Pharmacy Prior Authorization Criteria

Azole Antifungals - PA, NF

Indications for Prior Authorization

Cresemba (isavuconazonium sulfate) capsules

• For diagnosis of Treatment of Invasive Aspergillosis and Invasive Mucormycosis
  Indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adult and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater. Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Noxafil (posaconazole) tablets

• For diagnosis of Prophylaxis of Invasive Aspergillus Infection
  Indicated for the prophylaxis of invasive aspergillus infections in adult and pediatric patients 2 years of age and older who weigh greater than 40 kg, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

• For diagnosis of Prophylaxis of Invasive Candida Infection
  Indicated for the prophylaxis of invasive Candida infections in adult and pediatric patients 2 years of age and older who weigh greater than 40 kg, who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

• For diagnosis of Treatment of Invasive Aspergillosis
  Indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. [N]

Noxafil (posaconazole) oral suspension

• For diagnosis of Prophylaxis of Invasive Aspergillus Infection
  Indicated for the prophylaxis of invasive aspergillus infections in patients 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

• For diagnosis of Prophylaxis of Invasive Candida Infection
  Indicated for the prophylaxis of invasive Candida infections in patients 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

• For diagnosis of Oropharyngeal Candidiasis
  Indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients 13 years and older.

Noxafil PowderMix (posaconazole) for delayed-release oral suspension

• For diagnosis of Prophylaxis of Invasive Aspergillus Infection
  Indicated for the prophylaxis of invasive aspergillus infections in patients 2 years of age and older who weigh 40 kg or less, who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

• For diagnosis of Prophylaxis of Invasive Candida Infection
  Indicated for the prophylaxis of invasive Candida infections in patients 2 years of age and older who weigh 40 kg or less, who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Sporanox (itraconazole) capsules

• For diagnosis of Blastomycosis
  Indicated for the treatment of the blastomycosis, pulmonary and extrapulmonary, in immunocompromised and non-immunocompromised patients. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly.

• For diagnosis of Histoplasmosis
  Indicated for the treatment of histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, in immunocompromised and non-immunocompromised patients. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly.

• For diagnosis of Aspergillosis
  Indicated for the treatment of aspergillosis, pulmonary and extrapulmonary, in immunocompromised and non-immunocompromised patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly.

• For diagnosis of Toenail Onychomycosis
  Indicated for the treatment of onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium) in non-immunocompromised patients. Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.

• For diagnosis of Fingernail Onychomycosis
  Indicated for the treatment of onychomycosis of the fingernail due to dermatophytes (tinea unguium) in non-immunocompromised patients. Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.

Sporanox (itraconazole) oral solution

• For diagnosis of Oropharyngeal and Esophageal Candidiasis
  Indicated for the treatment of oropharyngeal and esophageal candidiasis.

Tolsura (itraconazole) capsules

• For diagnosis of Blastomycosis
  Indicated for the treatment of blastomycosis, pulmonary and extrapulmonary, in immunocompromised and non-immunocompromised patients. Limitations of Use: TOLSURA is not indicated for the treatment of onychomycosis. TOLSURA is NOT interchangeable or substitutable with other itraconazole products.

• For diagnosis of Histoplasmosis
  Indicated for the treatment histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis, in immunocompromised and non-immunocompromised patients. Limitations of Use: TOLSURA is not indicated for the treatment of onychomycosis. TOLSURA is NOT interchangeable or substitutable with other itraconazole products.

• For diagnosis of Aspergillosis
  Indicated for the treatment of aspergillosis, pulmonary and extrapulmonary, in immunocompromised and non-immunocompromised patients who are intolerant of or 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.

Vfend (voriconazole) oral suspension, Vfend (voriconazole) tablets

• For diagnosis of Invasive Aspergillosis
  Indicated for the treatment of adults and pediatric patients 2 years of age and older. In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus.

