Under some plans, including plans that use an open or closed formulary, Diflucan, Eraxis, fluconazole, itraconazole, Lamisil, Mycamine, Noxafil, Sporanox, terbinafine, Vfend and Vfend inj are subject to precertification. If precertification requirements apply Aetna considers Diflucan, Eraxis, fluconazole, itraconazole, Lamisil, Mycamine, Noxafil, Sporanox, terbinafine, Vfend and Vfend inj to be medically necessary for those members who meet ANY ONE of the following precertification criteria:
For Diflucan, fluconazole, itraconazole, Lamisil, Sporanox, terbinafine, Vfend and Vfend inj
Diflucan, fluconazole
Sporanox, itraconazole
Vfend
Lamisil, terbinafine
A. Onychomycosis†
Documented diagnosis confirmed by either a positive KOH stain (potassium hydroxide), positive PAS stain (para-aminosalicylic acid), or positive fungal culture
AND
One of the following:
Member is experiencing pain which limits normal activity OR,
Member has diabetes OR,
Member has an iatrogenically-induced or disease-associated immunosuppression, such as that due to AIDS, antirejection treatment for bone marrow or solid organ transplant, or chemotherapy for cancer OR,
Member has a systemic dermatosis with impaired skin integrity (e.g., pemphigus, ichthyosis) OR,
Member has a significant vascular compromise (peripheral)
AND
One of the following:
Contraindication to terbinafine (Lamisil) OR,
Intolerance to terbinafine (Lamisil) OR,
Failure of an adequate trial of 6 weeks of terbinafine (Lamisil) OR,
Presence of hepatic dysfunction or increased risk for liver disease OR,
Fungal culture indicating lack of sensitivity to terbinafine (Lamisil) OR,
Non-dermatophyte fungal infection (mixed infection, a mold or yeast infection)
AND
One of the following:
Contraindication to itraconazole (Sporanox) OR,
Intolerance to itraconazole (Sporanox) OR,
Failure of an adequate trial of 6 weeks of itraconazole (Sporanox)
X
X
X
X
X
(capsules ONLY)
X
(capsules ONLY)
X
(capsules ONLY)
X
X
†For onychomycosis, new courses of therapy should not be initiated until 32 weeks following the end of therapy unless infection is noted in a previously unaffected nail (since cure rate continues to increase through the 11th month following initiation of a 12 week course of therapy).
OR
B.Diagnosis of Blastomycosis
X
X
(capsules and injection ONLY)
OR
C.Diagnosis of Histoplasmosis
X
X
(capsules and injection ONLY)
OR
D. Diagnosis of Coccidioidomycosis (valley fever)
X
X
(capsules ONLY)
OR
E. Diagnosis of Coccidiomeningitis
X
X
(capsules ONLY)
OR
F. Diagnosis of Cryptococcus
X
OR
G. Diagnosis of Febrile neutropenia
X
X
(injection and oral solution ONLY)
OR
H. Diagnosis of systemic Candidiasis
X
OR
I. Diagnosis of Urinary tract infection or balanitis with candida
X
OR
J. Diagnosis of Vulvovaginal Candidiasis
X
OR
K. Diagnosis of Mastitis or a candidal infection of the breast (due to breast feeding/ oral thrush in the infant)
X
OR
L. Diagnosis of Oral (thrush), esophageal, intestinal candidiasis
X
OR
M. Diagnosis of Chronic cutaneous candidal infection
X
OR
N. Diagnosis of HIV/AIDS or cancer
X
X
X
OR
O. Diagnosis of Bone marrow transplant (using for prophylaxis)
X
OR
P. Diagnosis of Aspergillosis
X
(capsules and injection ONLY)
X
OR
Q. Diagnosis of Fusarium species
X
OR
R. Diagnosis of Scedosporium apiospermum
X
OR
S. Infection withCandida sp which is resistant to fluconazole/ Diflucan
1. Documented diagnosis of resistant Candida sp
AND
2. One of the following:
Failure of fluconazole/Diflucan (at least one week of therapy) OR
Laboratory evidence of fluconazole resistance
AND
3. NOT RECEIVING A CONTRAINDICATED MEDICATION -contraindicated medications can include: pimozide (Orap), quinidine, sirolimus (Rapamune), rifampin, carbamazepine, long-acting barbiturates (phenobarbital), rifabutin, ergot alkaloids (ergotamine and dihydroergotamine/ DHE-45), ritonavir, efavirenz
X
X
X
OR
T.Cutaneous dermatophyte infection
1. Documented diagnosis of cutaneous dermatophyte infection
AND
2. One of the following:
Contraindication to two covered alternatives (one of which should be topical) OR
Intolerance to two covered alternatives (one of which should be topical) OR
Failure of an adequate trial of two weeks each of two covered alternatives (one of which should be topical OR
Failure of an adequate trial of two weeks EACH of two oral formulary alternatives if a very large body surface area is being treated and treatment with a topical would be inadequate OR
