Stumbling Toward Access to Evidence-Based Care for the Chronic Disease of Obesity

September 18, 2015

Many hoped the 2013 declaration by the American Medical Association that obesity is a disease would open the door to improved coverage for pharmcotherapy. That did not happen right away, but signs of change are emerging.

One of the most substantial medical and financial threats to American healthcare is untreated obesity. Although options and guidelines for pharmacotherapy are growing, access to care is falling behind advances in treatment.

A COMPLEX, CHRONIC, AND COSTLY DISEASE

Obesity is a complex, chronic, and costly disease that has been shown to be the key driver behind 4 of the 10 most deadly and expensive diseases worldwide—ischemic heart disease, stroke, hypertension, and diabetes. More than one-fourth of total healthcare expenses in the United States are attributable to the rise in the prevalence of excess weight and obesity.1 Obesity has been characterized as the greatest threat to American health for this century,2 and it is rapidly becoming apparent that obesity will soon undermine the affordability of American healthcare, due to the epidemic of chronic diseases it is causing.3

In 2013, the American Medical Association (AMA) joined with the National Institutes of Health, the Obesity Society, the American Association of Clinical Endocrinologists, and the Endocrine Society in recognizing obesity as a complex chronic disease that requires a range of interventions for treatment and prevention.4 Because of the symbolic significance of this decision, it has been both hailed as a significant milestone to pave the way for more evidence-based obesity care and criticized by others as “medicalizing” a condition associated with unhealthy lifestyles.

ACCESS TO CARE HAS BEEN LIMITED AND EXTREMELY VARIABLE

Historically, access to evidence-based care for obesity has been limited by the small number of healthcare providers skilled in obesity treatment, by inadequate treatment options, and by poor coverage in health plans. Responding to the need for more skilled providers, the American Board of Obesity Medicine has now certified 1182 diplomates in the emerging specialty of obesity medicine.

The number of diplomates continues to grow, with more than 400 physicians taking the exam in 2014.5,6 The primary tools for evidence-based obesity care are intensive behavioral therapy (IBT), pharmacotherapy, and surgery. Coverage for IBT is improving under the Affordable Care Act (ACA) because of the requirement that effective preventive services (as determined by the US Preventive Services Task Force) be covered by health plans without any cost to patients. IBT is one of these services.

As evidence for the effectiveness of bariatric surgery has grown, coverage for bariatric surgery by health plans for people with severe obesity has also increased, though both patients and surgeons report that problems remain.7

Coverage for pharmacotherapy has been the most restricted of the options for obesity treatment. Drugs used for obesity treatment often have been considered “lifestyle” drugs and have been routinely excluded from prescription benefit programs, as is notably the case for Medicare Part D. In 2010, most health plans reported that 20% or fewer employers were including coverage for obesity medications in their benefits. Under the ACA, while 23 states classify bariatric surgery as an essential health benefit, only 5 states classify medical obesity treatment as an essential benefit.8 Poor coverage for obesity medications has been identified as a key barrier to the development and introduction of improved therapies.9

Limited coverage of pharmacotherapy for obesity leaves both clinicians and patients with a substantial gap in options. Between low success rates with diet and exercise and much higher efficacy at a much higher cost with bariatric surgery, new and effective obesity drugs are often unaffordable.

EVIDENCE-BASED OPTIONS ARE GROWING AND GUIDELINES ARE EVOLVING

In 2013, the American Heart Association, American College of Cardiology, and the Obesity Society jointly issued new evidence-based guidelines for the management of overweight and obesity in adults.10 These guidelines affirmed that clinical care to reduce weight by as little as 3% and prevent further weight gain can yield significant health benefits.

Those guidelines were followed in 2014 by new evidence-based guidelines of the Endocrine Society, the European Society of Endocrinology, and the Obesity Society for the pharmacological management of obesity.11 These drug treatment guidelines affirm the value of medications approved for chronic weight management as an adjunct to behavioral therapy for diet and exercise. They also emphasize the importance of considering the weight effects of other drugs that patients with obesity may be receiving.

