PCSK9 Inhibitors

With projected U.S. sales in excess of two billion dollars, Praluent and Repatha were two of the most widely anticipated launches of 2015. They generated compelling LDL cholesterol reductions and lacked the hepatic and musculoskeletal side effects that plagued the statins. With only one out of every three high-risk patients at goal, it seemed like there was room for new entrants. To everyone’s surprise these products were shunned rather than embraced and sales fell short of estimates. This case examines what can happen when launch scenario planning fails to incorporate changes in the regulatory landscape. It also examines what can happen when pricing decisions violate existing payer norms and helps marketers understand the importance of quantifying the impact of pricing decisions on patient copayments. Finally, this case helps marketers understand what can happen when companies prioritize large market segments over smaller ones in which they deliver more meaningful clinical benefit.

Benlysta

As the first new lupus drug approved in 56 years, Benlysta seemed poised for success. Existing agents induce remission but their toxicity can cause serious, sometimes fatal adverse events. When the final phase III data was parsed, questions about Benlysta’s efficacy, target patient population and pricing became less clear. This case examines the difficulty of evaluating efficacy when clinical standards are evolving. It examines the difficulty of demonstrating value for money when clinical benefits are hard to measure and it shows us what can happen when a brand lacks a clear point of entry in the treatment algorithm. Finally, this case examines the impact that accurate market sizing can have on pricing and forecasting decisions.

With projected annual sales in excess of two billion dollars, Actemra was the most widely anticipated launch of 2008. The first Interleukin 6 inhibitor approved for the treatment of rheumatoid arthritis, Actemra was expected to challenge Orencia’s dominance among TNF non-responders. The product’s new mechanism of action and serious side effects, however, relegated it to late line use. So it came as quite a surprise then when Actemra became a leader in the monotherapy segment of this market within six years of its launch. This case examines the impact of effective lifecycle planning on long term product performance and the role that risk taking plays in effective lifecycle management. It also helps marketers understand the role that focus plays in effective product positioning.

Krystexxa

Gout is one of the most common autoimmune conditions and its growth is fueled by the rising age and obesity level of the U.S. population. While effective treatments exist for mild to moderate disease, refractory chronic gout remained an unmet medical need. With its compelling efficacy profile, Krystexxa seemed poised to address that need. That it failed to do so raises questions about whether its IV formulation and adverse event profile were to blame or whether marketing malpractice was the primary culprit. This case examines the impact that accurate market sizing has on pricing and forecasting decisions. It also examines the role that pre-launch education plays in lowering barriers to uptake. Finally, this case examines the impact of effective lifecycle planning on long-term product performance.

Provenge

With projected U.S. sales in excess of two billion dollars, Provenge was one of the most widely anticipated launches of 2010. It was the world’s first immunotherapy and it delivered compelling survival benefit in metastatic patients. Its mild adverse event profile and ability to preserve quality of life were two additional features that set it apart from chemotherapy. To everyone’s surprise the product was shunned rather than embraced and sales fell short of estimates. This case examines what can happen when pricing decisions violate existing payer norms and helps marketers understand the importance of rapid market penetration when new market entrants are close behind. It shows us what can happen when new patients are difficult to identify and how unattractive buy and bill terms can discourage prescribing. Finally, this case examines the long-term consequences of failing to differentiate your brand from future competitors.