Anti-Infectives

benznidazole Tablets Approval Criteria:  

• An FDA approved diagnosis of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi; AND
• Benznidazole must be prescribed by or in consultation with an infectious disease specialist; AND
• Female members of reproductive potential must have a pregnancy test prior to treatment with benznidazole; AND
• Female members of reproductive potential must be willing to use effective contraception during treatment with benznidazole tablets and for 5 days after the last dose; AND
• Member must not have taken disulfiram within the last two weeks; AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug. 
• The approval duration will be for 60 days of therapy. 
  
  
  

mebendazole (Emverm™) Approval Criteria:

• An FDA approved diagnosis of any of the following: 
  • Treatment of Enterobius vermicularis (pinworm); OR
  • Treatment of Trichuris trichiura (whipworm); OR
  • Treatment of Ascaris lumbricoides (common roundworm); OR
  • Treatment of Ancylostoma duodenale (common hookworm); OR
  • Treatment of Necator americanus (American hookworm); AND 
• For the treatment of Enterobius vermicularis (pinworms), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), or Necator americanus (American hookworm), a patient-specific, clinically significant reason why a more cost-effective anthelmintic therapy, such as albendazole or pyrantel pamoate, cannot be used must be provided. 
• The following quantity limits will apply:  
  • Enterobius vermicularis (pinworms): 2 tablets per 30 days 
  • Trichuris trichiura (whipworm): 6 tablets per 30 days 
  • Ascaris lumbricoides (common roundworm): 6 tablets per 30 days 
  • Ancylostoma duodenale (common hookworm): 6 tablets per 30 days 
  • Necator americanus (American hookworm): 6 tablets per 30 days 

miltefosine (Impavido®) Approval Criteria:

• An FDA approved indication for treatment of: 
  • Visceral leishmaniasis due to Leishmania donovani; OR
  • Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, or Leishmania panamensis; OR
  • Mucosal leishmaniasis due to Leishmania braziliensis; AND  
• Female members must not be pregnant and female members of reproductive potential must have a pregnancy test prior to therapy initiation. Female members of reproductive potential must be willing to use effective contraception while on therapy and for five months after completion of therapy; AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling.
• A quantity limit of 84 capsules per 28 days will apply. 

Prior Authorization form  

Suprax® (Cefixime) and Cedax® (Ceftibuten) Approval Criteria:

• Indicated diagnosis or infection known to be susceptible to requested agent; AND
• A patient-specific, clinically significant reason why the member cannot use cephalexin and cefdinir, or other cost effective therapeutic equivalent medication(s). 

Fetroja® (Cefiderocol) Approval Criteria:

• An FDA approved diagnosis of 1 of the following infections caused by designated susceptible microorganisms:
• a.     Complicated urinary tract infection (cUTI), including pyelonephritis; or
• b.     Hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP); and
• Member must be 18 years of age or older; and
• The prescriber must verify that limited or no alternative treatment options are available; and
• A patient-specific, clinically significant reason why the member cannot use an appropriate penicillin/beta-lactamase inhibitor combination (e.g., piperacillin/tazobactam), a carbapenem (e.g., ertapenem, meropenem, imipenem/cilastatin), a cephalosporin (e.g., ceftriaxone, ceftazidime), or other cost-effective therapeutic equivalent alternative(s) must be provided; and
• Approval quantity will be based on Fetroja® Prescribing Information and FDA approved dosing regimen(s).

 Prior Authorization form  

isavuconazonium sulfate (Cresemba®) Approval Criteria:

• An FDA approved diagnosis of one of the following:
  • Invasive aspergillosis 
  • Invasive mucormycosis 
• For the treatment of invasive aspergillosis, a patient-specific, clinically significant reason why voriconazole cannot be used must be provided. 

 Prior Authorization form  

PA Criteria

• An FDA approved indication for the treatment of toxoplasmosis; OR
• An FDA approved indication for the treatment of susceptible strains of acute malaria; AND
• Member must take Daraprim® concomitantly with a sulfonamide; AND
• Approval length will be based on recommended dosing regimen specific to the member’s diagnosis. 

 Prior Authorization form  

Erythromycin 2% Swabs and 2% Topical Gel Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use erythromycin 2% topical solution must be provided. 

