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Health Policy 102 (2011) 170–177

Contents lists available at ScienceDirect

Health Policy
journal homepage: www.elsevier.com/locate/healthpol

A new prize system for drug innovation


Afschin Gandjour ∗ , Nadja Chernyak
Department of Public Health, Faculty of Medicine, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany

a r t i c l e i n f o a b s t r a c t

Keywords: We propose a new prize (reward) system for drug innovation which pays a price based
Drug innovation on the value of health benefits accrued over time. Willingness to pay for a unit of health
Prize system benefit is determined based on the cost-effectiveness ratio of palliative/nursing care. We
Value-based pricing
solve the problem of limited information on the value of health benefits by mathematically
relating reward size to the uncertainty of information including information on potential
drug overuse. The proposed prize system offers optimal incentives to invest in research
and development because it rewards the innovator for the social value of drug innovation.
The proposal is envisaged as a non-voluntary alternative to the current patent system and
reduces excessive marketing of innovators and generic drug producers.
© 2011 Elsevier Ireland Ltd. All rights reserved.

1. Introduction of asymmetric information about the costs and benefits


of research it might be better to offer patents. Hence, if
Pharmaceutical prices providing high profits under the value of health benefits becomes observable to pub-
patent protection has been the traditional incentive for lic authority, prizes rather than monopoly prices under
drug research and development (R&D) [48]. However, a patents should be employed to reward medical innova-
decreasing number of fundamentally new drugs in recent tion [57,34,47,49]. Ref. [49] suggested determining the
years, despite high costs of prescription drugs, and lit- social value of innovation based on the demand curve and
tle incentive to invest in R&D of drugs for rare and other sales data. They argued that, if the public authority’s ex-
“low-return” diseases demonstrate the shortcomings of post sales-related information about demand is as good as
the current patent system [22,6,37]. As a result, efficiency innovators’ ex-ante information, the innovators enjoy no
of patents to encourage medical innovation has been informational advantage that favors intellectual property
questioned and a variety of approaches substituting or rights (patents).
complementing the patent system have been proposed.1,2 When applying this insight to drug innovations, some
Several economic models have been developed to features of drug markets need to be considered. In many
explore the optimal design of patent systems and compare countries drugs are consumed by patients, chosen by doc-
patents to alternative incentives for R&D, e.g., contracts and tors, and financed by third-party payers. Hence, third-party
prizes/rewards.3 Ref. [57] was the first to analyze what payers are usually able to obtain significant information
research incentives should be preferred under what con- about demand from drug sales. However, market demand
ditions and found that the range of situations in which a for drugs may poorly reflect social value of health benefits.
patent system dominates other feasible alternatives may The reasons for this are following. First, pharmaceuti-
be narrower than commonly believed. Only in the presence cal companies are not generally required to demonstrate
relative efficacy and safety compared to existing inter-
ventions for licensing.4 Second, patients or doctors are
∗ Corresponding author. Tel.: +49 0171 2195713.
E-mail address: gandjour@gmx.com (A. Gandjour).
1
For a current discussion see http://ccg.merit.unu.edu/prizefund/.
2 4
For the analysis of four alternatives to the patent system see [4]. Under the regulations operating in most jurisdictions, pharmaceutical
3
For a review see Gallini and Scotchmer [58] as well as [31]. manufacturers have to demonstrate efficacy, safety, and quality of man-

0168-8510/$ – see front matter © 2011 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.healthpol.2011.06.001
A. Gandjour, N. Chernyak / Health Policy 102 (2011) 170–177 171

