Thought Leadership

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.

In competitive therapeutic areas, like immunology and oncology, optimizing market share depends on creating a more structured, holistic market access story. By augmenting traditional market access datasets with real-world data from claims and labs, manufacturers can follow patients’ progression along the care continuum—and uncover new opportunities to improve access.

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.

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.

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.

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.

The rising cost of specialty pharmaceuticals has motivated payers to implement tighter restrictions and seek both traditional and value-based contracts. 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.

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.

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).

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.