With Cell and Gene Therapies Proliferation, Specialty Pharmacy Faces New Pricing, Distribution Pressures

This article was previously published on our sister brand, Managed Healthcare Executive.

Cell and gene therapies are currently niche products, even within specialty pharmacy, drugs that, by most definitions, are treatments for a smaller number of patients. But at a session today on cell and gene therapy at the 2026 Asembia specialty pharmacy meeting in Las Vegas, the panelists discussed a future of many more cell and gene therapies that would scramble how the therapies are currently distributed, priced, and paid for.

The existing payment and distribution are not broken, said Stephanie Wirkes, Diplom-Kauffrau, head of distribution strategy and execution at Bayer Pharmaceuticals U.S. “Do the models break the moment we start to scale, so the moment it's not one patient per month, one patient in six months? What if it's 80 per six months, 100 per month. When we get to scale how do these existing models break or not break?” Bayer has a gene therapy for Parkinson’s disease in development that would, if it proves to be safe and effective, pose some of the problems of scale that Wirkes talked about.

“I think from a manufacturing side, we were very concerned,” Wirkes continued. “These are like our little babies, and we don't want anything to break. We don't want anything to get stuck somewhere, so we put a lot of protective layers on it. But it also creates a lot of redundancies. Well, once you're scaling, you don't have that luxury of having redundancies or duplications and things like that. So how do we have to actually change the models to really make sure that it's really scalable?”

The panelists talked about a wide range of issues and challenges both in cell and gene therapy in its current state and scale and in a future posited to have a multitude of such therapies. Will Pih, Pharm.D., co-founder of Two Labs Pharma, a commercialization and access company, said the FDA has approved about 50 cell and gene therapies, and “there's a ton of drugs in the pipeline,” fueled by ample investment. By disease, two of the leading categories are drugs for hematologic cancers and neurology, he said but there are also therapies for retinal diseases and heart conditions. “It’s an amazing time. It's like the invention of penicillin and the polio vaccine, all happening at one time,” he said

The themes included what is likely to be a larger role for specialty pharmacies and changes to price and value assessments as cell and gene therapies move into the mainstream. Jennifer Lospinoso, managing director and consulting lead at Riparian LLC, a technology and consulting firm, said “there will definitely need to be a redesign of the pricing and contracting playbook” if cell and gene therapy becomes more common. She used a figure of 50,000 potential patients and a price of $3 million per treatment that would add up to $150 million in expenditures, which she characterized as a “significant portion of total U.S. drug spend.” Lospinoso said the “value story” of cell and gene therap;ies will also have to change as the therapies shift from treatment for ultrarare diseases that affect the entire life of a very small number of patients to more common conditions for which there are existing treatments.

“With these new therapies, we’ll have to be thinking about the comparison against an already established, standardized care, so there's a lot of work to do on the pricing front in order to make sure, from a market access perspective, that these new cell and gene therapies are successful,” Lospinoso told the Asembia audience.

Morgan Olson, senior vice president of biopharma business development at Orsini, was one of the panelists at a session about cell and gene therapy.

During the session and in a brief interview with Managed Healthcare Executive immediately afterward, Morgan Olson, senior vice president of biopharma business development for Orsini, spoke about the role that specialty pharmacies have in gene therapy. Orsini, a specialty pharmacy headquartered in Elk Grove, Illinois, specializes in rare disease. Olson said the company currently distributes 12 cell and gene therapies, 10 of which are gene therapies.

Manufacturers of cell and gene therapies typically prize experience when looking for specialty pharmacies to work with, according to Olson. That experience requirement is, she acknowledged, a “chicken and egg” problem: the only way to have experience is to get experience. Olson also noted that many of these therapies are covered by the medical benefit, which may be a hurdle for some specialty pharmacies.

“When you think about a true specialty pharmacy, many of them are only contracted on the pharmacy benefit side of the house,” she said.

In contrast, her company “grew up, as Orsini, in the medical benefit, and then we added our pharmacy benefit over time, so we've had 30 years in the medical benefit space and understanding the dynamics of how to process insurance claims.” Orsini “started to refine that muscle uniquely to the cell and gene portfolio” she said. “Over the last 10 years, we've built a repository of how to navigate the payer contracting on the cell and gene side,” she said.

Pih outlined the two prevailing ways of distributing cell and gene therapy. In the “flash title model,” the manufacturer owns the therapy and bears the risk until it is delivered to the site of care. An intermediary, such as a drug wholesaler, may be involved, but specialty pharmacies are not.

The “specialty pharmacy drive-by model” does, as the name implies, involve specialty pharmacies, but specialty pharmacies do not physically take possession of therapy. They do, however, pay the manufacturers for it. According to information that Pih presented on a slide, the specialty drive-by model shifts the cash outlay and inventory risk away from the treatment centers. It is catching on, according to Pih, as cell and gene therapy become more common.

Olson said that manufacturers have used different strategies, some of them choosing to launch products through a specialty pharmacy while others work directly with treatment centers that buy the therapy and then bill the payer—the “buy-and-bill” channel, Olson called it.

But executives at the manufacturers who work directly with treatment centers are changing their minds, she said.

“We're getting calls from a lot of the manufacturers that launched only with the buy-and-bill channel,” she said. They want to outsource to a specialty pharmacy. “They want to have a specialty pharmacy partner for certain therapies and/or certain patients, and so they're looking to add us as a channel after the fact,” Olson said.

Olson added that “especially as outpatient administration continues to grow, I think we're going to continue to see a rise in the number of cases that go through specialty pharmacy as those outpatient centers gain their understanding and figure out if they want to be a true cell and gene dispenser, buy and biller, or if they want to just manage the outpatient specialty pharmacy.”

Because Orsini is taking on the financial risk, it has an incentive to manage access and execution of cell and gene therapy well, Olson observed.

“We want to make sure that that patient gets on therapy, and the insurance claim is getting paid, so we get paid as well. Otherwise, we're taking a huge risk. As you know, the average gene therapy is $3 million.”