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New Developments in Pharma Market Access in the US

Although clinicians and drug manufacturers have always touted the value of certain treatments, cost-effectiveness hasn’t always been an integral part of the pharma market. However, priorities have shifted in recent years and value-based pricing has begun to dominate the US pharma market. As market access shifts, pharma companies must change their business model or risk being left behind.
Adapting to these market shifts isn’t easy. But robust data-collection and strategic decision-making can protect your company in the decades ahead.

Increasing Demand and Rising Medical Costs
Although global demographics vary, most 21st century governments face a similar challenge: their populations are aging and each year the demand for medical care increases. Yet many regions still haven’t fully recovered from the 2007 recession. Patients may have lost some or all of their savings. Tax revenue has faltered, while personal debt has exploded.

The United States is no exception to these trends and many US citizens rely on private insurance plans. These plans often carry a high deductible or steep out-of-pocket costs. As a result, healthcare spending in the United States has skyrocketed.

Both government agencies and private payors are now under heavy pressure to control medical costs. Value-based pricing has emerged as a promising solution, but the move toward it hasn’t been seamless.
Many pharma companies have tried riding out these changes by making minor alterations to their marketing strategies. However, adapting to value-based pricing cannot be an afterthought. Instead, companies must alter their business models to emphasize the growing importance of payors within the industry.

The Rise of Payors
Today, payors exert tremendous influence over the pharma market, and pharma executives must revolutionize the way they develop and market drugs. In the past, executives might have focused on quickly getting drugs approved and marketing them directly to physicians.

But in recent years, the market influence held by physicians has plunged. KOLs and payors have become the key decision-makers. As their authority grows, payors have begun to realize that costly new treatments don’t always deliver improved results.

Under previous business models, many companies sought to demonstrate that their drug was effective and safe for patients. This approach worked well when marketing to physicians, but payors have a different set of motives. To thrive in the current marketplace, pharma companies must understand what drives decision-making for payors.

Payor-focused market access planning reflects a significant change in perspective and priorities. Modern payors require pharma companies to justify the value of their drug compared with currently available therapies. They also expect robust data to be gathered at every stage of the development process.
This approach may not come naturally for some pharma companies. Considering the payor’s perspective throughout the decision-making process helps your company avoid expensive roadblocks.

The Challenge for Pharma Companies
With value-based pricing, companies must prove that each new candidate represents a significant improvement over existing agents. Alternately, they must demonstrate that their drug tackles “a greater burden of illness.” The days when a company could generate a safe, useful drug and jump straight into marketing are over. Now, companies face increased competition as they strive to show that their products are superior to their competitors’.

Pharma companies also grapple with the burden of demonstrating efficacy and cost-effectiveness in a real-life setting. The industry-wide shift toward real-life data represents a dramatic change for many established companies. Controlled clinical trials are no longer enough to persuade payors. Instead, they want data from uncontrolled studies and real-life patient groups.

To succeed in this changing marketplace, pharma companies must understand how stakeholders responsible for market access define value. They also need to understand what types of data support their value claims.

Consider the following strategies for success:

Pick the Right Opportunity
With the new approach to market access, companies must be selective about research and development. Choosing to develop a drug for an already saturated market can be a tremendous waste of time and money. Pharma companies may have better luck focusing on treatments with fewer competitors.

Collect Economic Outcomes Data
Payors often reject treatments that use expensive clinical trials to justify their price. New drugs may also be ignored if they fail to demonstrate an impact on patients’ quality of life. Real-life data are indispensable for this part of the process.

Effectively Communicate Value
Often, multiple groups within a company are responsible for communicating with payors. These groups may send conflicting data or provide inconsistent responses. Poor communication can discourage payors from covering certain drugs. However, clear and consistent reports help pharma companies justify their drugs’ value.

Case Study – Controversies Over Rising Prices
In 2016, Mylan Pharmaceuticals sparked national controversy over the cost of its life-saving EpiPen®. Prices rose from $103.50 in 2009 to over $600 in 2016. Public outrage ensued and the debate eventually led to a congressional investigation.

