Since April of 2016 my treatment regimen has been Pomalyst (pomalidomide) and Darzalex (daratumumab), with dexamethasone in the early months. That combination brought my IgG and M-Spike down to the lowest levels seen since diagnosis 14 y…
Before I started the current regimen, a PET scan last April 9 displayed five different lytic lesions, three of them in the spine. Last Wednesday’s PET scan showed that all five lesions are significantly decreased, and most are gone. One isn…
They say there’s no cure. And “they” may be right, but there are a lot of things that we can do.
Heard from doctors fairly recently (but note: I am not a doctor):
Gargle with warm salt water to sooth and treat the throat.
Use a neti pot (nasal …
Friday, August 19, 2016:
Wednesday I brought a Mayo Clinic blood draw “kit” to the local clinic, where they drew the blood and shipped it overnight back to Mayo. Last evening the results showed up on Mayo’s patient portal, and I’m happy!
June 22, 2016
After the 10th Darzalex infusion, with daily 2 mg Pomalyst and weekly dexamethasone (DEX), IgG is down once again, from 644 to 515 mg/dL, another drop of 20%. M-spike is down too, by a similar ratio, from 0.6 to 0.5 g/…
Who is ICER?
ICER is the Institute for Clinical and Economic Review. As far as I can tell, it is funded primarily by insurance companies and by nonprofit organizations who, in turn, are funded by insurance companies. They claim some funding by the federal government as well. Other members include pharmaceutical companies who apparently participate in order to have some voice in ICER’s proceedings. A quick Google search shows that the title of many of ICER’s documents is “Building Trust through Rationing,” which I believe is their mantra and suggests that rationing health care is their real purpose.
ICER deals in statistics, not medicine, and a primary goal is to control costs. I assume that this is why they don’t want participation by patients. They have been working on a report for multiple myeloma, and we myelomiacs have been concerned that they would produce a one-size-fits-all treatment algorithm that doctors might be expected to follow and insurers might try to enforce.
Garbage In, Garbage Out
ICER issued their final report on Myeloma on June 9, 2016, attempting to grade different myeloma treatments to provide comparative medical and cost values. In my opinion this report is ridiculous on its face, saved only by one of its final recommendations. ICER claims to have found over a thousand potentially relevant literature references to myeloma treatment, considered 38 worth reading, and exactly six Phase III studies worth analyzing to form their conclusions.
Thus they chose to ignore all Phase I and Phase II studies, which provide by far the largest part (I’d guess 90%?) of the current, up-to-date information that the FDA uses for myeloma drug approval and that doctors actually use in their day-to-day care of myeloma patients. For this reason, ICER’s entire analysis is fatally flawed. As we say in the computer industry: “Garbage in, garbage out.”
As just one example of this blinders approach, the report ignores an old but widely-used myeloma treatment called cyclophosphamide (Cytoxan), which is frequently combined with dexamethasone (DEX) and either bortezomib (Velcade) or lenalidomide (Revlimid). Indeed, many patients will recognize cyclophosphamide with bortezomib and DEX as the CyBorD regimen. Because cyclophosphamide is relatively low in cost, it certainly should have been included in any economic analysis, but it appears nowhere except peripherally in the addenda.
ICER’s peculiarly superficial analysis also minimizes or omits many other commonly-used and highly-effective regimens. Worst of all, it gives especially poor grades to the treatments that are newest and possibly the most effective, such as pomalidomide (Pomalyst) and daratumumab (Darzalex).
Saved by the disclaimer:
One recommendation near the bottom of the final report and in the shorter Report-at-a-Glance, saves the report from total disrepute. This appears under the heading “Insurers:”
Multiple myeloma is a condition in which many patients will cycle through most or all available treatments, and there is substantial variation in drug mechanisms of action and in the personal patient values that guide consideration of the trade-offs between extended survival and different side effect profiles. Given this background, and in the absence of better evidence, payers should not consider step therapy or “fail first” coverage policies for myeloma treatments.
Amen. This statement seems to have two important implications:
- ICER recognizes that their report has no value in guiding treatment for any particular patient (i.e. it turns out that we wasted our time producing this report); and
- The PATIENT (the payer) is responsible for choosing an insurer or a plan which does not demand step therapy or “fail-first.”
Let that be a lesson to us patients! Maybe the best advice I’ve seen today – if you have a choice of insurers, choose very carefully.
My bottom line opinions:
- A doctor attempting to use the results of this ICER report as the primary guide for treating a patient would be committing medical malpractice, and if so
- It follows that an insurance company or plan that denied coverage based upon this report would be demonstrating a singular contempt for their own client, the policyholder.
Whether you agree or disagree, or have a factual correction, you are invited to comment. – Don
Wednesday, May 25, 2016:
My sweeties and I bought a nice bouquet of yellow roses to celebrate my latest treatment results. In the last four weeks on Pomalyst (pomalidomide)(POM) and Darzalex (daratumumab)(DARA) my IgG has dropped 20% from 807 to…
Weekly Infusion Number 6: Blood draw, doctor visit, pre-medications, and Darzalex, about 6 hours total.
I took 20 mg dexamethasone last night, as part of the Pomalyst regimen, and received 100 mg of prednisone IV before the Darzalex, as part of …
And the Orange County Marathon in California last Sunday, my 95th since diagnosis, Whooee – still on track for 100 marathons this year.
This was also the third weekly Darzalex infusion at our local hospital. Arriving at the infusion center…
In the three weeks of this new three-drug regimen, Pomalyst, Darzalex, and dexamethasone (DEX), IgG has dropped 39%, from 1330 mg/dL to 807 mg/dL, in tests done by Mayo Clinic. This spectacular result brings IgG to the lowest level I have seen si…