Failure of covered oral terbinafine (Lamisil)
X
X
X
(capsules only)
X
(capsules only)
X
X
OR
U.Tinea capitis
1. Documented diagnosis of tinea capitis
AND
2. One of the following:
Contraindication to the covered alternative Lamisil OR
Intolerance to the covered alternative Lamisil OR
Failure of an adequate trial of two weeks of the covered alternative Lamisil OR
Member requires a liquid dosage form
X
X
X
(capsules and oral solution ONLY)
X
OR
V.Otitis externa
1. Documented diagnosis of otitis externa
AND
2. One of the following:
Contraindication to one covered topical alternative OR
Intolerance to one covered topical alternative OR
Failure of an adequate trial of one week of one covered topical alternative
X
X
OR
W. Diagnosis of Chronic Candidal Paronychia
1. Documented diagnosis of chronic candidal paronychia
AND
2. One of the following
Contraindication to one covered alternative (oral or topical ketoconazole) OR
Intolerance to one covered alternative (oral or topical ketoconazole) OR
Failure of an adequate trial of one course of one covered alternative (1 week oral ketoconazole OR 2 weeks topical ketoconazole)
X
X
OR
X. Diagnosis of tinea versicolor
1. Documented diagnosis of tinea versicolor
AND
2. One of the following
Contraindication to one covered alternative (oral or topical ketoconazole) OR
Intolerance to one covered alternative (oral or topical ketoconazole) OR
Failure of an adequate trial of one course of one covered alternative (1 week oral ketoconazole OR 2 weeks topical ketoconazole)
AND
3.One of the following
Contraindication to fluconazole single dose [400mg po one time] OR
Intolerance to fluconazole single dose [400mg po one time] OR
Failure to fluconazole single dose [400mg po one time]
X
X
X
(capsules and oral solution ONLY)
X
(capsules and oral solution ONLY)
X
(capsules and oral solution ONLY)
Under some plans, including plans that use an open or closed formulary, fluconazole and Diflucan may be subject to quantity limits.
Quantity Limits: According to the manufacturer, a single oral dose of Diflucan or fluconazole 150mg tablets is indicated for vaginal candidiasis. Diflucan or fluconazole can be dosed at interval(s) as indicated in the table below. A quantity of Diflucan or fluconazole 150mg tablets will be considered medically necessary as indicated in the table below.
Drug
Maximum Daily Dose/ Dosing Interval
Dosage Strength
Quantity Limits
Diflucan
fluconazole
Once daily
150 mg
Up to 1 tablet in 30 days
For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of fluconazole or Diflucan for those members who meet the following criterion:
Member has a diagnosis of vulvovaginal candidiasis, and has tried and failed one tablet of fluconazole/Diflucan 150mg (up to 2 tablets per 30 days can be approved) OR
Member has a diagnosis of recurrent (4 or more episodes per year) vulvovaginal candidiasis OR
Member has a diagnosis of vulvovaginal candidiasis complicated by antibiotic use or an immune compromised state such as HIV/AIDS, diabetes, cancer, or chronic corticosteroid use OR
Member has a diagnosis other than vulvovaginal candidiasis and meets precert criteria above and an appropriate dosing regimen cannot be achieved by using other strengths of fluconazole/Diflucan (50mg, 100mg, 200mg) OR
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
For Eraxis
A. A documented diagnosis of one of the following:
Treatment of Candidemia and other forms of Candida infections, such as intra-abdominal abscesses and peritonitis
Treatment of Esophageal Candidiasis
AND
B. A documented:
Contraindication to the covered generic alternative- fluconazole OR
Intolerance to the covered generic alternative- fluconazole OR
Allergy to the covered generic alternative- fluconazole OR
Failure of an adequate trial of 14 days of the covered generic alternative- fluconazole OR
Resistance has occurred or has been observed with fluconazole
For Mycamine
A. A documented diagnosis of one of the following:
Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation
Treatment of Esophageal Candidiasis
AND
B. A documented:
Contraindication to the covered generic alternative- fluconazole OR
Intolerance to the covered generic alternative- fluconazole OR
Allergy to the covered generic alternative- fluconazole OR
