Managed Care - October 2008 - (Page 50) TOMORROW’S MEDICINE an amino acid sequence similar to endogenous TPO. It is produced by recombinant DNA technology in E. coli. Thrombopoietin receptor agonist Manufactured by Amgen, romiplostim is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, intravenous immunoglobulin, or splenectomy. It should only be used in patients whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Romiplostim should not be used in an attempt to normalize platelet counts. Dosage is 1mcg/kg once weekly as a subcutaneous injection. Dosage is adjusted weekly by 1mcg/kg increments to achieve and maintain a platelet count of ≥50,000/ml of blood as necessary to reduce the risk of bleeding. Physicians should not exceed a maximum weekly dose of 10 mcg/kg and should not administer the drug if the platelet count is greater than 400,000. Recommended monitoring includes the platelet count, CBCs, and microscopic examination of peripheral blood smears before, during, and for at least two weeks following cessation of romiplostim. Romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the maximum dose. Romiplostim is supplied in single-use vials as a sterile, preservative-free white lyophilized powder that must be reconstituted and administered with a syringe with 0.01ml graduations, as very small volumes are needed. It is distributed in 250 and 500 mcg vials costing $1,063 and $2,125 respectively. Romiplostim is available only through a restricted distribution program called the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program. Only prescribers and patients registered through NEXUS are able to prescribe, administer, and receive romiplostim. Prescribers and patients are required to understand the risks of romiplostim therapy in order to be registered in NEXUS. Managed care implications Romiplostim is the first targeted therapy for ITP. Since ITP is not very common, it is unlikely that romiplostim will create a budget shortfall in aggregate, but individually, the cost of this therapy will be noticed. At roughly $4 per microgram, an average 150-lb. patient at maximum dose (10mgm/kg/week) could potentially cost over $140,000 per year, virtually ensuring that health plans will develop management processes. Of more import is that another class of drugs — peptibodies — is now in existence. Peptibodies’ antibody level of specificity in a biologic molecule is simple enough for E. coli to create, a process much less complicated than mammalian bioreactors. Others are in development and will certainly be a highlight of Tomorrow’s Medicine. MC The author is a director in the value-based health department at Genentech Inc. During the last three years, before taking the Genentech position, he received honoraria or other financial benefits from: Amgen, Amylin Pharmaceuticals, AstraZeneca, Biogen Idec, Centocor, Galderma, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Procter & Gamble, Q-Med, Sanofi-Aventis, Teva Pharmaceuticals Industries, UCB, and Wyeth. The views expressed in Tomorrow’s Medicine are the author’s alone. ADVERTISING INDEX FOREST LABORATORIES Namenda 35–36 HEALTH DIALOG Health Plans 7 INSPIRE PHARMACEUTICALS Corporate 25 MDDATACOR Quality Improvement Solutions 3 MEDIMMUNE, INC. Synagis 11–12 MERCK HUMAN HEALTH Janumet 17–19 QUALITYMETRIC Health Outcomes Solutions C2 WELLPOINT nextRx 23 WYETH PHARMACEUTICALS Effexor 29–31 Pristiq 52,C3,C4 50 MANAGED CARE / OCTOBER 2008
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