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Weekly View
December 15, 2023
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(Programming note: Weekly View will be back in your inbox on January 5th) | |
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From all of us at ICER, we wish you a happy holiday season and a healthy new year. And as always, we thank you for your continued support of our efforts to nudge the United States toward a system of fair drug pricing and fair patient access.
Let’s look back at some of the most important ICER storylines from 2023...
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Top 10 ICER Stories of 2023 | |
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We proudly announced the promotion of Sarah Emond – our long-time Executive Vice President and Chief Operating Officer – as President-Elect for the remainder of 2023. Current President Steve Pearson will step down at the end of the year to transition into an advisor role. Since 2006, Steve has guided ICER to where we are today – an independent, non-profit organization with impact far and wide across the health care and drug pricing ecosystems.
In her role as President and CEO starting on January 1, 2024, Sarah will continue to marshal expertise across ICER's entire team to oversee the next stage of ICER’s evolution. We remain committed to transparency and our role in helping to inform public and private sector decision-making, along with our work to foster a better understanding of how we can balance fair pricing and fair access and keep innovative drugs and treatments affordable for patients and our health care system.
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In October, we published a Special Report evaluating the evidence on apixaban (Eliquis®, Bristol-Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF). ICER’s President Steve Pearson, MD, MSc explained:
“The US is beginning a new era in which the federal government will engage in negotiating drug pricing. In this task, CMS faces the challenge of evaluating a large evidence base and of integrating considerations regarding unmet need and other factors to arrive at price targets for negotiation.
ICER has submitted a Special Report to CMS on two of the drugs whose prices will be negotiated as part of the public comment process defined in CMS guidance. This ICER report includes sections on multiple elements related to value, providing different options for translating evidence into initial offer prices and for assessing counter-offers from drug makers. We recognize that our report will be one of many inputs CMS may consider, and we hope that it will help them as they build a reliable and transparent drug price negotiation process on behalf of the American people.”
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ICER published an updated Value Assessment Framework (VAF) document outlining the principles, methodology, and deliberation procedures that will guide future ICER assessments. The updates are based on ICER’s ongoing efforts to evolve our methods to reflect core principles of respect for all participants, transparency of methods and decision-making rationales, inclusivity of all perspectives, and objectivity grounded in rigorous evaluation of all relevant evidence.
The process of updating ICER’s value assessment framework included extensive benchmarking with health technology assessment (HTA) organizations around the world and consideration of input from numerous organizations and individuals across the US health system. During this process, ICER received feedback from over 30 organizations.
ICER's President Steve Pearson, MD, MSc, explained:
“ICER’s value assessment framework serves an important purpose: to create a clear picture of what we are trying to accomplish and how we go about it. We use the framework as a guidebook to ensure that all participants in our reviews, and all stakeholders using or impacted by our work, understand what our goals are, the technical methods we use, and the ‘rules of the road’ for engaging with the process. We want the framework to empower stakeholders to fully participate in every stage of our work, because only with that engagement will our work reflect the broad perspectives needed to ensure that value assessment moves our health care system toward a future of fair pricing, fair access, and sustainable innovation.”
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In July, the Peterson Center on Healthcare launched the Peterson Health Technology Institute (PHTI), a nonprofit organization that provides independent evaluations of innovative healthcare technologies to improve health and lower costs. ICER partnered with the PHTI to establish an original assessment framework developed specifically for digital health tools. | | |
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This White Paper evaluated the functions of health technology assessment (HTA) through an equity lens and proposed key methods through which HTA can support society’s goal of improving health equity for racial, ethnic, and other groups. This work also informed ICER's 2023 Value Assessment Framework update, which included new methods to evaluate the demographic diversity of clinical trials (and implement other methods adaptations related to health equity).
Finally, we hosted a webinar to discuss the key findings of this paper.
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In April, we released our Final Evidence Report assessing the comparative clinical effectiveness and value of lecanemab (Leqembi, Eisai Inc.) for the treatment of Alzheimer’s disease. Leqembi has a list price of $26,500 per year, and ICER analyses suggested the treatment would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year.
