In the early days of the COVID-19 pandemic, there were fears it could hinder drug development.
However, those concerns didn't prove to be entirely founded; although clinical trials did slow, they didn't stop, a new report from Optum shows. Clinical trials did experience some delays, the report notes, with one study tracking 2,500 trials planned for 2020 and finding 65% experienced a delay. The mean setback was 2.6 months.
But overall, 41 drugs have been approved by the Food and Drug Administration (FDA) so far this year, compared to 48 in 2019, according to the report.
And while some segments of the pipeline may have slowed down due to COVID-19, drug development's quick response to the pandemic likely offers lessons for the future, Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx, told Fierce Healthcare.
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He said the industry went from essentially first identifying the virus about a year ago to now having multiple therapies and vaccines coming to market. The vaccine developed by Pfizer and BioNTech took a massive step closer to emergency approval Thursday, when an FDA panel voted in favor of emergency use authorization.
Dreitlein said the pharmaceutical pipeline achieved "things we never thought we could do" in an effort to combat the pandemic quickly.
"Last year, COVID just burst onto the scene and here we are a year later and we have a vaccine for it," he said. "The magnitude of development that has taken place and the speed with which it has happened is really remarkable."
While drug developers moved quickly to bring these products to market, the FDA also streamlined its own processes to allow for speedier approvals and access. Dreitlein said that while it's not entirely clear at present how this could impact drug approvals in the future, it shows that it's possible to develop these products in a more streamlined manner.
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He expects to see some of those impacts shake out over the next year as a result.
"There’s got to be things along the way there to do drug development and regulatory review in a better way," Dreitlein said.
The analysis of the pandemic's impact on the pipeline is included in Optum's fourth-quarter pipeline report, which also highlights five drugs payers should be watching in the coming year as they're set for approval soon. They are:
- Roxadustat, an oral medication to treat the anemia associated with chronic kidney disease (CKD)
- Relugolix, an oral medication for prostate cancer
- Inclisiran, which treats elevated low-density lipoprotein cholesterol in patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia
- Berotralstat, a drug to prevent hereditary angioedema attacks
- Lisocabtagene maraleucel, a drug for adult patients with diffuse large B-cell lymphoma that either relapses or does not respond to at least two prior therapies
Notably, the drugs included in the fourth-quarter report largely treat more common conditions, while past reports have often highlighted orphan drugs that treat rare and complex conditions.
Dreitlein said a common thread among the drugs included in the report is that they're entering markets currently dominated by specialty pharmacy products. Roxadustat, for example, is the first novel therapy for CKD-related anemia that has come to market since 1989, and it could offer an attractive oral alternative to the injectables available to patients.
Berotralstat is also an oral medication that is entering a market dominated by injectable biologic drugs, Dreitlein said.
"I think if you were to kind of see what the theme is there, they really do connect in some way to specialty pharmacy," he said.
That said, payers shouldn't take their eyes off of orphan drugs, Dreitlein said. These therapies, which are often costly, are still a trend to watch. Smaller health plans, especially, can feel the financial strain of offering these therapies, he said.
"Those types of conditions can really have a major impact on a health plan," Dreitlein said. "If it’s a small health plan, a few of those patients really could affect the whole plan and we’ve heard some cases of that."