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Medical Policy

Policy Num:       11.001.023
Policy Name:   PROCALCITONIN AS A MARKER IN THE SYSTEMIC INFLAMMATORY RESPONSE   

 Policy ID:          [11.001.023][Ar L M P ][0.00.00]

Last Review:      November 10, 2021
Next Review:      N/A
Issue:                   11:2021

Related Policies:

None

Archived

PROCALCITONIN AS A MARKER IN THE SYSTEMIC INFLAMMATORY RESPONSE

Summary

Severe infection and sepsis are frequent causes of morbidity and mortality in intensive care units. Infection and sepsis are accompanied by clinical signs and changes in laboratory analysis, as well as changes in body temperature, leukocytosis and tachycardia. However, these signs and symptoms of systemic inflammation (SIRS) may have an infectious or non-infectious etiology. They are not specific or sensitive to sepsis. A similar inflammatory response can be seen in patients with pancreatitis, severe trauma and burns without infectious complications.

Sometimes it is difficult to distinguish patients with systemic infection, organ dysfunction and "shock" from other patients with the same clinical symptoms and laboratory findings that do not have infection. Bacteriological evidence of the infection may not develop at the same time as the clinical symptoms of sepsis. Positive bacteriological tests may result from contamination and similarly negative tests do not necessarily exclude sepsis. Since this symptomatology and laboratory analysis are not sufficiently sensitive or specific, an initial marker that identifies the infection as a cause of the systemic inflammatory response is necessary. Recently the measure of procalcitonin has been proposed as that marker.

Objective

To review the utility of procalcitonin in critical care setting, in management of suspected sepsis and septic shock.

Policy Statements

Policy Guidelines

While the diagnostic value of procalcitonin in patients with sepsis is poorly supported by evidence, its value in deescalating antibiotic therapy is well established in populations other than those with sepsis, in particular, those with community acquired pneumonia and respiratory tracts infections. Measurement of procalcitonin to guide duration of antibiotic use is appropriate in those populations.

Benefit Application

BlueCard/National Account Issues

N/A

Background

N/A

Regulatory Status

N/A

Rationale

N/A

Population Reference No. 1 Policy Statement

Critical setting with sepsis to differentiate infectious vs non-infectious process

Supplemental Information

N/A

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

N/A

References

1. 2004 TEC Special Report: Genotyping for Cytochrome P450 Polymorphisms to Determine Drug-Metabolizer Status. Tab 9.
2. Wadelius M, Sorlin K, Wallerman O et al. Warfarin sensitivity related to CYP2C9, CYP3A5, ABCB1 (MDR1) and other factors. Pharmacogenomics J 2004; 4(1):40-8.
3. Gage BF, Eby C, Milligan PE et al. Use of pharmacogenetics and clinical factors to predict the maintenance dose of warfarin. Thromb Haemost 2004; 91(1):87-94.
4. Hillman MA, Wilke RA, Caldwell MD et al. Relative impact of covariates in prescribing warfarin according to CYP2C9 genotype. Pharmacogenetics 2004; 14(8):539-47.
5. Rieder MJ, Reiner AP, Gage BF et al. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. N Engl J Med 2005; 352(22):2285-93.
6. Yuan HY, Chen JJ, Lee MT et al. A novel functional VKORC1 promoter polymorphism is associated with inter-individual and inter-ethnic differences in warfarin sensitivity. Hum Mol Genet 2005; 14(13):1745-51.
7. Geisen C, Watzka M, Sittinger K et al. VKORC1 haplotypes and their impact on the inter-individual and inter-ethnical variability of oral anticoagulation. Thromb Haemost 2005; 94(4):773-9.
8. D'Andrea G, D'Ambrosio RL, Di Perna P et al. A polymorphism in the VKORC1 gene is associated with an interindividual variability in the dose-anticoagulant effect of warfarin. Blood 2005; 105(2):645-9.
9. Wadelius M, Chen LY, Downes K et al. Common VKORC1 and GGCX polymorphisms associated with warfarin dose. Pharmacogenomics J 2005; 5(4):262-70.
10. Sconce EA, Khan TI, Wynne HA et al. The impact of CYP2C9 and VKORC1 genetic polymorphism and patient characteristics upon warfarin dose requirements: proposal for a new dosing regimen. Blood. 2005; 106(7):2329-33.
11. McClain MR, Palomaki GE, Piper M et al. A rapid ACCE1 review of CYP2C9 and VKORC1 allele testing to inform warfarin dosing in adults at elevated risk for thrombotic events to avoid serious bleeding. Available at: http://www.acmg.net.
12. Hillman MA, Wilke RA, Yale SH et al. A prospective, randomized pilot trial of model-based warfarin dose initiation using CYP2C9 genotype and clinical data. Clin Med Res 2005; 3(3):137-45.
13. Millican E, Lenzini PA, Milligan PE et al. Genetic-based dosing in orthopaedic patients beginning warfarin therapy. Blood 2007; 110(5):1511-5.
14. Zhu Y, Shennan M, Reynolds KK et al. Estimation of warfarin maintenance dose based on VKORC1 (-1639 G>A) and CYP2C9 genotypes. Clin Chem 2007; 53(7):1199-205.
15. FDA press release August 16, 2007: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html

    16.  FDA Questions and Answers: http://www.fda.gov/cder/drug/infopage/warfarin/qa.htm

Codes

Applicable Modifiers

As per Correct Coding Guidelines 

Policy History