As a giant bear peered through the glass of the Colorado Convention Center, key stakeholders in pharma, biotech, and managed care focused on the elephant in the room: How to evolve the healthcare system, and improve patient benefit? The Klick Market Access team was there and Khawar Khokhar, head of the group, shares highlights and insights…
The Academy of Managed Care Pharmacy (AMCP) had their annual meeting last week, and Klick Market Access was there to listen and share in the vision and voices from across the healthcare system. From providers to payers, administrators to medical directors, physicians to marketers, the conference brought together a wide spectrum of stakeholders to share the latest legislation, regulation, research, formulary management approaches, and other topics—with a focus on specialty pharmacy as the pivot point of managed care.
The nearly week-long conference covered a vast range of compelling subjects, presented by the industry’s top thought leaders and drivers—a recurring theme being patient access throughout the care continuum. As the healthcare system experiences acute “VUCA” (volatility, uncertainty, complexity, and ambiguity), the industry’s ability to benefit the ultimate customer—the patient—remains a primary motivator. From prevention to management, reimbursement to access, critical challenges such as cost sharing for disease correcting and life changing therapies are top of mind and demand feasible solutions.
With an eye on discovering innovative and effective ways to assist our clients, the Klick Market Access Team explored ways to develop programs that measurably deliver better outcomes; increase transparency by broadly sharing our successes; and engage in difficult discussions that first and foremost considers the patient health benefit—with all other factors being of secondary importance! By absorbing business trends in managed care, current affairs in specialty pharmacy management, the practical applications of research, formulary management, legislative and regulatory changes, and the pharmaceutical market place, we’re pleased to share conference insights and offer actionable solutions to our diverse clients.
The Implications of Coverage Decisions for Specialty Medications
Ensuring the right patients receive the right treatment is critical—a process made all the more challenging with orphan conditions and specialty drugs. The key question to consider: Do payers have appropriate and routine access to sound evidence to help inform their medical policies and coverage decisions? Different data clearly results in different determinations, with significant implications for the healthcare systems and ultimately patients.
A recent analysis from a database of more than 3,000 coverage policies for specialty drugs confirmed this trend, revealing notable variation in data used and types of evidence used by payers for determining coverage, often resulting in variability of coverage. A breakout session on the first day of the conference examined the payer evidence used to make coverage and reimbursement determinations, and discussed the impact of using the appropriate evidence to guide decision-making.
The session demonstrated how clinical, health economics, and outcomes data specifically impact medical policy decision-making on a population health level, and examined the challenges facing payers in analyzing and operationalizing the information for appropriate coverage decisions. Specifically, clinical trial and other manufacturer provided product information were cited as most common sources for P&T monographs. The group also noted that FDA approval doesn’t necessarily mean payers have to pay for the drug, thereby making coverage and medical policies vary substantially.
With the overall goal set at improving patient health outcomes, delivering better patient experience while incurring the lowest cost is essential. Such a focus leads to coverage decisions that align interventions to patients who will have the greatest benefit, along the way reducing “futile treatments” and approving the most cost-effective options. The essential learning is building a value proposition that provides the most meaningful and complete information that your customers can leverage in their medical policies and clinical decision making processes. Klick Market Access partners with you to identify the value drivers, along with any gaps that need to be filled before connecting the dots to build the most impactful platform for your brands and franchise—with the still-untapped power of data as a central.
The Evolving Role of Real-World Data in Healthcare Decision-Making
Speaking of data, its primary source has traditionally been randomized, controlled clinical trials. Thanks largely to the development of digital health, the ubiquity of biometrics has made “real-world” data increasingly accessible and compellingly relevant for healthcare decision-making. Although skeptics continue to question the validity and quality of this data for evidence, acute regulatory interest and additional risk-based contracts suggest that real-world data will play a larger and larger role in evidence throughout the healthcare system. Payers especially require a solid understanding of what real-world data is all about, its implications for decision-making, and ultimately its benefit for patients in their day-to-day life activities.
The engaging session—developed in collaboration with the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and hosted by a panel of experts—helped address these questions, offering solutions and recommendations in the form of reviewing the fundamentals of real-world data, and various ongoing projects designed to improve the quality and relevance of the data. The team identified specific benefits and challenges, described the latest regulatory actions in support of evidence and evaluation for pharma and device manufacturers, and cited a case in which a payer actually used real-world data as part of their formulary decision-making process.