• For diagnosis of Candidemia and Candida Infection
  Indicated for the treatment of adults and pediatric patients 2 years of age and older with candidemia in non-neutropenic patients and other deep tissue Candida infections.

• For diagnosis of Esophageal Candidiasis
  Indicated for the treatment of adults and pediatric patients 2 years of age and older with esophageal candidiasis.

• For diagnosis of Scedosporiosis and Fusariosis
  Indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients 2 years of age and older intolerant of, or refractory to, other therapy.

Criteria

Cresemba oral capsule

Prior Authorization

Length of Approval: 6 Months [A, B]

• Diagnosis of one of the following fungal infections:
• Invasive aspergillosis
• Invasive mucormycosis
AND
• Both of the following:
• Patient is 6 years of age or older
• Patient weighs 16 kilograms or greater

Brand Sporanox capsules or generic itraconazole capsules

Prior Authorization

Length of Approval: 6 Months [A, C, D]
For diagnosis of Systemic Fungal Infections, Topical Fungal Infections (off-label)

• Diagnosis of a systemic fungal infection (e.g., aspergillosis, histoplasmosis, blastomycosis)
OR
• All of the following: [E]
• One of the following diagnoses:
• Tinea corporis (ring worm)
• Tinea cruris (jock itch)
• Tinea pedis (athlete's foot)
• Tinea capitis (scalp ringworm)
• Pityriasus versicolor
AND
• One of the following:
• The tinea infection is resistant to topical antifungal treatment
OR
• Trial and failure, contraindication, or intolerance to oral terbinafine

Brand Sporanox capsules or generic itraconazole capsules

Prior Authorization

Length of Approval: 5 Weeks [F]
For diagnosis of Fingernail Onychomycosis

• Diagnosis of fingernail onychomycosis as confirmed by one of the following:
• Positive potassium hydroxide (KOH) preparation
• Fungal culture
• Nail biopsy
AND
• The patient’s condition is causing debility or a disruption in their activities of daily living (e.g., limitations to manual dexterity, wearing shoes, or appropriately manicuring nails) [24]
AND
• Trial and failure (of a minimum 6-week supply), contraindication, or intolerance to oral terbinafine [23]

Brand Sporanox capsules or generic itraconazole capsules

Prior Authorization

Length of Approval: 3 Months [F]
For diagnosis of Toenail Onychomycosis

• Diagnosis of toenail onychomycosis as confirmed by one of the following:
• Positive potassium hydroxide (KOH) preparation
• Fungal culture
• Nail biopsy
AND
• The patient’s condition is causing debility or a disruption in their activities of daily living (e.g., limitations to manual dexterity, walking, standing, wearing shoes, or appropriately manicuring nails) [24]
AND
• Trial and failure (of a minimum 12-week supply), contraindication, or intolerance to oral terbinafine [23]

Brand Sporanox oral solution or generic itraconazole oral solution

Prior Authorization

Length of Approval: 1 Month [G]
For diagnosis of Candidiasis (Esophageal or Oropharyngeal)

• One of the following:
• Diagnosis of esophageal candidiasis
OR
• Diagnosis of oropharyngeal candidiasis (OPC)
AND
• One of the following: [G]
• Trial and failure, contraindication, or intolerance to fluconazole
• Susceptibility results demonstrate resistance to fluconazole

Tolsura

Prior Authorization

Length of Approval: 6 Months [A, C, D]

• Diagnosis of one of the following fungal infections:
• Blastomycosis
• Histoplasmosis
• Aspergillosis
AND
• Trial and failure or intolerance to generic itraconazole capsules

Brand Noxafil oral suspension or generic posaconazole oral suspension

Prior Authorization

Length of Approval: 1 Month [G]
For diagnosis of Oropharyngeal Candidiasis

• Diagnosis of oropharyngeal candidiasis (OPC)
AND
• Patient is 13 years of age or older
AND
• One of the following: [G]
• Trial and failure, contraindication, or intolerance to fluconazole
• Susceptibility results demonstrate resistance to fluconazole

