When it comes to biosimilars, there seem to be far more questions than answers, specifically when it comes to interchangeability. Now that the FDA has granted two biosimilar products “interchangeable” status—with more to come, surely—how will this development affect the biosimilars market? What do pharma manufacturers, payers and physicians need to know about this designation? And, crucially, how might interchangeability affect biosimilar uptake in 2023 and beyond?
As researchers continue to identify specific genetic markers within different diseases, more and more treatments targeting those markers are launching. In fact, more than 77,000 genetic tests currently are available. They can identify, for example, what type of breast cancer or non-small cell lung cancer a patient has. Some can determine a person’s risk for developing a disease, and others can predict the probability of a response to a drug. With so many tests available, it can be hard for payers to determine what to cover, resulting in a lot of coverage inconsistency. They are looking for what kind of value that a test can bring, not only toward a patient’s care but also in healthcare spending. Generally speaking, payers assume that they will have a member for up to two years before the person changes jobs and switches insurance, so they’re also looking for an imminent impact.
Next year’s staggered launch of adalimumab biosimilars will mark one of the largest losses of exclusivity for a pharmaceutical company in U.S. market history.
For years, Humira has been the top-selling drug worldwide, raking in more than $20 billion in revenue last year. Manufacturers of reference biologics will be monitoring the impending upheaval, while companies with biosimilars in the pipeline will be eagerly tracking utilization data. Which drugs will secure a place on payers’ formularies, and when? And how will payers respond to this anticipated influx of Humira biosimilars?
Every consumer is familiar with the rebates one may get when purchasing a product or service. However, if the rebate was invalid or was not submitted properly, the money does not always get back to the consumer. A similar issue of ineligible rebates and incurred costs also consistently occurs in the pharmaceutical industry, but on a much larger scale. As a consumer, you would be angry if you didn’t get your money back from a rebate. Why should pharma companies let this issue go unresolved?
Could previously launched drugs that significantly missed sales expectations have met a different fate if their manufacturers had accounted for payer perspectives in their early stage development strategy?
Let’s start with some stats.
A patient's journey to accessing life-saving therapies is rarely linear, and while much of that is due to factors within the healthcare system, many external influences are also at work. Social determinants of health are an example of these outside forces that play a crucial role in patient care, for better or for worse.
Given the spotlight that COVID-19 has shone on the glaring holes within the U.S. healthcare system, it’s not surprising that the current Biden administration has placed considerable importance on addressing key issues head-on. The focus on solving these issues has manifested as the Inflation Reduction Act (IRA), which passed along party lines in the Senate as well as the House of Representatives and was signed into law by President Biden on Aug. 16, 2022. The IRA attacks several major issues currently facing the U.S., with healthcare being among the most important. While the healthcare provisions within the IRA cover various issues, they all address—directly or indirectly—the same theme: greater access to healthcare.
The End of the COVID-19 Public Health Emergency Is Inevitable. Here’s What That Could Mean for Health Plans
With the continuation of the COVID-19 pandemic and resulting policy changes, the health plan landscape is facing some complex challenges ahead.
A key factor contributing to these challenges is the Public Health Emergency (PHE) that was declared in January 2020 and renewed on July 15. As a condition of receiving enhanced federal funds during the PHE, states have been required to ensure continuous Medicaid and CHIP coverage for most enrollees by pausing eligibility redeterminations—a process in which the state determines if a member is still eligible for coverage due to factors such as income level.
At age 19, my stepson has run the gamut of therapeutic options—combination therapies, cognitive behavioral therapy, you name it—for treating his attention deficit hyperactivity disorder (ADHD). After 10 years of searching, we have yet to find a treatment that truly works for him.
However, there’s one option that we haven’t tried: prescription digital therapeutics (PDTs). More specifically, an app-based video game called EndeavorRx. The game, which was approved by FDA in June 2020, is a first-of-its-kind treatment that uses stimuli and motor conditioning to target areas of the brain that control attention function. And the results are impressive: 68% of parents reported improvement in ADHD-related impairments after two months of treatment.
In oncology, clinical pathways—recommendations of specific treatments for a specified group of patients—have long been used to help control costs and treatment variation while improving outcomes. Clinical pathways may be payer-driven or provider-driven based on the organization that develops and controls the pathways, and financial incentives and policing mechanisms encourage provider buy-in and adherence.