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1. PROJECTING FUTURE DRUG EXPENDITURES SPECIAL FEATURE
AM J HEALTH-SYST PHARM | VOLUME 73 | 2016 e357
National trends in prescription drug expenditures
and projections for 2016
Glen T. Schumock, Pharm.D., M.B.A.,
Ph.D., FCCP, Department of Pharmacy
Systems, Outcomes and Policy, College
of Pharmacy, University of Illinois at
Chicago, Chicago, IL.
Edward C. Li, Pharm.D., M.P.H.,
BCOP, Department of Pharmacy
Practice, College of Pharmacy, University
of New England, Portland, ME.
Katie J. Suda, Pharm.D., M.S.,
Department of Veterans Affairs, Center
of Innovation for Complex Chronic
Healthcare, Edwards Hines Jr. VA
Hospital, Hines, IL, and Department
of Pharmacy Systems, Outcomes and
Policy, College of Pharmacy, University of
Illinois at Chicago, Chicago, IL.
Michelle D. Wiest, Pharm.D., BCPS,
FASHP, UC Health, Cincinnati, OH, and
James L. Winkle College of Pharmacy,
University of Cincinnati, Cincinnati, OH.
JoAnn Stubbings, B.S.Pharm.,
M.H.C.A., Department of Pharmacy
Systems, Outcomes and Policy, College
of Pharmacy, University of Illinois at
Chicago, Chicago, IL.
Linda M. Matusiak, B.A., IMS Health,
Plymouth Meeting, PA.
Robert J. Hunkler, M.B.A., IMS Health,
Plymouth Meeting, PA.
Lee C. Vermeulen, B.S.Pharm.,
M.S., FCCP, FFIP, Center for Clinical
Knowledge Management, UW Health,
Madison, WI, and School of Pharmacy,
University of Wisconsin, Madison, WI.
Address correspondence to Dr. Schumock
(schumock@uic.edu).
This article will appear in the July 15,
2016, issue of AJHP.
DOI 10.2146/ajhp160205
Supplementary material is available with the
full text of this article at www.ajhp.org.
Purpose. Historical trends and factors likely to influence future pharmaceu-
tical expenditures are discussed, and projections are made for drug spend-
ing in 2016 in nonfederal hospitals, clinics, and overall (all sectors).
Methods. Drug expenditure data through calendar year 2015 were obtained
from the IMS Health National Sales Perspectives database and analyzed.
Other factors that may influence drug spending in hospitals and clinics in
2016, including new drug approvals and patent expirations, were also re-
viewed. Expenditure projections for 2016 were based on a combination of
quantitative analyses and expert opinion.
Results. Total U.S. prescription sales in the 2015 calendar year were $419.4
billion, which was 11.7% higher than sales in 2014. Prescription expendi-
tures in clinics and nonfederal hospitals totaled $56.7 billion (a 15.9% in-
crease) and $33.6 billion (a 10.7% increase), respectively, in 2015. In nonfed-
eral hospitals, growth in spending was driven primarily by increased prices
for existing drugs. The hepatitis C combination drug ledipasvir–sofosbuvir
was the top drug overall in terms of 2015 expenditures ($14.3 billion); in
both clinics and nonfederal hospitals, infliximab was the top drug. Individual
drugs with the greatest increases in expenditures in 2015 were specialty
agents and older generics; these agents are likely to continue to influence
total spending in 2016.
Conclusion. We project an 11–13% increase in total drug expenditures
overall in 2016, with a 15–17% increase in clinic spending and a 10–12%
increase in hospital spending. Health-system pharmacy leaders should care-
fully examine local drug utilization patterns in projecting their own organiza-
tion’s drug spending in 2016.
Am J Health-Syst Pharm. 2016; 73:e357-73
Recent data show that healthcare
spending in the United States in-
creased at a faster pace in 2014 than
previously. While total spending in-
creased 2.9% in 2013, it increased 5.3%
in 2014 to a total of $3.03 trillion, or
17.5% of the U.S. gross domestic prod-
uct.1
Total healthcare expenditures in
2015 are estimated to have been $3.23
trillion, a 5.3% increase from 2014.2
This growth rate was partially attribut-
able to economic recovery and partly
due to increased healthcare coverage
resulting from the Affordable Care Act
(ACA). Nevertheless, at $3.23 trillion
annually, the United States outspends
all other countries on healthcare.
Pharmaceuticals have generally
been viewed as a reasonable invest-
ment because of the potentially large
impact on clinical outcomes and the
relatively small amount spent on drugs
as a percentage of total healthcare
expenditures. While the high rate of
growth in pharmaceutical spending in
the 1990s and early 2000s was a chal-
lenge for pharmacy and health-system
leaders, its moderation over the past
decade—largely driven by patent expi-
rationsandtheincreaseduseofgeneric
medications—led to somewhat dimin-
ished scrutiny of drug costs. However,
recently there has been a dramatic
shift, and high drug costs are now a top
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2. SPECIAL FEATURE PROJECTING FUTURE DRUG EXPENDITURES
e358 AM J HEALTH-SYST PHARM | VOLUME 73 | 2016
to those used in previous years.10,11
We examined both historical trends
in drug expenditures and expected
changes in the drug marketplace that
may influence drug expenditures in
nonfederal hospitals and clinics, in-
cluding anticipated new drug approv-
als and patent expirations. Data for the
analysis of historical trends in expen-
ditures were obtained from the IMS
Health National Sales Perspectives
(NSP) database; data coverage extend-
ed through December 31, 2015 (i.e.,
the most recent available data were
used).12
NSP data are derived from a
statistically valid audit that projects
100% of the purchases in every major
class of trade and distribution chan-
nel for prescription pharmaceuticals,
nonprescription products, and select
self-administered diagnostic prod-
ucts in the United States, measuring
both unit volume and invoice dollars.
The NSP database has been described
KEY POINTS
• Total prescription sales in the
United States in the 2015 cal-
endar year were $419.4 billion,
which was 11.7% higher than
sales in 2014.
• Prescription expenditures in
nonfederal hospitals in 2015
totaled $33.6 billion (a 10.7%
increase from 2014), driven
primarily by price increases for
existing drugs.
• We project that overall pre-
scription drug spending will
rise by 11–13% in 2016, with
increases in the clinic and
hospital settings of 15–17%
and 10–12%, respectively.
• Health-system pharmacists
should carefully consider the
mix of medications used in
their own institution when
forecasting drug expenditures
for budgetary purposes.
concern not just of pharmacists but of
the media and the public as well.
This was perhaps best illustrated by
the case of pyrimethamine (Daraprim).
Turing Pharmaceuticals acquired the
exclusive marketing rights to pyri-
methamine in August 2015 and then
raised the price by over 5,000%—from
$13.50 to $750 per tablet.3
The public
outcry, which included street protests,
was inflamed by the brash comments
of Turing’s then chief executive offi-
cer, Martin Shkreli.4
In fact, pyrimeth-
amine is just one of many older drug
products that have been subject to
huge price increases that typically oc-
cur after manufacturer consolidation,
drug shortages, or other situations that
limit competition. These drugs then
become targets for predatory pricing
practices, and companies such asVale-
ant Pharmaceuticals have apparently
pursued this as a business model.5
However, the media and consumer
outcry has not been isolated to older
drugs.3,6
The $100,000-plus-per-year
price tags of new drugs for cancer and
hepatitis C infection have also raised
enormous concern and have even led
to physicians and policymakers weigh-
ing in on the matter.7-9
This article describes drug expen-
diture trends in 2015, reviews factors
likely to influence future drug expen-
ditures, and projects drug spending for
2016. Our intent is to provide informa-
tion to aid health-system pharmacists
and other healthcare leaders in deter-
mining how future clinical, regulatory
and fiscal changes will affect drug ex-
penditures in their own organizations.
