OR WAIT 15 SECS
The Medicare for All debate surrounds the 2020 election-but is it truly understood?
Years ago, I was lecturing on the topic of formulary development to a class of pharmacy students at my alma mater, the University of Minnesota College of Pharmacy. One of them asked why the United States did not have a socialized healthcare system like many countries in Europe. I quickly replied, “because Americans aren’t ready for it.”
Noticing the student’s perplexed reaction, I went on to elaborate with case examples of, at the time, recently released tyrosine kinase inhibitors for the treatment of renal cell carcinoma.
At that time, those therapies had been approved and were in use in the U.S. but not available in the U.K. because the National Institute for Health and Care Excellence (NICE) had determined them not to be cost effective-despite data showing improved overall survival versus standard of care.
“Can you imagine,” I said to the student, “the outcry if the government denied a life extending drug to a patient because they deemed it not being ‘worth it?’”
As the debate on Medicare for All heats up, it may be time to revisit the question: Would Americans be ready to wait?
Buried among the large dollar estimates and Herculean operational undertaking details in the Congressional Budget Office’s report on Medicare for All was the following point: “potentially longer waits for some treatments and technologies.”
The length of these delays, if any, can be debated, but there are real case examples with socialized medicine systems today. Probably the most publicized as of late has been the back and forth between the UK and Vertex Pharmaceuticals around the cystic fibrosis drug, Orkambi. Orkambi was approved in Europe in 2015 but still isn’t available in the U.K. because the two sides cannot agree on a price.
Meanwhile, thousands of eligible patients in the U.K. wait, disease worsening, as the debate rages. On the U.S. side, Orkambi was approved in 2015 and covered by most payers shortly thereafter, albeit at higher cost than what will likely be paid in the U.K.
The example of Vertex and the U.K. may be one of the more public examples, but delays in access are not uncommon-especially considering the higher price tags of emerging therapies. Nivolumab, a member of the rapidly growing checkpoint inhibitor class of cancer drugs, received initial rejections by NICE for non-small cell lung cancer (NSCLC), adjuvant melanoma, recurrent melanoma, and advanced bladder cancer. Many of these decisions were later reversed after additional data and discounts were provided but it is a significant difference compared to the U.S. where therapies and new indications are covered shortly after approval and in some cases, even before.
Yescarta, one of the new CAR T agents met a similar fate in the U.K., but was granted access later in specific populations. While these cases all vary, there is one core attribute: waiting for innovation. And in these cases, the waiting is not in relatively benign conditions but rather in serious, life-threatening conditions where waiting may have fatal results.
There are certainly counter arguments-and the U.S. system is not perfect by any means. Advocates for Medicare for All argue that patients with no insurance or poor insurance do not have access at all. Rising coinsurance and deductibles have also been associated with spikes in nonadherence and prescription abandonment in the U.S. In addition, a lower price on drugs may allow more patients to be treated when budgets are limited. But the discussion here is whether those who currently have insurance and access-a population significantly expanded under the ACA-will be willing to wait in order to potentially lower out of pocket cost and access barriers for everyone.
Will the suburban mother be willing to wait potentially months for her child with cystic fibrosis to get a new medication? Will (or can) an elderly person with metastatic bladder cancer be willing to wait for the next innovative therapy? Will an individual be willing to wait for a new drug if in doing so, their friends or family get access to care that they didn’t have before? These questions are particularly relevant for individuals with private insurance that may be giving up more rapid access, albeit at a higher cost, to expand access to others.
PhRMA, the lobbyist organization for pharmaceutical manufacturers, has stated that concepts like price controls and price regulation could impair innovation. Medicare for All would include a provision of the government negotiating prices with manufacturers, similar to what is seen in other nations. Pharmaceutical manufacturers would have to come to the table due to the size of the U.S. market, but would they take the same risks in development?
The last few years have seen the introduction of immunotherapy in cancer, CAR T agents, and the burgeoning pipeline of gene therapies. One could reasonably question if manufacturers would pursue risky endeavors if the largest and most profitable market in the world suddenly became far less profitable. The result would be eternal waiting when research programs were discontinued or never started at all.
If Medicare for All is to have a real evaluation, the details of how such a bill would impact a person’s access to care and innovation need to be provided so consumers can make informed decisions. Healthcare bills that are all flash but no substance and written for the purpose of campaigning rather than policy making are not helpful. Americans need to understand how a change like Medicare for All would affect their healthcare and the healthcare of their families. Would patients have access to the same drugs they do now? Would access be delayed? Would drugs not be developed at all?
Jeremy Schafer, PharmD, MBA, is SVP, director Precision for Value.