Interferons and definition of compensated liver disease

[participant1]

What standards are used to define compensated liver disease? What are plans using in their peg-interferon policies?

[jacqueline.kostick]

According to the American Association for the Study of Liver Diseases (AASLD) practice guidelines issued for the diagnosis, management, and treatment of hepatitis C (2004), the specific criteria for compensated liver disease include all of the following: a total serum bilirubin < 1.5 g/dL; INR < 1.5; albumin > 3.4 g/dL; platelet count > 75,000 k/mm3; and no evidence of hepatic encephalopathy or ascites. However, these criteria do not establish a comprehensive definition of compensated liver disease. In fact, the AASLD guidelines refer to compensated liver disease as Grade A based on the Child Pugh-Turcotte (CPT) classification scoring system.

The CPT classification scoring system is a more encompassing approach used to determine if a patient has compensated clinical hepatic disease. It uses similar parameters as the ones listed in the AASLD guidelines; however, the CPT system applies different thresholds to determine the total score and the corresponding classification of hepatic disease:

Child-Pugh-Turcotte (CPT) Parameters and Points:
o Serum bilirubin, mg/dL: < 2 (1 point), 2–3 (2 points) > 3 (3 points)
o Serum albumin, g/dL: > 3.5 (1 point), 2.8–3.5 (2 points), <2.8 (3 points)
o Prothrombin time, sec [OR INR]: 1–3 [OR <1.7] (1 point), 4-6 [OR 1.7-2.3] (2 points), >6 [OR >2.3] (3 points)
o Ascites: Absent (1 point), Slight (2 points), Moderate (3 points)
o Encephalopathy: None (1 point), Grade 1-2 (2 points), Grade 3-4 (3 points)

Child-Pugh-Turcotte (CPT) Parameters and Points:
o 5–6 points = Grade A (compensated liver disease)
o 7–9 points = Grade B (significantly functional compromised liver disease)
o 10–15 points = Grade C (decompensated liver disease)

Therefore, it’s possible that patients that technically don’t meet the criteria listed by the AASLD can still have compensated disease based on the CPT score, To demonstrate this point, consider the following three hypothetical cases:

Case 1- Patient A has a total serum bilirubin of <1.5 g/dL, an INR of < 1.5, albumin of > 3.4 g/dL, and no evidence of hepatic encephalopathy or ascites. This patient has compensated disease based on the AASLD definition and the CPT classification system (a score of 5, Class A).

Case 2- Patient B does not meet all of the criteria as described in the AASLD guidelines (e.g., serum bilirubin 2.5, INR 1.6). However, based on the CPT classification system, this patient has a score of 6, which is still considered grade A. Only 1 measure (bilirubin) is truly out of range.

Case 3- Patient C has a total serum bilirubin of > 3 g/dL, an INR of > 2.3, albumin of < 2.8 g/dL, moderate ascites, and grade 3 encephalopathy. This patient has decompensated disease based on the AASLD definition and the CPT classification system (a score of 15, Class C).

Sources:
Strader DB, Wright T, Thomas DL, et al. AASLD PRACTICE GUIDELINE Diagnosis, Management, and Treatment of Hepatitis C. 2004. Available at:
http://www.aasld.org/practiceguideli...hepatitisc.pdf

Goldman: Cecil Medicine, 23rd ed., 2007; Cirrhosis and its Sequelae. Reference book is available online via MD Consult MD Consult -- Start Session Cookie Error.

Rakel & Bope: Conn's Current Therapy 2008, 60th ed, Ch. 128. Bleeding Esophageal Varices. Reference book is available online via MD Consult MD Consult -- Start Session Cookie Error.

[chantell.reagan]

An analysis of pegylated interferon policies for 11 regional and national plans showed that 9/11 addressed “compensated liver disease” as part of the approval criteria. However, only 2 plans explicitly describe the definition of “compensated liver disease.”

• Aetna’s policy uses criteria that combine the AASLD and CPT definitions:

•bilirubin < 2 mg/dL; albumin stable and within normal limits; INR < 3; WBC > 3000/mm3; platelets > 70,000/mm3; no history of hepatic encephalopathy, variceal bleeding, ascites, or other clinical signs of decompensation; serum creatinine normal or near normal

• BlueCross BlueShield of Illinois’ policy requires criteria consistent with CPT:

•”histological evidence of cirrhosis (Child-Pugh class A)”

Sources:
BCBS Alabama Pegasys policy and BCBS Alabama Peg-Intron policy
Regence Pegasys policy and Regence Peg-Intron policy
BCBS Florida Medical Coverage Guidelines
Cigna Pegasys policy and Cigna Peg-Intron policy
Aetna interferons and ribavirin policy
Excellus Hepatitis C policy
Wellmark Interferons for Hepatitis C policy
Horizon BCBS ribavirin policy
BCBS Illinois peginterferon policy
United Healthcare/Oxford interferon and ribavirin policy
MVP Healthcare Hepatitis C policy