Managed Care - January 2009 - (Page 48)

TOMORROW’S MEDICINE ing 231 patients. Approximately 40 percent had had a splenectomy. More than 50 percent had received more than three therapies for their disease. Entry criteria and baseline platelet counts were similar for those in the romiplostim studies, although the romiplostim studies involved only 125 patients. The primary endpoint in the eltrombopag trials was an increase in platelet count to ≥50 Gi/L. The outcomes in the eltrombopag trials for active versus placebo groups were 70 percent versus 11 percent in trial A and 59 percent versus 16 percent in trial B. This compares to an overall platelet response of 88 percent versus 14 percent and 79 percent versus 0 percent, respectively, in the two pivotal romiplostim clinical trials. encing grade 4 elevations in serum liver test values during therapy that was accompanied by worsening of underlying cardiopulmonary disease and death. Overall serum liver test abnormalities were reported in 10 percent and 8 percent of active and placebo groups, respectively. There is limited experience in retreatment with eltrombopag; seven patients who experienced hepatobiliary laboratory abnormalities and ceased therapy were readministered eltrombopag with six again experiencing elevations. Of these, one had to discontinue the use of eltrombopag. Thus it is likely that most physicians will consider the alternative in cases of hepatobiliary issues of any magnitude. Every two weeks Adverse reactions Serious adverse reactions differ between the two drugs, as might be predicted based on their structure. The serious adverse reactions for romiplostim were bone marrow reticulin deposition and worsening of thrombocytopenia after romiplostim discontinuation. Other adverse reactions seen in the active vs. placebo group for romiplostim were: arthralgia, 26 percent vs. 20 percent; dizziness, 17 percent vs. 0 percent; insomnia, 16 percent vs. 7 percent; myalgia, 14 percent vs. 2 percent; pain in extremity, 13 percent vs. 5 percent; and abdominal pain, 11 percent vs. 0 percent. For eltrombopag, serious adverse events included hepatotoxicity, with one patient experiADVERTISING INDEX AMGEN, INC. Neulasta C2,1 CENTOCOR, INC. Corporate 5 FOREST LABORATORIES Bystolic 29–30 Namenda 17–18 NOVO NORDISK, INC. Levemir C3,C4 The prescribing information for eltrombopag recommends measuring serum ALT, AST, and bilirubin before initiation of eltrombopag, every two weeks during the dose adjustment phase, and monthly following the establishment of a stable dose. Eltrombopag is to be discontinued if ALT levels increase to more than three times the upper limit of normal and are progressive, or persist for more than four weeks, or are accompanied by increased direct bilirubin or accompanied by clinical symptoms of liver injury or hepatic decompensation. Both products carry similar warnings for several situations: Discontinuation of the active therapy may be accompanied by rebound thrombocytopenia. In addition, both carry warnings concerning thrombotic and thromboembolic events from excessive increases in platelet counts and a concern that stimulation of the TPO receptor may increase risk of malignancies. Neither product is indicated for the treatment of thrombocytopenia that results from causes other than chronic ITP. Many differences Romiplostim is administered as a onceweekly subcutaneous injection at a dose that is based on weight and titrated to the desired endpoint. Eltrombopag is administered as a once- 48 MANAGED CARE / JANUARY 2009

Table of Contents Feed for the Digital Edition of Managed Care - January 2009

Managed Care - January 2009 Editor's Memo Contents Legislation & Regulation News and Commentary Medication Management Compensation Monitor Health Care's Disruptive Innovations Q&A With Clayton Christensen 'Disruption' May Be Plans' Best Bet Avoid the PBM Rebate Trap HealthPartners Puts Diabetes on Notice Formulary Files Plan Watch Tomorrow's Medicine Ad Index Outlook Unmet Needs in the Management of Plaque Psoriasis Impact of RSV: Implications for Managed Care

Managed Care - January 2009

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