How much would this cost? There are currently 30 to 35 new active substances approved each year , but several of these are only used in the hospital setting or in special institutions, such as cancer treatment centres, and schemes to evaluate the effectiveness and safety of these drugs should already be in place. Consequently, the number of new drugs suitable for conditional release is approximately 15 per year. From a small sample of new drugs approved in 1997 that are normally used in the outpatient setting, the average annual cost of treatment per person in 1998 was approximately $1,500 (personal communication, IMS Health Canada) so that the estimated cost for 10,000 patients receiving a new drug is $15 million per year ($225 million for 15 Canadian drugs). While these figures may seem expensive and may limit the number of drugs that can be monitored under conditional release each year, it is worth noting that more than $10 billion is spent annually on drugs.
Once a full NOC is granted, provincial and private insurers will have the opportunity to examine cost effectiveness data collected during the conditional release phase to decide whether the drug should receive permanent listing status on their formularies. The granting of a full NOC would not guarantee listing on any formulary. This process may require the introduction of more effective and timely methods for the removal of drugs from provincial formularies.