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Anti-Infectives

Denavir® (Penciclovir Cream), Sitavig® (Acyclovir Buccal Tablets), and Xerese® (Acyclovir/Hydrocortisone Cream) 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 tablets must be provided; and
  • A patient-specific, clinically significant reason why the member cannot use acyclovir cream must be provided.; and
  • For penciclovir cream, a patient-specific, clinically significant reason why the member cannot use the brand formulation must be provided.

 

Livtencity® (Maribavir) Approval Criteria:

  • An FDA approved diagnosis of post-transplant cytomegalovirus (CMV) infection and disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet in adults and pediatric members (12 years of age and older weighing ≥35kg); and
  • A previously failed trial at least 14 days in duration with ganciclovir, valganciclovir, cidofovir, or foscarnet; and
  • Prescriber must verify the member does not have CMV disease involving the central nervous system including the retina (CMV retinitis); and
  • Prescriber must verify member will not receive concurrent treatment with ganciclovir and/or valganciclovir while taking Livtencity®; and
  • Prescriber must verify the member will be monitored for virologic failure during and after treatment with Livtencity®; and
  • Livtencity® 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 Livtencity® will not be used concomitantly with strong inducers of CYP3A4 (e.g., rifampin, rifabutin, St. John’s wort) except carbamazepine, phenobarbital, or phenytoin. Use of carbamazepine, phenobarbital, or phenytoin concomitantly with Livtencity® will require dose adjustment according to package labeling; and
  • Prescriber must agree to monitor drug concentrations of immunosuppressant drugs that are CYP3A4 and/or P-glycoprotein (P-gp) substrates (e.g., tacrolimus, cyclosporine, sirolimus, everolimus) throughout treatment with Livtencity® and adjust the dose of immunosuppressant drug(s) as needed; and
  • Approvals will be for a maximum duration of 8 weeks, and a quantity limit of 112 tablets per 28 days will apply.

 

Prevymis® (Letermovir Tablets, Oral Pellets, and Injection) Approval Criteria [Hematopoietic Stem Cell Transplant (HSCT) Diagnosis]:

  • An FDA approved indication of prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogenic HSCT; and
  • Member must be 6 months of age or older and weigh at least 6kg; and
  • Member must be CMV R+; and
  • Member must have received a HSCT within the last 28 days; and
    • If the member was previously started on Prevymis®, the date of the first dose must be provided; 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
  • For Prevymis® oral pellets, an age restriction will apply. The oral pellet formulation may be approvable for members 6 years of age and younger. Members 7 years and older must have a patient-specific, clinically significant reason why the member cannot use the Prevymis® tablet formulation; 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; and
  • Approvals may be extended to 200 days post-transplant if the member is at risk for developing a late CMV infection (the member’s risk factors must be provided); and
  • The following quantity limits will apply:
    • Tablets and vials for IV injection: 1 tablet or vial per day; or
    • Oral pellets:
      • 20mg: 4 packets per day; or
      • 120mg: 2 packets per day; and
      • For requests exceeding the quantity limit, additional information about why the member cannot use the oral tablet formulation must be provided.

 

Prevymis® (Letermovir Tablets, Oral Pellets, and Injection) Approval Criteria [Kidney Transplant Diagnosis]:

  • An FDA approved indication of prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients; and
  • Member must be 12 years of age or older and weigh at least 40kg; and
  • Member must be at high risk [i.e., donor CMV-seropositive/recipient CMV-seronegative (D+/R-)]; and
  • Member must have received a kidney transplant within the last 7 days; and
    • If the member was previously started on Prevymis®, the date of the first dose must be provided; 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
  • For Prevymis® oral pellets, member must have a patient-specific, clinically significant reason why the member cannot use the Prevymis® tablet formulation; and
  • Prevymis® must be prescribed by an oncology, hematology, infectious disease, or transplant specialist (or an 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 200 days post-transplant; and
    • 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; and
  • The following quantity limits will apply:
    • Tablets and vials for IV injection: 1 tablet or vial per day; or
    • Oral pellets:
      • 20mg: 4 packets per day; or
      • 120mg: 2 packets per day; and
      • For requests exceeding the quantity limit, additional information about why the member cannot use the oral tablet formulation must be provided.

