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EDITED BY

SUSAN L. CRADDOCK



University of Minnesota Twin Cities, United States

REVIEWED BY

TEMMY SUNYOTO



Global Health Center, Graduate Institute of International and Development
Studies, Switzerland

JONATHAN DARROW



Harvard University, United States

TABLE OF CONTENTS

 * * Abstract
   * Albenza (Albendazole)
   * Impavido (Miltefosine)
   * Looking Ahead
   * Data Availability Statement
   * Author Contributions
   * Conflict of Interest
   * References


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PERSPECTIVE ARTICLE

Front. Sociol., 22 October 2020
Sec. Medical Sociology
https://doi.org/10.3389/fsoc.2020.540478

THIS ARTICLE IS PART OF THE RESEARCH TOPIC

Global Health and Pharmacology

View all 13 Articles


ANTIPARASITIC DRUGS IN THE UNITED STATES—TWO ROADS TO HIGH PRICES

Arman A. Shahriar1* and Jonathan D. Alpern2,3
 * 1University of Minnesota Medical School, Minneapolis, MN, United States
 * 2HealthPartners Institute, Bloomington, MN, United States
 * 3Department of Medicine, University of Minnesota, Minneapolis, MN, United
   States

High prescription drug prices contribute significantly to healthcare spending in
the United States and compromise patients' access to quality medical care. A
number of factors allow drug manufacturers to set much higher prices in the US
than in other comparable high-income nations. Price-control depends primarily on
the entry and persistence of generic products following the expiration of the
market exclusivity period granted to the manufacturer of the brand name drug.
Unfortunately, barriers to generic entry are common, allowing off-patent drugs
like albendazole to remain relatively expensive despite having been marketed in
the US for decades. By contrast, miltefosine became FDA approved more recently
and has maintained a high price tag by way of a novel incentive program—the
neglected tropical disease (NTD) priority review voucher (PRV) program. The
voucher has a high market value and can be sold or transferred well before the
drug for which it was awarded becomes available on the market. While both drugs
are used to treat parasitic infections that are uncommon in the US, they differ
by market and regulatory conditions—each telling an interesting pricing story.



The United States spends nearly twice as much on healthcare as other comparable
high-income countries in the Organization for Economic Cooperation and
Development (OECD), while performing worse by several key public health
outcomes. An important driver of this difference in spending are the high prices
of prescription drugs (Emanuel, 2018; Papanicolas et al., 2018). Brand-name
drugs account for the majority (74%) of US prescription drug spending despite
constituting only 10% of total prescriptions (Association for Accessible
Medications, 2017). This is primarily due to the combination of
government-granted market exclusivities (“monopoly rights”) and the limited
ability of public US payers—namely Medicare and Medicaid—to limit coverage and
negotiate drug prices with manufacturers. By contrast, in countries with
national health insurance systems, such as Canada or the UK, a central body
negotiates drug prices or rejects coverage of products if the price demanded by
the manufacturer outweighs the benefit of the product (Kesselheim et al., 2016).
At the level of the patient, a recent nationally representative survey found
that one in four Americans have difficulty paying for prescription medications
(Kaiser Family Foundation, 2019).

Once the exclusivity period for a brand-name drug ends, the entry and
persistence of generic manufacturers often leads to decreased prices (Kesselheim
et al., 2016). After about 2–3 years, generic drug prices generally decrease by
60–70% compared to their branded equivalents, and the degree of price decrease
is strongly associated with the number of manufacturers (IMS, 2016). This
“free-market” system is the primary mechanism of cost-control for drugs that no
longer have market exclusivity in the US (Shrank et al., 2006; Gupya et al.,
2019).

Sufficient market competition among generic manufacturers is generally a
predecessor to low-cost generic drug products. However, barriers to generic
entry are common and can lead to monopoly-like conditions that result in high
prices. A recent analysis of over 1,000 generic drugs found a clear association
between price hikes and lack of competition. On average, drugs with the lowest
levels of market competition experienced a 47% price increase over the 5-year
study period (Dave et al., 2017). By comparison, generic drugs with relatively
high levels of competition decreased in price by an average of 32% in the same
time period (Dave et al., 2017).

One reason why manufacturers may not bring a generic drug to the US market is a
low financial incentive, stemming from low clinical demand for that particular
drug in the US. From the standpoint of the manufacturer, the incentive to enter
such a market may be outweighed by the risk: that subsequent generic entry
causes a downward pressure on the price of a drug with already-low sales
volumes, jeopardizing profit. Paradoxically, these low-volume generic US markets
appear to have become incubators for opportunistic manufacturer behavior: a
recent study of generic drug price changes between 2008 and 2016 identified a
much higher prevalence of price-hikes among infrequently prescribed (low-demand)
generic drugs as compared with their more-frequently prescribed counterparts
(Dave et al., 2019).

