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13 introduced in 2011, only 1 per cent was ranked as breakthrough and only 5 per cent were classed as Substantial Improvement. 10 Subsequently, prices can rise at a rate no faster than amoving average of the Canadian consumer price index. There is currently no process for the PMPRB to reset Therapeutic Class prices over time if market conditions change. 10 Michelle Boudreau, Executive Director, PMPRB, presentation at Pharma Pricing and Market Access Outlook Europe 2013 conference in London, UK (http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1511) Expanding Indications Impacts on Potential Market Demand: Case of Remicade The experience of the drug Remicade over the last decade illustrates the significant impact expanding indications over time can have on the potential market for a new drug. Remicade is Canada's second largest drug product, with sales of over $500 million. It was first approved in 2001 for Crohn's disease and its price was set accordingly. The cost of Remicade can vary by patient based on body weight and indication, but generally has an annual cost of about $35,000 per patient. Since 2001, Remicade has been approved for an additional eight indications. While it is important to note that not all individuals with these conditions will be prescribed Remicade, based on the incidence of these additional indications in Canada, it is clear that there has been a material increase in the potential market for Remicade since launch. It should be noted that in addition to these additional indications, Remicade has also been used in off-label prescribing for auto- immune disorders such as Lupus and Graft versus Host disease, further increasing its potential market. Indication Number of Canadians Impacted Original Indication Crohn's Disease 130,000 Expanded Indications Ulcerative Colotis 88,500 Reumatoid Arthritis 300,000 Anklyosing Spondylitis 300,000 Psoriatic Arthritis 250,000 Plaque Psoriasis 470,000 Lupus 50,000 Total 1,588,500 Even though Remicade's potential market had dramatically increased, no follow-up review of its therapeutic class price has been undertaken by the PMPRB and, as a result, Remicade's price has remained constant over this period.