Medicynic

#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.

Discussion of “Industrial Policy for Big Pharma” in the Washington Note. The point of the article seems to be that this poor industry, which happens to be one of three most profitable sectors in our economy, is somehow suffering from relatively few new drugs being approved in the last year. Something must be done!!!

A more relevant consideration, in my view, is how to afford the new technology–pricing of new drugs is beyond the means of our system. More on this in future posts.

When I was in practice the the drug industry’s promotional efforts at meetings, in the hospital, in our offices, even as a sponsor of information on the internet was overwhelming. In evaluating recommendations, medicynic found himself always reviewing the declared conflicts of interest of speakers/authors/researchers (if they were available) and frequently deciding that their conclusions were unduly influenced by the sponsor.

Financial interactions between physicians and the drug industry (this could also refer to insurers and other suppliers as well) compromise our integrity and that of the entire health care system. Not only must we avoid frank conflicts of interest but we must also avoid even the appearance of these conflicts in order to maintain our role as fair, ethical, and independent patient advocates.

Jerome Kassirer a former editor of the New England notes the extent of the industry’s influence in On the Take–How Medicine’s complicity with Big Business can Endanger your Health (Oxford Press 2005). It’s a good educational read. His suggestions for addressing this issue follow.

“Items for immediate implementation:

1. Exclusion of all gifts from industry (by law if necessary), even including items that might be considered useful in a doctor’s practice or education; elimination of physician participation in company-sponsored speaker’s bureaus.

2. Prohibition of consultations with industry for anything except scientific matters, and outlawing of marketing by physicians of drugs or devices in which they have a financial interest.

3. Full disclosure to patients in all doctors’ private offices of any and all financial incentives for patient care or clinical research.

4. Elimination of “finder’s fees” for identifying patients to drug companies or their intermediates; no “farming out” of patients for clini-cal research.

5. Permission to conduct clinical research on devices or drugs in which the investigator has a financial interest should be proscribed.

6. The requirement of full accessibility for independent analysis of all data in any published clinical trial in which the investigators had a financial conflict.

7. A requirement of full, detailed disclosure in legible handouts at all teaching events of the type (drugs or devices), dollar amounts, and duration of all financial ties of the lecturer that relate to the subject at hand; full disclosure of the sponsorship of all such events.

8. The selection of journal editors, officers of major professional o-ganizations, and leaders of academic institutions among; physicians who have no financial conflicts.

9. A demand for increased scrutiny by medical editors of all financial conflicts of authors, with full disclosure not only of the com-pany relationships but also the specific relevancy of the conflicts to the subject matter (specific drugs and devices).

10. Pressure for a comprehensive analysis of the problem by the Institute of Medicine that would include drafting principles and guide-lines for all types of financial conflicts, not just those associated with research.

Items for further analysis and debate:

1. If CME lectures by individuals with financial conflicts cannot be prohibited, should physicians boycott courses given by financially conflicted lecturers?

2. If clinical-practice-guideline committees cannot be constituted exclusively by non-conflicted individuals, what safeguards can be introduced to reduce the chance of biased recommendations?

3. If ownership of stock in a company that could benefit from a researcher’s work and scientific consultations with a company create conflicts, what is the basis for any specific “minimally acceptable” amount that researchers can hold in stock or receive yearly in compensation for consultations?

4. How could a universal Web-based registry of physicians’ financial conflicts of interest be implemented?

5. How can the financial arrangements of professional organizations with industry be disclosed, including the amounts, duration, and purposes for which the funds were used?

6. How can the dependence of professional organizations on industry support be reduced?

7. Can industry be convinced that in the long run the harm of physicians’ collusion with their marketing practices is more serious than the short-term gain in sales?

None of these questions will be addressed without strong pressure of the public and the avid participation of leaders of professional organizations and academic medicine. I challenge them to take up the battle.”

Read the book for the details.

The FDA has approved the papilloma virus vaccine. It’s cost will be a burden if mandated.

Good article in NY Review of Books, Marcia Angell is a former editor of the New England Journal of Medicine–one of Medicine’s most prestigious jounals.

Some interesting references from the article–a medicynic reading list.

Merrill Goozer, The $800 Million Pill: The Truth Behind the Cost of New Drugs (University of California Press, 2004);

Jerry Avorn, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs(Knopf, 2004);

John Abramson, Overdosed America: The Broken Promise of American Medicine (HarperCollins, 2004);

Jerome P. Kassirer, On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health(Oxford University Press, 2004);

No Child Left Different, edited by Sharna Olfman (Praeger, 2006);

Ray Moynihan and Alan Cassels, Selling Sickness: How the World’s Bigest Pharmaceutical Companies Are Turning Us All into Patients (Nation Books, 2005).

The Truth About the Drug Companies: How They Deceive Us and What to Do About It (Random House, 2005).

Double digit increases in drug spending on new “specialty” drugs is noted here.

In the article it is noted that “Spending on cancer drugs known as antineoplastics, which were administered outside a doctor’s office, rose 19.2 percent, the third largest jump. The price per prescription rose by almost 15 percent to nearly $1,600 on average, making inflation the primary driver of the spending increase.”

I hadn’t noticed inflation at over 15% in other sectors.  Remember, the fiduciary responsibility of drug industry executives is not providing quality health care, rather it is to maximize profits. This needs to change!

On a recent road trip to Yellowstone, the price of gasoline to ranged from $3.27 in Washington State to $2.77 in Montana and Idaho. There is no explanation or for the price differential and we’ve heard all manner of outrage and protests about it from the media and our elected representatives!!!

Meanwhile at the ASCO (American Society of Clinical Oncology) meeting “major” progress in the treatment of kidney cancer was announced. See also here.

Nexavar (sorafenib) Sutent (sunitinib malate) and temsirolimus all seem to have activity against kidney cancer. This is real progress but it should be noted that these drugs do not cure the cancer and the survival improvement appears to be limited to be only a few months. Yet Nexavar will be sold to the public at a cost of over $4000/,month and Sutent at $38,000/year. Temsirolimus has not yet been approved for sale in the U.S.

We do not have a free market in pharmaceuticals. The government provides patent protection for 20 years to manufacturers developing new products. During this protected period the company can charge whatever it wishes for the product. It has a monopoly.

One would think that the quid pro quo of such a system would be that the companies price the medications fairly not take advantage of their government protected market. Yet these new drugs that have yet to show major benefit are priced higher than the average and median incomes in our country. Who can afford them? Where is the outrage?