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Evidence-Based Diabetes Management June 2019
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Managing Costs in Diabetes Means Intervening Early to Avoid Complications Later, Experts Say

Mary Caffrey
The Los Angeles gathering of the Institute for Value-Based Medicine focused on the need to intervene early in the course of diabetes, so that patients can avoid long-term complications. Over the past decade, cardiovascular outcomes trials for glucose-lowering therapies have revealed unexpected benefits, offering new opportunities for cardiologists. 
Watson said the document has 3 essential points: (1) Cardiologists should screen for T2D, (2) they should treat the risk factors, and (3) they should treat with antihyperglycemic agents, specifically SGLT2 inhibitors and GLP-1 receptor agonists. “We understood that when we put out this document, cardiologists would need a lot of hand-holding.”

The document further identified empagliflozin as the preferred SGLT2 inhibitor, and liraglutide as the preferred GLP-1 receptor agonist; as Peters did, Watson identified SGLT2 inhibitors as the preferred class for those at risk of heart failure. If patients have osteoporosis, are overweight, or are at risk for amputation, GLP-1 receptor agonists may be the better choice.

SGLT2 inhibitors, Watson noted, compare favorably in treating heart failure to many drugs developed specifically to target this condition; several trials are studying this class in heart failure for patients with and without diabetes. The first studies will report findings in 2020.11-15 “I’m putting my money on the agents,” she said.

Evidence Propels Change in Thinking

Prescribing antihyperglycemic agents is just one area where cardiologists have shifted their thinking in light of new evidence, Watson said. Besides ACC’s Expert Consensus Pathway, updated primary prevention guidelines16 reflect recent findings:

Aspirin. Watson said the ASCEND trial results, which showed that taking aspirin for primary prevention reduced vascular events but was offset 1:1 by bleeding risk, was “the nail in the coffin” for giving aspirin to older adults who do not have coronary heart disease.17 Under the new primary prevention guideline, ACC has sharply curtailed who is recommended to receive daily aspirin. 

Hypertension. New guidelines adopted in 2017 by ACC and the American Heart Association redefined what constitutes high BP and lowered the threshold for treatment, based on the SPRINT study results.18,19 BP ≤120/80 mm Hg or below is considered normal. Systolic BP >120 and ≤130 mm Hg is elevated; stage 1 high BP is defined as systolic BP >130 and ≤139 mm Hg or diastolic BP >80 and ≤89 mm Hg. Stage 2 high BP is defined as systolic BP <140 mm Hg or diastolic BP <90 mm Hg.

Cholesterol. Watson was an author on the 2013 guidelines that identified 4 groups that need statins: (1) patients who have had an event, (2) patients with low-density lipoprotein (LDL) cholesterol above 190 mg/dL, (3) patients with diabetes, and (4) very-high-risk primary prevention patients, based on age and other factors.

The idea of cardiologists screening for diabetes and treating risk factors is new, but necessary, Watson said. “If we don’t do something to improve outcomes in patients with diabetes, they’re going to keep having events, and that’s why cardiologists are going to become diabetologists.”

Organizing Healthcare Delivery Around the Whole Patient

So, if every patient just gets the right medication, we can solve this problem called diabetes, right? If only.

CareMore’s Jain reminded the providers gathered at the session of a disturbing fact: “We are developing 21st century medicine with a 19th century delivery model,” he said. The idea that closing the gaps in healthcare is as simple as making patients better consumers might make sense to economists and people who don’t practice medicine, Jain said. Then he shared an anecdote that illustrated how the solutions being developed for consumers don’t always match the needs—or desires—of the people who use the most healthcare.

Early in his career, Jain served in the Office of the National Coordinator (ONC) for Health Information Technology. So, when he was home visiting his family recently, his mother asked him to put that experience to use and set up all her patient portals with her doctors. The bell went off that so much money and time has been expended on something that has very little value for his mother. “There is the false idea that people want to use this stuff,” he said, that patients are going to order healthcare the way they order things on Amazon.

Patients with chronic disease, the kind of patients that CareMore sees, are likely not using this type of technology in a meaningful way. The health system held a town hall with them at a hotel and listened to what the patients had to say.

“Healthcare should anticipate and deliver on people’s needs,” he said. Instead of giving them choices they don’t understand, healthcare should understand that expertise matters and that the cheapest solution may not be the best one. The idea that poor people need “skin in the game” to responsibly use healthcare is also out of touch. “People should not pay out of pocket for the things they need,” he said. “We should not have co-pays for the things that people need to live,” such as insulin.

If health systems want to keep patients from returning to the hospital, then things like using Lyft to get them home, ensuring there’s a healthy meal waiting for them when they arrive, making sure they have social contacts, and confirming that they see the same doctor for follow-up care all matter.

