We hear so much about exciting potential stem cell therapies, but what about stem cell treatment cost?
Some of these “therapies” are rigorously evaluated ones in the FDA clinical trial pipeline and others are available right now mainly through predatory stem cell clinics. Earlier this year I posted about the cost of the offerings of dubious stem cell clinics.
In this post, I address the cost of a future, legitimate, FDA-approved stem cell therapy. How high will that be? (2020 update: See this polling and other info on stem cell treatment cost as of 2019 here).
This is a critical question because if many patients cannot afford a stem cell therapy then the impact of that therapy is reduced. Cost is inversely related to access. On the other hand, stem cell biotechs must make some profit or they will go out of business. Investors, who are often enthusiastic boosters of the stem cell field, will lose large sums of money and confidence in the field too in that scenario if stem cell treatments are priced “too low”. What is the “right” price?
There is likely to be increasing pressure on biologics drug prices as well from the federal government. Witness Hillary Clinton’s recent tweet on this topic below that sent people into a tizzy.
Price gouging like this in the specialty drug market is outrageous. Tomorrow I'll lay out a plan to take it on. -H https://t.co/9Z0Aw7aI6h
— Hillary Clinton (@HillaryClinton) September 21, 2015
At the state level, such as here in California, the question of stem cell treatment cost is also becoming more pressing including for our state stem cell agency, CIRM. As CIRM-funded clinical trials advance, which is a wonderful thing, at the same time we get closer to where someone will have to decide on stem cell price tags.
We can look at what other cellular drugs have cost as guidance for the price tag range for stem cell treatments. For instance, Prochymal (its old name under Osiris) that is now rebranded as TEMCELL from Mesoblast/JCR likely will cost about $200K for a full treatment for GVHD (HT to Alexey). Provenge, the cellular prostate cancer drug from the controversial biotech Dendreon had (has?) a price tag of $93K. The most expensive drug in history, the gene therapy med Glybera will cost around $1.5 million per patient.
Realistically, a typical legit stem cell therapy could easily be $100K per patient. A personalized cellular medicine such as an autologous stem cell-based therapy could easily run into the hundreds of thousands per patient. Some therapies could go as high as $500,000 (see this helpful piece by David Jensen) or even into the millions.
Irv Arons (@iarons) has come up with a great table of cost estimates focused in the area of vision therapy (free registration required). Thanks to Irv for permission to use it here (above).
How will patients afford such expensive therapies?
Will such therapies be covered by governmental agencies or insurance companies? They should.
We should also be keeping in mind the current costs of treating today’s patients with major and sometimes chronic diseases. These costs run into the hundreds of billions or above a trillion dollars each year in the US alone. That’s important context and rightly indicates that the costs of stem cell therapies to society may be appropriate even if at an individual level they seem high.
How does this compare to stem cell treatments at predatory clinics?
Such “treatments” range from $5,000-$20,000 each and most patients with whom I have talked either received or were pitched at least two such treatments, amplifying the total cost. The cost to the clinic of the treatment itself can be as low as $500-$1,000. Some clinics claim to have treated thousands of patients suggesting they are making millions in profits.
Why are stem cell clinic offerings typically relatively cheaper than legit treatments? Frankly, it is because they don’t follow the rules or do the necessary studies to prove safety and efficacy. Ten thousand dollars is still a lot to pay for something that doesn’t work and could even be harmful.
Even so some consumers may perceive dubious stem cell treatments as the way to go because of the lower cost, particularly if the legitimate stem cell field fails to do a good job at educational outreach and the FDA continues to effectively do nothing about the stem cell clinic problem.
The bottom line remains a question. Where’s the stem cell price sweet spot where we can help the most patients, but also generate a needed profit for the biotechs?
We need to find an answer to this question soon.
Knoepflerr, in your cross eyed view you equate “legit” with “FDA-approved” and “successful therapy” for everything that goes through clinical trials and gets approved. There are many FDA approved drugs that are killing patients faster than the disease, bankrupt patients or merely marginally extend their lives. In the pursuit of successful clinical trials, big money and “legitimate” treatments, it has become a common place for researchers to fake data (retraction watch, pubpeer) to advance their own career and create data for drug approval, such as the Duke-Potti case, Astrazeneca, etc. Now we have other “fast-track” categories to contend with that do not get the same long-term scrutiny and companies are using this pipeline to push their agenda. In addition, there are companies that rescue failed drugs or are contracted the clinical research and get the data for drug approval that way, still posing a big danger to patients, CRO Cetero for example. Given these issues, public has lost its faith in FDA and their claims that they protect people. This is similar to the loss of trust these days in politicians, media, academicians (who are viewed as shills by most patients) and our other agencies. Point is that FDA approval does not guarantee a disease cure in one shot (or many), not does it justify the high price and patients are arguing that it does not even guarantee safety, if you listen well to patients. For all the money that California is spending, which will be $6 billion with interest, it is astonishing to us patients as to why you guys are still talking and talking and talking…conferences….symposia….summits…..moving headquarters….avoiding meeting with public….and not showing us the cure in hand in the market. I am sure for that kind of money, one would assume, you guys would at least have done the simple math of pricing the treatments by now, a high school exercise, as patients would view it.
On the other hand, you also seem to equate “unapproved” with harmful, quackery, predatory and useless. Most of the patients know that medical innovations are occurring across the globe and US is way behind. In the end, in this new age, patients will seek treatments anywhere they know they will get results and at a price they are willing to pay. At this point, it seems that Japan and China are beating US in this game, so while our researchers are busy blogging and passing gossip along through social media, these countries every single day strengthen their position in this field, and pretty soon will be set to capture the global market. THAT, Knoepflerr, is the existential threat biotechs face and the threat to our efforts here in USA, and pricing is a mere lazy mind’s haggle at this point.
Paul – also keep in mind there are other proxies that fly against what you are proposing.
Case in point: FDA currently “oversees” two identical type of products:
Dietary Supplements:
http://www.fda.gov/Food/DietarySupplements/
and Botanical Drugs:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090946.htm
The first has minimal requirements – No long term clinical trials for efficacy; No long term clinical trials for safety; No short term human testing for sudden cardiac events; No long term animal carcinogenicity studies; No interaction studies; GRAS status can be by “affirmation”, no structured CMC, etc. etc.
These “non-legit” products, as you may refer to them, generate est. $50-100 billion globally, are consumed by millions of people, and come with a fairly decent safety record for an “unregulated” option
Botanical Drugs on the other hand, the “legit” version of such products you may say, require everything as would a traditional FDA registered drug, are priced at a much higher premium, and rarely have enjoyed any more that niche success in the market
The “pills” in both cases contain the same exact API
Large pharma (including Pfizer and others) got into the botanical drug space in the late 1990s / early 2000s thinking they could enjoy a 10-20X bump from what the dietary supplement makers were getting with their new FDA approved versions and had visions of a new $Trillion market materializing
The strategy failed miserably
If people start enjoying success with non-legit stem cell options, and feel the risk – reward is acceptable, the more legit market will disappear
Investors will no longer fund it in the short term, and pharma won’t pick up registrational work
The pharma industry used to justify its existence by showing how therapeutics had a pharmco-economic benefit over some other intervention
But when you get into such numbers as you reference, you risk making the whole segment irrelevant if the outcomes are anything but stellar
Timely post given CA efforts to cap drug prices and Pharma’s efforts to block the proposal that would curb drug spending.
FiercePharma:
Big Pharma teams up to defeat drug pricing proposal in California
October 8, 2015 | By Emily Wasserman
http://www.fiercepharma.com/story/big-pharma-teams-defeat-drug-pricing-proposal-california/2015-10-08