1 TITLE PAGE 2 TITLE: US Health Policy and Prescription Drug Coverage of FDA-Approved Medications for the 3 Treatment of Obesity 4 AUTHORS: 5 Gricelda Gomez, MD, MPH; Harvard Medical School, Boston, MA 02115 6 Fatima Cody Stanford, MD, MPH, MPA; Massachusetts General Hospital Weight Center, Boston, MA 7 02114 8 KEYWORDS: Obesity, health policy, weight-reducing drugs 9 CORRESPONDING AUTHOR CONTACT INFO: 10 Dr. Fatima Cody Stanford, fstanford@mgh.harvard.edu, 50 Staniford St. #430 Boston, MA 02114 11 WORD COUNT: 2815 12 DISCLOSURE: The are no relevant financial disclosures. 13 AUTHOR CONTRIBUTIONS: Drs. Gomez and Stanford participated in concept, study design, and 14 manuscript preparation. Dr. Gomez collected the data and completed the statistical analysis. 15 16 17 1 18 ABSTRACT 19 Objective: Obesity is now the most prevalent chronic disease in the United States, which amounts to an 20 estimated $147 billion in health care spending annually. The Affordable Care Act (ACA) enacted in 2010, 21 included provisions for private and public health insurance plans that expanded coverage for 22 lifestyle/behavior modification and bariatric surgery for the treatment of obesity. Pharmacotherapy, 23 however, has not been included despite their evidence-based efficacy. We set out to investigate the 24 coverage of FDA-approved medications for obesity within Medicare, Medicaid, and ACA – established 25 marketplace health insurance plans. Methods: We examined coverage for phentermine, diethylpropion, 26 phendimetrazine, Benzphentamine, Lorcaserin, Phentermine/Topiramate (Qysmia), Liraglutide 27 (Saxenda), and Buproprion/Naltrexone (Contrave) among Medicare, Medicaid, and marketplace 28 insurance plans in 34 states. Results: Among 136 marketplace health insurance plans, 11% had some 29 coverage for the specified drugs in only 9 states. Medicare policy strictly excludes drug therapy for 30 obesity. Only 7 state Medicaid programs have drug coverage. Conclusions: Obesity requires an integrated 31 approach to combat its public health threat. Broader coverage of pharmacotherapy can make a significant 32 contribution to fighting this complex and chronic disease. 33 34 Word Count: 178 35 36 2 37 INTRODUCTION 38 39 An alarming 39.8% of men and women in the United States suffer from obesity. This represents a 40 rising trend over the past 20 years.1, 2 Obesity is associated with several co-morbidities including heart 41 disease, Type 2 diabetes mellitus, and stroke, which are all leading causes of death in the United States. 3 42 In the US, obesity-related health care spending is estimated at $147 billion annually. 4 43 These trends in obesity, the most prevalent chronic disease in the US, have alerted policymakers 44 and elected officials and has stimulated impetus to shaping better health policies. 5 The recognition and 45 medical community consensus of obesity as a disease helped bring this issue to the forefront. 6, 7The 46 enactment of the Affordable Care Act (ACA) gave the Federal government and States leverage to make 47 policy changes to its public programs, Medicare and Medicaid, in addition to setting standards for the 48 private insurance marketplace to tackle the obesity epidemic. 4 Some of the health mandates for obesity 49 integrated in the ACA included no consumer cost-sharing for obesity screening and counseling and no 50 premium surcharges for having obesity. 8 Also, the Essential Health Benefits (EHB) Benchmark provision 51 expanded coverage for bariatric surgery and nutrition counseling. However, because of wide variation in 52 states’ own EHB benchmarks, only 26 states have health plans offering bariatric surgery 8, 9 Medicare 53 now is required to cover intensive behavioral counseling and therapy for its’ beneficiaries who have 54 obesity. Through the ACA, states are eligible for an enhanced federal Medicaid matching rate if their 55 programs cover preventive services with no cost sharing to the beneficiary. 