QUESTION 1: Do these regimens meet an important need?
Yes. On that we can agree. ICER may not think they are worth the QALY they have set forth, but they do seem to agree they are meeting an important need.
Score one for patients!
QUESTION 2: How strong is the evidence that these new treatments improve patient outcomes?
ICER loves the phrase “there is insufficient evidence.” Perhaps there is, but does the patient who is feeling better on the right combination for them really care? Do the patients worry that there is insufficient evidence for how great they are feeling today? Or if there is insufficient evidence for how lousy the are feeling today? Probably not. If we put the patients at the top of the equation, the best path forward comes into focus for everyone.
The way we conduct clinical trials and move through a four stage trial process has not changed in the United States since before color televisions were invented. For a quick timeline, the first chemotherapy drug was approved in 1949. There was no such thing as an oncology specialty in 1960. 57 years later, look at where we are.
- Clinical trials have not changed – but cancer treatment has, and it has changed most drastically in the past decade.
- There have been more than 60 new cancer treatments approved since 2004. Now we can target specific genes across cancer types, and more are being discovered and added to the genetic testing results each year.
- There have been six new drugs approved for just myeloma since 2012.
- To know these words is to know progress is on the march: Targeted therapies. Personalized medicine. Immunotherapies. Gene therapies. Hormone therapies. Angiogenesis inhibitors. Apoptosis inducers. To name a few …
We produce panels called Right Patient, Right Treatment, Right Now because we believe that each patient is unique. Each patient must trust their doctor to provide them with all of the information they need to make the best treatment decision for them. Period. We believe that diseases like myeloma — where there is no cure – the very best hope patients have today is outsmarting the cancer for as long as possible.
Outsmarting the cancer means these survivors are counting on continued innovation. Price controls cannot help but stifle innovation. If we as a society start reading 185-page documents full of complicated math formulas and assumptions to help insurance companies figure out what they should pay and tell doctors how to treat the patient sitting right in front of them – we will lose more than the war on cancer.
QUESTION #3: What is a fair price for the newer regimens based on their value to patients and the health care system?
To this we simply reply back with this question: Who is ICER to anoint themselves the ‘trusted non-profit organization’ that decides value for not just patients, not just payers – but the entire health care system?
The last couple of pages of the report are dedicated to their votes on various treatment options – and it basically comes out as a wash. The whole exercise was completely useless for patients, and we’re not sure it will be all that helpful to the group ICER states they are helping: payers.
Michael Kolodziej, MD, National Medical Director for Oncology Strategy at Aetna says two things are missing from value frameworks like ICER’s: real-world evidence and the patient voice.
Score two for patients!
On page 10 of the report they offer some advice to the various stakeholders, we’ll leave you with these:
Note to Insurers: Forget about ‘fail first’ and step therapy. Not appropriate in myeloma since patients generally cycle through all available treatments at some point.
Score three for patients!
Note to Patients and Patient Advocates: Larger role in current clinical trial design.
Score four for patients!
The final page says everything you need to know:
The introduction of most newer regimens for second and third-line use in multiple myeloma appears to confer clinical benefits in terms of lengthening progression-free and possibly overall survival as well as improved quality of life. However, at current wholesale acquisition costs, the estimated cost-effectiveness of these regimens exceeds the range of $100,000-$150,000 per QALY that is used as a benchmark for reasonable long-term value. The potential budget impact for newer regimens of refractory multiple myeloma is not estimated to exceed ICER’s short-term (five-year) threshold to national health care cost growth targets.
Note to ICER: We could have told you that without this report.
If you want to read a myeloma doctor’s perspective, check out Dr. Brian Durie’s blog here.