Category Archives: Uncategorized

Zocor’s patent has expired. The article in the Times describes the financial ramifications on statin manufacturers Merck, Pfizer, Schering Plough, and Astra Zeneca.

Statins (a common class of drugs to lower cholesterol) are big business, in case you ever doubted it. Lipitor generates revenue of 12 billion dollar a year while Zocor generates 10 billion. With profits of drug companies in the 15% of revenue area these drugs are cash cows.

Even considering the drug companies estimate of $800,000 (a disputed number) to develop a new drug these revenues imply excessive and remarkable profits–but that’s our system, or is it?

The drug development equation is complex with a long pipeline consisting of basic research, identification of drug candidates, testing for toxicity and efficacy and finally release on the market. Pharma, however, is rewarded with market monopoly’s for 20 years, or more; pricing that seems to have nothing to do with real development costs; and profits that are quite remarkable–see Marcia Angell’s article and book of the same name or John Abramson’s book Overdosed America (review here).

Try this.

It’s amazing that we simply roll over and watch this happen. We’ll be having a discussion of drug patents next week.

Another medicynic!

$56,000 reported here for a course of treatment with Erbitux (cetuximab), which “has not yet been proven to extend the lives of colorectal cancer patients. It does shrink tumours in some patients and delay tumour growth, especially when used as a combination treatment.”

NCI notes that the use of this drug is based on an “open-label, single-arm trial (138 patients) of Erbitux plus irinotecan and an open-label single-arm trial (57 patients) of Erbitux as a single agent. All studies enrolled patients with EGFR-expressing (75-82 percent of those screened were positive), recurrent, metastatic colorectal cancer. All patients had received prior irinotecan; two-thirds of the patients in the randomized study and half of those in the supportive study had progressed during or within 30 days of receiving an adequate course of irinotecan.

In the randomized trial, 38 percent had also received prior oxaliplatin. Determination of clinical benefit was based on evidence of durable responses without evidence of an effect on survival. In the randomized trial, the overall response rate was 23 percent with a median duration of response of 5.7 months in the Erbitux plus irinotecan arm. The overall response rate was 12 percent with a median duration of response of 4.1 months in the Erbitux monotherapy arm.

The median time to progression was significantly longer for patients receiving combination therapy (4.1 vs. 1.5 months). Comparable results were observed in the single arm studies of Erbitux plus irinotecan (15 percent Overall response rate, 6.5 months median response duration) and Erbitux monotherapy (9 percent overall response rate, 1.4 months median response duration).”

These results are real, there are no typos. We are spending $56,000 for a drug with 23%, 9% and 15% response rates in three studies–duration of response from 1.5-6.5 months. This may be progress but is it worth it? Cost effective? Can we afford it?

We live in a world in which doctors prescribe medications costing up to $100,000/patient and in which this and this and this is happening.

#6057: Examining the cost and cost-effectiveness of adding bevacizumab to carboplatin and paclitaxel in advanced non-small cell lung cancer. The addition of bevacizumab (Avastin) an inhibitor of vascular endothelial growth factor (VEGF), to platinum-based chemotherapy (paclitaxel and carboplatin) improved survival of advanced lung cancer patients from 10.2 months to 12.5 months. This abstract reviewed the cost of adding this new drug to the treatment regimen. Bevacizumab patients lived 2.3 months longer and accrued costs of between $66,000-$80,000 more. The cost/QALY (see previous post for explanation) was over $345,000 and is not considered cost effective.

Note: The good news is that the targeted treatment had an impact on survival. The bad news is that the treatment, as priced, is not cost effective. Patients with advanced cancer given the choice of therapy with a small possibility of remission will almost inevitably give the treatment a try despite toxicity and cost. ence the Hence the high costs of care in the last year of patient’s lives.

#6048: Is it cost-effective to add erlotinib to gemcitabine in advanced pancreatic cancer?
569 patients were randomized to receive standard therapy with gemcitabine alone or gemcitabine + erlotinib (tyrosine kinase epidermal growth factor inhibitor) as first line therapy. There was a small but statistically significant difference in survival (6.0 vs 6.4 months, respectively, p = .028). Gemcitabine alone costs $23,493. Erlotinib (Tarceva) increased cost by $16,613 retail. Erlotinib improved survival by .4 months but estimates for the cost/year of life gained were between $364,680 wholesale pricing and $498,379/YLG retail.

Note: Another study with some positive news, the improvement of survival. However, the cost is prohibitive given the very limited benefit.

ASCO’s (the American Society for Clinical Oncology) yearly meeting was in early June. As usual there were many press releases. In the next few days I’ll highlight a few studies that were not noted in the news.

When one treats a patient with expensive interventions and there is improved survival it’s prudent to calculate the costs of the life extension. The best measure of a response to treatment is the QALY (quality adjusted life year). It is described here and here. Over the past several years expenditure of $50,000 in costs to improve survival a year has been considered acceptable for a therapeutic intervention. The question in our debt ridden system is whether we can we afford more for treatment interventions. The following implies that if the drug companies have their way we’ll be paying way more.

This abstract (#3515) is from the 2006 ASCO meeting. Direct cost-survival analysis of therapies for metastatic colorectal cancer reports the cost of increasing survival of patients with colorectal cancer (CRC) using various strategies. The chart from the abstract shows various treatment choices, their cost to the payer and the estimated improvement in survival.

It should be further noted that none of the interventions has been reported to cure metastatic CRC. Note that using the least effective treatment 5FU/LV patients survive a little over a year and with the most aggressive therapies just over two years. Note the cost for this improvement is over $150,000 for that additional year.

My conclusion is that we have some wonderful new biotech and chemotherapeutic approaches but unfortunately, as priced by the drug industry, they are not affordable. Such treatments are a little like trees falling in the woods.

Total Cost, Life Expectancy and CE Ratio compared to 5FU/LV and FOLFOX

Some good advice on “Best Doctor” lists.

Reality bites in Texas in this article about the Medicare drug program.

Innumerable insurers try to get a piece of the action. Recently I searched for the most economical provider of the drug Arimidex (anastrozole). In our area there were over 40 providers and the total costs (premium, copay, etc.) for a year of the drug ranged from about $1100 to over $1600.

Consider the inefficiency of this system–the 20% or so administrative costs for each of the 40 insurers; their duplication of effort; and each insurer’s attempt to game the system. It’s not surprising you have a gap that requires the $3600 out of pocket expenses before coverage is resumed. This is driving seniors a little crazy.

It’s intuitive that a more efficiently administered program would eliminate this.