Expert: Specialty Approvals Pharmacists Should Look for on the Horizon

Pharmacy Times interviewed Ray Tancredi, divisional vice president of Specialty Pharmacy, Development & Brand Rx/Vaccine Purchasing at Walgreens, on his presentation at Asembia Summit 2022 on specialty pharmaceutical pipeline updates.

Question: In your session at Asembia, you break down the FDA pipeline into 4 categories: rare and orphan, specialty, gene therapy, and oncology. Upon assessment, have you noticed that breaking down the pipeline into these categories have helped to elucidate any current trends in the marketplace, and what might those trends be?

Ray Tancredi: Over the years, I've had the opportunity to present this to the specialty pharmacy industry, and the audience could be pharmacists, it could be people from pharma, you have physicians, payers, and many folks interested in the pipeline. At one point, I used to put the presentation together, and it was in no particular order, sometimes it was in chronological order, but I think over time, what we found was people have an inherent interest in certain areas, and some of those that I've outlined, such as oncology, and now I've added a cell and gene section.

It was really just to organize the products and have people understand. Some folks are looking at the rare and orphan space, which is exploding. Oncology is always an interesting area, and it has really the most drugs in the pipeline. It was really more organizational than anything else, but I think to answer your question, we found that oncology probably has the most products, rare and orphan disease, has many interesting diseases and products that we probably would have never thought of, and then cell and genus novel.

This presentation continues to evolve, but those are some of the reasons why I put the presentation to that organizational structure.

Question: Would you say that the specialty pipeline and the oncology pipeline are somewhat in their own silos in terms of research, development, and assessment?

Ray Tancredi: Yeah, that's a good question, and maybe, I never really thought about them in silos, and I guess when I put them in my own silo, maybe I was doing that. But again, oncology has just the bulk of drugs in the pipeline. I was looking at the pipeline the other day, and I saw it through evaluate pharma, there's like 2000 drugs and oncology in the pipeline. Of those 2000, 24 of them have actually been filed through NDA and 183 are in phase 3, 830, I believe, are in phase 2, and the remainder, which is over 900 are in phase 1.

So that pipeline, in and of itself, is full of new and interesting drugs for many of the cancers that require or have an unmet need. Then I looked at traditional specialty, and there were almost 900 drugs, of which 20 were filed, very similar number to oncology, 155, and phase 3, over 400 in phase 2, and about 300 in phase 1. As you look at these, oncology just has so many drugs that are being looked at by pharma that will bring new and novel therapies to the marketplace.

Question: How has defining what is and isn’t under the umbrella of the specialty pharmacy changed in recent years, and what are your predictions for this on into the future?

Ray Tancredi: I get asked about that all the time, and I think to look forward, we almost have to look back a little bit. Before we even kind of defined specialty pharmacy, there were drugs like in 1992, which came out and in a limited distribution marketplace because there were manufacturing issues when it was first approved. Then we saw Crixivan in the middle 90s for HIV, came out an exclusive distribution out of a small pharmacy in Pittsburgh, and you start to see this specialty world evolve. Then I think the drug that made specialty in the late 90s, when I was at a managed care organization was Synagis for premature infants that had a proclivity to get respiratory syncytial virus.

Then you looked at this the specialty evolving to more therapies that were injectable like the multiple sclerosis drugs which were all injectable drugs for multiple sclerosis where patients had needed high touch care complex therapies. Then the whole industry changed in 2005 and 2006 when there were 3 oral oncology drugs.

Before that, most of the drugs were injectable complex therapies managing injection site reactions and how to administer the product. Then, in that 2006 timeframe, you had Revlimid, Nexavar, Tykerb, 3 oral oncolytic agents and you saw specialty pharmacy evolve, complex therapy but oral and an oncology space.

After 201, we saw an explosion of rare and orphan diseases, very small pharmacy networks, intense and complex therapy regimens, small patient populations, and we thought at that point, we maybe were stabilizing industry but no it continues to evolve.

You all may have seen the biosimilars. Biosimilars have been around for a while, but they're really starting to gain traction, and then I think a drug that will impact us as a specialty pharmacy, will be Humira in 2023. Humira will have multiple biosimilars available in the marketplace, including 1 that's interchangeable. So, it's evolving there, and then Eylea, which is another specialty drug, will have a biosimilar in the near future.

One thing that we hadn't seen in specialty for many years now is that many of the oral products are now becoming generic. One of the biggest drugs in specialty pharmacy, Revlimid for myelodysplastic syndrome and multiple myeloma of REMS therapy, very complex, had a generic available for the first time and multiple manufacturers in September, and next year, we'll be bringing generics to the market.

So you had Revlimid generic, you had Copaxone, Tecfidera, now we have generics in the marketplace for both injectables and orals continues to evolve.

Then finally, the most interesting products, I think, are the precision medicines, cell and gene and regenerative therapies that we're beginning to see get approved, and we'll see more in the marketplace. These cell and gene drugs, probably well over $1 million per administration, are curative, and just when we thought we were stabilized, and we have a new business and specialty pharmacy that may actually be a brand-new business.

When I look at selling gene and regenerative medicine, I'm almost thinking back to the time when we were trying to name and identify what were the drugs in the late 90s and early 2000s that ultimately became specialty drugs. Now we're looking at perhaps a complete and new business line in cell and gene therapies and regenerative medicines.

So as you look at the definition, it's changing, right? Some of the old definitions that you that we used to put around the specialty drugs may be obsolete pretty soon.