Editor’s Note: The following post is adapted from IntegriChain’s 2021 Access Insights Conference panel session: Best Practices for Launch featuring DBV Technologies, Karyopharm Therapeutics, and Sesen Bio. Responses have been edited for clarity. Click here to view the full webinar recording.

 

A product launch is a critical time for any pharma manufacturer, with alignment that must span across Market Access and Brand teams, as well as Finance and the C-Suite. We asked three market access leaders with significant launch experience across multiple therapeutic categories from companies planning to launch or have launched their first product several questions about their launch journey. For the first question of the series we asked: Other than a larger budget, is there anything you would change in hindsight leading up to your first launch?

 

Mike McCarthy

VP, Market Access at DBV Technologies:

I feel like I’ve made a living in market access out of using the term “it depends.” In my opinion, it depends on a few things like the type of market you’re in, your timeframe for launch, and whether or not it’s a first-time launch–either for your company or a unique indication.

For the sake of brevity, I’ll focus on the last point: With a first-time launch, you’re so focused on the internal component in managing your own company while you also need to manage launching into a market that no one’s been in before and pricing in a market that no one’s priced in before. Because pricing was a new territory, we didn’t know just how much of an impact that was going to have on the sensitivity and the budgets of payers with our drugs coming into the market, which directly impacts things like the patient and the practice experience, delays in dispense time, and physician resistance to prescribing. So if there’s anything I would change, I would say to take a deep dive into these areas and make sure that you’re examining the market from these angles and you’re thinking like your customer.

 

Steve Barbera

VP, Market Access at Sesen Bio

You can do all the preparation internally because you know what goes on within your organization, but those external forces and unknowns are things you really have to be thinking about. We used our external partners at IntegriChain to leverage their knowledge and experience with these government agencies. For example, our product had a mixing component, so we had to think about how it would affect patient access as well as our gross-to-net. This ripple effect meant we really had to be collectively communicating extensively with our external partners to try to understand what’s going on. So for me, it was just a matter of being able to course-correct and make sure that internally and externally, all of our key stakeholders were ready as we evolved into the marketplace. It’s all about being flexible and able to pivot.

 

Dan Ryan

Senior Director, Commercial Finance at Karyopharm Therapeutics

So far I’ve been part of five product launches and a few product acquisitions and with every launch, I always end up saying, “I wish I had a little bit more time.” So if you’re getting ready to launch, as early as 15 months out I would start wholesale agreements and pick your distribution channels. You have to make some big decisions early on that will really set the course for your entire product path. Ask yourself: Are you going to be a full-line wholesaler? Are you going specialty or hybrid? I recommend you start those negotiations as soon as possible. 

Also, it’s not too early to set up your 3PLs. Talk to the third-party data aggregators and determine things like who’s going to process your Medicaid claims. Are you going to bring that in-house or are you going to have somebody like IntegriChain do it for you? We utilized IntegriChain for Medicaid but also for other government pricing like 340B, coverage gap, Medicaid, and FSS contracts. 

With so many moving parts, being collaborative is absolutely necessary. Although I’m in Finance, I work really closely with Market Access to closely align our strategies because all of these contracts will affect our best price, government price calculations, and ultimately gross-to-net. When all of those things are in place, then you can factor in your GTN. For your first six to four quarters, you’re utilizing launch assumptions where you have to purchase analog data, so having a clear picture of your Market Access landscape from the points I mentioned previously is so important. Because you’re not going to get Medicaid or coverage gap data until at least 45 days post-quarter, you’re going to be relying on a lot of that analog data in your launch assumptions. 

Last but not least is the necessary factoring of your auditors, so make sure SOX controls are in place. You want to be very close with your auditors in order to get ahead of what their expectations are. 

Basically what I’m saying is to take some time and really think about the downstream processes as early as possible because so much of that is guesswork. Having the right partner can help you make informed, supported decisions, but it’s still important to not leave these decisions to the last minute.

 

Check back for part two in the series in which we asked our panelists about critical factors in a successful launch and ways to achieve a pre-launch sales forecast.

 

Learn more: 

Learn more about Launch Readiness solutions

Design a smarter product launch with IntegriChain’s Launch Timeline

Watch the webinar “Industry Panel: Best Practices for Launch”