Pharmaceutical Commerce - July/August 2013 - (Page 6)
Medical Affairs’ changing role in
market access and reimbursement
By Mike Menta and Thao Sutter, Campbell Alliance
With the shift toward evidence-based medicine
and value-based pricing, the needs of payers are
evolving. Whereas in the past a pharmaceutical
organization’s Market Access and Reimbursement
(MA&R) group would primarily engage payers
around the economic benefits of a product, payers are
now increasingly interested in patient outcomes data
and clinical evidence supporting the product. Some
of the large payers, such as Aetna or United Healthcare, go even further, seeking heavy medical
representation from pharma in order to conduct multi-year studies to evaluate outcomes.
As a result, the role the Medical Affairs (MA) organization plays in supporting MA&R
has expanded as medical science liaisons (MSLs) are called upon to interface and engage
with payers to discuss the science behind the drug. Meanwhile, companies are beginning
to transition the health economics and outcomes research (HEOR) function out of the
Commercial organization where it traditionally resides and are aligning the function under
MA. Adding HEOR responsibilities to MA has major implications, however, in terms of
interactions with stakeholders, the way interactions are documented, and the activities and skill
sets that will be required.
Recently, Campbell Alliance brought together MA leaders from a diverse range of
pharmaceutical and biotechnology companies as part of its annual Medical Affairs Leadership
Summit. In a survey of 17 Summit members, 68% of respondents cited HEOR knowledge as
one of the unique skills expected from the MA resources providing MA&R support. Other skills
cited by more than half of respondents include payer market/managed care knowledge and
health outcomes and/or health economic study design and execution experience. Depending
on the level of MA&R support needed, companies will have to determine the best approach for
building HEOR capability, whether that means training existing MSLs or creating a separate,
specialized HEOR role.
The nature of communications with MA&R stakeholders is seen as different from
traditional MSL communications, with some organizations allowing proactive communication
Outsourced facilities management saves precious financial
Life sciences companies—including midmarket ones—are finding value in an outsourced service
By Richard McBlaine, Jones Lang LaSalle
Outsourcing facilities management
is a time-tested strategy in industries
like banking, consumer products,
technology—and the multinational life
sciences companies have long recognized
the benefits of outsourced facilities
management. Yet, it is commonly held
that only the global companies truly
benefit from this strategy’s economies of scale. Middle-market
life science companies can actually benefit enormously by
outsourcing facilities management and related services.
Service providers can ensure that best practices drawn from
life sciences and other industries are infused into every
program regardless of company size.
A qualified facilities management provider can generate
millions of dollars in savings through operational efficiency
improvements, create workplace environments that
promote sustainability and productivity, and ensure safety
and regulatory compliance across a life science company’s
Aside from the very largest companies, the life sciences
sector has been relatively slow to entrust facilities to outside
with payers. Most dedicated MSL groups, meanwhile, respond reactively to specific requests.
Companies will need to give this issue a lot of consideration, particularly in terms of how it
Because most MA&R groups are currently under the commercial organization, the
personnel are compensated similarly to sales representatives. Compensation is based on getting
drugs on formulary and increasing access as measured by sales or volume. But if elements
of this function are integrated under the MA organization, this type of metric would be
challenging under the regulatory restrictions that govern MA.
Another important issue around compliance is in how conversations are documented.
Everything that an MSL does has to be documented because of the regulatory requirements
around non-promotional activity. For the individuals who are currently providing payer
support, the same level of diligence is not required in documenting their conversations or
rationale. If and when those individuals are brought under MA, companies will be faced with
the issue of finding common ground for documenting conversations depending on whether
they are allowed to be proactive or purely reactive. Integrating and managing that diligence
level could prove to be a challenge.
The evolution of healthcare systems will dictate the need for MA&R support globally. In the
US specifically, the implementation of healthcare reform will bring about a redesign of payment
structures and service delivery models, shifting the management of clinical and financial risk
from payers toward providers. Of all the various models and concepts that the Affordable Care
Act promotes, accountable care organizations (ACOs), comparative effectiveness research, and
value-based pricing are most likely to have a significant impact on access and reimbursement.
As these new models take effect, MA organizations will need to discuss these issues with payers
to see if any common ground exists between the payer and the pharma company.
As the implementation of healthcare reform is still in its infancy, many unknowns exist in
terms of implications. Companies would be advised to stay on top of future developments
as they emerge in order to build an understanding of what is going to be required to support
payers in the future.
ABOUT THE AUTHORS
Mike Menta is senior vice president, Medical Affairs Center of Excellence, Campbell Alliance.
He can be reached at firstname.lastname@example.org. Thao Sutter is a senior engagement
manager, Campbell Alliance. She can be reached at email@example.com. For
more information on Campbell Alliance’s Medical Affairs Leadership Summit, visit www.
providers. Historically, the perceived risks to sensitive R&D
operations and highly specialized production environments
were considered too high to justify the advantages of
However, the sector is now one of the top three in terms
of demand for facilities management outsourcing, according
to KPMG’s 2012 Real Estate and Facilities Management
Outsourcing Pulse survey. Companies have learned that the
risks of facilities management outsourcing can be mitigated
by working with a real estate services provider that has a
proven track record in working with the unique requirements
of life sciences companies.
What does professional facilities management include?
Real estate and facilities comprise one of the largest line
items on the balance sheets of life sciences firms of all sizes,
so facilities operations is arguably one of the best places to
look for cost containment without negative impact on the
business. Real estate offers many opportunities that not only
save money, but also enhance the business overall.
Consider energy usage: about one-third of the energy
used by buildings is typically wasted through inefficient
equipment or machinery working improperly. An expert
in facilities energy management can gather useful data on
building systems performance, and continually implement
improvements that save millions of dollars and reduce its
Energy management is just one aspect of an integrated
facility management program. The benefits are clear in
virtually every area of outsourced services:
• Best practices for corporate real estate management. An
outsourced real estate services provider with a global
6 Visit our website at www.PharmaceuticalCommerce.com July | August 2013
client base that includes life sciences organizations will
bring diverse best practices to bear on a life sciences
company’s portfolio. For example, an outsourced real
estate service provider can apply best practices to shorten
the considerable—and costly—lag time between the
completion of a merger and execution of the follow-on
real estate strategy.
• Critical environment management and regulatory
compliance. Outsourcing can help a company improve
its compliance procedures and prevent manufacturing
plant shut-downs. A facilities management provider with
expertise in life sciences operations can offer expertise in
regulatory compliance, hazardous waste management,
safety and security, and more.
• Improved safety and security. With life sciences expertise,
an outsourced real estate services provider can help a
company manage risks associated with handling
extremely valuable or hazardous materials. The provider
also can manage sophisticated security systems required
to reduce the risks of intellectual property theft or threats
to employees working with highly valuable ingredients or
on controversial projects.
• Sustainability. The better real estate service companies
train their engineers and facility managers in energy
efficiency and environmental sustainable practices and
continued on page 30
ABOUT THE AUTHOR
Richard McBlaine (312 228 2793 or richard.mcblaine@
am.jll.com), is an international director and chairman, strategic
consulting, at global real estate firm Jones Lang LaSalle, where
he leads a team of consultants providing leading-edge real
estate solutions for life sciences companies.
Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2013
Pharmaceutical Commerce - July/August 2013
Brand Marketing & Communications
Manufacturing & Packaging
Legal & Regulatoryv
Meetings and Editorial Index
Pharmaceutical Commerce - July/August 2013