4 56 The broader understanding of obesity as a disease and its biochemical and metabolic effects on 57 one’s physiology has enlightened the clinical management of obesity.7 Lifestyle and behavior 58 modification alone leads to a reduction in food intake and/or increases in energy expenditure that 59 facilitate weight loss. However, our body’s adaptive biologic responses to weight loss leads to altered 60 physiology that ultimately results in weight regain.7 Clinical guidelines reflect this knowledge and do not 61 recommend lifestyle and behavior modification for the treatment of obesity alone. It is recommended that 62 patients with obesity be treated with adjuncts such as pharmacotherapy and/or bariatric surgery to 63 decrease weight recidivism.7 . Despite this, most of the changes in the ACA encouraged health insurance 3 64 plans to cover lifestyle and behavior modification as the primary treatment modality for persons with 65 obesity without concurrent consideration for adjunctive therapies. Concurrently, the Food and Drug 66 Administration (FDA) approved several new drugs for the short and long-term treatment of obesity. There 67 are now several US FDA approved medications for the treatment of obesity (Table 1). 10, 11 These drugs, 68 of which many were FDA approved as late as 2014, are recommended as an adjunct to lifestyle therapies. 69 12 Compared to new drugs available for diabetes, these new obesity drugs are 15 times less likely to be 70 dispensed and have only taken 20% of the obesity medication market share.6 With obesity serving as a 71 major public health concern in the US, are policymakers, health care systems, and health insurance 72 markets incorporating these new therapies and making prescription drugs available for the treatment of 73 obesity? We set out to investigate the coverage of FDA approved medications for obesity within 74 Medicare, Medicaid, and State Marketplace health plans. 75 METHODS 76 Medicare and Medicaid are public health insurance programs. Newly established ACA 77 marketplace exchanges are facilitated by the government, but they provide private insurance plans to 78 individuals. 79 Marketplace Exchanges. Post-ACA States’ Exchanges take one of four forms: 1) a State-based 80 marketplace, 2) Federally-supported state-based marketplace, 3) State-partnership marketplace (SPM) and 81 4) a Federally-facilitated marketplace (FFM). 13 We chose to investigate health insurance plans in states 82 participating completely or at a partial capacity in the FFM through healthcare.gov. 34 States fall into this 83 category, 27 FFMs and 7 SPMs (Table 2). We investigated the drug formularies of four “silver” plans 84 with the lowest, second-lowest, median, and highest premiums. We chose silver plans, because according 85 to 2016 enrollment data, 71% of enrollees using healthcare.gov chose silver plans. 14 86 For each state, we first chose the most populous county based upon number of enrollees. 15 We 87 then used 2016 Qualified Health Plan (QHP) Landscape Data 16, which includes data from health plans 88 from states participating in FFMs and SPMs. We identified health plans for individuals and families and 4 89 assessed the 4 silver plans we mentioned above. We investigated each plan’s formularies to determine 90 coverage for the FDA-approved obesity medications listed in Table 1. 91 Medicare. In December 2003, the Medicare Prescription Drug, Improvement, and Modernization 92 Act of 2003 (MMA) was enacted into law updating provisions of the Social Security Act regulating the 93 Medicare prescription drug benefit which established what we now know as Medicare Part D. 17 CMS 94 provides guidance to sponsors of Part D plans with regards to their formularies and outlines benefits and 95 establishes protections for beneficiaries, which sets limits to cost-sharing, co-insurance, deductibles, in96 network and out of network pharmacy access, and mail-in services. 18 Therefore, we investigated 97 coverage of the obesity medications through the Centers for Medicare and Medicaid Services (CMS) 98 website and their specific policy guiding health insurance plans. 19 99 Medicaid. States establish and administer their own Medicaid programs and determine scope of 100 benefits and services within broad federal guidelines. While the federal law established by the Social 101 Security Act denote prescription drug coverage as an optional benefit, all States currently provide 102 coverage for outpatient prescription drugs to enrollees within their state Medicaid programs. 