Dive Brief:

• The Institute for Clinical and Economic Review, a nonprofit and frequent critic of drugmakers for excessively high drug prices, now plans to assess how health insurance policies harm patient access to care, the group announced Tuesday. This follows research by the group that argued cost-sharing should not be structured to shift healthcare costs to patients when they have no medically appropriate lower-cost option.

• ICER’s review will not, however, look at whether cost-sharing should be reduced for drugs on which payers receive large rebates or whether payers should be asked to demonstrate how their policies on drug access save overall healthcare costs.

• Drugmakers have repeatedly tried to shift the blame for high out-of-pocket costs and limited access to drugs by pointing to the design of insurance plans. ICER’s review suggests a new emphasis by the group on examining the role insurers play alongside pharmaceutical companies in determining patient access and costs.

Dive Insight:

While ICER usually judges new drugs to be priced above levels it considers cost effective, the group’s public pressure may have helped shape the launch of several drugs that met its criteria, including the cell therapies Kymriah and Yescarta, as well as the gene therapy Zolgensma.

Now the nonprofit plans to shine a spotlight on insurance plan design, which can also put new drugs out of reach for patients. ICER’s targets include “multi-tiered” health plans that increase patient cost-sharing for branded and specialty drugs, as well as policies that control access to more expensive drugs by requiring physicians seek permission to prescribe an expensive drug. The group will also look at policies that patients must first fail to gain relief on a cheaper drug, before accessing a newer, more expensive medicine — a practice called “step therapy.”

Specifically, ICER will look into insurers’ justification for placing similar drugs on differing tiers, particularly if they have all been shown to be cost-effective, and whether it is reasonable to increase cost-sharing on higher-tier drugs subject to step therapy.

For drugs subject to step therapy, ICER will consider whether it’s appropriate for all or mostly all patients, whether there’s a reasonable chance they will meet their goals on a lower-tier drug, and what harms can occur from any delays to moving to the higher-tier drug.

Whether step therapy saves overall healthcare costs will not be part of the ICER review, however, nor will whether patients who progress to a higher-tier drug as part of step therapy be subject to cost-sharing of the lower-tier drug.

ICER’s work group also will not consider whether cost-sharing should be based on the list price or the “net price” — the amount that’s paid by insurers once rebates and discounts are taken into account. The latter approach is one that’s gained support from lawmakers as well as the former Trump administration.