The Expanding Role of New Medications in the Treatment of Type 2 Diabetes Mellitus | Page 3
Published Online: August 21, 2013
Kristen Harrison, MPH; Frederick Brown, PharmD; Brandeis Seymore, RPh; Anthony Palmieri, PharmD, MBA; Olga S. Matlin, PhD; and Steven M. Kymes, PhD
It should be noted, however, that incretin-based therapies have signifi cant shortcomings. GLP-1 receptor agonists require subcutaneous administration, which can be a challenge for elderly diabetics. There is also the concern of a potential link between people being treated with GLP-1 receptor agonists or DPP-4 inhibitors and pancreatitis and pancreatic cancer.8,9,11 It must also be recognized that the enhanced efficacy of the incretin based therapies comes at a higher fi nancial cost. The cost of pharmaceutical treatment of people with diabetes has been rising since 2008 in spite of a decline in the cost of biguanides and sulfonylureas. This has been largely due to the adoption of incretin-based therapies that have a higher cost than these first-line therapies. We estimate that in 2012, the cost of incretin-based medications added $282 per utilizer per year to the cost of treatment for the average person with T2DM. Extrapolating this to the total population of people with T2DM in the United States,this represents an annual burden of $6.6 billion to the US healthcare system. Given the trend toward increased use of these medications, we would expect to see the economic burden increasing by over $2.9 billion annually over the next few years. However, at least a portion of the increased costs for medication may be offset by lower healthcare expenditures for diabetics who benefi t from improved glycemic control and fewer side effects. Pharmaceutical manufacturers have continued to invest heavily in the development of incretin-based therapies. In 2013, 3 new medications were approved for the US market: Nesina (alogliptin), Kazano (alogliptin/metformin), and Oseni (alogliptin/pioglitazone) by Takeda Pharmaceutical.12,13 Alogliptin, an active ingredient in each of these medications, is a new DPP-4 inhibitor.13 Several new incretin-based therapies are also pending US Food and Drug Administration approval or are in phase 3 clinical trials in the United States (Table 4).
It is a limitation to our analysis that we excluded members who were on insulin. We recognize that this eliminates from our analysis a substantial subgroup of people. However, we felt it to be very important that we eliminate from our analysis people with type 1 diabetes, or other non–type 2 conditions that would reduce the applicability of our results to people with T2DM. It is likely that this approach led to a very modest underestimation of the absolute prevalence and incidence of diabetic medication use (we suspect that our prevalence estimate is at most 1.5 points below the true prevalence and the incidence estimate is at most 0.2 points below the true incidence). However, comparisons between the medications would be affected only to the extent that insulin use would be associated more with one medication than another. As there is no reason to expect that to be the case, these comparisons are likely to be unbiased.
Incretin-based therapies have proved to be effective in the treatment of people with T2DM who are not responsive to fi rst-line therapy with biguanides and sulfonylureas. As medical therapies for T2DM advance, so do the complexities of recommended treatment options. The role of incretin-based therapies will likely evolve and continue to challenge formulary managers and payers weighing effectiveness and cost in management of people with T2DM.
Author Affiliations: From the Division of Enterprise Analytics (KH, OSM, SMK), CVS Caremark, Northbrook, IL; Clinical Sales and Account Services (FB, BS, AP), CVS Caremark, Northbrook, IL
Author Disclosures: The authors report no relationship or fi nancial interest with any entity that would pose a confl ict of interest with the subject matter of this article.
Funding Source: None reported.
Address correspondence to: Steven M. Kymes, PhD, CVS Caremark, 2211 Sanders Rd NBT 326, Northbrook, IL 60062. E-mail: Steven.Kymes@caremark.com.
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15. GSK announces positive data from Harmony 8 and completion of clinical registration package for albiglutide in type 2 diabetes. http://us.gsk.com/html/medianews/pressreleases/2012/2012-pressrelease-1178461.htm. (See also Harmony 7 results at http://us.gsk.com/html/media-news/pressreleases/2012/2012-pressrelease-1125277.htm.) Accessed May 3, 2013.
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17. Lilly announces positive results of phase III trials of dulaglutide in type 2 diabetes. Eli Lilly and Company Newsroom Press Release. April 16, 2013.
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20. The once-weekly human GLP-1 analogue semaglutide provides signifi cant reductions in HbA1c and body weight in patients with type 2 diabetes. Novo Nordisk website. http://www.novonordiskscientifi cmaterial2012.com/EASD/Presentations/2.pdf. Accessed May 2, 2013.
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22. Phase IIb data showed Merck’s investigational once-weekly DPP-4 inhibitor MK-3102 significantly lowered blood sugar in patients with type 2 diabetes: phase III trials of MK-3102 underway. Merck website. http://www.mercknewsroom. com/press-release/research-and-development-news/phase-iib-datashowed-mercks-investigational-once-weekly. Accessed May 6, 2013.
23. The final phase 3a trial for IDegLira completed, and FIAsp approved for phase 3 development. Novo Nordisk website. http://www.novonordisk.com/include/asp/exe_news_attachment.asp?sAttachmentGUID=eb27510c-b564-43b8-a3b0-f9fc2d833f16. Accessed May 2, 2013.
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