Promising drugs often struggle early with slow uptake and missed sales targets. Achieving commercial traction requires securing a strategic beachhead: a targeted focus area such as concentrating on a guideline-backed patient group, eliminating a key payer barrier, or publishing real-world data to resolve prescriber hesitation.

This case study is part of Triangle Insights Group’s series, Levers for Launch: Navigating Early Market Resistance Across Four Archetypes.  

The Commercial Dilemma 

Novartis launched Entresto (sacubitril/valsartan) in 2015 as a novel therapy for heart failure with reduced ejection fraction (HFrEF). Entresto introduced a dual-acting neprilysin inhibitor and angiotensin receptor blocker (ARNI) designed to replace decades-old ACE inhibitors and ARBs as the standard of care. 

The asset fits the Paradigm Shaper archetype, characterized by high product differentiation within a nascent market.  

Initial market uptake fell short of early expectations. Entresto missed its 2016 sales target, falling approximately $30 million short of internal forecasts. 

Three main factors caused this early adoption lag:

1. Fragmented Early Positioning: Initial promotional narratives emphasized the individual chemical components, sacubitril and valsartan, which created confusion regarding the compound identity. Early disease awareness campaigns were perceived as alarmist by healthcare providers, increasing physician reluctance to adopt the novel neprilysin inhibition mechanism.
2. Payer Resistance and Step Edits: Payers heavily restricted access through strict prior authorization criteria. Insurers mandated step-through therapy requiring patients to fail an established ACE inhibitor before covering Entresto.
3. Physician Reluctance to Switch: Clinicians exhibited inertia in transitioning clinically stable heart failure patients from familiar, low-cost generic regimens to a newly approved branded therapy. 

Activating the Four Levers to Galvanize Growth

Novartis systematically deployed the four strategic launch levers to reverse early performance gaps and secure long-term market leadership:

Positioning Strategy: Novartis replaced component-focused messaging with an emotional campaign titled “Entrust Your Heart to Entresto” centered on trust, later expanding messaging across ejection fractions to withstand emerging SGLT2 inhibitor competition.

Advocacy and Guideline Inclusion: Novartis contracted roughly 40% of AHA and ACC guideline authors across 2016 and 2017, securing a Class I strong recommendation by 2019 and reinforcing adherence through initiatives like Implement-HF and TRANSFORM.

Evidence Generation: Novartis reinforced the pivotal PARADIGM-HF trial with four Phase IV real-world studies in 2018, followed by trials in preserved ejection fraction (HFpEF) that earned an expanded label in 2021. 

Market Access: Novartis executed early outcomes-based contracts with Aetna and Cigna, then leveraged real-world cost-effectiveness data with Prime Therapeutics to eliminate prior authorizations across most commercial and Medicare plans by 2021.

Key Strategic Considerations for Launch Teams

The commercial turnaround of Entresto highlights five considerations for commercial, medical, and market access leaders planning brand launches:

1. Characterize the “who and when” on day one. Make the decision easy: spell out the exact patient profile, the setting of care, and the plan for a switch from existing standard of care.
2. Remove the top payer hurdles quickly. Attack the most common prior authorization and step edit hurdles for HCPs early with targeted contracts and patient support programs. Give clinics prior authorization aids and benefits verification support to enable ease of prescribing.
3. Publish proof that answers key anticipated questions. Prioritize studies and RWE data that clarifies questions raised by HCPs and other key stakeholders (initiation timing, safety/tolerability in typical patients, etc.). Share the proof of data to key adopters and market movers.
4. Turn proof into rules of care. Convert new data into momentum for guideline language and clinical document updates so the new default includes use of the product. Leverage this product inclusion to drive widespread adoption.
5. Reframe when new classes enter. When novel competitors surge, adjust positioning to retain your product as a core element of standard of care alongside new entrants. Update message maps, prescribing sequences, and access materials to show paths where products can be used together. 

Read the summary of the entire 5-part series.