The document outlines strategies for a manufacturer to encourage payers to consider the broader costs of disease rather than just the cost of medication. It recommends conducting longer randomized controlled trials to demonstrate the safety of Product X as maintenance therapy and using studies to support its use in patients with comorbidities like diabetes and osteoporosis. It also suggests creating models to show how Product X could reduce other medical costs like hospitalization and presenting cost comparisons to other treatment alternatives.

1. The manufacturer could encourage payers’ broader assessment of
disease costs, rather than singular focus on cost of medication
1
Develop tactical action plans to implement the value messaging strategy
Clinical evidence
• Design placebo-controlled, randomized trials with longer duration to show the better safety profile
of Product X as a maintenance therapy
• Use investigator initiated studies and other publications to support the use of Product X in
patients with comorbidities such as:
- Diabetes
- Osteoporosis
- Other comorbidities: psychiatric history, hypertension, and cardiovascular issues
Non-clinical
evidence
Other activities
• Show patient-reported outcomes from Product X use, i.e., less fatigue or weight gain with
Product X vs. steroids
• Create cost offset models to show potential avoidance of other medical costs, i.e.,
hospitalization, dialysis, kidney transplant
• Draft and communicate the budget impact to show the true total treatment costs
• Perform cost comparison analysis of other treatment alternatives to understand the total cost of
treating a patient instead of only looking at the price of the available treatments
• Educate the payers on Product X’s approval for rare diseases, the subset of patients, the DESI
review process, and the label modernization; Counter that some other treatment options are not
FDA approved or also lack supporting data
• Recommend KOLs to help shape the discussion with payers
• Explore payers’ receptivity toward contracting and develop preliminary contracting strategy
• Create model indication-specific policy with specific approval criteria
ActionPlans
MarketAccess
Barriers
PayerMessaging
Goals