Report on New Patented Drugs – Infergen

Under its transparency initiative, the PMPRB publishes the results of the reviews of new patented drugs by Board Staff, for purposes of applying the PMPRB's Price Guidelines, for all new active substances introduced after January 1, 2002.

Brand Name: Infergen

Generic Name: interferon alfacon-1

DIN: 2239832 9 mcg/vial

15 mcg/vial

Patentee: InterMune Inc.

Indication (as per product monograph):

Treatment of chronic hepatitis C virus infection. Treatment of chronic hepatitis C virus infection in patients who have failed to respond or relapsed after prior administration of an interferon alpha.

Notice of Compliance: March 9, 1999

Date of First Sale: July 9, 1999

Infergen was sold from July 1999 to August 2001 by Amgen Canada Inc. The patent pertaining to Infergen was granted on September 18, 2001. InterMune Inc. began selling Infergen in January 2002 and it came under the PMPRB's jurisdiction at that time.

ATC Class: L03AB09

immunostimulants, cytokines and immunomodulators, interferons

Application of the Guidelines

Summary:

The introductory prices of Infergen at the 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 and the prices did not exceed the range of prices in other comparator countries where Infergen was sold. These prices continued to be within the Guidelines when Infergen came under the PMPRB's jurisdiction.

Scientific Review:

Infergen 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. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs.

Although there are a number of drugs in the same 4th level ATC, the HDAP recommended that only Roferon-A (interferon alfa-2a) and Intron-A (interferon alfa-2b) be included in the TCC for Infergen as they were clinically equivalent in addressing the approved indication.

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 Infergen and the comparators are based on their respective product monographs and supported by clinical literature.

Price Review:

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

The price of Infergen 9 mcg/vial was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.

A Reasonable Relationship Test was conducted for Infergen 15 mcg/vial as this represented a second presentation of the same DIN. The introductory price of Infergen 15 mcg/vial ($58.651) was considered to be within the Guidelines because it bore a reasonable relationship to the price of Infergen 9 mcg/vial.

1 Association québécoise des pharmaciens propriétaires (AQPP), October 2003
2 AQPP, April 2002
3 Ontario Drug Benefit Formulary, 2002

At the time of introduction, Infergen 9 mcg/vial was also being sold in France, Germany, Italy and the United States; Infergen 15 mcg/vial was only being sold in the United States. In compliance with the Guidelines, the price in Canada did not exceed the range of prices in these countries; the price of Infergen 9 mcg/vial was 3rd highest, below the median, and the price of Infergen 15 mcg/vial was lower than the price in the United States.

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.

Evidence/References:

Manns MP et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001 Sep 22;358(9286):958-65
Gray J (ed). Therapeutic Choices, 3rd edition. Canadian Pharmacists Association, 2000; Ottawa.
Drug Product Database on the Health Canada Website.

Welbanks L, editor. Compendium of Pharmaceuticals and Specialties, 37th Edition. Canadian Pharmacists Association, 2002, Ottawa.
Levine M. Drugs of choice : A formulary for general practice. Canadian Medical Association, 1995, Ottawa.
Levien T, Baker DE. Hyaluronic acid and interferon alfacon-1. Hospital Pharmacy 1998;33(6):713-26.

Fawziah M. Treatment of hepatitis C. The CE Advisor. Hospital Pharmacy Practice 1998;5(3):1-9.
Lam NP. Hepatitis C: Natural history, diagnosis and management. AM J Health-Syst Pharm 1999;56(10):961-75
Liang TJ. Combination therapy for hepatitis C infection. N Engl J Med 1998;339(21):1549-50.

Tong MJ et al. Treatment of chronic hepatitis C with consensus interferon: A multicenter, randomized, controlled trial. Hepatology 1997;26(3):747-754.
Heathcote JE et al. Re-treatment of chronic hepatitis C with consensus interferon. Hepatology 1998;27(4):1136-1143.
Product Monograph: Infergen, February 19, 1999.

CDC: Recommendations for prevention and control of (HCV) infection and HCV-related chronic diseases. October 16, 1998. Accessed on the web: www.cdc.gov.