Checklist

Evaluate your CGT strategy and readiness for payer engagement

Payer decision-making trends are affecting access to critical cell and gene therapies (CGTs). To help manufacturers determine their ability to respond to these trends with actionable market access strategies, we have compiled the following checklist. It’s designed to evaluate your readiness to meet payers’ needs and optimize patient access pre-approval, through the approval phase, and post-approval. 

It is based on a proprietary survey of 19 payer decision-makers Cencora recently conducted to understand the challenges payers face in making CGT coverage decisions and the support manufacturers can provide to help. 

For each question, select a yes/no answer from the dropdown menu. Your responses will help to inform steps you can take — from value-based contracting, long-term evidence, operational clarity, to sustainable reimbursement models — to support CGT coverage and optimize market access.  
1. Question 1
2. Question 2
3. Question 3
4. Question 4
5. Question 5
6. Question 6
7. Question 7
8. Question 8
9. Question 9
Score: 0 / 9

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Pre-approval phase: Engagement with payers 

  1. Have you reach out to payers 6 months or more before an expected approval?
  2. Have you shared key clinical data points – including comparative effectiveness, durability of response, and clinical endpoints – with payers before approval? 
  3. Have you engaged with payers to determine their preferred formats for communicating clinical data before sharing the data? 

Approval phase: Clear communication and sufficient evidence 

  1. Have you shared comprehensive data on your therapy’s clinical differentiators with payers, including clinical endpoints, clinical guidelines, and any differences from standard of care? 
  2. Have you communicated the full value story – including treatment cost, unmet needs, eligible population, and operational, logistical, and manufacturing considerations – with payers to help them with their evaluations? 
  3. If your product is on an accelerated pathway, have you provided payers with your post-approval evidence generation plans? 

Post-approval phase: Reinforce the value and optimize reimbursement 

  1. After launching your therapy, are you continuing to share RWE evidence with payers? 
  2. Have you established the infrastructure for collection, monitoring, and reporting of patient outcomes data, including through digital tools, registries, and partnerships with healthcare providers? 
  3. Billing codes create significant complexities for sites of care, particularly as many CGTs are billed under miscellaneous codes. Have you put together clear guidance for providers on how to use miscellaneous codes appropriately, with examples of common scenarios and supporting documentation? 

Your score:

Scoring and results after completing the self-evaluation 

0-3 points: Basic readiness 
There are significant gaps in your readiness to engage payers.  

4-6 points: Intermediate readiness 
You are partially successful engaging payers, but there are areas for improvement. 

7-9 points: Advanced readiness  
Your payer engagement is robust, but continuous evaluation and improvement are essential 

Connect with our experts

To learn more about the steps you should be taking to help payer with the challenges they face with CGTs and insights on how to optimize market access, see Cencora’s Cell and Gene Therapy Playbook for Payer Engagement or contact Cencora’s CGT team for customized recommendations.  
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