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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 500mg tablets
  • cephalexin 750mg capsule (Keflex® 750mg)
  • doxycycline hyclate delayed-release tablet (Doryx®)
  • doxycycline monohydrate extended-release 40mg capsule (Oracea®)
  • 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.

acyclovir buccal Tablets (Sitavig®) Approval Criteria:

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

 

Fluoroquinolones

PA Criteria 

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 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), Cedax® (Ceftibuten), and Spectracef® (Cefditoren) 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  

 

 Anthelmintics  

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

 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  

 
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  

Last Modified on Dec 29, 2020
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