In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and medical device manufacturers need to plan strategically for both reform and market-driven initiatives. As the healthcare landscape transforms, products both on the market and in the pipeline will be affected. By conducting alternative scenario planning and modeling possible initiatives, manufacturers can help ensure patients will continue to have access to their products, as new channels emerge and a new market takes shape.

Four Key Focus Areas for Pharmaceutical, Biotech and Device Manufacturers

To sustain success, pharmaceutical, biotechnology and medical device leaders not only need to understand the new trends and models re-inventing healthcare but also play a role in creating them. There are four key areas most critical to consider in building access plans and determining how to participate in a re-invented healthcare system:

  • The Growing Insured Patient Population. The main objective of the ACA is to increase access to health insurance. By eliminating pre-existing conditions as a reason to deny coverage or justify higher premiums, the ACA opens options to consumers who previously either were unable to obtain insurance or couldn’t afford it. While details of the state Exchanges are still emerging, we can already see that, although there may be similarities in Exchange approaches among states, there also can be significant variations. It will be important for manufacturers to be aware of local differences.

States have chosen among three government Exchange models—state-based, federally facilitated and partnership—and are creating implementation approaches for communicating their plan options to new consumers. Encouraging new patient enrollments will help to expand the risk pools. For manufacturers to build effective market access strategies, they must understand how Exchanges are developing across geographies and the corresponding choices available to patients in each state. They also need to gain insight into how patients will select the plan that is right for them.

  • Growth of the Underinsured Population. Even with Exchanges in place, there will continue to be individuals who, although they technically have health insurance, are unable to access their benefits due to affordability issues. Sometimes referred to as the “functionally uninsured,” these patients have coverage but can’t afford the deductible or copay. As more individuals purchase health insurance, it is possible that we will see this underinsured segment grow—particularly for certain disease states. Manufacturers already play an important role in assisting underinsured patients. Moving forward, they will need to re-examine the payer mixes for their product portfolios to identify where coverage gaps might emerge and determine new ways they can support patients with affordability challenges. In addition, they will have to assess the influence the underinsured will have in the new market--and understand what that means for access strategies.
  • Integrated Payer and Provider Models.The goals of integrated models are to drive better health outcomes and improve care quality while managing costs. There are financial incentives for delivering cost-effective patient care. To ensure their brands are available to patients in integrated environments, it’s essential that manufacturers demonstrate both the clinical and the economic value of their products. They must understand the evolving definition of “value”—and ensure they create value stories that communicate their products’ ability to deliver both better health results and greater cost efficiency. This dual focus is critical to keeping access pathways open to patients who participate in integrated care models.
  • New Types of Caregivers and New Sites of Care. Challenges to physician reimbursement will continue in 2014. The percentage of medical school students choosing a career in primary care is declining. Fewer than 1 in 5 medical school graduates are now choosing primary care specialties, and the percent of PCPs in the U.S. has dropped from 50% (where it is in most countries) to less than 30%. Instead, today’s graduates are gravitating toward more lucrative specialties. As a result, the American Association of Medical Colleges projects a shortage of 45,000 primary care physicians by 2020. At the same time, there will be a 36% increase in the number of Americans over 65—the very segment with the greatest healthcare needs. Physicians are aging, as well, with almost a third planning to retire in the next decade, contributing to the shortfall. For new physicians, the high cost of medical education makes primary care a difficult choice, since PCPs earn less than other specialties.

With health reform bringing an additional 32 million Americans into the system, there will be a pressing need to fill the care gap. As a result, the importance of physician assistants, nurse practitioners and pharmacists as care providers will grow. In addition, new sites for care delivery--from pharmacies to airports to schools--will continue to emerge. Manufacturers will need to create different types of access models for these new providers and sites.


When open enrollment begins in October, it will be a landmark event for healthcare delivery in the United States. The start of health reform implementation will signal the rise of new patients, providers, delivery models and sites of care. Manufacturers have the opportunity to take an active role in creating the new healthcare system. To maintain access for existing brands—and establish it for new ones--they will need to understand and adapt to the needs and demands of new delivery systems. Key to their success will be developing and communicating credible evidence that their products deliver both components of value—positive outcomes and cost effectiveness.