Welcome To The Week In Review.
- $158,000? “There Is No Justification”
- Last week, the Food and Drug Administration approved Relyvrio, a drug combination to treat amyotrophic lateral sclerosis (ALS), a progressive and fatal disease of the nervous system that affects tens of thousands of people in the United States. Relyvrio is not proven to work, yet the company that makes the drug, Amylyx Pharmaceuticals, set an annual price of $158,000. Independent reviewers say the upper limit of a reasonable price should be a maximum of $30,700 with the important caveat: “if the therapy actually works.” This week, experts and patient advocates are calling out this latest example of Big Pharma greed. “We’re not talking about [Amylyx] setting a price to recoup their investments or anything like that,” said Stacie Dusetzina, associate professor of health policy at Vanderbilt University Medical Center. “This is basically taking advantage of the fact that we allow the price to be what the market will bear.” P4AD’s David Mitchell released a statement saying, “There is no justification for pricing Relyvrio, a drug that has not been proven effective, at $158,000. It is a poster child for what is wrong with drug pricing in America and why our system must be reformed to arrive at appropriate prices that maximize accessibility and affordability for drugs that are shown to be both safe and effective.” — (The New York Times, Common Dreams, Politico, P4AD)
2. New Reform In Action
- The very first provision of the Inflation Reduction Act went into effect last Saturday Oct. 1. Drug corporations will now have their drug price hikes assessed against the rate of inflation. “Pharmaceutical companies that raise the price of their products more than the rate of general inflation will have to pay Medicare a rebate for those outsize price hikes,” explains AARP’s Peter Urban. “The provision is designed to help reduce the size and frequency of prescription drug price increases.” A new report released by the Department of Health and Human Services (HHS) says that Big Pharma raised the price of over 1,200 prescription drugs past the rate of inflation from July 2021 to July 2022 — price hikes that would likely now be subject to steep penalties. This reform will be life-changing for patients. “The Inflation Reduction Act is really historic legislation that is going to save millions of people in America millions of dollars over time,” P4AD’s David Mitchell said on iHeartRadio’s podcast, It Could Happen Here. — (AARP, The Hill, Florida Politics, Ohio Capital Journal, Bangor Daily News, Cleveland.com, Colorado Times Recorder, It Could Happen Here)
3. Time To Tackle PBMs
- Lina Khan, chair of the Federal Trade Commission (FTC), vowed to use all of the tools at the commission’s disposal in its investigation into the business practices of pharmacy benefit managers (PBMs) — that includes law enforcement and rule-making. Over the summer, “the FTC unanimously voted to launch a probe into the business practices of PBMs and how they influence drug prices and the pharmacy business.” The investigation is a much-needed next step to scrutinize PBMs and ensure they work for patients. — (Axios)
Have a great weekend, everyone!