Baxdela™ (Delafloxacin Injection and Tablets) Approval Criteria:

• An FDA approved diagnosis of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria; AND 
• A patient-specific, clinically significant reason why the member cannot use vancomycin, linezolid, doxycycline, trimethoprim/sulfamethoxazole, or other cost effective therapeutic equivalent alternative(s). 
• Approval quantity will be based on Baxdela™ prescribing information and FDA approved dosing regimen(s).
  • For Baxdela™ vials, an initial quantity limit of 6 vials for a 3-day supply will apply. Continued authorization will require a patient-specific, clinically significant reason why the member cannot switch to the oral tablets for the remainder of therapy.  

Baxdela® (Delafloxacin) Tablet and Vial Approval Criteria [Community-Acquired Bacterial Pneumonia (CABP) Diagnosis]:

• An FDA approved diagnosis of CABP caused by designated susceptible bacteria; AND
• A patient-specific, clinically significant reason why the member cannot use an appropriate beta-lactam (e.g., ceftriaxone, cefotaxime, ceftaroline, ertapenem, ampicillin/sulbactam) in combination with a macrolide (e.g., azithromycin, clarithromycin) or doxycycline, monotherapy with a respiratory fluoroquinolone (e.g., levofloxacin, moxifloxacin, gemifloxacin), or other cost-effective therapeutic equivalent alternative(s) must be provided; AND
• Approval quantity will be based on Baxdela® prescribing information and FDA approved dosing regimen(s); AND
  • For Baxdela® vials, an initial quantity limit of 6 vials for a 3-day supply will apply. Continued authorization will require a patient-specific, clinically significant reason why the member cannot switch to the oral tablets for the remainder of therapy. 

Ciprofloxacin 100mg Oral Tablets Approval Criteria:

• Approval requires a patient-specific, clinically significant reason why the member cannot use alternative strengths of ciprofloxacin tablets, levofloxacin tablets, moxifloxacin tables, or other cost effective therapeutic equivalent medication(s).

Ciprofloxacin 500mg and 1000mg Extended-Release Tablets Approval Criteria:

• Approval requires a patient-specific, clinically significant reason why the member cannot use the immediate-release formulation of ciprofloxacin tablets, levofloxacin tablets, moxifloxacin tablets, or other cost effective therapeutic equivalent medication(s).

Levofloxacin 25mg/mL oral solution, ciprofloxacin 250mg/mL oral suspension, and ciprofloxacin 500mg/mL oral suspension:

• Members older than six years of age would require a patient-specific, clinically significant reason why the oral tablet formulations cannot be used. 

Ofloxacin 300mg and 400mg Tablets Approval Criteria:

• Approval requires a patient-specific, clinically significant reason why the member cannot use ciprofloxacin tablets, levofloxacin tablets, moxifloxacin tabltes, or other cost effective therapeutic equivalent medication(s).

 Prior Authorization form  

PA Criteria

• FDA approved indication of systemic fungal infections with one of the following:
  • blastomycosis
  • coccidioidomycosis
  • histoplasmosis
    
  • chromomycosis
  • paracoccidioidomycosis; and
• Member is 3 years old or older; and
• Member does not have underlying hepatic disease; and
  
• Trials with other effective oral antifungal therapies, including fluconazole, itraconazole, and voriconazole, have failed to resolve infection; or
• Other effective oral antifungal therapies are not tolerated or potential benefits outweigh the potential risks; and 
• Hepatic function tests must be done at baseline and weekly during treatment. 
• A clinical exception may apply for members with a diagnosis of Cushing’s disease when other modalities are not available.   

 Prior Authorization form   

Kimyrsa™ (Oritavancin) Approval Criteria:

• An FDA approved indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by or suspected to be caused by susceptible isolates of designated gram-positive microorganisms; and
• Member must be 18 years of age or older; and
• The prescriber must verify that limited or no alternative treatment options are available; and
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use Orbactiv^® (oritavancin) or other cost-effective therapeutic equivalent alternative(s) must be provided; and
• Approval quantity will be based on Kimyrsa™ Prescribing Information and FDA approved dosing regimen(s).

Metronidazole 1% Gel Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use metronidazole 0.75% gel, which is available without prior authorization, must be provided; AND
• Metronidazole 1% gel is not covered for members older than 20 years of age.

Noritate^® (Metronidazole 1% Cream) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use metronidazole 0.75% cream, which is available without prior authorization, must be provided; AND
• Noritate^® is not covered for members older than 20 years of age.

posaconazole (Noxafil®) Approval Criteria:

• An FDA approved diagnosis of one of the following:
  • Prophylaxis of invasive Aspergillus and Candida infections in high-risk patients 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; OR
  • Treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole; OR  
• Treatment of invasive mucormycosis; OR
• Other appropriate diagnoses for which Noxafil® is not FDA approved may be considered with submission of a manual prior authorization; AND
• For the diagnosis of OPC, only the oral suspension may be used.