And, according to Pink Sheet, the Department of Veterans Affairs (VA) has decided to cover the therapy at a price, “just below the $21,500 cost-effectiveness threshold set by the Institute for Clinical and Economic Review (ICER).” This is a great example of how ICER reports can be used to recommend a fair price, resulting in greater access for patients.
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In August, we released a Final Evidence Report on two gene therapies for sickle cell disease: exagamglogene autotemcel (Casgevy, “exa-cel”, Vertex Pharmaceuticals/CRISPR Therapeutics) and lovotibeglogene autotemcel (Lyfgenia, “lovo-cel”, bluebird bio).
An independent appraisal committee found that current evidence for each therapy demonstrated a net health benefit when compared to the standard of care.
ICER's analysis found that both medications would achieve common thresholds of cost-effectiveness if priced between $1.35M to $2.05M. Last week, both companies received FDA approval and announced prices. Vertex priced Casgevy at $2.2M, and bluebird bio priced Lyfgenia at $3.1M.
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This week, we released our latest Unsupported Price Increases (UPI) of prescription drugs in the United States. Of 10 high-expenditure drugs that had substantial 2022 net price increases, eight were not supported by new clinical evidence; these increases accounted for $1.27 billion in additional costs over one year.
The analysis also found that one of three Medicare Part B drugs with high list price increases in 2021 lacked adequate supporting new evidence, directly raising annual out-of-pocket expenses for Medicare patients by up to $680 per year.
ICER’s Chief Medical Officer David Rind, MD stated:
“We continue to see list price increases above inflation for many of the most costly drugs. When we look further at those drugs whose net price increases led to the largest increases in US expenditures, many had no substantial new evidence to support such price increases. Additionally, list price increases can present real hardships to patients who must pay deductibles or coinsurance.”
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ICER published the third annual "Barriers to Fair Access” assessment of how well major insurers' prescription drug coverage policies align with a set of “Fair Access Standards” developed by ICER with expert input from patient advocates, clinical specialty societies, payers, pharmacy benefit managers, and life science companies.
ICER's President-Elect Sarah Emond, MPP stated:
“Every day, patients face barriers to access because of policy choices made by payers and employers. Our report highlights key areas where payers should consider changes to improve the fairness and transparency of their coverage policies, especially for policy choices, like copay accumulators, that impact patient cost-sharing. For the drugs and health plans we assessed, coverage policies were largely structured to provide fair access on paper, but it is difficult to determine how well that translates into real-world access and affordability for patients. This annual report highlights the importance of transparency and analysis in helping the system move to what we all want – fair prices and fair access."
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ICER continuously looks for new ways to solicit and act on external feedback. This year was no different. ICER created a new Patient Council and added two new Governance Board members.
The Patient Council provides feedback on ICER's patient engagement strategy, outreach, and process for input into drug reviews and broader initiatives. The Council comprises several patient representatives with a range of expertise on health technology assessment (HTA) and engagement with ICER, offering a variety of perspectives for evaluating the ICER process. Patient Council members are participating as individuals and do not represent their affiliated organizations' views.
ICER also added two new members to our Governance Board. Linda Goler Blount, MPH, is the President of the Black Women's Health Imperative, the leading national organization focused on Black women and girls' emotional, physical, and financial health and wellness. Dr. Roberta Herman is the CEO and President of Joslin Diabetes Center. Both of them share the sentiment that ICER's role as an independent, objective source of evidence is critical to help support more transparent health care policy decisions.
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Want to work for a fast-paced, mission-driven organization? Look no further! ICER is looking to expand our team, which includes a diverse set of clinicians, researchers, and policy experts. | |
Health Economics
Program and Operations
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1/8: Pulmonary Arterial Hypertension -- Final Evidence Report
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1/25: Schizophrenia -- revised Evidence Report
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2/1: Paroxysmal Nocturnal Hemoglobinuria -- revised Evidence Report
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