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Outcomes Research Centers & Health Plans




The Challenge for
Pharmaceutical Industry...


  Demonstrate a product's value for money, beyond traditional safety & efficacy to
  • Payers/Decision-makers
  • Employers
  • Providers
  • Patients


... A Mission for Health Outcomes

Market Challenges

Industry Needs

  Unmet medical needs

→ Right endpoints

Balance Benefit/Risk

→ Right CT designs

Rising healthcare cost

→ Right patient

Rapid reimbursement

→ Right access

Rapid patient access

→ Right price

Crowded market

→ Right cost-effectiveness

Rise of consumerism

→ Right affordability



SPC consultations could encompass the following, but not limited to:
  • Critical evaluations of evidence generated to date and conduct gap analysis.
  • Identifying effective outcomes research strategies for clinical trials, prospective and retrospective observational studies.
  • Outline regulatory considerations for outcomes related endpoints in clinical trials and promotional messages.
  • Implementation strategies for clinical trials and promotional messages as it relates to FDA Guidance on Patient Reported Outcomes.
  • Evaluate and input into global and US formulary/reimbursement submission packages.
  • Organize and develop international or US health outcomes advisory board to provide additional strategic input into research program.
  • Identify and develop outcomes thought leaders.
  • Identify strategies to increase internal stakeholder's understanding the value of outcomes data and communication mechanisms.
  • Identify and outline strategies to effectively communicate, promote and leverage outcomes data.
  • Formulate formulary and/or reimbursement negotiation strategies.
  • Establish outcomes department/function within an organization.
  • Identify process improvement for outcomes department/function.
  • Develop training and development program for outcomes staff.