Responding to the medical need for better treatment options in obesity, the FDA has approved 4 new obesity medications since 2010: phentermine/topiramate, lorcaserin, bupropion/naltrexone, and liraglutide. Each of these drugs met FDA criteria for efficacy, namely providing sustainable weight loss of 5% or more—either on average or in more than 50% of patients treated. Consistent with guidelines for obesity care, this level of efficacy was shown for each of these new drugs to provide significant improvements in diabetes, cardiovascular disease, and quality of life.

However, incorporation of these new drugs into clinical care of people with obesity has been slow, in large part due to poor coverage under drug benefit plans.12

EVIDENCE-BASED OBESITY CARE CAN DELIVER GOOD VALUE

Exclusive reliance upon changes in diet and exercise to reduce the health impact of obesity is often unsuccessful. Metabolic adaptation triggers potent biological responses that act to protect an individual’s highest lifetime weight indefinitely.

Economic analysis shows that 5% weight loss can deliver substantial financial benefits, even in a person with a high body mass index (BMI). Cawley et al documented the potential for savings of $2000 per year in medical costs with a 5% weight reduction in persons with a BMI above 40.13 And because the cost curve is even steeper for people with diabetes, they found further value in preventing progression to diabetes in people with obesity.

In this analysis, the greatest economic benefit comes from the first 5% of weight loss, which is the efficacy standard for FDA approval of new obesity medicines. Thorpe et al recently analyzed the impact of weight loss on health costs for seniors and concluded that “Medicare can realize significant cost savings through anti-obesity medications that produce substantial weight loss.”14

SIGNS OF CHANGE ARE EMERGING

On several fronts, tentative signs of change in coverage for obesity pharmacotherapy are visible. The AMA resolved in 2014 to press for patient access to the full spectrum of evidence-based obesity treatment, including pharmacotherapy.15

Also in 2014, the federal Office of Personnel Management ruled that health plans for federal employees could no longer exclude obesity medicines by characterizing them as “lifestyle” drugs.16 The guidance further encouraged coverage of both behavioral therapy and pharmacotherapy for obesity. The National Conference of Insurance Legislators resolved in July 2015 that state legislatures should provide for “coverage of the full range of obesity treatment.”17 The growing support for access to evidence-based obesity care is beginning to show up in drug benefit plans. In 2012, Reuters reported that Express Scripts and Aetna had begun to cover new obesity drugs, phentermine/topiramate and lorcaserin.18 More recently, CVS Caremark has been reported to have included liraglutide, the newest obesity treatment, on its 2016 formulary.19

Finally, legislation to open the door for obesity drugs in Medicare Part D is gaining support. The Treat and Reduce Obesity Act has been introduced in both the Senate and the House, with more than 100 bipartisan supporters.20 It would remove the now archaic prohibition on coverage for obesity drugs by CMS.

WITHOUT ACCESS TO EVIDENCE-BASED CARE, COSTS CONTINUE TO MOUNT

Recent suggestions that growth in the prevalence of obesity might be ending are misleading. Alhough the overall prevalence of obesity may be reaching equilibrium at an unacceptably high rate, the rate of severe obesity is continuing to grow and is driving tremendous growth in the burden of chronic diseases.3 Obesity is a key driver, for example, of chronic liver disease, and is becoming a key factor in the growing need for liver transplantation.21 Obesity is increasingly recognized for contributing to growth in the prevalence of many forms of cancer. All this is in addition to the long-recognized relationship with cardiovascular disease and diabetes.

So health plans are indeed paying a high price for treating the consequences of untreated obesity. Without evidence-based treatment, obesity persists, progresses, and causes chronic diseases that affect virtually every organ system.

Advising people with obesity to eat less and move more is sound advice, but it is a strategy that most people with obesity have already pursued, finding limited success. A growing body of scientific knowledge explains how the body adapts to keep people from losing their excess body weight.22 It is now apparent that obesity will typically progress without biologically potent treatment.

As those treatments are emerging, health plan coverage will need to keep up. Without routine, evidence-based treatment, medical costs for obesity—especially severe obesity—are becoming unsustainable. References

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2. Dietary Guidelines Advisory Committee (2010). Report of the dietary guidelines advisory committee on the dietary guidelines for Americans, 2010, to the Secretary of Agriculture and the Secretary of Health and Human Services. Agricultural Research Service.

