Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain

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Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
Pharmaceutical industry
changes and market insights
Survey of leaders in the pharma value chain
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain

Ernst & Young LLP and YourEncore alliance overview
Ernst & Young LLP and YourEncore have formed a strategic alliance to help life sciences and
consumer products clients accelerate product development, strengthen regulatory compliance
and improve productivity.
This first-of-its-kind relationship unites EY advisory, transaction advisory and tax services with the
real-world experience of YourEncore’s 10,000 on-demand industry experts to help clients innovate,
drive growth, manage risk and comply with increasing regulatory challenges.

About YourEncore
Indianapolis-based YourEncore, named a “100 Most Brilliant Company” by Entrepreneur Magazine,
is a leading provider of proven expertise, delivering flexible resourcing and consulting services to
the biopharma, medical devices and diagnostics and consumer goods industries.
With its network of highly experienced subject matter experts, including MDs, PhDs, regulators
and scientists, YourEncore mobilizes the wisdom and know-how of its experts to help companies
out-think, out-pace and outperform.
For more information, visit www.yourencore.com.

II | Parthenon-EY
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
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.

We asked 10 simple questions, soliciting input from more
than 50 past and present industry executives and experts
from pharmaceutical, consulting and pharmacy backgrounds.
What we heard was informative, provocative and in some
cases unsurprising — but important to consider.

Here is what we have learned.

                                             Parthenon-EY | 1
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain

Q1                    Which top regulations could have the greatest impact
                      on accelerating discovery and getting breakthrough
                      products to market faster?

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

For novel therapies, especially in oncology, there was                                                          30
                                                                             30
a desire to allow smaller studies with greater definition                                                                   27
                                                                                                     26
                                                                                               24
around endpoints and an accelerated approval path.                                 22                                                        22
                                                                                                           21
One participant responded, “a review of the clinical                         20                                                                   The decline
                                                                                          18
requirements by therapeutic area should [occur] to ensure                                                                                         of NME
                                                                                                                                                  approvals
that the most streamlined processes are in place to speed                                                                                         in 2016
                                                                                                                                                  concerns
up the development process. Inclusion of real-life evidence                  10                                                                   stakeholders
in supplemental applications [should also occur] across all                                                                                       across the
                                                                                                                                                  value chain.
therapeutic areas.”
                                                                              0
There was also a consensus that the US is falling behind                          2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

other developed countries in the use of genomics and
                                                                           Food and Drug Administration

2 | Parthenon-EY
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
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 - Survey of leaders in the pharma value chain
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain

Q3                   Which top regulations or agencies
                     create the largest barrier to collaboration
                     (research or otherwise)?

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.”

Other respondents believed that the FDA and NIH can
do more to foster collaboration, but that the current
complexity of different departments with different
processes makes it seem as though they are dealing with
multiple agencies. Every submission and request seems to
be a “first” or “one-time exception” rather than a standard
operating procedure.

Several respondents felt that funding should be directed
to small start-ups and innovative companies that are willing
to partner. These respondents suggested government
assistance in identifying partners and financing or,
alternatively, private equity and smaller investors could

4 | Parthenon-EY
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
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.

Phase 3 or late-stage clinical trials were also cited because
                                                                   The issue with the middleman has become very prominent
of the number of endpoints that need to be evaluated and
                                                                   in recent national conversations, as the market asks why
the manual process by which data is collected and evidence
                                                                   there is still a need for handoffs in a highly consolidated
is submitted to the FDA for approvals. Several respondents
                                                                   sector. One respondent indicated “distribution, insofar
indicated the clinical trial process heavily depends on
                                                                   as insurance companies and PBMs increase their profits
inefficient processes that are not automated or consistent
                                                                   at the expense of patient choice and co-pay/co-insurance
and even incremental improvements could yield significant
                                                                   increases … also leads to increased noncompliance to
savings to the industry.
                                                                   prescribed therapies.”

