Wednesday, September 24
For the most up-to-date agenda, please download the full event guide.
7:30 am Check In, Coffee & Light Breakfast
8:25 am Chair’s Opening Remarks
EMBEDDING MARKET ACCESS ACROSS THE CNS DEVELOPMENT LIFECYCLE
8:30 am Designing for Access: Embedding Market Access Strategy into CNS Evidence Generation from Phase II Onward
Synopsis
- Integrating market access strategy, education and networking early into clinical infrastructure to prevent post-approval access hurdles
- Aligning pivotal trial design and package insert content with downstream payer expectations
- Using advisory boards, consultants, and early payer engagement to shape evidence generation
- Embedding market access considerations into Phase IIb–III decisions without disrupting regulatory-first priorities
9:00 am Navigating Medicaid and Medicaid Managed Care, From Launch to Ongoing Product Management
Synopsis
- Medicaid Landscape & Coverage Control: CNS drug access is highly influenced by state-level policies, with Fee-for-Service (FFS), Managed Medicaid (MMC), statewide Preferred Drug Lists (PDLs), and carve-outs driving coverage decisions. Antipsychotics are often treated as a protected class, though policies vary by state
- Preferred Drug Lists & Rebating: Nearly all states now operate PDLs to manage costs. CNS drugs face challenges because most classes are dominated by generics, making supplemental rebates critical for new branded agents to gain favorable positioning
- Post-Launch Review Mechanisms: Drug Utilization Review (DUR) Boards and Pharmacy & Therapeutics (P&T) Committees evaluate CNS products for clinical criteria, PDL placement, and prior authorization requirements. Engagement in these forums is key for influencing access
9:30 am Speed Networking, Morning Break & Refreshments
Synopsis
A prime chance to make the most of in-person networking and forge new connections as new companies enter and existing ones broaden their presence within the CNS therapeutics space. This is designed to maximize your exposure to a wide range of new individuals and serve as a catalyst for ongoing discussions throughout the Summit.
10:00 am Panel Discussion: Starting with the End in Mind: Strategic Access Planning at the Earliest Stages for CNS Therapeutics
Synopsis
- CNS drugs face uniquely complex access hurdles: diagnostic ambiguity, subjective endpoints, societal stigma, infrastructure gaps, and payer scepticism toward psychiatric or neurodegenerative indications
- Market access strategy cannot wait until Phase 3 – strategy and decisions need to be made at the earliest stages of development to lock in value later
Key Questions:
- Why is it essential to begin market access planning before clinical proof of concept, particularly for CNS assets?
- How do you define and stress-test a Target Product Profile (TPP) at the pre–Phase 2 stage to align with future payer and HTA expectations?
- What is different about market access planning in CNS vs. other therapeutic areas at this stage?
BREAKING BARRIERS ACROSS THE LIFESPAN: ADVANCING ACCESS & EMPATHY IN NEUROPSYCHIATRIC CARE
10:30 am Perspectives From Healthcare Professionals: Roadblocks to Patient Access with Low Motivation & Aging Patient Populations
Synopsis
- Discuss how REMS certifications, product-specific dosing protocols, and prolonged in-clinic observation times discourage uptake, even when treatments are clinically appropriate
- Real-world challenges of initiating and maintaining treatment in aging or low motivation patient populations
- Strategies for simplifying care models (e.g., co-located services, enhanced patient support programs)
- Exploring strategies and tools to help healthcare professionals maintain empathy when patients do not respond to clinically appropriate therapeutic interventions
ACCESS INFRASTRUCTURE: DISTRIBUTION, DELIVERY & SCALABILITY FOR MODERN CNS THERAPEUTICS
11:00 am Roundtable Discussion: Specialty vs. Retail Pharmacies in CNS Therapeutics – Navigating Access, Margins, & Patient Support
Synopsis
- How shrinking margins, generics, and store closures have impacted retail’s role in CNS therapy access, and why it’s becoming less viable for novel treatments
- The growing importance of specialty pharmacies for large-molecule and complex CNS drugs, and their role in delivering enhanced services like prior authorization and assignment of benefits
- Strategic considerations for manufacturers in choosing the right distribution model early, balancing prescriber burden, payer requirements, and patient logistics
12:00 pm Lunch & Networking Break
1:00 pm Panel Discussion: From Policy to Practice – Bridging the Gap Between Payer Access & Clinical Reality
Synopsis
- Explore how mismatches between labelled indication and payer policy (e.g., differing “line of therapy” requirements across insurers and states) create treatment denial risks and force patients or physicians into appeal processes, especially for time-sensitive psychiatric interventions
- The gap between contracted payer coverage and real-world access: address claim denials, administrative friction, and the need for improved payer-provider alignment
- Address the difficulty clinicians face in staying current with plan-specific formularies and access criteria, especially across multiple insurers, plan tiers, and evolving coverage decisions, and discuss where education, digital tools, or standardization could help
INTERACTIVE WORKSHOP
1:45 pm From Trial to Treatment: Navigating Formulary Access, Package Insert Constraints, & Payer Expectations in CNS Therapeutics
Synopsis
This workshop examines the gap between regulatory approval and market success in CNS therapeutics. Through psychiatry and neurology case studies, participants will explore how trial design, labeling, and payer expectations impact adoption. Attendees will share best practices and strategies to overcome access hurdles in mental health, where generics, weak algorithms, and patient heterogeneity challenge competitiveness.
Key Questions Addressed:
- How do payer formularies interpret and enforce narrow inclusion criteria from clinical trials via package inserts?
- What role do early payer engagements and MSLs play in reshaping access parameters for novel CNS drugs?
- How can access teams anticipate and counteract payer “cost containment” tactics like delayed reimbursement or formulary exclusion?
- How can clinical development teams better design trials to anticipate payer-driven access restrictions post-launch?
- What are the risks and opportunities of post-launch PI revisions in shaping ongoing access and reimbursement outcomes?
4:45 pm Chair’s Closing Remarks
Happy Hour Drinks
Synopsis
Please join us in the exhibition space for a drinks reception and further networking opportunities. This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. Don’t miss out on the chance to connect and learn.