We examine trends in pharmaceutical
expenditures, both generally and by
setting (with an emphasis on nonfeder-
al hospitals and clinics), that may help
predict expenditures in 2016. We also
examine other factors that may influ-
ence future pharmaceutical spending,
including new drugs and newly avail-
able generics. Finally, drug expenditure
growth for 2016 is predicted for non-
federal hospitals, clinics, and overall.
Methods
The methods used were similar
in detail in previous versions of this
forecast.10
All drug dosage forms were
included in the analysis (except where
noted), and drug class groupings were
based on IMS Health’s proprietary
Uniform System of Classification.13
For all drug expenditure data from
NSP, we reported total dollars spent
as well as growth, with the latter be-
ing the percentage change (increase
or decrease) in expenditures from the
previous 12 months. All of the analy-
ses in this article were based on full-
calendar-year data, which was not the
case in previous editions of this report.
Our historical analysis included data
on expenditures across all pharma-
ceutical distribution channels (e.g.,
retail, mail order).Within channels, we
categorized factors that drive changes
in pharmaceutical expenditures as
(1) new products, (2) price inflation,
and (3) volume and mix. Definitions
of these categories were provided in
a previous version of this report.10
We also examined the top medica-
tions based on expenditures, as well
as the medications with the greatest
growth in expenditures from the pre-
vious year. In these analyses, expen-
ditures for each drug were totaled for
all brand and generic products and for
the various dosage forms. Because the
primary focus of this forecast is drug
expenditures in nonfederal hospitals
and clinics, we analyzed trends in
these sectors in more detail.
We also conducted separate analy-
ses of selected drug classes thought
likely to significantly influence drug
spending in hospitals or clinics, includ-
ing antimicrobials, with special empha-
sis on drugs indicated for treatment of
hepatitis C virus (HCV) infection and
biosimilars. Antimicrobials were cat-
egorized, based on their spectrum of
activity, as antibacterials, antifungals,
and antivirals. Antivirals were further
stratified into antiretrovirals, non-hu-
man immunodeficiency virus (HIV)–
targeted agents (i.e., not including
those targeting HIV), and HCV antivi-
rals. HCV antiviral agents included rib-
avirin, interferon, telaprevir, simepre-
vir, sofosbuvir, boceprevir, daclatasvir,
3. PROJECTING FUTURE DRUG EXPENDITURES SPECIAL FEATURE
AM J HEALTH-SYST PHARM | VOLUME 73 | 2016 e359
ledipasvir–sofosbuvir, and ombitasvir–
paritaprevir–ritonavir (available with
or without dasaburvir). The analysis
of biosimilars included filgrastim, tbo-
filgrastim, and filgrastim-sndz. We as-
sessed the impact of tbo-filgrastim and
filgrastim-sndz on overall expenditures
and units of granulocyte colony-stimu-
lating factor (GCSF) products sold from
January 2014 through December 2015;
one unit was defined as 480 mg, with
the number of units sold calculated by
dividing the total quarterly expendi-
tures of a product by the corresponding
quarterly average sales price (ASP) for a
480-mg dose.
Drug approvals anticipated in
2016 were reviewed because they are
expected to contribute to increased
drug expenditures; the methods for
this analysis were similar to those
described in our 2015 report.11
Infor-
mation for new drug approvals was
obtained from company websites
and the Food and Drug Administra-
tion (FDA).14-33
Pharmaceuticals an-
ticipated to lose patent protection in
2016 and become available in generic
form were reviewed to understand the
potential for reducing drug expendi-
tures; these products were identified
from several sources, including FDA
and pharmaceutical company web-
sites and pharmaceutical and biotech-
nology business news sources.34-36
Ad-
ditionally, NSP data on generic drug
expenditure trends were analyzed.
Special emphasis was placed on ge-
neric products likely to have a signifi-
cant impact on expenditures for the
entire market and those of particular
importance in the hospital or clinic
setting.
Finally, we projected drug expen-
diture growth in 2016 for nonfed-
eral hospitals, clinics, and all settings
combined. These estimates were
generated through a combination of
quantitative and qualitative analyses
but should be viewed as opinions of
the authors made in consideration of
major factors believed to influence fu-
ture drug expenditures, as discussed
herein. Projections from other sourc-
es were also examined. These inputs
were evaluated by the authors, and
consensus opinion was reached as to
anticipated ranges for drug expendi-
ture growth in 2016.
Results
Historical trends in prescrip-
tion expenditures. Total prescrip-
tion expenditures in the United States
for the 2015 calendar year were $419.4
billion, which was 11.7% higher than
total expenditures in 2014. Table 1
shows drug spending in 2015 across
each of the various distribution chan-
nels and sectors. The retail pharmacy
sector continued to account for the
largest portion of prescription ex-
penditures ($203.8 billion, or 48.6%
of total expenditures), followed by
mail-order pharmacy ($96.7 billion,
or 23.0% of total expenditures), clinics
($56.7 billion, or 13.5% of total expen-
ditures), nonfederal hospitals ($33.6
billion, or 8.0% of total expenditures),
and long-term care ($16.5 billion, or
3.9% of total expenditures). Among
these top sectors, mail-order pharma-
cies had the largest percent growth
from the previous year (18.9%), which
was also the case in 2014. Clinics and
nonfederal hospitals also experienced
double-digit growth in 2015 (15.9%
and 10.7%, respectively).
Factors driving growth. The 11.7%
growth in overall pharmaceutical
expenditures in 2015 resulted from
increased prices of existing drugs
(8.4%), spending on new drugs (2.7%),
and changes in the volume of drug use
(0.5%). Factors that drove growth in
2015 differed by sector. For example,
in the clinic setting the 15.9% total
growth was driven mostly by an in-
creased volume of drug use (9.0%), as
shown in Table 2, with increased pric-
es of existing products and spending
on new products contributing 3.8%
and 3.1%, respectively. In the clinic
environment, the majority of spend-
ing ($43.9 billion of $56.7 billion) was
for injectable products. However,
growth in spending in clinics in 2015
was greater for noninjectables ver-
sus injectables—particularly branded
noninjectables, which saw a 26.4%
increase from 2014. In nonfederal
hospitals, the 10.7% increase in drug
spending in 2015 was driven primar-
ily by increased prices of existing drugs
(7.6%); new products and volume
changes contributed 2.6% and 0.5%,
respectively. As was the case in the clin-
ic setting, the majority of spending in
hospitals ($24.9 billion of $33.6 billion)
in 2015 was for injectable products, but
in this setting generics and branded
generics saw the largest growth (16.5%
and 19.5%, respectively).
Trends in overall drug spending.
Figure 1 shows the annual changes (in-
creases or decreases) in prescription
drug expenditures in the United States
from 1999 to 2015 in clinics, nonfed-
eral hospitals, and all sectors overall.
Although erratic, the patterns suggest
a general decline in the rate of growth
through 2008, followed by a leveling-
off period and then a steep increase
beginning in 2013. The growth in drug
expenditures in 2015 (15.9%, 10.7%,
and 11.7% for clinics, for nonfederal
hospitals, and overall, respectively)
was higher than anticipated.11
Top drugs overall. The top 25 drugs
based on expenditures across all sec-
tors during the 2015 calendar year are
shown in Table 3. The HCV combina-
tion drug ledipasvir–sofosbuvir was
the top drug, accounting for $14.3 bil-
lion in expenditures in 2015. It replaced
sofosbuvir (single agent), which was the
number 1 drug in 2014 but fell to 24th
place in 2015, with a 61.9% year-over-
year decline in expenditures (to $3 bil-
lion). Adalimumab (at $10.6 billion in
expenditures), insulin glargine (at $9.2
billion), and etanercept and rosuvatatin
(each at approximately $6.5 billion)
rounded out the top 5. Aripiprazole,
which became available as a generic
in 2015, fell from 2nd to 6th place, with
an annual reduction in expenditures
of 20.6%. Esomeprazole expenditures
dropped 23.0% after the oral product
became available as a generic in 2015.