not best placed to assess value, i.e., identify and synthe- of health benefits and adjust it for equity considerations
size all relevant evidence and undertake the computation and uncertainty (risk preferences). Finally, it summarizes
required [14]. Third, in countries such as the United States, important advantages of the proposed prize system over
Switzerland, and Germany drug prices have, at least until the current patent system.
recently, been set with little or no regard to their relative
therapeutic value and cost-effectiveness.
2. Value-based pricing: formal approach
Since the value of new drugs might be unobservable
to patients, it seems reasonable to give an independent
The fundamental principle of the VBP approach is that
assessment authority the responsibility for assessing the
costs of new medical technologies should not exceed their
value of new drugs and signaling the market demand curve
health benefits. The prize system we propose builds on this
for drugs. Several authors [18,3,23,44] have proposed that
fundamental principle of VBP. Compared to existing pricing
licensing authorities (e.g., the U. S. Food and Drug Adminis-
proposals we make specific suggestions on how to adjust
tration and the European Medicines Agency) should begin
health benefits for uncertainty in cost-effectiveness and
to anticipate the needs of assessment authorities/third-
equity considerations. Furthermore, we derive the WTP for
party payers when specifying their requirements and insist
health benefits from the cost-effectiveness ratio of pallia-
on more demanding pre-marketing studies. That is, require
tive or nursing care, appropriate the full social value to
clinical trials which compare new drugs’ efficacy with that
the innovator, and discuss implications for generic price
of previously available alternatives rather than placebo;
competition.
use endpoints which are more related to indicators of clin-
To further explain the VBP approach, consider that the
ical benefit; and consider longer follow-up periods.
relative efficiency of medical intervention is traditionally
Pricing of drugs based on the value they provide is called
summarized as the incremental cost-effectiveness ratio
value-based pricing (VBP). Two much discussed proposals
(ICER) and assessed with reference to a threshold value for
that use VBP are the Health Impact Fund [5] and a model
the WTP [33]:
developed by University of York health economists [15].
The Health Impact Fund [5] provides rewards for global C1 − C0 C
health improvements and considers overuse of drugs in the = (1)
E1 − E0 E < 
assessment of health improvement. However, the Health
Impact Fund does not have a rational basis for the underly- where C1 − C0 denotes incremental costs of the new ther-
ing willingness to pay (WTP) per health gain and, instead, apy, i.e., additional cost compared to the current treatment
uses an arbitrary figure such as 0.03% of the gross national pattern, E1 − E0 denotes incremental health benefit of
income. Furthermore, it assumes an arbitrary duration of the new therapy, i.e., the difference in health outcomes
reward (e.g., 10 years) and does not adjust health gains for between the new therapy and the current treatment pat-
equity concerns and uncertainty. tern, and  is an acceptable price per unit of health outcome.
The proposal by York health economists [15] considers Current treatment pattern is the appropriate comparator
drug overuse, uncertainty in cost-effectiveness, and equity because this is the treatment being substituted in the real
considerations in VBP. However, it does not appropriate world. That is, only incremental costs and benefits com-
the full social value to the manufacturer and therefore pared to current treatment represent the real-world costs
does not provide optimal incentives for R&D. Furthermore, and benefits of the new therapy.
it acknowledges difficulties in determining the WTP per Note that with current treatment pattern as a compara-
health gain. tor, a new therapy may be compared to several different
This paper proposes a new prize system based on the alternatives including no treatment. Hence, incremen-
VBP principle that deals with the shortcomings of alterna- tal costs and benefits represent weighted averages with
tive approaches as described above. The proposal rewards weights representing the current market share of the dif-
the innovator for the full social surplus over product life- ferent comparators.
time. Furthermore, it derives the WTP for health benefits Traditionally, the price of a drug has been set by the
from the cost-effectiveness ratio of palliative or nursing manufacturer and is an input to the calculation of the ICER.
care. Additional features are presented and implications for Alternatively, a cost-effective drug price can be derived
generic price competition are discussed. from a threshold analysis by setting the ICER equal to the
The paper proceeds as follows. First, it outlines a VBP5 acceptable price per unit of health outcome () [54]:
approach to rewarding medical innovation, shows how a
reward size can be linked to the value of health benefits, C1 − C0 C
= = (2)
and proposes a new prize system based on the VBP princi- E1 − E0 E
ple. Next, it discusses how to estimate the monetary value
Decomposing the price of the new drug from its total
costs yields:

ufacture for their products. Approval is frequently granted even if a new C1 − C0 C1 − p + P − C0