Prior Authorization form  

Approval Criteria:

• An FDA approved diagnosis of bacterial vaginosis in non-pregnant women; AND
• A patient-specific, clinically significant reason why the member cannot use MetroGel-Vaginal® 0.75% (metronidazole vaginal gel 0.75%) or the generic metronidazole oral tablet.

Prior Authorization form  

letermovir (Prevymis™) Approval Criteria:

• An FDA approved indication of prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogenic hematopoietic stem cell transplant (HSCT); AND      
• Member must be CMV R+; AND
• Member must have received a HSCT within the last 28 days; AND
• Members taking concomitant cyclosporine will only be approved for the 240mg dose; AND
• Members must not be taking the following medications:
  • Pimozide; OR
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine); OR
  • Rifampin; OR
  • Atorvastatin, lovastatin, pitavastatin, simvastatin, or repaglinide when co-administered with cyclosporine; AND  
• Prevymis™ must be prescribed by an oncology, hematology, infectious disease, or transplant specialist or advanced care practitioner with a supervising physician who is an oncology, hematology, infectious disease, or transplant specialist; AND
• Prescriber must verify the member will be monitored for CMV reactivation while on therapy; AND
• Approvals will be for the duration of 100 days post-transplant.
  • For Prevymis™ vials, authorization will require a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation; AND
  • Approval length for vial formulation will be based on duration of need. 
• A quantity limit of one tablet or vial per day will apply. 

 Prior Authorization form  

PA Criteria:

• An FDA approved diagnosis of 1 of the following infections caused by designated susceptible microorganisms:
  • Complicated intra-abdominal infection (cIAI); OR
  • Complicated urinary tract infection (cUTI), including pyelonephritis; AND 
• Member must be 18 years of age or older; AND
• The prescriber must verify that limited or no alternative treatment options are available; AND
• A patient-specific, clinically significant reason why the member cannot use an appropriate penicillin/beta lactamase inhibitor combination (e.g., piperacillin/ tazobactam), a carbapenem (e.g., ertapenem, meropenem, imipenem/cilastatin), a cephalosporin (e.g., ceftriaxone, ceftazidime) in combination with metronidazole, or other cost-effective therapeutic equivalent alternative(s) must be provided; AND
• A quantity limit of 56 vials per 14 days will apply. 

 Prior Authorization form  

PA Criteria

Sivextro™ (Tedizolid Phosphate) Tablet or Vial Approval Criteria:

• An indicated diagnosis or infection known to be susceptible to requested agent and resistant to the cephalosporin-class of antibiotics and other antibiotics commonly used for diagnosis or infection; AND
• A patient-specific, clinically significant reason why the member cannot use Zyvox® (linezolid), or other cost effective therapeutic equivalent medication(s).
• A quantity limit of six tablets or vials per six days will apply. 

Dalvance™ (Dalbavancin) Approval Criteria:

• An indicated diagnosis or infection known to be susceptible to requested agent and resistant to the cephalosporin-class of antibiotics and other antibiotics commonly used for diagnosis or infection; AND
• A patient-specific, clinically significant reason why the member cannot use vancomycin, Zyvox® (linezolid), or other cost effective therapeutic equivalent medication(s).
• A quantity limit of three vials per seven days will apply.

 Prior Authorization form    

Approval Criteria:

• An FDA approved diagnosis of bacterial vaginosis; AND
• A patient-specific, clinically significant reason why the member cannot use metronidazole, tinidazole, or other cost effective therapeutic equivalent alternative(s).
• A quantity limit of 1 packet per 30 days will apply. 

Prior Authorization form  

Oral Antibiotic Special formulation Prior Authorization Criteria:

• Member must have a patient specific, clinically significant reason why the immediate release formulation and/or other cost effective therapeutic equivalent medication(s) cannot be used.  
• The following oral antibiotics currently require prior authorization and the special formulation approval criteria will apply:
  • amoxicillin 500mg tablets
  • amoxicillin/clavulanate potassium extended-release tablet (Augmentin XR®)
  • cephalexin 250mg and 500mg tablets
  • cephalexin 750mg capsule (Keflex® 750mg)
  • doxycycline hyclate 75mg and 150mg tablets (Acticlate®)
  • doxycycline hyclate delayed-release tablet (Doryx®)
  • doxycycline monohydrate 150mg capsules and tablets
  • doxycycline monohydrate extended-release 40mg capsule (Oracea®)
  • minocycline ER tablets (Minolira™) 
  • minocycline extended-release tablet (Solodyn®) 
  • minocycline extended-release capsules (Ximino™)

