Author: Wayne Winegarden

SACRAMENTO – A new issue brief released today by the Center for Medical Economics and Innovation at the Pacific Research Institute calls for reforms to expand the reach of the Program of All-Inclusive Care for the Elderly (PACE), a joint Medicare and Medicaid program that delivers comprehensive medical and social care services to lower-income seniors eligible for nursing home-level care so they can live safely at home. Click here to download the brief Expanding PACE’s reach by supporting additional for-profit providers participating...

The flaws driving up costs across the broader health care landscape are also driving up the costs for innovative drugs. After all, pharmaceuticals are an integral component used in combination with the broader healthcare system. As a result, spending on medicines both influences and is influenced by the spending on all other healthcare services. Evaluating the total amount of spending on drugs as a share of total healthcare spending provides important perspective, consequently. As Drug Channels notes, “total net drug spending...

The government explicitly grants innovators temporary market exclusivity to provide an opportunity for groundbreaking pharmaceutical companies to recover the costs of capital associated with developing novel treatments. This was one of the express purposes of past federal reform legislation, such as the Hatch-Waxman Act signed in 1984 and the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The reality that, since 2000 alone, 750 new medicines have been developed, demonstrating that these acts are achieving their stated purpose. The pharmaceutical...

Recently, the Federal Trade Commission (FTC) held its first of three listening sessions on the pharmaceutical market. The goal was to discuss reforms that will improve drug affordability by increasing “generic and biosimilar availability” and promoting “competition”. Achieving these goals is essential. The flaw of the first listening session is its focus on the ill-founded claims of “anticompetitive practices” by incumbent manufacturers. This focus demonstrates an inherent misunderstanding of the strengths and flaws of the current pharmaceutical market. Consequently, it will...

International drug price comparisons aren’t just like comparing apples and oranges, they’re like comparing apples and iPhones. That’s because half of brand drug spending in the U.S. goes to PBMs, 340B hospitals and other middlemen, a dynamic that doesn’t exist in other countries. In some instances, the revenues of some U.S. middlemen exceed the total cost of medicines in other countries by as much as 700 percent. I previously highlighted how estimated rebates and fees PBMs receive for 10 commonly used...

The Pacific Research Institute’s Center for Medical Economics and Innovation today released a new issue brief warning that continued federal underpayment of doctors is fueling a looming healthcare crisis by accelerating the nation’s physician shortage and undermining access to care. Written by PRI senior fellow in business and economics and CMEI director Dr. Wayne Winegarden, the brief (titled “It’s Time for Medicare to Stop Shortchanging Physicians”) finds that Medicare reimbursement rates are well below market value and have failed to keep...

To Improve Drug Affordability Congress Should Fix the Payment System President Trump has issued an Executive Order (EO) demanding that drug prices in the U.S. equal the lowest price among comparable industrialized countries. This EO fails to understand the complex drug payment system and threatens to harm patients. Demanding that drug prices in the U.S. equal overseas prices is akin to demanding that the price of all expensive handbags should equal the prices for the knockoffs that people purchase from street vendors. Of...

At the top of the new executive order’s priorities for pharma is the pill penalty, which Trump said threatens innovation and favors biologics. Currently, small molecule drugs are eligible for price negotiations sooner than biologics — nine years versus 13 years — and critics have said the law disincentivizes small molecule R&D. The order asks Kennedy to work with Congress to end “the distortion that undermines relative investment in small molecule prescription drugs.” “We’re already seeing it where research is being skewed...

Surveys confirm that most Americans recognize the value of prescription drugs. But the same surveys also show that Americans are worried that they will be unable to afford needed medicines. These conflicting feelings exemplify the inherent tension when it comes to prescription drugs – how do we incentivize innovation to help patients who lack efficacious treatments while also promoting greater affordability for medicines today? Too often, proposals get this balance between innovation and affordability wrong. Read the entire op-ed. ...

Rising demand for long-term care is inevitable as more and more baby boomers retire. Meeting this demand will be a challenge. Recent evidence from the PACE program demonstrates that for-profit care providers can help meet this growing demand, but only if the regulatory environment allows it. Read the entire op-ed here....

