Words reflect intent. There was a time in the 1980s and early ’90s that brand success required little more than an FDA approval. It was a time of “me too” products that found a niche with the help of a solid message. Patients faced few obstacles to access, and “see your doctor” translated often into a prescription. Yet, patients are now at the center of everything we do—more than a DTC activation channel—their enthusiastic advocacy is the measure of pharma achievement.
When HMO formularies entered the fray in the mid-1990s, the vine of Rx “me too’s” started to wither. “First-in-class” and “breakthrough” became part of the pharma communications lexicon. Approval to market a product in a new category was a likely fast-lane to success.
This was a period of firsts. The first FDA-approved biotherapeutics for the treatment of cancer. The first statins for bad cholesterol, insulin pens to make diabetes management easier, and easier ways to administer asthma medication. AIDS was transformed from an epidemic to chronic condition. Market response was immediate and the lines between invention and innovation blurred.
Competitive Pricing in Therapeutic Classes
Since that time, “innovation” has been pharma’s go-to word. First-in-class medicines translated into people’s lives saved. Society needed these treatments and the stream of blockbusters medicines were “innovative.”
Today, HMOs have evolved into payer formularies and initiated prior authorization, step-through therapy, and Pharmacy Benefit Management (PBM) non-medical switching—mechanisms to encourage competitive pricing when multiple medications share a therapeutic class. These economic tools work to keep prices in check. But, is biomedical innovation passé? Not at all!
Scientists—like their engineering compatriots—imagine, construct, test, and create life-improving inventions. Like Apple or Samsung or Boeing or Tesla, pharma researchers work tirelessly in their cause to overcome illness. As Apple learned through the failure of its hand-held device, Newton, invention does not translate into market innovation. The give and take of payers, providers, policymakers, and patients determine whether “new” meets an unmet need and is worth adopting. Today, “if you build it, they may not come.” Customers decide what is innovative—not the inventor!
Here are three tips to keep patients at the center of the conversation so that biomedical inventions are considered potentially as innovative:
- Engage patient advocates and ask for advice about trial design, awareness efforts, and cost offset. Patients have copays and must be ready to work through payers. Earn the right to have advocates acknowledge your therapy as “innovative.”
- Encourage external experts to use real-world independent data to explain why patient type and need has not been met and why a new solution is urgent.
- Engage corporate leadership to think collaboratively and talk about how invention benefits others in the health ecosystem.
The market will reward life-changing science by deeming newer therapies innovative. How? Access and use! Innovation is defined by customer experience—efficacy, safety, and affordability—not by what pharma invents and no matter how great the science. Access does not magically appear. It is secured by addressing health ecosystem needs. It all starts with invention!