throbber
Eni'rtfiuifi:
`
`relates of class 3 obesity in the United States from 1990 through 2000.1AMA.
`2002;238:1F58—1?E‘|.
`4. Kencharah S. Evans J'C. Levy D. et al. Obesity and the risk of heart failure.
`N Eng!) Med. 2002;34?:305-3’|3.
`5. Lee IM. Rexrode KM. Cook NR. eta}. Physical activity and coronary heart dis—
`ease in women. JAMA. 2001;285:144?—1454.
`S. Wirth A. Krause J. Long—term weight loss with sibutramine: a randomized con-
`trolled trial. JAMA. 2001;286:13314339.
`3’. Davidson MH. Hauptman J. DiGiroIamo M, et al. Weight control and risk fac-
`tor reduction in obese subjects treated for 2 years with orlistat: a randomized con-
`trolled trial. JAMA. 1999;231:235-242.
`8. Nakazato M. Murakami N, Date Y, et al. A role for ghrelin in the central regu-
`lation of feeding. Nature. 2001;409:194—198.
`
`9. Batter‘ham Rt. Cowley MA, Small C1. or at. Gut hormone P‘r’Yt'j-Bo) physi
`ologically inhibits food intake. Nature. 2002418650654.
`10. Taubes G. What if it's all been a big fat lie? New York limes. July I. 2002:
`section 6:22.
`11, Food and Nutrition Board. institute of Medicine. Dietary reference intakes for
`energy. carbohydrate, fiber. fat. fatty acids. cholesterol. protein. and amino acids
`tmacronutrients). National Academy Press. Available at: httpzriwwwnapedu
`rbooksf0309085373rhtmlr'. Accessibility verified September 19. 2002.
`12. Eden KB. Orleans CT, Mulrow CD. et al. Does counseling by clinicians im—
`prove physical activity? a summary of the evidence for the US Preventive Services
`Task Force. Ann intern Med. 2002;137:208—215.
`13. JAMA Instructions for Authors. JAMA. 2002;288:108—113. Available at:
`httprfrwwwiamacom.
`
`Pharmacy Benefit Plans
`and Prescription Drug Spending
`
`
`
`
`“
`l)onaldElli-1fT-ltrinwutdls, Phil
`l‘AIfl'I—l CARI? COSTS ARE INCREASING RAPIDIX AGAlN.
`
`A recent employer survey reported that health in-
`surance premiums increased 12.7% from 2001 to
`2002, the largest increase since. 1990‘ The. fastest
`rising component of health care cosLs is pharmaceuticals. 1" mm
`1999 to 2000, national expenditures for prescription drugs
`inercascd 17.3% overall. and 19.6% for private insurance}
`Since the late 19905, when prescription costs began rising more
`rapidly than other health care costs. employers have. been
`working with their insurers and pharmacy benefit managers
`to develop prescription drug coverage plans that would bet—
`ter control costs. Many employers now offer 2- or 3-ticr prc-
`scription drug coverage plans, with the amount of out-of-
`pockct cost increasing from bottom to top tiers. Although plans
`vary, the lowest tier usually includes the low—cost generic
`drugs, the second tier may include brand-name drugs for
`which no generic exists. and the third tier brand-name drugs
`for which generic substitutes do exist.
`In this issue of'l‘liE JOURNA]..,Joycc and colleagues3 have
`evaluated the cost impact of the multiticrcd plans, as well
`as the impact of increasing co-paymcnts and coinsurance
`within plans. Their findings make clearer which plans are
`least costly overall. and how the costs are shared between
`the employer and the employee. The analysis shows that em—
`ployer insurance costs can be reduced substantially by in-
`creasing lhc employee's out-of-pockct costs." The findings
`consistently show employer costs decline as the patients out-
`of—pockct costs increase with higher co—payments, both in
`single-tier and multiticr plans. A 2002 Employee Health Ben-
`cfits Survey reported that the use of 3—ticr plans has in-
`
`See also p 1733.
`
`creased since 200] to include 57% of workers, with an ad-
`ditional 28% having a Z-tiercd plan. ' In addition. the average
`co-paymcnt level at each tier has increased since last year.
`)0ch ct 211" also show that as co-paymcnts become larger.
`patients fill fcwcr prescriptions and pay a larger propor~
`tion of total drug costs. As co—payments increased, iridi—
`viduals filling any prescription during a year declined mod-
`estly (78.0% to 74.3%), although the average number of
`prescriptions filled declined substantially by more than 30%
`(12.3 to 9.4 annual prescriptions per person).3 The share
`of total prescription costs paid by the. patient ranged from
`16.9% to 32.3% in the 3—tier, high co-paylncnt plan.
