Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
Consideration of patients’ social determinants of health (SDoH) has been a facet of healthcare delivery in the United States for decades. The CDC defines SDoH as the nonmedical factors that influence a patient’s health outcomes, such as access to care services and medication, housing and food stability, education levels, and employment.
During the COVID-19 pandemic, SDoH became a more prominent area of focus for providers and insurers, as inequities in access to healthcare became more apparent. Most healthcare professionals have an…
When it comes to the degree of payer management within a therapeutic area, pharma companies are becoming the victim of their own successes. One prime example is the rapid growth of competitive therapies across tumor types, pharmacological classes, and mechanisms of action in oncology. Payers have responded to the launch of more innovative and highly effective therapies with increased utilization management restrictions to balance the cost and quality of care.
Traditionally, the oncology space has been subjected to minimal management from…
It has now been over a year since the first Humira biosimilar, Amgen's Amjevita, entered the U.S. market. Eight additional adalimumab biosimilars followed suit, offering lower-cost alternatives to AbbVie’s blockbuster drug via a variety of dual-pricing and discounting strategies.
Some PBMs, including Express Scripts and Optum Rx, were quick to add some biosimilars to their formularies, embracing a mix of low-list-price and high-list-price/high-rebate biosimilars. Many other payers, however, have been somewhat slow to place biosimilars on their formularies, both within the…
In our collective experience working with dozens of clients, we’ve found that smaller pharma companies and biotechs wrestle with many common challenges, regardless of their therapeutic area. From limited budgets to a late start on market access activities, we see the same roadblocks time and again.
Here are four tips for smaller manufacturers on how you might approach the journey to commercialization—and come out ahead, despite the obstacles.
1. Get an early start on commercialization Small-sized pharma companies do not usually…
Manufacturers are continuing to wrestle with the effects of the Inflation Reduction Act (IRA) on their business plans and revenue streams. Although some of the IRA’s impacts are still uncertain, real-world evidence (RWE) is an important tool for manufacturers navigating the road ahead, as it will help them demonstrate the value and comparative effectiveness of their treatments.
One of the IRA’s requirements is the Medicare Drug Price Negotiation Program, which allows Medicare to negotiate the prices of certain high-cost, single source drugs without…
The category of treatments known as ‘digital therapeutics’ is widely misunderstood. Though the term is often conflated with ‘digital health’ tools, such as fitness trackers or meditation apps, digital therapeutics (DTx) are distinguished by their reliance on clinical evidence.
DTx products use evidence-based, clinically evaluated software to deliver medical interventions directly to patients to prevent, manage, or treat a disorder or disease. Many prescription digital therapeutics (PDTs) are software-only, while some are connected to wearable devices, and others are paired with…
Many years ago, I became one of the first people to be diagnosed with an ultra-rare vasculitis syndrome, a dangerous inflammation of the small blood vessels. My disease is so rare that I had a much better chance of winning the lottery, but instead, I ended up sick.
The story of how I was finally diagnosed is as unlikely as my disease, but it also speaks to a few broader truths about the importance of understanding the patient journey.
Soothing the…
The CDC estimates that more than 33,000 Americans are living with hemophilia, an inherited bleeding disorder which affects primarily men. Patients with hemophilia have a deficiency of the blood proteins, known as coagulation or clotting factors, that help blood to clot properly. The two most common subtypes are hemophilia A (factor VIII deficiency) and hemophilia B (factor IX deficiency).
While patients with mild hemophilia may have only sporadic episodes of uncontrolled bleeding, typically following injury or surgery, patients with severe hemophilia…
In the realm of oncology, the advent of clinical pathways has gained substantial traction in the past two decades as the increasing cost and complexity of cancer care demanded structured, multidisciplinary, and cost-effective approaches. Pathways have become a critical strategy for both physicians and payers to streamline treatment decision-making, standardize evidence-based care, improve patient outcomes by minimizing unnecessary variation, and reduce cost by guiding care to the most cost-effective treatments. These pathways, often referred to as care pathways or clinical guidelines,…
For the past few years, the industry has grappled with the rise of a controversial new pharmacy benefits strategy: alternative funding. Alternative funding programs (AFPs), also known as specialty carve-out programs, are intended to reduce the cost of specialty drugs for both patients and payers.
According to proponents, AFPs can help employers improve access while keeping costs in line. But according to detractors, these programs are by nature unsustainable—and potentially illegal. Despite these concerns, AFPs have been on the rise. According…
