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One of a continuing series of articles from Precision Medicine Group offering new strategies for market access and reimbursement.  

With less than 11%* of drugs in development finding market approval, pre-launch marketing strategies have to consider the possibility of market access failure. New drugs entering established markets have trouble differentiating themselves from the many competing agents already occupying the space, and payers often don’t see the value in a new alternative. At the other end of the pharma spectrum are multitudes of small niche areas now being explored by hundreds of boutiques as well as big pharma, and there’s vigorous debate about how or if value will be recognized by a host of global payers, and what framework will be used to assess that value.

According to Dan Renick, RPh, President of global market access specialists Precision for Value, it’s the rock and the hard place scenario, and that’s just where what he calls “the wedge strategy” comes in. “You cut a small slice out of the overall target population for a drug to gain initial access,” he explained, “and after that you look to grow the product from within the market using meaningful, real-world data from a small group that can be developed into evidence that supports efficacy, safety and outcomes, in support of broader access over time.”

Renick noted that “it’s not enough just to get FDA approval, you have to have the right kind of evidence within the approval — and, that means information that can allow for more specific initial patient targeting.” When the label indications appear too broad, it becomes a struggle to gain market access due to payer fears of over utilization, while conversely, very narrow labels have to find a treatment population yielding enough utilization to provide claims data that is meaningful to the marketplace.

He pointed to new treatment options in therapeutic areas such as cholesterol management, heart failure, and anticoagulation. At launch, all met with significant formulary access obstacles leading to very limited early uptake, despite being highly effective drugs. This was due to initial payer perceptions of the therapies as very expensive with limited advantages over existing, largely generic treatment options. Payers were proactive in positioning these drugs ahead of early data as being of low value and potential budget busters that should be highly restricted, and drug developers were slow to counter that messaging by focusing on specific patient populations with high unmet needs. Ironically, in the case of nearly all of these examples, the labels for these products ended up being broader than many initially expected, and those broad indications actually hindered their uptake in the market.

‘Niche’ has long been a bad word in pharma marketing, particularly in broad-based disease areas like diabetes, cholesterol management and even certain kinds of oncology, Renick observed. But the recent therapies mentioned are a good example of where it is actually better to embrace the niche concept by slicing up the treatment population into smaller targeted patient groups, or wedge pieces, where the product has stronger support from clinical trials data and unmet patient need. “This gives you the opportunity to convince payers the drug meets a real need for a specific treatment group,” he said. “That allows for some traction and real-world experience which also validates that the drug has a place in the market.”

A wedge strategy is not usually the frontline approach, but the ready alternative that looks to establish a tight, solid niche market within a much bigger one, building experience with the drug to expand its use within that market. We call it the “wedge for an edge,” Renick said, and it has to be done thoughtfully from the start by gathering broad input, such as thorough market research involving numerous stakeholders. “If it’s becoming clear in prelaunch work that there is potential resistance to broad uptake of the novel medication, then the wedge strategy should be seriously considered as the way to go. The only thing worse than a somewhat limited launch is a failed launch that yields no meaningful data to reinforce real-world effectiveness.”
*Smietana K, Siatkowski M, Moller M. Trends in clinical success rates. Nature Reviews Drug Discovery, June 2016.

Precision Medicine Group (PMG) supports next-generation approaches to drug development and commercialization. PMG provides the infrastructure and expertise that extracts and enhances the long-term value of biotech and pharma products.

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