The Hope and Challenge of Personalized HealthCare

"Industry should take on the burden of showing the value of new technologies in terms of relative costs and benefits to the Federal government."

That was one of Hoffmann-La Roche Inc. CEO George Abercrombie’s key points in his address on Personalized Healthcare during Windhover's FDA/CMS Summit for Biopharmaceutical Executives December 6. (You can read more about the Summit's various talks elsewhere on the IN VIVO Blog--here, here, here, and here--and in the upcoming issue of The RPM Report.)

"It is our fault if we allow Federal programs and other insurers to view each advance in personalized healthcare as merely adding the costs of an additional test to their program without taking into account the health and economic benefits of prevention, safer health interventions and more effective health outcomes," Abercrombie said.

He offered an example from Roche's own experience, the commercial failure of AmpliChip, the first FDA approved micro-array. "Even though the FDA cleared it, many insurers declined to cover it because its utility was considered experimental, investigational, or unproven. Others declined to cover it because its clinical value has not been established."

If industry does its part, Abercrombie said, government needs to do its part too. "Even if the new therapy results in additional costs to the Federal government in the short term, the government should still provide premium reimbursement for these products if a case can be made for coverage based on the relative benefits to patients and the product saves the government money over the long term."

An example? How about Roche's once-monthly bisphosphonate ibandronate (Boniva), marketed to treat osteoporosis.

"Biochemical markers of bone turnover in patients with osteoporosis are reliable indicators of successful treatment as early as three months after start of bisphosphonate therapy," Abercrombie says. "Adoption of inexpensive testing, combined with pharma therapy should be embraced by the Government to control costs and improve individual patient outcomes."

Unfortunately, "payers have decided to cover bone mineral density screenings after one to two years of bisphosphonate therapy."

"We believe early feedback and positive reinforcement from biochemical markers of bone turnover in patients with osteoporosis could encourage responders to continue to take their medicine regularly. Likewise, if the bone turnover markers show that a patient is a non-responder; their physician should have that information available in deciding whether to change the patient’s bisphosphonate therapy or discontinue therapy, even if it hurts Roche’s market share."

All in all, sounds like a company willing to put its money where its mouth is.

If you missed Abercrombie's keynote address at the FDA/CMS Summit December 6, you can read it here.