CAR-T & Cell Therapy Products: Next generation of oncology products create chance for boom or bust

STUDY OVERVIEW

The next big step in the long fight against cancer took place in the fall of 2017 when Novartis and Gilead launched the first generation of chimeric antigen receptor T-cell (CAR-T) therapies. The therapies - both based around using a patient's own re-engineered T-cells to attack their cancer - won priority reviews and quick approvals based on significant early results. The therapies meant a one-time treatment could mean lasting remission, even for the sickest patients.

The potential of Novartis' Kymriah and Gilead's Yescarta fueled blockbuster projections from analysts and a flurry of industry interest in CAR-T development. But large price tags ($373,000 - $475,000), manufacturing challenges, and serious side effects have stymied wide-scale utilization of the therapies.

Why have these promising drugs under-performed, and what is the future of CAR-T?

Best Practices, LLC conducted an extensive research project to examine the genesis, launch and market struggles of these ground-breaking therapies. "CAR-T & Cell Therapy Products: Next generation of oncology products create chance for boom or bust" is a new 78-page case study that examines:

· CAR-T's pathway to the marketplace
· Kymriah's and Yescarta's market entry strategies…and slow launch curves
· The manufacturing and pricing challenges facing CAR-T therapies
· Why payers and pharma need to find reimbursement common ground
· What the future holds for next generation CAR-T therapies and pharma

Novartis and Gilead each took billon-dollar gambles with CAR-T, and now face heavy headwinds from payers that have hit the pause button to figure out how to afford $400,000 products. But the possibilities of CAR-T as a powerful weapon against other cancers has attracted an unprecedented wave of new T-cell therapy companies - as well as Top 10 pharma companies - that are investing heavily in next generation CAR-T products.

This study pulls together multiple sources of information across key issues affecting CAR-T development and launch to give new product development leaders critical insights into the potential and challenges facing CAR-T development and launch.

KEY TOPICS

• Executive Summary
• Novartis’ & Gilead’s Pathway to CAR-T Marketplace
• Gilead & Novartis Used Different Market Entry Strategies to Capture CAR-T Market
• Slow Launch Curves & Politics Create Head Winds for Both Companies
• Manufacturing CAR-T is a Complicated Bioengineering Challenge
• The Complexity of CAR-T Market is Amplified Due to Logistics & Supply Chain
• First-in-Class CAR-T Therapies Called for Extensive Market Education
• Pricing is Another Delicate Dance
• Government and ICER Weigh-in with their Opinions on Pricing CAR-T Therapies
• Kymriah & Yescarta Also Faced Problems at Global Front
• Competitive Forces Grow
• Future Unclear for CAR-T; Next Gen Products will Overcome Older Cell/Gene Therapies
• What Lies Ahead for CAR-T?

KEY METRICS

• Key Insights & Findings
• Kymriah and Yescarta Market Entry Timelines
• Kymriah and Yescarta Target Patient Groups
• Launch Curves Slow for Kymriah and Yescarta
• Kymriah and Yescarta Projected Sales and Consensus Estimates
• Manufacturing Turnaround Challenges for Kymriah and Yescarta
• Type of Treatment Centers Favored by Novartis and Gilead
• Kymriah and Yescarta Market Entry Price Tags
• ICER Analysis of Cost Effectiveness for Kymriah and Yescarta
  

• Problem: Payer Pressure: Both government and private payers were vocal in their criticism of CAR-T costs. To keep a grip on costs, private payers are reviewing CAR-T utilization on a case-by-case basis rather than setting standard coverage guidance; CMS was slow to set reimbursement levels, causing patient access issues.

• Solution: Use Innovative Payment Methods and Negotiate Higher CMS Reimbursement: Novartis used outcome-based & indication based pricing for ALL and DLBCL. Both Novartis and Gilead are eyeing innovative approaches such as installment or annuity payments. While CMS has boosted its inpatient reimbursement level for CAR-T, some say it is still too low. Likewise, CMS is still years away from creating a separate reimbursement category for CAR-T.

The report was based on extensive secondary research that involved dozens of industry, media, company and government reports and regulatory filings.

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