TABLE 3.

Key Benefits and Challenges to a PBRSA Contract Template (N = 27)

	Illustrative Payer Comments
Benefits
Aligns interests of all parties involved	“Keeps both teams on track and levels the field as to what is expected from a final contract.” “Helps legal [from both organizations] get on the same page quickly.”
Standardizes and expedites the process	“Provides a framework based on past experience that would avoid reinventing the wheel.” “Each PBRSA agreement from manufacturers is them starting from scratch asking us to come up with something and we send them back to develop something. We don’t have the time.” “Standardized approach, no surprises.”
Creates transparency in expectations	“Keeps both teams on track and levels the field as to what is expected from a final contract.” “Easier to understand, moves agreement, negotiations forward.” “It helps define the parameters on both the business and legal aspects that are approved by the manufacturer for consideration.”
Provides comprehensive overview of contract terms	“Includes all key elements of contract.” “Ability to use template across multiple contracts—irrespective of product/disease area.”
Challenges
Evidence-based approach	“Need to be based on clinical guidelines that are well accepted or will not move forward.” “[PBRSAs] need real-world validation.”
Lack of adaptability	“Not all parts of the template may be needed for each contract, so the template would need to be customizable.” “Would have to be altered dependent upon the disease-state and outcome needed.” “The MCO or the manufacturer could end up agreeing to a contract that may be not in each other’s best interests in terms of costs and outcomes.… PBRSA templates would be with one manufacturer but what about several manufacturers because using several drugs like asthma and diabetes. That is why we selected HCV as a potential candidate.”
Not widely accepted or limited applicability	“Still not a standard for industry and will require time by pharmaceutical manufacturer and payer to negotiate to their liking.” “May not be applicable to our situation.”

HCV = hepatitis C virus; MCO = managed care organization; PBRSA = performance-based risk-sharing arrangement.