drug is merely better than placebo at improving surrogate measures in = = (3)
E1 − E0 E
brief modest-sized clinical trials. Clinical trials comparing a new drug with
existing treatments are typically required only when placebo controls are
ethically unacceptable. See, e.g., [18].
where P is the price of the new drug and C1−p denotes
5
We use the term “value-based pricing” following the terminology of costs induced by the new drug (i.e., costs of side effects,
the UK Office for Fair Trading. See [41,14]. savings from avoiding morbidity, and costs from avoiding
172 A. Gandjour, N. Chernyak / Health Policy 102 (2011) 170–177

premature death). Rearranging Eq. (3) yields the maximum Since there is no patent protection in the current sense,
acceptable drug price: approval of bioequivalent drugs should be abolished to pre-
vent inefficiency due to free riding and excessive entry
P = E ·  − (C1 − p − C0 ) (4) of new firms. The possibility to license copycat drugs
(generics) would lead to the inability of the innovator to
As price P is a function of , the acceptable price per unit
appropriate full benefits and reduce the firm’s incentives
of health outcome is explicitly considered. The size of the
to invest in R&D. As long as the threshold value  reflects
reward is thus placed into the broader context of societal
real willingness/ability to pay for health gains, the VBP
willingness/ability to pay for health improvements.
approach would create no welfare losses due to restricted
Independent of the threshold value  chosen, innovators
access. Consequently, generic price competition, which is
that develop drugs providing high incremental health ben-
usually assumed to improve access by reducing prices, is
efits are generally more highly rewarded than firms that
not necessary under the proposed approach. Still, today’s
develop drugs offering only marginal improvements over
generic drug producers would have a role in the proposed
existing treatments. Drugs that yield a lower benefit but
prize system as the innovator would be able to outsource
demonstrate savings compared to existing treatments are
drug manufacturing. Hence, the license to produce iden-
also priced based on Eq. (4). Hence, incentives are created to
tical drugs would be issued by the innovator and not the
develop cost saving therapies, which are equally or slightly
government as under the current system. In any case, the
less effective compared to the common practice.
innovator would be rewarded with the same prize as if it
produced the drug itself.
3. New prize system based on value-based pricing However, the proposed prize system considers the
cumulative nature of medical innovation and does not
As implied above and discussed by [32], cost- preclude approval of therapeutically similar innovations
effectiveness thresholds are not only a means to control (me-too drugs) if they offer additional health benefits or
prices but also to reward innovation. Hence, reimburse- cost savings. There have been concerns that therapeu-
ment prices derived from the cost-effectiveness threshold tic substitutes might crowd out drastic innovations by
could be considered a form of a monetary reward (prize) reducing the budget available for R&D. But different drug
for marginal health benefits created by the drug [11]. versions are often innovated in so-called R&D races, imply-
Our proposal is to determine the prize based on total ing that therapeutically similar innovations are already
population health benefits. To determine the latter, we in the ‘pipeline’ when the first drastic innovation enters
