ASCO Advocates Value in Drug Pricing
Potential solutions to improve affordability of cancer drugs require prioritizing and testing and then should be applied in a standardized way to assess drug value, according to a new position statement from the American Society of Clinical Oncology (ASCO).

Potential solutions to improve affordability of cancer drugs require prioritizing and testing and then should be applied in a standardized way to assess drug value, according to a new position statement from the American Society of Clinical Oncology (ASCO).

Value and affordability have emerged as central issues in cancer drug development, as the cost of new cancer drugs routinely exceeds $100,000 a year. Many patients delay or forgo treatment because they cannot afford drugs, which have become the fastest-growing component of cancer care costs, ASCO officials said in a statement.

A majority of patients with cancer report distress related to financial aspects of their care, and they declare bankruptcy twice as often as the general population.

"In what, undoubtedly, is one of the most difficult times in their lives, individuals with cancer should be focused on getting the best care possible, not worrying about financial strain on their families," said ASCO CEO Clifford Hudis, MD. "As cancer doctors, we're accountable for ensuring our patients receive the right drug at the right time, but that alone isn't going to rein in costs. We need our nation's leaders to tackle the major drivers of patients' cost burdens, including rising prices."

As a first step toward reducing the cost of cancer drugs, ASCO calls on stakeholders from "across the healthcare sector" to come together to identify, prioritize, and test potential solutions to address the affordability of cancer drugs. The stakeholders should then develop or define a standard, broadly applicable approach to assess the value of drugs and inform drug pricing and reimbursement.

A number of potential solutions have already been set forth by various individuals and groups, but prioritizing and testing cannot proceed without an agreed-upon definition of value, said position statement co-author Blase Polite, MD, of the University of Chicago.

"Once you define value, once you reach some general agreement, then you can test all sorts of different proposals," Polite told MedPage Today. "But you can't do any of it until you can come up with some fundamental agreement on how to assess the value of a drug."

Several "pretty sophisticated" efforts to define value have been put on the table, each with its own strengths and weaknesses, Polite continued. Evaluation of those definitions will require policymakers to prioritize testing and authorize demonstrations, perhaps beginning with one or two payment models.

ASCO officials acknowledged "unprecedented success" with recent therapeutic development in oncology but noted that "in some cases, the price of a new drug bears no relation to its effectiveness." One study showed that only 19% of cancer drugs recently approved by the FDA met criteria for "clinically meaningful outcomes."

In the position statement, ASCO suggested the FDA consider using meaningful clinical outcomes when assessing new and supplemental drug applications, rather than "small benefits that achieve statistical significance in large trials." ASCO previously published a position statement that included a recommended definition of clinically meaningful outcomes.

ASCO also suggested that Medicare test the feasibility of a "value-based pathway" to encourage providers to use higher-value drugs and encourage the pharmaceutical industry to develop high-value treatments.

"We begin setting the expectation that, when pharma designs trials, they understand what the rules of the game are in terms of value thresholds," said Polite. "If you say 'these are the kinds of hazard ratios, tails on [survival] curves, quality of life that we expect for something to have real uptake in the market,' then we hope they start designing clinical trials around that."

The complete position statement is available on the ASCO website.

Charles Bankhead is senior editor for oncology and also covers urology, dermatology, and ophthalmology. He joined MedPage Today in 2007. Follow

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