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The Value of Regulatory and Healthcare Policy Changes in Oncology Care

Surabhi Dangi-Garimella, PhD
At the The American Journal of Managed Care®'s Spring 2017 Oncology Stakeholders Summit, the discussion touched off-label communication, the evolving clinical trial design, and healthcare reform, all while ensuring care is patient-centered.
With a new administration in Washington, DC, change is expected over the next year, including a new direction in healthcare policy. Although the American Health Care Act (AHCA) failed to garner support from the House of Representatives in March, Republican efforts to replace the Affordable Care Act (ACA) are expected to continue. Concurrent changes within the drug regulatory body are expected—policies that will provide wheels to the FDA’s slow-moving drug approval process. 

At its Spring 2017 Oncology Stakeholders Summit, The American Journal of Managed Care® hosted Robert W. Carlson, MD, CEO of the National Comprehensive Cancer Network (NCCN); Elizabeth Carpenter, senior vice president, Avalere Health; John L. Fox, MD, associate chief medical officer, Priority Health; and Bhuvana Sagar, MD, national medical director, Cigna Healthcare, to discuss how these changes will affect how a patient receives care in the clinic. The discussion was moderated by Joseph Alvarnas, MD, director of value-based analytics and associate clinical professor in the Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, in Duarte, California, and editor-in-chief of Evidence-Based Oncology™. 
Off-Label Communication 
The conversation began with a discussion around the level of evidence and the scope of off-label communications, which the FDA has been openly pursuing. The FDA even conducted a public hearing in November 2016 to gather input as it continues to review its policy prohibiting the promotion of FDA-approved drugs for off-label uses.1 

Carlson explained that the FDA buckets off-label communication into health economic information—which, he said, might be of most interest to payers and pharmacy and therapeutic (P&T) committees—and off-labelled indications, meaning “uses of the drug for which there is a label, but using them in circumstances or situations where the drug is active, presumably, but not actually, on the label.” 

The FDA has made available an updated draft guidance,2 which Carlson said provides specific criteria on appropriate off-label communication between the pharmaceutical industry and the provider, payer, and patients. With both scientific and legal issues surrounding off-label communications, Carlson said that with patient safety as its top priority, the FDA wants to ensure appropriate communication that is not false or misleading. 

As for vetting this information for accuracy, Carlson told Alvarnas that the pharmaceutical industry, fearing legal backlash, has not provided much healthcare economic information to P&T committees, and drug companies are extra cautious with the off-label information. The FDA’s guidance in this regard, Carlson said, says that such information: 
  • Should not be derived from a primary request by a company, such as an article written and funded by industry 
  • Should be readily available in the public domain 
Healthcare Costs 
Fox, citing concerns with the health economics data provided by the pharmaceutical industry, brought up the conflict that is introduced for a company’s health economics and outcomes research (HEOR) department, which often claims that the product will reduce healthcare costs. “If everybody reduces the cost to the degree that they said, healthcare would be free, I think,” Fox said. To ensure that the health economics data reviewed by a health plan is valid, Fox would like to see HEOR data generated by an independent, unbiased source. He added that the FDA opening a door for increased communication may not “make life any better or the information any more credible.” 

Fox drew attention to the NCCN Guidelines, which he said is information vetted by experts and is readily accessible to everyone, including health plans, especially information on the safety and issues related to drug administration. Using this comment as a segue, Alvarnas was curious about the level of evidence that a manufacturer should share with physicians. 

Carlson noted that for a new drug, there will be a significant amount of evidence available for the on-label indications. “Unapproved does not mean unproven,” he added, explaining that off-label evidence for a drug might be equally good. As data emerge on older off-patent agents that support off-label indications, “someone who had a vested interest in getting a labeled indication could do so,” Carlson said. The motivation is stunted by the fact that it would require generating high-level data for drugs that are now less expensive and may not yield much profit. 

Does this assist or obstruct patient access? “It varies by state,” Fox replied, adding that in Michigan, where Priority Health operates, all FDA-approved drugs are covered. Off-label indications are covered if a physician can provide documentation in the form of 2 peer-reviewed articles for the indication or if the indications are included in a compendium, such as the NCCN Compendium.3 “Most health plans today will cover that as long as it’s in the Compendium, as will Medicare,” Fox added. 

Carlson emphasized the importance of considering the “totality of evidence,” because peer-reviewed literature may not always be credible. “Having a therapy in the peer-reviewed literature does not necessarily mean it’s an appropriate therapy, even if that study shows advantage, because it may be poorly conducted, poorly analyzed, [or] may not include a meaningful endpoint,” he added. 
Drug Price Policy
Looking at the bigger picture, would off-label information assist with formulary management and healthcare costs? Carlson said that off-label communication would mainly be available for patent-protected drugs because generic manufacturers do not gain much to communicate such information to payers or providers. For Fox, the bigger challenge is dealing with decisions made when information is taken out of context. “While off-label indications may not impact the practice of medicine, if physicians take this out of context, it could have a deleterious effect on patients when we have better evidence to support alternative therapies,” he said. 

Alvarnas asked Carpenter to share her thoughts on how the new administration might address drug costs, since prices have been on President Donald Trump’s radar since the early days of his campaign. Carpenter agreed that although Trump has been outspoken about the role of drug prices, “perhaps more fascinating and challenging for the pharmaceutical industry is what’s going on at the state level.” She cited New York as an example of a state that passed legislation to create a drug price control program within Medicaid.4 During his 2017 State of the State address in January, New York Governor Andrew Cuomo announced a 3-pronged approach: protecting the Medicaid program from prescription price overcharge, a surcharge on manufacturers that charge exorbitant prices, and protection from intermediaries who cause a spike in drug prices. 

Lack of competition creates an uneven playing field, Fox said. “What we see typically is that with each new incremental improvement, the 6 weeks of overall survival (OS) or progression-free survival (PFS), that there is a nonincremental price increase,” he added, voicing his support for Medicare to negotiate drug prices, which, he added, would be a game changer since most payers follow in Medicare’s footsteps. 

Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
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