From my America Out Loud Pulse podcast with Kenneth H. Schell, Pharm.D – https://www.americaoutloud.news/kenneth-h-schell-pharm-d-a-pharmacist-tells-all/
Medications have changed the face of medicine. Untreatable conditions became treatable. Many surgeries were made unnecessary.
Prescription medications can be lifesavers or a substitute for a comprehensive look into a patient’s health status, including family and work life. Let’s look at prescription drugs by the numbers.
- As of 2020, there are more than 20,000 prescription drugs that are approved for marketing by the FDA.
- According to the Centers for Disease Control and Prevention (CDC), in 2019, almost 1 billion prescriptions were written in doctors’ offices. Put differently, 70 percent of office visits involved prescriptions.
- Almost half of people in the U.S. have taken a medication in the last 30 days. And one quarter of people take 3 or more medications.
- During the Covid pandemic, there was a 20 to 30 percent increase in prescriptions for various antidepressants.
We love our pharmaceuticals but we hate the prices. Sometimes paying cash is cheaper than using your insurance. The Inflation Reduction Act of 2022 has a set of provisions (Sections 11001(c) and 11002(c)) aimed at lowering prices for Medicare program starting in 2026. Medicare plans to negotiate prices for up to 60 drugs over the next four years, and then up to 20 more drugs every subsequent year.
The program starts with 10 drugs that account for the highest Medicare spending—$3.4 billion in 2022. The list includes Eliquis® and Xarelto®, for preventing strokes and blood clots. They now cost about $450 for a 3 month supply. Also included is Entresto® for heart failure that costs $650 per month. Others are Jardiance® for diabetes and heart failure, Januvia® for diabetes, Farxiga® for chronic kidney disease, Enbrel®, for arthritis and other autoimmune conditions, Imbruvica®, for blood cancers, Stelara®, for Crohn’s disease, Fiasp® and NovoLog® insulin products, for diabetes.
The Congressional Budget Office (CBO) projects that the negotiation program would save the government $98.5 billion over 10 years.
Not so fast. Even the CBO admits that the program would result in decreased research and development of new drugs. One economist estimates that 135 fewer drugs will be brought to market, resulting in loss of 331.5 million life years in the U.S.
Additionally, the new drug program is coercive. The Centers for Medicare and Medicaid Services (CMS) set the deadline at October 1, 2023 for drug companies that manufacture the selected drugs to sign agreements to participate in the program. A manufacturer that does agree to the negotiation process will be assessed an escalating noncompliance fee levied as an excise tax, potentially increasing to 95 percent of product sales. CMS plans to send an initial price offer to companies by Feb. 1,2024 and the drugmakers have 30 days to either accept the offer, make a counter-offer or decide to withdraw their drugs from coverage under Medicare and Medicaid. CMS will only have 3 negotiating meetings. Worse, there are many aspects of the program that are exempt from administrative or judicial review.
Consequently, several companies and industry groups have sued to block the program, arguing that the negotiations will stifle drug development and that the program is unconstitutional, saying it violates the First Amendment (compelled speech), Fifth Amendment (due process and unlawful taking), and the Eighth Amendment (excessive fines) as well as other constitutional harms.
We want lower prices but not at the expense of the Constitution and advancements in research and ultimately of our health.
My guest is going to talk about the world of pharmaceuticals and what we can do to improve access and affordability.
Bio
Kenneth H Schell, Pharm.D earned his Doctorate in Pharmacy from the University of California, San Francisco. He has almost 40 years’ experience in clinical pharmacology and pharmaceutical science, including overseeing pharmacy operations in managed care, pediatric and adult hospitals, medical groups, home infusion, hospice and mail order organizations. Dr. Schell served as president of the California State Board of Pharmacy and on the Board of Directors and as Presidential Officer of the California Society of Health System Pharmacists. He is also lectures at the Skaggs UCSD School of Pharmacy and Pharmaceutical Sciences where he teaches Pharmacy Law and Ethics. He currently serves on the Sharp Healthcare Institutional Review Board for research projects. He also served in compliance and privacy as Chief Compliance and Privacy Officer at a major Pharmacy Benefit Manager (PBM).
Dr. Schell also serves on several other Boards including Disability Rights Now, which champions disabled individuals seeking to become attorneys and ACTG Biopharma, an organization seeking to support novel therapies for individuals with brain injuries.