Epoetin alfa (–9.1%) and oxycodone
(–3.4%) also experienced reductions in
expenditures from 2014 levels, which is
a continuing trend for both. Among the
top 25 drugs by expenditures in 2015,
4. SPECIAL FEATURE PROJECTING FUTURE DRUG EXPENDITURES
e360 AM J HEALTH-SYST PHARM | VOLUME 73 | 2016
those with the largest percentage in-
creases from 2014 were adalimumab
(37.1%), pregabalin (23.4%), and sev-
eral insulin products, including insulin
detemir (34.8%), insulin aspart (28.8%),
and insulin lispro (23.2%).
Top drugs in clinics. The top 25
drug products by 2015 expenditures in
the clinic setting are listed in Table 4.
Table 1. Prescription Drug Expenditures and Growth by Sectora
Sectorb
2015 Expenditures
($ Millions)
Percent of Total
Expenditures
Percent Change From
2014
Retail pharmacies 203,802 48.6 8.2
Mail-order pharmacies 96,668 23.0 18.9
Clinics 56,709 13.5 15.9
Nonfederal hospitals 33,580 8.0 10.7
Long-term care 16,495 3.9 2.9
Staff-model HMO 4,766 1.1 25.3
Home healthcare 3,640 0.9 18.4
Federal facilities 2,698 0.6 –2.0
Other 1,083 0.3 14.5
Total 419,440 11.7
a
HMO = health maintenance organization.
b
Retail pharmacies including standalone chain and independent stores, as well as mass merchandisers and food and convenience stores with a
licensed pharmacy. Mail-order pharmacies include licensed mail service pharmacies, including both private-sector and federal facilities. Clinics include
physician offices and outpatient clinics, including general, family medicine, and specialty clinics covering oncology, nephrology, dialysis, family plan-
ning, orthopedics, and urgent care centers. Nonfederal hospitals include all non–federally owned facilities licensed as hospitals, including inpatient
treatment and rehabilitation facilities, in addition to general and specialty acute care institutions. Long-term care includes nursing homes and
residential care facilities. Staff-model HMO includes closed-panel HMO pharmacies and hospitals, union clinics and pharmacies, and workers’
compensation clinics. Home healthcare includes licensed home health organizations and visiting nurse entities. Federal facilities include Public
Health Service and other federal hospitals and U.S. ships at sea (Veterans Health Administration facilities are normally included in the federal
facility sector, but data on expenditures were not available after December 31, 2013). Other covers a variety of otherwise unclassified government
accounts, as well as entities such as jails, prisons, and veterinary hospitals and clinics.
Table 2. Factors Driving Growth of Pharmaceutical Expenditures in Clinics and Nonfederal Hospitals in 2015, by
Product Categorya
Clinics Nonfederal Hospitals
Total
Percent
Growth
Percent Growth Due to Factor
Total
Percent
Growth
Percent Growth Due to Factor
Product Category
New
Products Price
Volume
and Mix
New
Products Price
Volume
and Mix
All products 15.9 3.1 3.8 9.0 10.7 2.6 7.6 0.5
Injectables 13.9 2.0 3.4 8.5 11.3 2.4 7.3 1.6
Brands 13.9 1.8 3.6 8.5 8.6 1.2 4.2 3.1
Generics 7.3 4.4 –1.7 4.6 16.5 9.1 6.4 1.0
Branded generics 20.3 1.7 6.2 12.5 19.5 0.3 25.7 –6.4
Noninjectables 23.3 7.2 5.3 10.9 9.2 3.4 8.4 –2.6
Brands 26.4 7.9 6.4 12.1 10.4 3.3 11.4 –4.3
Generics 19.5 8.3 –1.0 12.2 15.2 7.4 5.2 2.5
Branded generics 8.1 0.8 6.8 0.5 1.7 0.1 6.8 –5.3
a
Total growth comprised growth due to three factors: new products (products that were not on the market during the previous year), primarily
newly approved and marketed agents; price (changes in the unit cost of drugs that were on the market in the previous year; and volume and mix
(changes in volume of utilization of existing products or changes in utilization patterns [e.g., a shift from one product to another, as when prescribing
moves from brand to generic products]).
6. SPECIAL FEATURE PROJECTING FUTURE DRUG EXPENDITURES
e362 AM J HEALTH-SYST PHARM | VOLUME 73 | 2016
Infliximab was the top drug, account-
ing for $3.3 billion in expenditures,
followed by pegfilgrastim, rituximab,
epoetin alfa, and bevacizumab—each
accounting for expenditures of $2–3
billion. Among the top 25 drugs in
clinics, those with the biggest percent-
age increases in expenditures from
2014 to 2015 were pneumococcal vac-
cine (73.8%), pertuzumab (47.8%),
sevelamer (41.9%), darbepoetin alfa
(29.5%), immune globulin (26.9%),
and denosumab (20.5%). Among
the top 25 drugs in clinics, the only
agents with reduced expenditures in
2015 versus 2014 were ranibizumab
(–13.4%), epoetin alfa (–9.7%), and
pemetrexed.
Top drugs in nonfederal hospitals.
The top 25 prescription products by
2015 expenditures in the nonfederal
hospitalsettingarelistedinTable5.The
5 top-ranked drugs were unchanged
from 2014. These were infliximab (with
$1.0 billion in expenditures), ritux-
imab, pegfilgrastim, immune globulin,
and alteplase. Among drugs included
in the top 25 for nonfederal hospitals,
those with the largest increases in ex-
penditures were pneumococcal vac-
cine (90.1%), radium-223 (45.3%), tras-
tuzumab (22.8%), alteplase (20.8%),
and natalizumab (20.6%); drugs with
large decreases in expenditures in 2015
were linezolid (–39.4%), bivalirudin
(–27.7%), and enoxaparin (–16.7%).
The therapeutic drug categories
that accounted for the highest per-
centages of drug expenditures in non-
federal hospitals in 2015 are shown in
Table 6. The top 25 categories shown in
the table represented 82.7% of all ex-
penditures in hospitals. As in the past,
antineoplastic agents were the top
category, accounting for 17.3% of the
drug spend in hospitals. As a class, an-
tineoplastic drugs also had significant
growth in 2015 (16.6%). Among other
categories within the hospital sector
with high growth in expenditures in
2015 were hormones (49.9%), cardiac
agents (47.8%), antiarthritics (34.6%),
vascular agents (32.5%), biologicals
(27.0%), and antiviral drugs (26.9%).
Trends in antimicrobials. In 2015,
$48.4 billion was spent on antimicro-
bials across all healthcare sectors, of
which 42.8% of the total spend was for
antivirals (not including those target-
ing HIV), 34.2% was for antiretrovirals,
18.1% was for antibacterials, and 4.9%
was for antifungals. Expenditures on
antibacterial agents decreased (–5.2%)
in 2015, as compared with 2014, while
spending on antifungals, antiretrovi-
rals, and antivirals increased by 18.8%,
36.0%, and 35.8%, respectively. Almost
half (45.3%) of antimicrobial expen-
ditures were in retail pharmacies,
followed by mail-order pharmacies
(29.7%), nonfederal hospitals (9.1%),
and clinics (6.9%).
The top antimicrobials by expen-
ditures in clinics and nonfederal hos-
pitals in 2015 are shown in eTable 1
(available at www.ajhp.org). Clinic
antimicrobial expenditures increased
6.9% from 2014. In nonfederal hospi-
tals, antimicrobial expenditures (in-
cluding antivirals and antifungals) in-
creased 8.3%. Interestingly, at a period
when infections by multidrug-resistant
organisms were increasing and new
parenteral agents were added to the
antibiotic armamentarium, antibacte-
rials (as a class) had only a small (1.9%)
increase in expenditures.
