Overcoming the Challenges in Bringing Cell & Gene Therapies to Market – Part 3

As cell and gene therapies (CGTs) continue to enter the market, treatment centers have become the primary gatekeepers to patient access. Capacity limitations, operational burden, financial exposure, and increasing competition—both from other approved therapies and ongoing clinical trials—are forcing centers to be increasingly selective in what they adopt and sustain.

In this four-part blog series, we will address four major challenge areas manufacturers face in bringing cell and gene therapies to market, and the best practices to follow in overcoming them. Challenges and solutions discussed include:

1. Treatment Center Capacity Constraints
2. Operational Complexity and Workflow Burden
3. Financial Concerns and Reimbursement Exposure
4. Market Competition in Clinical Trials and Commercial Applications

Challenge 3: Financial Risk & Reimbursement Exposure

The cost of cell and gene therapies is enormous. Research, product development, administration – all carry a heavy cost burden. Although research and development costs are borne by the manufacturer, treatment centers can also face a significant financial risk when taking on your cell and gene therapy in the commercial setting. This financial risk needs to be taken into consideration, and ameliorated wherever possible, to successfully establish a cell and gene therapy program at a treatment center.

During a clinical trial, the manufacturer is compensating a treatment center for all of their services so there are no significant financial risks to consider. However, when the therapy is a commercial product, potential challenges with reimbursement can significantly change the financial viability equation.

The treatment center has to navigate the insurance reimbursement issue to determine its financial exposure and if it can handle the risk. It needs to determine what will be covered, and at what negotiated reimbursement amount, in order to determine its ability to take on the therapy. This needs to be addressed through upfront education and the onboarding process in order to establish a successful partnership.

The financial concerns in commercialized cell and gene therapy

Treatment centers administering commercialized cell and gene therapy depend on payer reimbursements to cover the costs of product and treatment administration. Due to the high-cost nature of some of these products, the timing of reimbursement is critical to manage lines of credits particularly when leveraging a “buy and bill” model where they purchase the treatment upfront and are subsequently reimbursed by payers.

Treatment centers who elect to leverage a “buy and bill” model, face significant financial risk, particularly when dealing with treatments costing $1million +. Payment terms tend to lag at 60 – 90 days post billing, creating considerable financial exposure during this time, which can eventually limit the rate at which patients are treated.

To address this potential financial burden on treatment centers, manufacturers can provide an option to obtain the treatment through a specialty pharmacy. However, any costs associated with treatment preparation and administration may still require insurance navigation and significant wait times for reimbursement.

Without a doubt, the amount of time cell and gene therapies take, and the additional work they create for staff is a cost for treatment centers. Since the nature of securing reimbursement can also be lengthy and tedious, the process is burdensome and time-consuming for staff in administrative and support roles.

In addition, time spent on patient and caregiver education is significant and takes away from other work staff might be doing. To address this if the volume of work is substantial enough, some centers take on the financial costs of dedicated cell and gene staff.

What you can do to minimize the financial risk

Most costs treatment centers incur when implementing cell and gene therapy are unavoidable. However, there are ways to reduce the financial burden, and it is in your best interest to partner with your treatment centers so they see the value in administering your therapy despite the costs.

For instance, you could help simplify documentation requirements and billing pathways when a treatment center is implementing a commercial therapy. Since insurance is the primary payer in commercial applications, helping the treatment center through the approval and reimbursement process is key to a smooth treatment process. There are a number of ways you can assist with this:

• Present a specialty pharmacy option – egotiating with a specialty pharmacy to carry your product reduces the treatment center’s financial exposure. The specialty pharmacy bills the insurer directly for the therapy, thereby minimizing reimbursement concerns and financial risk for the treatment center.
• Support the reimbursement process – When treatment centers must deal directly with the payer, they are often faced with a significant administrative burden. Education on how to obtain prior authorization (PA), how to develop statements of medical necessity, what are the proper billing procedures and how to properly file for reimbursement is paramount to a successful relationship with your treatment center. Training should meet the treatment center’s needs and providing tools in the form of Billing and Coding guides are essential to make the process easy for treatment centers.
• Follow up regularly – For patients enrolled in a support program, leveraging that program to provide education can help offset some of the responsibilities that treatment centers take on. Supporting the patient through a potentially stressful process of securing access and addressing open questions they may have is key. Representatives of the program can potentially follow up with payers to understand delays that may be occurring and/or to make sure things are moving smoothly, as well as provide reminders on next steps when necessary.

A treatment center’s financial risk in undertaking cell and gene therapy can be considerable, but can be minimized with attention to its process needs, leading to a successful treatment partnership.

Look for our next and final blog in this series, where we will address the challenges associated with market competition in clinical trials and commercialization.

Want guidance with your upcoming CGT project?

Contact our team at Nuvera to leverage our deep treatment experience capabilities with allogenic and autologous therapies.

See our Case Example on CGT Therapy: Designing an End-to-End Therapy Order Management Process – Nuvera