Getting a life-saving therapy into the hands of a patient who needs it is much easier said than done. While overcoming the numerous hurdles to adequate access typically falls to manufacturers, there are many stakeholders involved in this effort, from providers to payers to patients themselves.

Pharmacists, too, play a key role in helping patients get the medications they need, yet most aren’t taught the ins and outs of managed care or market access in pharmacy school. Instead, their training revolves around clinical education and is oftentimes geared toward earning a spot in residency.

Today’s healthcare world is seeing a shift from acute medicine to health management. A contributing factor to this has been the COVID-19 pandemic. A recent report shows that 66% of respondents with chronic conditions were more interested in taking a proactive approach to health than prior to the pandemic. People are taking a more vested interest in their health and are starting to focus more on preventative medicine instead of symptom management. Rather than waiting for a heart attack to happen, an individual can use health management—like healthy eating and exercise—to prevent that heart attack from happening in the first place.

As a society, we have made great strides in improving cancer care and outcomes in recent years. There are now more treatment options across more tumor types than ever before. There are targeted therapies designed for specific genetic mutations, which carry fewer side effects than traditional chemotherapy and lead to higher rates of remission and better progression-free survival.

As we wrote in our last article, “To Ace Your Product Launch, Don’t Fail At Market Access,” launching a drug into a crowded market without understanding the market access landscape is like failing to study for a make-or-break final.

Yet while inadequate patient access to a life-saving treatment is much graver than a disappointing grade, of course, our point remains: Pharma manufacturers aren’t doing their homework before launch, which prevents patients from accessing a much-needed, oftentimes long-awaited therapy.

Imagine that it’s senior year of high school, and you show up to chemistry class completely unprepared for the midterm exam—a midterm that’s worth half of your grade. Instead of studying the periodic table, you spent the previous evening rehearsing your choir solo. And while extracurriculars are important, messing up a few lyrics during the fall recital won’t have the same ramifications on your GPA and college opportunities as bombing that chemistry test.

According to the National Institutes of Health (NIH), nearly one in five U.S. adults (approximately 52 million) live with some form of mental illness. Unfortunately, those struggling with a mental health disorder often aren’t getting the treatment they need, and when undertreated, can have considerable economic impact on national healthcare budgets due to the cost of hospitalization for patients with worsening conditions.   

While vertical integration and consolidation within the U.S. health system has been a steady trend over the years, now we’re seeing it go even further with the creation of pharmacy benefit manager group purchasing organizations (PBM GPOs), which create yet another tollgate requiring payment in the drug therapy supply chain.

Approximately 80% of all prescription drug claims are managed by the top three PBMs: Express Scripts’ Ascent Health, OptumRx’s Emisar Pharmacy Solutions and CVS Caremark’s Zinc Health Services. Express Scripts, owned by Cigna, has set up Ascent in Switzerland. Ascent’s clients, in addition to Express Scripts and Cigna, include Kroger, Prime Therapeutics and Humana Commercial. Optum Rx, owned by UnitedHealthcare, has chosen Ireland as the headquarters for its GPO, Emisar. Zinc, the GPO created by CVS Health (which owns Aetna), is located within the U.S.

Pharmaceutical manufacturers that are nearing the commercialization stage of pre-approval planning are faced with a lot of realities about managed markets. Manufacturers are so engrossed in the details of a clinical trial, and its eventual success, that beginning to plan for commercialization can be daunting. However, for physician-administered therapies or IV therapies, understanding and navigating the nuances at play in the medical benefit landscape of payer organizations can significantly impact a product’s success.

Historically, access for medical benefit therapies was largely through buy-and-bill. Providers (integrated delivery networks [IDNs], clinics and practices) would acquire the product from the manufacturer via the manufacturer’s contracted specialty pharmacy wholesaler. The provider would hold that therapy at a financial risk but make up for it on the back end. Providers would seek reimbursement for administration and the cost of the therapy from the payer, and then they could mark up the cost of the therapy. This meant that reimbursement for a physician was largely impacted by how they negotiated the reimbursement rates with payer organizations.

The drug development pipeline is dominated by specialty therapies, more and more of which are being managed under the medical benefit. Therefore, payers will increasingly need to manage those drugs themselves, given that the PBMs they’d normally rely on don’t process these sorts of claims.

As a result, payers are looking to better manage medical drugs, and one way of doing that is by implementing an NDC mandate—a trend that has been on the rise over the last five years. According to RJ Health’s recent NDC Mandate Survey, payers requiring the NDC mandate went from 62% in 2016 to 68% in 2021.

Amid a global pandemic that has been the foreground of thought and development in medicine the past two years, another epidemic has been lingering for decades: HIV and AIDS were first recorded in the early 1980s, and their presence has grown exponentially over the last 40 years. In that time, HIV has fostered significant innovations and advancements across various fields including pharmaceuticals, access to care, public health education, and legislation, yet the U.S. still can’t seem to get control on the HIV epidemic.

Factors such as continued education around disease transmission and safe sex have been vital to reducing infection over the years, but in 2019, the government took steps to increase access to the daily HIV pill known as pre-exposure prophylaxis, or PrEP.