Biotechnology Healthcare - September/October 2008 - (Page 42)

son says. “And then there’s whether the extra value in clinical terms is worth the extra cost that is being presented to you.” How that works in the United Kingdom, though, isn’t easily translated to the U.S. healthcare system. “There would be some aspects of the framework you use to establish value that are transferable,” says Longson, “but there are other things that wouldn’t be.” Some aspects of the process can be generalized, but there are issues specific to each country that could influence the cost-effectiveness of a therapy. For example, she says, “The way that clinical care is delivered has a very big impact on comparative effectiveness. How long people stay in hospital might be very different across countries, and that could have a very big impact.” From Jimenez’s perspective, this is one trend that rightfully belongs in the hands of the manufacturers. “I think it’s best left to the drug developers, because the onus is on us to prove to the payers that our drugs are safe, effective, and costeffective. To the extent payers are conducting comparative effectiveness analyses, there will be questions about the study design. Are those trials truly going to measure safety and effectiveness if they’re not fully developed by entities that have many years of experience designing trials?” The answer, says Longson, is to ensure that the manufacturer understands the requirements for comparative clinical effectiveness and for evaluation of cost-effectiveness. EMERGING ART FORM In the Single Technology Appraisal Process at NICE, the manufacturer produces a dossier, but there’s also an independent assessment of the submission. “We don’t see any particular issues of principle in relying on a submission from a manufacturer with an appropriate independent review,” Longson says. However, she continues, it is crucial to present the right evidence in the right way. That, she says, “is why we think it is important to enter into early dialogue with drug developers about the types of evidence we need, so that they can incorporate this into their development plans.” The emphasis for Novartis is on intelligent design, says Jimenez. By incorporating the work into a planned study, the advice from NICE was used in a way that makes sense. “In this case, we were able to [make minor modifications] to the phase 3 trial design in a way that didn’t change the cost but answered questions that NICE had,” says Jimenez. If the changes had added to the amount of time and cost of developing the therapy, then it would not have been nearly as appealing. It’s not really a surprise that costeffectiveness studies are controversial in the United States, says Aitken, at IMS. When you analyze the relative costs of a therapy, it inevitably brings up the notion of rationing — a “third rail” issue that government won’t want to touch. “We don’t want to believe that we have to ration healthcare,” says Aitken. “The reality is that we do ration healthcare but just don’t do it in a very transparent way. “That third rail issue is very deeply ingrained in the United States. This is a big issue in the United States, and it will take a long time to sort it out.” But it is happening, and as pharma companies try to get ahead of the issue, they will continue to advance ideas like early dialogue with NICE. Third-party payers also will press forward steadily, seeking more evidence of the actual value of what they are covering. “It’s going to happen one way or another,” Aitken says. “This pressure between budgets and innovation coming into the market is going to continue. Payers are looking to be more creative in how they can bring evidence to bear on pricing and access levels to members. So, too, pharmaceutical companies are looking to build up ever-greater evidence of the value of their medications. Pharma companies want to be sure they are on the front end of the curve in developing the case for their products — to develop the value proposition based on solid evidence and to be communicating that ever more effectively. The demonstration of costeffectiveness, he says, “is still an emerging art form. There are still significant variations and debate about the appropriate way it should be done. And this is going to continue to evolve.” Aitken says the key here is less about who agrees to pay for new trials — an expensive and lengthy process — and more about whether payers and policy makers can figure out how to use the growing mountain of data in utilization reports to analyze the cost-effectiveness of a given therapy. Once those data can be swiftly accessed and analyzed, payers and developers both will have an efficient tool to analyze the cost-effectiveness of all therapies on the market. Senior contributing editor John Carroll is a freelance writer and is the editor of Fierce Biotech. 42 BIOTECHNOLOGY HEALTHCARE · SEPTEMBER/OCTOBER 2008

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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