Clinical UM Guideline


Subject:Intravenous versus Oral Drug Administration in the Outpatient and Home Setting
Guideline #:  CG-DRUG-25Current Effective Date:  07/09/2013
Status:ReviewedLast Review Date:  05/09/2013

Description

Certain intravenous (IV) drugs have documented clinical efficacy that is bio-equivalent to the oral (PO) route of administration. When this is the case, and a stable individual requires long-term drug therapy, then PO administration of the drug is generally preferred. The purpose of this document is to help ensure that the most effective and least invasive form of drug administration is used when the IV and PO routes are bio-equivalent and used in the outpatient or home setting.

Note: This document pertains to IV and PO versions of exactly the same drug, not to different drugs within the same therapeutic class.

Clinical Indications

MedicallyNecessary:

The use of the oral route of drug administration is considered medically necessary if both of the following are met:

The use of the IV route of administration is considered medically necessary if both of the following are met:

*Examples of bio-equivalent IV and oral medications include, but are not limited to:
Flouroquinolone Antibiotics

Other Antibiotics

Proton Pump Inhibitors

Not Medically Necessary: 

The IV route of administration for medications that have oral preparations which are bio-equivalent and the individual can tolerate oral intake is considered not medically necessary.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS 
 Examples include, but are not limited to, the following injectable drugs:
C9113Injection, pantoprazole sodium, per vial
J0744Injection, ciprofloxacin for intravenous infusion, 200 mg
J1450Injection, fluconazole, 200 mg
J1956Injection, levofloxacin, 250 mg
J2020Injection, linezolid, 200 mg
J2280Injection, moxifloxacin, 100 mg
S0030Injection, metronidazole, 500 mg
S0039Injection, sulfamethoxazole and trimethoprim, 10 ml
S0164Injection, pantoprazole sodium, 40 mg
  
ICD-9 Diagnosis 
 All diagnoses
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
 All diagnoses
  
Discussion/General Information

If the oral and IV routes of select medications are bio-equivalent (per Food and Drug Administration [FDA]-approved package insert), there would be no apparent clinical benefit to using the IV over the PO route unless the GI tract is somehow compromised.

A Cochrane review (Kilburn, 2010) reported on the safety and efficacy of interventions for cellulitis. It was determined that no two trials reported on the same drug. Many trials compared the addition of corticosteroid to antibiotic treatment versus antibiotic treatment alone. The authors concluded "There is a need for trials to evaluate the efficacy of oral antibiotics against intravenous antibiotics in the community setting as there are service implications for cost and comfort."

References

Peer Reviewed Publications:

