Joel Wayment, Cardinal Health 3PL Services

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.

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.

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.

. 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.

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:

How trained are the carriers handling the product/what training do they receive?

Does the courier have a wise range of cold chain supply avenues with vast networks across the US and internationally?

Does the courier have various different packaging solutions to offer CGT manufacturers? In addition to transportation and courier services, more companies are developing specialized shipping containers that can uniquely handle these types of therapies, providing the capability to monitor multiple points of data in real-time that is critical to ensuring the safety and security of these shipments while in the supply chain.

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.

 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?

 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.

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.

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.

 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.

Joel Wayment, VP of Operations at Cardinal Health Third Party Logistics Services

https://www.prnewswire.com/news-releases/cold-chain-monitoring-market-worth-10-2-billion-by-2026--exclusive-report-by-marketsandmarkets-301436015.html

https://blood-cancer.com/living/car-t-cost

https://www.healio.com/news/hematology-oncology/20211213/cart-provides-value-despite-high-price-tag-oncologists-say

Articles

As more of these novel—and costly—cell therapies gain approval, revamped strategies around scaling, coordination and workflow are critical to their launch

CAR-T Therapies: Three Supply Chain Considerations

When I began writing this headline, I was struck by the degree to which the role and importance of 3PL outsourcing has expanded in just the last several years. Back in 2012, a colleague of mine at Cardinal Health 3PL Services 

 — but back then, the topic wasn’t ‘which 3PL model is best for your business?’ That article, written just seven years ago, sought to help manufacturers work through the questions that would help them determine 

if they needed the support of a 3PL partner at all

Today, that question has shifted, as an increasing number of manufacturers, large and small, are turning to 3PL partners to help reduce inefficiencies, gain economies of scale, speed products to market and free up dollars to focus on innovation.

 reinforce this idea. In the report, Deloitte predicts that global life sciences businesses will continue to place an increasing focus on outsourcing in the next several years, and that pharmaceutical companies specifically will “shift from transactional outsourcing relationships to more strategic, relationship models for biologics, data-driven clinical elevation and novel therapy manufacturing capacity.” The report also predicts that manufacturers will outsource expertise in various areas, “to increase efficiencies, lower costs and decrease clinical timelines.”

Indeed, for many pharma companies, the current focus is less about “should I or shouldn’t I outsource?” but instead 

 in a way that best supports the needs of their business and the success of their products.

Here, I’ll share some of the benefits that are driving more manufacturers to outsource key 3PL functions, as well as an overview of key 3PL models, and the ways each model can meet different manufacturer and product needs.

What’s in it for you? Why more manufacturers are outsourcing 3PL services

While cost efficiency is a primary reason that many manufacturers choose to outsource to a 3PL, it is certainly not the only benefit. Creating strategic partnerships with 3PL providers can empower manufacturers of all sizes to:

Get the flexibility they need to expand capacity as they add new products to their portfolio. This flexibility is key to driving efficiency, particularly for products that require refrigeration and other costly special handling procedures.

More easily manage ebbs and flows in product demand.  An outsourced provider can manage this unpredictability without having to add additional shipping routes or hiring extra staff, which can drive savings for the manufacturer.

Leverage best-in-class distribution and financial resources and technology, without making significant infrastructure investments.

Gain expert support with meeting Drug Supply Chain Security Act (DCSCA) track-and-trace requirements.

Strategic 3PL relationships are also ideal for smaller manufacturers and emerging biopharma companies — a segment that Deloitte defines as having less than $200 million in estimated spending on R&D, or less than $500 million global revenue. Although these companies are increasingly contributing to life sciences innovation (accounting for 73% of late-stage research and holding the original patents for 29 of the current top 100 drugs), they don’t often have the scale to build, staff or operate the infrastructure and processes need to store and ship products.

Deloitte’s report indicates that emerging biopharma companies launch new drugs more than 30% more slowly than other manufacturer segments. Developing strategic, long-term relationships with key outsourcing partners — including 3PL providers — can help these up-and-coming manufacturers expedite their products’ speed to market.

Which distribution model is best for your product?

Determining the 3PL outsourcing model that’s best for you starts with defining your business need, product profile, sites of care or administration, and target patient population. Here’s a high-level overview of different 3PL models — and how each can benefit your business or product.

 This model is ideal for orphan, ultra-orphan and other limited distribution products, because the 3PL provider ships the product directly to sites of care, including hospitals, practices and specialty pharmacies. This model can remove the burden of having to build back-office teams to manage the often time- and cost-intensive order-to-cash and customer service models that these types of products require.

In this model, the outsourced 3PL team acts as an extension of your team — and generally operates more efficiently than in-sourced teams, thanks in large part to economies of scale. Customers can order product online — and customers and the manufacture alike benefit from having full visibility of the product, as it moves through the supply chain.

• Traditional 3PL Model — aka the Wholesale Distribution Model:

 This model is best for products that are distributed through retail pharmacies or hospitals, and ship in cases or pallets to wholesalers/distributors, before they reach the end customer. Under this model, the 3PL provider serves as the finished goods warehouse for the manufacturer and handles shipping of the product to wholesalers. The manufacturer maintains control and ownership of the products as they move through the supply chain — but can also benefit from the same order-to-cash services that are available from a direct distribution model.

 This model is ideal for manufacturers who are looking to launch a product quickly but don’t have all of the required state licenses that are needed to sell medications in each state. Because the 3PL takes title of the product, the manufacturer can utilize the 3PL provider’s state licenses to distribute products nationwide. This can potentially accelerate a product’s launch date by months, or even up to a year.

Title model can also be a good fit for manufacturers that are looking to reduce their accounts receivables risks. The 3PL provider takes title of the product and handles warehousing, distribution and order-to-cash management on the manufacturer’s behalf. This model also mitigates the significant risks inherent in the distribution process — freeing up manufacturer’s cash flow to invest in other areas of the business.  Title model services can be as short or as long as a manufacturer requires.  Working with an experienced 3PL can help in developing the right strategy for your title model needs.

Because the 3PL title model program is fully manufacturer-branded, the manufacturer is also able to remain at the center of the customer interaction through branded invoices, customer service phone lines, and web portals for order management.

 Ideal for cell and gene therapies, with flash title model, the 3PL partner takes ownership of the product, but may not handle physical storage or distribution. Working in close communication with the internal or third-party hub to align with the patient and product journey, the 3PL partner takes responsibility for invoicing and collecting the payment for the product from the sites of care where it’s sold or administered, which helps to reduce the accounts receivable risk for the manufacturer.  By tapping the expertise of a 3PL partner that is familiar with credit profiles and payment practices of different sites of care, this model can also be helpful in supporting manufacturers in developing and designing payment terms for these high-value therapies.

Regardless of the degree to which you’re outsourcing 3PL services now, you should carefully consider each of these models and the extent to which each may be able to support your business or product’s growth and profitability objectives. There’s no “one size fits all” 3PL model for any brand, so it’s important to select a 3PL partner who understands the pros and cons of each model and who brings experience working with products like yours.  Remember that the best partnerships result when you take the time to align around goals, define clear standard operating procedures, and establish open lines of communication.  When it comes to 3PL, your partner should be committed to not only moving your product from point A to point B, but to implementing the right strategy to drive the optimal success for your brand.

Cardinal Health 3PL Services is a third-party logistics supplier that provides a full range of distribution and order-to-cash solutions. To learn more, visit cardinalhealth.com/3PL