propose using sales data but adjust them for treatment the market [10]. Thus, increased competition because of
overuse. Furthermore, sales data need to be combined with the race to be the first might further stimulate innovation
information on incremental health benefits of a unit of sales and possibly speeds up commercialization. Moreover, even
(i.e., the individual health benefit). To provide a real-world drugs with the same effectiveness can provide incremental
estimate of the latter, the comparator of the new drug has benefits because of reduced side effects or improved com-
to be the current treatment pattern. pliance [35]. In any case, the prize system considers as a
The approach we suggest sets a maximum WTP for comparator of a new drug the current treatment, which
research activities based on the maximum WTP for a health may be a recently approved drug or no treatment in case
gain. Hence, we suggest rewarding an innovator for the full of market expansion.
social value which is in line with [52] as well as [32]. If drug VBP allows a more exact assessment of social value cre-
prices are increased beyond societal WTP, further research ated by the drug over time than one-time fixed prizes and
activities may be stimulated, but these additional activi- patent buyouts schemes. In the latter the government or
ties, even if they lead to great discoveries, are, by definition, a wealthy non-profit foundation purchases patents and
not acceptable pricewise. On the other hand, if drug prices turn over the rights to the public for free. However, it is
are reduced below societal WTP, it may decrease research difficult for a purchasing agency to estimate all future ben-
activities and may prevent discoveries that society is actu- efits ex-ante given changing market conditions (such as
ally willing to pay for. the appearance of other innovative drugs), changing health
Varying WTP for R&D across industries (biomedical, needs of the public [28], and new indications for the drug.
energy, agriculture, etc.) to provide differential incentives Hence, ex-ante inducement prizes and patent buyouts
and maximize overall research activities presupposes that can under/overestimate future benefits. When payment is
the public has more information on where research yields a based on real sales, there is no need for the purchasing
higher return for society than the market. Assuming that no agency to foresee at one moment all future benefits and
such information is available (on which areas of investment discount them to present value. The VBP approach allows
yield a higher return) which corresponds to the assumption a refinement of the reward size as additional information
that each field has the same return, WTP per health gain is flows to the purchasing agency, e.g., from post-marketing
set equal across industries. drug trials and observational studies.
By pricing new drugs according to the outlined principle VBP precludes reimbursing manufacturers for overuse
the meaning of patents is changed. Patents would no more of a new drug, i.e., inappropriate prescribing which does
reward medical innovation by profits from monopoly pric- not add to health benefits. Thus, by monitoring drug
ing, but rather represent a claim for getting a prize based overuse excessive marketing expenses can be prevented.
on a monetary valuation of the incremental health benefits The National Committee for Quality Assurance and other
created. organizations have developed, specified, and tested a
A. Gandjour, N. Chernyak / Health Policy 102 (2011) 170–177 173

