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is a leading provider of proven expertise, delivering flexible resourcing and consulting services to
the biopharma, medical devices and diagnostics and consumer goods industries.
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For more information, visit www.yourencore.com.
II | Parthenon-EY
Introduction
Parthenon-EY and YourEncore recently conducted a
nationwide survey of life sciences experts to query them
on recent market trends, uncover their points of view on
potential regulations, refine their current business models
and gain insights into what discovery efforts might yield
better results. With all the rhetoric surrounding the drug
industry from political, news and personal channels, we
wanted to know what “those who know” think of various
ways to improve the system.
Parthenon-EY | 1
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain
Overall, respondents did not mind operating in a regulated stem cell research, and that domestic restrictions on their
environment, and we did not hear many say they would use will not stop experimentation. There is a belief that
prefer an unregulated market. In fact, many believed that US restrictions may result in long-term harm if research
patient safety regulations and those governing effective conducted in countries with fewer controls leads to harmful
clinical trials are both necessary and protect the general or false therapies that eventually enter the US market.
public. Of top concern for our respondents was the ability
of the Food and Drug Administration (FDA) to review trial
Figure 1: Number of new molecular entities (NME) approvals
results, issue opinions and findings and provide consistent by the FDA, 2006-2016
guidelines by therapy area.
Average: 36
This response was unexpected — we initially thought that drug approvals
fewer regulations would be preferred. There was wide per year between
2011 and 2016
support for the standard clinical trial model, with some
recommendations to create consistent protocols by
50
therapeutic area and streamline the process for disease-
45
specific reviews to include the same outcome measures, Average: 22
drug approvals 41
whether those are biomarkers or real-world evidence with 40 per year between 39
the same endpoints. 2006 and 2010
2 | Parthenon-EY
Q2 Which top regulations or agency reform
would have the biggest impact on lowering
the cost of drugs?
Our respondents named several potential changes that could those in European countries where list prices are public
help lower the cost of drugs. Mentioned quite often was and competition is more open. There was a broad
reforming how the US uses generic drugs. For many years, consensus that pricing needs to be transparent, not only
payers and pharmacy benefit managers (PBMs) have driven for manufacturers, but for everyone in the value chain —
the “generic conversion rate” — mandating that patients particularly PBMs and pharmacies — that profits from
switch from branded drugs to generics — with the belief unit price arbitrage vs. services provided.
that costs would decline.
Patient and provider education
Role of generics Marketing and direct-to-consumer advertising is the one
Drug prices have continued to rise due to how drugs area that most respondents agreed is a huge cost to
are placed on formularies, the use of non-transparent manufacturers and drives up the wholesale price of the
incentives, and the lack of generics in high-cost disease drug to recover investment for capturing patients. Use
states. Several respondents indicated that the role of of paper for product inserts, packaging and marketing
generics may be limited as new therapies and biologics hit materials, rather than moving to electronic labeling were also
the market. Others believed that generics still have a long considered to drive up unit cost. Patients’ lack of allowed
way to go and can be lower-cost alternatives for the right time with physicians creates both a greater burden to educate
disease states. These respondents believed that payers the public and costs associated with paper-based materials.
need better guidelines for how products are reimbursed,
Formulary reviews
such as comparing the net retail costs between a generic
Other respondents believed that formularies need to be
and brand after all incentives are included. Affordability
overhauled and that exclusions, substitutions, and non-preferred
for the patient should be the priority, not unit costs of a
products need to be thoroughly reviewed with new guidelines
single product.
and clinical protocols, not just price comparisons. There was
Accelerating generic drugs to market through improved a consensus that payers need to apply more clinical rigor in
processes was seen as one path to less-expensive making decisions and focus on outcomes instead of unit price.
alternatives making it to market faster. There was a belief
that introducing competition to the pioneer product
Figure 2: Year-over-year growth of branded drug prices in US, 2012-2015
earlier can impact overall drug costs. Rapid approval of
biosimilars was another category believed to lower costs as
brand patents expire. One respondent said savings could 12.5%
10.0 10.1%
be realized if Code of Federal Regulations Part 314 were to 8.0% 8.3%
7.5 7.5%
require third-line drug approvals to be superior to the first
5.0
two products on the market and have the same or better
2.5
safety and efficacy profile.