An analysis by the American First Policy Institute released today correctly notes that the drug price controls most OECD countries impose on innovative medicines jeopardize future innovations. Yet, while correctly diagnosing their high cost, the authors still recommend that price controls should be imposed on U.S. patients. Adopting such a policy will worsen health outcomes while potentially raising overall healthcare spending even more. The cost of capital for developing a new drug is $2.9 billion, including post approval research and development costs. Meanwhile, the...

SACRAMENTO – Nevada taxpayers could face millions in new bureaucratic costs and patients will likely see less access to life-saving drugs if state government mandates so-called “Maximum Fair Price” price controls on prescription drugs, finds a new brief released today by the Center for Medical Economics and Innovation at the nonpartisan, California-based, free-market think tank, the Pacific Research Institute. “Some Nevada lawmakers want to enact government price controls on prescription drugs in the name of lowering costs for patients,” said Dr....

CMS recently announced the next 15 drugs that will be subject to price negotiations under the Inflation Reduction Act of 2022 (IRA). These are negotiations in name only because CMS can levy penalties on any manufacturer that fails to comply with the process. Since the penalties include an excise tax up to 95% of a drugs total U.S. sales revenue, the law essentially empowers CMS to set its desired prices (e.g. price controls). Price controls discourage R&D spending. With less investment...

READ THE PDF Executive Summary Reforms that will strengthen the biosimilar market and expand savings opportunities include: Reforming (ideally repealing) the Inflation Reduction Act’s price control measures. Improving the incentives underlying the current buy-and-bill system to better align the financial incentives of providers, payers, and patients. Promoting greater transparency to the opaque drug rebating system including addressing the rebate wall problem through comprehensive reform or prohibiting the anti-competitive rebating practices that are generally outlawed in other markets. Given biosimilars’ demonstrated ability to...

READ THE PDF Executive Summary The Inflation Reduction Act’s price controls discourage biosimilar development. Payment system inefficiencies, such as the buy-and-bill payment system and rebate walls, disincentivize the use of lower cost biosimilars. Despite the savings biosimilars have already enabled, there are barriers to further progress. First, the price controls from the Inflation Reduction Act (IRA) disincentivize biosimilar development. Second, the convoluted pricing system discourages greater use of lower cost alternatives. How the payment system disincentivizes their use varies depending on whether...

READ THE PDF Executive Summary Since 2019, biosimilars have obtained a majority share of most markets where they compete. The combination of lower prices (both biosimilar and originator) and rising market share could have generated up to $35 billion in savings in 2024 dollars compared to an all-originator baseline based on PRI’s latest analysis. These savings demonstrate that, just like with small molecule medicines, biosimilars strike a beneficial balance between incentivizing innovation and promoting affordability. Lower-cost Biosimilars Are Gaining Market Share The share...

“On the other side of the political spectrum is Wayne Winegarden, Ph.D., the Senior Fellow in Business and Economics at Pacific Research Institute, and Director of PRI’s Center for Medical Economics and Innovation. “He and his colleagues believe that patients are not in control of the health care system and that we suffer from an opaque and complex pricing structure that harms patients. “Winegarden’s free market approach means he advocates for doing away with the Obamacare subsidies that Congress must consider, as...

READ THE PDF Executive Summary In the competitive biologic markets, biosimilars have reduced average prices by 56 percent. The lower prices have reduced total expenditures by 51 percent in the competitive biologic markets even though total use is higher. Developing biosimilars is a long and costly endeavor that can take up to 9 years and $300 million. Market conditions should encourage uptake and appropriate reimbursement for physicians and manufacturers. Biologics – innovative medicines made, or derived, from biological processes – treat devastating...

In a patently politicized press release, Senator Bernie Sanders (I-VT) who is  Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, claims that the U.S. price of Ozempic is too high. As evidence, he cites generic companies that claim they can sell Ozempic for less than $100 a month, an inherently flawed JAMA study that claims that these same diabetes drugs can be profitably produced for less than $5 a month, and inaccurate price comparisons with other countries. Debunking...

The Inflation Reduction Act (IRA) effectively imposed price controls on a portion of the pharmaceutical market. Worse, by design, the reach of these price controls will expand every year. The intended consequence of the policy is to reduce overall spending on drugs, but all regulations have unintended consequences, too. While these consequences may be unintended, they need not be unexpected. In the case of the IRA, these unintended impacts now threaten to undermine the entire purpose of the policy. Read the full...