Report on New Patented Drugs – Aranesp

Brand Name: Aranesp

Generic Name: darbepoetin alfa

DIN: 02246354 10 mcg/syr
02246355 20 mcg/syr
02246357 30, 40, 50 mcg/syr
02246358 60, 80, 100 mcg/syr
02246360 150 mcg/syr

Patentee: Amgen Canada Inc.

Indication (as per For the treatment of anaemia associated with chronic renal failure product monograph): (CRF), including patients on dialysis and patients not on dialysis.

Notice of Compliance: August 2, 2002

Date of First Sale: August 2002
In most cases, patents are issued before the drugs come to market. In this case, the first patent pertaining to Aranesp was issued November 5, 2002 and it came under the PMPRB's jurisdiction at that time.

ATC Class: B03XA02
Antianemic Preparations, Other Antianemic Preparations

Application of the Guidelines

Summary:

The introductory prices of Aranesp at date of first sale were found to be within the Guidelines because the cost of therapy did not exceed the cost of therapy of existing drugs in the therapeutic class comparison or did not do so by an amount sufficient to trigger the investigation criteria and the prices did not exceed the range of prices in other comparator countries where Aranesp was sold. These prices continued to be within the Guidelines when Aranesp came under the PMPRB's jurisdiction in November 2002.

For information on the Criteria for Commencing an Investigation, please see Schedule 5 of the Compendium of Guidelines Policies and Procedures, as posted on our website under Legislation, Regulations and Guidelines.

Scientific Review:

Aranesp is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) reviewed it as a category 3 new medicine (provides moderate, little or no therapeutic advantage over comparable medicines).

The Therapeutic Class Comparison (TCC) test of the Guidelines provides that the price of a category 3 new drug product cannot exceed the prices of other drugs that treat the same disease or condition. Comparators are generally selected from among existing drug products in the same 4th level of the Anatomical, Therapeutic, Chemical (ATC) System that are clinically equivalent in addressing the approved indication.

The only other agent that falls within the same 4th level ATC class as Aranesp is Eprex (epoetin alfa). Eprex also shares the same indication as Aranesp and is used in Canada for treating anaemia in patients with chronic renal failure. Consequently, the HDAP recommended that Eprex be the sole comparator for purposes of a TCC for Aranesp.

The PMPRB's Guidelines provide that the dosage recommended for comparison purposes will normally not be higher than the maximum of the usual recommended dosage. The recommended comparable dosage regimens for Aranesp and the comparator are based on the respective product monographs and supported by clinical literature. See the following table.

Price Review:

Under the Guidelines, the introductory price of a new category 3 drug product will be presumed to be excessive if it exceeds the prices of all of the comparable drug products based on the TCC test, and if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations.

As shown in the table below, the prices of Aranesp were considered within the Guidelines relative to the TCC test as they did not exceed the prices of the other drugs in the therapeutic class or did not do so by an amount that triggered the investigation criteria.

1 Liste des médicaments, Régie de l'assurance maladie du Québec, 2003

Aranesp was also sold in France, Germany, Italy, Sweden, Switzerland, and the United Kingdom in 2002. In compliance with the Guidelines, the prices in Canada did not exceed the range of prices in those countries; the prices in Canada were lower than the prices in those countries.

Where comparators and dosage regimens are referred to in the Summary Reports, they have been selected by the PMPRB Staff and the HDAP for the purpose of carrying out the PMPRB's regulatory mandate, which is to review the prices of patented medicines sold in Canada to ensure that such prices are not excessive. The publication of these reports is also part of the PMPRB's commitment to make its price review process more transparent.

The information contained in the PMPRB's Summary Reports should not be relied upon for any purpose other than its stated purpose and is not to be interpreted as an endorsement, recommendation or approval of any drug nor is it intended to be relied upon as a substitute for seeking appropriate advice from a qualified health care practitioner.

Published in PMPRB October 2003 NEWSletter

References – Aranesp

1. Product Monograph of Aranesp (darbepoetin alfa). Amgen Canada Inc., Mississauga, ON. February 13, 2002.

2. Aranesp Physician Package Insert. Amgen Inc., Thousand Oaks, CA, USA. September 17, 2001.

3. Coyne DW, Ling BN, Toto R et al. Novel erythropoiesis stimulating protein (NESP) corrects anemia in dialysis patients when administered at reduced dose frequency compared with recombinant-human erythropoietin (abstract). J Am Soc Nephrol 2000;11(suppl):A1380.

4. Locatelli F, Olivares J, Walker R et al. Novel erythropoiesis stimulating protein for treatment of anaemia in chronic renal failure. Kidney International 2001;60:741-7.

5. Vanrenterghem Y, Barany P, Mann J et al. Novel erythropoiesis stimulating protein (NESP) maintains hemoglobin in ESRD patients when administered once weekly or once every other week. J Am Soc Nephrol 1999;10(suppl):A1365

6. Nissenson AR, Swan SK, Lindberg JS et al. Novel erythropoiesis stimulating protein (NESP) safely maintains hemoglobin concentration levels in hemodialysis patients as effectively as r-HuEPO when administered once weekly. J Am Soc Nephrol 2000;11(suppl):A1326.

7. Graf H, Lacombe JL, Braun J et al. Novel erythropoiesis stimulating protein (NESP) effectively maintains hemoglobin when administered at a reduced dose frequency compared with recombinant human erythropoietin in dialysis patients. J Am Soc Nephrol 2000;11(suppl):A1317.

8. Joy MS. Novel erythropoiesis-stimulating protein: an erythropoietin analogue with an extended half-life and less frequent dosing. Formulary 2001;36:19-25.

9. The NESP Usage Guidelines Group. Practical guidelines for the use of NESP in treating renal anemia. Nephrol Dial Transplant 2001;16(suppl 3):22-8.

10. Macdougall IC. An overview of the efficacy and safety of novel erythropoiesis stimulating protein (NESP). Nephrol Dial Transplant 2001;16(suppl 3):14-21.

11. Nissenson AR. Novel erythropoiesis stimulating protein for managing the anaemia of chronic kidney disease. Am J Kidney Diseases 2001;38:1390-7.

12. Ibbotson T, Goa KL. Darbepoetin alfa. Drugs 2001;61:2097-104.

13. Cada DJ, Levien T, Baker DE. Darbepoetin alfa. Hosp Pharm 2002;37:46-54.