20 103 We first searched federal policy guiding excluded drug coverage for Medicaid enrollees through 104 Medicaid’s federal website. 21 Each state has its own list of excluded drugs that are not covered under 105 their Medicaid program. We investigated these lists for the same 34 states we investigated in the Federal 106 marketplace exchanges. Since some of the excluded drug coverage policies for each state were updated as 107 recently as 2009, we also investigated each state’s individual Medicaid program’s prescription drug 108 policies and coverage, which are updated on an annual basis. We identified each state’s Preferred Drug 109 List (PDL) and their pharmacy and provider policy handbooks to formulate an accurate picture of the 110 coverage offered by each state within their Medicaid health insurance plans. 111 In certain states, Medicaid programs have historically contracted with managed care entities 112 (MCE) to provide their benefits rather than health insurance plans that function under a traditional fee113 for-service model. Table 3 lists whether states utilize managed care programs for their beneficiaries and 114 how many beneficiaries are enrolled. Whether Medicaid finances a health insurance plan with a FFS 5 115 model or under a MCE, they both operate under the state’s approved prescription drug formulary and the 116 state’s PDL. The plans differ with regards to reimbursement. Managed care entities receive a pre117 determined amount of money for caring for a Medicaid beneficiary from the government, which it then 118 uses to cover the costs of certain medical services, mental health services, and/or prescription drugs. The 119 covered services of a MCE may differ from one state to the next. If a MCE is responsible for the payment 120 of prescription drugs, referred to as being “carved in” to the plan, then they work directly with pharmacies 121 and pay their beneficiaries’ drugs needs with the lump sum received by the state’s Medicaid agency. 22 122 Whereas, with a FFS model, the government provides the reimbursement for a drug directly to the 123 pharmacy. 124 When reviewing each states’ Medicaid Excluded Drug Coverage information, by default, all lists 125 included the statement “Drugs when used for anorexia, weight loss, or weight gain.” If there were an 126 exception to this statement it would be listed below the statement. It would include a list of drugs or it 127 would include the drug class that was not excluded from coverage. If there were no additional statements 128 added to the default statement, then the state received a score of “0” for this category. If the state added a 129 favorable statement providing an exception to the default statement that included coverage for an obesity 130 medication, the state received a score of “1.” If the state included an unfavorable statement that 131 specifically excluded an obesity medication the state received a score of “-1.” 132 When reviewing their preferred drug lists and their policy handbooks, if it included none of the 133 FDA approved obesity medications, the state received a score of “0”, “1” if it included some coverage, 134 and “-1” if information was mentioned that excluded any of the obesity medications. 135 RESULTS 136 In the marketplace exchanges, only 9 states had at least one silver plan that included some type of 137 coverage for obesity medications. These were Arizona, Nebraska, North Carolina, North Dakota, South 138 Dakota, Virginia, Delaware, Iowa, and West Virginia (Table 4A and 4B). The other 25 states had no drug 139 coverage provided within the four silver plans investigated. Among the 9 states, only 15 plans out of the 140 36 silver plans evaluated, offered some type of coverage for obesity medications: 2 low-premium plans, 5 6 141 second lowest premium plans, 3 median premium plans, and 5 highest premium plans. For most of the 142 plans there were medications available as tier 1. The covered medications were generally the older FDA 143 approved medications for the treatment of obesity. The newer FDA approved obesity medications tend to 144 be covered as tier 3 medications. Prescription drug tiering for health insurance plans is a mechanism 145 utilized to build in cost sharing for the beneficiary. Lower tiered drugs tend to be generic and often are 146 included in the plan’s drug formulary, in which case the co-payment is lower and often does not require 147 prior authorization. Higher tiered drugs tend to be brand named drugs which are more expensive. 