Weekly View
December 17, 2021
(Programming note: Weekly View will be back in your inbox on January 7th)
Good morning, everyone.
From all of us here 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. To mark our final Weekly View of the year, let’s look back at some of the more important ICER storylines from 2021...
2021 ICER Storylines
The FDA’s 2021 approval of aducanumab (Aduhelm) for Alzheimer’s disease captured all the tensions inherent in the US pharmaceutical market: unmet need, uncertainty about evidence, pricing overreach, health disparities, and overwhelming costs for American taxpayers. Other than ICER, no organization was able to: 1) independently evaluate the clinical evidence when the FDA’s internal disagreements raised doubts; 2) convene a transparent, public discussion with all key stakeholders; 3) set the benchmark for fair pricing; and 4) establish guidelines for coverage and future research.

Our assessment was cited by members of Congress, referenced by US payers and policy makers, and covered by hundreds of media outlets including Bloomberg, Boston Globe, CNN, Financial Times, Forbes, Fortune, Fox News, Health Affairs, Los Angeles Times, National Geographic, Nature, NBC News, New Yorker, Newsweek, Philadelphia Inquirer, Reuters, Time, USA Today, Washington Post and Vox.
ICER’s white paper on opportunities to strengthen the FDA’s accelerated approval pathway prompted a national policy discussion about potential reforms that could ultimately improve evidence development, speed of confirmatory trials, costs of unproven drugs, and patient confidence. Our paper was cited in several policy journals including Health Affairs, JAMA, BMJ, and JCER, as well as in dozens of DC and pharma media outlets.
Several influential policymakers spent much of the year calling for ICER-like value assessments to help inform Medicare drug-price negotiations. UC-Berkeley professor James Robinson described the attractiveness of a potential “grand bargain” between payers and manufacturers:

“I think everyone understands the dysfunction [of this system]. The payers want the manufacturers to reduce their prices, the manufacturers want the payers to reduce their prior authorizations, doctors want prior authorization to go away, and patients want cost-sharing to go away… Manufacturers should use ICER pricing as benchmarks for their pricing, and then the quid pro quo is that payers should eliminate onerous prior authorization and cost-sharing to make sure patients are getting the drugs they need.”

Meanwhile, Thomas Waldrop from the Center for American Progress argued that value-based pricing would stimulate additional pharmaceutical R&D in the areas of greatest clinical need:

“Switching to a value-based pricing system would better serve patients and improve the efficiency of health care spending in the United States. Importantly, making such a switch would promote, rather than hinder, pharmaceutical innovation, especially into the health needs that are currently unmet… Rather than allow pharmaceutical companies the ability to charge whatever high price they have concluded will maximize their profits, the value-based framework ties the price to whether and to what extent the drug helps patients more than current treatment options. It also works to ensure that patient access to innovative drugs is included when determining the appropriate price for a drug.” 
State policymakers have also been aggressive in finding additional ways to apply ICER’s research to help manage their overall drug spending. Kaiser Family Foundation found that at least 35 different states review comparative effectiveness studies when determining their coverage criteria, with the most commonly cited studies coming from ICER. Several state legislatures considered bills in 2021 that would penalize drug manufacturers for price increases not supported by clinical evidence, based in part on ICER's annual unsupported price increase reports. And according to NASHP, New York’s process for negotiating supplemental Medicaid rebates -- a process that is anchored by a potential public meeting where the manufacturer’s price is compared to ICER’s cost-effective benchmark range -- has now generated more than $500 million in savings for the state since 2018. 
ICER’s analyses of unsupported price increases (UPI) occurring in both 2019 and 2020 were cited in more than 200 news articles. The good news? Faced with increased scrutiny over the past few years, the pharmaceutical industry as a whole appears to be moderating its year-over-year price hikes. The bad news? Outliers still remain.

Even after factoring in rebates and other concessions, Americans paid an estimated $1.4 billion more on Humira in 2020 than they would have if the treatment’s net price remained where it was at the end of 2019. Back in 2017, we found that Humira would require at least a 55% discount off its list price to reach common thresholds for cost-effectiveness when used to treat rheumatoid arthritis. Since we issued that report in 2017, Humira’s net price in the US has continued to climb nearly 30%. And in that timespan, we’ve seen no evidence that the treatment delivers any additional benefits for patients than what we already recognized back in 2017. Over this same three-year window, Humira’s price has been falling steadily in other countries where it faces biosimilar competition.
ICER's first annual “Barriers to Fair Access” assessment is the first-ever scorecard for judging how fairly the largest US commercial insurance plans are providing access to fairly priced prescription drugs, based on a set of criteria we established last year through a multi-stakeholder process. There’s something in our report to please and displease every stakeholder group: the PBM trade association touted ICER’s report as “underscor[ing] the work that PBMs and their P&T Committees do to give patients affordable access to needed prescription medications,” while the pharmaceutical industry’s research association countered that our report “acknowledges that patients are still facing barriers to needed treatments as a result of their health benefit design.”

In a way, both industry groups are correct. But the core takeaway is that our assessment was severely hindered by a lack of transparency around several aspects of patient access, and that the simple process of shining more light into this area of our health system can lead to more patient-friendly policies. Even during this limited initial assessment, six different payers improved their coverage after we showed them our preliminary analysis.
ICER believes that assessing the value of a new therapy must be guided by patients who know the condition, understand the diversity of patient experience, and who can provide a truly comprehensive view of what types of health improvement would matter most to patients. Only by making the patient perspective central can ICER usefully judge the evidence on how well a treatment improves patients' lives.

College student Sam Bittner discussed her experience serving as a patient voice during ICER’s public meeting to deliberate over new treatments for atopic dermatitis: “I was incredibly nervous at first. But as I started telling my story, I noticed how every single person was paying close attention. I felt like my voice, and other patient voices, were finally being heard.”

Separately, several patient organizations -- Lupus and Allied Diseases Association, Lupus Foundation of America, and Lupus Research Alliance -- voiced their support for ICER’s assessment of therapies for lupus nephritis, and the process we took to carefully consider their input and embed the patient perspective throughout our assessment and policy recommendations.
The FDA declined to approve roxadustat for anemia of chronic kidney disease, citing the need for an additional clinical study. The Agency's decision followed ICER's review of roxadustat earlier this year, when our independent appraisal committee voted unanimously (15-0) that the evidence wasn’t adequate to demonstrate the treatment provides a net health benefit, largely due to the uncertainty of roxadustat's safety data related to cardiovascular events and all-cause mortality. 
Bernstein’s biopharma analyst Ronny Gal published an investor note -- “ICER Analytics: the ultimate pharma ESG tool?” -- in which he recommends ICER Analytics as a helpful scorecard for socially conscious investors:

“When it comes to the biopharma industry, the main industry-specific issue is drug prices in the US… In looking at the ICER database, we realized the data set can be used as an in-depth, independent, objective, and transparent, systematic analysis of how fairly individual companies set US prices. Further, the database offers quantitative targets to what prices should be. Thus, it offers an actionable decision-making tool for ESG investors and offers an alternative way to legislation to pressure the industry to control their prices (boards and CEOs care about their stock prices).”
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