Other components cited were product recalls, packaging,
destruction costs and labor associated with the management
of product in the channel. Of course, also on the list was
marketing, especially direct-to-consumer advertising,
which is more expensive than a sales force that calls
on physicians. Recent rules on how much time a drug
rep can spend with a physician have shifted marketing
expenses into digital and media advertising, which
requires significant investment and constant updating.

                                                                                                                 Parthenon-EY | 5
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain

Q5                           What changes to regulations would
                             lower prices the most?

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

Figure 3: Percentage of respondents indicating type of reform

   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

Parthenon-EY and YourEncore pharmaceutical survey results, 2017

6 | Parthenon-EY
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
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.”

Others discussed the rise of direct-to-consumer advertising
in response to tight restrictions around profiling and
educating physicians directly. One respondent said that we
should “limit direct-to-consumer advertising and sales calls
to physicians. Information on medicines should be provided
to physicians from objective, peer-reviewed sources, funded
publicly or by the industry as a whole — not by individual
companies.”

Some respondents indicated a preference for limits to
direct-to-consumer advertising and rebalancing those
with physician education and the establishment of
“an industry-wide, peer-reviewed resource as a central
depository for drug information.”

Many respondents want to see more rapid approval of
biosimilars and shortening of the time allowed before
generic approvals. Respondents generally do not want to
see broad decreases in FDA oversight, and they mentioned
patient safety as a critical issue that the FDA should
continue to oversee.

                                                               Parthenon-EY | 7
Pharmaceutical industry changes and market insights - Survey of leaders in the pharma value chain
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain

Q6                   What changes to the value chain (discovery,
                     manufacture, distribution) need to occur to
                     eliminate unnecessary costs or reduce prices?

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.

There was also a willingness to work within an environment
with greater price transparency for the market to see
relative pricing/value along the entire distribution channel
and know who really profits from drug delivery. Many
respondents believe there are too many players profiting
from low-value services, such as distribution and price
triaging by intermediaries.

Some respondents also referenced inefficient internal
practices within pharma, such as excess production
capacity in manufacturing plants that is not well-utilized.
If fewer studies and patients studied were required, cost

8 | Parthenon-EY
Q7                   What should providers be doing that they
                     are not doing today to improve prescribing
                     patterns or therapy outcomes?

When asked specifically about providers, respondents
commented on how the physicians’ role has changed
and how critical their attention to the details
surrounding appropriate drugs matters to overall
clinical outcomes. Most respondents believe that
physicians have a significant responsibility to better
understand how drugs work in the body, when it is
medically necessary to prescribe a drug and how
it will interact with other agents. Several respondents
commented about how most treatments are now a
prescription vs. a procedure and that not allotting
enough time to educate physicians may detrimentally            Respondents want to see payers take more responsibility
affect their efficacy in treating disease.                     in enabling physicians and electronic medical record
                                                               (EMR) standards rather than delegating those standards
Respondents want more time for physicians to learn             to a fragmented provider market. A specific comment
about new therapies/products and assess and ensure             around EMRs was that “electronic medical records must
the appropriateness of their use after initial availability.   be reorganized to capture therapeutic outcomes so they
There were comments about bringing more physicians             can be a tool for real-world evidence (value) — and not
into trials to better understand how investigations are        just for cost assessment (price).”
conducted and suggest improvements to the process.
Many physicians are never a part of trials and often           Many buzzwords were also mentioned, such as value- and
don’t understand how to enable patient therapies, so           outcome-based reimbursements, real-world evidence and
only a small pool of physicians shapes how trials are          evidence-based medicine. However, there were some specific
conducted.                                                     recommendations for more head-to-head trials between
                                                               competitor products in the same therapy class, especially
A common barrier noted was the shortage of physicians          with interchangeable products — the goal being to
in primary care and payer pressure to see more patients.       gather more data on the drivers for efficacy and better
This pressure leaves little time for continuing medical        understanding of clinical performance vs. patient behavior.
education and patient counseling, thought to majorly
impact clinical outcome improvement. Compliance and            Other respondents wanted to see more pressure on
adherence were mentioned repeatedly as a responsibility        physicians to stop overprescribing, especially antibiotics
of both the patient and the physician, who should check in     and to polypharmacy patients, without doing more
to evaluate the progress and efficacy of the therapy.          research into the patients’ history.

