To the astonishment of many observers, the Institute for Clinical and Economic Review (ICER) recently concluded that a $2.1 million gene therapy for a life-threatening blood disorder called beta thalassemia, is priced cost-effectively. The surprise was especially pleasant, given that ICER’s methodology had, in the past, displayed bias against rare disease treatments and undervalued the lives of people living with disabilities.
About William Smith
William S. Smith is Visiting Fellow in Life Sciences at Pioneer Institute. He has 25 years of experience in government and in corporate roles, including as vice president of public affairs and policy at Pfizer, and as a consultant to major pharmaceutical, biotechnology and medical device companies. He held senior staff positions for the Republican House leadership on Capitol Hill, the White House, and in the Massachusetts Governor’s office. He earned his PhD at The Catholic University of America.
Entries by William Smith
Pioneer Institute Senior Fellows William Smith and Robert Popovian submitted public comments about PBM business practices to the Federal Trade Commission (FTC). Pioneer recommended that PBM discounts be passed along to patients when they are meeting their deductible or coinsurance requirements.
This report reviews the federal 340B drug discount program, showing that, over the past decade, the revenue for hospitals generated by the program, initially intended to serve low-income, uninsured populations, has exploded even while a number of important Massachusetts hospitals have reduced the level of charity care they provide. The study notes that nationwide, 340B drug sales rose from $9 billion in 2014 to $38 billion in 2020.
The Wall Street Journal echoes our warning about the rise of non-COVID-related deaths.
Testimony submitted on February 4, 2022 in opposition to S. 2651, legislation that would impose price controls on one of Massachusetts most important economic sectors, biopharmaceuticals.
On November 9th, 2021, William Smith, Pioneer Institute Visiting Fellow in Life Sciences, submitted the following testimony to the Massachusetts Legislature in support of House Bill 201, which addresses a number of flaws and infirmities in the Quality Adjusted Life Years (QALYs) methodology that is utilized by a number of foreign nations in evaluating the value of medicines.
This report examines whether, after the COVID-19 pandemic subsides, the U.S. will have another looming public health crisis emerging from patients failing to have had their cardiology needs addressed properly during the lockdowns. Moreover, if we surmise that a follow-on public health crisis will emerge, we can also conclude that certain population segments are going to be more impacted by CVD, as there are documented health disparities in this therapeutic area. Finally, there are policy changes that could be taken to mitigate a possible spike in CVD adverse events; the paper will close by recommending certain policy changes.
As a way to tackle drug prices, President Joe Biden recently announced that he supports the so-called “inflation rebate,” which would require drug companies to give the federal government any revenue from Medicare drug prices above the general rate of inflation. Senate Finance Committee Chairman Ron Wyden and House Speaker Nancy Pelosi have also publicly endorsed the inflation rebate.
The Boston-based Institute for Clinical and Economic Review (ICER) sells itself as an independent source of information on the value of pharmaceuticals. But earlier this month, their bias was again evident when they tried to kneecap a drug for a dreaded disease before there’s even enough data to determine how valuable the drug really is. ICER has adopted this same strategy in the past on innovative drugs for cancer, cystic fibrosis, and other devastating diseases. This time ICER’s target is aducanumab, Biogen’s drug for Alzheimer’s disease.
This report examines the alarming methodological and contextual shortcomings of the Quality Adjusted Life Years (QALY)-based methodology in evaluating new cancer therapies. It reveals five specific problems with ICER’s evaluation of cancer treatments and demonstrates the urgent need to prohibit the use of the QALY amid trends in rapid cancer innovations and personalized medicine.
A recent Institute for Clinical and Economic Review (ICER) “Report on Unsupported Price Increases,” concluded that: “Among the top drugs with price increases in 2019…ICER determined that seven of 10 lacked adequate new evidence to demonstrate a substantial clinical benefit that was not yet previously known.” The impression left by the report is that drug companies arbitrarily raise prices without good reason. As with so many ICER products, the study is misleading and demonstrates a profound lack of business acumen.
Ever-larger rebates are distorting the market for branded drugs and producing outcomes that often benefit neither consumers nor the healthcare system, according to a new study published by Pioneer Institute.
Contrary to conventional wisdom that says the coronavirus pandemic will generally benefit biopharmaceutical companies, a new Pioneer Institute study finds many companies will emerge from the pandemic commercially weaker, dealing with delays in new product launches and with fewer resources to invest in research and development.
This report examines how the QALY methodology to determine drug treatment value threatens to discriminate against older adults by placing a lower value on treatments that would extend the life of or improve quality of life for older patients. This clear bias against providing access to therapies to seniors comes at a critical and especially vulnerable time for older Americans given the coronavirus disease (COVID-19).
This new report outlines several potential legal violations and negative implications for disabled individuals related to the adoption of the quality adjusted life years (QALY) approach to drug value assessment, used most prominently by the Institute for Clinical and Economic Review (ICER).
This report examines why the Institute for Clinical and Economic Review (ICER) and the Quality Adjusted Life Years (QALY) approach to value assessment is particularly ill-suited to assess the cost-effectiveness of orphan and rare disease treatments, which represent a rapidly growing sector of the biopharmaceutical marketplace.
As states continue to grapple with prescription drug costs, a new Pioneer Institute study lays out the key ethical, methodological and disease-specific questions policy makers should address before deciding whether to contract with the Institute for Clinical and Economic Review (ICER) to conduct cost effectiveness reviews used to make decisions about the purchase of medicines and other medical innovations.
This report finds that most new drug pricing transparency laws do not lower consumer out-of-pocket costs, and that expensive and onerous compliance rules would likely put upward pressure on prices. The report reviews recent New England legislative attempts to reduce costs by requiring the disclosure of wholesale drug prices and other information about industry pricing practices.