Comparative net cost impact of the utilization of romiplostim and intravenous immunoglobulin for the treatment of patients with immune thrombocytopenia in Québec, Canada.

OBJECTIVES: Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by platelet destruction, sub-optimal platelet production, and mild-to-severe bleeding. Nplate® (romiplostim), a thrombopoietin receptor agonist, and intravenous immunoglobulin (IVIg), an expensive and occasionally scarce blood product, are used in the treatment of ITP. The objective of this study was to compare the total cost of treating patients with romiplostim vs IVIg in Québec, Canada. METHODS: A net cost impact model was developed to calculate the annual cost of romiplostim compared with IVIg based on actual practice observations in all patients (n = 95) treated for chronic ITP with IVIg from April 2010 to March 2011 in two participating hospitals. The model included costs of: drug acquisition, drug preparation and administration, patient monitoring, and indirect costs. Healthcare practitioners were consulted regarding romiplostim and IVIg treatment algorithms and the resources involved in patient monitoring. RESULTS: The average annual drug acquisition costs of romiplostim and IVIg were $48,024 and $98,868, respectively. Lower costs for drug preparation and administration ($309 vs $1245) and less time lost from work ($256 vs $2086) were attributed to romiplostim. The cost of follow-up monitoring was the same for both romiplostim and IVIg ($121). The total average annual per patient costs for romiplostim vs IVIg were, respectively, $48,710 and $102,320. The use of romiplostim was projected to save, on average, almost $54,000 per patient per year. LIMITATIONS: The study was conducted in two hospitals in Québec. Romiplostim may show different cost savings in other hospitals and other provincial and national jurisdictions. CONCLUSIONS: Scarce blood products must be used wisely. Romiplostim can allow for improved healthcare resource allocation by reserving IVIg for use in other areas of greater need while also providing cost savings for the overall provincial healthcare budget.

Insulin glargine for type 2 diabetes.

Insulin glargine is a biosynthetic human insulin analogue that controls blood glucose levels over 24 hours without a pronounced peak. In most studies in patients with type 2 diabetes mellitus (DM), insulin glargine did not significantly reduce fasting blood glucose, fasting plasma glucose or hemoglobin A1c compared to NPH insulin. Most trials showed a statistically significant decrease in the incidence of nocturnal and symptomatic hypoglycemia. This may not be as much of a concern in most patients with type 2 DM compared to type 1 DM. Current evidence suggests that patients who are adequately controlled with NPH insulin will not gain additional benefit from insulin glargine.

Insulin glargine: a long-acting insulin for diabetes mellitus.

Insulin glargine is a once-daily, biosynthetic, human insulin analogue. Some trials show that in patients with type 1 diabetes mellitus, insulin glargine offers an advantage in blood glucose control compared with NPH insulin. There is some evidence of decreased nocturnal and symptomatic hypoglycemia in patients receiving insulin glargine compared with those receiving NPH insulin, but there are no significant differences in the incidence of severe hypoglycemia. Insulin glargine is approved for use in Canada, but it has not yet been marketed.

Atomoxetine for attention deficit/hyperactivity disorder.

Seven randomized, double-blinded, controlled trials in children, adolescents and adults have shown that atomoxetine improves attention deficit/hyperactivity disorder (ADHD) symptoms compared to placebo. There is no evidence that atomoxetine has greater efficacy or a better safety profile than currently used therapy. Atomoxetine has been submitted for regulatory approval in Canada and is currently approved in the US. The price of atomoxetine in Canada has not been established.

Drug eluting stents: managing coronary artery stenosis following PTCA.

Drug eluting stents (DES) release drugs that inhibit tissue growth in narrowed coronary arteries in an effort to prevent restenosis, a renarrowing of the artery. Several types of DES are under investigation in clinical trials; however, none are currently approved for use in Canada. Preliminary trial data are encouraging, demonstrating greater lumen diameter and reduced restenosis with DES versus uncoated stents. If DES prove to be more effective than uncoated stents in the treatment and/or prevention of restenosis, this technology may diffuse rapidly. The total health care costs, including the cost of the stents, post-intervention therapy and possible re-intervention costs, will require assessment to determine the ultimate impact of DES.

Fondaparinux for post-operative venous thrombosis prophylaxis.

Fondaparinux (Arixtra TM ) belongs to a new class of synthetic antithrombotic agents called pentasaccharides. It was recently approved in Canada for the prevention of venous thromboembolic events (VTE) in patients undergoing orthopedic surgeries of the lower limbs such as hip fracture, knee surgery and hip replacement surgery. Fondaparinux was more efficacious in three of four phase III trials comparing fondaparinux and enoxaparin for the prevention of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients undergoing major orthopedic surgery. However, there was no difference in the incidence of pulmonary embolism (PE) between the two treatment groups in any of the four trials. The overall major bleeding rate associated with fondaparinux was higher than the rate associated with enoxaparin, although the statistical significance of this difference is inconsistent.

Activated protein C for severe sepsis.

Severe sepsis is a systemic inflammatory response to infection involving organ dysfunction. Severe sepsis is a common cause of death and is associated with a 20% to 56% mortality rate. Drotrecogin alpha (activated) is a recombinant human activated protein C(rhAPC) approved in the U.S. for the reduction of mortality in adult patients with severe sepsis who have a high risk of death. Drotrecogin alpha (activated), when administered to adult patients with clinically defined severe sepsis, demonstrated a 6.1% absolute reduction (p=0.005) in 28-day all-cause mortality in one published, randomized, double-blind study of 1,690 patients (PROWESS). Drotrecogin alpha (activated) is used as an adjunct to standard therapy and is therefore and "add-on" cost. Close attention must be paid to proper patient selection for treatment with drotrecogin alpha (activated). Certain individuals, such as those at a greater risk of bleeding, could be harmed from therapy. The benefit or harm in individuals not meeting the trial selection criteria is uncertain.