In addition to the three most important elements in any launch, there are a lot more moving pieces to keep track of when you’re putting together your first product launch.
Consider this blog as your starting point checklist to help keep things moving as smoothly as possible while you’re assembling partners and processes.
Compendia databases are much more than pricing: they provide a real-time picture of what’s on the market and where opportunities are. And while it’s the FDA that approves a product, it’s the compendia organizations that dictate and list what your therapeutic class assignment is. So before you file with the FDA, you want someone with deep compendia knowledge to review your draft labeling and package insert to see what opportunities exist for a class assignment.
2) Product Packaging
When you’re looking at the whole journey of a launch, product packaging can seem somewhat trivial in comparison. But this minor detail can determine whether or not you can follow through with your desired channel strategy and even patient adherence. If your packaging cannot perform in the channel strategy you had planned, you might be forced to go back to the drawing board on the channel strategy, which could impact several of your other launch operations.
3) DSCSA & Serialization
With the deadline approaching, a lot of manufacturers, trading partners, and pharmacies are scrambling to become compliant. With limited industry resources and support partners available to process all that needs to be done, we are seeing some bottlenecks build up.
The best thing to do is to build as much time as possible to plan your tracing and serializing operations. There will be delays that might have nothing to do with your launch strategy or partners but still occur because there is so much activity happening in the industry right now.
4) State Licensing
State licensing has always been a complicated process. But right now, it’s the most complex that it’s ever been due to more states becoming FDA-approval states. In these states, you can only get a resident or home state license once you have your first FDA-approved product.
State pharmacy boards are also still coming out from the COVID lag and dealing with staffing issues. Our team sees the timelines for license approval, and they keep getting worse and worse. So, the longer your runway, the better your chances of not having to delay your launch.
5) Gross to Net
Building a gross-to-net model is an excellent example of the difference in needs between big pharma and emerging pharma. When you’re at a large pharmaceutical organization with a hefty budget to back you up, you might get away with setting a high number as your gross-to-net catch-all. However, emerging manufacturers need a breakdown of the many pharma expenses that come with your chosen channel strategy and insight into the nuances of how these expenses change during your product’s time on the market.
The most important thing to remember about gross to net is that this part of your planning needs to stay active for the length of your launch journey and beyond. It should be continually evaluated in response to any decisions that are made as part of the launch. Our advice is never to make assumptions about the long term.
6) Patient Services
At the most basic level, patient services involves a co-pay card to help patients cover the cost of your product. The more complicated the product, the rarer the disease, or the higher the initial price tag, that’s when you can expect patient services to turn into a more comprehensive component that you’ll work with payers and logistics partners on.
7) Trade Management
After all the work that goes into a launch plan, the most frustrating post-launch scenario is when a patient can’t access a drug. Unfortunately, since so many manufacturers rely on multiple partners to move a product through the supply chain, these scenarios are more common than anyone would like.
The core of any trade function is active inventory management, which requires visibility into what is happening in your channels and the ability to proactively intervene when inventory levels aren’t adequate. While the bulk of trade management activity is focused on post-launch success, there are several overlaps with other pieces of launch planning that make trade management a pre-launch priority.
8) Government Price Reporting
In order for products to be covered under federally-funded programs, manufacturers must agree to participate in programs such as the Medicaid Drug Rebate Program, and the 340B Drug Discount Program. Participation in these programs requires that manufacturers calculate prices for their products based on actual sales and discounts in different market segments and report these prices on a monthly, quarterly, and annual basis.
Although this is primarily thought of as a post-launch activity, various pre-launch decisions can affect both the prices that will be reported and the discounts that are applicable. This makes it critically important that a launch plan includes a workstream that is focused on how pricing and contracting decisions will impact government pricing program discounts.
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For more in-depth insights on these foundation pieces, as well as the many other elements that are integral to supporting a launch, download our most recent ebook, “280 Launches Later: Two Labs’ Insights on the Commercialization Journey.”