Three Essential Tactics for Successful Drug Commercialization

Three Essential Tactics for Successful Drug Commercialization

By Liz Turner and Ross Maclean

As clinical stage biotech and pharmaceutical firms face unprecedented challenges in raising capital to fund their clinical trial program, strategic trade-offs are coming fast and furious. One of those at the top of the list is when and how to build a commercialization strategy, including navigating the complex work of securing market access.

In the world of real estate, the Golden Rule on determining value is often expressed as – location, location, location. The same holds true for demonstrating the value of a new drug treatment, but the rule of thumb in this instance is guided by the key words – early, early, early. And, as trade-offs are being debated, three modest activities can solve for critical commercialization and market access challenges despite pressures to delay until after a positive Phase III readout. They include early payer perspective, early clinical and economic predictive models, and an early real-world evidence (RWE) plan.

Early payer perspective
When it comes to understanding potential coverage challenges, the earlier the better. By enlisting the opinions of the entities that may reimburse your drug you’ll get feedback on the acceptability and often reaction to clinical trial design, whether a H2H is necessary and what end points best translate into payer value. Since payers come in all shapes and sizes – from the largest commercial health insurance firms and state Medicaid agencies to small, regional niche insurers – be sure to consider whether these insights can be applied to other organizations. It’s not necessarily to receive feedback from every type of payer, but it is critical to consider where and when these insights and feedback might be best served.

Ideally, you will want to incorporate payer insights into a Phase III trial design (and for other post marketing clinical considerations being made). Early engagement will reassure commercialization viability, as well as identify clinical value drivers and how they may translate into both the health and economic story for the asset. Many times, payers are assessing therapeutic classes years ahead of when assets launch to predict financial impact to their per member per month costs.

Note that before embarking on gathering payer feedback. it is important that the drug developer is ready to respond, even if this means making changes to the planned regulatory-facing trials. And this can trigger some tough internal discussions especially in firms that have previously shown little affinity for incorporating commercialization planning into early R&D.

Early clinical and economic predictive models
The development of mathematical models that extrapolate an observed near-term clinical benefit to long-term health and economic value has conventionally been reserved for after the Phase III readout, but by then it’s too late to make any clinical adjustments to course correct for the development of a meaningful value proposition. Early clinical and economic modeling can be done off observed or anticipated Phase II data and, in some cases even earlier, given the significant developments in predictive modeling capabilities.

Describing the long-term value (“cost effectiveness”) of a new drug is increasingly a factor in determining drug price, value, and market access in the United States. Leading this charge has been the Institute for Clinical and Economic Review (ICER). If they have not evaluated the therapeutic class you are launching into, then chances are it isn’t far off. Running an early assessment on the viability of pricing considerations for the United States and health technology assessment (HTA)-based markets provides clarity around where and what needs to be adjusted to meet volume and value goals for the product. The bonus of conducting earlier modeling also expedites future formal cost effectiveness work done prior to launch when bottlenecks can slow down output due to conflicting priorities.

Early real-world evidence (RWE) plan
As sure as night follows day, you will be asked “How does the efficacy observed in your trial convert to effectiveness in a real-world setting?” As soon as you decide to proceed with a Phase II study, you can begin to build a plan for future RWE studies to address this challenge from patients, doctors and payers. Begin by understanding what patient-level, real-world data (RWD) currently exist and how easy they are to procure. The answers to these questions should be the baseline for any decisions around RWD and RWE development plans.

If little to no data exist, or it is harder to find than a needle in a haystack, this should trigger considerations to be made around the investment needed to build this infrastructure and when does that best make sense. These types of studies and initiatives can take years to set up. You can easily work with one of the many organizations specializing in RWD and RWE to determine the level of investment it will require to build this from scratch. If you’re lucky enough to find and have reasonable access to such data you must start early with engaging these “owners” on what type of contracting, investment and timeline is going to be required to build the base case.

The RWE planning phase should ideally be well underway before you finalize your Phase III trial design to help inform teams and even regulators on how evidence of real-world effectiveness may be generated in the 12–18 months post launch to solve for a potential data “void.” This is where payer input is also paramount. Appropriately designed RWE can also support future risk-sharing/value-based agreements between the manufacturer and insurer. Knowing ahead of time how easily this information is accessed, used and processed by key stakeholders can inform on how different data types may be required (claims vs. charts vs. surveys vs. modeled data vs. trial data).

Summary
The key takeaway is that regardless of whether your organization has an internal commercialization capability prior to a Phase III readout the above three high-value tactics should be conducted early to avoid costly missteps that could impact product success. Delaying these considerations can have substantial implications on a drug launch or even commercialization opportunities. Early, can never be early enough.

	Liz Turner, MBA, is an experienced pharma executive and most recently VP of Operations at Anton Health.
	Ross Maclean, M.D., is EVP and Head of Medical Affairs at Precision Value & Health.