- Skyrocketing drug prices, insufficient healthcare data transparency, and slugglish precision medicine innovation cycles are placing a significant strain on Medicare patients, many of whom are unable to access cutting-edge treatments and are struggling to cope with how to cover the costs of their medications, said CMS Acting Administrator Andy Slavitt last week.
In remarks before the Biopharma Congress in Washington, DC, Slavitt urged pharmaceutical stakeholders to help CMS control drug prices, expand access, continue the progress of precision medicine, and develop the big data competencies to drive innovation in a $457 billion portion of the healthcare industry.
“Ultimately, our goal is to bring highest quality, cutting edge health care and medicine to our beneficiaries as affordably, as quickly and as safely as possible,” said Slavitt. “Because it’s patients that drive everything we do at CMS.”
CMS is engaging in several initiatives to support the affordability of treatments, starting with encouraging research and clinical trials to develop precision therapies.
“We’re looking for more ways to invest in research. I’ve been a proud member of Vice President Biden’s Cancer Moonshot Task Force, which worked to break down barriers between the research community, the federal government, community oncologists, and other innovators on processes to address the full range of issues impacting breakthrough medical discoveries,” Slavitt said.
CMS is also helping to connect researchers with patients by covering the cost of care for Medicare beneficiaries enrolled in certain clinical trials and studies.
The FDA, National Institutes of Health, and CMS have also established a leadership program that hopes to develop “critical ties that can eventually create a single front door to research safety, efficacy, coverage, and pricing – with appropriate firewalls and safeguards,” Slavitt explained.
The three-pronged partnership aims to simplify the drug and device development and review process to speed up the process of determining CMS coverage for innovative products. CMS and the FDA have extended their parallel review collaboration that allows CMS to review new devices for coverage even before they obtain FDA approval.
The two agencies have already seen success with this process, Slavitt says, in the case of a rapid screening test for colon cancer. Several more products are currently in the pipeline, including a comprehensive genomic profiling assay that may support precision medicine decisions for oncology patients.
Approving new therapies for coverage is a good first step, but ensuring that precision medicine products end up with a sustainable and affordable price tag for patients is a whole separate challenge, Slavitt continued.
Prescription drug spending consumes nearly 17 percent of all healthcare spending, and CMS is anticipating average annual increases of 6.7 percent until 2025, Slavitt said. Specialty drugs are a significant driver of these increases. While they comprise only one percent of prescriptions, they accounted for 31.8 percent of spending in 2014.
“These numbers don’t give us the full picture, but they do help to draw attention to a problem that is an increasing source of worry for families across the country. Drug costs have become the health policy issue Americans are most anxious to see us act on, and we have a responsibility to them to explore all the options available us to make their medications more affordable,” Slavitt asserted.
In order to understand these remarkable trends – and gain a better idea of how high prices are translating into value for patients – CMS and the rest of the healthcare industry must make data more available, said Slavitt.
CMS has repeatedly voiced its commitment to more transparency over the past few years, and has followed through by releasing datasets on Medicare spending and utilization in “unprecedented detail,” he added.
“These data releases cover more than 85 percent of Medicare payments and include information not just on individual clinicians but also hospitals, skilled nursing facilities, home health agencies, and hospice providers. In addition, Medicare claims data shows us that we provided coverage for more than 145,000 beneficiaries in over 7,500 clinical studies in 2015,” he said.
“We recognize the potential contribution this knowledge can add to studies in which large numbers of our beneficiaries enroll. We are interested in collaborating with you to consider how we can leverage the size of the Medicare program and the quantity of data we collect to help you develop real-world evidence to show improved health outcomes from use of your products.”
Pharmaceutical developers should follow suit to encourage collaboration and help the industry create balanced, fair, and affordable policies for drug pricing in the future.
“What you choose to do as an industry will help define the next several years,” said Slavitt. “So the question is: can we have both innovation and the affordability necessary to make it accessible? I think the answer is yes. These two goals shouldn’t be in opposition. In every-forward looking industry outside of health care, we see that competition actually fuels innovation, and affordability improves alongside the development of new technologies.”
“CMS wants to be a partner in innovation. For those of you who look at data, find solutions, and pay for value, we want to partner with you.”