Trendsrx Pre-Approval Alert

Specialty TrendsRx Availability Alert NovoSeven RT® (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) Drug Approval NovoSeven RT® [Novo Nordisk] was approved by the U.S. Food and Drug Administration (FDA) on May 9, 2008 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX and in patients with acquired hemophilia; the prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX and in patients with acquired hemophilia; the treatment of bleeding episodes in patients with congenital Factor VII deficiency; and for the prevention of bleeding in surgical interventions or invasive procedures in patients with congenital Factor VII deficiency.1,2 Mechanism of action: Coagulation factors are proteins that assist the body in the clotting process to limit blood loss that occurs after an injury. Patients with hemophilia produce altered coagulation factors that have reduced activity or are virtually inactive. NovoSeven RT is a recombinant form of the human coagulation factor VIIa that activates the clotting process.1,3 Adverse effects:1  Commonly reported adverse events with NovoSeven RT include fever, hemorrhage, injection site reaction, joint pain, headache, altered blood pressure, nausea, vomiting, pain, swelling and rash.  Hypersensitivity reactions may occur with the use of NovoSeven RT.  As with other coagulation factor replacement products, patients receiving NovoSeven RT should be monitored for the development of neutralizing antibodies (inhibitors). Launch:  Anticipated for August 4, 2008 Comments:  NovoSeven RT is supplied in single-use vials containing 1.0 mg, 2.0 mg, or 5.0 mg of recombinant factor VIIa per vial. After reconstitution with the supplied diluent, each vial contains approximately 1.0 mg per mL of recombinant factor VIIa.1  NovoSeven RT is approved for the same indications, is similar in efficacy and is dosed in the same manner as the original formulation, NovoSeven.1,3  Unlike the original formulation, NovoSeven RT does not require storage under refrigeration. In addition, NovoSeven RT is reconstituted with a different diluent, is available in different vial sizes and, once reconstituted, is delivered in higher concentrations than the original formulation.1,3  NovoSeven RT will replace the original formulation, NovoSeven. Patients should finish using their current supply of NovoSeven and then switch to NovoSeven RT. NovoSeven and NovoSeven RT should not be mixed together.3 Background4,5  Hemophilia is a bleeding disorder that slows the normal blood clotting process.  Patients with hemophilia often experience prolonged bleeding or oozing following an injury, surgery or dental procedures. In severe cases, heavy bleeding occurs after minor trauma. Spontaneous bleeding in the absence of injury can also occur.  This bleeding can cause organ and tissue damage; in some cases, the bleeding can be fatal.  Hemophilia typically only occurs in males. Approximately 1 in 4,000 males worldwide are born with hemophilia A while 1 in 20,000 males are born with hemophilia B. Expected Budget  Based on the wholesale acquisition cost (WAC), the cost of each dose of Impact NovoSeven RT is expected to be similar to the cost of NovoSeven. CVS Caremark  CVS Caremark recognizes the unique needs of plan participants with Initial hemophilia. Recommendation  CVS Caremark recommends for your consideration and at your discretion, the management of NovoSeven RT with the same clinical management tools you use for NovoSeven and other hemophilia therapies.  NovoSeven RT will be available through the CVS Caremark Specialty Pharmacy Services Network. CVS Caremark  For more information, call your CVS Caremark account representative or Contact CaremarkConnect® toll-free at 1-800-237-2767.

Please Note: This document provides a brief overview of the subject. This review is provided as a reference only, and is based in part on information derived from third parties.

References 1. NovoSeven RT Prescribing Information. Princeton, NJ: Novo Nordisk, Inc.; May 2008. 2. U.S. Food and Drug Administration. FDA approves new formulation of coagulation therapy. Media Release May 9, 2008. Available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01833.html. Accessed July 15, 2008. 3. Novo Nordisk. Transition to NovoSeven® RT: questions and answers. Available at http://www.novosevenrt.com/qa.aspx. Accessed July 24, 2008. 4. Genetics Home Reference. Hemophilia. Available at: http://ghr.nlm.nih.gov/condition=hemophilia. Accessed July 24, 2008. 5. National Heart Lung and Blood Institute. What is hemophilia? Available at http://www.nhlbi.nih.gov/health/dci/Diseases/hemophilia/hemophilia_what.html. Accessed July 24, 2008.