FDA Perspective: Reducing Cost, Increasing Access to Cancer Care

January 2019, Vol 9, No 1

In a time when the country feels more politically divided than ever, there is broad consensus that Medicare should be allowed to negotiate prescription drug prices directly with drug makers, and that the FDA should expedite approvals of generic cancer drugs to lower patients’ out-of-pocket costs.

At the 2018 Palliative and Supportive Care in Oncology Symposium, Tatiana M. Prowell, MD, Breast Cancer Scientific Liaison at the FDA, and Assistant Professor of Oncology, Johns Hopkins University, discussed ways in which the FDA can help ease the financial burden on patients with cancer while improving access to clinical trials.

“Our system is broken,” said Dr Prowell. “It’s not really designed for the disease that we treat, and the kind of drugs that we prescribe, so it’s necessary to explore alternative payment models.”

Disparity in Drug Costs

Despite being the largest drug purchaser in the world, Medicare is prohibited by law from negotiating prices for Medicare Part B drugs, which provides a potential financial incentive for providers to prescribe high-cost drugs. To discourage price inflation, the current federal government has proposed the International Pricing Index model to base drug payment levels on international prices of the same drug, to be phased in over 5 years. According to the Centers for Medicare & Medicaid Services, this should reduce costs for Medicare beneficiaries, by increasing adherence and access to prescription drugs, as well as introducing competition into the system of paying for physician-administered drugs by bringing in private sector vendors.

“The administration’s goal, to a large degree, is to address this disparity in drug pricing between the United States and the rest of the world,” said Dr Prowell. “The narrative is that we are subsidizing drug development and innovation for the rest of the world, and many view this as unfair,” she added.

“Although it’s not a perfect solution, this model could potentially reduce costs to the American taxpayer,” Dr Prowell said.

According to Dr Prowell, the FDA has been exploring ways to bring generic drugs to market faster. By offering expedited review of the first 3 generic drug applications, for example, the FDA is trying to ensure the availability of at least 2 competitors and, ideally, a third, in case one company stops manufacturing the drug.

“We’ve reduced review times for generics by more than 50%, while addressing some loopholes for impeding introduction of generics and biosimilars,” Dr Prowell said. “Unfortunately, the majority of drugs that we’re treating patients with these days in oncology are not drugs that have generics available. These are drugs that are still on patent, or are still under periods of exclusivity.”

Improving Access to Care

Another priority is better patient access to care. Concerns about missed work and lost wages may be prohibiting some patients from participating in clinical trials, according to Dr Prowell. Although the Affordable Care Act mandates that most private insurers cover routine costs of care, said Dr Prowell, it does not require coverage of clinical trials if they are out of network, which is a problem for patients who have limited network options.

“Coverage of complications is less well-defined and exposes patients to a lot of risk, which is a huge barrier to patients going on clinical trials,” Dr Prowell said. “Patients are nervous about what happens if they get a complication…and their insurance refuses to cover.”

Potential Solutions

What regulators can fix most readily, according to Dr Prowell, are the substantial ancillary costs of clinical trials, such as travel, lodging, childcare, and lost wages.

“Medicaid still has no federal mandates for trial coverage, and this is a place where I think there really needs to be advocacy,” said Dr Prowell, adding that patient advocates are also encouraging companies to conduct clinical trials in underserved areas. The FDA is currently investigating opportunities to decentralize clinical trials to address disparities in trial participation.

“The notion that patients all have to come in a central fashion to have their blood drawn, or get their scans done, is false,” said Dr Prowell. “We are also looking at ways in which telemedicine and wearable devices can help us capture patient history and vital signs.”

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