0.0
2012 2013 2014 2015
Medicare/Medicaid price negotiations
Some said that Medicare, Medicaid and other government
programs should be able to negotiate prices similar to EY analysis, Morgan Stanley and UBS industry analyst reports
Parthenon-EY | 3
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain
In looking at the regulatory environment, we had to ask assume this role. Supporting biotech incubators and helping
whether current legislation and agencies were a barrier to fund partnership creation were seen as a way to increase
clinical collaboration between pharmaceutical manufacturers. competition and collaboration.
We heard that there is significant concern about collusion,
One respondent indicated Hatch-Waxman Amendments
patent protection and sharing of information. However,
(patent reform and generic drug regulations) may help
when we queried the market, many told us that these fears
with price, but they also favor generic drug companies.
are overblown, and that internal legal and leadership risk
Moreover, the respondent indicated patent protections
tolerance represent the largest barrier.
for new chemical entities should be extended so larger
One respondent said that “regulations and agencies pharmaceutical companies have the money needed for
are not a meaningful barrier to collaboration among additional research.
companies or between companies and medical institutions/
Lastly, there is also a belief that PBMs and payers have not
universities/NIH (National Institutes of Health). The barriers
fostered collaboration when they could have largely helped
are far more related to the diverging interests of these
reconcile inconsistencies in the industry around common
organizations.” Another responded, “Much could be done
practices and data sharing. One respondent said insurance
on the industry side to encourage collaboration, especially
companies could have implemented clearer requirements
in therapeutic areas that are advancing cures in areas of
for routine standards of care and covered the increased
unmet medical need. This has always been a problem due
frequency of testing to capture data on valuable health
to competitive environment and patent enforcement but
outcomes.
is worthy of a dialog session to discuss solutions.”
4 | Parthenon-EY
Q4 What components of the value chain
(discovery, manufacture, distribution)
contribute the most to drug prices?
Unsurprisingly, research and development (R&D) was There was, however, a new category that has emerged
most often cited as the most expensive component and recently as a contentious element in the cost of drugs:
contributor to drug prices. Obviously, the sunk cost of failed the expenses associated with “middlemen.” This includes
trials was the primary driver, as these investments need to prescription benefit managers (PBMs) and wholesalers that
be incorporated into the cost for successful programs. are using their dominant positions in the value chain to
drive up profits by demanding more rebates or “discounts”
According to one respondent, “In my opinion, manufacturing
for products that are not passed on to consumers and do
(i.e., cost of goods) has a major impact on the ultimate drug
not add value to the process. One respondent called the
price. Having said that, however, the cost of development is
distribution chain an “antiquated model” that involves
very high and very risky. Numbers of studies, numbers of
far too many middlemen. Restrictions around distribution
patients, late-stage failures all contribute to the soaring cost
have created excessive handoffs before a product reaches
of drug development and therefore drug prices.”
the consumer.
Parthenon-EY | 5
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain
While respondents indicated many diverse approaches and transitioning that information to electronic labeling”
to lowering prices, many were in agreement that the could reduce costs. One respondent indicated “lowering the
quantity and complexity of regulations can contribute to preclinical burden and opportunity potential for approval
higher drug prices. One respondent said, “The relationship with one pivotal trial (or counting a good Phase II as a
between regulatory expansion and higher prices cannot pivotal in some cases)” could also lower costs. This is done
be ignored. Price increases caused by regulation have now in some orphan indications but “should be allowed
a disproportionately negative effect on low-income more generally.”
households. The poorest households tend to spend
Some respondents believe that allowing Medicare and
a larger proportion of their income on goods that are
Medicaid to negotiate prices or limiting prices to a ceiling
heavily regulated and are subject to both high and volatile
based on European price lists will have an impact. The
prices. This cost should be recognized in policymakers’
topic of value-based pricing came up quite a bit, and one
efforts to consider the costs and benefits of new and
respondent said, “Regulators should allow for more
existing regulations.”