3. Finkelstein EA, Khavjou OA, Thompson H, et al. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012;42(6):563-570.

4. American Medical Association. Resolution 420 (A-13): recognition of obesity as a disease. In Proceedings of the House of Delegates 162nd Annual Meeting. June 18, 2013.

5. Directory of diplomates. American Board of Obesity Medicine website. http://abom.org/diplomate-search/. Accessed August 18, 2015.

6. ABOM Newsletter, January 2015. American Board of Obesity Medicine website. http://abom.org/abom-newsletter-january-2015-volume-5/. Accessed August 18, 2015.

7. Brantley PJ, Waldo K, Matthews-Ewald MR, et al. Why patients seek bariatric surgery: does insurance coverage matter? Obes Surg. 2014;24(6):961-964.

8. Weiner J, Colameco C. Essential health benefits: 50-state variations on a theme. Leonard Davis Institute of Health Economics, University of Pennsylvania. http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2014/rwjf416179. Published October 2014. Accessed August 15, 2015.

9. Baum C, Andino K, Wittbrodt E, et al. The challenges and opportunities associated with reimbursement for obesity pharmacotherapy in the USA. Pharmacoeconomics. 2015;33(7):643-653.

10. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63(25, pt B):2985-3023.

11. Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological management of obesity: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342-362.

12. Osbourne S. Orexigen: Contrave leading the way in a slow race. Seekingalpha.com website. http://seekingalpha.com/article/3390675-orexigen-contrave-leading-the-way-in-a-slowrace. Published August 3, 2015. Accessed August 17, 2015.

13. Cawley J, Meyerhoefer C, Biener A, Hammer M, Wintfeld N. Savings in medical expenditures associated with reductions in body mass index among US adults with obesity, by diabetes status. Pharmacoeconomics. 2015;33(7):707-722.

14. Thorpe KE, Yang Z, Long KM, Garvey WT. The impact of weight loss among seniors on Medicare spending. Health Econ Rev. 2013;3(1):1-6.

15. American Medical Association. Resolution 111: patient access to evidence-based obesity services. In Proceedings of the House of Delegates 163rd Annual Meeting. June 11, 2014.

16. US Office of Personnel Management. FEHB Program Carrier Letter No 2014-04. https://www.opm.gov/healthcareinsurance/healthcare/carriers/2014/2014-04.pdf Published March 20, 2014. Accessed August 17, 2015.

17. NCOIL legislators adopt resolution encouraging coverage for obesity treatment. National Conference of Insurance Legislators website. https://www.ncoil.org/HomePage/2015/07292015ObesityResolutionPR.pdf. Published July 29, 2015. Accessed August 17, 2015.

18. Dey E, Siddiqui Z. Vivus’s obesity pill to be covered by Express Scripts. Reuters website. http://www.reuters.com/article/2012/12/20/us-vivus-obesitydrug-coverage-idUSBRE-8BJ0KW20121220. Published December 20, 2012. Accessed August 17, 2015.

19. Novo Nordisk says any tussle with Sanofi’s Toujeo will come down to formulary access. Medical marketing & media website. http://www.mmm-online.com/payermanagedmarkets/novo-nordisk-says-any-tussle-with-sanofis-toujeo-willcome-down-to-formulary-access/article/431233/. Published August 6, 2015. Accessed August 17, 2015.

20. Treat and Reduce Obesity Act gaining momentum. Healio website. http://www.healio.com/endocrinology/obesity/news/online/{f1f871f4-4461-48fb-8eb0-8327797d6e4d}/treat-and-reduce-obesity-act-gaining-momentum. Published August 1, 2015. Accessed August 17, 2015.

21. LaBrecque DR, Abbas Z, Anania F, et al. World Gastroenterology Organisation global guidelines: nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. J Clin Gastroentrol. 2014; 48(6):467-473.

22. Ochner CN, Tsai AGm Kushner RF, Wadden TA. Treating obesity seriously: when recommendations for lifestyle change confront biological adaptations. Lancet Diab Endocrinol. 2015;3(4):232-234.

Stumbling Toward Access to Evidence-Based Care for the Chronic Disease of Obesity