Table 3. Top 25 Drugs by Expenditures Overall in 2015
Druga
2015 Expenditures
($ Thousands)
Percent Change
From 2014
Ledipasvir–sofosbuvir 14,256,452 . . .b
Adalimumab 10,555,712 37.1
Insulin glargine 9,199,002 16.3
Etanercept 6,558,015 13.3
Rosuvastatin 6,415,420 9.3
Aripiprazole 6,364,092 –20.6
Fluticasone salmeterol 5,348,330 1.9
Infliximab 4,983,314 10.7
Esomeprazole 4,581,231 –23.0
Insulin aspart 4,519,650 28.8
Glatiramer 4,493,395 12.1
Pegfilgrastim 4,111,876 7.3
Sitagliptin 4,107,780 18.5
Insulin lispro 3,829,984 23.2
Pregabalin 3,820,486 23.4
Interferon beta-1a 3,750,432 1.1
Rituximab 3,634,107 4.9
Tiotropium bromide 3,573,982 7.2
Insulin detemir 3,558,944 34.8
Dimethyl fumarate 3,469,448 20.0
Bevacizumab 3,137,829 8.8
Epoetin alfa 3,078,543 –9.1
Albuterol 3,051,641 10.2
Sofosbuvir 2,988,767 –61.9
Oxycodone 2,960,431 –3.4
a
For each drug listed, the expenditures shown are the total for brand and generic products and
for various dosage forms.
b
Not calculated because product was not available for entire year in 2014.
7. PROJECTING FUTURE DRUG EXPENDITURES SPECIAL FEATURE
AM J HEALTH-SYST PHARM | VOLUME 73 | 2016 e363
HCV antivirals as a class continued
to experience significant growth in
expenditures—an increase of 60.8%,
from $11.5 billion in 2014 to $18.4
billion in 2015. Mail-order and retail
pharmacies constituted the majority
(82.8%) of all HCV agent expenditures,
as shown in eTable 2 (available at
www.ajhp.org). However, while clinics
and nonfederal hospitals accounted
for small proportions of HCV antivi-
ral expenditures (6.7% and 1.2%, re-
spectively) in 2015, spending on those
agents in these sectors grew signifi-
cantly, by 74.2% and 242.4%, respec-
tively. As described previously,11
utili-
zation (and thus expenditures) in this
class tends to shift rapidly to newer
agents. For example, the combination
agent ledipasvir–sofosbuvir, which
became available in 2014, accounted
for the largest portion (77.4%) of HCV
antiviral expenditures in 2015.
Trends in biosimilars. Data on
total expenditures and units sold for
each GCSF product on the market in
2014 and 2015 are shown in eFigure
1 (available at www.ajhp.org). During
the first quarter of 2014, expenditures
for tbo-filgrastim were approximately
$11 million, representing 5.0% of to-
tal GCSF expenditures. Tbo-filgrastim
expenditures grew to approximately
$39 million (17.8% of total GCSF ex-
penditures) by the last quarter of 2015.
Filgrastim-sndz was launched during
the last quarter of 2015 and so cap-
tured only a small percentage of the
market (2.7% of all GCSF expendi-
tures). The number of 480-mg units of
GCSFs sold was slightly higher in 2015
(2,003,185) than in 2014 (1,979,181),
while total expenditures for all GCSF
products decreased slightly, from 2014
($947 million) to 2015 ($915 million).
Recent and anticipated drug
approvals. Selected novel agents that
may receive FDA approval for sale in
the United States by the end of 2016
are shown in Table 7. As in recent
years, new approvals expected in 2016
are largely specialty products. Agents
for treating inflammatory disorders
(e.g., rheumatoid arthritis, psoriasis)
and viral infections (HIV and HCV in-
fections) are well represented in the
list of expected approvals in 2016. A
relatively low proportion of expected
approvals are oncology agents, but it
has been more difficult to predict on-
cology approvals due to the fact that
most of these agents are granted the
“breakthrough” designation by FDA
and thus have an average approval
time of approximately four months.37
For example, there are several agents
targeting immune checkpoint PD-
L1 (atezolizumab and durvalumab)
and cyclin-dependent kinase (CDK)
proteins 4 and 6 (abemaciclib) that
currently have the FDA breakthrough
designation, but the corresponding
new drug application or biologics li-
cense application has yet to be filed
with FDA.30,38,39
It is likely that these
agents will be approved in 2016 or
early 2017.
As in the past, we analyzed recent
oncology drug approvals to under-
stand the potential impact of these
agents on future expenditures. As
shown in Table 8, 16 oncology drugs
were approved in 2015; data on the ap-
Table 4. Top 25 Drugs by Expenditures in Clinics in 2015
Druga
2015
Expenditures
($ Thousands)
Percent Change
From 2014
Infliximab 3,280,663 11.2
Pegfilgrastim 2,976,527 9.7
Rituximab 2,462,831 3.6
Epoetin alfa 2,456,606 –9.7
Bevacizumab 2,382,695 7.0
Trastuzumab 1,923,290 12.8
Pneumococcal vaccineb
1,815,005 73.8
Ranibizumab 1,522,626 –13.4
Denosumab 1,345,258 20.5
Pemetrexed 949,987 –2.0
Ledipasvir–sofosbuvir 932,428 . . .c
Immune globulin 850,967 26.9
Sevelamer 815,945 41.9
Influenza virus vaccines 781,295 4.0
Natalizumab 652,902 13.6
Pertuzumab 646,794 47.8
Darbepoetin alfa 644,625 29.5
Varicella virus vaccine 637,381 0.4
Human papillomavirus vaccine 614,987 12.1
Paclitaxel 593,923 6.4
Nivolumab 577,649 . . .
Bendamustine 575,377 7.2
Octreotide 552,099 12.4
Abatacept 540,298 18.7
Bortezomib 496,842 9.1
a
For each drug listed, the expenditures shown are the total for brand and generic products
and for various dosage forms (unless otherwise indicated).
b
Includes Prevnar (Wyeth) and Pneumovax (Merck Sharp & Dohme) products.
c
Not calculated because product was not available for entire year in 2014.
8. SPECIAL FEATURE PROJECTING FUTURE DRUG EXPENDITURES
e364 AM J HEALTH-SYST PHARM | VOLUME 73 | 2016
proximate cost for 28 days of therapy,
based on average wholesale price, are
presented.40
Of note, most of these
drugs are indicated for use in treating
tumor types with a relatively low in-
cidence (e.g., multiple myeloma, thy-
roid cancer, soft tissue sarcoma), and
most of those used to treat a higher-
incidence cancer such as lung cancer
are targeted toward patients with a
specific genetic mutation; thus, the
overall impact of new oncology agents
on expenditures may be limited. Fur-
ther, 10 of the 16 drugs are oral agents.
These are also not likely to raise in-
patient expenditures but may have a
spending impact at institutions that
manage their own specialty pharmacy.
Institutions that have a pharmacist-
led oral oncology monitoring program
may observe an increase in the work-
load for adherence and toxicity moni-
toring. The anticipated new i.v. agents
for treatment of multiple myeloma
(daratumumab and elotuzumab) are
likely to raise outpatient drug expen-
ditures, especially for institutions that
have a robust oncology program, be-
cause these agents address a previ-
ously unmet need.
It should be noted that in analyz-
ing 2015 drug expenditures, we found
that the drugs with the highest per-
centage growth in spending tended
to be recently released cancer agents.
For example, the immune checkpoint
inhibitors nivolumab ($764 million
in expenditures in 2015) and pem-
brolizumab ($393 million in 2015)
were among the drugs with the high-
est growth increases from 2014. The
orally administered CDK4/6 inhibitor
palbociclib, used in the treatment of
breast cancer, entered the market in
early 2015 and quickly rose toward the
top of the list of oncology drugs by ex-
penditures that year, with $749 million
in expenditures.
