Drug Class Prior Authorization Criteria Intravenous Antibiotics

Transcription

1 Drug Class Prior Authorization Criteria Intravenous Antibiotics Line of Business: Medicaid P&T Approval Date: August 15, 2018 Effective Date: October 1, 2018 This drug class prior authorization criteria have been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutic Subcommittee. CRITERIA: Antibiotic at long term care is considered medically necessary when all the following are met: Covered Uses: Exclusion Criteria: Required Medical Information: Age Restrictions: Prescriber Restrictions: Other Criteria: a. See antibiotic guide below for common indication(s) b. For requested indication(s) not listed below, please consult IEHP pharmacist N/A Must meet all of the following requirements: a. Documentation of culture and sensitivity report has been ordered b. No documentation of allergy to the requested antibiotic. N/A N/A Reauthorization Criteria: Documentation of clinical assessment and medical justification for extending duration of therapy

2 Antibiotic Guide (Common Indications & Species): Note: Below guide only provides common indications and species. For requested indication not listed below, please consult clinical pharmacist. Drug Ampicillin- Sulbactam (Unasyn) Common Indications & Species o Skin and skin structure infection (e.g. cellulitis) o Intra-abdominal infection Common susceptible species: Staphylococcus aureus (methicillinsusceptible strains), H. Influenzae, E. Coli, Klesiella, anaerobes Ceftazidime (Fortaz, Tazicef) o Bacterial septicemia o Bone and joint o CNS (e.g. meningitis) o Empiric therapy in the immunocompromised patient o Gynecologic (e.g. treatment of endometritis, pelvic cellulitis, and other of the female genital tract) o Skin and skin structure (e.g. cellulitis, cutaneous abscess, ischemic/diabetic foot infection) o Urinary tract (e.g. complicated UTI) Common susceptible species: Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible strains), Enterobacter spp, Neisseria meningitidis, Proteus mirabilis, Serratia spp Cefotaxime (Claforan) o Bacteremia or septicemia o Bone or joint o CNS (e.g. meningitis) o Genitourinary (e.g. urinary tract, uncomplicated gonorrhea) o Gynecologic (e.g. pelvic inflammatory disease, endometritis, and pelvic cellulitis) o Skin and skin structure (e.g. cellulitis) Common susceptible species: Escherichia coli, Serratia marcescens, Staphylococcus aureus (methicillin-susceptible strains), Streptococcus species (including Streptococcus pneumoniae), Neisseria meningitidis, Haemophilus influenzae, Klebsiella pneumoniae, and Enterococcus species

3 Ceftriaxone (Rocephin) o Bacteremia or septicemia o CNS (e.g. meningitis) o Genitourinary (e.g. urinary tract, uncomplicated gonorrhea) o Gynecologic (e.g. pelvic inflammatory disease) o Skin and skin structure (e.g. cellulitis) Common susceptible species: Escherichia coli, Serratia marcescens, Staphylococcus aureus (methicillin-susceptible strains), Streptococcus species (including Streptococcus pneumoniae), Neisseria meningitidis, Haemophilus influenzae, S. pneumoniae, Klebsiella pneumoniae, and Enterococcus species, N. gonorrhoeae Cefepime (Maxipime) o Febrile neutropenia o Skin and skin structure (e.g. cellulitis, cutaneous abscess, ischemic/diabetic foot infection) o Urinary tract (including pyelonephritis) Common susceptible species: Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Proteus mirabilis Ceftaroline (Teflaro) o Community acquired pneumonia o Skin and skin structure Common susceptible species: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli Daptomycin (Cubicin) o Skin and skin structure o S. aureus bacteremia o Endocarditis Common susceptible species: Staphylococcus aureus (methicillinsusceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis

4 Imipenem and Cilastatin (Primaxin) o Bacterial septicemia o Bone and joint o Endocarditis o Gynecologic o Skin and skin structure o Urinary tract Common susceptible species: Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing), Escherichia coli, Klebsiella species, Pseudomonas aeruginosa, Serratia species, Enterobacter species, Bacteroides species (including Bacteroides fragilis), Streptococcus species (e.g. group B streptococci), Proteus species, Morganella morganii, Citrobacter species, Haemophilus influenzae, Acinetobacter species Linezolid (Zyvox) o Skin and skin structure (e.g. cellulitis, ischemic/diabetic foot infection) o Vancomycin-resistant Enterococcal (e.g. bacteremia) Common susceptible species: Enterococcus faecium (including vancomycinresistant strive), Streptococcus pneumoniae (including multi-drug resistant strain), S. aureus (methicillin-susceptible and resistant isolates) Meropenem (Merrem) o Bacterial meningitis o Complicated skin and skin structure o Intra-abdominal (e.g. complicated appendicitis and peritonitis) Common susceptible species: Staphylococcus aureus (methicillinsusceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycinsusceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species

