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November 9, 2011 07:06  by Dr. Lorne Brandes

I have some very good news to report: we are in the midst of a virtual explosion of new, approved, oncology drugs and vaccines that can prolong the lives of patients with many types of advanced (metastasized) cancer.

In most cases, they are high-tech masterpieces that work by targeting abnormal genes and chemical pathways in malignant cells, or powerfully stimulating the immune system. These new therapies offer patients a chance at increased survival when conventional treatments have failed or, in the case of melanoma, where no effective therapy previously existed.

That said, I must now report the bad news: without exception, drug companies are setting an extremely high cost for an “average course” of these new treatments. Here are but a few recent examples, based on U.S. prices:

  • $5000/month for Zytiga (abiraterone) pills for late-stage prostate cancer
  • $8,000 every 3 weeks for intravenous Jevtana (cabazitaxel) for late-stage prostate cancer
  • $93,000 for 3 injections of Provenge (Sipuleucel-T) vaccine for late-stage prostate cancer
  • $9600/month for Zelboraf (vemurafenib) pills for late-stage melanoma
  • $120,000 for 4 injections of Yervoy (ipilimumab) vaccine for late-stage melanoma
  • $9600/month for Xalkori (crizotinib) capsules for late stage non-small cell lung cancer (NSCLC)
  • $13,500 every 3 weeks for intravenous Adcetris (brentuximab) for Hodgkin and anaplastic large cell lymphoma

It is important to understand that most of these therapies offer a very modest survival benefit. For example, Provenge adds an average of 4 months of life, Zytiga and Zelboraf add 6 to 7 months, while Jevtana adds a meager 2.5 months.

And while Yervoy sometimes produces long-term remissions in stage 4 melanoma, tumours shrink in only 25% of patients, while the other 75% are not helped at all. Moreover, severe auto-immune side effects and deaths have resulted from its use. Yet, faced with a disease that is virtually always fatal, who would not want to receive the vaccine?

But, as desperate patients clamour for each new exorbitantly-priced therapy, governments and private insurers are increasingly refusing to fund them.

As an example, the National Institute of Health and Clinical Excellence (NICE), an independent agency that advises Britain’s National Health Service (NHS) on issues such as new medicines and treatments, caused a public outcry when it recommended rejection of Yervoy, Jevtana, and late-stage breast cancer drug, Halaven (eribulen), ruling that they are not cost-effective therapies.

In coming to this conclusion, the NICE panel employed a standard, but controversial algorithm, called the QALY (quality-adjusted life years) measurement.

As explained on the NICE website, “a QALY gives an idea of how many extra months or years of…reasonable quality [life] a person might gain as a result of treatment (particularly important when considering treatments for chronic conditions).

“Having used the QALY measurement to compare how much someone's life can be extended and improved, we then consider cost effectiveness - that is, how much the drug or treatment costs per QALY. This is the cost of using the drugs to provide a year of the best quality of life available - it could be one person receiving one QALY, but is more likely to be a number of people receiving a proportion of a QALY - for example 20 people receiving 0.05 of a QALY.

“Cost effectiveness is expressed as ‘[$] per QALY'.

“Each drug is considered on a case-by-case basis. Generally, however, if a treatment costs more than [$50,000] per QALY, it would not be considered cost effective.”

Why has NICE (as well as many countries, including Canada) chosen a $50,000 limit? Historically, this was the average cost, determined in a 1984 Canadian study, of maintaining one person on life-saving dialysis for a year, a treatment fully covered by public and private insurers around the world since its inception.

In other words, using the annual 1980’s cost of dialysis as the “gold-standard”, the value placed by healthcare systems on one year of human life was, and has remained, pegged at $50,000, despite the fact that, by 2008, when adjusted for inflation, the annual cost per dialysis patient had risen to $129,000! Moreover, since each year on dialysis has been estimated at 0.5 QALY (taking into account the decrease in quality of life resulting from the treatment), the actual cost of dialysis in today’s dollars is approximately $285,000 per QALY.

Is it any wonder then, that pharmaceutical companies are employing this updated equation to arrive at prices for new cancer therapies that extend life by a few months on average? Moreover, oncology drug costs, largely determined by U.S.-based companies, are tailored for the American system of healthcare and group physician practices (where many oncologists buy and dispense anti-cancer drugs for profit), with little or no regard for the ways and means of the rest of the world.

Is there a solution to this dilemma? Sadly, barring a radical change in thinking by Big Pharma, and/or a re-evaluation by governments of the dollar value of a human life, I do not see one on the horizon. That is very bad news, indeed.

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