Brand Noxafil oral suspension or generic posaconazole oral suspension

Non Formulary

Length of Approval: 1 Month [G]
For diagnosis of Oropharyngeal Candidiasis

• Submission of medical records (e.g., chart notes) confirming diagnosis of oropharyngeal candidiasis (OPC)
AND
• Patient is 13 years of age or older
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting one of the following: [G]
• Trial and failure, contraindication, or intolerance to fluconazole
• Susceptibility results demonstrate resistance to fluconazole

Brand Noxafil oral tablet, generic posaconazole oral tablet, Brand Noxafil oral suspension, generic posaconazole oral suspension, or Noxafil PowderMix

Prior Authorization

Length of Approval: 6 Months [H-J]
For diagnosis of Prophylaxis of Systemic Fungal Infections

• Used as prophylaxis of invasive fungal infections caused by one of the following:
• Aspergillus
• Candida
AND
• One of the following:
• For Noxafil (posaconazole) oral tablet, both of the following:
• Patient is 2 years of age or older
• Patient weighs greater than 40 kg
OR
• For Noxafil (posaconazole) oral suspension, patient is 13 years of age or older
OR
• For Noxafil PowderMix, both of the following:
• Patient is 2 years of age or older
• Patient weighs 40 kg or less
AND
• One of the following:
• Patient is at high risk of infections due to severe immunosuppression from one of the following conditions:
• Hematopoietic stem cell transplant (HSCT) with graft-versus-host disease (GVHD)
• Hematologic malignancies with prolonged neutropenia from chemotherapy
OR
• Patient has a prior fungal infection requiring secondary prophylaxis [J, 27]

Brand Noxafil oral tablet, generic posaconazole oral tablet, Brand Noxafil oral suspension, generic posaconazole oral suspension, or Noxafil PowderMix

Non Formulary

Length of Approval: 6 Months [H-J]
For diagnosis of Prophylaxis of Systemic Fungal Infections

• Submission of medical records (e.g., chart notes) confirming requested drug will be used as prophylaxis of invasive fungal infections caused by one of the following:
• Aspergillus
• Candida
AND
• One of the following:
• For Noxafil (posaconazole) oral tablet, both of the following:
• Patient is 2 years of age or older
• Patient weighs greater than 40 kg
OR
• For Noxafil (posaconazole) oral suspension, patient is 13 years of age or older
OR
• For Noxafil PowderMix, both of the following:
• Patient is 2 years of age or older
• Patient weighs 40 kg or less
AND
• Submission of medical records (e.g., chart notes) documenting one of the following:
• Patient is at high risk of infections due to severe immunosuppression from one of the following conditions:
• Hematopoietic stem cell transplant (HSCT) with graft-versus-host disease (GVHD)
• Hematologic malignancies with prolonged neutropenia from chemotherapy
OR
• Patient has a prior fungal infection requiring secondary prophylaxis [J, 27]

Brand Noxafil oral tablet or generic posaconazole oral tablet (off-label)

Prior Authorization

Length of Approval: 6 Months [A]
For diagnosis of Treatment of Systemic Fungal Infections [N]

• Diagnosis of invasive aspergillosis
AND
• Patient is 13 years of age or older

Brand Noxafil oral tablet or generic posaconazole oral tablet (off-label)

Non Formulary

Length of Approval: 6 Months [A]
For diagnosis of Treatment of Systemic Fungal Infections [N]

• Submission of medical records (e.g., medical records) confirming diagnosis of invasive aspergillosis
AND
• Patient is 13 years of age or older

Brand Vfend oral tablet, generic voriconazole oral tablet, Brand Vfend oral suspension, or generic voriconazole oral suspension

Prior Authorization

Length of Approval: 6 Months [A]
For diagnosis of Invasive Aspergillosis

• Diagnosis of invasive aspergillosis
AND
• Patient is 2 years of age or older

Brand Vfend oral tablet, generic voriconazole oral tablet, Brand Vfend oral suspension, or generic voriconazole oral suspension

