Last night I got a call from a Regulatory consultant who’s working with a pre-clinical biotech. They need pricing and market access insights before their NDA is approved. The technology is great, the leadership team is experienced, and they want to make sure they ‘get it right’.
Instead of doing a capabilities presentation, I decided to put together the list of pricing and market access questions that EVERY brand team needs to have nailed in advance of launch to be successful. In the spirit of helping the industry in general, I figured I’d share the framework here. Chiral Logic has extensive experience in answering these questions both from the manufacturer’s and consultant’s point of view.
· What is your likely weighted average net price cut by relevant books of business?
· What is the optimal WAC price to communicate the value of the product to the market?
· Are there relevant price versus access tradeoffs for your product? What are competitors likely to do in response to your competitive launch? What will you do to avoid a price war over the life of the asset?
· Are there other indications, patient types, or clinical attributes that your product will develop over time that may unlock additional value? How do they influence pricing at launch and over the course of the asset’s lifecycle?
· What are the expected discounts to achieve your market access goals? What are your breaking points – where you’d like to return to senior management for guidance and potentially delay contracting due to margin erosion?
· What is your plan for the period when the product will be NDC blocked by most payers?
· What are the likely restrictions on your product if you do minimal contracting?
· What is the BEST possible market access that you can achieve, whether through extensive payer education, contracting, or both?
· Are there restrictions including Step Edits, Prior Authorization, or quantity limits (etc.) that dramatically decrease your commercial opportunity? Conversely, are there sets of these restrictions that you can ‘live with’ because >90% of your target market will already have completed them?
· What kind of payer segmentation can you expect for your product? Is it based on behavioral or perceptional criteria?
Patient Pay / Out-of-pocket / Couponing
· Will you employ Relay Health or Coupons or both to keep patient out-of-pocket reasonable?
· What is your strategy regarding transitioning your coupon program from launch mode into long-term growth stability mode?
· What are your expected out-of-pocket costs for patients? What will your TARET copay be? What are your maximum contribution limits? Why? (these should be tied to your market access and profitability objectives)
Answering these questions is the FIRST STEP on the road to generating your payer launch strategy. As I’ve mentioned before, it’s possible to answer these questions via qualitative or quantitative means AND feed your forecast. While the legwork to get these answers doesn’t have to be time consuming and expensive, this probably isn’t an area to skimp. After all, now more than ever, pricing provides critical input into overall product profitability.
So as my dermatologist says, ‘even if you don’t come to me, get checked out’. Invest to answer these questions – your stakeholders deserve the answers and your commercial partners (including payers) will expect that you know the answers and have a plan.
Image credit: Maina Kiai – https://www.flickr.com/photos/mainakiai/
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