 

Zovirax® (Acyclovir 5% Cream) Approval Criteria:

  • A patient-specific clinically signification reason why the member cannot use the following products, which are available without prior authorization, must be provided:
    • Oral acyclovir, famciclovir, or valacyclovir tablets.
    • Zovirax® (acyclovir ointment); and

Zovirax® (Acyclovir Suspension) Approval Criteria:

  • An age restriction of 7 years and younger will apply. Members older than 7 years of age will require a patient-specific, clinically significant reason why a special formulation product is needed.

Alinia® (Nitazoxanide Tablet) Approval Criteria:

  • An FDA approved indication for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum; and
  • Member must be 12 years of age or older; and
  • For Giardia, member must have a recent trial of metronidazole or tinidazole or a patient-specific, clinically significant reason why the member cannot use metronidazole and tinidazole must be provided; and
  • A quantity limit of 6 tablets per 3 days will apply.

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 

Daraprim® (Pyrimethamine) PA Criteria

  • An indication of 1 of the following:
    • Treatment of toxoplasmosis; or
    • Prophylaxis of Toxoplasma gondii encephalitis in members with human immunodeficiency virus (HIV); and
      • Member is Toxoplasma IgG seropositive; and
      • CD4 count is <100 cells/mm3 (or <200 cells/mm3 for secondary prophylaxis); and
      • A patient-specific, clinically significant reason why trimethoprim/sulfamethoxazole cannot be used must be provided; and
  • Member must take Daraprim® concomitantly with a sulfonamide (for treatment of toxoplasmosis) or with a guideline-recommended regimen (for Toxoplasma prophylaxis); and
  • Approval length will be based on recommended dosing regimen specific to the member’s diagnosis.

Lampit® (Nifurtimox) Approval Criteria:

  • An FDA approved diagnosis of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi; and
  • Member must be younger than 18 years of age and weigh ≥2.5kg; and
  • Lampit® must be prescribed by, or in consultation with, an infectious disease specialist; and
  • Prescriber must agree to counsel the member on the contraindication and potential drug interaction that may occur with concomitant use of Lampit® with alcohol, if applicable, based on the Lampit® Prescribing Information; and
  • Female members of reproductive potential must not be pregnant and must have a negative pregnancy test prior to initiating treatment with Lampit®; and
  • Female members of reproductive potential must be willing to use effective contraception during treatment with Lampit® and for 6 months after the last dose; and
  • Male members with female partners of reproductive potential must be willing to use condoms for contraception during treatment with Lampit® and for 3 months after the last dose; and
  • Prescriber must agree to monitor the member’s weight every 14 days and adjust the Lampit® dosage accordingly, as recommended in the Lampit® Prescribing Information; 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; and
  • Initial approvals will be for 30 days. For continuation of therapy after 30 days, an updated weight must be provided in order to authorize the appropriate amount of drug required for the remaining 30 days of treatment. The total approval duration will be for 60 days of treatment; and
  • A quantity limit of 270 tablets per 30 days will apply to the 30mg tablets, and a quantity limit of 225 tablets per 30 days will apply to the 120mg tablets.

Qualaquin® (Quinine Sulfate) Approval Criteria:

  • An FDA approved diagnosis of malaria; and
  • Off-label use for the prevention/treatment of leg cramps and other related conditions will not be covered.

Xdemvy™ (Lotilaner Ophthalmic Solution) Approval Criteria:

  • An FDA approved diagnosis of Demodex blepharitis; and
  • Member must be 18 years or older; and
  • Must be prescribed by an ophthalmologist or optometrist; and
  • Member must meet all of the following in at least 1 eye:
    • >10 lashes with collarettes present on the upper lid; and
    • Presence of at least mild erythema of the upper eyelid margin; and
  • Member must agree to remove artificial eyelashes (if present) and forego their use during treatment with Xdemvy™; and
  • A quantity limit of 10mL per 42 days will apply. Approvals will be limited to 1 treatment course per year.