More specifically, the session outlined how real-world data continues to become more important in decision-making as the endpoints for this type of data are delineated across three types: Clinical, economic, and PRO/QoL categories. Real-world data has many distinct benefits (effectiveness vs efficacy, long-term view, etc.) that supplement outcomes from clinical trials, providing decision-makers additional data to guide their reimbursement policies. While real-world data collection and dissemination has its challenges, AMCP and ISPOR, along with other organizations, are actively working to improve the use of such data.
In parallel, health outcomes teams and departments are working diligently to track and show the value of their therapies in the real-world setting. Their focus is to translate the outcomes/successes of those efforts into actionable intelligence and effective solutions throughout the healthcare system. Klick Market Access understands this need and the FDA guardrails around generating and disseminating such outcomes data; with our deep roots in technology and digital engagement, we continue to help define the strategic approach and tactical activation of your real-world implementation plan.
Making the Leap from Value Measurement to Value-Based Reimbursement
Given the progressively increasing importance of data, the measurement and assessment of “value” becomes even more critical—especially in contrast to more traditional and antiquated standards based on volume. But debate continues on how value should and shouldn’t be measured, while stakeholders throughout the healthcare system remain uncertain about applying these metrics to optimizing system efficiencies and patient health benefit. Although several “value frameworks” have been suggested, their applicability to reimbursement and access decision-making remains unsubstantiated and ambiguous. Challenges also continue when trying to develop outcome- or value-based contracts.
To help address these issues and provide viable solutions, the session evaluated several approaches to value assessment, and reviewed academic, payer, and provider perspectives on value-based pricing—a particularly hot button issue. Several innovative approaches to value assessment were also described, including contracting and various alternative methodologies for pricing. One such idea featured “pay-for-performance,” to drive higher-quality by aligning incentives for providers and manufacturers in pursuit of improved patient outcomes. Others included creating meaningful incentives, appropriate measurement of value, accommodating patient preferences, program simplicity, and real reward for progressive innovation.
Proven best practices have already shown payers increasingly use value frameworks to drive value-based agreements as they look for new ways to partner with manufacturers. These increased value-based engagements refocus the dialogue around quality of care vs cost of care, ultimately bringing better patient outcomes front and center. After all, in today’s healthcare market, providing added value to drive partnerships is key. Defining approaches that are simple to implement, measure and replicate can differentiate you from all of the others looking to engage on more value-based terms. The Klick Market Access Team leverages our innovation Lab, researchers, and data scientists to create the added value models that can supplement the clinical value delivered by your therapies.
The Basics of Mobile Health and its Potential Impact
And speaking of Klick Labs, research, and data, our team enthusiastically embraced the conference session focused on mhealth. The consumer electronics revolution has made biometrics accessible and now even expected by millions worldwide. But questions linger, and often get in the way of genuine progress: Of the tens of thousands of health and wellness apps, why are so few ever actually used? How can the various healthcare system stakeholders make them relevant for patients and professionals? And as they become more powerful, when do they cross the line between helpful tool and fully regulated medical device? What about data security, privacy, and ownership? How can the “church/state” boundary between providers and payers be crossed in a way that remains compliant and beneficial to patients?
The session provided a compelling overview of all these issues, and answered these and other questions regarding mobile health relevance, implementation, and regulation. Most significantly, the end-goal of seamless integration across every touch point in the patient journey through the healthcare system was emphasized as the primary goal. Mobile health by virtue of its ubiquity and facility can and should be a primary driver for exactly this kind of integration, so vital to the success of payer-focused objectives: Reducing costs and waste, heightening care and access, and ultimately improving health outcomes for patients.
Klick Market Access Team: Here to Help!
You’ve read our blogs—let’s get the conversation started. Our proven experience in multiple specialties uniquely qualifies us to help you use the latest insights and innovation to maximize value throughout your brand’s commercialization trajectory. Are you connecting the dots between stakeholders? From formulary management to digital health integration, Klick Market Access is your trusted and proven consultative partner. Let’s get started.