Prior Authorization

Length of Approval: 6 Months [K]
For diagnosis of Serious Fungal Infections

• Diagnosis of a serious fungal infection (e.g., Scedosporium apiospermum, Fusarium species including Fusarium solani)
AND
• Patient is 2 years of age or older
AND
• Patient is intolerant of, or refractory to, other therapy (e.g., amphotericin B)

Brand Vfend oral tablet, generic voriconazole oral tablet, Brand Vfend oral suspension, or generic voriconazole oral suspension

Prior Authorization

Length of Approval: 1 Month [L]
For diagnosis of Candidemia in Non-Neutropenic Patients and Other Deep Tissue Candida Infections

• Diagnosis of one of the following:
• Candidemia
• Deep tissue Candida infection (e.g., disseminated in skin, infection in abdomen, kidney, bladder wall, and wounds)
AND
• Patient is non-neutropenic
AND
• Patient is 2 years of age or older
AND
• One of the following:
• Trial and failure, contraindication or intolerance to fluconazole [L]
• Susceptibility results demonstrate resistance to fluconazole [M]

Brand Vfend oral tablet, generic voriconazole oral tablet, Brand Vfend oral suspension, or generic voriconazole oral suspension

Prior Authorization

Length of Approval: 1 Month [G]
For diagnosis of Esophageal Candidiasis

• Diagnosis of esophageal candidiasis
AND
• Patient is 2 years of age or older
AND
• One of the following: [G]
• Trial and failure, contraindication, or intolerance to fluconazole
• Susceptibility results demonstrate resistance to fluconazole

P & T Revisions

2026-01-02, 2025-12-12, 2025-12-08, 2025-08-06, 2025-01-13, 2024-01-17, 2023-09-29, 2023-08-22, 2023-01-24, 2022-12-09, 2022-07-05, 2022-01-21, 2021-10-26, 2021-08-03, 2021-05-20, 2021-01-28, 2021-01-20, 2019-12-17, 2019-10-28

