Biotechnology Healthcare - September/October 2008 - (Page 39)

COST-EFFECTIVENESS: AN EVOLVING SCIENCE Payers want ever more evidence to support drug pricing and to help determine access levels for members. Biopharmas want to be in front of the curve when developing the value proposition for their products. Slowly, the two are moving toward the middle. BY JOHN CARROLL Senior Contributing Editor L ast year, Novartis and regulatory officials in the United Kingdom hatched an unusual collaboration. Preparing to launch a late-stage clinical trial for an experimental psoriasis medication, the company approached the National Institute for Health and Clinical Excellence (NICE) with an interesting idea: How could it design the study to gather the data NICE needed to evaluate the cost-effectiveness of the drug? “We had proof-of-concept data,” says Joseph Jimenez, chief of pharmaceuticals at the Swiss pharma giant, “but we had not yet designed the phase 3 trial. So we asked, ‘What evidence would you need to see when we come with the full clinical package of results to be able to recommend that this be reimbursed on the U.K. market at a particular price, based on the risk/benefit profile?’ “They looked at the benefit of the drug, what it could do for patients, and costs that could be avoided downstream, and NICE was able to come back to us with very valuable and clear information on what they would need to see. And that enabled us to design the phase 3 [trial] in a way that could answer some of those questions.” Jimenez isn’t about to let all the details out of the bag for the competition to see, but he’s clear that in a world in which third-party payers are taking a hard look at the therapies they’re paying for, the earlier you start making your case for costeffectiveness, the better chance you’ll have of getting approval for reimbursement. That view does not stop at the borders of the United Kingdom. Australia and other countries have signaled their interest in the test pilot study. It also could play a role in the United States, says Jimenez, where there are a variety of public and private payers to court. And this is one trend, adds Jimenez, that can only swell in significance with time. “I do believe that this will spread and will benefit pharmaceutical companies, payers, and reimburse- Comparative effectiveness analysis, believes Joe Jimenez, CEO of Novartis Pharma, “is best left to the drug developers, because the onus is on us to prove to payers that our drugs are safe, effective, and cost-effective.” SEPTEMBER/OCTOBER 2008 · BIOTECHNOLOGY HEALTHCARE 39

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - September/October 2008

Biotechnology Healthcare - September/October 2008 Openers Editorial/David B. Nash, MD, MBA Contents At a Glance: Multiple Sclerosis Drug Track Personalized Medicine Healthcare Reform’s Effects on Biologic Access Breast Cancer Status Testing: A Crapshoot With Deadly Odds Trends, Issues, and Perspectives In the Management of MS So High-Tech, Yet So Simple The Evolution of Ascertaining the Value Proposition Specialty Pharmacy Employer to Employer Health Plan Confidential Trends

Biotechnology Healthcare - September/October 2008

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