Radar on Drug Benefits

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee (ERIC), a lobbying group for companies managing self-funded health insurance plans.

Biosimilars have demonstrated the potential to save patients money in the studied drug categories, according to Mariana Socal, a physician and researcher at the Johns Hopkins Bloomberg School of Public Health and one of the study’s authors.

With the death toll from COVID-19 now surpassing 14,000 in the U.S., President Donald Trump and some of his advisers have repeatedly touted the promise of certain anti-malarial drugs to combat the disease caused by the novel coronavirus. That enthusiasm has sparked increasing concern that the surge in demand for such drugs, hydroxychloroquine and chloroquine, is imperiling access for patients who take them to treat autoimmune conditions such as lupus and rheumatoid arthritis. To help alleviate the issue, some major PBMs tell AIS Health that they’re placing utilization management controls on off-label use of hydroxychloroquine, chloroquine and other drugs with the potential to treat COVID-19.

OptumRx, one of the country’s largest PBMs and part of UnitedHealth Group, as of March 31 is limiting prescriptions for hydroxychloroquine and chloroquine to 30 tablets within a 90-day time period, “with an automatic bypass for members utilizing for chronic conditions such as rheumatoid arthritis or systemic lupus,” Chief Medical Officer Sumit Dutta, M.D., says in comments emailed to AIS Health. Members who are newly starting on hydroxychloroquine for rheumatoid arthritis or systemic lupus will be able to request quantities beyond 30 tablets.

✦ A case before the U.S. Supreme Court, which will determine how far states can go in regulating PBMs, will be delayed due to the COVID-19 crisis. Oral arguments in Rutledge v. Pharmaceutical Care Management Association were scheduled for April 27 but have now been postponed to an unspecified date. The case, which challenges a 2015 law enacted in Arkansas, concerns whether PBMs are acting as agents under the Employee Retirement Income Security Act of 1974 (ERISA) and therefore are exempt from state-level regulation. Read more at https://bit.ly/2Rmyuyd.

✦ Before oral arguments were rescheduled for Rutledge v. Pharmaceutical Care Management Association, America’s Health Insurance Plans (AHIP) filed an amicus brief supporting PCMA — the PBM trade group that is one of the parties in the case. AHIP said its brief focuses on the importance and need for the uniform administration of employer sponsored plans under ERISA” and “details the negative effects laws like the one passed in Arkansas have on the design and uniform administration of employer sponsored plan benefits, and why they are preempted by ERISA.” Read the brief at https://bit.ly/34kjNAY.

Hydroxychloroquine and chloroquine are far from the only drugs being tested for their potential to treat COVID-19, the disease caused by the novel coronavirus that has ballooned into a pandemic.

Another potentially promising therapy is remdesivir, an experimental antiviral drug developed by California-based Gilead Sciences, Inc. Previously, it has been tested on patients infected with Ebola and two other coronaviruses: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

Express Scripts said it saved enrolled plans some $4.3 billion in 2019 through its SafeGuardRx programs, which combine multiple cost- containment strategies such as value- based contracting and payments from financial guarantees.

The PBM first launched its “cure value” program in 2015 for hepatitis, shortly after the FDA approved Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir), the first among a slate of pricey second-generation hepatitis C therapies.