Providing Channel Optionality for Cell and Gene Therapies

Cell and gene therapies (CGTs) represent a significant shift in how diseases are treated and how therapies are brought to patients.

Unlike traditional medicines, CGTs are often highly individualized, involve complex manufacturing and logistics, and carry a high cost per treatment. These characteristics make CGTs among the most complex medicines to commercialize.

The Stacking Effect

• For treatment centers, as high‑cost therapies are layered into a portfolio, balance‑sheet risk stacks quickly and long, unpredictable reimbursement timelines further strain cash flow.
• Large academic medical centers may be better positioned to absorb the cumulative risk, but many community‑based sites of care are not.
• As CGTs move into broader clinical use, this stacking effect can limit a center’s ability to treat patients today and to adopt new therapies tomorrow.
• How CGTs are purchased and managed is therefore becoming a key factor in sustaining CGT programs and ensuring continued patient access over time.

At InspiroGene by McKesson, we support the commercialization of CGTs in a rapidly expanding market. In this article, we examine the differences between Buy-and-Bill and Specialty Pharmacy models, and how each approach influences financial risk, payer coordination and operational complexity.

What access models are used today for CGTs?

Today, treatment centers generally access cell and gene therapies through one of two channels:

• Buy-and-Bill
• Specialty Pharmacy

Each model supports patient treatment, but they operate very differently behind the scenes.

How does the Buy-and-Bill model work?

Under the Buy-and-Bill model, the treatment center purchases the therapy upfront and later seeks reimbursement from the payer.

Key characteristics:

• The treatment center manages insurance verification and prior authorization.
• The treatment center covers the cost of the therapy.
• The center submits claims for both the therapy and related services.
• Cash flow is directly dependent on payer timelines and claim outcomes.

For some health centers, this approach is familiar and may align with existing workflows. For others, the financial exposure associated with upfront purchasing can introduce risks, particularly as treatment volumes grow.

How does the Specialty Pharmacy model differ?

The Specialty Pharmacy channel shifts the purchasing and reimbursement responsibilities away from the treatment center.

Key characteristics:

• The specialty pharmacy purchases and manages the therapy, including managing insurance verifications, prior authorizations, financial assistance for patients and securing payment for therapy.
• The treatment center bills only for ancillary services related to administration.
• Upfront financial exposure for the treatment center is reduced or eliminated.

This model offers an alternative way to manage financial risk with maximum patient benefit, especially in environments where capital constraints or reimbursement timing might be a concern.

Why are more treatment centers considering the Specialty Pharmacy channel?

As the CGT pipeline expands, so does the financial pressure on treatment centers.

“Many treatment centers might see what we call a ‘stacking effect,’ where multiple high-cost therapies come to market simultaneously, each requiring significant upfront investment," says Joe DePinto, head of cell, gene and advanced therapies at InspiroGene by McKesson. "Even for well-established treatment centers, maintaining this level of financial exposure while awaiting reimbursement can pose substantial challenges. More channel options can expand sustainable access for treatment centers and patients across the board.”

The Specialty Pharmacy channel can help address this challenge by:

• Reducing upfront capital requirements
• Limiting financial risk tied to reimbursement delays
• Supporting operational sustainability as therapy volumes increase

For some treatment centers, this flexibility can help maintain access to innovative therapies over the long term.

What does this shift mean for biopharma companies?

From a biopharma perspective, evolving access models create new opportunities.

By offering both Buy-and-Bill and Specialty Pharmacy options, companies can:

• Accommodate a wider range of treatment center needs
• Support faster network expansion
• Enable more sites of care to participate in CGT programs to help ensure patient access or maximize it

Providing channel optionality allows treatment centers to select the model that best fits their operational and financial realities, while helping biopharma companies accelerate adoption and patient access.

Why does access strategy matter more than ever?

As CGTs continue to advance, the success of these innovations depends on clinical outcomes and sustainable commercial access.

“Embracing innovative channel strategies for cell and gene therapies is essential to expanding patient access and driving the future of CGT,” DePinto noted. “By prioritizing flexibility and collaboration, we can unlock new possibilities for care and ensure these groundbreaking treatments reach those who need them most."