148 Consequently, it is accompanied with higher co-payments and often requires prior authorization and/or 149 has quantity limits. 150 In terms of Medicare prescription drug coverage, CMS outlines Medicare’s Formulary 151 requirements for qualifying prescription drug plans (PDPs) in Chapter 6 of its Prescription Drug 152 Coverage Manual. We did not need to investigate each individual drug because CMS’s policy specifically 153 states in Section 20.1 – “Weight loss drugs are excluded from Part D Coverage – even if used for a non154 cosmetic purpose.” 23 155 Of the 34 States’ Medicaid prescription drug policies reviewed, 8 states have some form of 156 possible coverage for obesity medications for beneficiaries (Table 5). These were Alabama, North 157 Dakota, South Carolina, South Dakota, Texas, Virginia, Wisconsin, and Delaware, but they do require 158 prior reauthorization and extensive medical evaluation for demonstration of treatment need. One state, 159 Texas, is one of the 8 because it did include “lipase inhibiting drugs” as not excluded in their excluded 160 drug coverage. However, when reviewing their pharmacy handbook, Orlistat (Xenical) is only covered for 161 hypertension only, not for weight loss. 162 DISCUSSION 163 Obesity remains a significant public health threat in the United States. It is associated with three 164 of the top 10 leading causes of death including the first leading cause of death, cardiovascular disease. 24 165 Despite growing evidence of efficacy of pharmacotherapy for the treatment of obesity and recent FDA 166 approval of obesity medications for long term use, the US government’s health policy and health 7 167 insurance programs have not embraced this form of therapy for the treatment of obesity. Medicare strictly 168 does not cover the cost of any of the obesity medications in their prescription drug plans for their 169 beneficiaries. Medicaid health insurance plans cover obesity medications with wide variation from state to 170 state. Only a quarter of the states evaluated had some sort of coverage. Within the ACA marketplace 171 health insurance plans, we observe state-to-state disparities in the coverage of obesity medications, with 172 also only a quarter of the states evaluated providing some coverage. Among the 34 states evaluated, 13 173 states had some form of coverage among their health insurance plans within their Medicaid programs or 174 their Marketplace plans. Of these 13 states, six are among the states with the highest prevalence of 175 obesity. 25 Conversely, six of the 21 states with no coverage for obesity medications are among the states 176 with the highest prevalence of obesity. The difference among states for coverage of weight loss 177 medications may be logical if the health insurance plans with coverage existed among the states with the 178 highest prevalence of obesity. However, clearly that is not the case, when six states – Arkansas, Kansas, 179 Louisiana, Mississippi, Missouri, Oklahoma, and Tennessee – do not offer their Medicaid beneficiaries 180 and Marketplace enrollees’ access to obesity medications. 181 However, patient access to obesity medications through health insurance plan coverage is not the 182 only barrier to the wide adoption of these medications. There are patient and healthcare provider factors 183 that thwart the use of obesity medications. First, patients, providers, and our governmental health policies 184 continue to stigmatize obesity as a lifestyle and behavior condition, when in fact, we know the underlying 185 biology and physiology of obesity is much more complex. The medical community, represented by the 186 American Medical Association (AMA), recognized obesity as a disease only four years ago in June 2013. 