Looming FDA Decisions Could Swell Number of Gene Therapies on Market

In its latest drug pipeline report, UnitedHealth Group-owned PBM Optum Rx takes a look at two high-priced gene therapies that are slated for FDA approval soon. But those are far from the only gene therapies that payers should be watching, an Optum Rx executive tells AIS Health.

Both drugs highlighted in Optum’s report, Zynteglo (betibeglogene autotemcel) and Skysona (elivaldogene autotemcel), are manufactured by bluebird bio, Inc., a Massachusetts-based biotech company. An FDA advisory panel in June recommended both drugs for approval. Currently, only two gene therapies are on the U.S. market: Luxturna and Zolgensma.

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Leslie Small

Leslie Small

Leslie has been working in journalism since 2009 and reporting on the health care industry since 2014. She has covered the many ups and downs of the Affordable Care Act exchanges, the failed health insurer mega-mergers, and hundreds of other storylines spanning subjects such as Medicaid managed care, Medicare Advantage, employer-sponsored insurance, and prescription drug coverage. As the managing editor of Health Plan Weekly and Radar on Drug Benefits, she writes and edits for both publications while overseeing a small team of reporters who also focus on the managed care sector. Before joining AIS Health, she was a senior editor for the e-newsletter Fierce Health Payer, and she started her career as a copy editor at multiple local newspapers. She graduated with a dual degree in journalism and political science from Penn State University.

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