Cornerstones of ‘fair’ drug coverage: ICER and OHE release new white paper

Written by Jennifer Sander

On 28 September 2020, the Institute for Clinical and Economic Review (ICER), in collaboration with researchers at the Office of Health Economics (OHE) in the UK, published a new white paper: Cornerstones of ‘Fair’ Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals.

The aim of the paper was to examine whether specific cost-sharing provisions and the design and implementation of utilization management policies are delivering appropriate coverage and access.

The paper provides recommendations across 5 key domains:

  • Cost-sharing provisions and tier placement as part of the drug benefit design – Cost‑sharing should be based on the net price of a drug to the plan sponsor, not the list price.
  • Timing of development of prior authorization protocols following FDA approval – Payer evaluation of treatments should be expedited to minimize delays in access.

  • Clinical eligibility criteria – Prior authorizations should only be when necessary to protect patients from inappropriate use of treatments, or when necessary to manage costs of expensive interventions and to negotiate lower prices for drugs. Clinical eligibility criteria should not extend beyond reasonable use of clinical trial inclusion/exclusion criteria to interpret or narrow the FDA label language in a way that disadvantages patients.

  • Step therapy and coverage requirements to switch medications – Economic step therapy policies should ensure that patients are able to receive first-line therapy that is clinically appropriate for them and that will reduce the overall costs of care, not just costs for drug spending. Required switching policies can only be justified in very limited circumstances when the risks of harm from inadequate response or new side effects with the lower cost agent are minimal.

  • Restrictions on prescriber qualifications – In order to maintain broad access, restrictive qualifications for prescribers should be used only when necessary to ensure appropriate patient selection, adherence to evidence-based guidelines, dosing, monitoring for side effects, and overall care coordination.

This white paper, a step towards understanding and dialog between parties, aims to describe how these insurance features represent an attempt to manage the inherent ethical tension between cost control and the freedom for clinicians and patients to access a wide array of treatment options.

It is important for stakeholders, both payers and manufacturers, to consider how they are engaging with ICER while there is increased prominence and scrutiny on drug pricing in an evolving political landscape.

The complete list of fair access criteria is included within the white paper:

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