Optimizing the channel strategy for your CGT: Considerations for a purpose-built approach

There’s a common misconception that developing a channel strategy simply means deciding how providers will access a medication. However, other critical components could be considered part of channel strategy, including determining which sites of care can access the therapy, how the distribution network is structured, and how sites of care will order the therapy.  

Optimizing these components is particularly important for cell and gene therapies (CGTs) because a channel strategy that isn’t built for the specific requirements of CGTs can create unnecessary complexity, delays, and challenges for patient access. CGTs typically have strict temperature and handling requirements, short shelf lives, high up-front costs, and multiple stakeholders involved. Some CGTs like autologous cell therapies are made for individual patients, adding further complexity to distribution and requiring close coordination to ensure the therapy reaches the right patient at the right time. 

No single approach to channel strategy works for every CGT. The right combination of the distribution model, customer network, and how therapies are ordered will depend on the therapy, its handling requirements, treatment setting, expected patient population, and more. These needs may also change as the therapy moves from launch to broader use, which may require the channel strategy to adapt as the therapy evolves.  

Taking account of the range of options and considerations for a channel strategy can help you develop a strategy purpose-built to your therapy. This article explores the components of a specialty distribution channel strategy, including the options and considerations for building a strategy that meets your therapy's specific needs. 

Critical components of a CGT channel strategy 

A channel strategy includes three key components that are critical to addressing a therapy's specific needs. 

These key components are:

1. Distribution model 
2. Customer network  
3. Order submission 

These components are all connected. The distribution model can affect which distributors you can use, while the customer network impacts the sites of care you can serve. How an order is submitted impacts the ability of sites of care to access your therapy. Considering these components together can help CGT manufacturers choose an approach that best fits the therapy. 

The sections below explore these components individually, providing some examples of common options and key considerations for emerging CGT manufacturers.

1. Choosing the right distribution model 

The distribution model defines the distributors that are included in a therapy’s network. 

Some common options include:

• Exclusive: One distributor handles distribution. 
• Limited: A small, select group of distributors handles distribution. 
• Open: A broad, unlimited network of distributor partners handles distribution. 

What should CGT manufacturers consider? 

Exclusive and limited models are commonly used for CGTs because they give manufacturers more control over distribution and enable a consistent customer experience. CGT distribution can involve multiple handoffs and stakeholders, which makes visibility across the supply chain especially important. Having only a select number of distribution partners can make it easier to integrate them with orchestration platforms or patient support programs, connecting these stakeholders and providing the data needed to coordinate delivery. 

As CGTs reach larger patient populations and wider patient access becomes a priority, an open model with a broader distributor network may become more useful. For example, a CGT initially approved to treat a condition for a select patient population that meets certain conditions may have its indications expanded to treat more patients. As demand grows, expanding the distribution network could help make the therapy available to more providers and patients.  

2. Choosing your customer network 

The customer network sets out which sites of care can access the therapy, either directly from the manufacturer or through a specialty pharmacy or distributor. 

Common options include:

• Limited: A manufacturer selects a group of authorized sites of care to have access to the therapy from the manufacturer. 
• Specialty Pharmacy: A manufacturer chooses one or more specialty pharmacies for its therapy, where sites of care send prescriptions and the specialty pharmacy ships the therapy to the site of care. 
• Open: Any manufacturer-authorized site of care can access the therapy through specialty distribution partners. 

 
What should CGT manufacturers consider? 

Limited customer networks are widely used for CGTs because they give manufacturers control over which sites of care can receive, dispense, and administer the therapy. It also allows for manufacturers to onboard and train providers and sites of care to ensure they meet the requirements to safely store, prepare, administer, and monitor patients after treatment. These requirements can vary by therapy, and may include:

• Specialized storage equipment, such as a cell therapy lab or ultra-low temperature freezers 
• Laboratory or pharmacy capabilities to prepare the therapy 
• Staff trained to administer the therapy, particularly when administration involves a surgical procedure 
• Infrastructure and expertise to monitor and care for patients after treatment 
• Processes and staff in place to identify and manage adverse events and escalate care when needed 
• Willingness and ability to take on both the financial risk of a therapy with a high upfront cost and the administrative burden of managing its reimbursement process 

In particular, the financial risk and administrative burden may lead manufacturers to consider specialty pharmacies. In a limited customer network, sites of care use a buy-and-bill acquisition model for therapies. This requires sites of care to take on the financial risk and burden of having to submit the reimbursement claim for the expense. When using a specialty pharmacy, the specialty pharmacy   manages the reimbursement process, removing these obstacles for sites of care.  