Patent expirations and gener-
ics. Generic drugs, including brand-
ed generics, continued to capture a
significant proportion of the overall
drug spend, accounting for 17.3% of
injectable drug spending and 30.9%
of noninjectable drug spending across
all channels in 2015. In the nonfederal
hospital sector, generics accounted
for 32.7% of drug spending (30.5% of
expenditures on injectables and 38.9%
of expenditures on noninjectables). In
this sector, spending for noninject-
ables grew 2.0% for generics and 3.0%
for branded generics in 2015, as com-
pared with 2014, and this was largely
due to increased prices (Table 2). In
the clinic setting, generics accounted
for 15.9% of spending (13.6% of ex-
penditures on injectables and 24.0%
of expenditures on noninjectables).
Much of the growth in expenditures
for generics in clinics was due to in-
creased utilization of these agents—
although increased prices also con-
tributed to spending growth in the
case of branded generics.
Medications with patent expira-
tions in late 2014 or early 2015 were
mostly items used in the retail setting;
those expirations were thus unlikely to
have had a meaningful impact on hos-
pital and clinic spending. However,
some generics launched in 2015 had
a significant impact on spending in
nonfederal hospitals; these included
bivalirudin and linezolid, for which
expenditures were reduced by 27.7%
and 39.4%, respectively (Table 5). Ge-
Table 5. Top 25 Drugs by Expenditures in Nonfederal Hospitals in 2015
Druga
2015 Expenditures
($ Thousands)
Percent Change
From 2014
Infliximab 1,044,624 8.1
Rituximab 1,007,033 8.1
Pegfilgrastim 846,688 –1.2
Immune globulin 825,446 –1.2
Alteplase 731,292 20.8
Natalizumab 698,851 20.6
Daptomycin 644,964 –6.1
Bevacizumab 619,684 14.0
Pneumococcal vaccineb
619,468 90.1
Trastuzumab 509,862 22.8
Piperacillin–tazobactam 440,142 11.6
Radium-223 437,472 45.3
Influenza virus vaccine 356,889 10.8
Epoetin alfa 325,962 –1.9
Filgrastim 320,024 –8.1
Bivalirudin 312,217 –27.7
Regadenoson 299,820 0.6
Denosumab 297,575 18.4
Enoxaparin 281,336 –16.7
Albumin 265,580 7.2
Darbepoetin alfa 220,151 –0.4
Pemetrexed 219,543 –5.4
Acetaminophen (i.v. only) 218,605 4.5
Iohexol 216,268 1.8
Linezolid 212,269 –39.4
a
For each drug listed, the expenditures shown are the total for brand and generic products
and for various dosage forms (unless otherwise indicated).
b
Includes Prevnar (Wyeth) and Pneumovax (Merck Sharp & Dohme) products.
9. PROJECTING FUTURE DRUG EXPENDITURES SPECIAL FEATURE
AM J HEALTH-SYST PHARM | VOLUME 73 | 2016 e365
Table 6. Top 25 Therapeutic Drug Categories by Expenditures in Nonfederal Hospitals in 2015
Drug Category
2015 Expenditures
($ Thousands)
Percent Change
From 2014
Percent of Total 2015
Expenditures
Antineoplastic agents 5,848,224 16.6 17.3
Hemostatic modifiers 3,071,269 0.7 9.1
Antiinfectives, systemic 2,724,544 1.0 8.1
Blood factors 2,029,880 –0.7 6.0
Biologicals 1,845,266 27.0 5.5
Gastrointestinal agents 1,817,896 10.2 5.4
Immunologic agents 1,489,837 19.8 4.4
Antiviral drugs 1,297,264 26.9 3.8
Hospital solutions 1,194,442 1.0 3.5
Respiratory therapy agents 1,132,022 4.7 3.4
Anesthetics 1,101,273 –5.5 3.3
Miscellaneous 1,000,847 7.5 3.0
Diagnostic aids 998,702 1.6 3.0
Analgesics 807,730 2.5 2.4
Psychotherapeutics 806,528 2.1 2.4
Hormones 615,854 49.9 1.8
Vascular agents 608,866 32.5 1.8
Musculoskeletal agents 594,240 15.7 1.8
Cardiac agents 545,775 47.8 1.6
Neurologic disorder drugs 524,528 21.9 1.6
Antiarthritics 472,793 34.6 1.4
Diabetes therapy 412,858 5.8 1.2
Antifungal agents 371,481 10.4 1.1
Ophthalmic preparations 367,374 –0.5 1.1
Enzymes 336,925 5.9 1.0
neric aripiprazole and esomeprazole
products contributed to reductions in
expenditures across all channels, with
2015 spending declines of 20.6% and
23.0% from 2014 levels, respectively
(Table 3).
Select branded agents expected
to lose patent protection in 2016 are
shown in Table 9. Estimating when a
patent will expire is complex due to
potential litigation, exclusivities, and
other factors. However, medications
important to drug expenditures in hos-
pitals and clinics that could be avail-
able in generic versions in 2016 include
albuterol sulfate (for delivery via dry
powder inhaler), daptomycin, imati-
nib, oseltamivir, and rosuvastatin.
While the availability of generics
usually reduces overall expenditures,
recently there have been sharp in-
creases in the prices of some generic
drugs that have led to growth in ex-
penditures. Such increases may be
spurred by consolidation of manufac-
turers, arbitrary price hikes, or drug
shortages. We examined the top 15
generic products with high growth in
expenditures in 2015 (Table 10). The
15 drugs listed collectively accounted
for an increase in expenditures of $2.4
billion (85.6%) over the previous year.
One factor influencing high drug ex-
penditure growth for certain generic
drugs is the FDA “Unapproved Drugs
Initiative,” which targeted for enforce-
ment older unapproved products and,
as a consequence, reduced the number
of manufacturers of some drugs.41
In
2015, this initiative had a drastic im-
pact on the prices of and subsequent
expenditures on vasopressin, neostig-
mine, and hydroxyprogesterone, for
which annual spending increased by
697.7%, 409.2%, and 270.9%, respec-
tively. Other drugs such as isoprotere-
nol, flucytosine, and nitroprusside had
dramatic expenditure growth (275.7%,
126.4%, and 112.8%, respectively) due
to consolidation of manufacturers.
Drug expenditure forecast for
2016. Based on the drug expenditure
trends described above, anticipated
new drug approvals, expected approv-
10. SPECIAL FEATURE PROJECTING FUTURE DRUG EXPENDITURES
e366 AM J HEALTH-SYST PHARM | VOLUME 73 | 2016
Table 7. Selected Drugs and Biologicals That Have Received or May Receive FDA-Approved Labeling in 2016a
Drug or Biological Manufacturer Indication Route
Quarter and
Year
of PDUFA Dateb
Elbasvir–grazoprevir Merck Chronic hepatitis C (genotypes
1 and 4)
Oral Q1 2016
Coagulation factor IX
(recombinant), albumin
fusion protein
CSL Behring Hemophilia B I.V. Q1 2016
Brivaracetam UCB Partial-onset seizures I.V. or oral Q1 2016
Daclizumab high-yield
process
Biogen and AbbVie Relapsed multiple sclerosis Subcutaneous Q1 2016
Rilpivirine–emtricitabine–
enofovir alafenamide
Gilead HIV-1 infection (in combination
with other HIV antiretroviral
agents)
Oral Q1 2016
Emtricitabine–tenofovir
alafenamide fumarate
Gilead HIV-1 infection (in combination
with other HIV antiretroviral
agents)
Oral Q1 2016
Recombinant factor VIII Bayer Hemophilia A I.V. Q1 2016
Eteplirsen Sarepta
Therapeutics
Duchenne muscular dystrophy
amenable to exon 51 skipping
I.V. Q1 2016
Defibrotide Jazz
Pharmaceuticals
Hepatic venoocclusive disease
with multiorgan dysfunction
after hematopoietic stem cell
transplantation
I.V. Q1 2016
Safinamide Newron
Pharmaceuticals
Add-on therapy in early- and
mid- to late-stage Parkinson’s
disease
Oral Q1 2016
Sofosbuvir–velpatasvir Gilead Chronic hepatitis C (genotypes
1–6)
Oral Q2 2016
Reslizumab Teva Pharmaceutical
Industries
Asthma and elevated blood
eosinophils inadequately
controlled on inhaled
corticosteroids
I.V. Q2 2016
Obeticholic acid Intercept Primary biliary cholangitis Oral Q2 2016
Lixisenatide Sanofi Adult type 2 diabetes mellitus Subcutaneous Q2 2016
Pimavanserin Acadia
Pharmaceuticals
Psychosis associated with
Parkinson’s disease
Oral Q2 2016
Deutetrabenazine Teva Pharmaceutical
Industries
Chorea associated with
Huntington disease
Oral Q2 2016
Venetoclax Roche Chronic lymphocytic leukemia Oral Q3 2016
Etelcalcetide Amgen Secondary hyperparathyroidism
in chronic kidney disease
requiring hemodialysis
I.V. Q3 2016
Brodalumab Valeant
Pharmaceuticals
Moderate-to-severe plaque
psoriasis
Subcutaneous Q4 2016
Sarilumab Regeneron
Pharmaceuticals
and Sanofi
Moderately to severely active
rheumatoid arthritis
Subcutaneous Q4 2016
Atezolizumab Roche Locally advanced or metastatic
urothelial carcinoma
I.V. Q4 2016
Baricitinib Eli Lilly and
Company
Moderately to severely active
rheumatoid arthritis
Oral Q1 2017
a
FDA = Food and Drug Administration, HIV = human immunodeficiency virus, PDUFA = Prescription Drug User Fee Act, Q = quarter.