187 26 The US government recognized obesity as a disease, earlier than the AMA, in 2004. 5 The stigma of 188 obesity however, is still widely pervasive. One views obesity as a reflection of a person’s self-control or 189 nutrition status, which prevents the adoption of pharmacotherapy. When we view obesity as a disease 190 process affecting a person’s metabolic and hormonal homeostasis, we may begin to accept 191 pharmacotherapy as a solution. 5, 26, 27 8 192 Patients and providers, furthermore, may feel the perceived risks of these medications outweigh 193 their benefits. Due to the widely publicized scandal of early obesity medications such as Fen-Phen® that 194 were linked with significant adverse cardiovascular effects and even death, patients and providers may 195 not be comfortable with pharmacotherapy for the treatment of obesity. 28 Some of the common adverse 196 side effects associated with the current FDA-approved medications include dry mouth, insomnia, nausea, 197 constipation and other gastrointestinal complaints In phentermine/topiramate users, an increased heart rate 198 was an associated side effect of the medication. However, there was also an associated induced blood 199 pressure (BP) reduction with its use. In a study of patients with obesity and concurrent hypertension, there 200 was a dose-dependent reduction in the number of participants using anti-hypertensive medications with 201 the use of phentermine/topiramate. These results were after a 56-week study, and more data with longer202 term use is needed to evaluate cardiovascular endpoints with phentermine/topiramate, in addition to the 203 other obesity medications. There were also favorable results of decreased major cardiovascular events 204 (HR=0.88) with the use of naltrexone/bupropion compared to placebo, but long-term evaluation of 205 cardiovascular endpoints is needed. 28 Since cardiovascular disease is the number one leading cause of 206 death in the United States, demonstrating the associated benefit of obesity medication use for 207 cardiovascular disease may ease the concerns of patients and providers and increase the use of these safe 208 medications. 209 Another barrier to the use of pharmacotherapy for the treatment of obesity may be due to the 210 increased knowledge and established efficacy of bariatric surgery for the treatment of obesity. After 211 establishment of the ACA and increased focus on obesity as a public health concern, we observed an 212 increase in the coverage for bariatric surgery. 9, 29 However, a patient must meet strict guidelines to 213 qualify for bariatric surgery, such as having a BMI>=40, or BMI>=35 with co-morbidities which include 214 hypertension, diabetes, or sleep apnea. For patients who have overweight or obesity with a BMI<35, 215 pharmacotherapy can be an effective treatment to achieve weight control to prevent weight gain. Bariatric 216 surgery also is not without significant risks that include, nausea, vomiting, dehydration, and severe 217 surgery related adverse effects, which may include death and suicide. 28 9 218 In addition, since more and more patients with obesity are undergoing bariatric surgery, patients 219 still need to manage their obesity, although it may be in remission. For patients who do have weight 220 regain after achieving a healthier BMI or with inadequate weight loss, pharmacotherapy may be an option 221 for postoperative patients to achieve a healthy weight. 30 222 223 224 CONCLUSION 225 The use of anti-obesity pharmacotherapy will not solve the obesity epidemic in the US, but they 226 do serve as part of the solution. We must embrace an integrated obesity treatment framework which 227 incorporates changes in the way we think of obesity as a disease and provides measures on how we will 228 begin to destigmatize obesity. The integrated framework may also create useful strategies that will 229 provide a meaningful investment in the future of our citizens by preventing and controlling obesity in 230 ways supported by scientific evidence. To ensure all US citizens benefit from these successful strategies, 231 our national, state, and local health policies should lead the way by incorporating them in the fight against 232 obesity. With annual spending of $147 billion due to obesity-related healthcare, not only is obesity a 233 public health threat, it is also a risk to our nation’s financial security. 