Anti-Infectives 2017 Archives

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.

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   

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  

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®) 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

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®) 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  

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  

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  

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  

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