CMS released guidance on IRA price negotiation last week. Below are some highlights regarding how drugs will be selected. Which drugs are eligible for negotiation? For small molecules, drugs have to be (i) FDA-approved, (ii) be FDA-approved at least 7 years ago, and (iii) have no generic equivalent on the market. For biologic molecules, drugs have to be (i) FDA-approved, (ii) be FDA-approved at least 11 years ago, and (iii) have no biosimilar equivalent on the market. Combination medications that are always prescribed together will be considered as if one treatment. Drugs ranking in the top ..read more

That is the title of my article with Melanie Whittington and Louis Garrison in STAT News. An excerpt is below: The changing landscape of drug pricing policy in the U.S. has implications for the global pace and direction of innovation. Drug policy changes are being influenced by perceptions of the value of novel medicines relative to their budgetary impacts, with some believing that many medicines may not be worth their cost, creating an important role for health technology assessments (HTA). The goals of these assessments are to ensure that society does not overpay for new medicatio ..read more

To account for differences in disease burden across a Medicare Advantage (MA) plans patient population, uses risk adjustment based on patient disease burden. Specifically, MedPAC notes that: Medicare uses beneficiaries’ characteristics, such as age and prior health conditions, and a risk-adjustment model—the CMS hierarchical condition categories (CMS– HCCs)—to develop a measure of their expected relative risk for covered Medicare spending. In February 2023, CMS CMS published a notice of proposed rulemaking to update their HCC risk adjustment algorithm (v28). These changes included (i) levera ..read more

ISPOR is next week…IRA is a hot topic. Spending on AI vs. the Manhattan Project. Competition and dating apps. Coverage of UnitedHealth cyberattack Good news Friday ..read more

In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas: A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites, public hearings and regulations (i.e., proposed/final rules). FDA also added new data resources including publishing a modernized version of the Purple Book in February 2020. FDA also collaborated with other agencies such as FTC, and p ..read more

A federal judge says ‘no’. Endpoints reports: A New Jersey federal judge on Monday tossed cases brought by Johnson & Johnson and Bristol Myers Squibb against the Inflation Reduction Act, another victory for the law while Medicare works through the first year of price negotiations with industry. In a summary judgment, Judge Zahid Quraishi ruled the IRA provisions don’t constitute a physical taking of property or a violation of speech, the two constitutional claims at the core of the drugmakers’ arguments. The opinion could impact similar cases playing out in other courts across the country ..read more

According to the 2019 NSDUH survey, 27.7 percent of 18-22 year olds who are not enrolled in college full-time and 33.0% of 18-22 year old full-time college students reported binge drinking in the past month. Should society impose stricter restrictions on drugs and alcohol for younger individuals? On the one hand, drugs and alcohol harm both the individual and often others (e.g., drunk driving accidents, increased crime). On the other hand, draconian laws can lead to elicit markets and other types of criminal activity. Further, many individuals value the right to choose whether or not to use dr ..read more

While CMS has a target of getting 100% of Medicare beneficiaries into value-based payment (VBP) programs–such as accountable care organizations–by the end of the decade, implementing VBP in practice will be challenging. An editorial by Navathe et al. (2024) in Health Affairs provides some key considerations. Providers forego certain revenue for uncertain ‘bonus’ payments. “One flaw is built into many VBP incentive designs: They require participants to forgo revenue for the opportunity to earn just a fraction of it back as shared savings. The math doesn’t work. These VBP contracts ask particip ..read more

Progression-free survival (PFS) is a surrogate endpoint is defined as follows (by ChatGPT): In essence, PFS refers to the length of time during a clinical study or treatment regimen where a patient’s disease doesn’t worsen or progress. For instance, in cancer research, it measures the time from the start of treatment until the cancer shows signs of growth, spread, or relapse. Understanding PFS is vital because it helps clinicians and researchers assess the effectiveness of a treatment in controlling the disease. A longer PFS suggests that the treatment is successfully slowing down the progres ..read more

Medical debt in the U.S. is a major problem. While over 90% of individuals have health insurance, many people are uninsured and even those with insurance may be liable to high deductibles and copayments. A Kaiser Family Foundation (KFF) analysis uses data from Survey of Income and Program Participation (SIPP) and finds that: …20 million people (nearly 1 in 12 adults) owe medical debt…people in the United States owe at least $220 billion in medical debt. Approximately 14 million people (6% of adults) in the U.S. owe over $1,000 in medical debt and about 3 million people (1% of adults) owe medi ..read more