Intellectual Property Protection and Drug Plan Coverage: Evidence From Ontario

Canada has strengthened intellectual property (IP) protections for pharmaceutical drugs several times over the last 3 decades. This study investigates whether the IP changes had an effect on the market exclusivity time of brand products on the Ontario Drug Benefit (ODB) formulary. We constructed a database that included the first brand approval date for drugs launched between 1974 and 2012, the first ODB listing date of the brand drug, and the first ODB listing date of the generic form of the drug. We then calculated the time of formulary exclusivity to detect any changes in market exclusivity times associated with changes to Canada’s IP regimen. There were 595 drugs launched between 1974 and 2012 that were available for analysis. Exclusivity gradually declined from the late 1970s to 1990. Drugs approved in 2004 received 7.6 years of exclusivity, and drugs approved in 2005 received 5 years of exclusivity. Over the time period we analyzed, market exclusivity time of brand drugs experienced marked changes, but we did not detect any systematic effects of Canada’s stronger pharmaceutical IP laws on the market exclusivity.

Sex/Gender -Based Pharmacology and Statin Utilization Amongst Elderly Patients with Diabetes

Purpose: The purpose of this study was to explore the ten-year trends in utilization of bioequivalent doses of statin amongst elderly patients with diabetes according to sex/gender in Ontario, Canada. Methods: A cohort of patients with diabetes (>65 years) was constructed using the Ontario Diabetes Database Statin utilization data (2003-2012) was obtained from the Ontario Drug Benefit Program for both women and men. Bioequivalent doses for statins were calculated according to the dosing conversion factor in therapeutic interchange programs in clinical practice. Utilization pattern of high potency (Atorvastatin and Rosuvastatin) vs. low potency statins (Simvastatin, Lovastatin, Fluvastatin, Pravastatin) were also analyzed. Results: The average bioequivalent Simvastatin utilization in 2003 was 29.22 mg/day for women and 30.35 mg/day for men. By 2008, this gap in dosing was higher for both women and men and by 2013 it had increased to 47.75 mg/day for women and 52.98 mg/day for men. For average number of day supply per year, there was no significant trend of changes over the 10-year period, although the use of high potency statins increased significantly (P

Prescribing and Drug Costs in the Province of Ontario

The Report of the Pharmaceutical Inquiry of Ontario documented dramatic increases in the cost of the Ontario Drug Benefit (ODB) program. This article demonstrates that the rise in ODB costs for those 65 and over is due to two factors: more intensive prescribing—physicians prescribing to the elderly more often and writing more prescriptions each time they see an elderly patient—and physicians writing prescriptions for more expensive drugs. Neither of these two changes in prescribing behavior has resulted in any demonstrable improvement in the health of the elderly. Efforts to control costs through some form of copayment or by eliminating some drugs from the ODB formulary should not be undertaken since they probably will result in a reduction in the use of medically necessary drugs. Ultimately, drug costs will only be controlled by improving the appropriateness of physicians' prescribing.