Depending on your perspective and role in the healthcare industry in early 2010, your opinion of the imminent enactment of the Patient Protection and Affordable Care Act (ACA) potentially fell within two camps: “Healthcare Utopia” or “The Sky Is Falling.” Depending on your perspective today, you could say that both sides of the perspective spectrum have influenced time and events in our professional (and personal healthcare) activities. As the pendulum of change has swung wide over the past five years of the ACA, the assimilation of such change is still a work in progress, with a more moderate presence on a daily basis, and a significant presence with respect to short-, medium- and long-term planning.

Broad, sweeping transformation has a tendency to polarize the groups it will impact, and back in 2010 (and earlier) the pharmaceutical industry was alert, listening intently and vocal—though perhaps a bit careworn from a previous decade (plus!) worth of change. Although manufacturers certainly had a seat at the table during the development of the ACA, and were quite emphatic about how proposed changes might impact the drug industry, the overall tenor was one of concession and cooperation, perhaps largely driven by a motivation to ensure long-term viability of traditional pharmaceutical therapeutics.

Response to the New World Order

In addition, day-to-day operations within the walls of pharmaceutical organizations were at the nascent stages of responding to the new world order. Some companies adopted a prudent approach to research, and investigated before making changes, polling their key customers’ attitudes and awareness of the ACA.

Others took stock of their own operations to become more patient-centric and to analyze how to best align with expectations that would ultimately be driven by the Triple Aim of improved outcomes, patient satisfaction and cost-effective (or at least cost-conscious) care. Fast-forward to present day, and although we have yet another example of the old saying hindsight is 20/20, it turns out our foresight wasn’t so bad, either.

Anticipation of almost any major event, whether on a personal or on a larger social scale, is often fraught with concern, planning and more planning, conjecture and overgeneralizing. Once the train of change actually leaves the station, the ability (or perhaps necessity) to adjust and adapt leads us to accept and assimilate the change, taming the beast of trepidation by spurring us into action.

As such, some of the effects of the implementation of the ACA have been significant, affecting real change for patients, providers, payers and manufacturers. Others have been subtler, fleeting or not yet fully realized. As we are now living in the post-ACA era, how are manufacturers working within this new set of challenges and opportunities, and how will we work towards the common goals of improved outcomes and population health, now and in the future? Here are just a handful of considerations for the palpable healthcare shift, and what might be needed to simultaneously embrace, and brace against the years to come.

The Good: Patient-Centricity

One of the most favorable aspects of the ACA evolution is the continued and heightened focus on the patient. Not that the industry was ignoring the patient prior to the ACA—to the contrary, certainly an idealist notion about industry helping patients existed pre-ACA. But now, there is explosive focus on everything from the patient treatment journey to the patient experience to patient satisfaction. Supportive clinical research, including quality of life and patient-reported outcomes, which in previous years had received a fair share of labeling as “soft science,” are now getting their due. And through a renewed focus on outcomes, the patient voice can be heard in a new and somewhat unexpected way—loud and clear through the din of clinical trials analyses.

Manufacturers can continue to fan the fire of patient-focused activity by not just understanding the patient journey through a particular illness or disease or treatment process, but also by really studying touchpoints through the journey where they can most help—or even interfere. A truly thorough review of the patient journey has implications for multiple company endeavors: Public relations, clinical trial design, patient and provider education and health plan or health systems relationship development, to name a few.

The Difficult: Conversations About Cost

This era of pharmaceutical industry activity is not for the faint of heart. At every turn, a spotlight of derision and concern is shone brightly on acquisition costs of pharmaceuticals. Drug costs have been a major focus of the ACA since its inception, and the subject has only grown in gravity, reach and frequency. Manufacturers anticipate the influence of the evolving ASCO Value Frameworks and NCCN Evidence Blocks in oncology, the emergence of biosimilars in many specialty therapeutic areas, and the need to make adjustments in response to pressures of noted increases in patient cost sharing.

