Unlike “1 for Many” treatments that have a one-directional supply chain – from manufacturer to distributor to medical facility to patient, “N of 1” CGTs are more difficult and expensive to produce, with a bidirectional supply chain involving nearly triple the number of steps. Autologous CGTs, where a patient’s own blood or tissue is transformed into a therapy, are especially complicated and present the most risk if there is a single misstep. They depend on upwards of 40 coordinated digital and analog handoffs between disparate teams of health care providers, manufacturers, third-party logistics companies (3PLs) and insurers and payers.
When steps, stakeholders, and systems multiply, there are bound to be issues and delays. Today, patients must wait an average of six to eight weeks for treatments, and 90% of therapies may not be delivered as originally planned. Imagine what will happen when the thousands of CGT patients today evolve into hundreds of thousands by decade’s end. In addition, CGTs come with high price tags, testing the limits of current reimbursement strategies.
For several years, as part of its purpose of “building a better working world,” EY has been studying the CGT landscape and collaborating with private and public sector stakeholders worldwide to identify and manage issues that threaten CGT scalability. Acting as both a convener and advisor, EY has embarked on what it now calls the “industrialized collaboration movement to advance CGTs.”
EY identifies three key hurdles for the CGT field:
- Eliminating supply chain friction points
- Streamlining bespoke manufacturing
- Making therapies affordable
Eliminating supply chain friction points
A recent EY qualitative survey of CGT supply chain representatives from leading manufacturers, hospitals, 3PLs and payers identified specific supply chain pain points. The majority of interviewees agreed that the CGT supply chain is fragmented, labor-intensive and lacking in standardization, with 75% citing too many different software systems that don’t “talk” to each other as a significant problem. As such, the absence of real-time visibility along the patient and therapy journey is a significant threat, especially as therapies scale. In order to ensure that the right patients receive the right treatments at the right time and place, hospitals, manufacturers, logistics providers and payers must integrate and accommodate each other’s workflows while maintaining a secure chain of identity and chain of custody. Most survey participants called for better collaboration and industry standards – including a unified digital platform – to cost-effectively and safely facilitate the anticipated high-volume distribution of the near future.
Streamlining bespoke manufacturing
Now that patient numbers are small, CGT manufacturing processes are highly manual and require numerous skilled operators. With the expected increase in patients, the industry is focused on solutions that scale at 1,000 times the current rate. Automation and technology are going to be key to streamlining processes and reducing manpower and risk. Moreover, more and more manufacturers are realizing the power of collaboration in keeping up with the continued influx of new therapies, material demands and processes.
Making therapies affordable
While CGTs can deliver tremendous value, they typically come with high price tags, coupled with uncertainty around response durability. Current models of drug pricing, which are based on utilization, don’t work. CGT companies and payers are considering new payment models, such as: outcomes- or value-based contracts (OBCs/VBCs); “drug mortgages”; and subscription-based models.