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Drug Use Research & Management Program OHA Division of Medical Assistance Programs 500 Summer Street NE, E35; Salem, OR 97301-1079 Phone 503-947-5220 | Fax 503-947-1119

Drug Use Evaluation: Colony Stimulating Factor use in patients with Hepatitis C

BACKGROUND

Colony stimulating factors (CSFs) have been suggested for the off-label treatment of neutropenia caused by peg- alfa treatment for hepatitis C.[1] The use of CSFs for the treatment of neutropenia is thought to increase the sustained virologic response (SVR) by maintaining therapeutic levels of peg-interferon alfa.

Although CSFs for the treatment of neutropenia seems promising, it is unlikely that the benefits of use for outweigh the risks. Patient who are treated with CSFs are at an increased risk of developing myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).[2]

There is low level of evidence supporting CSFs superiority over temporarily reducing the peg-interferon alfa dose.[3] According the American Association for the Study of Liver Guidelines and Veterans Affairs (VA) guidelines CSFs should only be considered when the patient experiences persistent neutropenia despite dose reduction of peg-interferon alpha. Factors that put patients with hepatitis C at a higher risk for neutropenia and possibly a higher response rate to CSFs include HIV infection, liver cirrhosis, or a liver transplant.[4,5]

Goal: To evaluate CSFs use in hepatitis C patient. If inappropriate use was found, further prior authorization criteria would be brought to the committee for review. Specifically, these questions were addressed:

1) What is proportion of hepatitis C patients who are also on CSF? 2) What proportion of hepatitis C patients on CSFs also have the following risk factors for developing infection: Cirrhosis, Liver transplant, HIV co-infection? 3) What is proportion of hepatitis C patients on CSFs, that failed a previous dose reduction of peg-interferon?

DUE: CSF in Hepatitis C

METHODS

Paid fee-for-service (FFS) medical and drug claims from July 1, 2011 to June 30, 2012 were used to identify patients with hepatitis C and treated with CSFs. Hepatitis C patients were identified with medical claims with ICD9 equal to 070.41, 070.44, 070.51, 070.54, 070.70, 070.71, V12.09 or V02.62 in any position or a drug claim for either peg-interferon alfa-2B or peg-interferon alfa-2A (see Appendix 1). Only those patients also treated with CSFs as identified in Appendix 1 were included.

Medical and pharmacy claim profiles were generated for all patients and reviewed by a fourth year Doctor of Pharmacy student.

RESULTS There were 5,545 patients with a diagnosis of hepatitis .Of this population, 11 patients (<0.2%) were also on CSF therapy. Ten of these 11 patients had a concomitant diagnosis of a malignant . These 10 patients were likely using a CSF to treat induced neutropenia. The last patient was a complex case with a history of diabetes mellitus, chronic back pain and appeared to have significant infectious complications from a back surgery. There was a single billing for CSF during this time.

CONCLUSION/RECOMMENDATIONS While this analysis was fraught with the limitations of missing information that all administrative claims analyses are, there was no apparent inappropriate CSF use in the population with a hepatitis C . Since there is no apparent inappropriate use of CSFs in the population of patients with hepatitis C, there is no need for prior authorization at this time.

REFERECENCES 1. Tandon P, Doucette K, Fassbender K, Vandermeer B, Durec T, Dryden DM. Granulocyte colony-stimulating factor for hepatitis C therapy-associated neutropenia: systematic review and economic evaluation. Journal of Viral Hepatitis. 2011;18(7):e381–e393 2. Anon. DynaMed: . Available at: http://web.ebscohost.com.liboff.ohsu.edu/dynamed/detail?vid=3&hid=118&sid=0d7f46e7-3b38-4208-a0c4- b22303a1ee3%40sessionmgr113&bdata=JnNpdGU9ZHluYW1lZC1saXZlJnNjb3BlPXNpdGU%3d#db=dme&AN=233423 accessed December 3, 2012. 3. Anonymous. Treatment of Anemia and Neutropenia in Patients with Chronic Hepatitis C Infection Treated with Peginterferon- Based Regimens With or Without Protease Inhibitors: A Review of the Clinical Evidence. www.cadth.ca. 2012. Available at: http://www.cadth.ca/media/pdf/htis/mar-2012/RC0327- 002%20Anemia%20Final.pdf. Accessed December 3, 2012. 4. Diagnosis, Management, and Treatment of Hepatitis C: An Update. American Association for the Study of Liver Disease. Available at http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/Diagnosis_of_HEP_C_Update.Aug%20_09pdf.pdf. Accessed January 19, 2013. 5. Tororice K, Yee H, Bini E, Chapko M, Chiao T, Goetz M, et al. Granulocyte Stimulatint Colony Factor Criteria for Use for Hepatits C Treatment-Related Anemia. Available at http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/Diagnosis_of_HEP_C_Update.Aug%20_09pdf.pdf. Accessed January 19, 2013.

Author: Rose/Ketchum January 28, 2013 Page 2 DUE: CSF in Hepatitis C

6. Appendix 1: Peg-interferon drug claim selection codes GSN GEN NAME BRAND 45877 PEGINTERFERON ALFA-2B PEGINTRON 45878 PEGINTERFERON ALFA-2B PEGINTRON 48814 PEGINTERFERON ALFA-2B PEGINTRON 48815 PEGINTERFERON ALFA-2B PEGINTRON 58877 PEGINTERFERON ALFA-2B PEGINTRON REDIPEN 58878 PEGINTERFERON ALFA-2B PEGINTRON REDIPEN 58879 PEGINTERFERON ALFA-2B PEGINTRON REDIPEN 58880 PEGINTERFERON ALFA-2B PEGINTRON REDIPEN 51151 PEGINTERFERON ALFA-2A PEGASYS 53612 PEGINTERFERON ALFA-2A PEGASYS

CSF drug selection codes a. Drug claim with GSN = GSN GEN NAME BRAND 15917 FILGRASTIM NEUPOGEN 15927 LEUKINE 29260 SARGRAMOSTIM LEUKINE 45996 FILGRASTIM NEUPOGEN 45997 FILGRASTIM NEUPOGEN 46004 FILGRASTIM NEUPOGEN 49872 NEULASTA

b. Medical claim with J-code = J1440 Filgrastim 300 mcg injection J1441 Filgrastim 480 mcg injection J2820 Sargramostim injection J2505 Injection, pegfilgrastim 6mg

Author: Rose/Ketchum January 28, 2013 Page 3