Launching A Specialty-Care Blockbuster Franchise in Hepatitis C: How Sovaldi & Harvoni Rewrote New Product Launch History

STUDY OVERVIEW

When it was approved by the FDA in December 2013, Sovaldi represented a new era for treating hepatitis C patients. It was the first all-oral HCV medication that, for some types of HCV patients, offered near-perfect cure rates without difficult side effects.

Sovaldi's elevated cure rate, its short dosing period, and the promise of less severe side effects for many HCV patients propelled the drug to $2.3 billion in its first quarter on the market. While its safety and efficacy profile attracted tens of thousands of patients, Sovaldi's price tag of $84,000 was not met with open arms by private and public payers.

Clearly, Gilead Sciences had to create and execute a launch plan that would ensure Sovaldi found a place on payers' formularies, was accessible for those lacking coverage/resources and dominated the competition.

This extensive case study reviews:

• The prevalence of Hep C and the distribution of patients geographically and by genotype
• How Sovaldi advanced Hep C therapies from treatments to a cure
• Key factors behind Sovaldi's historic launch
• Sovaldi's pricing war - how payers battled the high cost and Gilead justified it
• How Gilead fought off predatory patent challenges
• The entrance of Harvoni, Gilead's next generation Hep C treatment that did not require interferon and ribavirin

• Playbook of a Blockbuster: Key Insights from Sovaldi & Harvoni’s Launch Year Success
• Birth of A Specialty Medicine Blockbuster -The First Oral Cure for Hepatitis Virus C (HCV)
• Having The Insight & Expertise To Envision Transforming HCV Treatment Paradigm
• The Seeds of Success: Sovaldi Method of Action Moved Therapy From Treatment to Cure
• The Seeds of Success: Epidemiology of Hepatitis C Created A Tsunami of Global Unmet Need
• Market Entry History: The Back Story of The New Blockbuster Model
• Sovaldi Launches Like A Rocket Ship
• Other Noteworthy Market-Entry Tactics and Practices
• Pricing New Therapies Offers Multiple Risk Frontiers
• Public Reaction Ranged From Jubilation To Outrage
• The Global Launch & Pricing Strategy Divided The World Into Key Regions
• Payers Crafted Different Strategies Both To Access The New Therapy & Manage Its High Price
• Where Blockbusters Grow, Patent Challengers Quickly Spring up
• By Its First “Birthday” Gilead’s HVC Franchise Had Rewritten Biopharma Launch History – But Still Faced Many Challenges

• Prevalence of Hepatitis C genotypes
• Sovaldi treatment and cure rates across genotypes
• Gilead's overall performance Q1 2013 compared with Q1 2014
• Sovaldi's early sales and patient numbers
• Pricing comparison between Sovaldi and competitors
• Sovaldi's pricing around the world
• Impact on total cost in California when 75% of chronic Hep C patients are treated
• Impact on total cost in California when 75% of total Hep C patients are treated
• Gilead's revenues in 2013 compared with 2014
  

This case study was created using multiple secondary research sources. It contains a wealth of qualitative data.

Industries Profiled:
Pharmaceutical; Health Care


Companies Profiled:
Gilead Sciences; Merck

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