The nationally-publicized case of Daraprim (pyrimethamine), the first-line drug
to treat toxoplasmosis, is an example of this opportunistic behavior. In 2015,
Turing Pharmaceuticals (now Vyera Pharmaceuticals) acquired the rights to
Daraprim and increased the price by 5,433% in 1 day (Alpern et al., 2016). This
tactic was heavily scrutinized by the public (Pollack, 2015, September 20),
professional infectious disease organizations (Calderwood and Adaora, 2015), and
bipartisan presidential candidates (Eunjung Cha, 2015; LoGiurato, 2015). Yet,
the negative press appeared to have no impact on the price of the drug, which
remains cost-prohibitive. Turing's strategy was legal and demonstrates the
vulnerability of certain drug markets to exploitation by the pharmaceutical
industry.

Daraprim is not unique among antiparasitic drugs approved for use in the US—a
market that has become the embodiment of price hikes on off-patent essential
medicines (Alpern et al., 2019). Many of these drugs are widely available and
low-cost in the developing world where tropical parasitic infections are
endemic, but have become more expensive in the United States where these
infections have relatively low incidence and prevalence. In this article, we
describe the pricing and market conditions of two anti-parasitic drugs:
albendazole and miltefosine.

Whereas albendazole has become the poster child of price hikes on essential
off-patent drugs (Alpern et al., 2016), miltefosine was only recently approved
by the FDA and has ongoing regulatory market exclusivity. Although very
different drugs with respect to their market and regulatory conditions, both
drugs are used to treat neglected tropical diseases that are relatively uncommon
in the US: hydatid disease, neurocysticercosis, and soil-transmitted helminth
(STH) infections (albendazole) and leishmaniasis (miltefosine).


ALBENZA (ALBENDAZOLE)

In October 2019, a 12-year old girl, who recently arrived in Minnesota from
Ecuador, presented to a free clinic with diffuse abdominal pain and fatigue. She
was diagnosed with hookworm infection—a soil-transmitted helminth (STH) that
affects over 500 million people worldwide (Hotez et al., 2004). Like other STH
infections, hookworm has a much higher prevalence in areas of extreme
poverty—predominantly in the developing world—where a common mode of
transmission is walking barefoot on soil (Hotez et al., 2004; CDC, 2013).
Hookworm infection can cause chronic blood loss and may reduce school attendance
in children, with subsequent effects on productivity and wage-earning potential
in adulthood (Hotez et al., 2004). The clinic is usually able to provide free
prescription medicines to the patients it serves, many of whom are uninsured or
underinsured. In this case, however, the average wholesale price (AWP) of the
first-line treatment—a single dose of 400 mg albendazole—was over $400 (Dynamed
Plus, 2020; Micromedex 2.0, 2020). At the time, the lowest price available with
a coupon discount on GoodRx was still prohibitive for both the clinic and the
patients' family. Instead, she was prescribed a trial of pyrantel pamoate, a
less-effective over-the-counter alternative which failed to resolve the
infection. Out of options, the free clinic referred the patient to a nearby
federally-qualified health center, hoping she would be able to access
albendazole or mebendazole through a public program.

The antiparasitic medication, albendazole, has been marketed outside the US
since 1982 and was approved by the FDA in 1996. In addition to the treatment of
hookworm (ancylostoma duodenale and necator americanus) it is first-line for the
treatment of neurocysticercosis and echinococcosis and is a preferred treatment
option for ascaris lumbricoides and pinworm (enterobius vermicularis)—the most
common parasitic infection in the US (CDC, 2013).

In 2010, CorePharma acquired the marketing license for Albenza (albendazole)
from GlaxoSmithKline (GSK) and then sold the drug to Amedra Pharmaceuticals, a
private equity firm. Amedra then purchased the primary competitor in the US
market, mebendazole. Between 2010–2015, the AWP of Albenza increased by 3,299%,
from $5.92 per 200 mg tablet in 2010 to $201.27 in 2015 (Alpern et al., 2016).
In 2015, Impax Labs (now Amneal Pharmaceuticals Inc.) acquired Amedra. This led
to subsequent increases in the price of Albenza, eventually landing on its
current average wholesale price of $291.21 per tablet, and bringing the total
increase in AWP since 2010 to 4,819% (Micromedex 2.0, 2020). It took until
September of 2018 for the first generic manufacturer to begin to market
albendazole in the US, and since then five other companies have entered (FDA,
2020). According to a recent FDA report, drug prices decline to ~47% of
brand-name drug prices with 2 generic manufacturers, 32% with 3 manufacturers,
and 14.4% with 5 manufacturers (Food and Drug Administration, 2019a).