References

1. Cresemba Prescribing Information. Astellas Pharma US, Inc.; Northbrook, IL. April 2025.
2. Noxafil Prescribing Information. Merck Sharp & Dohme Corp.; Rahway, NJ. October 2024.
3. Sporanox Capsules Prescribing Information. Janssen Pharmaceuticals, Inc.; Titusville, NJ. December 2024.
4. Sporanox Oral Solution Prescribing Information. Janssen Pharmaceuticals, Inc.; Titusville, NJ. December 2024.
5. Tolsura Prescribing Information. Mayne Pharma Commercial LLC; Raleigh, NC. October 2024.
6. Vfend Prescribing Information. Roerig; New York, NY. March 2025.
7. Itraconazole Capsule Prescribing Information. Alembic Pharmaceuticals Inc.; Bedminster, NJ. March 2025.
8. Itraconazole Solution Prescribing Information. Camber Pharmaceuticals, Inc.; Piscataway, NJ. January 2025.
9. Posaconazole Prescribing Information. ENDO USA, Inc.; Malvern, PA. June 2024.
10. Voriconazole Tablet Prescribing Information. Zydus Lifesciences Limited.; Baddi, India. September 2025.
11. Voriconazole Powder for Suspension Prescribing Information. Camber Pharmacueticals Inc.; Piscataway, NJ. August 2025.
12. Posaconazole Tablet Prescribing Information. Lupin Pharmaceuticals, Inc.; Naples, FL. December 2025.
13. Patterson TF, Thompson GR, Denning DW, et al. Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016; 63(4):e1-e60.
14. Limper AH, Knox KS, Sarosi GA, et al; the American Thoracic Society Fungal Working Group. An official American Thoracic Society statement: Treatment of fungal infections in adult pulmonary and critical care patients. Am J Respir Crit Care Med. 2011; 183(1):96-128.
15. Cox GM, Kauffman CA, White N. Mucormycosis (zygomycosis). Wolters Kluwer. Last updated December 2, 2025. Available with subscription from: https://www.uptodate.com. Accessed December 3, 2025.
16. Chapman SW, Dismukes WE, Proia LA, et al. Clinical practice guidelines for the management of blastomycosis: 2008 update by the Infectious Diseases Society of America. Clin Infect Dis. 2008; 46(12):1801-1812.
17. Bradsher, Jr RW, Kauffman CA, Bogorodskaya M. Treatment of blastomycosis. Wolters Kluwer. Last updated April 24, 2025. Available with subscription from: https://www.uptodate.com. Accessed December 3, 2025.
18. Arnold SR, Spec A, Baddley JW, et al. 2025 clinical practice guideline update by the Infectious Diseases Society of America on histoplasmosis: Treatment of asymptomatic histoplasma pulmonary nodules (histoplasmomas) and mild or moderate acute pulmonary histoplasmosis in adults, children, and pregnant people. Clin Infect Dis. 2025; ciaf256.
19. Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: Histoplasmosis. National Institutes of Health, HIV Medicine Association, and Infectious Diseases Society of America. Last updated October 29, 2024. Available from: https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection. Accessed December 3, 2025.
20. Caplan AS, Gold JAW, Smith DJ, Ely JW. Diagnosis and management of tinea infections. Am Fam Physician. 2025; 112(4): 382-392.
21. Goldstein AO, Goldstein BG, Dellavalle RP, et al. Dermatophyte (tinea) infections. Wolters Kluwer. Last updated August 19, 2025. Available with subscription from: https://www.uptodate.com. Accessed December 3, 2025.
22. Goldstein BG, Goldstein AO, Dellavalle RP, et al. Tinea versicolor (pityriasis versicolor). Wolters Kluwer. Last updated January 2, 2025. Available with subscription from: https://www.uptodate.com. Accessed December 3, 2025.
23. Goldstein AO, Bhatia N, Dellavalle RP, et al. Onychomycosis Management. Wolters Kluwer. Last updated September 4, 2025. Available with subscription from: https://www.uptodate.com. Accessed December 8, 2025.
24. Gupta A, Mays R. The Impact of Onychomycosis on Quality of Life: A Systematic Review of the Available Literature. Skin Appendage Disord. 2018; 4(4):208-216.
25. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016; 62(4):e1-e50.
26. Neofytos D, Steinbach WJ, Hanson K, Carpenter PA, Papanicolaou GA, Slavin MA. American Society for Transplantation and Cellular Therapy Series, #6: Management of invasive candidiasis in hematopoietic cell transplantation recipients. Transplant Cell Ther. 2023; 29:222-227.
27. Per Clinical Consultation with an Infectious Disease Specialist. January 24, 2014.
28. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Prevention and Treatment of Cancer-Related Infections: Version 1.2025. https://www.nccn.org/professionals/physician_gls/pdf/infections.pdf. Accessed December 12, 2025.
29. Food and Drug Administration. Noxafil; NDA 205053. Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). US Dept of Health and Human Services. Accessed December 12, 2025. Available from: https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=205053#18561

