The Institute for Clinical and Economic Review (ICER) has gained industry-wide notoriety for their cost effectiveness analyses, which typically investigate the value of available treatments within a specific disease state. Recently, ICER has made waves with the announcements of two new reviews: the "Unsupported Price Increase" (UPI) report and the “Valuing a Cure” project.
“Unsupported Price Increases”
ICER is expanding beyond their traditional remit, as they seek to investigate 13 therapies that have undergone the “most significant” increases over the past two years. The goal of ICER’s analysis is to assess whether or not the data supports the premise that the drug is “significantly more beneficial for patients.”
Which therapies they will review remains a mystery, but ICER did give some guidance on their process for selection.
- They will identify the top 100 drugs by sales revenue, and determine their two-year net price increase.
- They will then rank drugs by budget impact and select the top 10 “whose net price increase would have generated the largest increase in budget impact at the national level.”
- ICER will include up to 3 additional drugs based on public input.
Manufacturers will be asked to contribute any evidence that supports the price increase. This could be new evidence on improved clinical or economic outcomes, new data of clinical advantage of their therapy or even data that demonstrates large health system savings associated with their drug.
A timely development
ICER’s announcement comes amid consistent media coverage of 2019 price increases and mounting bipartisan interest in action on drug pricing. Just days before ICER announced their new report, the House Oversight Committee scheduled a hearing on drug price increases for late January.
News of this report - and the various report-development milestones on the calendar for 2019 - will certainly add continued “fuel to fire” that is scrutiny on drug price increases. And as the first UPI report will be released in the fall of 2019, it could level renewed focus on price increases right before annual adjustments take place in 2020.
Any manufacturer with a therapy on the “top 100” list will need to prepare for the impact of this review, but certain disease states will be at higher risk.
Chronic categories are at risk. While drugs in some chronic categories may not meet ICER’s main criteria for inclusion, public input could change that. ICER specifically notes they will consider public input on drugs that affect “millions of Americans.” High risk categories include: diabetes, inflammation, MS, mental health and some oncologics.
Advocates will play a role. Disease states with particularly active, highly-networked advocacy communities may be more relevant in this review. That’s because one of ICER’s criteria for inclusion is simply “drugs whose price increases raise concerns about the fairness of the price increases.” We can anticipate that any advocacy community that feels aggrieved about pricing will try to effectively make that case for this review.
The Oversight hearings may be a catalyst for conversation. Disease states with high Medicaid and/or Medicare spending will be front and center both the Oversight hearings, as will disease where prescriptions costs significantly outweigh other healthcare expenses.
“Valuing a Cure”
Some in the industry are concerned that current frameworks, like ICER’s, do not accurately account for the cost-effectiveness of potentially curative therapies. Criticism has focused on the current models’ failure to capture measures around the improved quality of life patients and their families experience as a result of being cured. There are also questions about the durability of response beyond available short-term data, and concerns that current methods would assign “unrealistically high” prices to potentially curative treatments.
In their announcement ICER noted that they will undertake the project in collaboration with “methodology experts, stakeholders, and several leading international health technology assessment (HTA) groups, including both the United Kingdom’s National Institute for Health and Care Excellence (NICE) and the Canadian Agency for Drugs and Technologies in Health (CADTH).” This collaboration will allow ICER to tailor their methodology to the “distinctive nature of the evidence base for potential cures,” and their efforts will be included in ICER’s 2019 update to their framework.
ICER has posted a number questions surrounding methodology, on which they are accepting public comments until February 20.
Do you need to prepare for these reviews?
The Reputation & Risk Management group handled 70% of ICER reviews in the last two years and our Value Promotion and Protection model helps justify price decisions to diverse stakeholders. If you need help, reach out to our team.