PCSK9 Inhibitors

With projected annual 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 statins. With only one out of every three eligible patients at or below 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 the hidden sources of bias in launch scenario planning and helps marketers understand the importance of quantifying the impact of pricing decisions on patients. It also helps them understand the role that marginal benefit plays in prioritizing product positioning options.

Benlysta

As the first new lupus drug approved in 56 years, Benlysta seemed poised for success. Existing agents may induce remission but their toxicity can cause collateral damage. 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 also examines the difficulty of demonstrating value for money when clinical benefits are hard to measure. 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 the leader in an important 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 rising age and obesity levels. 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 did not 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 and the impact of effective lifecycle planning on long term product performance.