Yesterday the WSJ ran an article about how Express Scripts wants to tie the cost of cancer drugs to how well they work.
Let's deal with how hypocritical and self-serving this ploy is.
1. Health outcomes are a function of adherence to medication. Why doesn't Express Scripts tie what it makes in rebates to how well they help keep people on medicines. To do this, it would have to eliminate cost sharing for specialty medicines that are shown to discourage compliance.
2. Health outcomes are a function of getting the right medicine at the right time as soon as possible. Why doesn't Express Scripts invest in precision medicine profiling and eliminate cost sharing for medicines that are best for patients? Why doesn't Express Scripts refund copays when drugs dont work under a fail first or step therapy approach?
The answer: all this would get in the way of their profits. Discrimination against sick people by designing benefits in way that put all meds in the highest cost sharing tier is good for business.
Next, what about the feasbility and clinical impact of the Express Scripts proposal to tie payment to impact in specific uses or indications. The company borrowed this idea from Peter Bach who has been noodling about ways to control drug prices for years.
"Express Scripts’ approach would be similar to that proposed by Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.In an article published last year in the Journal of the American Medical Association, he suggested that in an indication-specific arrangement, the monthly price for Eli Lilly & Co.’s cancer drug Erbitux (cetuximab) would plummet from $10,320 a patient to about $470 a patient for its least effective use, treating recurrent or metastatic head and neck cancer. The drug also is used to treat locally advanced head and neck cancer, as well as colorectal cancer."
So let's look at how this would work. Not only does Express Scripts want to do use the Bach approach, the Amercican Society for Clinical Oncology wants to use the it in telling cancer doctors what medicines.
Bach claims that the use of Erbitux for head and neck cancer is a "least effective use". Let's set side the curious math used to arrive at the $470 figure. It is more important to note that Bach ignores not only individual differences in response but the impact of Erbitux relative to existing need and treatment protocols. Bach uses an average 2.3 months more of survival as his benchmark. The price controllers love to focus on that number because it sounds so small. Express Scripts and Bach dishonestly ignore context.
Here's what we know about pre-Erbitux treatment of recurrent, metastatic squamous cell carcinoma of the head and neck (SCCHN):
"None of the trials performed in the past, even those with a reasonable sample size, have shown that aggressive platinum-based combination chemotherapy leads to survival benefit when compared to single agent methotrexate, cisplatin or 5-fluorouracil.
What difference does Erbitux makes?
After decades without real progress, a recent European randomized trial showed that adding cetuximab, the first clinically available EGFR-directed monoclonal antibody, to a standard chemotherapy regimen (platinum/5-fluorouracil) leads to an important survival benefit and this, with support of an additional smaller study in the US, has changed practice." J. B. Vermorken and P. Specenier Optimal treatment for recurrent/metastatic head and neck cancer. Ann Oncol (2010) 21 (suppl 7): vii252-vii261 doi:10.1093/annonc/mdq453
Hence, the Bach-Express pricing approach would whittle away payment for the hardest to treat cancers for patients that have had no real advances in care for decades. Maybe Bach supports paying doctors less for people who are the farthest gone because the relative health gains are well, not worth it??
Second, the use of Erbitux, which targets the overexpression of EFGR associated with poor outcomes in SCCHN has lead to the development of biomarkers that that identify individuals that will have 4 times greater survival than the one size fits all studies Bach and Express Scripts would use to price treatment
Thanks to research done with the drug, we now have assays measuring evidence that Hypermethylation of the p16 gene is associated with KRAS mutation and response to Erbitux .
So now we have groups of patients that Patients with p16-unmethylated tumors had significantly longer time to progression (TTP, median 9.0 vs 3.5 month; and overall survival (OS, median 44.9 vs 16.4 months than those with p16-methylated tumors. Patients with both KRAS and p16 aberrancy had markedly shortened TTP (median 2.8 months) compared to those with either KRAS or p16 aberrancy ... Cancer Res Treat. 2015 Apr 24. doi: 10.4143/crt.2014.314. [Epub ahead of print] p16 Hypermethylation and KRAS Mutation are Independent Predictors of Cetuximab Plus FOLFIRI Chemotherapy in Patients with mCRC.
Kim SH1, Park KH2, Shin SJ3, Lee KY4, Kim TI3, Kim NK4, Rha SY3, Roh JK3, Ahn JB2.
In the studya above, hypermethylation of the p16 gene was detected in 14 of 49 patients (28.6%) which means an even smaller group of patients then the number of patients in one size fits all studies. Following the Express Scripts logic, using a drug for a smaller group of patients that have had no progress in treatments and limited 5 year survival prospects should be priced LESS than $470.
Heaven forbid looking at the effect of 'even' 3 months of survival -- or 25 months of survival in a small subgroup -- this way:
Each year 60000 people are diagnosed with head and neck cancer each year. Fifty three percent have recurrent metastatic types.
Running the numbers for the 28.6 percent of high responders with metastatic (31800 x.286=17160) we get 20008 years of additional life worth $3.01 billion.
For the benefit, Express Scripts and Bach would pay $17 million. Meaning that they think an additional year of life for such patients isn't worth more than $583.
I didn't get into how patients receiving Erbitux spend about 30 fewer days hospitalized or in nursing homes and hospice. Or that total costs per treatment is lower with Erbitux. I don't have the time or patience right now to walk people who don't care or don't want to know through the economics.
Too bad no one in the media has run the math instead of running with this as a novel way to deal with health care costs. This is madness. As Isaiah Berlin put it, ‘disregard for the preferences and interests of individuals alive today in order to pursue some distant social goal that their rulers have claimed is their duty to promote has been a common cause of misery for people throughout the ages.”