(651) 348-6928 BradQ@DuNordRe.com

GENE AND CELL THERAPY: The Wave Continues, and the FDA is Gearing Up!

Are you concerned about whether you’re ready for the coming wave of expensive therapies? The tides have been changing, bringing new challenges and opportunities.

The FDA recently received increased funding, allowing for 60 additional reviewers of proposed Gene and Cell Therapies. There are currently 694 Gene and Cell Therapies (GCT) in the trial phase, of which 48 are late-stage and five in stage III. Could the FDA be gearing up for faster-than-anticipated approvals? The target market for GCT is also expanding beyond serious and rare diseases to include cardiology, metabolic, and central nervous systems. The expected cost of these treatments ranges from a few hundred thousand to a few million dollars.  

What does it mean for health plans? The confluence of increased approval funding, an expanding pipeline, and catastrophic costs has caused many payors to rethink their risk management strategies and left wondering if they are buying the right reinsurance coverage.

We are a hands-on consulting firm that collaborates directly with underwriters of select reinsurers to design reinsurance solutions for regional health plans. We’ve replaced other brokers that had procured treaties that either had gaps in their coverage or paid premiums on members that were excluded.

Have DuNord perform a complementary review of your reinsurance treaty to test the adequacy of your coverage and terms against your exposures. Call (651) 348-6928 if you would like more information.
Source: https://www.clinicaltrialsarena.com/analyst-comment/cell-gene-therapy-landscape-us

Principal, DuNord Reinsurance Consulting
O: (651) 348-6928
C: (612) 382-5094

Account Executive
DuNord Reinsurance Consulting

C: (651) 503-2577