Drugmakers are tripping over themselves to pair potential blockbusters with companion diagnostics, but uncertainty in reimbursement and divergent goals between developers and diagnostics partners could stand in the way of success, according to a Tufts panel.
The school's Center for the Study of Drug Development examined the current state of the companion diagnostics world, finding that while CDx can help get targeted therapies through regulatory bodies, insurers are not always on board with covering a test in addition to reimbursing for a drug treatment.
Efficacy-based tests, used to target patients for a drug, are cost-effective for payers, but many companion diagnostics are safety-based, presenting up-front costs for an assay that will only work to limit a drug's treatable population, something insurers may well deem wasteful.
Furthermore, when pharmas partner with diagnostics outfits, the marriages aren't always ideal. Both parties need to rectify their different business models based on different development platforms that employ different technologies, said Christopher-Paul Milne, director of research at Tufts CSDD.
"Despite these difficulties, interest in developing companion diagnostics remains strong," Milne told the panel. "That's because drug companies recognize that companion diagnostics co-developed with a therapeutic can increase the probability of winning regulatory approval for the drug."
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