Healthcare reform is forcing a value drive in the industry where companies will feel more pressure to prove value as much as outcomes.
The development of targeted drugs has been a big shift from the one-size-fits-all approach pharmaceutical companies have traditionally taken.
The approval of GlaxoSmithKline’s skin cancer therapeutic and companion diagnostic last month served as only the latest reminder that the list of personalized medicines and diagnostics is continuing to grow.
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In a recent interview with life science investor Steven Burrill, CEO of Burrill & Co, who is keynoting the annual personalized medicine conference by BioNJ this week, stressed that many more changes lay ahead for an industry that he sees will need to work more closely with payers. Payers are driving many of the changes because they’re willing to pay for improved outcomes at a lower cost so value is being measured differently.
Burrill sees the US moving closer to a system of reimbursement that’s more like the UK’s National Institute for Clinical Excellence –a cost-effectiveness assessment body will have to do more to justify the price of their drugs. “We see pharma companies becoming disease managers.”
Some see room for more efficiency and value in personalized medicine, particularly with the structure of clinical trials. One of the greatest advantages of companion diagnostics is they can help optimize dosages of the drug they’re developed with and could improve clinical trial outcomes. Data from the FDA shows that up to half of companies’ drug pipelines are targeted therapies.
On the other hand, it can also be a big challenge to develop a diagnostic test in time for approval with the drug. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, made that observation at a personalized medicine event in Washington last month.
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Woodcock called for a new definition of clinical trials because a single trial to answer questions raised by each biomarker candidate isn’t feasible. She called for setting up ongoing trials with broad intake and many strata based on biomarkers.
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