`The results of the study byjoycc ct a]3 raise a significant
`public health policy concern. The finding that increasing
`out-of—pockct costs for prescriptions contributes to pre-
`scribed medications not being filled cannot be ignored. There
`is limited research on the health consequences of not tak—
`ing prescribed medications because they are not afford—
`able. The available evidence comes from rcscarch in the pub—
`lic sector and changes in coverage policy. For instance, a
`study in a Canadian province where drug co—paymcnts and
`coinsurance were. introduced showed new out—of—pockct costs
`led to fewer prescriptions filled among medications classi—
`fied as essential (cg, insulin) and among those classified as
`less essential (cg, dipyridamolc).“ in addition, rates of se—
`rious adverse events and emergency department visits as-
`sociated with reductions in the use of essential drugs also
`increased significantly. Adverse health events not only have
`important consequences for patients but can lead to greater
`
`use of health care services and higher health care costs.
`
`Author Affiliation: Department of Health Policy and Management. Johns Hop—
`kins Bloomberg School of Public Health. Baltimore. Md.
`Corresponding Author and Reprints: Donald M. Steinwachs. PhD. Department
`of Health Policy and Management. Johns Hopkins Bloomberg School of Public Health.
`624 N Broadway. Baltimore, MD 21205 te-mail- dsteinwa®jhsph.edu).
`
`'51 35‘. Malt-ed? -‘|-~--'--" i'.:‘
`
`-r!
`
`\ll .i-tfl'w :' n'tstvi
`
`(Reprinted) JAMA. (lctuhcr L}, 2002—4501 3.88, ho. H 1773
`
`Downloaded From: httpu’ijamajamanelworkcomf by a Reprints Desk [filter on 05i27f2016
`
`Medac Exhibit 2051
`
`Koios Pharmaceuticals v. Medac
`
`IPR2016-01370
`
`Page 00001
`
`Medac Exhibit 2051
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`

`

`EhflORIALS
`
`The rapidly escalating costs for drugs makes ensuring ad-
`equate prescription drug coverage more critical. especially
`for drugs essential for the care of chronic health problems.
`The evidence in support of the need for drug coverage is
`compelling. Comparisons made between Medicare benefi—
`ciaries with and without drug coverage show those in poor
`health with no drug coverage fill 36% fewer prescriptions
`than those with coverage, and those with incomes below the
`poverty line and without coverage fill 48% fewer annual pre—
`scriptions than those with coverage" Other studies have
`shown the negative effects ofreducing drug coverage among
`poor elderly patients and the consequences of inadequate
`drug coverage for elderly patients receiving medications that
`can prevent serious adverse health consequences.6
`The president? and Congress8 have promised Medicare
`beneficiaries prescription drug coverage. Congress is seek-
`ing to add a drug benefit to the Medicare program in which
`there would be substantial out—of~pocket costs." in the l louse-
`passed plan,“ the beneficiary would pay a monthly pre—
`mium of approximately $33 with a deductible of $250 and
`cost—sharing would begin at 20% and increase to 50% and
`then to 100% until the annual out—of-pocket maximum of
`$3700 is reached. The costssharing arrangements are simi—
`lar in the tri-partisan Senate plan.” The Graham planH in—
`corporates somewhat different cost~sharing, including a
`monthly premium of$25, no deductible. and co—paymcnts
`of $10 for generic drugs and $40 for brand drugs up to a
`maximum 0154000 annual out~of—pocket costs. All the plans
`include some provisions to reduce costs for poor and near-
`poor elderly. The out—of—pocket costs in these plans are gen—
`erally higher than those in the employer plans evaluated by
`joyce et a],i which is cause for concern.
`Even ifone of the proposed Medicare drug bills is passed
`and employers were to stop increasing out—of—pocket costs
`for drugs, out—ollpocket costs for prescriptions will be high
`enough to force many patients to choose which prescrip-
`tions will not be filled.12 However, the current health care
`system provides little or no assistance for individuals fac—
`ing such difficult and complex decisions. There is little or
`no research-based information available regarding the con~
`sequences of such choices for patients. it is not clear how
`often physicians are consulted by patients about how to make
`this choice. A patient being cared for by several physicians
`for multiple health problems may have difficulty determin—
`ing which physician should be asked for advice.
`The driving force behind the movement toward multi-
`tiered pharmacy benefit plans and higher co—payments is cost
`control. Joyce et al3 found no evidence that changing to
`2-tiered and 3-tiered drug coverage plans or imposing higher
`co—payrnents or coinsurance levels had any effect on the rate
`of increase in prescription costs over time. Patients, physi-
`cians. and policy makers all have reason for concern, con-
`sidering a likely future of continuing increases in health care
`costs and more cost-shifting to patients. it is not clear which
`patients will be able to afford high-quality health care in the
`
`future and benefit from the continuing advances in medi—
`cal science.
