Part D wave will ripple over diabetes care market

Michelle L. Kirsche

While diabetes is but one disease, its treatment represents multiple business opportunities for the drug store channel.

Beginning in January, the new Medicare Part D benefit will open the door for reimbursement for medication therapy management services, with diabetes care serving as a logical target in terms of improving patient outcomes and reducing overall health care costs. According to recent World Health Organization estimates, at least 300 million people worldwide will be living with diabetes by 2025.

Even with as much as 90 percent of the 18.2 million Americans currently living with diabetes under the care of a physician, a 10-minute office visit a few times a year may not be enough to help patients manage the disease successfully. So pharmacists are stepping up to the plate in increasing numbers.

A study appearing in the March/April issue of the Journal of the American Pharmacists Association looked at 80 community pharmacy providers certified in diabetes training that were reimbursed by local employers for providing diabetes patient care services. After one year, patients in the program reduced their glycosylated hemoglobin, or A1C, levels on average to 7.1 percent from 7.9 percent and decreased mean low-density lipoprotein cholesterol levels to 104 from 113. Patient satisfaction with overall quality of care improved to 87 percent from 57 percent after six months in the program. Most important, total mean health care costs per patient were reduced by 10 percent per patient per year based on projected expenditures.

Outside of MTMS, pharmacist care also can impact patient compliance and persistence positively.

Roger Austin, chair-elect of the pharmacy specialty practice group of the American Association of Diabetes Educators and a clinical pharmacist with the Henry Ford Health System in Detroit, recommends that pharmacists engage patients with diabetes in an interactive dialogue. Through a series of open-ended questions, patients come away with a better understanding of why the medication is necessary, how and when to take it, possible side effects and how glucose monitoring helps measure the effects of the medication. According to Austin, this kind of interchange with diabetes patients can increase the likelihood they will take their medications properly by as much as 50 percent.

Today, 53 percent of patients with diabetes take oral medications, 19 percent take insulin, and 12 percent take both insulin and oral medications, according to the National Diabetes Clearing House.

In terms of emerging therapies, Eli Lilly’s Byetta (exenatide), an injectable, received Food and Drug Administration approval in April as an add-on therapy for type 2 patients who haven’t achieved adequate control on metformin or a sulfonylurea. Byetta is predicted to reach sales in excess of $800 million by 2009.

Meanwhile, Bristol-Myers Squibb and Merck have filed a new drug application for Pargluva (muraglitazar), which has been shown to help control both blood glucose and lipid levels. If approved proved as expected in late October, sales of Pargluva could reach $950 million by 2009, according to some estimates.

Takeda also has submitted an NDA for Actoplus Met, which combines Actos and metformin to reduce the amount of glucose the liver produces in patients with type 2 diabetes.

Also currently under FDA review is Sanofi-Aventis’ Acomplia, an obesity drug that may exert direct metabolic effects on patients with type 2 diabetes.

For those patients taking insulin to manage their diabetes, currently three major pharmaceutical companies have an inhaled insulin device in advanced stages of clinical trial. Analysts project that if suppliers can bring inhaled insulin devices to market successfully, sales could exceed $5 billion.

Pfizer, working jointly with Sanofi-Aventis and Nektar Therapeutics, is closest to bringing its inhaled insulin, Exubera, to market, with FDA approval expected as soon as October. Novo Nordisk and Aradigm’s inhaled insulin system, AERx, as well as Eli Lilly and Alkermes’ inhaled insulin device called AIR Insulin, also are in late-stage clinical trials.

Newer insulin delivery devices should help boost the U.S. market for insulin, estimated to reach $2.7 billion by 2014, according to Kalorama Information, which tracks the U.S. market for blood glucose monitors growing at an annual compound rate of 7.1 percent.

COPYRIGHT 2005 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.

COPYRIGHT 2005 Gale Group

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