Expanding the network with an open model can make the therapy available to more patients, which may become increasingly important as CGTs are approved for larger populations. But an open network could only be used as long as providers and sites of care have the equipment, trained staff, and processes needed to safely store and administer the therapy, as well as the willingness to take on the financial risk and reimbursement burden. 

This could still be particularly relevant to some allogeneic or gene therapies, particularly those requiring multiple doses. These may be able to be stored in advance and may not require the same level of specialized handling and administration associated with other CGTs. If these therapies can be stored and administered at a wider range of sites, a broader customer network could help make them more accessible to patients.

3. Choosing how orders are submitted  

Another major component of channel strategy for a CGT is determining how an order will be submitted.  

This involves several considerations, including: 

• Order processing: Determining how an order will be processed. 
• Payment terms: Setting up payment terms to reduce the financial risk for sites of care. 
• Data collection: Acquiring the prescribing data needed for the unique distribution logistics of a therapy.  

What should CGT manufacturers consider? 

CGT manufacturers will need to determine how an order will be processed. For example, will it be ordered directly from a distributor, a portal, or through a mandatory hub. Autologous therapies in particular tend to require sites of care to enroll their patients in an orchestration platform in order to facilitate the high level of coordination required.  However, sites of care can place the purchase order with a portal, directly with the specialty distributor, or with both when manufacturers allow sites to choose their preferred ordering method.  

Manufacturers should also carefully consider payment terms. CGTs can carry a high upfront cost, and sites of care may face significant exposure when therapy is ordered, delivered, or staged before final access or administration is complete. Patient scheduling or reimbursement delays can create balance-sheet pressure on sites of care, that can be enough to slow or limit program participation — even when there is clinical interest and patient need. 

Furthermore, it’s also important to a have an exception process or some other form of protection if a reimbursement claim is denied. This helps the manufacturer to provide support to a site of care in case a claim is denied despite initial approval from a payer. 

Finally, CGTs often require collecting or validating critical information. This can include, but is not limited to, the following: 

• Capturing or verifying information like a Chain of Identity (COI) ID or a patient ID 
• Confirming the specific date and time the therapy needs to be delivered 
• Sign-off of specific contacts that are needed to approve therapy delivery 
• The individual dose in a series if it's part a multi-dose therapy 
• Whether ancillary supplies are needed by a site of care 

When setting up an ordering platform, manufacturers or their distribution partners will need to accommodate the extensive information that tends to be needed for a CGT.  

Putting your channel strategy into practice 

As you work with distribution partners, consider the different components of a specialty distribution channel strategy, including the options and considerations for each. Taking these into account can help you develop an approach that meets your therapy’s needs at launch and adapts as those needs change over time. 

The Cencora CGT team has partnered with more than 200 manufacturers and supported more than 30 CGTs and advanced therapy medicinal products (ATMPs) approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Cencora brings 47 years of specialty distribution experience, including 31 brand and specialty products in exclusive distribution. 

Within the CGT portfolio, the Specialty Distribution team helps biopharma companies launching CGTs make informed, confident decisions about channel strategy and advanced therapy distribution and logistics. Our CGT manufacturer partners rely on our deep CGT experience, broad site-of-care reach, and flexible distribution options — including integrated access to critical 3PL and specialty courier services. With these strengths, we help manufacturer partners develop an optimal channel strategy, reach targeted sites of care, and use distribution and logistics solutions purpose-built for their CGT, supporting patient access to these advanced therapies without delay. 

Cencora also allows sites of care to conveniently access new CGTs via Cencora’s ordering platform, which sites of care are already using and have standardized processes in place that align with their workflows.  

Cencora’s Orchestration Exchange also enables integrations between manufacturers and their stakeholders using orchestration platforms, such as TrakCel’s OCELLOS. This helps facilitate the significant coordination involved in distributing advanced therapies. 

Contact Cencora to learn more about the insights and options available to help you develop a channel strategy that is purpose-built for the specific needs of your therapy.