Levers for Launch

 Levers for Launch

Written By:

Vaibhav Shrishail

William Sheehan

Wes Yanowitch

September 4, 2025

How Five Analog Brands Used Positioning, Advocacy, Evidence, and Access Levers for Launch and Beyond

Pharmaceutical product launches are complex and critical to get right. In today’s environment, marked by heightened payer scrutiny, crowded markets, and compressed timelines for demonstrating value, even promising therapies often face slow uptake and missed forecasts in their earliest months. Without early traction, clinically strong therapies risk falling behind, making launch execution a make-or-break moment for long-term success.   

Several high-profile assets that stumbled early have gone on to become commercial successes. They accomplished this through the identification and activation of strategic beachheads (targeted focus areas such as removing a single access barrier or generating real-world validation that resolves prescriber ambiguity.)  

The Launch Framework: Four Strategic Levers

In this series, we examine five examples of novel brands that shaped or reshaped their commercial trajectory through the deliberate activation of key levers. Using a consistent framework, we examine each case through four strategic levers:   

  • Positioning Strategy: How the product was initially positioned in the market, messaging strategy, differentiation from competitors, early HCP engagement, and refinements in positioning post-launch based on market feedback.  
  • Advocacy and Guideline Inclusion: The role of KOLs and professional society engagement, efforts to secure inclusion in treatment guidelines, and partnerships with academic and industry organizations to reinforce credibility.  
  • Evidence Generation: How clinical trial data supported market entry, alongside post-launch evidence generation (Phase IV studies, real-world data, health economics studies) to strengthen positioning.
  • Market Access: Initial payer coverage, formulary positioning, access challenges, use of value-based pricing models, outcomes-based contracts, price adjustments, and methods used to navigate reimbursement hurdles to drive broader adoption.  

Defining the Launch Archetypes

The five case studies featured in this series are categorized into distinct launch archetypes based on market maturity and product differentiation, providing context for the strategic levers activated at each stage of commercial evolution.   

Market maturity is defined by the degree of branded and generic competition within an indication. Identifying where your own product sits among the four archetypes provides appropriate context for evaluating each case study. 

  • Paradigm Shaper: High product differentiation within a nascent market.
  • First Mover: Low product differentiation within a nascent market.
  • Late Challenger: High product differentiation within a mature market.
  • Opportunist: Low product differentiation within a mature market.

A Summary of the 5 Case Studies    

This series demonstrates how 5 brands found their beachheads for launch and pulled the right levers to achieve commercial success.    

ProductDisease AreaLaunch Archetype Case Study Overview 
Entresto (sacubitril/valsartan)

Read the case study
HFrEF / HFpEFParadigm ShaperNovartis reversed slow sales and steep insurance hurdles for Entresto by building doctor trust, earning top medical guideline endorsements, and partnering directly with health plans.
Nuplazid (pimavanserin) 

Read the case study  
Parkinson’s Disease PsychosisFirst MoverAcadia steadied Nuplazid after public safety concerns by communicating openly about risks and benefits, teaming up with patient groups, and providing hands-on coverage support for families.
Repatha (evolocumab)

Read the case study
LDL-CLate Challenger Amgen expanded patient access to Repatha by cutting its price by 60 percent, proving it prevents heart attacks, and enlisting cardiologists to challenge insurance denials. 
Vyndamax (tafamidis)

Read the case study
ATTR-CMParadigm Shaper Pfizer established Vyndamax as the standard treatment by teaching doctors how to spot a rarely diagnosed heart disease and establishing simpler scans to identify patients earlier. 
Kadcyla (ado-trastuzumab emtansine)

Read the case study
HER2+ Breast CancerLate Challenger Genentech turned Kadcyla into a routine breast cancer therapy by showing strong results in advanced disease first, then using definitive trial data to treat patients right after surgery.

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