CareMore has pioneered services like toenail clippings because they offer regular touch points with the healthcare system, Jain said. When the average daily cost of a hospital bed in Los Angeles County is $3500 to $4000, he said, “You can buy a lot of prevention” by focusing on cost avoidance. 

CareMore integrates dental coverage and uses a patient’s time in the chair to check on other vital signs. Its Togetherness Program touches at-risk seniors who either live alone or need support to adhere to medications or get engaged in community or fitness programs. 

How does CareMore do it? The fully integrated care and delivery system for Medicare and Medicaid patients is fully at risk, because as Jain puts it, CareMore’s way of doing things would not be possible in “our broken fee-for-service delivery system.”

“We believe risk is freedom,” he said.

So, when Butler asked how to explain why the field of diabetes has better drugs than ever, but the average A1C is not better than it was 10 years ago, Jain said the need to reinvent the delivery system is the issue.

“A lot of the talk in health policy is around delivery science,” he said. “A lot of what we need is more common sense. Radical common sense.”

References

1. American Diabetes Association. Economic costs of diabetes in the US in 2017. Diabetes Care. 2018;41(5):917-928. doi: 10.2337/dci18-0007.

2. Kaiser AB, Zhang N, van der Pluijm W. Global prevalence of type 2 diabetes over the next ten years (2018-2028). Diabetes. 2018;67(suppl 1). doi: 10.2337/db18-202-LB.

3. Zinman B, Wanner C, Lachin JM, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-2126. doi: 10.1056/NEJMoa1504720.

4. Neal B, Perkovic V, Mahaffey KW, et al, for the CANVAS investigators. Canagliflozin and cardiovascular and renal events in type 2 diabetes.N Engl J Med. 2017;377(7):644-657. doi: 10.1056/NEJMoa1611925.

5. Wiviott SD, Raz I, Bonaca MP, et al, for the DECLARE TIMI 58 investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;308(4):347-357. doi: 10.1056/NEJMoa1812389.

6. Kosiborod M, Cavender MA, Fu AZ, et al. Lower risk of heart failure and death in patients initiated on sodium-glucose cotransporter-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study (comparative effectiveness of cardiovascular outcomes in new users of sodium-glucose cotransporter-2 inhibitors). Circulation.
2017;136(3):249-259. doi: 10.1161/CIRCULATIONAHA.117.029190.

7. Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013;36(8):2271-2279. doi: 10.2337/dc12-2258.

8. Rates of new diagnosed cases of type 1 and type 2 diabetes on the rise among children teens [press release]. Bethesda, MD: National Institutes of Health; April 13, 2017. nih.gov/news-events/news-releases/rates-new-diagnosed-cases-type-1-type-2-diabetes-rise-among-children-teens. Accessed May 6, 2019.

9. FDA Center for Drug Evaluation and Research. Guidance for industry: diabetes mellitus – evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. fda.gov/downloads/Drugs/Guidances/ucm071627.pdf. Published December 2008. Accessed December 4, 2018.

10. Das SR, Everett BM, Birtcher KK, et al. 2018 ACC expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2018;72(24):3200-3223. doi: 10.1016/j.jacc.2018.09.020.

11. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). clinicaltrials. gov/ct2/show/NCT03057951. Updated December 11, 2018. Accessed December 10, 2018.

12. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). clinicaltrials. gov/ct2/show/NCT03057977. Updated December 11, 2018. Accessed December 10, 2018.

13. Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure (DAPA-HF). clinicaltrials.gov/ct2/show/NCT03036124. Updated October 15, 2018. Accessed December 10, 2018.

14. Dapagliflozin Evaluation to Improve the LIVEs of Patients With Preserved Ejection Fraction Heart Failure. (DELIVER). clinicaltrials.gov/ct2/show/NCT03619213. Updated November 29, 2018. Accessed December 10, 2018.\

15. Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial). clinicaltrials.gov/ct2/show/NCT03521934. Updated December 10, 2018. Accessed December 10, 2018.

16. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 S0735-1097(19)33876-8. doi: 10.1016/j. jacc.2019.03.009.

17. ASCEND Study Collaborative Group. Bowman L, Mafham M, Wallendszus K et al. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med. 2018;379(16):1529-1539. doi: 10.1056/NEJMoa1804988.  

18. Arnett DK, Blumenthal RS, Albert MA, et al, for the Writing Committee. 2019 ACC/AHA Guideline on the primary prevention of cardiovascular disease: Executive Summary. [published March 17, 2019]. J Am Coll Cardiol. doi: 10.1016/j.jacc.2019.03.009.

19. The SPRINT Research Group. A randomized trial of intensive versus standard blood pressure control. N Engl J Med. 2015;373:2103-2116. doi: 10.1056/NEJMoa1511939.
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