Jennifer E. Michael, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “IG Approval of Free Kymriah Might Be Model for Other CAR T Makers,” by John Wilkerson. (Read the full version – subscription required.)

Following is an excerpt:

Novartis may give away its $475,000 cancer drug Kymriah to low-income patients who either don't have insurance or have been denied access to the CAR T therapy by their insurer, according  to an HHS Inspector General advisory opinion. Although specific to Novartis' Kymriah, the opinion could be a model for makers of other chimeric antigen receptor T-cell treatments, according to Epstein Becker Green Partner Jennifer Michael.

"I definitely think another manufacturer could use this opinion to structure a similar arrangement," said Michael, who was the chief of the HHS IG's Industry Guidance Branch …

Although the IG has rejected requests for some types of financial assistance, including copay assistance, the agency is often amenable to companies that provide free drugs, Michael said. The IG worries about free drugs inducing future drug referrals once taxpayers are covering the cost, but that's not a concern for CAR T because it's a one-time treatment that cures patients…

The IG also dislikes the so-called practice of "patient funneling," Michael said, but that's not an issue in this case because Novartis certified that it is not providing cost-sharing assistance…

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