Prior Authorization form  

Blujepa (Gepotidacin) Approval Criteria:

  • An FDA approved diagnosis of uncomplicated urinary tract infection (uUTI) caused by designated microorganisms (culture/sensitivity results must be submitted); and
  • Member must be a female 12 years of age or older and weigh ≥40kg; and
  • Member must have an estimated glomerular filtration rate (eGFR) >30mL/min/1.73m2) and must not be on dialysis; and
  • Member must not have severe hepatic impairment (Child Pugh C); and
  • Prior to and during treatment, the potential for drug interactions should be evaluated, including:
    • Avoid concomitant administration with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) or inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort); and
    • Avoid concomitant administration with CYP3A4 substrates with a narrow therapeutic index (e.g., quinidine, cyclosporine); and
    • Monitor digoxin serum concentrations as clinically indicated; and
    • Monitor for adverse effects with concomitant administration with acetylcholinesterase inhibitors, anticholinergic medications, or non-depolarizing neuromuscular blocking agents; and
  • Prescriber must verify that members with medical conditions that may be exacerbated by acetylcholinesterase inhibition will be monitored for adverse effects; and
  • If administration of Blujepa cannot be avoided in members with a history of QTc interval prolongation, taking antiarrhythmic medications, or taking other medications that may prolong the QTc interval, prescriber must verify that serum electrolyte abnormalities will be corrected and monitored and an ECG should be collected prior to administration and duration treatment, as clinically indicated; and
  • A patient-specific, clinically significant reason why the member cannot use an appropriate cost-effective, therapeutic alternative (e.g., nitrofurantoin, sulfamethoxazole/trimethoprim, fosfomycin) must be provided; and
  • A quantity limit of 20 tablets per 5 days will apply. 

Avycaz™ (Ceftazidime/Avibactam) Approval Criteria:

  • An FDA approved diagnosis of one of the following infections caused by designated susceptible microorganisms (culture/sensitivity results must be submitted):
    • 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 at least 31 weeks gestational age or older; AND
  • For the diagnosis of cIAI, Avycaz™ must be used in combination with metronidazole; OR
  • 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 when indicated, or other cost effective therapeutic equivalent medication(s).
  • Approval quantity will be based on Avycaz® prescribing information and FDA approved dosing regimen(s). 

Suprax® (Cefixime) 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).

Zerbaxa™ (Ceftolozane/Tazobactam) Approval Criteria:

  • An FDA approved diagnosis of one of the following infections caused by designated susceptible microorganisms (culture/sensitivity results must be submitted):
    • Complicated intra-abdominal infections (cIAI), used in combination with metronidazole; OR
    • Complicated urinary tract infections (cUTI), including Pyelonephritis; OR 
    • Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP); AND
  • For the diagnosis of HABP/VABP, 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 when indicated, or other cost effective therapeutic equivalent medication(s).
  • Approval quantity will be based on Zerbaxa® prescribing information and FDA approved dosing regimen(s).

 Prior Authorization form  

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.

Defencath® (Taurolidine/Heparin) Approval Criteria:

  • An FDA approved indication of reducing the incidence of catheter-related bloodstream infections (CRBSIs) in adult members with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC); and
  • Member must be 18 years of age or older; and
  • Must be used for prevention of CRBSIs; and
  • Prescriber must verify Defencath® is used only as a catheter lock solution (CLS) in CVCs and will not be administered systemically or used as a catheter lock flush product (i.e., it should be aspirated from the catheter and discarded prior to the next utilization of the CVC); and
  • Member must not have a known history of heparin-induced thrombocytopenia (HIT) or known hypersensitivity to pork products, taurolidine, heparin, or other components of Defencath®; and
  • A quantity limit of 2 vials per HD session or 24 vials per 28 days will apply; and
    • For requests exceeding the quantity limit, supporting documentation (e.g., HD schedule, number of CVC lumens, CVC lumen volumes) must be provided for a quantity limit override; and
  • Approvals will be granted for 1 year.

Emblaveo™ (Aztreonam/Avibactam) Approval Criteria:

  • An FDA approved diagnosis of complicated intra-abdominal infections (cIAI) caused by susceptible gram-negative microorganisms (e.g., Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, Serratia marcescens) in adults who have limited or no alternative treatment options (culture/sensitivity results must be submitted); and
  • Member must 18 years of age or older; and
  • 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, a fluoroquinolone (e.g., ciprofloxacin or levofloxacin) in combination with metronidazole, or other cost-effective therapeutic equivalent alternative(s) must be provided; and
  • A quantity limit of 57 vials per 14 days will apply. 

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; and
  • Member must be 20 years of age or younger.

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  

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
  • 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.