234 Ironically, federal government employees, with 2.7 million beneficiaries, have benefitted from 235 the recognition of obesity as a complex disease. Their health benefit plans are not allowed to exclude 236 coverage of obesity medications. In this cohort, one study has determined that “with adequate medication 237 reimbursement, patients stay on [obesity] medication longer, see their doctor more often, and lose more 238 weight.” 26Medicare, Medicaid and ACA-established Marketplaces should have health insurance plans 239 that incorporate these changes in order to affect a broader group of our country’s population who suffer 240 from obesity. 26 Federal/state coverage mandates and the emergence of quality-driven healthcare 241 initiatives (that include obesity-related chronic diseases) might contribute to broader coverage of obesity 242 medications. 26 243 10 244 REFERENCES 245 246 1. Hales CM CM, Fryar CD, Ogden CL. Prevalence of Obesity Among Adults and Youth: 247 United States, 2015–2016. In. Hyattsville, MD: National Center for Health Statistics, 2017. 248 249 2. Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among 250 Adults in the United States, 2005 to 2014. JAMA 2016; 315(21): 2284-91. 251 252 3. Heron M. Deaths: Leading Causes for 2014. In: Reports NVS, (ed). Hyattsville, MD: National 253 Center for Health Statistics, 2016. 254 255 4. Winterfield A, Cauchi R. Obesity: Progress and Challenges. In: Legisbrief. Washington, D.C.: 256 National Conference of State Legislatures, 2014. 257 258 5. Kahan S, Zvenyach T. Obesity as a Disease: Current Policies and Implications for the Future. 259 2016; 5(2): 291-297. 260 261 6. Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U et al. 262 Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin 263 Endocrinol Metab 2015; 100(2): 342-62. 264 265 7. Thomas CE, Mauer EA, Shukla AP, Rathi S, Aronne LJ. Low adoption of weight loss 266 medications: A comparison of prescribing patterns of antiobesity pharmacotherapies and SGLT2s. 267 Obesity (Silver Spring) 2016; 24(9): 1955-61. 268 269 8. Cauchi R. Health Reform and Health Mandates for Obesity. In: Health. Washington, D.C.: 270 National Conference of State Legislatures, 2016. 271 272 9. Yang YT, Pomeranz JL. States variations in the provision of bariatric surgery under affordable 273 care act exchanges. Surgery for Obesity and Related Diseases 2015; 11(3): 715-720. 274 275 10. Colman E. Food and Drug Administration's Obesity Drug Guidance Document. Circulation 2012; 276 125(17): 2156-2164. 277 278 11. Daneschvar HL, Aronson MD, Smetana GW. FDA-Approved Anti-Obesity Drugs in the United 279 States. The American Journal of Medicine 2016; 129(8): 879.e1-879.e6. 280 281 12. Butsch WS. Obesity medications: what does the future look like? Curr Opin Endocrinol Diabetes 282 Obes 2015; 22(5): 360-6. 283 11 284 13. Foundation KF. State Health Insurance Marketplace Types. In: Source: Data compiled through 285 review of state legislation and other Marketplace document by Kaiser Family Foundation: KFF, 2016. 286 287 14. Services USDoHaH. Health Insurance Marketplaces 2016 Open Enrollment Period: Final 288 Enrollment Report: Washington, D.C., 2016. 289 290 15. Plan Selection by Zip Code and County in Health Insurance Marketplace:March 2016. In. 291 Washington, D.C.: U.S. Department of Health and Human Services, 2016. 292 293 16. 2016 QHP Landscape Data. In. HealthCare.gov: Centers for Medicare and Medicaid Services, 294 2016. 295 296 17. 42 CFR Parts 400, 403, 411, 417, and 423 Medicare Program; Medicare Prescription Drug 297 Benefit; Final Rule. In: Services DoHaH, (ed). Washington, D.C.: Federal Register, 2005. pp 4193-4742. 298 299 18. Tudor C. Medicare Prescription Drug Benefit Manual – Chapter 5 Update. In: Services DoHaH, 300 (ed). Baltimore, MD: Center for Medicare and Medicaid Services, 2011. 301 302 19. Prescription Drug Coverage - General Information. In: Medicare. Baltimore, MD: Center for 303 Medicare and Medicaid Services, 2016. 