b
Extrapolated based on new drug application submission date and review status (i.e., 10 months for standard review and 6 months for priority
review).
11. PROJECTING FUTURE DRUG EXPENDITURES SPECIAL FEATURE
AM J HEALTH-SYST PHARM | VOLUME 73 | 2016 e367
als of generic drugs in 2016, and our
overall assessment of the impact of an-
ticipated changes in the industry, we
estimate an overall increase of 11–13%
in pharmaceutical expenditures in
2016.We also predict that drug spend-
ing in clinics will increase by 15–17%
while spending in nonfederal hospi-
tals will grow 10–12% in 2016. These
estimates for growth are considerably
higher than those we have made in the
past but consistent with recent trends
and other forecasts.2,42
In the hospital
environment, we have observed con-
sistent increases in growth over the
past three years. Factors driving this
continued growth, including price
increases by manufacturers, are not
likely to change in the next year. Fur-
ther, while politicians have lamented
drug price increases, actual legisla-
tion to rein in price hikes has not oc-
curred; even if such legislation or bal-
lott initiatives were enacted, it would
likely not be targeted toward curbing
hospital drug expenditures.43
In the
clinic setting, expensive new drugs for
cancer and specialty medications will
drive continued high growth.
Discussion
Growth in drug expenditures in
2015 in both clinics and nonfederal
hospitals continued to be marked by
a pattern of steep increases that be-
gan in 2013. While the overall growth
(i.e., growth in all sectors) was slightly
lower in 2015, it was still higher than it
had been for most of the past decade.
We predict continued high growth
in 2016 for prescription drug expen-
ditures in clinics, hospitals, and all
sectors combined. Our estimates for
anticipated growth in 2016 are higher
than those of the Centers for Medicare
and Medicaid Services (CMS), which
has projected that U.S. retail prescrip-
tion drug expenditures will increase
6.4% in 2016 and 5.5% in 2018.2,44
Our
estimates are also higher than those
of Express Scripts, a provider of in-
tegrated pharmacy benefit manage-
ment services, which projected a 6.8%
increase in 2016, followed by increases
of 7.3% in 2017 and 8.4% in 2018.45
However, both the CMS and Express
Scripts forecasts are specific to retail
drug expenditures, whereas ours are
focused on drug spending in hospitals
and clinics.
Table 8. Oncology Agents That Received FDA-Approved Labeling in 2015a
Drug Indication Route
Approximate Price
for 28 Days of
Therapy ($)b
Alectinib ALK-positive non-small-cell lung cancer Oral 13,800
Cobimetinib BRAF mutation–positive melanoma Oral 7,300
Daratumumab Multiple myeloma I.V. 24,000c
Elotuzumab Multiple myeloma I.V. 9,946
Gefitinib Non-small-cell lung cancer involving specific
EGFR mutations
Oral 8,104
Irinotecan liposome Pancreatic cancer I.V. 10,941
Ixazomib Multiple myeloma Oral 10,404
Lenvatinib Thyroid cancer Oral 24,192
Necitumumab Squamous non-small-cell lung cancer I.V. 12,800
Osimertinib Non-small-cell lung cancer involving specific
EGFR mutation
Oral 14,280
Palbociclib Breast cancer Oral 12,411
Panobinostat Multiple myeloma Oral 11,733
Sonidegib Basal cell carcinoma Oral 11,267
Talimogene laherparepvec Melanoma Local
injection
65,000d
Trabectedin Soft tissue sarcoma I.V. 11,232
Trifluridine–tipiracil Colorectal cancer Oral 6,569
a
FDA = Food and Drug Administration.
b
Approximate cost was calculated based on average wholesale price listed in Redbook Online.40
For drugs that are dosed by weight or body
surface area, standards of 70 kg and 1.73 m2
(respectively) were used. For talimogene laherparepvec, the price estimate was obtained from the
manufacturer.61
c
Price per 28 days for the first two months. After the first two months, the price decreases to $12,000 per 28 days for the next four months and to
$6,000 per 28 days thereafter.
d
Price for one course.
12. SPECIAL FEATURE PROJECTING FUTURE DRUG EXPENDITURES
e368 AM J HEALTH-SYST PHARM | VOLUME 73 | 2016
Overall spending on drugs in the
United States is influenced by many
different factors, the most important
of which are changes in the economy,
the population, and the healthcare
system. While the economy is difficult
to predict, it has been strengthening
for the past several years, and most
analysts forecast continued growth.
The United States also continues to
experience the long-term trend of
population aging and the associated
increases in healthcare needs and
spending. At the same time, while
the ACA has been credited for mod-
erating growth in healthcare spend-
ing, increased access to health insur-
ance with prescription coverage has
boosted medication expenditures ac-
cordingly. These and other factors are
expected to contribute to continued
growth in drug spending in 2016 and
beyond.2
In this article we have analyzed
specific drugs and drug classes that
contributed to growth in prescription
expenditures in 2015 and may be ex-
pected to do so in 2016. Much of the
recent and projected future growth
has been or will be driven by specialty
drugs. In 2015, FDA approved 45 novel
agents, most of which were specialty
drugs.46
New drugs were approved in
all major specialty classes in 2015, in-
cluding palbociclib for advanced met-
astatic breast cancer, secukinumab for
plaque psoriasis, daclatasvir for HCV
infection, lumacaftor–ivacaftor for
cystic fibrosis, and selexipag for pul-
monary arterial hypertension. In ad-
dition to the focus on complex, chron-
ic, or rare diseases, specialty drugs
are often high-cost products and may
have extensive monitoring, storage,
dispensing, administration, patient
education, safety, and data reporting
requirements. Because the pipeline
for specialty drugs is rich and with
over 1000 targeted cancer drugs cur-
rently in development, we anticipate
that these drugs will continue to be a
Table 9. Selected Potential Patent Expirations in 2016a
Drug Brand Name Indication(s)
Abacavir–lamivudine–zidovudine Epzicom HIV infection
Abacavir sulfate–lamivudine Trizivir HIV infection
Albuterol sulfate (dry powder inhaler) Proair HFA Asthma
Amlodipine besylate–olmesartan medoxomil Azor Hypertension
Amlodipine–hydrochlorothiazide–olmesartan Tribenzor Hypertension
Armodafinil Nuvigil Apnea, narcolepsy
Bexarotene Targretin Skin cancer
Clindamycin phosphate–tretinoin Ziana Acne
Daptomycin Cubicin Infection
Darifenacin hydrobromide Enablex Overactive bladder
Diclofenac (gel) Solaraze Arthritis, pain
Dofetilide Tikosyn Irregular heartbeat
Eletriptan hydrobromide Relpax Migraine
Ezetimibe Zetia Hyperlipidemia
Imatinib mesylate Gleevec Cancer
Lopinavir–ritonavir Kaletra HIV infection
Mesalamine Asacol HD Ulcerative colitis
Metformin Glumetza Diabetes
Olmesartan medoxomil Benicar Hypertension
Olmesartan medoxomil–hydrochlorothiazide Benicar HCT Hypertension
Oseltamivir phosphate Tamiflu Influenza
Quetiapine fumarate Seroquel XR Antipsychotic
Ritonavir Norvir HIV infection
Rosuvastatin calcium Crestor Hypertension
Tigecycline Tygacil Infection
a
HIV = human immunodeficiency virus.