value-based pricing innovation. The current minimum
Other respondents focused significantly on the discounts and best price rules around Medicaid,
manual, inefficient compliance processes that require Department of Defense (DoD), and the bloating of 340b
documentation by requesting a “commonsense approach (the federal drug discount program used by hospitals to
to documentation requirements.” “Eliminating the benefit lower income and vulnerable populations), [and]
requirement for printed packaging and physician leaflets the complex negotiations with PBMs all conspire to cause
40%
31%
30
20 19% 19%
12%
10 8%
4% 4% 4%
0
Clinical trial CMS Physician/consumer No change Value–based Documentation Drug Patent
reform negotiation communication needed pricing reform packaging reform
of prices
6 | Parthenon-EY
inflated list prices. Changing the rules to allow for more
innovation and more simplified market competition would
be beneficial. Allow drug companies to share information
with payers, including Medicaid, about future drugs so that
health systems can plan better.”
Parthenon-EY | 7
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain
The responses to questions #5 and #6 had subtle savings could potentially be realized, some respondents
differences. Responses to this question focused more on said, especially if trials could be conducted in a collaborative
R&D, price transparency and stakeholder collaboration environment, reducing redundancies for similar trials.
across the entire health care value chain. One respondent
One interesting observation is that there may be issues
indicated incentive structures are misaligned for some
with near monopolies in the distribution channel as
players in the value chain and questioned whether drug
secondary and tertiary wholesalers and payers/PBMs
companies should be publicly traded with Wall Street’s
retain deep discounts they receive from the pharmaceutical
financial performance expectations imposed.
manufacturers. Respondents said that all discounts and
One respondent said R&D is a long, risky process and savings, including rebates, should be passed on to consumers
collaborations are needed to enable greater value delivery in the form of lower co-pays and co-insurance rates. One
in product discovery. The respondent further indicated respondent said product liability expenses are a hidden
there is a need for the public to differentiate between form of costs as well.
a small number of “bad actors” that create a negative
public perception of pharma, and the majority of honest
companies that invest in research and development.
8 | Parthenon-EY
Q7 What should providers be doing that they
are not doing today to improve prescribing
patterns or therapy outcomes?
Parthenon-EY | 9
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain
Many respondents indicated that the physician, being they are best educated about pharmaceuticals and better
on the front lines of medical care, can drive change in understand how drugs work and how they affect patients:
prescribing trends. Improving continuing medical education “I would like to see pharmacists prescribe, based on physician
of physicians can position physicians to prescribe the most diagnosis. Pharmacists are the most underutilized brain
effective medicine, either branded or generic, that provides trust in the US.”
for improved clinical and financial outcomes.
Lastly, one respondent made a bold statement that we
Continuing medical education and the need to integrate need to “change the system totally. Insurance companies
electronic medical records with pharma databases was have no value, they only add cost. The best system I’ve
cited as critical for physicians to immediately access heard of has the care of each patient managed by a team
important information around drugs and their impact on that includes providers and patient advocates. Without that,
patient physiology. Once again, the topic of polypharmacy we have people who go to a doctor because they are bored
patients and the “sickest of the sick” came up as a specific or because they heard an ad on TV. The present system
area requiring much greater coordination, especially as including ACA [Affordable Care Act] will not work nor will
these patients are the highest cost claimants. Medicare for all.”
10 | Parthenon-EY
Q9 What improvements need to be made in
the reimbursement process to balance costs,
access to therapies and patient safety?
This question resulted in many very direct responses from Respondents want the reimbursement process to make
our survey respondents. The role of the payer has been therapeutic outcomes the primary measurement of
widely debated, and the responses from even a diverse reimbursement decisions, not price. Some want to see
set of survey participants were quite blunt about payers’ PBMs “disappear” and be replaced with a single-payer
responsibility to contribute to positive outcomes and not system and greater empathy for getting new therapies
focus solely on costs. to patients with life-threatening diseases.