This firestorm of criticism reflects a change in the way payors view prescription drug prices. Individuals and organizations are increasingly wary of price-gouging. Pharma companies face growing scrutiny. If they can’t provide evidence of their drug’s value, they risk public outcry and dire financial consequences. Mylan Pharmaceuticals learned this lesson the hard way, facing a $465 million settlement with the US Justice Department.

Case Study – Building Partnerships
In 2019, AstraZeneca and UPMC Health Plan announced that they had signed a value-based pharmaceutical contract for AstraZeneca’s cardiovascular drug BRILINTA®. The novel agreement incorporated dual-sided risk into the payor’s reimbursement algorithm.
AstraZeneca agreed to shoulder some of the risks associated with the drug, with reimbursements determined by outcomes in targeted populations. The contract also lowered out-of-pocket costs for BRILINTA for many UPMC patients.

The announcement received general praise from payors and industry experts. Harvard Pilgrim Health Care’s Chief Medical Officer noted that AstraZeneca had taken an exciting step in promoting value-based reimbursements. UPMC also expressed enthusiasm, pointing out that the contract would improve patients’ access to drugs and help remove cost as a potential barrier.

These dual-sided risk agreements are still somewhat controversial within the pharmaceutical industry. AstraZeneca’s approach reveals that perspectives on this issue are gradually changing.

Today, payors expect pharma companies to shoulder some of the risks associated with new treatments. Without such agreements in place, payors may be increasingly reluctant to approve coverage. Pharma companies will need to be willing to follow AstraZeneca’s example to adapt to a changing marketplace.

The Road Ahead
Although today’s pharma companies face some critical challenges, the situation is far from hopeless. However, organizations must make structural changes and rebuild their drug-commercialization process. Executives can lead the fight by integrating market access strategy with brand strategy. By considering payors’ motivations and priorities, pharma companies can streamline their decision-making processes. Market access can become a central part of how modern pharma companies function.

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Matthew Gordon

VP, Real-World Evidence
Matthew has more than 25 years of experience in real-world evidence and observational, non-interventional research. He has led studies across the full life cycle—from startup through publication—supporting objectives that range from understanding a disease’s natural history to fulfilling global safety surveillance requirements. Matthew brings deep expertise in orphan disease programs, having overseen more than 25 long-term, global initiatives, as well as in disease and product registries, prospective pharmacoeconomic studies, and systematic literature reviews. Matthew leads the RWE Registries team, responsible for building the business and team. Prior to joining Aptitude Health, he held senior leadership roles at Parexel, Worldwide Clinical Trials, inVentiv Health Clinical, Quintiles Outcome, and ICON Clinical Research. Matthew holds a BA in sociology from Boston University, is a long-standing member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and is a frequent speaker at ISPOR, the Center for Business Intelligence, and related industry conferences.

Gerald Stanvitch, PhD

VP, Scientific Content

Cate Browning, PhD

VP, Global Medical Affairs

Erin Zingales Rau

VP, Account Services

Kelly Kocor

VP, People & Culture
Kelly leads both the human resources and talent acquisition teams, ensuring that Aptitude Health attracts, retains, and develops top personnel to drive our continued success. With over 17 years of experience transforming global HR initiatives, Kelly is an expert in harmonizing HR policies and fostering a culture of engagement and partnership. She is committed to partnering with all areas of the business to ensure full regulatory compliance and delivering value-added services to our organization and its people. Kelly is passionate about developing and implementing HR strategies that help support our employees’ professional and personal growth. She is dedicated to fostering a culture that encourages innovation, collaboration, and inclusivity, helping Aptitude Health continue to be a great place to work.

Bart Zygmond

VP, Finance
Bart brings a wealth of experience to the organization, having worked in the life sciences, pharmaceuticals, manufacturing, and service industries. With his expertise in financial reporting, US GAAP, SOX, cash flow modeling, and financial analysis, he plays a crucial role in the company’s financial management and strategy. Prior to joining Aptitude Health as VP, Finance, Bart held several controller positions: at Q2 Solutions, he oversaw the global finance team and financial operations, ensuring the accurate and timely financial reporting of the company. He also held controller positions at Domtar Inc and Veristat.

