Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally more than three years prior to launch. This strategy should focus on addressing the nuanced market access challenges for such treatments, including but not limited to, distribution network design, tailored commercial site engagement, and early payer communication planning.
Designing an optimal limited distribution network (LDN) for launch
The complexity associated with advanced therapies requires a precisely designed network of limited treatment sites to ensure the safe distribution of patient-specific doses to sites of care that are capable to administer. “Sites need to be engaged early to confirm they have the capabilities to offer the product, and they will ask for as much detail as possible to understand who the patients are, what the patient and product journey look like, and the financial considerations, especially what is reimbursable,” says Fran Gregory, Vice President, Emerging Therapies, Cardinal Health. “Assuming the site has all the internal capabilities to administer, they will also need dedicated personnel to be trained on ordering procedures, product handling requirements and all patient care considerations,” she says.
Planning for a thoughtful LDN first includes assessing potential site readiness via a checklist of qualifications tailored to the product. Manufacturers should consider geographic spread of the network and proximity to patients, as well as their internal capacity to onboard the sites. A phased onboarding approach allows for the model to expand after launch. This model, which today largely exists in academic medical centers, will continue to evolve as new-to-market products with enhanced safety profiles seek expanded networks, including community practices to broaden patient access. Product specific distribution needs, such as storage, shipping, logistics, and financial management may also impact network design success at launch.
Tailoring provider engagement to site-specific access needs
Just as each CGT product and patient has unique access needs, so too have the healthcare providers administering these therapies and the sites of care where they operate. To administer advanced therapies such as CGT, sites may need to hire and train dedicated personnel, as well as scale their site capabilities requiring significant investment and time.
Once a preliminary LDN is established, CGT manufacturers may begin to develop detailed site profiles, noting individual challenges and pain points that their sites of care may experience. Many different departments and teams are involved in the successful commercial handling and administration of these products, requiring coordinated cross-functional communication between the CGT manufacturer and the site teams. 12-24 months pre-launch, CGT manufacturers should outline the anticipated product, financial, and communication flows at each site, and engage with the appropriate stakeholders in each department to provide clarity on the timing of key activities and communication.
Treatment site engagement is also elevated by a thoughtful and tailored field reimbursement strategy. By equipping your field team with resources and expertise to support providers with anticipated access challenges, tailored to site sophistication and payer mix, CGT manufacturers can educate their provider network with best practices, anticipated hurdles, and expectations for contracting and prior authorization. Pre-launch, manufacturers should leverage access journey mapping and understanding of access barriers to develop detailed playbooks and governance plans to inform field team engagement with sites. These playbooks may include key resources, best practices, and talking points tailored to site-specific needs and level of comfort with handling complex prior authorization and claims adjudication processes.
Engaging payers early during pre-approval information exchange
Payers require early and in-depth education to prepare for the launch of a novel therapy, which is even more pronounced for CGTs. In the US market, a fragmented network of hundreds of commercial payers is further sub-divided at the plan level. CGT’s present unique challenges in that even with potential long-term durability, high upfront costs are not aligned with a model designed for annualized budgets. Payers are looking for clarity as to what criteria may be appropriate to manage these products, sometimes further limiting access by including clinical trial criteria beyond FDA label language. Ensuring equitable patient access to these life-saving therapies will require new and innovative financing models, and payers are already signaling their expectation for CGT manufacturers to play a role in shaping these contracts. “The budget impact of these products is significant, and we know all stakeholder groups are willing to work together to find innovative payment solutions” says Anna Catalanotto, Senior Manager, Commercial Development, Advanced Therapy Solutions (ATS) at Cardinal Health. “But numerous challenges hinder the impact and feasibility of these discussions today: alignment on the contract design, the selection of and tracking of outcomes, as well as the administrative burden to collect patient follow-up data in our healthcare system where patients frequently switch payers and providers,” she says.
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