Unlocking the Future of Oncology Therapies: Strategic Trends in Market Access

The rapidly evolving landscape of oncology treatment presents both unprecedented opportunities and significant challenges for new therapies entering the market within the next couple of years. At Sigla Sciences, we specialize in navigating these complex dynamics to optimize market access strategies for our clients.

Here's a deep dive into how innovative market access marketing can revolutionize the launch of complex oncology therapies:

?? Understanding the Current Oncology Market The oncology sector is facing heightened scrutiny from payers and regulatory bodies, intensified by pricing pressures and policy changes such as those imposed by the Inflation Reduction Act (IRA) as well as payer pressure on reimbursement for accelerated approval products despite strong KOL backing and guidelines placement. This environment necessitates a nuanced approach to demonstrating clinical and economic value, and then using this evidence to continually leverage access through advocacy and policy routes.

?? The Power of HEOR (Health Economics and Outcomes Research) As we move toward a more value-based care environment, leveraging HEOR to articulate the cost-effectiveness and impact of new oncology therapies is crucial, particularly in ex-US markets where Joint Clinical Assessment in the EU is coming soon. Real-world evidence (RWE) can serve as a cornerstone, helping to establish a robust value proposition that resonates with all stakeholders. In the US, this evidence can be deployed by manufacturers, professional societies/HCP groups, and patient advocacy to influence payer policies and coverage.

?? Digital Engagement: More Than Just a Buzzword In an era where digital health is becoming the norm rather than the exception, developing and implementing cutting-edge digital strategies is vital for manufacturers to gain an edge. From patient support programs to digital biomarkers and telehealth services, digital tools can enhance patient outcomes and streamline provider interactions, helping to drive adherence, lower access barriers, and facilitate ongoing engagement and development.

?? Collaborating with Key Opinion Leaders (KOLs) Engaging with oncology KOLs across key markets including the US and Europe is more than just about gaining endorsements. It's about fostering genuine partnerships that can provide insights and drive advocacy throughout a health system and policy environment. These relationships are essential for understanding prescriber needs and tailoring your strategies to meet them, as well as understanding on-the-ground challenges and opportunities in areas such as clinical and pharmacy operations, reimbursement and coding, and policy navigation.

??? Things to Watch: Here are some of the priorities our clients are talking about...

1. Leveraging Adaptive Trial Designs: Using flexible clinical trial frameworks that can evolve based on real-time data, accelerating time to market for breakthrough oncology drugs, is one way to expedite the development of promising therapies and potentially do so in a cost-efficient manner. However, stakeholder education (from investigators to regulators) is a key piece that can't be overlooked. Market Access leaders sometimes underestimate the importance of trial design in leveraging HEOR/HTA data down the road, and oftentimes haven't been brought in early enough to development conversations, or aren't as educated on these topics themselves. Increasingly, Market Access, Clinical Development, and Medical Affairs teams will need to work hand-in-hand on these topics.
2. Biosimilars Market Dynamics: Strategic navigation of the biosimilars landscape to mitigate risk and capitalize on opportunities, ensuring brands can maintain a competitive edge, is especially important in a layered policy environment where Inflation Reduction Act (IRA) is already impacting Medicare add-on reimbursement for biosimilars and IRA price negotiation is coming soon. Biosimilars strategy, whether your product is a brand or a biosim product, is an art unto itself, and goes far beyond forecasting brand market erosion or assuming that it's all about price competition.
3. AI-Driven Predictive Analytics: Some manufacturers are deploying artificial intelligence (AI) to refine protocols, or to analyze large RWE/HEOR datasets, while other manufacturers have shied away from AI because of a lack of internal understanding or lack of preparedness. This "AI Divide" is already creating winners and losers as newly complex therapies come to market. Everybody now has access to big data; those who can deploy the best algorithms will consistently win.
4. Predicting the Pricing Future: Companies are working to stay ahead of the curve with evolving CMS policies and reimbursement changes that directly impact oncology drug market entries, particularly the IRA. As of now, no one knows exactly how CMS and manufacturers will adjudicate discounts, and predicting discount ranges is a challenge across the policy landscape. This has introduced a huge chill to the landscape as a whole, but as some manufacturers "bake in" an IRA strategy and emerge on the other side, those that haven't will wonder why they missed the boat.
5. Getting Smarter Around Advocacy: The savviest manufacturers are figuring out how to forge strategic alliances with a variety of advocacy groups and alliances — patients, physicians, and policy — to influence treatment accessibility and adoption. Not all advocacy groups or professional societies and alliances bring the same value to a manufacturer; figure out who has the real influence and reach in CMS, on Capitol Hill, and in decision-making groups that impact coverage decisions.
6. Decoding Complexity for Payers: Manufacturers that can develop clear, informative market access marketing materials that explain the intricacies of billing, coding, and reimbursement for cutting-edge therapies like cell and gene treatments will help prescribers understand the operational aspects of adopting these new therapies. HCPs will be more likely to adopt new products if they can help their institutions see an ROI and understand how to negotiate with payers, bill Medicare for outlier costs, and generally operationalize therapies that have many steps or components along the patient journey. If HCPs lack clarity in this area, it will hinder adoption and leave institutions scratching their heads.

?? Conclusion The future of market access for novel oncology therapies relies not only on the scientific breakthroughs in the lab but also on strategic innovations in market access. By staying ahead of trends and leveraging a well-rounded approach, companies can ensure that their innovative treatments achieve both commercial success and meaningful patient outcomes.

#Oncology #MarketAccess #DigitalHealth #HEOR #BiotechInnovation