PA Criteria:  

acyclovir 5% ointment (Zovirax®) Approval Criteria: BRAND Preferred

• An FDA approved indication of management of initial genital herpes or in limited non-life-threatening mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients; AND  
• A patient-specific, clinically significant reason why the member cannot use oral acyclovir, famciclovir, or valacyclovir tablets.
• Generic acyclovir 5% cream will require a patient-specific, clinically significant reason why the member cannot use the brand formulation. 

acyclovir 200mg/5mL suspension (Zovirax®) Approval Criteria:

• An age restriction of seven years and younger will apply.  Members older than seven years of age will require a patient-specific, clinically significant reason why a special formulation product is needed.  

acyclovir buccal Tablets (Sitavig®), acyclovir/hydrocortisone 5%/1% cream (Xerese®), and penciclovir 1% cream (Denavir®) Approval Criteria:

• An FDA approved diagnosis of recurrent herpes labialis (cold sores); AND
• A patient-specific, clinically significant reason why the member cannot use oral acyclovir, famciclovir or valacyclovir oral tablets; AND
• A patient-specific, clinically significant reason why the member cannot use acyclovir cream. 

amikacin liposome inhalation suspension (Arikayce®) Approval Criteria:

• An FDA approved indication for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options; AND
• Member must have had a minimum of 6 consecutive months of a multidrug background regimen therapy used compliantly and not achieved negative sputum cultures within the last 12 months. Dates of previous treatments and regimens must be listed on the prior authorization request; AND
  • If claims for a multidrug background regimen are not in the member’s claim history, the pharmacy profile should be submitted or detailed information regarding dates and doses should be included along with the signature from the prescriber; AND 
• Member must continue a multidrug background regimen therapy while on Arikayce®, unless contraindicated, or provide reasoning why continuation of a multidrug background regimen is not appropriate for the member; AND
• A patient-specific, clinically significant reason why the member requires an inhaled aminoglycoside in place of an intravenous or intramuscular aminoglycoside (e.g., amikacin, streptomycin) must be provided; AND
• Arikayce® will not be approved for patients with non-refractory MAC lung disease; AND
• Arikayce® must be prescribed by or in consultation with a pulmonary disease or infectious disease specialist (or be an advanced care practitioner with a supervising physician who is a pulmonary disease or infectious disease specialist); AND
• Initial approvals will be for the duration of 6 months after which time the prescriber must document the member is responding to treatment for continued approval.
• A quantity limit of 28 vials per 28 days will apply.   

ceftazidime/avibactam (Avycaz™) Approval Criteria:

• An FDA approved diagnosis of one of the following infections caused by designated susceptible microorganisms:
  • Complicated intra-abdominal infections (cIAI), used in combination with metronidazole; OR 
  • Complicated urinary tract infections (cUTI), including Pyelonephritis; AND
  • Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP); AND 
• Member must be 3 months of age or older; AND
• For the diagnosis of cIAI, Avycaz™ must be used in combination with metronidazole; AND
• A patient-specific, clinically significant reason why the member cannot use an appropriate penicillin-beta lactamase inhibitor combination (e.g. piperacillin-tazobactam), a carbapenem (e.g. ertapenem, meropenem, imipenem-cilastatin), a cephalosporin (e.g. ceftriaxone, ceftazidime) in combination with metronidazole, or other cost effective therapeutic equivalent medication(s).
• Approval quantity will be based on Avycaz® prescribing information and FDA approved dosing regimen(s). 
  
  

ceftolozane/tazobactam(Zerbaxa™)  Approval Criteria:

• An FDA approved diagnosis of one of the following infections caused by designated susceptible microorganisms:
  • Complicated intra-abdominal infections (cIAI), used in combination with metronidazole; OR
  • Complicated urinary tract infections (cUTI), including Pyelonephritis; AND 
  • Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP); AND
• Member must be 18 years of age or older; AND
• For the diagnosis of cIAI, Zerbaxa™ must be used in combination with metronidazole; AND
• A patient-specific, clinically significant reason why the member cannot use an appropriate penicillin-beta lactamase inhibitor combination (e.g. piperacillin-tazobactam), a carbapenem (e.g. ertapenem, meropenem, imipenem-cilastatin), a cephalosporin (e.g. ceftriaxone, ceftazidime) in combination with metronidazole, or other cost effective therapeutic equivalent medication(s).
• Approval quantity will be based on Zerbaxa® prescribing information and FDA approved dosing regimen(s).
  
