2021 Outlook: Gene, Orphan, CAR-T Therapies Are in Pipeline Spotlight

The pharmaceutical industry has undergone an unprecedented burst of innovation lately, led — but by no means limited to — the race to develop a vaccine to counter the COVID-19 pandemic, and this trend is showing no signs of slowing, with oncology, orphan drugs, cell and gene therapies leading the way. But with this innovation come premium prices, and though the previous administration issued a flurry of rules and executive orders focused on drug pricing, there was not much concrete action in this area. President Joe Biden has multiple issues to deal with, so it remains to be seen what he’ll do here in the upcoming year. AIS Health spoke with multiple industry experts to get their opinions on what we may see over the next year within the specialty drug space.

What do you expect to see on the issue of drug prices in 2021? Do you anticipate any legislation passing?

David Root, vice president of government affairs at Prime Therapeutics LLC: “We anticipate that the incoming Biden administration will be focused on combating the pandemic through public health measures and deployment of new vaccines and therapeutics and that this focus may take attention away from other issues. The incoming administration will also need to decide whether to retain the Trump administration’s proposed most-favored-nation proposal and the rebate rule.…Given how tight control of the Senate will be and narrower margins in the House, is it likely that only more targeted drug pricing issues reach the president’s desk. The FDA user fees programs need to be reauthorized in the next Congress and that may also bring attention to drug pricing issues.”

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