The Institute for Clinical and Economic Review (ICER) recently published its first Assessment of Barriers to Fair Access report examining coverage policies of 15 major commercial insurers for 28 drugs ICER determined to be fairly priced and evaluating concordance of payer coverage policies with appropriateness criteria for fair access – cost sharing, clinical eligibility, step therapy and provider qualifications. ICER also hosted a public meeting with a discussion among study authors, patient groups and providers.


  • The report is an analysis of whether or not major insurers are providing appropriate access for drugs that ICER has deemed to have been responsibly priced.
  • It assesses concordance of payer coverage policies with appropriateness criteria for fair access outlined in an ICER white paper last fall.  Those criteria fall into four key areas: cost sharing, clinical eligibility, step therapy and provider qualifications.
    • ICER engaged representatives from patient groups, clinical specialty societies, private payers and the life sciences industry to develop the appropriateness criteria used for the assessment.
  • It is intended to drive conversation and actions to “achieve fair access” in the best interest of patients by pushing for greater transparency from insurance companies about drug coverage policies.


  • With this report, ICER – the “pricing watchdog” – expands its purview beyond life sciences companies to other stakeholders in the healthcare ecosystem that impact access and value of medications and health plans/PBMs.
  • ICER acknowledges this is an initial effort. In the public meeting, ICER highlighted gaps where more work is needed to interpret and apply findings in the real world.
  • Limitations/areas for further refinement:
    • For some drugs, only a handful of policies could be found. Payers/PBMs do not always make the policies available/easily findable. Thus, results of the small sample size may be misleading.
    • While some drugs show 100% concordance with ICER fairness criteria, this is misleading. While it may be true in theory, the way policies are implemented in practice can differ.
    • Tiering is used as a surrogate marker for out-of-pocket expense for patients, but it doesn’t factor in additional burden placed on patients who are subject to High Deductible Health Plans (HDHPs) and copay accumulators.
    • Refining step therapy criteria. ICER fair access criteria did not establish a threshold for the number of steps that when viewed cumulatively represent an unreasonable barrier (many would agree that 10 steps to get to a fairly priced drug does not equate with fair access).
  • Despite limitations, ICER’s end goal is to push for payer policy/cost sharing clarity, transparency and fairness.
    • When not fair/transparent, patients face barriers to getting needed drugs. Fairness/transparency will prevent disease and premature death.
    • Public meeting commentary suggested that plan sponsors should incorporate Fairness Criteria into their RFP selection criteria for PBMs (evaluate PBMs on dimensions such as denial rates, time to Prior Auth, etc.).

Implications for life sciences companies:

  • For drugs deemed high value, ICER’s efforts make it easier for manufacturers to advocate for easier access to them.
    • Patient advocacy groups are likely to use the report/criteria as a tool as to advocate for removing unfair access barriers.
  • The report also provides momentum for life science companies to raise more awareness of how HDHPs and copay accumulators can also be a barrier to fair access to needed, valuable medicines.
  • May spur scrutiny around the practice of some manufacturers who negotiate with PBMs/payers around prior authorization criteria (this was bought up in the public meeting).

What life sciences companies can do:

  • Advocate for health plans to consider input from patients/caregiver when devising policies/formularies.
  • Encourage ICER to incorporate a “hassle factor” metric related to administrative burden that patients/provider support staff/case managers face.
  • Understand how clinical guidelines (developed by provider organizations) influence formulary decision and identify opportunities to engage with organizations that develop treatment guidelines. 
  • Consider being transparent around discussions with plans/PBMs about shaping policies and prior authorization criteria.
  • Encourage reassessment of formulary tiers and prior authorization criteria. 
    • A specialty medicine is often placed on 4th tier by PBMs/plans by default regardless of the magnitude of value it provides.
    • Prior authorization criteria for drugs should be reviewed not only at first market availability, but also as new information about a drug’s value is identified. Changes in criteria should be communicated to providers (providers may avoid prescribing certain drugs based on perception/past experience that Prior Auth criteria/process was burdensome).

About the Author:

Sarah Brawner is part of the Syneos Health Communications’ Reputation and Risk Management Practice where she helps clients navigate the complex policy environment and develop value and access campaigns. She has worked with organizations across the health ecosystem and excels at translating complex positions into powerful, reputation-building messages.