  

eravacycline (Xerava™) Approval Criteria: 

• An FDA approved diagnosis of complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms; AND 
• Member must be 18 years of age or older; AND  
• A patient-specific, clinically significant reason why the member cannot use an appropriate penicillin/beta lactamase inhibitor combination (e.g., piperacillin/ tazobactam), a carbapenem (e.g., ertapenem, meropenem, imipenem/cilastatin), a cephalosporin (e.g., ceftriaxone, ceftazidime) in combination with metronidazole, or other cost-effective therapeutic equivalent alternative(s); AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling. 

 itraconazole oral tablets (Onmel®) Approval Criteria:

• An FDA approved diagnosis of onychomychosis of the toenail caused by Trichophyton rubrum or T. mentagrophytes; AND
• A patient-specific, clinically significant reason why itraconazole 100mg oral capsules cannot be used in place of Onmel® 200mg tablets. 

itraconazole capsule (Tolsura™) Approval Criteria:  

• An FDA approved indication of 1 of the following fungal infections in immunocompromised and non-immunocompromised adult patients:
  
  • Blastomycosis, pulmonary and extrapulmonary; OR
  • Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis; OR
  • Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy; AND
   
• A patient-specific, clinically significant reason why the member cannot use itraconazole 100mg capsules, which are available without prior authorization, must be provided.  

minocycline extended-release (Ximino™) Approval Criteria:

• An FDA approved diagnosis of inflammatory lesions of non-nodular moderate to severe acne vulgaris; AND 
• Member must be 12 years of age or older; AND 
• Ximino™ is not covered for members older than 20 years of age; AND 
• A patient-specific, clinically significant reason why the member cannot use the immediate-release capsule formulation or and/or other cost effective therapeutic equivalent medication(s). 

plazomicin (Zemdri™) Approval Criteria:

• An FDA approved diagnosis of complicated urinary tract infection (cUTI), including pyelonephritis, caused by designated susceptible microorganisms; AND 
• A patient-specific, clinically significant reason why the member cannot use an appropriate alternative aminoglycoside (e.g., gentamicin, tobramycin) or other cost-effective therapeutic equivalent alternative(s); AND 
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling.  

sarecycline (Seysara™) Approval Criteria:  

• An FDA approved diagnosis of inflammatory lesions of non-nodular, moderate-to-severe acne vulgaris; AND
• Member must be 9 years of age or older; AND
• Seysara™ is not covered for members older than 20 years of age; AND
• A patient-specific, clinically significant reason why the member cannot use minocycline, doxycycline, tetracycline, or other cost-effective therapeutic equivalent alternative(s); AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate strength according to package labeling; AND
• A quantity limit of 30 tablets per 30 days will apply.

tetracycline 250mg and 500mg Oral Capsules Approval Criteria:

• Approval requires a patient-specific, clinically significant reason why the member requires tetracycline and cannot use doxycycline or minocycline capsules and/or other cost effective therapeutic equivalent medication(s). 

Prior Authorization form   

PA Criteria

• An FDA approved diagnosis of complicated urinary tract infection (cUTI) or pyelonephritis; AND
• A patient-specific, clinically significant reason why the member cannot use piperacillin/tazobactam or other cost effective therapeutic equivalent alternative(s). 
• Approval quantity will be based on Vabomere™ prescribing information and FDA approved dosing regimen(s).

Prior Authorization form  

PA Criteria:

• An FDA approved diagnosis of community-acquired bacterial pneumonia (CABP) caused by designated susceptible microorganisms; AND
• Member must be 18 years of age or older; AND
• A patient-specific, clinically significant reason why the member cannot use an appropriate beta-lactam (e.g., ceftriaxone, cefotaxime, ceftaroline, ertapenem, ampicillin/sulbactam) in combination with a macrolide (e.g., azithromycin, clarithromycin) or doxycycline, or other cost-effective therapeutic equivalent alternative(s) must be provided; AND
• Approval quantity will be based on Xenleta™ prescribing information and FDA approved dosing regimen(s).  

 Prior Authorization form  

PA Criteria:

• An FDA approved diagnosis of osteoarthritis (OA) pain of the knee; AND
• Zilretta™ will only be approvable for use in the knee(s) for OA pain; AND
• A patient-specific, clinically significant reason why the member cannot use Kenalog-40® (triamcinolone acetonide 40mg injection) and Depo-Medrol® (methylprednisolone injection) must be provided.
• A quantity limit of 1 injection per knee per 12 weeks will apply.

 Prior Authorization form