While historical data are limited, between January 2018 and August 2020, the
lowest out-of-pocket price of a single 200 mg tablet of albendazole (half of the
first-line 400 mg treatment dose for hookworm) after the use of GoodRx coupons
decreased from $191 to $49 (GoodRx, 2020; Wayback Machine, 2020). Interestingly,
despite the presence of multiple generic manufacturers and the decline of the
GoodRx post-coupon price for patients, the average wholesale price (AWP) of
generic albendazole remains high. As of August 2020, the mean AWP of a single
200 mg tablet, among the five available generic products, is $248 or 85.2% of
the brand-name (Micromedex 2.0, 2020). Although the AWP is not a good measure of
the price actually paid for a drug, it can translate to high out-of-pocket costs
for patients—particularly the uninsured. One possible explanation for this
observation is that insufficient time has passed to realize the effect of
competition on price. However, some evidence suggests that a more significant
AWP reduction for generic albendazole tablets should have been observed by now
(IMS, 2016; Food and Drug Administration, 2019c). Although prices do not
appreciably decline after the entry of one generic manufacturer, prices
typically decrease rapidly with the entry of subsequent generic manufacturers
(Food and Drug Administration, 2019c; Gupya et al., 2019).

The delayed entry of manufacturers for generic albendazole could reflect FDA
policy in the last few years to incentivize generic entry in non-competitive
markets. Since 2017, the FDA has maintained a list of off-patent off-exclusivity
(OPOE) drugs with one manufacturer in the US in order to encourage generic entry
for candidate drugs (Food and Drug Administration, 2019a). Under the FDA
Reauthorization Act of 2017 (FDARA) Congress also created a competitive generic
therapy (CGT) designation for Abbreviated New Drug Applications (ANDAs) in drug
markets with only one manufacturer (Food and Drug Administration, 2019b). The
CGT designation allows for an expedited and prioritized review process, as well
as eligibility for a 180-day period of market exclusivity (Food Drug
Administration, 2018). As of March 2019, the FDA had received more than 245 CGT
requests and granted over 70% of them (Food and Drug Administration, 2019b).


IMPAVIDO (MILTEFOSINE)

Miltefosine is the only oral drug FDA-approved to treat leishmaniasis, a
parasitic disease that can present in a cutaneous, mucocutaneous, or visceral
form. Untreated, the visceral form has a high mortality (Sunyoto et al., 2018)
and causes 20,000–30,000 deaths annually (WHO, 2019). Stigma and disability due
to cutaneous and mucocutaneous lesions can be devastating (Hofstraat and van
Brakel, 2016). Miltefosine costs ~$57,600 for a 28-day regimen in the US,
resulting in barriers to access due to high out of pocket costs (WHO, 2019). In
contrast to albendazole, which has generic manufacturer competition, the sole
manufacturer of miltefosine has orphan drug market exclusivity through March
2021.

The effort to bring miltefosine to the US market for the treatment of
leishmaniasis began in 2008 when Paladin Labs acquired the rights to the drug
from Zentaris for $8.5M. Between 2008 and 2014, Paladin acted as the drugs'
sponsor and spent roughly $10M working toward FDA approval (Doshi, 2014). In
late 2013, Paladin Labs was acquired by Endo Pharmaceuticals for $1.6B (WHO,
2019). By this point, Paladin's new drug application for miltefosine was nearing
approval and Paladin placed a $100M+ price tag on miltefosine, a price Endo was
unwilling to pay (Doshi, 2014). Thus, as Endo absorbed Paladin, Knight
Therapeutics—led by the CEO of Paladin—was spun off in February 2014 with
worldwide rights to miltefosine. Less than a month later, miltefosine was
approved by the FDA for the treatment of leishmaniasis, granting Knight a
tropical disease priority review voucher (PRV). The tropical disease PRV is a
reward meant to incentivize research and development (R&D) for neglected
tropical disease (NTD) drugs. Since the conception of the PRV program in 2007,
if a sponsor achieves approval for a new chemical entity that constitutes a
significant improvement for one of the listed tropical diseases, the sponsor can
be granted a PRV (Kesselheim et al., 2015). The voucher is redeemable at the FDA
for the priority review (as opposed to standard review) of a different drug or
biologic product, and may also be transferred or sold—with market value
estimates as high as $350M at the time (2017) (WHO, 2019).

Only 5 months after being granted the PRV, Knight Therapeutics sold the voucher
in November, 2014 to Gilead for US $125M in cash, well before the drug was made
available in the US market (DNDi, 2014; Garde, 2014; Knight Therapeutics Inc,
2014). The drug did not enter the US market until April 2016, priced at an
average wholesale price of US$685.70 per capsule, or roughly US$57,600 for a
28-day regimen (84 capsules).

