Is Your HEOR Group Commercially Relevant?

The greatest challenge to a building a commercially relevant HEOR group is not having well-trained and experienced researchers. The field has a plethora of highly skilled researchers and organizations like ISPOR have established robust standards for best practices across numerous methodologies.

The greatest HEOR need is strategy, as Sun Tzu stated, “Strategy without tactics is the slowest route to victory. Tactics without strategy is the noise before defeat”. To be strategic, a HEOR group must understand the environmental context and a drug’s Payer Value Proposition before developing and executing a research plan.

There are three steps to create a commercially relevant and strategic HEOR group; all require close collaboration with medical and marketing colleagues.

Step #1 – Understand the context.  Understand the environment outside of your company. This information may already exist within your company, in some cases you will need to collect the information.

• Who are the payers in the therapeutic category?
  • Commercial?
  • Medicare?
  • Medicaid?
  • Patient?
• What is the payer unmet need in the therapeutic category?
• How are payers managing patient access to new drugs in the therapeutic category?
• What are the current treatment guidelines?
• How will health policy, e.g., Affordable Care Act Medical Loss Ratio (MLR) requirements, impact the therapeutic category?

Step #2 – Understand the Payer Value Proposition.  Identify the HEOR evidence required to support your drug’s Payer Value Proposition. The Payer Value Proposition may already exist for your drug, if not, HEOR has the opportunity to collaborate with medical and marketing colleagues to define the Payer Value Proposition.

Payer Value Proposition Overview:

• Disease (problem)
  • Brief overview
    • Etiology
    • Epidemiology, e.g., incidence and prevalence
  • Payer relevant unmet need.
• Drug (solution)
  • Payer relevant clinical and economic evidence for your drug, addressing the payer unmet need.
  • Evidence defines a drug’s place in therapy or appropriate use, e.g., first line or second-line and starting and stopping rules.
• Value (benefit/cost).
  • What is the comparative value of the drug, based on efficacy and effectiveness evidence?

Step #3 – Define your tactics.  For HEOR to deliver evidence to support the drug’s Payer Value Proposition, there are two final steps before research execution and evidence dissemination.

• 1 – Define the Communication Plan
  • Promotional Channel, e.g., FDAMA 114
  • Non-promotional Channel, e.g., response to unsolicited requests

• 2 – Define the Evidence Plan to support your Communication Plan, understanding there are different evidence standards for promotional versus non-promotional communication.
  • Identify the research question
  • Plan efficacy evidence
    • Design:
      • Randomized clinical trial: Direct comparison
      • Randomized clinical trial: Indirect comparison
    • Methods:
      • Comparators
      • Endpoints
      • Patient populations (inclusion/exclusion criteria)
      • Data collection or source
      • Analytic plan
    • Plan effectiveness evidence
      • Design:
        • Modeling
        • Prospective
        • Retrospective
      • Methods
        • Comparators
        • Endpoints
        • Patient populations (inclusion/exclusion criteria)
        • Data collection or source
        • Analytic plan

Quiz – Is Your HEOR Group Commercially Relevant?

1 – Do you review and discuss your annual HEOR plan with your medical and marketing colleagues, to assure your comparators, endpoint and patient populations are commercially relevant?

• Yes, score = 10 points
• No, score = 0 points

2 – Is the majority of your annual technical promotion review process for HEOR researchers based on accepted posters and papers, independent of their commercial relevance?

• Yes, score = 0
• No, score = 10

3 – Does your company produce more than two FDAMA 114 pieces a year?

• Yes, score = 10 points
• No, score = 0 points

4 – Do you consider the external environment prior to planning research?

• Yes, score = 10 points
• No, score = 0 points

5 – Do you consider the Payer Value Proposition prior to planning research?

• Yes, score = 10 points
• No, score = 0 points

6 – Do you consider how you will communicate HEOR evidence prior to planning research?

• Yes, score = 10 points
• No, score = 0 points

Scoring

0 – 20 points: Good news! There is opportunity to better support the commercialization of your company’s drugs and the relevance of your HEOR group.

21 – 40 points: Great start! You are beginning to provide commercial value, more opportunities remain!

41 – 60 points: Move to the head of the class!