Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
Beginning with the basics, our Market Access 101 blog series has addressed how manufacturers can improve formulary placement for pharmacy benefit drugs, secure coverage and assess the need for contracting for medical benefit therapies.
In this final post, we’ll explore what it means to request a formulary exception or medical exception for a non-covered therapy. As we’ve said previously, payers and PBMs often place a mandatory six-month block on new therapies, to allow for review by the P&T committee as final…
This article was originally published in BioPharma Dive.
Over the past few decades, pharma companies have perfected the art of using market access data to support product launches, negotiate payer discounts, and secure preferred status and positioning. Manufacturers typically track formulary and medical policy guidelines and restrictions—including prior authorization and step therapy requirements—for a product and its competitors, using this data to inform their market access strategy.
For the most part, this approach works. But in competitive therapeutic areas, like immunology and oncology, optimizing…
Biotech and pharma companies have a vast range of capabilities and data sophistication, from their data acquisition strategy down to the way they consume, curate and present data internally.
In the last 10 years of my career, I've been involved in hundreds of data assessments on the side of the data supplier. Regardless of an organization’s data proficiency level, there are discrete steps all manufacturers can take to improve their partnerships with data vendors—and ultimately, to ensure commercial success.
Articulate your…
The COVID-19 pandemic illuminated a challenge to the U.S. healthcare system that continues to undermine effective patient care: medication shortages. A Senate report found that drug shortages increased nearly 30% last year, with a record five-year high of 295 active drug shortages by the end of 2022.
Most recently, these shortages include drugs used to treat ADHD, common over-the-counter children’s cold and flu medicine, and even a drug intended for diabetes treatment, which was used off-label to meet the tremendous demand…
Welcome back to our Market Access 101 blog series, which began with the basics of market access and covered how to improve formulary placement and secure coverage under the medical benefit. In this post, we’ll dive deeper into the medical benefit, explaining how payer/PBM contracting works—and why it’s increasingly necessary.
Essentially, all pharma companies want to know which of their competitors is contracting, but nobody wants to be the first to take the plunge. After all, once manufacturers begin payer/PBM contracting…
While the Inflation Reduction Act (IRA) may best be known for mandating Medicare drug price negotiation, the act did much more than that. Among its other accomplishments are the elimination of cost sharing for vaccines under Medicare Part D, as well as improved access to adult vaccines for Medicaid and Children’s Health Insurance Program (CHIP) enrollees.
Many vaccines target communicable conditions, and low use of these agents contributes to the diseases’ spread. When people are not vaccinated, they are at higher…
This article was originally published in Drug Channels.
In recent years, the rising cost of specialty pharmaceuticals has motivated payers to implement tighter restrictions and seek both traditional and value-based contracts with manufacturers. As manufacturers are already contracting with GPOs, distribution networks and medical practices, most would prefer to avoid contracting with payers and PBMs for their medical benefit products.
However, given the widespread adoption of medical benefit contracting, this trend is unlikely to lose momentum. Manufacturers must evaluate their current…
In 2021, Novo Nordisk’s Wegovy (semaglutide) gained FDA approval for chronic weight management in overweight or obese adults, hitting the market in June 2022 at a list price of $1,349 per 28-day supply. In clinical trials, patients achieved an astounding mean weight loss of nearly 15% after 68 weeks of treatment with Wegovy.
Excess body weight is a real problem in this country, as more than two-thirds of American adults are either overweight or have obesity. Despite efforts to diet and…
The past few years have seen an increase in the number of long-acting injectable (LAI) therapies for a variety of disorders and diseases, including schizophrenia, bipolar disorder, and HIV. These LAI antipsychotics and antiretroviral therapies include brand-name drugs such as Invega Sustenna (paliperidone palmitate by Jannsen), Abilify Maintena (aripirazole by Otsuka), and Cabenuva (cabotegravir/rilpirivine by ViiV).
Manufacturers with LAIs in the pipeline will need to be mindful about the persistent barriers to access faced by drugs with this formulation. Manufacturers with…
The Inflation Reduction Act (IRA), signed into law in August 2022, was intended in part to lower healthcare costs for families and small businesses. The IRA contains several provisions aimed at prescription drug costs which will roll out over the next few years, with the earliest taking effect this year. As of 2023, CMS will require pharmaceutical manufacturers to pay rebates to Medicare if their drugs’ prices increase at a rate which outpaces inflation.
The steady increase of drug prices has…