                                                                                                            Parthenon-EY | 9
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain

Q8                   What improvements need to be made in
                     the prescribing process to balance costs,
                     access to therapies and patient safety?

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.”

Some respondents also advocated for simplified national
policies from regulators and guidelines from payers around
how care should be triaged. One respondent said, “The
US should adopt NICE-like (National Institute for Health
and Care Excellence) reviews of therapies.” Others said
that payers need to start making the hard trade-offs
between products to rationalize the number of treatment
options without denying care and reviewing it after the
fact. Respondents want to see payers hold physicians
accountable to complying with safety requirements and
not just prescribe off label without the existence of a
standardized protocol.

Another respondent said the US can combat the shortage
of physicians by allowing pharmacists to prescribe, as

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.”

Another said, “Patients do not have transparent
information as to the cost of care. Require that the cost
of doctors, hospitals and drugs all be made clear when
treatment options are discussed. Patients learn about
costs at the back end after treatment is given — that is too
late to get involved in the right dialog. Weirdly, the only
cost patients know in advance is at the pharmacy. Doctor
offices, diagnostics centers and hospitals all say ’the cost
to the patient is up to the insurance company’ and never
answer what their billings will be or the net to the patient.
Both payers and providers need to start to deal directly
with the public on pricing.”

                                                                                                              Parthenon-EY | 11
Pharmaceutical industry changes and market insights: a survey of leaders in the pharma value chain

Q10                         What practices do payers employ that don’t
                            contribute to improved clinical outcomes or
                            cost reduction?

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.

The use of step edits and second-guessing of physicians
drive up hidden costs to the system, according to
several respondents, as patients need more phone calls,
consultation time or additional visits with their doctor to
get on the right medication. Fail-first mandates, mandatory
generic switching, higher co-pay tiers for

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

of rules and guidelines to wholesale changes    measured. Restrictions around sharing

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

Our team                                                                           YourEncore contributors

                 Alex Jung                                                                           Kyle Fenstermaker
                 Managing Director                                                                   Managing Director, YourEncore
                 Parthenon-EY                                                                        Bio-Pharmaceutical Practice
                 Ernst & Young LLP                                                                   1 609 240 5945
                 1 312 879 2778                                                                      Kyle.Fenstermaker@yourencore.com
                 alex.jung@parthenon.ey.com

                 Daniel Mater                                                                        Joseph Lamendola
                 Consultant                                                                          Senior Vice President, YourEncore
                 Parthenon-EY                                                                        Bio-Pharmaceutical Practice
                 Ernst & Young LLP                                                                   1 609 937 4552
                 1 312 879 3345                                                                      Joseph.Lamendola@yourencore.com
                 daniel.mater@parthenon.ey.com

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.

About the Parthenon-EY Life Sciences practice
The Parthenon-EY Life Sciences practice has dedicated life sciences professionals across member firms in 17 countries
spanning the Americas, Europe, Middle East and Asia-Pacific. Our global hub is based in the US and has life science leaders in
Boston, New York, Chicago and San Francisco. All Parthenon-EY Life Sciences professionals have extensive experience in life
sciences strategy consulting and academic degrees in science, clinical and business disciplines. The practice coordinates with
the Parthenon-EY Health care and Consumer practices as well, bringing the full gamut of convergence in consumer, health care
and life sciences offerings to clients in companies, investor groups, payers and providers worldwide.

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About EY
EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and
confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all
of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.
EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is
a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more
information about our organization, please visit ey.com.
Ernst & Young LLP is a client-serving member firm of Ernst & Young Global Limited operating in the US.
Parthenon-EY refers to the combined group of Ernst & Young LLP and other EY member firm professionals providing strategy services worldwide.
Visit parthenon.ey.com for more information.
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This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting, tax or other
professional advice. Please refer to your advisors for specific advice.
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