconazole)
Capsules
Oral solution
|
The treatment of blastomycosis, histoplasmosis, aspergillosis, onychomycosis of the toenail or fingernail
The treatment of oropharyngeal and esophageal candidiasis
|
Available as a generic; designated target as determined by client
|
1
|
|
terbinafine
Tablets
|
The treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium)
|
|
2
|
|
Tolsura®
(itraconazole)
Capsules
|
The treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients:
- Blastomycosis, pulmonary and extrapulmonary
- Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis
- Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
Limitations of use: Tolsura is not indicated for the treatment of onychomycosis. Tolsura is not interchangeable or substitutable with other itraconazole products
|
|
16
|
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
|
Esophageal candidiasis and candidemia
|
Infectious Diseases Society of America (IDSA) guidelines recommend fluconazole as the first line oral therapy for esophageal candidiasis and candidemia in nonneutropenic patients. Fluconazole is also recommended for prophylaxis against esophageal candidiasis in at risk patients. For patients with fluconazole-refractory disease, guidelines recommend itraconazole or voriconazole. Voriconazole has demonstrated effectiveness for both mucosal and invasive candidiasis, but offers little advantage over fluconazole as initial therapy. Its clinical use has been primarily for step-down oral therapy in patients with infection due to C. krusei and fluconazole-resistant, voriconazole-susceptible C. glabrata.(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 ciclopirox 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)
|
|
Safety
|
Sporanox capsules, Sporanox solution and Tolsura all carry a black box warning warning against their administration for the treatment of onychomycosis in patients with evidence of ventricular dysfunction. Tolsura can cause or exacerbate congestive heart failure. If signs or symptoms of CHF occur or worsen during administration of Tolsura, reassess the benefit-risk of continuing treatment.(1,16,17)
Terbinafine carries the following contraindication:
- Individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis.
Ciclopirox carries the following contraindication:
- Contraindicated in individuals who have shown hypersensitivity to any of its components
Sporanox carries the following contraindication:
- Should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
Tolsura carries the following contraindications:
- Co-administration of certain drugs that either affect metabolism of itraconazole or whose metabolism is affected by itraconazole.
- Hypersensitivity to itraconazole
|
REFERENCES
|
Number
|
Reference
|
|
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
|
Westerberg, Dyanne, DO and Voyack, Michael DO. Onychomycosis: Current Trends in Diagnosis and Treatment. Am Fam Physician. 2013; 88 (11):762-770.
|
|
12
|
Reference no longer used.
|
|
13
|
Jublia prescribing information. Bausch Health Companies, Inc. March 2022.
|
|
14
|
Kerydin prescribing information. Pfizer Inc. August 2018.
|
|
15
|
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.
|
|
16
|
Tolsura prescribing information. Mayne Pharma. December 2018.
|
|
17
|
Sporanox oral solution prescribing information. Janssen Pharmaceuticals, Inc. March 2019.
|
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
|
Target Brand Agent(s)
|
Target Generic Agent(s)
|
Strength
|
Targeted MSC
|
Available MSC
|
Final Age Limit
|
Preferred Status
|
|
Ciclopirox, Efinaconazole, Tavaborole Prior Authorization with Quantity Limit
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
M ; N ; O ; Y
|
Y
|
|
|
|
Jublia
|
efinaconazole soln
|
10 %
|
M ; N ; O ; Y
|
N
|
|
|
|
Kerydin
|
tavaborole soln
|
5 %
|
M ; N ; O ; Y
|
O ; Y
|
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
|
Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
QL Amount
|
Dose Form
|
Day Supply
|
Duration
|
Addtl QL Info
|
Allowed Exceptions
|
Targeted NDCs When Exclusions Exist
|
|
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
6.6
|
mLs
|
30
|
DAYS
|
|
|
|
|
Jublia
|
Efinaconazole Soln 10%
|
10 %
|
4
|
mLs
|
30
|
DAYS
|
|
|
|
|
Kerydin
|
Tavaborole Soln 5%
|
5 %
|
4
|
mLs
|
30
|
DAYS
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
|
Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
Client Formulary
|
|
Ciclodan
|
ciclopirox solution
|
8 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Jublia
|
efinaconazole soln
|
10 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
|
Kerydin
|
tavaborole soln
|
5 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
|
CLIENT SUMMARY – QUANTITY LIMITS
|
Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
Client Formulary
|
|
Ciclodan
|
Ciclopirox Solution 8%
|
8 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
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Jublia
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Efinaconazole Soln 10%
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10 %
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
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Kerydin
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Tavaborole Soln 5%
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5 %
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
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PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
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Module
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Clinical Criteria for Approval
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CiclopiroxEfinaconazoleTavaborole
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Jublia (efinaconazole), Kerydin (tavaborole), or ciclopirox will be approved when ALL of the following are met:
- The patient has a diagnosis of onychomycosis (tinea unguium) AND
- 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
- Treatment of the patient’s onychomycosis (tinea unguium) is medically necessary and not entirely for cosmetic reasons AND
- The fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture or nail biopsy) AND
- ONE of the following:
- The patient has tried and had an inadequate response to an oral antifungal agent OR
- The patient has an intolerance or hypersensitivity to an oral antifungal agent OR
- The patient has an FDA labeled contraindication to ALL oral antifungal agents OR
- The prescriber has provided information that an oral antifungal agent is not clinically appropriate AND
- If the requested agent is ciclopirox 8% topical solution; treatment will include removal of the unattached, infected nail(s) by an appropriate health care professional AND
- If the requested agent is a brand agent, ONE of the following:
- The patient’s medication history includes use of a generic antifungal onychomycosis agent (e.g., itraconazole, terbinafine, ciclopirox) in the past 90 days OR
- The patient has an intolerance or hypersensitivity to a generic antifungal onychomycosis agent OR
- The patient has an FDA labeled contraindication to ALL generic antifungal onychomycosis agents AND
- The patient does NOT have any FDA labeled contraindications to the requested agent
Length of Approval: 12 months
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
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QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
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Module
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Clinical Criteria for Approval
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CiclopiroxEfinaconazoleTavaborole
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Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
- The requested quantity (dose) does NOT exceed than the program quantity limit OR
- ALL of the following:
- The requested quantity (dose) exceeds the program quantity limit AND
- The requested quantity (dose) does NOT exceed the maximum FDA labeled dose AND
- The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
- ALL of the following:
- The requested quantity (dose) exceeds the program quantity limit AND
- The requested quantity (dose) exceeds the maximum FDA labeled dose AND
- The prescriber has submitted information in support of therapy with a higher dose for the requested indication
Length of Approval: 12 months
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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 Blue Cross and Blue Shield of Alabama’s 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.
Commercial _ PS _ Topical Antifungals, itraconazole, terbinafine _PAQL _ProgSum_ 1/1/Commercial _ PS _ Topical Antifungals, itraconazole, terbinafine _PAQL _ProgSum_ 1/1/2024
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