13. PROJECTING FUTURE DRUG EXPENDITURES SPECIAL FEATURE
AM J HEALTH-SYST PHARM | VOLUME 73 | 2016 e369
major contributor to drug expenditure
growth in 2016 and beyond.45
Among the specialty drugs, those
used to treat HCV infection were
among the top-ranked agents by ex-
penditures in 2015. Clinics and non-
federal hospitals accounted for a
small portion of total HCV antiviral
expenditures but are playing a great-
er role in HCV infection treatment
due in part to the growth of health
system–based specialty pharmacies.
While competition from newer HCV
drugs is expected to decrease prices,
subsequent savings may be offset by
increased utilization as new patients
with less severe disease are diagnosed
and treated. The Centers for Disease
Control and Prevention estimates that
chronic HCV infection affects 3.2 mil-
lion Americans, most of whom have
not yet been diagnosed.47
Although
payers have attempted to restrict use
of these medications to patients with
more advanced disease, guidelines
from the American Association for the
Study of Liver Diseases recommend
that all patients with chronic HCV in-
fection receive treatment,48
and CMS
has warned state Medicaid programs
not to unreasonably restrict coverage
of effective HCV-targeted treatment.49
Regardless, spending on HCV anti-
virals will continue to present an ex-
treme challenge for insurers, patients,
and healthcare providers.
Therapeutic categories that were
traditionally dominated by lower-cost
generics are also likely to be affected
by new specialty drugs in the future.
In late 2015, two new biologicals—
arilocumab and evolocumab—were
approved for the treatment of sub-
groups of adults who require ad-
ditional lowering of low-density li-
poprotein (LDL) cholesterol levels;
these drugs target the liver protein
PCSK9 (proprotein convertase sub-
tilisin/kexin type 9), inactivating it
and thereby reducing circulating
LDL cholesterol. There is concern
about potential overuse of these
PCSK9 inhibitors and subsequent
high spending.50
As a result, the pay-
er community instituted strict prior-
authorization criteria and coverage
policies. Nevertheless, both products
are on the type of steep growth curve
that is typical for a highly promoted
new product in a novel class. Dur-
ing only a short time on the market
in 2015, PCSK9 inhibitors accounted
for a total of about 4000 filled pre-
scriptions in retail and mail-order
pharmacies, with expenditures of
nearly $6 million for each product.12
As the specialty drug market
grows, hospitals and health systems
continue to face barriers to access
because of manufacturer-instituted
restricted distribution channels. Dis-
ruptions in continuity of care may
occur, adding to administrative bur-
dens on pharmacy staff. There is also a
trend toward more restricted distribu-
tion in which specialty drugs can only
be dispensed or administered from
a network of one or more specialty
pharmacies or infusion centers.51
These restrictions present challenges
for health systems, especially those
undertaking risk-based global pay-
ment or population health initiatives.
To address these challenges, some
health systems have implemented in-
tegrated specialty pharmacy as a new
ambulatory care pharmacy practice
model, which may include a variety of
services such as prior-authorization
submissions, medication assistance,
medication adherence management,
and prescription dispensing and de-
livery to patients. Although more than
100 such programs are established or
in development in the United States,
fewer than 20 are operated by fully ac-
credited specialty pharmacies; com-
pared with other pharmacy programs,
these programs have reported faster
prior-authorization approvals, higher
medication adherence, and greater
patient satisfaction.52
Another increasingly used third-
party payer tactic is the site-of-service
management strategy for infusion of
specialty injectable drugs. Under this
approach, health plans restrict pa-
tients to a contracted provider of infu-
sion services. In 2015, 31% of health
plans reported implementation of a
site-of-service management strategy,
Table 10. Top 15 Older Agents With High Growth in 2015 Expenditures
Druga
2015 Expenditures
($ Thousands)
Percent Change
From 2014
Vasopressin 160,977 697.7
Neostigmine 288,273 409.2
Isoproterenol 219,748 275.7
Hydroxyprogesterone 191,250 270.9
Hydroxychloroquine 506,761 237.6
Flucytosine 49,157 126.4
Flecainide 88,321 123.8
Nitroprusside 218,022 112.8
Allopurinol 180,478 106.2
Metformin 1,383,663 85.8
Pyridostigmine hydroxide 88,318 77.4
Amitriptyline 185,415 77.3
Chlorpromazine 202,104 66.8
Ursodiol 316,091 63.2
Bupropion 1,131,214 12.7
a
For each drug listed, the expenditures shown are the total for brand and generic products
and for various dosage forms.
14. SPECIAL FEATURE PROJECTING FUTURE DRUG EXPENDITURES
e370 AM J HEALTH-SYST PHARM | VOLUME 73 | 2016
with 43% indicating plans to imple-
ment one in the next 12 months.51
While site-of-service restrictions may
save money for health plans, these
programs can disrupt continuity of
care and reduce revenue for clinic and
hospital pharmacies.
Promising to moderate the growth
of expenditures in the specialty drug
category in the future are biosimi-
lars. To date, the only class of drugs
with biosimilar product options is
the GCSFs. Our analyses show that
total expenditures for all GCSF prod-
ucts decreased after the market entry
of competing products and with the
general lowering of prices. This may
be due to the significant difference in
the ASPs of tbo-filgrastim and filgra-
stim. Although tbo-filgrastim is not
technically a biosimilar, its ASP de-
clined significantly over the past two
years (from $405 to $370 per 480-mg
unit). By the fourth quarter of 2015,
the ASP of tbo-filgrastim was 24% less
than that of filgrastim. Further, rising
utilization of the less expensive prod-
uct (tbo-filgrastim), coupled with the
market entry of filgrastim-sndz, led
to an increase in the total number of
GCSF units sold from 2014 to 2015.
The phenomenon of biosimilars in-
creasing the total volume of GCSFs
sold has also been observed in Europe
and may be due to relaxed restrictions
on use or increased affordability.53
Increasing patient access to ex-
pensive medications was one goal of
efforts to expand the availability of
biosimilars in the United States. The
next biosimilar likely to hit the U.S.
market in 2016 is infliximab. Its mar-
ket entry (and presumptive ability to
moderate expenditure growth in this
area) has been hampered by launch
delays because of FDA review setbacks
and patent challenges. Other drugs for
which biosimilar applications have
been submitted to FDA include pegfil-
grastim, etanercept, and adalimumab.
