The launch of a new drug is a complex process. With so many factors playing into the final outcome, it may seem impossible to predict whether or not any given launch will be a success.
While it’s true that unforeseen circumstances may impact the result of a launch — such as the start of a global pandemic — there are telling signs that can indicate launch performance.
Medical affairs hiring happens early. The most successful launches tend to follow similar hiring timelines. A year before launch, a core team of 2-5 MSLs are hired and trained, 6 months before launch that team is expanded to 10+ including 1-2 MSL managers and 2-5 payer facing MSLs.
Market research is a priority. Companies that are successful spend time updating and validating their understanding of the market. Market research — such as competitive intelligence, landscape research, ad boards, demand study, TPP testing, baseline ATU, testing of campaign concepts and messages, patient services, etc. — is critical to understand market dynamics and to inform the go-to-market strategy.
Payers are engaged. Effective and early efforts to secure access is a key predictor. Developing relationships with payers, understanding what payers are looking for, having open pricing discussions with payers – these are consistent signs of a positive launch.
Outside resources are leveraged. Most likely, your commercial team is lean, and they are wearing many hats. Teams, like the Two Labs commercial team, are in place to jump in, leverage their experience to help develop strategy and to support the heavy lifting, so you can focus on what’s most important at any given time.
The product is readily and consistently available. It is important to have contingency plans in place to ensure a steady flow of product across the supply chain. Lack of immediate product availability can be a deciding factor between your product and a competitor.
Pricing is strategic. Every company believes they make “conscious” pricing decisions. Having a solid understanding of the market dynamics (perspectives form all stakeholders — prescribers, payers, patients) to inform pricing strategy is important and that doesn’t always mean charging the highest price possible. For example, Ocrevus launched at a price that was 20% below the average price of competitors in a very crowded MS market, and is now considered the most successful launch in its company’s history.
The launch team is inexperienced. The most successful launches are typically carried out by companies who already have a previous launch under their belt. For first launch companies, engaging an experienced launch partner can mitigate the risks and result in a more efficient, effective launch.
Differentiation isn’t prioritized. Failure to differentiate the product in the eyes of physicians and payers (even before launch) can be detrimental, especially when launching a new high-price therapeutic into a crowded market. A deep understanding of the market and how to stand out from the crowd is vital.
There are misaligned expectations between leadership and market realities. Over confidence in the asset (i.e. “This product will sell itself”) is often the cause for launch missteps. For a successful launch, prioritize pre-launch excitement about the product and garner HCP and patient interest in the clinical trials, new data, etc.
Underestimating launch coordination. There is an incredible amount of work and coordination involved in executing a successful launch that should not be underestimated. Even big companies can stumble but having a great product and the ability to educate the various stakeholders in advance is a huge advantage.