Advanced therapy manufacturers should consider new payment models that account for how their therapeutic benefits are spread over time, says Miguel Forte, MD, PhD, chief executive officer of Bone Therapeutics.
Forte, who spoke about the state of the cell and gene therapy industry at Advanced Therapies Live last month, told GEN that biomanufacturing costs are falling over time. But, in his view, they will not fall to the same level as small molecules—keeping treatment prices relatively high.
“We’re seeing a logarithmic increase in the number of batches we can make from a single donor collection, which brings down costs logarithmically,” says Forte, whose company has an allogeneic off-the-shelf bone cell therapy product in their pipeline.
“If you have twice the cells, but a similar process, you almost halve the costs,” he adds.
The company can now produce dozens to a few hundred doses of cell therapy from a single donation of health bone marrow, he says.
“We’ve already moved from flatbed to bioreactors with three-dimensional production, and we’re aiming to reach 100,0000 doses per batch,” he points out, explaining that scaling up allogeneic cell therapy production remains a challenge, but they’re confident in the progress they’re making.
However, despite progress across the advanced therapy industry, Forte doesn’t think prices will lower to the level of small molecule chemistry. He attributes this to, for example, the cost of gene delivery technologies as well as raw materials, such as collecting samples from patients.
“It’s not the cost of a single product, but the multiple products and procedures we bring together to deliver impactful treatment,” he explains.
As a result, Forte believes the industry needs to adopt new payment models that acknowledge that cell therapies have long-term benefits.
“With antibiotics, you pay for two weeks, and you’re done, but when you’re correcting a gene or have new cells engineered to perform a function, that model of payment needs to be revised,” he continues, comparing a gene therapy to a mortgage on a house where you spread the cost of the house, while benefitting from living in it.
Forte also says regulation is a major factor in making the production of gene therapies commercially viable. He argues that as the industry matures, it will be possible to speed up regulatory approvals by standardizing elements of the production process. For example, by creating products for treating multiple diseases by changing a single gene in a gene cassette.