variety of overuse measures. An example is prescription However, it has been argued recently that threshold cost-
of antibiotics for upper respiratory infections which are effectiveness can be thought of as the cost-effectiveness of
caused by a virus and are not effectively treated with antibi- the medical technologies which would be displaced by the
otics [38]. Still, in other cases there might be some effort new ones and empirical estimates are feasible [13]. As more
involved in finding out about a patient’s history and deter- benefits are produced we might expect that the value of 
mining whether treatment has been appropriate or not. On increases at a slower rate.
the other hand, information technology has great potential An alternative approach suggested in this paper is to
to facilitate this type of data collection. Furthermore, any define a minimum WTP based on the cost of palliative or
uncertainty in the degree of overuse can be reflected in the nursing care, which in Germany, e.g., is up to D 23,000 per
price, by downward adjustment. life year [30]. Palliative and nursing care provide a use-
Furthermore, if a drug causes more harm than bene- ful benchmark because they are generally accepted and
fit in some patient populations, then the resulting negative uncontroversial (i.e., we would not displace these services).
health benefits will be subtracted from the total gain, effec- We suggest using a uniform baseline WTP value across all
tively resulting in a punishment for the manufacturer. diseases. The benchmark may also consider quality of life of
The reward mechanism based on the VBP principle also patients receiving palliative or nursing care, by calculating
enables to adjust a reward size downward for uncertainty QALYs. Calculation of QALYs does not require comparing
surrounding health benefits, including uncertainty related different types of palliative treatments in terms of QALYs
to drug overuse (see Section 7). (such nuances may be difficult to capture) but to compare
the quality of life of a person in palliative care with that of
4. Measuring health outcomes a person in full health.
The minimum WTP can be easily adjusted over time, by
For the rest of the paper we use quality-adjusted life simply following changes in the WTP for palliative/nursing
years (QALYs) as a currency in which to express health out- care. In addition, the threshold value may be adjusted
comes. QALYs are the product of life years and a measure of upward based on the reduced health-related quality of
the strength of preference for different health states (see, life of nursing home inhabitants. It may also be adjusted
e.g., [53]). They enable comparisons of drugs producing upward based on the severity of disease and urgency of
different types of health outcomes (e.g., survival or health- treatment. This is formalized below. The latter two fac-
related quality of life) and are increasingly being used to tors are the most important equity criteria to be considered
measure health benefits of medical interventions [29,39]. along with cost-effectiveness [17].
A discussion of the limitations of the QALY model goes far
beyond the scope of this paper; in particular, we would
6. Incorporating equity considerations in the
like to point out that under expected utility theory QALYs
willingness to pay
are valid representations of the preferences of individuals
only under a set of restrictive assumptions [43]. Further-
We propose to set drug prices based on the social value
more, there is the question whose preference assessment
of health outcomes after adjustment for severity of dis-
for the calculation of QALYs should count (patients vs the
ease and urgency of treatment. Thus, industry priorities
general public). Moreover, QALYs may not be applicable
are “pulled” towards actual health needs of the public. To
in acute diseases of short duration [21] as well as chronic
consider urgency of treatment and severity of disease we
severe disease [51]. The new prize system outlined in this
suggest measuring the expected number of future QALYs
paper is not limited to the use of QALYs, however. Other
without treatment and the expected number of future
measures of health outcomes (e.g., life years saved, disabil-
QALYs without disease. While the first parameter is a
ity adjusted life years, healthy years equivalents, or WTP)
measure of treatment urgency (patients who die without
could be similarly used to assess the performance of a new
treatment have zero future QALYs), the difference between
medical therapy.
the two parameters indicates severity of disease. If we con-
sider both parameters in a power model, we obtain the
5. Monetary valuation of health benefits
following formalization of the social value (SV) of a health
gain:
Clearly, the reward size for the innovation depends on
the value of . The value of  is specific to time, place, per- SV (E, r, n, m) = E · (1 + r)n−m (5)
spective, available medical technologies, population needs,
and budgetary restrictions [25,29].  can be defined as a where r = inequality aversion parameter, n = expected
value function over health and money [1]. In case of a fixed health gain if the individual did not have the disease, and
budget, the value of  is a function of the size of the bud- m = expected health gain without treatment. Thus, an indi-
get and the incremental cost-effectiveness ratios of existing vidual with a life threatening disease obtains a large power
medical interventions, where  represents the opportunity factor and the reward size is adjusted upward accordingly.
cost of health care resources at the margin or equivalently Parameter n can be derived from a life table of the general
the shadow price of the budget constraint [56]. If the bud- population. Parameter m may be more difficult to estimate.
get is set by a socially legitimate process, then the threshold However, in clinical areas where there has been no effec-
value represents the implicit social valuation of health [13]. tive treatment so far, the comparator of the new drug is
In practice, full information about the cost-effectiveness no treatment and conventional cost-effectiveness analysis
of existing medical interventions is not available [24]. would need to estimate this parameter.
174 A. Gandjour, N. Chernyak / Health Policy 102 (2011) 170–177