One respondent said, “Currently, payers look at drug Lastly, respondents want to see a shift in “giving more
costs over the short term, because most of their insured power to personal physicians (of course with supportive
population will be covered by that particular payer for documentation) rather than layers and layers of ‘case
only a few years. Thus, payers have no real incentive to management’ who do not care about individual responses
spend on preventive and long-term therapies that could or needs. Make the physician responsible to confirm why
benefit the patient in the long run. So payers tend to the patient needs certain drugs or therapies. Now with
focus only on the immediate cost of drugs, not the value-based purchasing being tested in nine states, patients
long-term cost/benefit ratio.” are the guinea pigs – i.e., their orthopedist may limit or
deny necessary home care or outpatient PT after a joint
In fact, several respondents agreed that “payers need to
replacement.”
look at costs from an immediate and long-term perspective.
Some expensive therapies are not covered, which can lead
to longer term use of less expensive therapies that erode
the cost savings they seem to provide. We need revised
standards of care based on independent review of
therapies and outcomes.”
Parthenon-EY | 11
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain
Once again, we heard from respondents that “arbitrary more expensive treatments, non-reimbursement for
and generalized limitations imposed on prescribers, solely companion diagnostics, and excessive and burdensome
based on cost, interfere with the individualization of the prior authorization practices were cited as other drivers
patient-physician decision-making relationship” and that of hidden costs. One respondent said payers “should
there is a “great amount of administrative costs that require less outcomes/pharmacoeconomic data on novel
are burdensome to users and especially patients.” One products where there is no appropriate generic. The cost
respondent said “the fix would be either regulation of the of copays in tier three+ products is generally too high
payers in a way that requires a long-term perspective, or and restricts use of good drugs in patients who are likely
a single-payer option for pharmaceutical coverage.” to benefit.”
Another respondent believes forcing the use of generics Finally, one respondent said what we need is greater
does not always result in equivalent efficacy, safety or transparency overall, as well as the elimination of
manufacturing integrity. Several respondents said forcing paperwork, constantly changing reimbursement rules
prescribers to use generics does not always result in lower and hidden pricing deals with intermediaries.
costs and may in fact require multiple switches when there
are newer and better therapies available in brand-name
products. “Standard of care is for the average person.
It’s a waste of time and money for all of those instances
where a patient is not showing typical symptoms,” one
respondent said.
12 | Parthenon-EY
Conclusion
There are many conversations taking place models is needed and welcomed by the
in both public and private forums around the community of leaders in the industry.
current state of pharmaceuticals, drug prices
and public policy changes. Parthenon-EY and Parthenon-EY has been helping clients
YourEncore decided to conduct a survey to across the entire life sciences value chain
ask leaders in the industry value chain what assess whether they need to change their
they thought of the regulatory environment business, operating and economic models
and how changes may impact the industry. to help them be better positioned in the
What we heard was both interesting and future. There is broad openness to doing
affirming of many of the sentiments being things differently, but many clients are
reported by the general press. Everyone looking for guidance from regulatory
seems to want change and there is still authorities to help them design more optimal
widespread support around patient safety solutions. There are many ideas but little
and efficacy as a priority. The types of clarity around expectations and desired
changes needed range from simplification outcomes, much less how success will be
around the economic models to usher in information make it difficult for companies
greater transparency. The myriad of models to innovate and change their infrastructure,
and processes that have evolved over the so there is considerable stasis around
years are putting additional burdens and wholesale change. The will exists, the way
needs to be paved.
costs on a constrained system, so thoughtful
restructuring of business and economic
Parthenon-EY | 13
Parthenon-EY Life Sciences practice
For more information on our Life Sciences practice and our team, please visit parthenon.ey.com.
About Parthenon-EY
Parthenon joined Ernst & Young LLP on 29 August 2014. Parthenon-EY is a strategy consultancy, committed to bringing
unconventional yet pragmatic thinking together with our clients’ smarts to deliver actionable strategies for real impact in
today’s complex business landscape. Innovation has become a necessary ingredient for sustained success. Critical to unlocking
opportunities is Parthenon-EY’s ideal balance of strengths — specialized experience with broad executional capabilities — to
help you optimize your portfolio of businesses, uncover industry insights to make investment decisions, find effective paths
for strategic growth opportunities and make acquisitions more rewarding. Our proven methodologies along with a progressive
spirit can deliver intelligent services for our clients, amplify the impact of our strategies and make us the global advisor of
choice for business leaders.