304 305 20. Prescription Drugs. In: Medicaid Benefits. Baltimore, MD: Centers for Medicare and Medicaid 306 Services, 2016. 307 308 21. Excluded Drug Coverage. In: Prescription Drugs. Baltimore, MD: Centers for Medicare and 309 Medicaid Services, 2016. 310 311 22. Medicaid Managed Care: Key Data, Trends, and Issues. Kaiser Commission on Medicaid and the 312 Uninsured: Washington, D.C., 2012. 313 314 23. Medicare Prescription Drug Benefits Manual - Chapter 6. In: Medicare Part D. Baltimore, MD: 315 Department of Health and Human Services, 2016. 316 317 24. Leading Causes of Death, 2014. In: FastStats. Atlanta, GA: CDC National Center for Health 318 Statistics, 2015. 319 320 25. BRFSS Prevalence and Trends Data. In. Atlanta, GA: Centers for Disease Control and 321 Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of 322 Population Health, 2015. 12 323 324 26. Baum C, Andino K, Wittbrodt E, Stewart S, Szymanski K, Turpin R. The Challenges and 325 Opportunities Associated with Reimbursement for Obesity Pharmacotherapy in the USA. 326 Pharmacoeconomics 2015; 33(7): 643-653. 327 328 27. Dietz WH, Solomon LS, Pronk N, Ziegenhorn SK, Standish M, Longjohn MM et al. An 329 Integrated Framework For The Prevention And Treatment Of Obesity And Its Related Chronic Diseases. 330 Health Affairs 2015; 34(9): 1456-1463. 331 332 28. Gotthardt JD, Bello NT. Can we win the war on obesity with pharmacotherapy? Expert Rev Clin 333 Pharmacol 2016: 1-9. 334 335 29. Courcoulas AP, Belle SH, Neiberg RH, et al. Three-year outcomes of bariatric surgery vs lifestyle 336 intervention for type 2 diabetes mellitus treatment: A randomized clinical trial. JAMA Surgery 2015; 337 150(10): 931-940. 338 339 30. Stanford FC, Alfaris N, Gomez G, Ricks ET, Shukla AP, Corey KE et al. The utility of weight 340 loss medications after bariatric surgery for weight regain or inadequate weight loss: A multi-center study. 341 Surg Obes Relat Dis 2016. 342 343 13 TABLE 1. LIST OF FDA-APPROVED OBESITY MEDICATIONS FDA Approved for Short Term Use Drug Name (Brand Name) Year Approved Phentermine (Adipex, Suprenza) 1959 Diethylpropion (Tenuate) 1950 Phendimetrazine (Bontril PDM) 1956-1960 Benzphetamine (Regimex, Didrex) 1956-1960 FDA Approved for Long Term Use Drug Name (Brand Name) Orlistat (Xenical)a 1999 Lorcaserin (Belviq) 2012 Phentermine/Topiramate (Qysmia) 2012 Liraglutide (Saxenda) 2014 Bupropion/Naltrexone (Contrave) 2014 a- available over-the-counter since 2007 as Alli® 60mg TABLE 2. STATES BASELINE CHARACTERISTICS State Marketplace Type Countya # Silver Plans Available Alabama FFM Jefferson County 7 Alaska FFM Anchorage Municipality 6 Arizona FFM Maricopa County 27 Florida FFM Miami-Dade County 22 Georgia FFM Gwinnett County 30 Indiana FFM Marion County 30 Kansas FFM Johnson County 11 Louisiana FFM Jefferson Parish County 15 Maine FFM Cumberland County 10 Mississippi FFM Hinds County 13 Missouri FFM St. Louis County 18 Montana FFM Gallatin County 9 Nebraska FFM Douglas County 13 New Jersey FFM Bergen County 21 North Carolina FFM Mecklenburg County 10 North Dakota FFM Cass County 9 Ohio FFM Cuyahoga County 42 Oklahoma FFM Oklahoma County 9 Pennsylvania FFM Philadelphia County 9 South Carolina FFM Greenville County 33 South Dakota FFM Minnehaha County 11 Tennessee FFM Shelby County 30 Texas FFM Harris County 20 Utah FFM Salt Lake City County 27 Virginia FFM Fairfax County 16 Wisconsin FFM Milwaukee County 24 Wyoming FFM Laramie County 12* Arkansas SPM Pulaski County 17 Delaware SPM New Castle County 8 Illinois SPM Cook County 22 Iowa SPM Polk County 11 Michigan SPM Oakland County 50 New Hampshire SPM Hillsborough County 11 West Virginia SPM Kanawha County 8 a- Most populous county; FFM=Federally-facilitated Marketplace; SPM=State-Partnership Marketplace *All run by Blue Cross Blue Shield TABLE 3. STATE MANAGED CARE ENTITIES (MCE) WITH MEDICAID AND PERCENT OF TOTAL MEDICAID BENEFICIARIES ENROLLED IN AN MCE State Contract with MCE (Y/N) Medicaid beneficiaries enrolled in a MCE (%) 1 Alabama Y 64.3% 2 Alaska N 0.0% 3 Arizona Y 87.3% 4 Florida Y 79.0% 5 Georgia Y 66.4% 6 Indiana Y 77.9% 7 Kansas Y 95.0% 8 Louisiana