Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Tuesday, March 01, 2016

The Buying Time Dilemma

"[I reacted like] I'm nobody's guinea pig. Screw that. But then my wife and I argued about it, we cried and talked about it and I said, 'OK, I'll try it'."
"She [his oncologist] asked me 'What do you think you were on?' and she was chuckling."
"When you see the results from what I looked like two years ago -- I looked like the elephant man -- to where I am today, you don't have to be a rocket scientist."
Steve Rudaniecki, Hamilton, Ontario

"Looking at the list prices that are coming for these [cancer-specific pharmaceutical] products, it really does start to raise some serious questions around system sustainability, not just for Ontario or Canada but around the world."
Scott Gavura, director, provincial drug reimbursement programs, Cancer Care Ontario

"With the explosion of innovative oncology treatments, there's no question they're providing immense value to patients and to the health-care system."
"This is a challenge that we're all facing, and the alternative is we don't have medicines available and none of us want that."
Glenn Monteith, vice-president of innovation and health system, Innovative Medicines Canada

"When we have a limited amount of funds, we have to say, 'OK, where are we going to use them?' If I spend $100,000 on this to get a month of life, I can't use that in all these other scenarios where I could gain a lot more than a month of life."
Christopher Longo, McMaster University, Ontario Steering Committee for Cancer Drugs
Stock photo of a doctor prescribing a bottle of prescription medicine.
Newly approved cancer drugs cost an average of $10,000 per month, according to the American Society of Clinical Oncology

An ageing population is a population particularly susceptible to the appearance of various types of cancers. A prohibitively expensive disease to deal with in attempts to prolong life and destroy cancer cells to give the patient an opportunity to continued life. Steve Rudaniecki had been through the cancer-fighting mill for ten years after the onset of late-stage chronic lymphocytic leukemia. Three years ago he was informed that he would be welcomed in a clinical trial at the Juravinski Cancer Centre in Hamilton.

Typically when a new drug advances to the stage where it moves from the laboratory and animal testing to human testing, it is patients who have little left to lose who are invited to take part in clinical trials. This trial was the introduction of a new drug, ibrutinib, of a class of drugs described as small molecule therapies. Alternatively called targeted therapies where the operative element is minuscule, capable of slipping through the cancer cell membrane to disrupt its destructive path.

Trial patients received two types of therapy commonly used to kill cancer cells. Half of the trial patients then received the new drug in capsule form while the other half were to take a similar-in-appearance placebo, each to be taken three times daily, with no one, not the doctors and not the patients knowing which half was using the placebo. Mr. Rudaniecki was not left in the dark about which he was given for very long.

He could see the results amazingly quickly as the lumps began disappearing from his skin. What he noticed was also seen generally by the researchers, and the astonishingly conclusive results led to the trial being prematurely halted, with all of the patients involved then receiving the drug, the placebo set aside. "If I was getting the placebo, that very well could have been a memorial on the wall", Rudaniecki notes of a framed copy of a newspaper story about his miraculous rescue from imminent death.

His rescue comes with a steep price tag. One that neither he, nor the provincial drug plan has had to pay for. Janssen Inc., the maker of the new drug marketed as Imbruvica, has picked up the tab and it is considerable, with each capsule priced at around $100. At three capsules daily, a drug regimen that will be a lifelong companion until it may no longer work, the price tag is around $9,000 monthly, almost $110,000 for a year's worth of Ibrutinib.

While Mr. Rudaniecki has gained three years of life, all indications by his disease's trajectory and conventional therapies having previously failed, many more of the new, cancer-specific-targeted drugs will gain far less time for those who take them. Increasingly, cancer has become treatable but at a prohibitive cost beyond the capacity of individuals, drug plans and universal coverage to afford, having to weigh where best to put finite dollars to work to gain a health advantage for more people.

More sophisticated therapies and the new targeted cancer drugs equate with skyrocketing costs to prolong life sometimes just marginally. Of a dozen new cancer drugs that the U .S. Food and Drug Administration approved in 2012, eleven were priced in excess of $100,000 annually per patient.
Of the total, three succeeded in improving patient survival rates. Of the three, two of the drugs were able to increase survival by fewer than two months.

In the decade from 2005 to 2015, the cost of intravenous cancer drugs the Ontario government covers, has tripled from $112-million to $332-million a year. The cost for four doses administered over 12 weeks for example, of Ipilimumab, approved in late-stage melanoma treatment, is $120,000 with a survival benefit of 3.7 months on average, about the length of the treatment itself. A little reminiscent of a mechanical consumer product's reliability not outliving its warranty period.

"What counts as a benefit in cancer treatment? How much should cost factor into deliberations? Who should decide?" Some of the questions contained in an article titled "How Much Is Life Worth", written by two American cancer researchers, Tito Fojo and Christine Grady. The two cancer researchers with the U.S. National Cancer Institute state: "As oncologists, we cannot go on without answering these questions."

"In some sense, every life is of infinite value, and we naturally avoid confronting the tension between not wanting to put a value on a life and having limited resources. But the spiralling cost of cancer care in particular makes this dilemma inescapable." One new drug called cetuximab for a certain type of lung cancer improved survival by a 1.2 month period on average for which the cost for that one-and-a-half months came to $80,000.

"If we allow a survival advantage of 1.2 months to be worth $80,000, and by extrapolation survival of one year to be valued at $800,000, we would need $440-billion annually -- an amount nearly one hundred times the budget of the National Cancer Institute -- to extend by one year the life of the 550,000 Americans who die of cancer annually. And no one would be cured", they observe.

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