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End Notes

1. The optimal duration of therapy for aspergillosis has not been defined. The Infectious Diseases Society of American (IDSA) recommend treatment duration of at least 6 to 12 weeks for invasive pulmonary aspergillosis, a minimum of 3 months for invasive tracheobronchial aspergillosis, and a minimum of 8 weeks, with longer courses longer than 6 months often needed, for extrapulmonary aspergillosis. Duration of therapy is guided by the severity and continuation of immunosuppression, as well as the extent of resolution of clinical disease and radiographic manifestations. [13]
2. The optimal duration of therapy for patients with mucormycosis is not precise nor well-established. Maintenance treatment of mucormycosis with posaconazole or isavuconazole often extends for months, as therapy should be continued until clinical signs, symptoms, and radiographic evidence of active disease have resolved, and predisposing conditions have been corrected. If immune function cannot be restored, patients may need extended courses of maintenance antifungal therapy, sometimes even for life. [14, 15]
3. The IDSA recommends a treatment duration range in treating blastomycosis, with a minimum duration of 6 months. The exact length of time that treatment should be continued beyond 6 months has not been studied. Treatment of blastomycosis should generally extend several months beyond the time of resolution of clinical symptoms and radiographic findings. Patients are often treated for 6 to 12 months; Children with severe/life-threatening blastomycosis should also be treated for at least 12 months. [16, 17]
4. The treatment duration of histoplasma infections vary depending on the site, severity, and duration of the illness, as well as the immune status of the patient. Mild to moderate histoplasma infections have a treatment duration range of 6 to 12 weeks, whereas immunocompromised patients can require treatment beyond 12 months. [18, 19]
5. Oral antifungals are second line to topical antifungals and are preferred in patients with extensive disease, lack of response to topical therapy, or hair follicle involvement. For tinea capitis and onychomycosis, oral terbinafine is usually the preferred option. Over time, emerging tinea infections have become more severe than classic tinea infections and may require prolonged oral antifungal therapy beyond the standard treatment ranging from 1 to 4 weeks. [20-22]
6. The itraconazole labeled dosing recommends a duration of treatment for onychomycosis of the toenails (with or without fingernail involvement) of 12 consecutive weeks and a duration of treatment for onychomycosis of the fingernails of 5 weeks (as 2 1-week long treatment pulses, separated by a 3-week itraconazole-free period). Pulse therapy for toenail onychomycosis consists of one week per month dosing for 3 consecutive weeks, and continuous therapy for fingernail onychomycosis is for a duration of 6 weeks. [3, 23, 24]
7. For fluconazole-refractory OPC, either itraconazole or posaconazole for up to 28 days is recommended. For fluconazole-refractory esophageal candidiasis, itraconazole or voriconazole for 14 to 21 days is recommended. [3, 5] Patients may be expected to relapse shortly after discontinuing therapy with Sporanox oral solution. Limited data on the safety of long-term use (> 6 months) of Sporanox Oral Solution are available at this time. [3, 25]
8. The IDSA strongly recommends posaconazole for allogeneic HSCT recipients with GVHD who are at high risk for invasive aspergillosis, with continuation of antifungal prophylaxis throughout the duration of immunosuppression in patients with chronic immunosuppression associated with GVHD. For lung transplant patients, voriconazole or itraconazole are recommended for prophylaxis of invasive aspergillosis for 3 to 4 months post-transplant. Triazoles like itraconazole, voriconazole, and posaconazole are preferred agents for prevention of invasive aspergillosis in most patients. [13]
9. Anti-Candida prophylaxis is indicated for all allogeneic HSCT recipients, starting with either conditioning or stem cell infusion and continuing until 75 to 100 days post-transplantation. Posaconazole is indicated in GVHD patients treated with corticosteroids at doses greater than or equal to 1 mg/kg/day, discontinued with symptom resolution and corticosteroid dose taper to less than 20 mg/day. Other agents used for Candida prophylaxis in HSCT recipients include fluconazole and voriconazole. [25, 26]
10. NCCN recommends secondary prophylaxis with an appropriate antifungal agent in patients with prior chronic disseminated candidiasis or with invasive filamentous fungal infection during subsequent cycles of chemotherapy or HSCT. In patients with invasive aspergillosis before HSCT, antifungal therapy for more than a month and resolution of radiologic abnormalities correlate with a lower likelihood of post-transplant recurrence of infection. Secondary prophylaxis with a mold-active agent is advised for the entire period of immunosuppression. Secondary prophylaxis is generally administered for the duration of immunosuppression. Per recommendation from an infectious disease specialist, posaconazole is used for secondary prophylaxis of prior fungal infections. [27, 28]
11. The exact dosing and duration of treatment for emerging, rare infections (e.g., scedosporosis, fusariosis) are not precise; thus, infectious disease experts should be consulted regarding these decisions. [14]
12. The IDSA strongly recommends fluconazole or echinocandins as initial therapy in nonneutropenic patients with candidemia. Voriconazole is effective for candidemia but offers little advantage over fluconazole as initial therapy. Recommended duration of therapy for candidemia without obvious metastatic complications is for 2 weeks after documented clearance of Candida species from the bloodstream and resolution of symptoms attributable to candidemia. Treatment recommendations for intra-abdominal candidiasis are similar to that of candidemia treatment, but duration of therapy is guided by level of source control and clinical response. Voriconazole prescribing information states that for candidemia in non-neutropenic patients and other deep tissue Candida infections, patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer. [10, 25]
13. For infection due to Candida glabrata, transition to higher-dose fluconazole or voriconazole should be considered, depending on susceptibility. Of the Candida species, C. krusei and C. glabrata are the two species with higher likelihood of fluconazole-resistance for serious candida infections due to widespread azole treatment. In these cases, voriconazole may be used as oral therapy in patients with infections due to C. krusei or fluconazole-resistant, voriconazole-susceptible C. glabrata infections. [25]
14. The FDA has designated orphan drug exclusivity (ODE-355) to Noxafil for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. The exclusivity is set to expire June 17, 2028. Thus, generic posaconazole tablets do not carry the indication of treatment of invasive aspergillosis. [12, 29]

