Cell & Gene Therapy

Growing opportunities — but added complexity

Indistinct reimbursement models with payers remains a challenge for cell & gene therapies companies. Drug manufacturers can actively collaborate with payers to develop sustainable solutions that ensure broader availability and enhance accessibility.

Cell & gene therapies can help beyond the rare disease population. They can address more prevalent conditions, including neurodegenerative disorders and cardiovascular diseases, opening significant market opportunities.

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FDA approvals of CGT therapies increased 70% in 2023 compared to the preceding two years

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Over 80% of approved CGTs in the past decade have spearheaded progress in rare diseases through Orphan Drug designations — a trend expected to continue

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Exponential growth is anticipated for CGT approvals, projecting a 4x increase in 2024 compared to 2023 and soaring to 10x in 2027

When CGTs first emerged there was a lot of excitement, but the first treatments were in disease areas with small populations. In many ways we are still waiting for the larger wave of CGTs to come before we make any firm decisions on the category.

Chief Pharmacist

Regional MCO

We weren’t initially sure how to approach this new CGT category. Given that CGTs are commonly administered in an inpatient setting, we involve our medical policy teams in the review process. However, these teams historically focus on procedures & devices and aren’t accustomed to contracting.

Director of Value-Based Contracting

National Insurer

The early CGTs in rare diseases had initial N sizes in the literal single digits for our plan, so we were able to handle those requests with individual letters of agreement. But you can’t do that if you suddenly have dozens of CGTs across larger patient populations.

Director of Value-Based Contracting

National Insurer

Payers are the upfront price and durability of effect. You are bottling up 20 years of medical costs into one treatment, but what happens when the patient switches plans after 3 years or if re-treatment is required?

Medical Director

National Insurer

How can Acquis help?

Acquis understands the complexities of the development lifecycle. Thoughtful planning in the early stages of the product lifecycle is critical to reaching the right patient at the right time with the right drug, optimizing downstream peak revenue post-launch.

01 Cost and Affordability