PERSPECTIVE
`
`NO SUCH THING AS A FREE LUNCH
`
`Prescription-Drug Coupons — No Such Thing as a Free Lunch
`Joseph S. Ross, MD, and Aaron S. Kesselheim, M.D.,J.D., M.P.H.
`
`jisit nearly any official web—
`site for a brand—name drug
`available in the United States
`
`and, mixed in with links to pre—
`scribing and safety information,
`you’ll find links to drug “coupons,”
`including copayment—assistance
`programs and monthly savings
`cards. Most offers are variations
`
`on “Why pay more? With the
`[drug] savings card, you can get
`[drug] for only $18 per prescrip—
`tion if eligible” or “Get a free
`30—capsule trial of [drug] with
`your doctor’s prescription and
`ask your doctor if [drug] is right
`for you.” Why do manufacturers
`offer drug coupons? Are they
`good for patients in the long
`run? Are they even legal?
`Commercial
`drug-insurance
`plans typically have tiered phar—
`maceutical formularies to guide
`prescription—drug use, requiring
`relatively small patient
`copay—
`ments (approximately $5 to $15)
`for inexpensive generic drugs and
`higher copayments (perhaps $25
`to $100) for brand—name drugs.
`Manufacturers use coupons to re—
`imburse patients for this differ—
`ence in copayments when they
`buy brand—name medications, so
`that, for people with commercial
`insurance coverage,
`the out—of—
`pocket costs are the same as those
`for generic drugs.
`Drug coupons are implemented
`through subsidies paid by drug
`manufacturers. Patients nearly al—
`ways print coupons off manufac—
`turers’ websites, often after going
`through a registration process.
`Patients may also obtain coupons
`from physicians’ offices, where
`they may be distributed in lieu of
`samples. Coupons are redeemed
`
`when the drug is purchased at
`the pharmacy, although some re-
`quire that a physician submit cer—
`tain information — 0r instruct
`
`tion, such as their state of resi—
`dence and insurance coverage, to
`register and have their eligibility
`assessed. For more than 40% of
`
`patients to bring the coupon to
`their physician to request a pre—
`scription for the specified medi—
`cation, a behavior associated with
`an increased likelihood of brand—
`
`coupons, consumers were asked
`to provide additional
`informa—
`tion, such as contact details, socio—
`demographic characteristics, or
`clinical information.
`
`specific prescribing.1
`According to a report from
`IMS Health, coupons were avail-
`able for nearly 400 brand—name
`pharmaceutical products in 2011,2
`and drug-coupon use had in—
`creased by more than 50% in the
`previous year alone, although cou—
`pons were still used for less than
`5% of brand—name prescriptions
`dispensed in the United States.Z
`Other analysts have calculated
`that coupons were used for ap—
`proximately 100 million dispensed
`prescriptions in 2010 — about
`11% of prescriptions for brand-
`name drugs.3
`We did our own analysis by
`manually abstracting information
`on each coupon advertised in
`March 2013 at www.internetdrug
`couponscom,
`a
`large Internet
`drug—coupon repository. We iden—
`tified drug coupons for 374 brand—
`name, prescription—only drugs, ad—
`dressing a wide range of clinical
`conditions — from gastric reflux
`and seasonal allergies to cancer
`and HIV—AIDS. More than 75%
`were for chronic conditions for
`
`which therapies would be expect—
`ed to be used for 6 months or
`
`longer. The median monthly man-
`ufacturer subsidy was $60,
`al—
`though the amount ranged from
`$5 to $5,000. Most coupons re—
`quired consumers to provide at
`least
`limited personal
`informa—
`
`One important question in
`terms of drug coupons’ effect on
`health care costs is whether they
`are generally being offered for
`brand—name medications for which
`
`lower—cost therapeutic alternatives
`are available. We found (by search—
`ing the Food and Drug Adminis—
`tration [FDA] website and the
`Tarascon Pharmacopoeia)
`that a
`lower—cost FDA—approved thera—
`peutic equivalent was available
`for 8% of the drugs in our sam—
`ple (31 of 374; see pie chart). For
`more than half the remaining
`products (58%, 200 of 343), there
`was a lower—cost generic alterna—
`tive within the same drug class.
`Thus, 62% of coupons (231 of
`374) were for brand—name medica—
`tions for which lower—cost thera—
`
`peutic alternatives were available.
`The widespread availability of
`coupons for brand—name pharma—
`ceuticals that can be expected to
`be used long term and for which
`lower—cost alternatives are avail—
`
`able has important implications
`for patients. Despite the short—
`term savings achievable with cou—
`pons,
`they do not offset higher
`long—term costs, because they’re
`nearly
`always
`time-delimited.
`Some coupons can be used once,
`and others more than once. But
`we found few that offered sav—
`
`ings for more than a year. Once a
`coupon program ends, patients
`
`1188
`
`N ENGLJ MED 369;13
`
`NEJM.ORG
`
`SEPTEMBER 26, 2013
`
`The New England Journal of Medicine
`Downloaded from nejm. org on December 4, 2017. For personal use only. No other uses without permission.
`Copyright © 2013 Massachusetts Medical Society. All rights reserved.
`
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`ALCON 2077
`
`

`

`PERSPECTIVE
`
`NO SUCH THING AS A FREE LUNCH
`
`FDA-approved
`therapeutic
`equivalent
`
`8.3%
`
`Availability of Lower-Cost Alternatives
`to Brand-Name Drugs for which Coupons
`Are Offered.
