Biotechnology Healthcare - July/August 2008 - (Page 25)

Infusion-related oncology costs will become a prime target, with savings rippling across other therapeutic areas, says the Zitter Group’s Tom Baker. in 2005, the value of costly molecular diagnostics overall was questionable. Matthew K. Hudes, national managing principal, biotechnology, for Deloitte Consulting’s Life Sciences & Health Care practice, keeps a close eye on the molecular diagnostics field. As innovations in molecular diagnostics evolve, Hudes says, so must the way in which their value is perceived and the policies that govern their coverage. “We are approaching a point at which current [policies] will not permit the promise of science to reach patients who need the new targeted therapies and their companion diagnostics,” he says. At the same time, he acknowledges, some diagnostic tests entering the market may tell you a lot but a corresponding beneficial health intervention may be unavailable. Diagnostics manufacturers will have to prove the clinical and economic value propositions of their wares to gain favorable payment from insurers and recognition by regulatory agencies, medical societies, and healthcare quality organizations. That means being prepared to conduct well-designed, double-blinded, randomized studies to establish efficacy, safety, and relative performance, and the ability to produce economic health outcomes data to make the case for their value to the system — shorter length of hospital stay, reduced drug utilization, and resumption of normal daily activity, for instance. Biopharmaceutical manufacturers are something of a barrier to progress along those lines; many are reluctant to collaborate with test makers during the drug development process to help to advance the science. To be sure, the existence of a test that is highly specific for probability of response would make their drug well received for a certain niche, such as with HER2 testing and trastuzumab. “But the downside,” says Baker, “is that not all patients would get [your drug]. Whether it’s appropriate or inappropriate, if you’re a manufacturer, the more utilization you have, the more money you get — so manufacturers have not been a tremendous force for change.” But targeted therapies, which is where molecular testing will prove its worth, are not really about one drug for a large group of patients. As Deloitte points out in its 2007 report “Targeted Therapies — Navigating the Business Challenges of Personalized Medicine,” four targeted therapy models are emerging: • One drug for one phenotype • One drug fits a small group (where trastuzumab falls) • One regimen for one patient • One pill for one patient That’s a very different care model than what exists today, and Deloitte argues that these kinds of targeted therapies will change traditional stakeholder boundaries. From drug discovery all the way to care delivery, stakeholders will need to align their interests, and health plans could possibly act as third-party administrators to facilitate that continuum. A turn in this direction will come neither easily nor fast, considering the issues of confidentiality that must first be overcome. SO, WHAT COMES NOW? The influx of biologic products on the market, the emergence of better diagnostics, advances in personalized medicine, and the difficulty of establishing a regulatory pathway for biologic follow-ons — these will force more dramatic changes in benefit management during the second decade of the modern biologic era than what was tried during the first. Those interviewed for this article suggest that a number of techniques could supplement or even supplant the management models now in place. Centralized demand and case management. “Automation and the ability to integrate at a single point to manage lab, pharmacy, and medical services is just emerging, with the technology capability and largescale adoptions by most health care payers expected within the next 5 years,” says Kwok. Although he admits that this prediction reflects some hype and that the time line may be longer for smaller systems because of the expense involved, Kwok cites Anthem Blue Cross and Blue Shield’s pronouncement in January that by the end of this year, it will have a centralized process to assimilate all biologics, lab, and medical requests. That means it will have the ability to intervene at the point of service — with access to all available information that until now had been segregated in physician, payer, and other silos. These data will enable payers to intervene in referral processes, request lab work when pre- JULY/AUGUST 2008 · BIOTECHNOLOGY HEALTHCARE 25

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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