In the hospital setting, an issue
that has generated significant concern
for health-system pharmacy admini-
strators in the past year is high-cost
generics. While generic drugs gene-
rally continue to have a moderating
influence on prescription drug expen-
ditures overall, this impact has been
lessened by a decline in blockbuster
drugs subject to patent expiration and
changes in the generic marketplace
that influence prices. Substantial price
increases for some generic drugs have
been observed across dosage forms
and widely reported in the lay press.6
Injectable medications with triple-
digit price increases include calcito-
nin, hydralazine, and vasopressin. A
number of oral medications, includ-
ing hydroxychloroquine, fluoxetine,
atenolol, propranolol, digoxin, ami-
triptyline, tetracycline, phytonadione,
and captopril, were subjected to mas-
sive price increases in the last year.
These and other notable cases
of massive drug price increases—
including that of pyrimethamine
mentioned earlier—have led to sub-
stantial discussions by politicians
about potential solutions.54
On Febru-
ary 4, 2016, the House Committee on
Oversight and Government Reform
held a hearing titled “Developments
in the Prescription Drug Market: Over-
sight” to investigate the practices of
Turing Pharmaceuticals and Valeant
Pharmaceuticals. ASHP submitted a
statement urging Congress to explore
potential policy options and market-
based solutions to address the recent
trend of dramatic price increases for
generic drugs.55
It is unknown to what
extent congressional or organizational
efforts will influence pharmaceuti-
cal company pricing of medications.
A viewpoint article published in the
Journal of the American Medical Asso-
ciation identified three market-based
proposals to optimize generic drug
cost and availability, which included
restricting market entry, encouraging
long-term contracts with wholesal-
ers, and creating a futures market.56
While efforts to curb price increases
in the generic markets are explored,
pharmacists need to continue to con-
trol costs through proper formulary
management tactics such as waste re-
duction, implementation of stocking
efficiencies, and initiatives to ensure
appropriate medication use through
adherence to clinical criteria.
Another issue with the potential
to affect drug expenditures in some
health systems is the implementation
of major revisions to the federal 340B
Drug Pricing Program, which pro-
vides discounted drug prices on cov-
ered drugs to participating hospitals
and other eligible entities. The Health
Resources and Services Administra-
tion (HRSA) released the 340B Drug
Pricing Program omnibus guidance
on August 28, 2015.57
The guidance,
which touches on every aspect of the
340B program, proposes new criteria
for 340B program eligibility for offsite
outpatient facilities and clinics that
require that each facility be listed on
the covered entity’s Medicare cost re-
port and provide services that have
associated outpatient Medicare costs
and charges. These criteria would, if
implemented, prohibit the purchase
of 340B-covered drugs for offsite cor-
rectional facilities, since these facili-
ties do not have Medicare charges.
The guidance also proposes sweeping
changes to the definition of a patient
and requires that patients receive pre-
scriptions from a provider who is ei-
ther employed by the covered entity
or who is an independent contractor
for the covered entity. This would ex-
clude prescriptions generated as the
result of a referral to an outside pre-
scriber, such as in the case of cancer
patients who, after receiving prescrip-
tions from an outside specialist who is
not contracted with the covered entity,
return to their community hospital
for treatment. Patients must also re-
ceive prescriptions that result from a
billable outpatient visit, which would
exclude discharge prescriptions. Pa-
tients with emergency department
or observation visits would not be
eligible if the visit led to an inpatient
admission.
HRSA received 1264 comments to
the proposed guidance, and the final
guidance is expected in late 2016 or in
2017. Covered entities can expect re-
ductions in their 340B program–related
savings if any or all of the aforemen-
15. PROJECTING FUTURE DRUG EXPENDITURES SPECIAL FEATURE
AM J HEALTH-SYST PHARM | VOLUME 73 | 2016 e371
tioned proposals are approved, which
could have an impact on the breadth
of services they provide to uninsured
or underinsured patients.
As we have suggested previously,
pharmacy leaders must keep abreast
of important developments in
healthcare policy, finance, technol-
ogy, and practice in order to be opti-
mally prepared for changes that may
influence practice and thus have an
impact on medication spending. The
analyses and projections presented
here focus on factors likely to influ-
ence healthcare spending and pre-
scription drug expenditures in 2016,
but pharmacy leaders should also
carefully monitor other develop-
ments that are likely to have an im-
pact on departmental budgets in the
coming years. Additional guidance
on emerging issues that may influ-
ence drug spending can be found
in the newly released fourth annual
edition of the ASHP Foundation re-
port Pharmacy Forecast 2016–2020:
Strategic Planning Advice for Phar-
macy Departments in Hospitals and
Health Systems. We strongly urge
readers to review and use this report
in financial and strategic planning.
The complete report is freely avail-
able online (www.ashpfoundation.
org/pharmacyforecast).
Our analysis and forecast should
be considered with an understanding
of its important limitations. The pri-
mary source of the drug expenditure
trend data was the IMS Health NSP
database; while this is a very reliable
database, there are characteristics of
the data sets used in our analyses that
should be considered when interpret-
ing our results. The NSP database is
continually updated, and any analysis
may yield slightly different results de-
pending on the timing of data access.
For this article, data were extracted
on February 2, 2016. We refer readers
to a previous version of this forecast
for a complete description of other
characteristics and potential limita-
tions.10
One such limitation was that
the IMS data do not include expendi-
tures by the Veterans Affairs system.
The absence of these data began in
calendar year 2014. This limitation af-
fected our estimates of expenditures
for federal facilities, as shown in Table
1, and, to a lesser extent, the total for
all channels. Another limitation (one
not previously noted) was our catego-
rization of medication expenditures
by therapeutic drug class. Drugs that
are used across multiple indications
are categorized only by the primary
therapeutic drug class. On the other
hand, a previously noted limitation
that we have rectified in this version of
the annual forecast is the use of full-
calendar-year data for our analysis
of historical trends; previously in our
analysis of trends, data collection for
each year extended only through the
end of September, potentially leading
to conclusions unduly influenced by
seasonal fluctuations in utilization.
Finally, as in previous years, our anal-
ysis was also based on the availability
of information on new drug approv-
als and patent expirations, much of
which came from FDA sources as well
as pharmaceutical company news re-
ports. Because of the dynamic nature
of this information, some drugs may
have been overlooked, and accurate
information on some drugs may have
been unavailable.
The limitations noted above all
may have influenced both our find-
ings with regard to historical trends
and the accuracy of the predictions
made for spending in 2016. Further,
although based on a careful analysis
of key trends and factors expected to
affect medication spending, our fore-
cast was based primarily on the expert
opinion of the authors. We have ana-
lyzed the accuracy of our past predic-
tions, and, while not without error,
they have been comparable in accu-
racy to those of annual estimates from
CMS.58
Still, we caution readers not to
blindly use our projections as “mul-
tipliers” to adjust prior-year budgets
for the next period. Instead, local data
should be carefully and systematically
incorporated into an organization-
specific drug expenditure forecast,
with proper consideration of external
trends relevant to drug expenditures,
as described in this article.59,60
Conclusion
We project an 11–13% increase
in total drug expenditures across all
settings in 2016, with a 15–17% in-
crease in clinic spending and a 10–
12% increase in hospital spending.
Health-system pharmacy leaders
should carefully examine local drug
utilization patterns in projecting
their own organization’s drug spend-
ing in 2016.
Acknowledgments
The authors thank all of the individuals
who served as reviewers for this article
and the ASHP Section of Pharmacy Prac-
tice Managers for supporting this effort.
The statements, findings, conclusions, and
views contained and expressed herein are
those of the authors and do not necessarily
represent the views of ASHP, the U.S. gov-
ernment, the Department of Veterans Af-
fairs, or IMS Health Incorporated or any of
its affiliated or subsidiary entities.
Disclosures
Dr. Schumock has consulted for or received
research funding from Abbvie, Astellas, and
Baxter in the past three years; both he and
Mr. Vermeulen are uncompensated mem-
bers of the IMS Health Services Research
Network Steering Committee, from which
much of the evaluated data was obtained.
Dr. Li has received honoraria for advising
and/or speaking from Amgen, Hospira,
Merck, Pfizer, and Sandoz. The other au-
thors have declared no potential conflicts
of interest.
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