Eprex - Additional Dosage Forms 2009 10.pub

					                                                                                                                   This document posted
                                                                                                                       November 2009
                                             Recommendations and Reasons
Committee to Evaluate Drugs (CED)

Epoetin alfa – additional dosage forms
Product:                                     Highlights of Recommendation:
EPOETIN ALFA (Eprex®)                                                                         ♦ The 30,000IU prefilled syringe costs
20,000IU/0.5mL, 30,000IU/0.75mL              ♦ Epoetin alfa (Eprex) is a synthetic protein      $401.85, which is the same as the
                                               used to increase red blood cell production       currently listed 40,000IU prefilled syringe.
prefilled syringes (additional dosage
                                               and to decrease the need for red blood cell      This makes the 30,000IU prefilled syringe
forms)                                                                                          more expensive on a per unit basis.
                                             ♦ Epoetin alfa (Eprex) 10,000IU prefilled        ♦ Overall, the Committee noted that
Class of drugs:                                                                                 epoetin alfa (Eprex) 20,000IU
                                               syringe, 40,000IU prefilled syringe and
Erythropoiesis-stimulating agents                                                               prefilled syringe facilitates dosing in
                                               20,000IU vial are already listed on the
                                               Ontario Drug Benefit Formulary for the           the cancer setting and funding this
Indication:                                    treatment of anemia caused by                    additional dosage form will likely be
Treatment of anemia                            chemotherapy. Various dosage forms of            cost-neutral to the Ministry. On the
                                               this product are also available through the      other hand, the 30,000IU prefilled
Manufacturer:                                  Special Drugs Program for patients with          syringe is proportionately more
Janssen-Ortho Inc.                             end-stage renal disease and through the          expensive than the 40,000IU pre-
                                               Exceptional Access Program for a variety         filled syringe and options are
                                               of indications. This review considered the       available for patients requiring the
CED Recommendation                             funding of two additional dosage formats         30,000IU dose.
The CED recommended that epoetin               of epoetin alfa (Eprex): 20,000IU and
alfa (Eprex) 20,000IU prefilled syringe        30,000IU prefilled syringes.
be funded on the basis that this product     ♦ The 20,000IU and 30,000IU prefilled            Background:
will facilitate dosing in the treatment of     syringes are identical in formulation to the
anemia associated with cancer.                 existing 40,000IU/mL prefilled syringe,        Erythropoietin is produced naturally in the
                                               with the only difference being the fill        body, mostly by the kidneys. It signals the
                                               volumes.                                       bone marrow to produce red blood cells,
The CED recommended that epoetin
                                             ♦ In the treatment of anemia caused by           which carry oxygen in the blood. If the body
alfa (Eprex) 30,000IU prefilled syringe        chemotherapy, epoetin alfa (Eprex) is          does not produce enough erythropoietin,
not be funded on the basis that it is          typically dosed at 40,000IU weekly, with       anemia can occur.
priced the same as the 40,000IU                an increase to 60,000IU weekly if the
prefilled syringe.                             patient does not achieve an adequate           Epoetin alfa (Eprex) is synthetic
                                               response. The target hemoglobin is 120g/       erythropoietin and belong to a family of
Based on the CED’s recommendation,             L. (A target hemoglobin level of greater       treatments called erythropoiesis-stimulating
                                               than 120g/L has been associated with           agents. It can be used in patients who do
                                               increased risk of death and serious            not make enough erythropoietin because
Executive Officer Decision                     cardiovascular adverse event.) Treatment       their kidneys are not working properly, or to
                                               is stopped if the target hemoglobin level is   increase red blood cell production in certain
the Executive Officer decided to fund          exceeded, and treatment may be restarted       patients scheduled for surgery. It has also
epoetin alfa (Eprex) 20,000IU prefilled        at a dose of 20,000IU weekly. As such,         been used to treat anemia caused by certain
syringe and not fund the 30,000IU              the Committee agreed that the 20,000IU         drug therapies, such as chemotherapy and
prefilled syringe.                             prefilled syringe would facilitate dosing in   drugs used to treat chronic viral hepatitis.
                                               this clinical setting. The Committee could
                                               not identify a therapeutic need for the        Erythropoiesis-stimulating agents have been
                                               30,000IU prefilled syringe. Furthermore, if    associated with increased risks of death and
                                               30,000IU of epoetin alfa (Eprex) is            cardiovascular complications (such as stroke
Status           Funding for epoetin alfa
                                               required, the appropriate volume could be      and heart attack) in patients with cancer and
                                               withdrawn from the vials.                      kidney failure when treated with a target
(Eprex) 20,000IU prefilled syringe is        ♦ In the treatment of patients with end-         hemoglobin level that is greater than 120g/
available as a General Benefit on the          stage renal disease, epoetin alfa (Eprex) is   L. For this reason, it is advised that the dose
Ontario Drug Benefit Formulary for the         typically dosed according to body weight       of erythropoiesis-stimulating agents be
treatment of chemotherapy-induced              at a dosage of 150IU/kg three times            titrated to gradually increase the hemoglobin
anemia. Funding for various other              weekly. Hospitals and clinics treating         concentration to the lowest level sufficient to
                                               these patients typically use epoetin alfa      avoid blood transfusions. (For details, see:
indications is also considered through
                                               (Eprex) multi-dose vials rather than           http://www.hc-sc.gc.ca/dhp-mps/medeff/
the Exceptional Access Program.                                                               advisories-avis/prof/_2007/
                                               prefilled syringes.
                                             ♦ The 20,000IU prefilled syringe costs
Funding for epoetin alfa (Eprex)
                                               $267.90. This is the same price as the
30,000IU prefilled syringe is not              currently listed 20,000IU vial.

Detailed Discussion:                             CEDAC Recommendation:

No additional details. The full CED discussion   (http://www.cadth.ca/index.php/en/cdr/
is as outlined in the Highlights of              recommendations)
Recommendation section.
                                                 The Canadian Expert Drug Advisory
                                                 Committee (CEDAC) did not review epoetin
                                                 alfa (Eprex) 20,000IU/0.5mL and
                                                 30,000IU/0.75mL prefilled syringes.

                                                  Min istr y of
                                                  Health and Long-Term Care
                                                  Ontario Public Drug Programs

                                                  For more information, please contact:

                                                  Ministry of Health and Long-Term Care
                                                  Ontario Public Drug Programs
                                                  Hepburn Block, 9th Floor
                                                  80 Grosvenor Street, Queen’s Park
                                                  Toronto, Ontario M7A 1R3
                                                  or click: (http://www.health.gov.on.ca/english/