The case of miltefosine provided some of the earliest evidence that the PRV may
not be driving research and development of tropical drugs it had originally
intended. Manufacturers are able to bring an existing drug to the US market
while avoiding some or all of the research and development costs and receive a
tropical disease PRV—which can be sold for a profit (Kesselheim et al., 2015),
arguably over-compensating the manufacturer. In addition to the profits enjoyed
from the sale of the PRV, companies who commercialize orphan drugs are also
granted market exclusivity of up to 7 years, giving them the ability to demand
high prices. Global experts have suggested that preconditions on PRVs should
stipulate that applicants seek regulatory approval of the drug in endemic
countries and demonstrate appropriate access strategies (WHO, 2019).


LOOKING AHEAD

Some segments of the US antiparasitic drug market have been targeted by a
pharmaceutical industry increasingly focused on financialization and short-term
returns. This business model is troubling to healthcare providers because it
seems that vulnerable patients have been disproportionately affected (Hotez,
2014; Alpern et al., 2016). The examples of albendazole and miltefosine
highlight different but equally important ways in which the US drug development
mechanism has failed patients.

The neglected tropical disease PRV program has been in effect for over a decade.
The story of Miltefosine provides some evidence that the program may be
functioning sub-optimally. An analysis of NTD drug development in the 7-year
period preceding and succeeding the PRV program's conception demonstrated no
association between the NTD PRV program and an increase in innovative,
early-stage NTD product development (Jain et al., 2017). This finding stands in
contrast to other markets, such as drugs used to treat rare pediatric diseases,
where a similar PRV program has demonstrated some effect on early-stage drug
development (Hwang et al., 2019). If the PRV program is to persist in the NTD
space, requirements specific to the NTD market conditions may be warranted. For
example, the FDA could hold manufacturers accountable for certain access
benchmarks and consider withholding the voucher until the drug has been become
available at what is deemed to be a fair price.

In the case of albendazole, generic entry alone may not be sufficient to lower
prices significantly. If similar trends are identified in other drug markets,
additional policies may be needed. While this piece was being written, one of
the authors was traveling in Ecuador for the holiday and visited a licensed
local pharmacy. There, a 400 mg dose of albendazole (FAGOL 400), the first-line
treatment for hookworm (Dynamed Plus, 2020), sold for $0.33 USD—less than a pack
of gum. In Minnesota, as of August 2020, the lowest out-of-pocket price (after
coupons) of the same 400 mg dose is still $98.46 (GoodRx, 2020). It is indeed a
paradox that a patient from Ecuador seeking healthcare at a free clinic in
Minnesota would be better served receiving this care in Ecuador, where the
retail out-of-pocket cost of first-line treatment is <0.5% of what it is here.


DATA AVAILABILITY STATEMENT

The original contributions presented in the study are included in the
article/supplementary material, further inquiries can be directed to the
corresponding author.


AUTHOR CONTRIBUTIONS

AS: research and preparation of the manuscript. JA: critical review and
preparation of the manuscript. Both authors contributed to the article and
approved the submitted version.


CONFLICT OF INTEREST

The authors declare that the research was conducted in the absence of any
commercial or financial relationships that could be construed as a potential
conflict of interest.

The handling editor declared a shared affiliation with the authors at time of
review.


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Keywords: antiparasitic, drug pricing, drug costs, price hike, albendazole,
miltefosine

Citation: Shahriar AA and Alpern JD (2020) Antiparasitic Drugs in the United
States—Two Roads to High Prices. Front. Sociol. 5:540478. doi:
10.3389/fsoc.2020.540478

Received: 05 May 2020; Accepted: 10 September 2020;
Published: 22 October 2020.

Edited by:

Susan Leigh Craddock, University of Minnesota Twin Cities, United States

Reviewed by:

Temmy Sunyoto, Graduate Institute of International and Development Studies,
Switzerland
Jonathan Darrow, Harvard University, United States

Copyright © 2020 Shahriar and Alpern. This is an open-access article distributed
under the terms of the Creative Commons Attribution License (CC BY). The use,
distribution or reproduction in other forums is permitted, provided the original
author(s) and the copyright owner(s) are credited and that the original
publication in this journal is cited, in accordance with accepted academic
practice. No use, distribution or reproduction is permitted which does not
comply with these terms.

*Correspondence: Arman A. Shahriar, shahr019@umn.edu



Disclaimer: All claims expressed in this article are solely those of the authors
and do not necessarily represent those of their affiliated organizations, or
those of the publisher, the editors and the reviewers. Any product that may be
evaluated in this article or claim that may be made by its manufacturer is not
guaranteed or endorsed by the publisher.



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