5 Piperacillin- Tazobactam (Zosyn) o Intra-abdominal (e.g. appendicitis complicated by rupture or abscess and peritonitis) o Pelvic (e.g. postpartum endometriosis, pelvic inflammatory disease) o Skin and skin structure (cellulitis, cutaneous abscess, ischemic/diabetic foot infection) Common susceptible species: Beta-lactamase-producing strains of E coli and H. influenzae, Pseudomonas aeruginosa, S. aureus (methicillin-susceptible strains), K. pneumoniae, Acinetobacter 5alumni, Bacteroides fragilis Vancomycin (Vancocin) Susceptible Staphylococcal (e.g. septicemia, bone, lower respiratory tract, skin and skin structure ) Endocarditis Common susceptible species: Staphylococcus aureus (including methicillinresistant strains), Streptococcus spp including Streptococcus viridans and Streptococcus bovis; enterococci (eg. Enterococcus faecalis) Antibiotic Guide (Length of Therapy): Usual Length of Therapy Bacterial septicemia 7-10 days Longer courses may be warranted for patients who have a slow clinical response, an undrainable focus of infection, endocarditis, osteomyelitis, large abscesses, neutropenia, immunocompromised condition (please consult clinical pharmacist) Bone and joint Osteomyelitis: usually at least 6 weeks from the last debridement (please consult clinical pharmacist) Prosthetic joint infection: 4-6 weeks Catheter-related 7-14 days (cathether removal is preferred) bloodstream Cellulitis 5-7 days Diabetic foot Duration will depend on rapidity of response and presence of adequate blood supply. Usually 7-10 days after adequate surgical intervention. Longer therapy is warranted for osteomyelitis (please consult clinical pharmacist)

6 Endocarditis 6 weeks (uncomplicated) Longer courses may be warranted for patients who have perivalvular abscess, metastatic complication, poor controlled diabetes (please consult clinical pharmacist) Meningitis 7-21 days Peritonitis Primary peritonitis/spontaneous bacterial peritonitis (SBP): 5 days Secondary peritonitis (e.g. GI perforation): 4 days (complicated) Peritonitis related to peritoneal dialysis: days Pelvic Inflammatory 14 days Disease Pneumonia 3-14 days Urinary tract 3-14 days Glossary Antiretroviral therapy: Multiple medications taken to help treat HIV Atypical bacteria: Chlamydia, Bacteremic: presence of bacteria in the blood Bone Infections: osteomyelitis CD4 cells: white blood cells that help fight infection Culture and Sensitivity Tests: a test to find which specific bacteria and fungus are in a certain sample (e.g. blood, mucus, spinal fluid, etc.) and tells you if a certain antibiotic will work against the certain organism found in the sample Cutaneous : skin, e.g. Furuncle, Carbuncle, Abscess Debridement: removal of debris and damaged tissue from the wound Directly observed therapy: Treatment involving directly observing patients taking their antituberculous drugs. Empiric therapy: therapy begun on the basis of a clinical educated guess in the absence of complete or perfect information (such as culture and sensitivity tests or an unknown diagnosis); treatment based on experience, without knowing specifics about the disease Febrile: involving a fever Hematopoietic Stem Cell: Stem cells that turn into other types of blood cells Immunocompetent: well functioning immune system Immunocompromised: impaired immune system Induction: First phase of treatment Intra-abdominal : peritonitis, intra-abdominal abscess, diverticulitis, appendicitis, cholangitis, cholecystitis, peptic ulcer disease Intrathecal: An injection into the spinal canal so it reaches the cerebrospinal fluid Joint Infections: prosthetic joint infection, bacterial/septic arthritis Loading dose: An initial large dose before giving a lower maintenance dose Metastatic: spread of cancer to other parts of the body Monotherapy: when an antibiotic is used alone and with no other antibiotics

7 Glossary (cont ) Neutropenic: having low neutrophil count. A neutrophil is a type of white blood cell. Oropharyngeal candidiasis: Candida infection of the mouth Perioperative: the time before, during, and after an operation Peritonitis: Inflammation of the peritoneum, which lines the abdominal organs Polymicrobial: infection caused by more than one type of bacteria Primary prophylaxis: Treatment to prevent first episode of a disease Prophylaxis: antibiotic given to prevent disease, especially by specified means or against a specified disease; done to prevent infection from occurring again Pyelonephritis: infection of the upper urinary tract that involves spreading of bacteria to the kidney usually resulting from cystitis; symptoms usually include fever, chills, burning or frequent urination, aching pain on one or both sides of the lower back or abdomen, cloudy or bloody urine, and fatigue Refractory: Resistant to treatment Salvage therapy: Done when other treatments have failed Secondary bacterial infection of acute bronchitis: an infection that occurs during or after treatment for another infection Secondary prophylaxis: Treatment to prevent another episode from occurring again Skin and skin structure / Skin and soft tissue (SSTI): Furuncle, Carbuncle, Abscess, Necrotizing infection/fasciitis, Cellulitis, Erysipelas Species: when an antibiotic covers a whole species (e.g. Proteus species), if any of the organisms documented start with the name (ex. Proteus mirabilis, Proteus oxytoca, etc.), then the antibiotic may be an appropriate use for the patient. Susceptible : an antibiotic can be used to treat an infection if it works against one of the species or organisms listed Synergy: Gentamicin is used together with ampicillin (or another beta lactam antibiotic) for certain in order to help heal the infection more efficiently Trough concentration: Lowest concentration of drug in blood before next dose is to be given Uncomplicated cystitis: inflammation of the urinary bladder in a non-pregnant woman with no other comorbidities References: 1. Lexi-Comp, Inc. (Lexi-Drugs ). Lexi-Comp, Inc. Accessed April 13, John Hopkins Antibiotic Guides. The Johns Hopkins University, The Johns Hopkins Hospital, and Johns Hopkins Helath System. Accessed April 13, 2018.