Nuzyra® (Omadacycline) Approval Criteria [Acute Bacterial Skin and Skin Structure Infection (ABSSSI) Diagnosis]:

  • An FDA approved diagnosis of ABSSSI 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 vancomycin, linezolid, doxycycline, trimethoprim/sulfamethoxazole, or other cost-effective therapeutic equivalent alternative(s) must be provided; and
  • Use of Nuzyra® vials will require a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation; and
  • Approval quantity will be based on package labeling and FDA approved dosing regimen(s).

Nuzyra® (Omadacycline) Approval Criteria [Community-Acquired Bacterial Pneumonia (CABP) Diagnosis]:

  • An FDA approved diagnosis of 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 package labeling and FDA approved dosing regimen(s).
    • For Nuzyra® vials, an initial quantity limit of 4 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 tablet formulation for the remainder of therapy.

PA Criteria:

  • An FDA approved diagnosis of 1 of the following infections caused by designated susceptible microorganisms (culture/sensitivity results must be submitted):
    • Complicated intra-abdominal infection (cIAI); OR
    • Complicated urinary tract infection (cUTI), including pyelonephritis; OR
    • Hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP); 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 when indicated, 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  

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.

Approval Criteria:

  • An FDA approved diagnosis of bacterial vaginosis or trichomoniasis; 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/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 50mg tablet (Targadox®)
    • doxycycline hyclate delayed-release tablet (Doryx®, Doryx® MPC))
    • doxycycline monohydrate 75mg capsules
    • doxycycline monohydrate 150mg capsules and tablets
    • doxycycline monohydrate extended-release 40mg capsule (Oracea®)
    • metronidazole 125mg tablets
    • metronidazole 375mg capsules
    • minocycline ER tablets (Minolira™) 
    • minocycline extended-release tablet (Solodyn®) 
    • Nitrofurantoin 50mg/5mL suspension

PA Criteria:  

Arikayce® (amikacin liposome inhalation suspension) 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.   

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; and
  • Member must be 20 years of age or younger.

Likmez™ (Metronidazole 500mg/5mL Suspension) Approval Criteria:

  • A patient-specific clinically significant reason (beyond convenience) must be provided regarding why the member cannot use the 250mg and 500mg tablets, which are available without prior authorization, including but not limited to:
    • Member is unable to swallow the oral tablet (i.e., has diagnosis characterized by difficulty or inability to swallow); or
    • Clinically indicated dose cannot be achieved with available tablet formulations; or
    • Treatment course was initiated inpatient; and
  • For members who require weight-based dosing, the member’s recent weight (within the last 3 months) must be provided on the prior authorization request; and
  • A quantity limit of 200mL per 10 days will apply.

Meropenem 2 Gram Vial Approval Criteria:

  • An FDA approved diagnosis of bacterial meningitis; and
  • Member must be 3 months of age or older; and
  • A patient-specific, clinically significant reason why the meropenem 1 gram or 500mg vials, which are available without a prior authorization, cannot be used must be provided.

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.

Minocycline (50, 75, 100mg) immediate-release 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).

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.

tetracycline 250mg and 500mg Oral Capsules and Tablet Approval Criteria:

  • For the capsule formulation, a quantity of 56 capsules for 14 days is available without a prior authorization for a diagnosis of Helicobacter pylori (H. pylori) infection; or
  • For the tablet formulation, approval requires a patient-specific, clinically significant reason why the member requires the tablet formulation and cannot use the capsule formulation, which is available without prior authorization; and
  • A quantity limit of 56 capsules or tablets per 14 days will apply; and
    • A quantity limit override for longer durations of therapy for indications other than for the eradication of H. pylori infection will require a patient specific, clinically significant reason why the member requires tetracycline and cannot use doxycycline, minocycline capsule, and/or other cost effective therapeutic equivalent medication(s).

Prior Authorization form   

Ancobon® (Flucytosine) Approval Criteria:

An FDA approved indication for treatment of systemic fungal infections (e.g., sepsis, endocarditis, urinary tract infection, meningitis, pulmonary) caused by strains of Candida or Cryptococcus. 

Brexafemme® (Ibrexafungerp) Approval Criteria:

  • An FDA approved diagnosis of vulvovaginal candidiasis (VVC); and
  • Member must be an adult female or a post-menarchal pediatric female; and
  • Prescriber must verify that female members are not pregnant and are currently using reliable contraception; and
  • Member must not be taking concurrent strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort, long-acting barbiturates, bosentan, efavirenz, etravirine); and
  • Authorization consideration requires a patient-specific, clinically significant reason why oral fluconazole and all topical antifungals (prescription and over-the-counter) FDA approved for the treatment of VVC are not appropriate for the member; and
  • A quantity limit of 4 tablets for a 1-day supply will apply.

