Anti-Infectives

 

Special Formulation

Special formulation Prior Authorization Criteria


Consideration will be based on ALL of the following 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.  
  • amoxicillin 500mg tablets
  • amoxicillin/clavulanate potassium extended-release tablet (Augmentin XR®)
  • amoxicillin extended release 775mg tablet (Moxatag®)
  • cephalexin 250mg and 500mg tablets
  • cephalexin 750mg capsule (Keflex® 750mg)
  • doxycycline hyclate delayed-release tablet (Doryx®)
  • doxycycline monohydrate extended-release 40mg capsule (Oracea®)
  • Minocycline ER tablets (Minolira™) 
  • minocycline extended-release tablet (Solodyn®) 
  • minocycline hcl 50mg, 75mg, 100mg tablets

PA Criteria:  

doxycycline monohydrate immediate-release 75mg capsules, 150mg capsules, and 150mg tablets Approval Criteria:

  • Member must have a patient specific, clinically significant reason why the hyclate formulation cannot be used.

doxycycline hyclate (Acticlate®) 75mg capsules Oral Antibiotic Special Formulation Approval 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. 

 

acyclovir 5% ointment (Zovirax®) Approval Criteria:

  • 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.

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.

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
     
  • Member must be 18 years 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 carbapenam (e.g. ertapenem, meropenem, imipenem-cilastatin), a cephalosporin (e.g. ceftriaxone, ceftazidime) in combination with metronidazole, or other cost effective therapeutic equivalent medication(s).
  • A quantity limit of 42 vials per 14 days will apply.

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
     
  • 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 carbapenam (e.g. ertapenem, meropenem, imipenem-cilastatin), a cephalosporin (e.g. ceftriaxone, ceftazidime) in combination with metronidazole, or other cost effective therapeutic equivalent medication(s).
  • A quantity limit of 42 vials per 14 days will apply.

 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.

 minocycline Tablets Approval Criteria:

  • Approval requires a patient-specific, clinically significant reason why the member requires the immediate-release tablet formulation and cannot use the immediate-release capsule formulation and/or other cost effective therapeutic equivalent medication(s).

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   

 

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Fluoroquinolones

PA Criteria 

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. 
     

Ciprofloxacin 100mg Oral Tablets Approval Criteria:

  • Approval requires a patient-specific, clinically significant reason why the member cannot use alternative strengths of ciprofloxacin tablets or levofloxacin tablets and/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, and/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 and Moxifloxacin 400mg Oral Tablets Approval Criteria:

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

 Prior Authorization form  

 Cephalosporins 

PA Criteria

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).

 Prior Authorization form  

 

 

isavuconazonium sulfate (Cresemba®)

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  

Ketoconazole Oral Tablets 

PA Criteria

1. FDA approved indication of systemic fungal infections with one of the following:

        a. blastomycosis
        b. coccidioidomycosis
        c. histoplasmosis
        d. chromomycosis
        e. paracoccidioidomycosis; and


2. Member is 3 years old or older; and
3. Member does not have underlying hepatic disease; and
4. Trials with other effective oral antifungal therapies, including fluconazole, itraconazole, and voriconazole, have failed to resolve infection; or
5. Other effective oral antifungal therapies are not tolerated or potential benefits outweigh the potential risks; and 
6.
Hepatic function tests must be done at baseline and weekly during treatment. 
7. A
 clinical exception may apply for members with a diagnosis of Cushing’s disease when other modalities are not available.  

 

 Prior Authorization form   



posaconazole (Noxafil®)

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  

 

 Anti-Parasitic 

albendazole (Albenza®) Approval Criteria:

  • A quantity of six tablets per 180 days will process without prior authorization. For infections requiring additional doses, a prior authorization will need to be submitted and the following criteria will apply:
    • An FDA approved diagnosis of one of the following:
      • Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.
      • Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

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  

metronidazole vaginal gel 1.3% (Nuvessa™ )

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  

         

secnidazole oral granules (Solosec™ )

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  

 

pyrimethamine (Daraprim®)  

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  

 

Skin and Soft Tissue Infection (SSTI) Antibiotics

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.

Orbactiv™ (Oritavancin) 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 30 days will apply.
     

 Prior Authorization form  

 

                

letermovir (Prevymis™)

letermovir (Prevymis™) Approval Criteria:

  • Member must be cytomegalovirus (CMV)-seropositive [R+]; AND
  • Member must have received an allogeneic hematopoietic stem cell transplant (HSCT); AND
  • Members taking concomitant cyclosporine will only be approved for the 240mg dose; AND
  • Members must not be taking the following medications:
    • Pimozide; AND
    • Ergot Alkaloids (e.g., ergotamine, dihydroergotamine); AND
    • Atorvastatin, lovastatin, pitavastatin or simvastatin when co-administered with cyclosporine; AND
    • Rifampin; AND
  • Approvals will be for the duration of 100 days post-transplant; AND
  • A quantity limit of one tablet or vial per day will apply. 

 Prior Authorization form  

meropenem/vaborbactam injection (Vabomere™)

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  

 

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