`
`Data are for the 374 drug coupons adver-
`tised at www.internetdrugcoupons.com
`in March 2013. FDA denotes Food and
`
`Drug Administration.
`
`with chronic diseases face copay-
`ments for these brand-name med-
`
`than
`that are higher
`ications
`those for generic alternatives. By
`that point, however, patients may
`have developed loyalty to the par-
`ticular brand or may be skepti-
`cal about switching away from a
`medication that they perceive as
`effective — or they may not even
`be aware of alternative thera-
`
`pies. Physicians have been slow
`to switch patients from brand-
`name medications to available
`
`generic versions,4 either because
`of clinical inertia or simply be-
`cause they are unaware of the
`cost
`implications of their pre-
`scription choices.
`Drug coupons may also pose
`cost problems for society more
`broadly.5 On a population level,
`drug coupons undermine the
`tiered-formulary system that com-
`mercial insurers have implement-
`ed to limit prescription-drug
`spending. When patients use cou-
`pons to obtain brand-name medi-
`cations, their out-of-pocket spend-
`ing is reduced. But insurers must
`
`still pay the higher cost of the
`medication to the manufacturer.3
`
`The more that patients use drug
`coupons to obtain brand-name
`medications when lower-cost al-
`
`ternatives are available, the more
`expenses will rise for their insur-
`ers. A predictable response from
`the insurers would be to raise
`
`coverage rates for all patients.
`Beyond the cost implications,
`the legality of drug coupons has
`also recently been questioned.
`The intersection of drug coupons
`with the tiered-formulary system
`has inspired lawsuits against some
`of the largest manufacturers of-
`fering coupons. These lawsuits
`alleged that drug coupons sub-
`vert
`the cost-sharing arrange-
`ments established in patients’
`contracts with their
`insurance
`
`companies and should be dis-
`allowed as illegal kickbacks. The
`cases are still pending, although
`so far the judges have been skep-
`tical
`that
`the programs violate
`antitrust or racketeering statutes.
`The federal anti-kickback statute,
`however, prohibits knowingly pay-
`ing a party to stimulate business
`that is in turn paid for by a fed-
`eral health care program. Thus,
`federal policy currently prohibits
`the use of coupons by patients in
`publicly subsidized drug-insur-
`ance programs such as Medicare
`and Medicaid. Coupons had also
`not been redeemable in Massa-
`
`chusetts until this year; pressed
`by industry lobbyists,
`the state
`legislature and governor decided
`to temporarily allow the use of
`coupons for drugs for which a
`generic version is not available.
`It has famously been said that
`“there is no such thing as a free
`lunch." Drug coupons are no ex-
`ception to this rule. Everyone
`likes to save money, and coupons
`for essential
`therapies may be
`
`helpful for certain patients, par-
`ticularly those with life-threaten-
`ing conditions for which there
`are not reasonable generic sub-
`stitutes. However, the majority of
`drug coupons are for therapies
`for which lower-cost and poten-
`tially equally effective alternatives
`exist. Physicians need to talk to
`their commercially insured pa-
`tients about the implications of
`drug-coupon use and make sure
`that their inclination to reduce
`
`short-tenn out-oilpocket spend-
`ing doesn’t come at the cost of
`higher long-term expenses for
`themselves and society.
`Disclosure forms provided by the au-
`thors are available with the full text of this
`article at NEJM .org.
`From the Section ofGeneral Internal Medi-
`cine and the Robert WoodJohnson Clinical
`Scholars Program, Yale University School of
`Medicine. and the Center for Outcomes Re-
`search and Evaluation, Yale—New Haven
`Hospital — both in New Haven, CT (J.S.R.);
`and the Division ofPharmacoepidemiology
`and Pharmacoeconomics. Department of
`Medicine, Brigham and Women's Hospital,
`and Harvard Medical School — both in
`Boston (A.S.K.).
`
`This article was published on August 28,
`2013, at NEJM.org.
`
`l. Kravitz RL, Epstein RM, Feldman MD, et
`al. Influence of patients' requests for direct-
`to-consumer advertised antidepressants: a
`randomized controlled tria|.]AMA 2005;293:
`1995-2002. [Erratum JAMA 2005;294:2436.]
`2. IMS Institute for Healthcare Informatics.
`The use of medicines in the United States:
`review of 2011. April 2012 (http://www
`.imshealth.com/ims/Global/Content/Insights/
`|MS%20I nstitute%20for%20Healthca re%
`20|nformatics/lHII_Medicines_in_U.S_
`Report_2011.pdf).
`3. Phan'naoeutical Care Management Asso-
`ciation, Visante. How copay coupons could
`raise prescription drug costs by $32 billion
`over
`the next decade. November 2011
`(http://www.pcmanet.org/images/stories/
`uploads/2011/Nov2011/visante%20copay%
`20coupon%205tudy.pdf).
`4. ShrankWH, Choudhry NK, Agnew-Blais],
`et al. State generic substitution laws can
`lower drug outlays under Medicaid. Health
`Aft (Millwood) 2010;29:1383-90.
`5. Grande D. The cost of drug coupons.
`JAMA 2012;307:2375-6.
`DOI:10.1056/NEJMpl301993
`Copyright 0 2013 Massachusetts Medical Smitty.
`
`N ENGL) MED 369:1; NE)M.ORG
`
`SEPTEMBER 26, 2013
`
`1189
`
`The New England Journal of Medicine
`Downloaded from nejmorg on December 4, 2017. For personal use only. No other uses without permission.
`Copyright © 2013 Massachusetts Medical Society. All rights reserved.
`
`