Failure of an adequate trial of 14 days of the covered generic alternative- fluconazole OR
Resistance has occurred or has been observed with fluconazole
For Noxafil
A. A documented diagnosis of :
prophylaxis of invasive Aspergillus and 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 hematopoietic stem cell transplant (HSCT) recipients with Graft versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy
Medical Exception Criteria
Bio-Statin, Diflucan, Grifulvin V, Mycelex troche, Nizoral, Noxafil, Sporanox caps and Vfend tabs/susp are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted. Aetna considers Bio-Statin, Diflucan, Grifulvin V, Mycelex troche, Nizoral, Noxafil, Sporanox caps and Vfend tabs/susp to be medically necessary for those members who meet any of the following criteria:
For Bio-Statin, Diflucan, Grifulvin V, Mycelex troche, Nizoral, Sporanox caps and Vfend tabs/susp
A or (B and C)
A. A documented:
Contraindication to one covered alternative agent indicated for the member's condition OR
Intolerance to one covered alternative agent indicated for the member's condition OR
Allergy to one covered alternative agent indicated for the member's condition OR
Failure of an adequate trial of one month of one covered alternative agent indicated for the member's condition
OR
B. Diagnosis of HIV/AIDS or cancer
AND
C. Transition of Coverage (Biostatin and Vfend tabs/susp ONLY ):
Member is within 90 days of his or her effective date of enrollment
Member is stable on Biostatin or Vfend tabs/susp for 30 days or longer
If applicable, quantity limits, age or gender edits will apply. Approval is valid one year from the date of request.
If the member has been a Medicare member for 91 days or longer standard precertification, step-therapy, or medical exception criteria will apply.
For Noxafil
A. A documented diagnosis of:
prophylaxis of invasive Aspergillus and 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 hematopoietic stem cell transplant (HSCT) recipients with Graft versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
Table A: Maximum time of approval for some indications
Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR 2002;51(No. RR-6):45-50.
Cohen AD, et.al. An independent comparison of terbinafine and itraconazole in the treatment of toenail onychomycosis. J Dermatolog Treat. 2003 Dec; 14(4): 237-42.
Crawford F, Young P, Godfrey C, et al. Oral treatment s for toenail onychomycosis. Arch Dermatol. 2002;138:811-16.
Darkes MJ, et. al. Terbinafine: a review of its use in onychomycosis in adults. Am J Clin Dermatol. 2003; 4(1): 39-65. Review.
De Punzio C - Fluconazole 150 mg single dose versus itraconazole 200 mg per day for 3 days in the treatment of acute vaginal candidiasis: a double-blind randomized study Eur J Obstet Gynecol Reprod Biol FEB-2003;
Denning DW, Ribaud P, Milpied N, et al. Efficacy and safety of voriconazole in the treatment of acute invasive aspergillosis. Clinical Infectious Diseases 2002;34:563-71.
Denning DW, Tucker RM, Hanson LH, Stevens DA. Treatment of invasive aspergillosis with itraconazole therapy in aspergillosis: study in 49 patients. J Am Acad Dermatol 1990;23:607-14.
Lesher JL. Pityriasis versicolor and candidiasis. American Academy of Dermatology. http://www.aad.org/education/pityriasis.htm. (Accessed January 2004).
McEvoy GK, editor. American Hospital Formulary Service First Professional Edition, (online) Bethesda, Maryland 2004.
Medical Economics, Inc., Physicians' Desk Reference,online. (Montvale, NJ: Medical Economics, 2004).
Olin BR, editor.Drug Facts and Comparisons (online version). St Louis: J.B.Lippincott Company, Facts and Comparisons division, 2004.
Thomson Micromedex USPDI; (online version thru statref).Montvale, NJ. 2003.
Pickering, Larry K. editor, Red Book:American Academy of Pediatrics 26th edition 2003 accessed via online statref.
Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults.Arch Intern Med. 2003;163:2716-24.
Zahn C, Sangl J, Bierman AS, et al.Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29
Sporanox Injection Product Information. Abbott Laboratories, Inc., North Chicago, IL. January 2004.
Cancidas Product Information. Merck and Co., Inc., Whitehouse Station, NJ. February 2005.
Eraxis Product Information. Pfizer, Inc., NY, NY. March 2006.
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.
Close Window
