Nick Marasco, Chief Commercial Officer of Envision Pharma Group, has more than 25 years of pharmaceutical, biotech, and medical device industry experience, and he is a registered pharmacist by trade. He has filled roles on all sides of the table to help support bringing more than 250 assets to launch. This range of perspective has given him a front-row seat to some of the most significant shifts in the industry.
One of the most significant changes to the launch process in the last few decades is how we define commercialization itself. Historically, commercialization referred to sales and marketing: brochures, sales reps, slogans, and commercials. But the types of products that are filling the pipeline are forcing a change in how we define commercialization.
I’d argue that this change is for the better. Redefining commercialization yields better outcomes, cost efficiencies, and improved patient care and adherence.
What’s happening now?
Biopharma innovation is increasingly focused on products that have specialized clinical value, like cell and gene therapies and orphan and rare disease drugs, as follow-on drugs are no longer as viable on the market as they once were. As evidenced by recent legislation and the persistence of drug pricing scrutiny, the rising costs of these innovative drugs make it more important to show deep scientific value to payers (both government and private), prescribers, patients, caregivers, and other external stakeholders.
Commercialization strategies in today’s market extend beyond the reach, frequency, and share-of-voice game of the past. Instead, companies must achieve new objectives and new market needs to commercialize an asset, including:
- communicate the deep scientific value
- engage with payers early on to inform the clinical and communication profile
- advise on clinical trial design so that products can be optimally positioned for payers
- serve as the collaborative bridge between medical affairs and value access
With science playing an ever more prominent role in driving the discussion, I think it’s now essential for all other parts of the launch process to become comfortable with the fact that they can - and should - take ownership of commercialization. And none more so than the medical affairs function.
Medical Affairs Driving Commercialization
Because the heavy emphasis of commercialization used to be sales and marketing, medical affairs professionals were often quick to shy away from claiming to be a part of the commercialization process.
I’ve thought for a while, and more people are starting to agree, that commercialization really begins with medical affairs, value, and access.
We’re now in an environment where payers are hyper-focused on the differentiating clinical value that a new product brings to the table, and it is medical affairs professionals who are best poised (and credentialed) to drive that asset value messaging.
Medical affairs touches a launch strategy at several points along the path to launch. But the earlier they can get involved and collaborate with value and access, the better positioned a product can be for payers.
The Proof is in the Payers
Years ago, I worked at a pharma company and was responsible for nine assets in the pipeline. When the assets were in Phase II, we met with more than 100 national, regional, and local payers, IDNs, and health systems. And we asked them, in a very straightforward manner, what they wanted to see from our product when it came to market, and what would create significant value for their patients and providers. So, our Phase III trial design was based on showing the payer a differentiating value.
It was one of the first times in the history of that company that a Phase III trial was ever designed with payer positioning in mind, and I can confidently say that it was the connectivity between medical affairs and value access that drove the performance of the asset by the time it got to the market.
Since then, I have seen this theory gain more footing. If you look at the number of value access consultants that have emerged over the past 10 years, you can see that they’re providing value by connecting the payer to the company earlier in the development process. To me, this is proof that medical affairs insights can’t be leveraged early enough.
Why This Matters
If my memory serves me well, there was a time when people bought vehicles based on things like size, speed, color, and sex appeal. But today, why do people buy cars? Safety, braking, fuel efficiency. It’s progressed to being more about safety, accessibility, cost-effectiveness, and clinical value, versus later-stage sales and marketing appeals.
And something similar is happening in the emerging pharma space. Prescribers and patients have higher expectations, and if they’re also seeing a higher price tag, they want to go deeper into the scientific value of any product they’re considering.
When we give ownership of commercialization to different players on the launch team, with particular attention to medical affairs, there are a lot of benefits on the table. We’re bringing better drugs to the market, having a greater impact on patient outcomes, designing more optimal trials, and making efficient use of payer spend.