The drug company’s choice is to walk away from millions in revenue from a given country and deny their people a lifesaving drug, or swallow hard and accept an unfair price that is nowhere near the drug’s value. For the sake of shareholders and patients, drug companies typically accept the unfair price and devote the revenue to offsetting their previous investments. In short, other nations are freeloading off of American R&D.
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
The life sciences sector in Massachusetts — which has been flying so high for so long — is about to experience a very hard landing. With the adoption of prescription drug price controls in the Inflation Reduction Act (IRA), drug research and development — the heart of the life sciences sector in Massachusetts — is about to experience a nuclear winter.
Ron DeSantis proposed in November 2020 to import drugs from Canada for state agencies such as Medicaid, prisons and other public healthcare programs. The goal is to save $150 million in state taxpayer funds. But the Biden administration seems unlikely to approve the plan, and the FDA has raised objections. Here’s why the DeSantis plan will not — and cannot — save even a dollar.
The Biden administration’s formation of a working group to “develop a framework for the implementation of the march-in provision of the Bayh-Dole Act” could have serious adverse consequences for university research and biopharmaceutical innovation. It represents a particularly dangerous threat to the thriving life sciences cluster in Greater Boston.
In recent years, pharmacy benefit managers (PBMs) have instituted programs to keep out-of-pocket drug costs high for patients. Why is the administration so eager to protect federal employees from high out-of-pocket costs but is perfectly happy for PBMs to enroll millions of other patients in these programs?
Senator Bernie Sanders and his advisors have not caught onto the fact that the problem for consumers and patients is no longer the list prices of prescription drugs but skyrocketing out-of-pocket costs due to health insurance benefit design.
S. 609, a bill that would limit out-of-pocket costs for patients paying for prescription drugs, is a clear step in the right direction. Massachusetts should join 16 other states that have passed similar bills to protect patients.
Drug patents are one of the most important public policy innovations in all of human history, and a boon to patients awaiting cures. Inventions only come when inventors are rewarded, not punished. Patents are not a “necessary evil.”
The combination of legal disputes, a growing data repository and investigative reports have necessarily put the 340B Drug Pricing Program under the microscope. Combined with the fact that the policy lacks transparency, 340B has spiraled out of control to the point that no policymaker can ignore the need to look closer.
A common grievance about Harvard is that the university is out of touch with the concerns of everyday Americans. This perception is confirmed by recent research from Harvard Business School that contends patients should be denied assistance that helps them afford their prescription drugs. The Harvard study argues that in order to control drug prices, the government should deny patients’ access to copay assistance programs offered by drug manufacturers. It flies in the face of federal and state efforts to protect the value of such assistance programs for patients and ignores basic facts about how and when patients use copay assistance to access their medications.
Earlier this year, the Center for Health Information and Analysis (CHIA) released its Annual Report on the Performance of the Massachusetts Health Care System for 2020. The Massachusetts Legislature relies on CHIA data when considering bills to regulate drug costs and prices. The advocacy group Health Care for All reported that CHIA data showed prescription drug spending grew by 7.7 percent in 2020, more than twice the benchmark – but the most reliable data on prescription drugs indicates that spending in 2020 was essentially flat.
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.
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.