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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.

An “Impending Tsunami” in Mortality from Traditional Diseases?

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.

The QALY and Cancer Treatments: An Ill-Advised Match

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.

Antimicrobial Resistance: Learning from the current global health crisis to prevent another one

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The world was blindsided by COVID-19, but a new study finds that…

Five Reasons Why Drug Rebates Are Harmful to Patients and to the Healthcare System

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. 

The Negative Impact of COVID-19 Upon the Biopharmaceutical Sector

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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.

Quality Adjusted Life Years (QALY): The Threat to Older Americans

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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). 

The Legality of QALY under the ADA

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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).

Looming Challenges for ICER in Assessing the Value of Rare Disease Therapies

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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.

Key Questions for Legislators on the Institute for Clinical and Economic Review (ICER)

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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.

Will New England See Lower Prices from Drug Pricing Transparency Legislation?

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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.

Transparency in Retail Drug Prices: Easy to Obtain but Accuracy May Be Doubtful

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This paper is the fourth in a series on price transparency in the healthcare industry, and the first Pioneer report to focus on the retail price of prescription medications. Researchers called 44 retail drug stores across the state asking for the price of a 30-day supply of each drug in a common dosage. In each case the callers said they were self-pay and pressed the drug store for information about discounts.

Are Drug Prices Driving Healthcare Cost Growth?

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This report illustrates that state policy and legislative recommendations requiring pharmaceutical companies to disclose proprietary information would discourage the development of new innovative medicines, lead to higher healthcare costs over the long term, and potentially damage a big driver of Massachusetts' business economy.