Report on New Patented Drugs - BLES

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.

BLES

Brand Name: BLES

Generic Name: Bovine lipid extract sufactant

DIN: 02245464 27 mg/ml suspension

Patentee: BLES Biochemicals Inc.

Indication (as per product monograph):

For rescue treatment of Neonatal Respiratory Distress Syndrome (NRDS/Hyaline Membrane Disease).

Notice of Compliance: February 4, 2002

Date of First Sale: February 5, 2002

ATC Class: RO7AA02

Other Respiratory System Products

Lungsurfactants

Application of the Guidelines:

Summary:

The introductory price of BLES 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. Because BLES is only sold in Canada, the price could not be compared to the price in foreign countries.

Although BLES was first sold in 2002, it was not reported to the PMPRB for price review purposes until 2003.

Scientific Review:

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

Neonatal respiratory distress syndrome (NRDS) is a condition of increasing respiratory distress, commencing at, or shortly after birth. It is due to insufficiency of pulmonary surfactant and is mainly confined to preterm infants.

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.

At the time of introduction, there were two other medicines in the same 4th level class indicated for NRDS, Exosurf Neonatal (colfosceril palmitate) and Survanta (beractant), available in Canada. The HDAP identified both of these medicines as comparators.

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

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 price 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 BLES was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.

* Price filed by BLES Biochemicals Inc.
** PPS Pharma price (Premiere Pharmaceutical Product Reference Publication 2002)

BLES was not sold in any of the other countries listed in the Regulations at the time of its introduction on the Canadian market in 2002. In compliance with the Guidelines, at such time as it may become sold in any of the seven countries listed in the Regulations, the price in Canada cannot exceed the range of 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.

References – BLES

Product monograph of Survanta (beractant), Abbott Laboratories Ltd., St‑Laurent, PQ, February 12, 2002.

Product monograph of Exosurf (colfosceril palmitate), GlaxoSmithKline, Mississauga, ON, June 9, 2000.

Product monograph of BLES (bovine lipid extract surfactant), BLES biochemicals Inc., London, ON, February 4, 2003.

Peliowski A. A randomized, controlled, double-blinded multicenter trial to compare synthetic surfactant (Exosurf) with bovine surfactant (bovine lipid extract surfactant) for the treatment of respiratory distress syndrome of the newborn. Summary data presented to Health Canada within the Canadian New Drug Submission for BLES.

Ishisaka D. Exogenous surfactant use in neonates. Ann Pharmacother 1996;30:389-98.

Baroutis G et al. Comparison of tree treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome. Eur J Ped. Springer-Verlag 2003. 10.1007/s00431-002-1144-0.

Neonatal Respiatory Distress Syndrome. Neonatal electronic library for health. Acessed on line at: http://www.nelh.shef.ac.uk/nelh/kit/ch/docs.nsf/doc-k