  1. Aneziokoro CO, Cannon JP, Pachucki CT, Lentino JR. The effectiveness and safety of oral linezolid for the primary and secondary treatment of osteomyelitis. J Chemother. 2005; 17(6):643-650.
  2. Angeli P, Guarda S, Fasolato S, et al. Switch therapy with ciprofloxacin vs. intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis: similar efficacy at lower cost. Aliment Pharmacol Ther. 2006; 23(1):75-84.
  3. Ballow C, Lettieri J, Agarwal V, et al. Absolute bioavailability of moxifloxacin. Clin Ther. 1999; 21(3):513-522.
  4. Barquist ES, Gomez-Fein E, Block EF, et al. Bioavailability of oral fluconazole in critically ill abdominal trauma patients with and without abdominal wall closure: a randomized crossover clinical trial. J Trauma. 2007; 63(1):159-163.
  5. Breilh D, Jougon J, Djabarouti S, et al. Diffusion of oral and intravenous 400 mg once-daily moxifloxacin into lung tissue at pharmacokinetic steady-state. J Chemother. 2003; 15(6):558-562.
  6. Broder KW, Moise PA, Schultz RO, et al. Clinical experience with linezolid in conjunction with wound coverage techniques for skin and soft-tissue infections and postoperative osteomyelitis. Ann Plast Surg. 2004; 52(4):385-390.
  7. Chien SC, Rogge MC, Gisclon LG, et al. Pharmacokinetic profile of levofloxacin following once-daily 500-milligram oral or intravenous doses. Antimicrob Agents Chemother. 1997; 41(10):2256-2260.
  8. Chu SY, Deaton R, Cavanaugh J. Absolute bioavailability of clarithromycin after oral administration in humans. Antimicrob Agents Chemother. 1992; 36(5):1147-1150.
  9. Fischer MA, Solomon DH, Teich JM, Avorn J. Conversion from intravenous to oral medications: assessment of a computerized intervention for hospitalized patients. Arch Intern Med. 2003; 163(21):2585-2589.
  10. Gerloff J, Mignot A, Barth H, Heintze K. Pharmacokinetics and absolute bioavailability of lansoprazole. Eur J Clin Pharmacol. 1996; 50(4):293-297.
  11. Giordano P, Song J, Pertel P, et al. Sequential intravenous/oral moxifloxacin versus intravenous piperacillin-tazobactam followed by oral amoxicillin-clavulanate for the treatment of complicated skin and skin structure infection. Int J Antimicrob Agents. 2005; 26(5):357-365.
  12. Greenberg RN, Newman MT, Shariaty S, Pectol RW. Ciprofloxacin, lomefloxacin, or levofloxacin as treatment for chronic osteomyelitis. Antimicrob Agents Chemother. 2000; 44(1):164-166.
  13. Huber R, Hartmann M, Bliesath H, et al. Pharmacokinetics of pantoprazole in man. Int J Clin Pharmacol Ther. 1996; 34(5):185-194.
  14. Itani KM, Weigelt J, Li JZ, Duttagupta S. Linezolid reduces length of stay and duration of intravenous treatment compared with vancomycin for complicated skin and soft tissue infections due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). In J Antimicrob Agents. 2005; 26(6):442-448.
  15. Klepser ME, Zhu Z, Nicolau DP, et al. Oral absorption of trimethoprim-sulfamethoxazole in patients with AIDS. Pharmacotherapy. 1996; 16(4):656-662.
  16. Mahar PJ, Rana JA, Kennedy CS, Christopher NC. A randomized clinical trial of oral transucosal fentanyl citrate versus intravenous morphine sulfate for initial control of pain in children with extremity injuries. Pediatr Emerg Care. 2007; 23(8):544-548.
  17. Pratha V, Hogan DL, Lynn RB, et al. Intravenous pantoprazole as initial treatment in patients with gastroesophageal reflux disease and a history of erosive esophagitis: a randomized clinical trial. Dig Dis Sci. 2006; 51(9):1595-1601.
  18. Pue MA, Laroche J, Meineke I, de Mey C. Pharmacokinetics of pantoprazole following single intravenous and oral administration to healthy male subjects. Eur J Clin Pharmacol. 1993; 44(6):575-578.
  19. Rao N, Ziran BH, Hall RA, Santa ER. Successful treatment of chronic bone and joint infections with oral linezolid. Clin Orthop Relat Res. 2004; (427):67-71.
  20. Stalker DJ, Jungbluth GL. Clinical pharmacokinetics of linezolid, a novel oxazolidinone antibacterial. Clin Pharmacokinet. 2003; 42(13):1129-1140.
  21. Stass H, Kubitza D. Pharmacokinetics and elimination of moxifloxacin after oral and intravenous administration in man. J Antimicrob Chemother. 1999; 43(Suppl B):83-90.
  22. Welshman IR, Sisson TA, Jungbluth GL, et al. Linezolid absolute bioavailability and the effect of food on oral bioavailability. Biopharm Drug Dispos. 2001; 22(3):91-97.

Government Agency, Medical Society, and Other Authoritative Publications: 

  1. Kilburn SA, Featherstone P, Higgins B, Brindle R. Interventions for cellulitis and erysipelas. Cochrane Database Syst Rev. 2010; (6):CD004299.
  2. Pohl A. Modes of administration of antibiotics for symptomatic severe urinary tract infections. Cochrane Database Syst Rev. 2007; (4):CD003237.
  3. Rojas MX, Granados C. Oral antibiotics versus parenteral antibiotics for severe pneumonia in children. Cochrane Database Syst Rev. 2006; (2):CD004979.
  4. Vidal L, Ben-Dor I, Paul M, et al. Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients. CochraneDatabase Syst Rev. 2004; (4):CD003992.
Index

Ciprofloxacin
Clarithromycin
Fluconazole
Intravenous Drug Administration
Lansoprazole
Levofloxacin
Linezolid
Metronidazole
Moxifloxacin
Oral Drug Administration
Pantoprazole
Sulfamethoxazole/Thrimethoprim

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Reviewed05/09/2013Medical Policy and Technology Assessment Committee (MPTAC) review. No changes to Clinical Indications.
Reviewed05/10/2012MPTAC review. Updated Discussion/General Information.
Reviewed05/19/2011MPTAC review. Title change to "Intravenous versus Oral Drug Administration in the Outpatient and Home Setting." Updated Discussion/General Information and References.
Reviewed05/13/2010MPTAC review. No change to Clinical Indications.
Reviewed05/21/2009MPTAC review. Updated References. Removed Place of Service section.
New05/15/2008MPTAC review. Initial document development.