Report on New Patented Drugs - Orgalutran

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: Orgalutran

Generic Name: ganirelix acetate

DIN: 02245641 250 mcg/syringe

Patentee: Organon Canada Ltd.

Indication - as per product monograph: For the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH).

Notice of Compliance: May 1, 2002

Date of First Sale: August 23, 2002

ATC Class: H01CC01
Systemic Hormonal Preparations, excluding Sex Hormones and Insulins, Pituitary and hypothalamic hormones and analogues, Hypothalamic hormones, Anti-gonadotropin-releasing hormones

Application of the Guidelines:

Summary:

The introductory price of Orgalutran was 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 price did not exceed the range of prices in other comparator countries where Orgalutran was sold.

Scientific Review:

Orgalutran 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 Guidelines provide that it may, however, be appropriate to include products from other ATC classes if they are clinically equivalent for the appropriate indication to the drug product under review. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs.

In 2002, there were no other products on the Canadian market that shared the same 4th level ATC as Orgalutran. The HDAP recommended that Suprefact injectable (buserelin) and Lupron (leuprolide) be included as comparators for the conduct of the TCC for Orgalutran as these share similar indications and clinical use.

Controlled ovarian hyperstimulation in assisted reproduction techniques is usually attempted by using combination therapy. Differing doses of gonadotrophin releasing hormone agonists, antagonists and folicle stimulating hormone (Gonal-F) are required to achieve successful pregnancies in assisted reproduction techniques. As a result, the HDAP recommended that the combination of Orgalutran and

Gonal-F be compared to the combination of Gonal-F with the identified comparable medicines for purposes of the TCC.

The 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 Orgalutran and the comparators are based on product monographs, guidelines and published clinical trials.

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 prices of all of the comparable drug products in 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 Orgalutran was within the Guidelines, as the cost of therapy did not exceed the cost of therapy for the comparator medicines.

1 PPS Pharma, 2003
2 PPS Pharma, 2002
3 Ontario Drug Benefit Formulary, 2002

In 2002, Orgalutran was also being sold in France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States. In compliance with the Guidelines, the price in Canada did not exceed the range of prices in those countries. The price in Canada was second highest, above the median international price.

Evidence/References:

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.

References:

1. Product monograph of Orgalutran (ganirelix acetate injection).dated April 5, 2002.

2. Anon. Ganirelix: a well tolerated option for use in the treatment of female infertility. Drugs and Therapy Perspectives 2000;16(4):1-4.

3. Gillies RS, Faulds D, Barman Balfour JA, Perry CM. Ganirelix. Drugs 2000;59(1):107-11.

4. Borm G, Mannaerts B. Treatment with the gonadotropin-releasing hormone antagonist ganirelix in women undergoing ovarian stimulation with recombinant follicle stimulating hormone is effective, safe and convenient: results of a controlled, randomized, multicentre trial. Human Reproduction 2000;15(7):1490-8. (Electronic)

5. Van Hooren HG. Comparable clinical outcome using the GnRH antagonist ganirelix or a long protocol of the GnRH agonist triptorelin for the prevention of premature LH surges in women undergoing ovarian stimulation. Human Reproduction 2001;16(4):644-51. (Electronic)

6. Fluker M, Grifo J, Leader A, et al. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril 2001;75(1):38-45.

7. El-Nemr et al. Clinical evaluation of three different gondotropin-releasing hormone analogues in an IVF programme: a prospective study. European Journal of Obstetrics and Gynecology and Reproductive Biology. 103(2002);140-145.