Radar on Drug Benefits

As the U.S. continues to grapple with the COVID-19 pandemic, people with cancer continue to unsurprisingly be hesitant to visit a provider office or hospital for treatment. So, Cancer Treatment Centers of America (CTCA) is working with CVS Health Corp. to bring therapies into certain patients’ homes, helping keep immunocompromised people safer and allowing them to continue much-needed cancer treatment.

Multiple studies have shown how the pandemic has affected all aspects of cancer care, from screening and diagnostic workups to actual oncology treatments, follow-up services and patient support.

Thanks to recent regulatory moves as well as the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector. However, it’s still unclear how the Biden administration will approach the issue, industry experts say, so stakeholders on both sides of the debate should prepare for more uncertainty.

Copay accumulators work by preventing any monetary assistance that pharmaceutical companies offer commercially insured patients from counting toward their deductible or out-of-pocket maximum. Their close cousin, copay maximizers, take the total amount of a manufacturer’s copay offset program and divide it by 12, and that amount becomes the new monthly copayment for all patients on any given drug over the course of a year.

The National Academies of Sciences, Engineering, and Medicine, while acknowledging that payers are concerned about waste and extra expense that may occur when some of the medication in a single-use vial is discarded, says there’s little private payers can do to help offset this waste. In fact, it’s urging CMS to discontinue the requirement that providers report data on unused medication, while also recommending several regulatory steps that it says could help the overall cost problem.

The congressionally mandated report from the National Academies notes that many of these drugs are among the most expensive on the market. But the excess portions of single-dose vials that are discarded don’t necessarily represent waste at all, says study committee chair Edward Shortliffe, M.D., Ph.D., chair emeritus and adjunct professor at Columbia University’s Department of Biomedical Informatics.

As a new bill introduced by Sen. Bernie Sanders (I-VT) indicates, Congress is once again looking seriously at tackling drug pricing reform. D.C. insiders say that Democrats could pursue big changes to PBM regulation and Medicare’s ability to negotiate drug prices, likely through a budget reconciliation bill, and suggest that parts of previous pieces of legislation, such as the 116th Congress’ H.R. 3, are likely to serve as templates for a new bill.

While previous proposals are likely to be where the conversation starts, experts say that Congress is unlikely to pass all of the reforms proposed in existing bills. Those include H.R. 3, the new bill from Sanders and a Senate bill sponsored by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) — though all components of each bill contain elements that a new measure could include.

✦ Blue Cross and Blue Shield of Minnesota said on March 4 that it’s suing Vyera Pharmaceuticals and its infamous former CEO Martin Shkreli, claiming they “intentionally monopolized the pharmaceutical market for Daraprim in order to increase prices by more than 4,000 percent.” Daraprim is the leading treatment for toxoplasmosis, a parasitic infection that can be fatal for patients with HIV/AIDS, cancer, or compromised immune systems. Vyera, formerly Turing Pharmaceuticals, hiked the per-pill price for Daraprim from $17.50 to $750 after purchasing the rights to the drug in 2015, the Blues plan noted in a press release. Shkreli, dubbed the “Pharma Bro” by some media outlets, is currently serving a prison term after being found guilty of securities fraud. Read more at https://n.pr/3est69e.

✦ As the world struggled to fight the coronavirus in 2020, the FDA was unable to complete more than 1,000 of its planned drug inspections “and will likely face a backlog of inspections in future years,” according to a report from the U.S. Government Accountability Office (GAO) published March 4. The report noted that the FDA during the COVID-19 pandemic “used alternative inspection tools to oversee drug manufacturing quality,” but “these are not a comprehensive or long-term substitute for inspections.” Read more at https://bit.ly/3rx3oE6.