`
`Thus, it may be necessary to take a step back and consider
`whether the real problem is the way health care is organized.
`financed, and delivered. in some respects, the way health care
`is delivered today has not changed much from '50 years ago.
`even though the technology of health care is vastly changed.
`The Institute ol‘Medicine report Crossing the Quality Clinton”
`found that the. way medical care is delivered, particularly for
`chronic health problems, is failing to ensure high quality and
`is inefficient. The report provides recommendations to change
`fundamentally the patient-physician relationship. make health
`care truly continuous, open medical records to patients, and
`promote the use of evidence—based medical decisions. Al-
`though the goal is to improve quality, such approaches might
`also greatly improve the efficiency of the health care system.
`For instance, one possibility is having all prescribed medica-
`tions, even ifwritten by different physicians, in a single elec-
`tronic record. With this capability, the patient and treating phy-
`sician could have on—line access to drug prices and information
`on the actual out—of—pocket costs to be paid under the pa—
`tients prescription drug insurance coverage. 'l‘ogcther the pa-
`tient and physician could make better decisions about what
`treatments fit the patient‘s health care needs anti also could
`consider the patient‘s ability to pay. If this type of improved
`efficiency can be achieved, the driving and relentless erosion
`of health insurance by increasing costs might be restrained and
`affordable access to needed treaunents safeguarded.
`
`REFERENCES
`
`1. Kaiser Family Foundation. 2.002 employee health benefits survey. Available at:
`hitp:llwww.lci‘iorgi’contentl2002l20020905a. Accessed September 6. 2002.
`2. Centers for Medicare and Medicaid Services. Table 11: prescription drug, ex—
`penditures aggregate and per capita amounts. percent distribution and average
`annual percent change by source of funds: selected calendar years 1980-2001
`Available at: http:llcms.hhsgovlstatisticsrnhelprojcctrons-2001lt1tasp Ac-
`cessed September 11. 2002.
`3. Joyce CF. Escarce JJ, Solomon MD. Goldman DP. Employer drug benefit plans
`and spending on prescription drugs. Janna. 2002;288:1733-1239.
`4.
`'i'amblyn R. Laprise R.
`i-ianiey JA. et al. Adverse events associated with pre—
`scription drug cost-sharing among poor and elderly persons. JAMA. 2001:235-
`421,429.
`5. Poisal JA. Murray 1.. Growing differences between Medicare beneficiaries with
`and without drug coverage. Health All l'Mlllwood). 2001;20:24-85.
`6. Adams AS. Soumerai SB. Ross-Degnan D. The case fora Medicare drug born
`efit coverage: a critical review of the empirical evidence. Annu Rev Publicl lealtn.
`2001;22:49-61.
`7. The White House. President renews call for prescription drug coverage in Medi-
`care new HHS study highlights potential for medical breakthroughs. Available at;
`http:llwwwmhitehouso.govliniOcusrrx-medicarel. Accessibility verified Septem-
`ber 11. 2002.
`8. Kaiser Family Foundation. Prescription drug coverage for Medicare beneficia'
`ries: a side-by-side comparison of selected proposals. updated July 31. 2002. Avail -
`able at. http:llwwvv kf'f.orgrcontentl2002l6053l. Accessed Septemhers. 2002.
`9. Amend title XVlll of the Social Security Act to provide for a voluntary pro-
`gram for prescription drug coverage under the Medicare Program, 107th Cong.
`2nd Sess (lune 2.7. 2002} [reported by Mr tinder. from the Committee on Rules}.
`10. 2i‘st Century Medicare Act. 102th Cong (July 15, 2002) (introduced by Charles
`E. Grasslcy. Senator).
`11. Medicare Outpatient Prescription Drug Act 01‘2002. 102th Cong (June 14,
`2002) {introduced by Bob Graham. Senator).
`12. Steinman MA, Sands LP. Covinsky KE. Self—restriction of medications due to cost
`in seniors without prescription coverage. J Gen intern Med. 2001;16:293v299.
`13. Institute of Medicine. Crossing the Quality Chasm.- A New Health System for
`the 21:: Century. Washington. DC: National Academy Press; 2001.
`
`1774 JAMA. October 9. EDGE—Vol 288, No. 14 [Reprinted]
`
`@2001 -‘-.:r!t'ilt';n:
`
`\i‘lt'télcml
`
`."tssr-ici.
`
`
`
`. :' §<..~'\.'€H‘tl
`
`Downloaded From: littp:lljama.jamanetworkcoml by a Reprints Desk User on flSll'llZflIfi
`
`Page 00002
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`

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