Eugene Vissers, MD

Senior VP, Global Scientific Content
Eugene is a seasoned medical doctor with over 20 years of international experience in pharma, consultancy, and agency environments. Eugene leads the US team of dedicated experts responsible for developing high-quality medical content. Prior to joining Aptitude Health, Eugene served as medical director at Ipsen and AstraZeneca. With both his medical degree and an MBA, Eugene brings a unique perspective to his role. His clinical background, combined with his business acumen, allows him to develop innovative strategies that drive results. Under Eugene’s leadership, the medical content team delivers scientific information of the highest quality, providing valuable insights to our clients around the world.

Adrian Barfield

VP, US Business Development

Kelley Hernandez

Executive VP, US Business Development
Kelley has over 18 years of experience in the oncology space. Kelley joined Aptitude Health after working with Cardinal Health, where she was part of the Healthcare and Analytics Division, and finished her tenure there with VitalSource™ (GPO division). As the leader of the strategic business development team for the US, Kelley brings a wealth of expertise to the organization. Her experience in the healthcare industry, combined with her ability to identify and capitalize on new business opportunities, is invaluable in driving the company’s growth and success. Kelley’s dedication to building strong relationships with life science partners is a testament to her commitment to delivering exceptional value to the healthcare industry.

Adam Sinensky, MBA

Chief Technology Officer

Adam has over 20 years of experience in the healthcare industry and an MBA in healthcare management. After 10 years as a strategy consultant to life science companies, Adam has spent the last decade as a product and strategy leader focused on bringing technology products to market across the payor, provider, and life sciences segments. By combining his business acumen and experience working directly with software developers, engineers, and data scientists, Adam has successfully led numerous product launches and enhancements from ideation to development and go-to-market initiatives. His product and change management expertise has led organizational shifts from services to technology at companies such as Change Healthcare and Datavant/Ciox. At Aptitude Health, Adam is responsible for growing our portfolio of product offerings by leveraging real-world data and artificial intelligence with our existing solutions and industry-leading Axess Network of healthcare providers. He also oversees our IT and cybersecurity teams.

Stefanie Daniels

Chief Commercial Officer

Stefanie is a seasoned healthcare executive with over 20 years of experience in oncology. She brings a wealth of knowledge and expertise to the organization. Stefanie joined Aptitude Health after spending over a decade as a senior director at Physicians’ Education Resource, an oncology CME vendor. During her tenure, she led and managed teams responsible for grant development/acquisition, program creation/execution, and faculty management. Stefanie’s deep understanding of the oncology industry and her ability to lead teams through complex projects make her a vital part of the organization’s success. Her dedication to providing high-quality solutions to our life science partners is a testament to her commitment to improving cancer patient care.

Jason Cash

Chief Financial Officer

Jason is an accomplished finance professional with over 20 years of experience in the pharmaceutical services industry. Throughout his career, he has demonstrated a keen ability to navigate high-growth organizations, delivering exceptional results. Before joining Aptitude Health, Jason served as the CFO of Veristat International, a global contract research organization. In this role, he led the financial strategy and played a pivotal role in driving the company’s growth and success. Jason’s wealth of experience and expertise in financial management make him an essential member of the leadership team. His strategic thinking and ability to drive results are highly respected within the industry.

Jez Moulding

Chief Executive Officer
Jez is a seasoned leader with over 20 years of experience in general management and regional president roles. He has a proven track record of success in the healthcare industry, having worked in the US, Japan, Australia, Korea, South Africa, France, and the UK for Sanofi, where he supported the launch of 10 new drugs across various therapeutic areas. As chief commercial officer at UDG Healthcare and EVP at Ashfield, Jez demonstrated his expertise in developing and implementing successful business strategies. He joined Aptitude Health from Pharmaspectra, an IQVIA business, where he served as CEO since 2018. Jez’s extensive experience in the pharmaceutical industry and his leadership skills make him an invaluable asset to the organization.
Aptitude Health
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