Pharmaceutical Commerce - July/August 2013 - (Page 6)

Op-Ed 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 resources 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 facilities. 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 impacts compensation. 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 mmenta@campbellalliance.com. Thao Sutter is a senior engagement manager, Campbell Alliance. She can be reached at tsutter@campbellalliance.com. For more information on Campbell Alliance’s Medical Affairs Leadership Summit, visit www. campbellalliance.com/MAsummit. providers. Historically, the perceived risks to sensitive R&D operations and highly specialized production environments were considered too high to justify the advantages of outsourcing. 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 carbon footprint. 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 materials. 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. http://www.campbellalliance.com/MAsummit http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2013

Pharmaceutical Commerce - July/August 2013
Editorial
Contents
Op-Ed
Top News
Business/Finance
Brand Marketing & Communications
Supply Chain/Logistics
Information Technology
Manufacturing & Packaging
Legal & Regulatoryv
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2013

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