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
4,5
Background
 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
Impact
CVS Caremark
Initial
Recommendation
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CVS Caremark
Contact

Based on the wholesale acquisition cost (WAC), the cost of each dose of
NovoSeven RT is expected to be similar to the cost of NovoSeven.
CVS Caremark recognizes the unique needs of plan participants with
hemophilia.
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.
For more information, call your CVS Caremark account representative or
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.
©2008 Caremark. All rights reserved.