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Revision History

• 2026-01-02: Annual Review 2026 - Increased approval durations for Sporanox/generic caps fingernail onychomycosis to 5 weeks and Noxafil/generic tab systemic fungal infections to 6 months. Added (posaconazole) to Noxafil ppx of systemic fungal infection age criterion 2.2 to specify criterion applies to both brand & generic. Updated voriconazole serious fungal infections diagnosis criterion from plural to singular. Updated to standard age verbiage. Added requirement for medical records for diagnosis in NF Noxafil criteria. Specified "off-label" for Sporanox caps/generic itraconazole caps for topical fungal infections & generic posaconazole for Tx of systemic fungal infections. Removed EHB formulary. Removed Sporanox Pulse Pak as product is obsolete. Background updates to references, indications, endnotes.
• 2025-12-12: GPI clean up. Added IL statute operational note. Background updates to align with current FDA labeling. No clinical criteria changes.
• 2025-12-08: Update attached products
• 2025-08-06: Addition of note for prophylaxis of system fungal infection criteria: "If criteria are not met for approval, review for off-label"
• 2025-01-13: 2025 UM Annual Review. No criteria changes. Background updates
• 2024-01-17: 2024 UM Annual Review. Updated age criteria for Cresemba based on expanded indication. Addition of posaconazole oral suspension to criteria. Background updates
• 2023-09-29: Addition of Cresemba 74.5mg capsules
• 2023-08-22: GPI clean up
• 2023-01-24: 2023 UM Annual Review. Updated NF criteria to require submission of medical records to align with NF SOP.
• 2022-12-09: Added new product, Noxafil Powdermix to guideline.
• 2022-07-05: Addition of NF criteria for Noxafil
• 2022-01-21: 2022 UM Annual Review.
• 2021-10-26: Added new PA criteria for Brand Vfend/generic voriconazole and Cresemba oral formulations, to be effective 1/1/2022.
• 2021-08-03: Added criteria for new Noxafil tablet indication.
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2021-01-28: Added new PA criteria for Noxafil (posaconazole) oral formulations.
• 2021-01-20: 2021 UM Annual Review.
• 2019-12-17: 2020 UM Annual Review. Removed Onmel criteria and product from list as RxClaims obsolete date is 02/21/2020. Updated references.
• 2019-10-28: Updated criteria for Nov 2019 P&T - SL - 10.28.19

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