What the changing definition of patient access means for pharma manufacturers

By Lindsay Lorenzen
VP of Solution Consulting, Norstella

The shift away from blockbuster drugs has led the pharmaceutical industry toward more specialized drugs and therapeutic areas for rare diseases, oncology and gene therapy.

This wave of specialized, niche therapies has not only necessitated a more in-depth approach to commercialization but also led to increasingly complex payer policies that are changing the definition of patient access.

Whereas patient access had been largely thought of in terms of out-of-pocket costs, now the concept has evolved to reflect payers’ growing role as healthcare decision-makers. As a result, pharma manufacturers must become more proactive throughout the drug development and commercialization life cycle to understand today’s evolving payer landscape and ensure successful access to their therapies.

Changing definition of patient access: Why is this happening, and what are the repercussions?

This trend stems from pharma focusing on specialty biologics where populations are small and development is very costly. To combat narrow populations and high costs, payers have become creative in developing their coverage plans and making formulary decisions.

These tactics, such as stricter prior authorization or step therapy requirements, have set up a much more rigorous path for both patients seeking treatment and manufacturers creating new therapies. And this change hasn’t gone unnoticed: A 2022 report by the Medical Group Management Association found that 79% of physicians surveyed said they saw an increase in payer requirements within the past year.

When faced with barriers to access, it’s not uncommon for patients to take drug holidays or halt treatment altogether. According to a Kaiser Family Foundation poll, a quarter of adult respondents said they or a family member have let a prescription lapse, cut pills in half, or skipped doses of medicine in the last year because of the cost. The hoops patients have to jump through to receive therapies lead to a lack of trust and confidence in the health system and may deter them from advocating for future care.

For pharmaceutical manufacturers, this can completely alter how they approach commercialization. With many new and evolving roadblocks, navigating the road to a successful launch and patient access becomes more challenging, leading to missed launch expectations, lost revenue and decreased market share.

How manufacturers can combat the changing definition of patient access

To combat this, pharma manufacturers need rich data and insights at every point in the drug life cycle to make more informed decisions, avoid these undesirable situations, and, most importantly, ensure patients can access their therapy.

For example, before launch, manufacturers headed to market will need a thorough understanding of how previous drug launches fared in their therapeutic area (or in similar therapeutic areas if they are bringing a novel drug to market). By understanding recent past performance and gleaning insight into how a new market entrant might fare, manufacturers are better equipped to predict potential barriers to launch and make plans for overcoming them.

They need to know:
• How were similar products controlled by payers?
• How did payers’ utilization management decisions affect sales?
• How were their sales compared to their outlook?
• How might payers react to a new product launch in this therapeutic area?

Improve patient access with answers you can act on

The definition of patient access is continually evolving, and if pharma manufacturers want their drugs to be as accessible to as many patients as possible, they must have access to data and insights early and often.

Norstella illuminates every barrier they may face so that they can make informed decisions to get life-saving therapies to patients. We don’t just deliver information and insights, we deliver answers you can act on.

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