New cancer drugs should see their patents extended six months for companies that conduct clinical trials in older adults or patients with multiple comorbidities, according to a new Institute of Medicine (IOM) report released today. This report deemed that more trials—plus additional comparative effectiveness research and improved translation of evidence into clinical practice—were essential for addressing what it termed a crisis in the nation’s quality of cancer care.
Those essentials were part of a six-point conceptual framework for improved cancer-care quality laid out by an IOM-appointed committee of 17 experts. The framework also included more patient engagement; better-trained professionals to coordinate care with primary physicians and specialists; greater use of advanced IT; and new payment models that base reimbursement on quality of care rather than quantity of interventions.
“There is great need for high-quality, evidence-based strategies to guide cancer care and ensure efficient and effective use of scarce resources,” the IOM concluded in “Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis.” “Decisions about cancer care are often not evidence-based. Many patients also do not receive adequate explanation of their treatment goals, and when a phase of treatment concludes, they frequently do not know what they have received or the consequences on their future health.”
The committee was chaired by Patricia A. Ganz, director of cancer prevention and control research at the Jonsson Comprehensive Cancer Center at the University of Los Angeles, Schools of Medicine and Public Health, where she is a distinguished university professor. The committee’s recommendation for extending cancer-drug patents was based on results of clinical trials of pediatric drugs that had won additional exclusivity through exclusivity-based incentive provisions introduced in 1997 and made permanent last year.
For trials comparing new cancer treatments to standard therapies, the IOM panel added, the National Cancer Institute (NCI) and other agencies should not fund the studies without requiring investigators to “study a population that mirrors the age distribution and health risk profile of patients with the disease.”
However, the panel also acknowledged, “Such a mandate could make it more challenging to determine the efficacy and safety of a new treatment. This could make drug development more expensive, potentially require larger trials, and delay or prevent new drugs from entering the market.”
During a public webinar today, Dr. Ganz downplayed those possibilities by saying the additional trials did not constitute a change to the current clinical trial system.
Seeking Secondary Studies
“The patent protection that we suggest Congress should enact really is to do secondary studies that are focused specifically on the patient population that is going to receive the drug—it could be a 75-year-old with colon cancer—and to test it in those age-appropriate and comorbid-appropriate populations, and to demonstrate both its efficacy and toxicity in that setting,” Dr. Ganz said. “We think that’s an opportunity. Not all organizations will want to take us up on that. But it does allow us to get the kind of information we need in that target population.”
Despite concerns about patent extension in pediatrics, the panel concluded it “believes the need for more data on older adults with cancer and individuals with multiple comorbidities is so great that it justifies modeling this program in drugs used to treat older adults with cancer and individuals with multiple comorbidities.”
The IOM said that the NCI and funding agencies should join researchers, clinicians, and patients to develop common data sets collected from trials and studies that include patient-reported outcomes, relevant patient characteristics, and health behaviors.
The report called for developing clinical practice guidelines for translating evidence into actionable steps, based on the IOM’s 2011 report, “Clinical Practice Guidelines We Can Trust.” That report called for explaining the rationale behind guidelines; articulating recommended actions and when they should be performed; conducting external reviews; and updating guidelines periodically—as well as establishing transparency, managing conflicts of interest, creating broad multidisciplinary guideline development groups, and conducting systematic reviews.
Organizations that have developed such guidelines include the American Society of Clinical Oncology, the American Society for Radiation Oncology, the National Comprehensive Cancer Network, and the U.S. Preventive Services Task Force.