Y 71.0% 9 Maine Y - 10 Mississippi Y 67.0% 11 Missouri Y 50.5% 12 Montana Y 73.7% 13 Nebraska Y 74.0% 14 New Jersey Y 93.0% 15 North Carolina Y - 16 North Dakota Y 62.0% 17 Ohio Y 78.3% 18 Oklahoma Y 69.9% 19 Pennsylvania Y 70.0% 20 South Carolina Y 75.0% 21 South Dakota Y 86.0% 22 Tennessee Y 100.0% 23 Texas Y 88.0% 24 Utah Y 62.8% 25 Virginia Y 66.0% 26 Wisconsin Y 67.0% 27 Wyoming N - 28 Arkansas Y 57.6% 29 Delaware Y 90.0% 30 Illinois Y 79.3% 31 Iowa Y 49.0% 32 Michigan Y 77.0% 33 New Hampshire Y 89.8% 34 West Virginia Y 67.0% TABLE 4A. MARKETPLACE EVALUATION OF SILVER PLANS FOR COVERAGE OF OBESITY MEDICATION BY STATE State Silver Plans Provided No Drug CoverageA ✔1 Alabama ✔2 Alaska 3 Arizona 4 Florida 5 Georgia 6 Indiana 7 Kansas 8 Louisiana 9 Maine 10 Mississippi 11 Missouri 12 Montana ✔-✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ 13 Nebraska 14 New Jersey ✔-- 15 North Carolina -- 16 North Dakota 17 Ohio 18 Oklahoma 19 Pennsylvania 20 South Carolina ✔-✔ ✔ ✔ 21 South Dakota 22 Tennessee 23 Texas 24 Utah 25 Virginia 26 Wisconsin 27 Wyoming 28 Arkansas ✔-✔ ✔ ✔-✔ ✔ 29 Delaware 30 Illinois 31 Iowa 32 Michigan 33 New Hampshire ✔-✔-✔ 34 West Virginia -- A - All four silver plans investigated for each state TABLE 4B. STATES WITH AT LEAST ONE SILVER PLAN WITH OBESITY MEDICATION COVERAGE AND THEIR CORRESPONDING TYPE OF COVERAGE State Arizona Nebraska Plans with Coverage (#) 1 1 Plan Second Lowest- Premium Highest- Premium Type of Coverage Tier 1- Phentermine Tier 1 - Benzphetamine Tier 3 - Bontril, Regimex, Didrex, and Xenical North Carolina* 1 North Dakota* South Dakota* Virginia* 3 1 2 Delaware* 3 Iowa* West Virginia* 1 2 Highest- Premium Lowest- Premium Second Lowest- Premium Median- Premium Highest- Premium Second Lowest- Premium Median- Premium Lowest- Premium Second LowestPremium Median- Premium Highest- Premium Second Lowest Premium Highest- Premium Tier 1 - Bontril, Phentermine, Benzphetamine with Prior Review (PR) Tier 4 - Suprenza (PR and Restricted Access (RA)), Xenical, Adipex, Regimex, Belviq, Qsymia, Saxenda, Contrave, Phendimetrazine (PR) Tier 1 - Benzphetamine Tier 3 - Bontril, Regimex, Didrex, Xenical Tier 1 - Benzphetamine Tier 3 - Bontril, Regimex, Didrex, Xenical Tier 1 - Phentermine and Phendimetrazine with PA Tier 1 - Phentermine and Phendimetrazine with PA Tier 3 - Saxenda (Quantity Limit) and Contrave Tier 3 - Saxenda (Quantity Limit) and Contrave Tier 1 - Phentermine, Benzphetamine, Phendimetrazine Tier 3 - Adipex, Bontril, Didrex, Xenical, Belviq, Qsymia, Saxenda, Contrave Tier 1 - Phentermine, Benzphetamine, Phendimetrazine Tier 3 - Adipex, Bontril, Didrex, Xenical, Belviq, Qsymia, Saxenda, Contrave Tier 1 - Phentermine, Benzphetamine, Phendimetrazine Tier 3 - Adipex, Bontril, Didrex, Xenical, Belviq, Qsymia, Saxenda, Contrave Tier 1 - Benzphetamine Tier 3 - Bontril, Regimex, Didrex, Xenical Tier 3 - Adipex, Bontril, Didrex, Xenical, Belviq, Qsymia, Saxenda, Contrave, Phentermine, Diethylpropion, Phendimetrazine, Benzphetamine Tier 3 - Adipex, Bontril, Didrex, Xenical, Belviq, Qsymia, Saxenda, Contrave, Phentermine, Diethylpropion, Phendimetrazine, Benzphetamine TABLE 5. MEDICAID PRESCRIPTION OBESITY MEDICATION COVERAGE BY STATE State Expanded Medicaid? (Y/N) Excluded Drug Coverage List (EDL) EDL Year Last Updated Drug Coverage based on Preferred Drug List and Policy Handbook 1 Alabama 2 Alaska 3 Arizona 4 Florida 5 Georgia 6 Indiana 7 Kansas 8 Louisiana 9 Maine 10 Mississippi 11 Missouri 12 Montana 13 Nebraska 14 New Jersey 15 North Carolina 16 North Dakota 17 Ohio 18 Oklahoma 19 Pennsylvania 20 South Carolina 21 South Dakota 22 Tennessee 23 Texas* 24 Utah 25 Virginia 26 Wisconsin 27 Wyoming 28 Arkansas 29 Delaware 30 Illinois 31 Iowa 32 Michigan 33 New Hampshire 34 West Virginia N Y Y N Y Y Y Y N N N Y N Y N Y Y N Y N N N N N N N N Y Y Y Y Y Y Y 1 -1 0 0 0 -1 -1 -1 0 0 0 0 -1 -1 0 1 0 -1 -1 1 1 -1 1 0 1 1 0 -1 0 0 0 0 -1 0 2013 2014 2013 2013 2009 2009 2009 2009 2009 2014 2009 2009 2014 2013 2014 2013 2009 2009 2013 2014 2009 2014 2014 2014 2014 2014 2013 2009 2009 2009 2014 2009 2009 2013 0 0 0 0 0 0 0 0 -1 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 1 1 0 0 1 0 0 0 0 0