bility criteria make it difficult to apply findings to real-world populations, undercutting their ability to determine treatment effectiveness. To solve this problem, Dr. Bach asked, how can we develop evidence for cancer drug effectiveness after FDA approval?

On the theme of pharmaceutical pricing, Dr. Bach reviewed several approaches the workshop had discussed. Value-based pricing was one approach in which the price of a drug would be based on the health return of that drug, expressed in terms of cost per QALY, for instance. Another approach was the United Kingdom’s NICE model with an explicit upper limit on cost per QALY to drive down prices. Coinsurance, or increased co-pays for more expensive or less effective drugs, came up a number of times as a way to sensitize patients to higher drug prices and drive manufacturers’ prices down. Alternatively, a reimbursement-structured model, Dr. Bach said, would establish clinically-based drug interchangeability criteria to increase direct competition between drugs and manufacturers, interrupt the monopoly pricing structures manufacturers now benefit from, and drive down prices.

High coinsurance burden has ethical challenges, Dr. Bach said. If patient sensitivity to price varies as a result of different coinsurance rates, this may interfere with patient autonomy. There is no question that higher co-pays reduce utilization, and for tier-4 drugs with a coinsurance rate of 20 percent, the patients’ financial disincentive can be on the order of thousands of dollars a month or tens of thousands of dollars a year. An intriguing question, Dr. Bach said, was whether the financial burden of the co-pay poses an ethical risk to autonomy, or the simple presence of coinsurance of any size is enough to be ethically problematic.

Lastly, Dr. Bach reiterated the theme that clinicians at the bedside should not be expected to ration care on their own, especially in cases when their patients may benefit from treatments with extraordinarily high costs. Dr. Bach had concerns about putting clinicians in this role—given that clinicians’ ability to provide evidence-based care has been uneven at best, should they be solely responsible for limiting care at the bedside? The reality is that clinicians have a strong independent streak and feel that they should be autonomous decision makers, and they are unlikely to accept external pressures to ration care.

Dr. Bach then turned to the panel of moderators for their comments.

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