Also frequent debates take place regarding what resources can be spared from the use of a particular drug in a particular patient—certainly an offshoot of the value conversation, though we are yet to achieve a fully accepted and integrated view of therapeutic value. Although cost concerns are not the only challenge facing the industry, they are the proverbial 800-pound gorilla that cannot be ignored. Manufacturers need to make tough calls on pricing and strive to find a balance with support services for patients and healthcare providers. Not to mention a need still remains to walk through an ongoing complex system of drug coverage, with formulary tiers and restrictions becoming even more detailed and defined.

Indeed, the cost conversation is not limited to pharmaceuticals—as health plans raise premiums and member contributions through cost-sharing increases, they are also in the line of cost-concern fire. Moreover, health savings accounts and health insurance exchanges bring health expenditure conversations to the dinner table and common hospital procedures are posted online for consumer-patients to comparison shop. Yet even though there is no shortage of cost-control responsibility, pharmaceuticals remain a key target. Manufacturers who can take initiative to demonstrate the value of their portfolio, and who work to build viable outcomes measures into product development (and even R&D), can also increase credibility with transparency and responsiveness to market demands for solid Triple Aim focus and communications and practices that underscore value.

The Complicated: New World, New Customers, New SOPs

ACOs. IDNs. Centers of excellence. Health systems. Patient-centered medical homes. New customer types, models, care provider systems and health plans are consolidating and/or sub-specializing, and otherwise morphing at a rapid pace. Traditional healthcare providers and payers no longer exclusively dominate the market, and new customer models are in turn not limited to traditionally defined roles.

In addition, new customer models have created microclimates in which norms and SOPs vary from region to region, prompting an increase in the practices of geo-targeting and segmentation to help manufacturers structure field teams and deliver key messages. And within each new health system, the expansion of healthcare provider roles—including nurse practitioners, physician assistants and care managers—only increases the complexity of planning and interacting with customers. In light of how dynamic the changes are to the world of customer management, companies are wise to continue to align processes that anticipate and respond to new customer needs and influences.

Customer models in and of themselves are not the only accelerated change that manufacturers need to consider in aligning their operations effectively—they also must consider direct effects of the ACA on their customers such as quality monitoring and reporting, EMR/EHR, physician performance and patient satisfaction, to name a few. No-call physician lists are increasing so digital communication needs are also on the rise, giving way to needs for content planning and management, specialized messaging and digital promotion acumen.

Future Perfect: Outcomes Excellence Plus Effective Customer Solutions

Many post-ACA publications underscore the need for pharmaceutical organizations to offer not just a drug, but an effective drug, plus wrap-around services that support optimal use of the drug in a defined patient population, as well as to improve or minimize impact on costs. This new product model is sometimes referred to as pills plus, or addressing Triple Aim needs. As we move more fully into the Age of the ACA, a greater understanding is needed in ways that pharmaceutical companies can offer therapies for better health outcomes as well as business performance support to those agencies in charge of purchasing, administering and reimbursing those therapies.

In a land before ACA, mastery of the randomized controlled clinical trial was enough to gain product acceptance and use. Over time, clinical endpoints evolved and expanded to include surrogate endpoints and best care standard comparators. Several manufacturers have modeled and conducted head-to-head studies. As the ACA has evolved, the demand for and appeal of real-world evidence and alternate data sources has only increased. It is no longer “enough” to stop at Phase III studies—new customers, patient advocates and consumer-patients are asking for more—more understanding of how therapeutics will perform in larger populations and over time. Likewise, manufacturers can also benefit from access to real-time, patient-level data that can help further target and refine best outcomes and business performance.

Are all of these observations solely due to the ACA over the past five years? Probably not, as they all had established roots prior to that. However, it is clear that the ACA has hastened movement and change, and will continue to drive market and industry shifts that lead to greater efficiencies and new opportunities as we all work through the ongoing challenges and benefits of healthcare in the United States.


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