Brexafemme® (Ibrexafungerp) Approval Criteria [Recurrent Vulvovaginal Candidiasis (RVVC) Diagnosis]:

  • An FDA approved indication to reduce the incidence of RVVC; AND
  • Member must be an adult female or post-menarchal pediatric female; AND
  • Member has a history of RVVC with at least 3 symptomatic episodes of acute vulvovaginal candidiasis (VVC) in the previous 12 months; AND
  • Member has experienced a recurrence of VVC during or following 6 months of fluconazole-only maintenance treatment for RVVC or member has a contraindication to fluconazole (e.g., hypersensitivity, drug-drug interactions); AND
  • Prescriber must verify member is not pregnant, not lactating, and is currently using reliable contraception and will continue to use throughout the treatment duration and 4 days after last dose; AND
  • Member must not be taking concurrent strong CYP3A inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin); AND
  • A quantity limit of 24 tablets per 180 days will apply.

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 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   

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 with product use as follows:
      • Delayed-release (DR) tablets: Adults and pediatric members 2 years of age and older who weigh >40kg; OR
      • Intravenous (IV) injection: Adults and pediatric members 2 years of age and older; OR
      • Oral suspension: Adults and pediatric members 13 years of age and older; OR
      • PowderMix for DR oral suspension: Pediatric members 2 years of age and older who weigh ≤40kg; OR
    • Treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric members 13 years of age and older with product use as follows:
      • For the treatment of OPC, including rOPC to itraconazole and/or fluconazole, only the oral suspension may be used; OR
    • Treatment of invasive aspergillosis in adults and pediatric members 13 years of age and older with product use as follows:
      • For the treatment of invasive aspergillosis, only the IV injection or DR tablets may be used; 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. 

Prior Authorization form  

Oravig® (Miconazole Buccal Tablets) Approval Criteria: 

  • An FDA approved diagnosis of oropharyngeal candidiasis in adult members 18 years of age and older; AND
  • Recent trials (within the last month) of the following medications at the recommended dosing and duration of therapy:
    • Clotrimazole troches; AND
    • Nystatin suspension; AND
    • Fluconazole tablets; OR
  • Contraindication(s) to all available alternative medications.

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. 

Vivjoa® (Oteseconazole) Approval Criteria:

  • An FDA approved indication to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC); AND
  • Member must be a female who is not pregnant, not lactating, and not of reproductive potential; AND
  • Member has a history of RVVC with at least 3 symptomatic episodes of acute vulvovaginal candidiasis (VVC) in the previous 12 months; AND
  • Member has experienced a recurrence of VVC during or following 6 months of fluconazole-only maintenance treatment for RVVC or member has a contraindication to fluconazole (e.g., hypersensitivity, drug-drug interactions); AND
  • Prescriber must verify member will be monitored if taking breast cancer resistance protein (BCRP) substrates (e.g., rosuvastatin, mitoxantrone, methotrexate, topotecan, imatinib, irinotecan); AND
  • A quantity limit of 18 capsules per 84 days will apply.

Rezzayo™ (Rezafungin Injection) Approval Criteria:

  • An FDA approved diagnosis of candidemia or invasive candidiasis; and
  • Member must be 18 years of age or older; and
  • Prescriber must verify that limited or no alternative treatment options are available; and
  • A patient-specific, clinically significant reason why the member cannot use anidulafungin, caspofungin, or micafungin, which are available without a prior authorization, must be provided; and
  • Member must not have endocarditis, osteomyelitis, or meningitis due to Candida; and
  • Must be administered by a health care provider in a setting that is appropriately equipped to administer Rezzayo™; and
  • A quantity limit of 5 vials for 28 days will apply; and
  • A limit of 4 weeks of treatment will apply. 

PA Criteria

  • An FDA approved diagnosis of complicated urinary tract infection (cUTI) or pyelonephritis (culture/sensitivity results must be submitted); 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  

Xerava™ (Eravacycline) 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.

Zemdri™ (plazomicin) 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.
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