Experienced partners can help developers navigate the regulatory landscape efficiently by facilitating productive interactions with regulatory bodies, assisting in preparing and submitting regulatory documents, ensuring compliance with regulatory frameworks, and supporting the design and execution of long-term follow-up studies.
Demonstrating Value: Supporting Efficient Launches and Access Globally
In the crowded oncology landscape, demonstrating a product’s clinical and economic value to key stakeholders, like payers, is critical. Developers should be to address fundamental payer questions, such as:
- Why do patients need this?
- What am I currently paying for the treatment of this disease?
- How is your drug better than the alternatives in my specific setting?
- How much is the drug worth and why is it worth the cost?
- Can I afford it and what part of my budget will I use to fund it?
- What are the consequences of not funding?
Conducting a market landscape analysis and engaging payers early allows developers to gain feedback on target product profile, evidentiary needs, and value proposition, all of which can inform critical decisions, such as clinical trial design, endpoint selection, and data collection methodologies. The communication, coupled with clinical trial results, real-world evidence, and health economic research, will help developers create a robust evidence package that showcases the product’s value and addresses questions from key stakeholders related to clinical safety, efficacy, and cost-effectiveness.
As part of pre-commercial planning in the United States, developers should consider engaging in pre-approval information exchange (PIE) with payers. About half of the US payers surveyed by Cencora indicated PIE impacts the timing of patient access to certain product categories, specifically oncology, products for rare diseases, and cell and gene therapies. Developers can leverage traditional and digital channels to communicate product-related information, including product and indication overview, patient use projections, clinical study results, and pricing information.
Launching oncology products efficiently in markets around the world requires local market expertise and a thorough understanding of the varying regulations and processes, including the factors that influence access, pricing and reimbursement in each market.
In Europe, companies developing oncology products and ATMPs must now adhere to Joint Clinical Assessment (JCA) process. The JCA, which went live in January as part of the EU’s new Health Technology Assessment (HTA) regulation, aims to streamline the clinical assessment of products across the member states to reduce redundancies and bring life science innovation faster to patients in Europe.
We are partnering with companies to deliver support at all stages of the EU HTA journey, from early evidence advice to post-JCA implementation at the national level. In fact, a team at Cencora is leading the development of the first tumor-agnostic dossier submission through the HTA framework.
Closing Gaps: Reducing Barriers Along the Provider Journey, Patient Experience
While advances in science have led to an influx of oncology therapies, there remain barriers that impact the use of—and access to—products.
Research published prior to ASCO found nearly three out of four oncologists find the pace of new treatment development overwhelming, and 73% believe there is a gap between the availability of new/cutting-edge treatments and their successful implementation in clinical practice. The findings underscore the importance of increasing awareness among healthcare providers and reducing potential barriers, including those related to reimbursement, that providers and patients face, which can ultimately impact access.
Developers can reduce barriers through a robust provider engagement strategy, supported by effective clinical messaging, that builds brand awareness as well as patient support program services tailored to the patient population. For example, clinical specialists can educate providers about the product’s clinical information, while field teams work closely with providers and their staff to support access and reimbursement issues for physician-administered products.
Unlocking the potential
As seen at ASCO, the oncology field is advancing rapidly, offering hope to patients worldwide. To truly realize the potential of these therapies, developers must successfully navigate the challenges along the product lifecycle and treatment journey, from early discovery and clinical development through to commercialization and post-launch.
Through strategic planning and engaging stakeholders early in the development process, developers will be better positioned to overcome challenges, accelerate time-to-market, and achieve broader market penetration, ultimately enabling more patients to benefit from these therapies. As a partner to these companies, we remain focused on delivering the support needed to advance innovation and access—helping to simplify the path to market and enable patients to receive the treatment they need.
About the Authors
Tommy Bramley, SVP of Global Consulting Services at Cencora, and Eric Monzon, SVP of Enterprise Solutions & Sales, Global Pharma Services, at Cencora.