Why Early Market Access Planning is Crucial in CGT Commercial Strategy

Cell and gene therapies (CGTs) offer fresh hope to patients with serious and debilitating diseases, often where no other treatment options are available. Yet the process of getting to market and enabling patient access is far from simple. The complex clinical planning, potential for nuanced regulatory hurdles, payer scrutiny, and supply chain complexity all necessitate early market access planning to optimize patient access to these novel treatment options.

Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally 3+ years pre-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.

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.

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.

Conclusion

Partnering with a commercialization specialist that can offer deep expertise in the CGT ecosystem is essential to an early and sophisticated market access strategy. Cardinal Health Advanced Therapy Solutions helps CGT pioneers bring novel advanced therapies to patients who need them most.

Visit our website to learn about our expertise and explore longitudinal solutions from development to commercialization.