With this model, rare diseases also receive priority: if order to surely avoid double counting of risk aversion, one
industry neglects rare diseases, the value of health bene- may correct utility estimates for risk or loss aversion [8].
fits and hence the reward size increases relative to more In order to consider risk aversion with respect to
prevalent diseases (as n − m in Eq. (5) increases). Thus, it health outcomes Eq. (4) needs to consider a risk aversion
becomes more attractive to invest in drug R&D for rare dis- parameter6 :
eases. Furthermore, if competitors neglect rare diseases,  r

the manufacturer of an orphan drug will be able to reap P= Ē − · var(E) ·  − (C̄1−p − C̄0 ) (8)
benefits for a longer period of time than manufacturers 2
for more prevalent diseases. Still, the private sector may
where var(E) denotes the variance of incremental health
not fully account for all the future benefits and returns
benefits and r is a risk aversion parameter. Thus, for given
from developing treatments for rare/neglected diseases in
Ē and var(E), we calculate the price of a new drug. Eq.
its investment decisions if it discounts the future bene-
(8) implies that price increases with mean health bene-
fits more highly than society or if it irrationally fears that
fits and decreases with the variance of health benefits or
returns may be recouped by subsequent superior market
risk aversion. Thus, the presence of even modest degrees
entrants. In these cases public sector need to provide push
of uncertainty may lead to a substantial decrease in price.
incentives for innovation, e.g., by directly funding research
Uncertainty cannot only be considered with respect to
or providing tax incentives. Since direct funding offsets
individual health gain, but also with respect to the number
some of R&D costs, the threshold value  and thus the max-
of people are treated appropriately. This includes a consid-
imum drug price needs to be corrected for the amount of
eration for treatment overuse. Uncertainty in the degree of
initial funding when calculating a reward size. For exam-
overuse of the new drug would lead to downward adjust-
ple, if 50% of drug R&D is financed by the public sector,
ment of the price.
the firm will be later paid half the drug price. Otherwise,
Other formulations of utility functions for health bene-
costs to society exceed the value it places on the health gain
fits and costs are possible [see, e.g., [1,20]]. We use a very
produced.
simple stylized model to demonstrate how drug prices can
be adjusted for risk preferences, thus trading off expected
7. Incorporating uncertainty
returns to investment in health care and the variance of
those returns. As argued above, risk neutrality with regard
It is never possible to know the true incremental costs
to health benefits is difficult to justify. An adjustment of the
and effects of a new technology with certainty. Usually,
reward size for uncertainty could be deemed unnecessary
mean point estimates of incremental costs and effects
only if the magnitude of uncertainty were equal across all
(C̄ and Ē) are reported in conjunction with bounds (e.g.,
medical technologies.
95% confidence limits) within which the mean cost and
Similar to our proposal, [13] as well as [27] suggest a
effects can be expected to lie. Thus, the expected cost-
downward adjustment of drug prices in case of uncertainty
effectiveness of the new technology under uncertainty can
on cost-effectiveness. While their approach formally con-
be expressed as:
siders the costs of decision uncertainty, it does not account
C̄ C̄1 − C̄0 for risk aversion with respect to uncertainty in health.
= (6)
Ē Ē1 − Ē0 Downward adjustment of a drug price because of
uncertainty and upward adjustment because of reduced
Accordingly, a cost-effective drug price is calculated as
uncertainty create appropriate incentives to invest in clin-
follows:
ical trials early in the development of drugs and preserve
P = Ē ·  − (C̄1−p − C̄0 ) (7) incentives for the manufacturer to conduct post-marketing
evaluative research. While additional placebo-controlled
Calculating the price solely on the basis of mean point
trials may be considered unethical after drug approval,
estimates only makes sense if we assume a linear util-
there is still opportunity for head-to-head studies against
ity function, i.e., risk neutrality with regard to money and
other interventions or evaluations of real-world data from
health effects. For a discussion on whether this assumption
observational studies and patient registries.
is reasonable and whether risk aversion for health out-
comes, costs, or both should be incorporated in the analysis
see, e.g., [7,12,40,26]. 8. Prize system vs current patent system
Let us now assume risk neutrality with regard to costs
because following the Arrow–Lind theorem [2] the risk of It is widely recognized that, left to itself, the market does
investments is spread across many taxpayers and the dis- not support an adequate amount of biomedical research:
tribution of costs can be ignored in a collectively funded if consumers pay only the marginal cost of production,
health care system. The assumption of risk neutrality with revenues are insufficient to cover the cost of future drug
regard to health outcomes is less convincing, however. R&D. However, it does not automatically follow that patent
Since it is not possible to compensate individuals for lost life monopolies provide the best mechanism to encourage drug
years it seems reasonable not only to consider the mean, R&D [4].
but also the distribution of health benefits in the valua-
tion of the medical technology. When using QALYs as a
measure of health outcome, preference-based instruments 6
For a similar approach which applies the risk-aversion parameter to
might capture some degree of risk or loss aversion [9]. In the variance in cost-effectiveness see [26].
A. Gandjour, N. Chernyak / Health Policy 102 (2011) 170–177 175

