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As more of these novel—and costly—cell therapies gain approval, revamped strategies around scaling, coordination and workflow are critical to their launch
Since the first chimeric antigen receptor T-cell (CAR-T) therapy was approved by the FDA in 2017, scientists and providers have begun looking at the future of medicine differently. As a cell-based treatment, the process of CAR-T therapy involves genetically engineering T-cells to help them attack cancer. And while the innovation behind this massive development continues to see great success in patients, the advent of an entirely new approach to healthcare has already resulted in the need for an innovative approach to the administrative and logistical nature of these promising—yet, highly expensive—therapies.
Given that these products utilize patients’ own cells to treat and cure diseases, the collection, manufacturing and return of the cells is a complex process that carries unprecedented implications for the already-strained pharmaceutical supply chain. As new CAR-T therapies continue through the drug development pipeline, pharmaceutical manufacturers must now ensure standardization in the supply chain for scale, connecting the many stakeholders and reinventing new workflows for these innovative products.
Based on our experience, here are three major supply chain considerations in the launch strategy to evaluate.
Understanding the end-to-end logistics management
Unlike more traditional therapies, using a patient’s own cells to create a therapy requires the need for a concerted logistical effort that leaves no room for error. This process must not only ensure the chain of identity remains intact, but that the timing for collection, manufacturing and infusion is on the patient’s timeline (e.g., they are not too sick to receive the treatment).
While these products rarely use a typical warehouse storage with third-party logistics (3PL), it does not mean the logistics from ordering, delivery and everywhere in between should be taken lightly.
Ordering platforms. In order to respond to the real-time nature of these therapies, the ordering platform for CAR-Ts implemented by pharma manufacturers may need to be as personalized as the therapy it is supporting. For healthcare providers (HCPs) and hospitals, cumbersome logistics remains the top concern for ordering these therapies for patients. This means it is vital for pharma manufacturers to look for ways to incorporate their unique requirements into a HCP’s standard order processes, rather than adding further administrative burden onto an already taxed healthcare system.
Focusing on making the ordering process as seamless (and in some cases, self-service) as possible ensures a quicker turnaround time that is vital for these therapies, given that these patients often have very small windows where they may be healthy enough to sustain treatment.
The ordering process must do more than just ordering, however. The circular logistics of getting cells from the patient, genetically engineering them in a different location, and then returning the therapy to the site of care at the same time a patient is able to receive treatment necessitates that the platform has the capabilities to also schedule delivery of initial collection, pickup for altering and delivery of the final product for patient infusion.
Transportation. Unlike more traditional cold chain pharmaceutical products, CAR-Ts and other cell and gene therapies (CGTs) often are cryo-frozen (-150°C, -238°F) and need to be delivered within a very narrow specific time period, which usually requires specialized transportation– mainly, a dedicated cold chain courier service. While the pharmaceutical market for cold chain products grows, there are many companies offering dedicated cold chain courier services that can ensure both product quality and safety of these products. However, it’s important to ask the right questions to ensure these organizations have the right experience to handle these high-value products. Manufacturers should request previous case studies showing how the couriers have transported similar products and should ask how they handle unforeseen circumstances (e.g., natural disasters), delivery times to approved collection and infusion facilities and consistent management of product temperature from end-to-end.
Supply chain visibility. As the world continues to ramp up the technological approach to supply chain logistics, understanding where your product is in the supply chain is becoming more important; however, for CAR-T therapies, this capability is vital.
Between the cost of these products, the necessity for temperature-control and the time-based nature, the cold chain monitoring market it expected to grow more to more than $10 billion by 2026 (<100% increase) to keep up with the overall need of supply chain visibility.1
Many times, logistic services and courier services offer monitoring capabilities like radio frequency identification (RFID), GPS tracking and Wi-Fi or Bluetooth-enabled thermometers. Needs for CAR-T products should be determined by considering both chain of identity and chain of custody monitoring by asking questions like:
Establishing relationships with sites of care
The complexity of the supply chain and time-sensitive nature of the therapy means that CAR-T manufacturers and sites of care need to work hand-in-hand to ensure that the drug is delivered to the facility at exactly the right time. Without this coordination, there is a significant risk—both in terms of the patient outcome and the financial burden for the manufacturer and the site of care.
While only a few cancer centers around the country have been certified to administer these types of therapies, the logistical nature of these highly expensive products necessitates the need for specific relationship-building with the sites of care.
Setting up standard operating procedures. Commercially available CAR-T and other CGT products are some of the most expensive products on the market right now, costing anywhere between $300,000 to $1 million per patient.2 Now, with the expectation that more CAR-T therapies will soon be approved, pharma manufacturers must work with sites of care to confirm standard operating procedures (SOPs) are in place to ensure therapies are carefully managed throughout the collection, delivery and infusion process. Without proper training or SOPs, these products that are delivered could be mishandled and inadvertently destroyed.
When setting up these SOPs, consider the following: who are the main points of contact? Does the site of care have the proper credentials and qualifications? What training materials are necessary for the site of care team?
Mitigating financial risk. Due to the nature of these treatments, there are times when the product just cannot be administered after ordering. Whether due to patient disease state, improper product handling or timing considerations, pharmaceutical manufacturers should work with sites of care beforehand to understand and mitigate any financial risks.
Manufacturers and sites of care should understand the process for chargebacks, reimbursements and current terms. As value-based contracts becomes more common, especially in oncology where CAR-T therapies have had great success, manufacturers should consider how hospitals are paying for products, and terms for non-responsive patients. Medicare and non-insured patient policies may also vary state-by-state.
Understanding the patient access logistical challenge (and what to do about it)
New research shows that almost 40% of oncologists who have referred patients for CAR-T therapy have experienced an incident where their patient was not able to complete a treatment due to a health deterioration. This can often occur when additional time is needed by payers and other stakeholders to get these therapies approved.
Despite the advances in medicine, and similar to supply chain logistics, patient access logistics remains a massive barrier that must be addressed by pharmaceutical manufacturers in the launch process.
Insurance and paperwork. Priced up to $1 million, the novel therapies are some of the most expensive treatments on the market, usually requiring help through insurance and payers. Yet, this often creates a new barrier for patients as access to these therapies may be delayed by days, weeks or even months due to payer approvals, something that more than 30% of providers have identified as a reason for treatment delay.3
Two of the most time-consuming areas in the limbo between doctors prescribing and infusion can happen through benefits investigations and prior authorizations (which are required for most specialty medications). Pharma manufacturers should plan on supporting patients by looking for opportunities to automate and partner with payers to avoid delays in things like prior authorizations and benefits investigations, thereby reducing the patient deterioration roadblock so many patients and their providers are dealing with.
Travel. With just more than 150 hospitals currently administering these novel treatments in the country, patients referred for these therapies often need multi-day trips to get to the closest certified site of care. This can provide both a logistical and financial burden for patients and their families, who may already be struggling with the state of the disease. Pharmaceutical manufacturers should consider programs or hub services to cover travel and lodging costs for these patients, which may enable faster access to therapy.
It’s important to think through travel for both collection and infusion, along with any follow-up requirements and the health of the patient with travel concerns; not to mention weather or pandemic-related delays that may delay treatment.
The medical world is on the brink of a new way to approach healthcare, and it is not without its growing pains. By examining what works and what doesn’t with the first CAR-Ts already on the market, pharma manufacturers will be able to stand up better processes moving forward.
About the Author
Joel Wayment, VP of Operations at Cardinal Health Third Party Logistics Services