New Drugs and State Price Transparency - A Heavy Lift Made Lighter

New Drug Reporting related to State Price Transparency laws can be a heavy lift, especially when the launch price of the drug will match or exceed the Specialty Drug threshold (currently $950 in 2025).

Most of the State Transparency-related reporting will be triggered when that Specialty Drug Threshold is breached, but there are some state reporting requirements that must be addressed even if the Launch WAC is below that threshold.

For example, both Connecticut and Washington require that the new drug information is filed within their state portals for launches, regardless of WAC pricing.

And speaking of portals, it’s a good idea to register for user accounts with all the state portals related to state transparency reporting, not just the ones that you’ll need to use before, during or immediately after launch.

Another important consideration is the content you’ll need to address prior to each New Drug Report submission. There are some tough questions that you’ll need to answer once the launch price exceeds the Specialty Drug Threshold. Various states will require you to submit your Marketing and Pricing Strategies, and some will even ask for data points like the Estimated Number of Patients and the Amount Spent ($) on Research, Marketing and Distribution in the 12 months prior to the product launch.

Finally, if you plan to request that the report information you are submitting should be considered a “Trade Secret”, be prepared with an explanation from your legal counsel as to why that data should not be posted on the states’ drug transparency websites. Not all state portals allow you to request that the submitted data is kept confidential, so include time for legal counsel review before submitting the New Drug Report data to the states.

Our STARS (State Transparency Analytic Reporting System) tool can help you collect all the necessary data points once prior to the drug’s launch:

As the New Drug Report filing dates approach, STARS can create extracts in the formats required by each state and will indicate which information is missing from each report:

As you can see from the screenshot above, the WAC price formatting for California is different than for Connecticut and Minnesota. This is just one of many examples of date and dollar formatting differences between states.

For drug launches with WAC pricing at or above the Specialty Drug Threshold, we recommend that you plan to start this New Drug Reporting effort at least 6 months prior to your expected launch date.

Pharosity can guide you through these New Drug Reporting steps – as this effort is arguably the most challenging part of the entire state transparency reporting process. Contact us to get your own instance of STARS up and running so that we can take this stressful responsibility off your To-Do List!