Monopoly profits from patent-protected prices are excessive entry and competition for market share could
often criticized for creating two types of inefficiency. On change the proportion between R&D and marketing expen-
the one hand, the gap between the competitive market ditures.
price and the patent protected price may reduce access To provide sufficient incentives for innovation the terms
to drugs and generate inequality of drug use [34,4,6]. On of any award must be fixed before the informational asym-
the other hand, monopoly profits may offer insufficient metry with regard to costs and benefits of research is
incentives for R&D because they reward inventors with resolved [57]. The threshold value , which is used for mon-
less than the social value of their innovations—monopoly etary valuation of health benefits under VBP, may offer
advantages last for a limited number of years and inno- credible and time consistent incentives for medical innova-
vators cannot fully capture consumer surplus [50,34,49].7 tion, particularly if based on the cost of palliative or nursing
This is especially true for drugs since their actual value can care. Of course, future WTP for health improvements may
be unobservable for consumers and prices may be held change due to government budgetary pressures. However,
below the profit-maximizing level if adverse public reac- under current patent system there is also a risk of future
tion is feared [48]. Furthermore, once a drug is off-patent, modifications of patent law as well as enforcement of dis-
the innovator has little incentive to conduct trials on other counts by the government.
indications, as the drug price does not promise an adequate
return.
The outlined VBP approach to reward medical innova- 9. Global implementation issues
tion minimizes the failures of the patent system outlined
above. First, as long as threshold value  reflects real will- Differential pricing of drugs has been discussed as a
ingness/ability to pay for health gains, the VBP approach tool to increase affordability of on-patent drugs in devel-
is superior to monopoly profits under patents because no oping countries while preserving incentives for innovation
unrealized social benefits (deadweight loss) are created. (e.g., [19,16]). An important reason why manufacturers
Note that even if drug prices are higher than the marginal are reluctant to charge lower prices in developing or low-
costs of their production, a deadweight loss may not occur. income countries is that they fear that this will undermine
A deadweight loss does not occur as long as, from soci- the prices they charge to higher-income countries [45].
etal perspective, marginal costs equal marginal benefit (i.e., The proposed prize system might help to set and maintain
costs of a drug including downstream cost effects equal appropriate price differentials between countries based on
societal WTP). Note that manufacturers may set the price their ability or WTP for the surplus created. Since the abil-
just below the level of the threshold ICER, which could ity or WTP for health benefits depends inter alia on the
lead to higher prices than without a VBP system. Still, this per-capita income, a fair relationship between income and
may not necessarily be an undesirable reaction as it may prices is established. In addition, fair R&D cost sharing can
increase future R&D activities. In any case, a threshold be achieved, as each country contributes according to its
based on the cost of palliative or nursing care, which in economic capacity. Incentives to spill over too much costs
Germany, e.g., is no more than D 23,000 per life year, does to low-income countries as well as incentives for each
not seem to allow for much upward shifting of prices. country to free ride with regard to R&D paying only the
Second, as long as the expected social benefits exceed marginal cost of production and distribution and leaving
costs, private research incentives are in line with social others to pay the joint fixed costs of R&D are eliminated. If
incentives. If a drug price is based on the threshold cost- a certain country offers a price that is lower than suggested
effectiveness ratio reflecting the social value of incremental by its willingness/ability to pay, pharmaceutical companies
health benefits, the innovator will be rewarded for the will not be forced to sell at this price. Conversely, if the
net health benefit actually created over time. Hence, the manufacturer offers a price below the willingness to pay,
innovator also has an incentive to conduct trials on new there will be no need to adjust the price upward. Further-
indications for a drug that is already approved. more, it might be the case that pharmaceutical companies
In addition, as the reward system does not provide for negotiate a higher price than suggested if the social value
licensing copycat drugs, it prevents welfare losses from free in a given country is not adequately captured (i.e., there
riding and excessive market entry. This is in line with the are additional values). This would not mean, however, that
reasoning of [36], who argued that if an entrant causes other countries could lower prices compensatory.
incumbent firms to reduce output, entry is more desir- Still, differential pricing might be unsustainable due to
able to the entrant than to society. Further, there is no parallel trade and external referencing (the latter occurs
need to subsidise start-up and production costs of generic when governments or other purchasers use low foreign
manufacturers. Litigation costs because of patent infringe- drug prices as a benchmark for regulating their domestic
ment lawsuits against generic manufacturers also vanish. prices [16]). To prevent parallel trade and external refer-
Finally, firms currently allocate substantial resources to encing, [16] suggest that manufacturers and purchasers
marketing8 in order to protect their profits. Restricting in low income countries use confidential rebates as part
of their procurement arrangements, such that low prices

7
Ref. [34] provided examples from the empirical literature suggesting
that the social rate of return on R&D is at least twice the private rate of
return, given the quantities consumed under monopolistic pricing. research expenses. Other statistics suggest that for the 10 largest phar-
8
According to publications by the pharmaceutical industry, promo- maceutical companies, 14% of revenue is devoted to R&D, while 34% goes
tional costs including the value of samples amount to about 60% of the to marketing, general, and administrative costs [6].
176 A. Gandjour, N. Chernyak / Health Policy 102 (2011) 170–177

granted to one purchaser are unobservable to others and voluntary alternative to the current patent system. In this
cannot be copied. system approval of bioequivalent drugs including generics
Under the VBP approach prices can exceed marginal cost is abolished.
of production and distribution only as long as the cost to The proposed prize scheme can improve allocative effi-
society does not exceed the value it places on the health ciency of drug spending compared to the current patent
gains or savings produced. If forecasted prices from antici- system because no unrealized social benefits (deadweight
pated health benefits do not provide a return on investment loss) are created, as long as the threshold value reflects
for the private sector, the development of drugs for diseases the real WTP for health gains. This prize system also
that are prevalent in low income countries might not occur. provides strong incentives for innovation because the inno-
That is, there would be no R&D in the first place. In case the vator reaps the full social surplus. Furthermore, the system
WTP for health improvement in developing/low-income prevents welfare loss from excessive marketing of the inno-
countries are not sufficient to stimulate R&D, the incentives vator and firms producing copycat drugs (me-too drugs
to invest in the development of technologies beneficial for with no proven additional benefit and generics). While
poor countries will depend on the altruistic value placed on generic drug producers may still market their production
expected health benefits in developing countries by high capability to the innovator, the corresponding marketing
income countries [42]. effort seems small compared to that for the general popu-
Calculating ICERs in each jurisdiction may require a lation under the current system.
large effort. One may consider, as a second-best solution, As a final notion, the proposed prize scheme could prin-
tying drug prices directly to health gains. This approach cipally also be applied to other types of medical products
would not consider downstream savings, however. On the such as medical devices and diagnostics. With such a sys-
other hand, it would be in line with using the ICER of pal- tem in place there would be an incentive for more formal
liative or nursing care as a benchmark, as palliative and evaluation of the effectiveness of medical devices or diag-
nursing care do not aim at changing progression of the dis- nostics.
ease and hence do not lead to downstream savings either.
In developing countries the outlined prize system can 11. Conclusions
be implemented by international organizations already
financing drug development for poor countries, such as the Under our proposal monopoly profits are turned into
International Financing Facility for Immunization, as well prizes linked to the social value of health benefits. If prop-
as by drug purchasing organisations such as UNITAID. The erly implemented, the proposed reward system
threshold value placed on health benefits can be used as
a benchmark to allocate available funds between “push” • allows to allocate available government spending on
and “pull” instruments, i.e., between targeted research to pharmaceuticals in a more cost-effective way,
develop drugs for specific diseases and commitments to • directs innovative activity to drugs most valued by soci-
procure the developed drugs. ety,
• ensures commercialization of innovations since prize
10. Discussion payments are conditional on sales,
• reduces incentives to promote drug overuse and
In this paper we propose a new prize system for drug decreases related marketing costs,
innovation, where public authority (e.g., a third party • offers transparent and unambiguous incentives to invest,
payer) is committed to pay a price based on the value of • can stimulate research on drugs addressing
health benefits accrued over time. We define a minimum rare/neglected diseases,
WTP for health benefits based on the cost-effectiveness • offers incentives for continuing development and follow-
of palliative or nursing care and provide a formal method up innovations, and
to adjust the price upward based on the severity of dis- • makes generic price competition unnecessary.
ease. The proposed methodology allows us to overcome
the lack of a formal method to determine reward size Further refinement of the proposed prize system should
which is inherent in some other proposals linking prize involve stakeholders as this would increase its acceptance
payment to the value of health benefits.9 Furthermore, we [46].
suggest a formal method to adjust prizes downward for
imperfect information on health benefits, including infor- Acknowledgement
mation on potential drug overuse. Therefore, our approach
does not presuppose perfect information on health bene- The paper did not receive funding. There is no conflict
fits. The proposed reward mechanism enables refinement of interest.
of a reward size by periodic reassessment of health bene-
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