Ruminations

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

Saturday, May 13, 2017

The Bottom Line for Pharmaceuticals or the Top Line for Saving Lives?

"It is becoming increasingly difficult to disregard the costs of these new therapies -- side effect costs, costs to quality of life and financial costs ... especially when the benefits are very, very small."
"The vast majority ... are associated with extremely modest advances [in life-extension]."
Dr. Chris Booth, oncology professor researcher, Queen's University, Kingston, Ontario

"I just look back over the last fifteen years and [feel] we've really squandered a lot of resources pursuing meaningless targets."
Dr. Tito Fojo, oncology professor, Columbia University, New York, New York

"Lack of evidence doesn't mean there's lack of benefit, and sometimes with a patient you don't know until you've tried."
"There is nothing so powerful as seeing a patient who should be dead, who's had a complete remission."
Deb Maskens, kidney cancer patient, founder, CanCertainty, advocacy group
cancer cell
Cancer treatment has changed dramatically over the past several decades, and there have been some acclaimed success stories, with people recovering in greater numbers, and more people than ever 'beating' cancer, going on to live their lives. There is general agreement that some new cancer drugs have been transformative in the success of cancer treatment, but there is also an increasingly reluctant-to-admit but obvious failing in many others; the hype surrounding them is hopeful, but the reality belies the hype.

For all such drugs, those that have true merit and the others that promise while not delivering, the costs of their procurement and use is steep, so costly that they strain the ability of drug plans, governments, workplace insurance and patients to pay for them.Only three of 17 cancer drugs on the market since 2014 and 2015 rated well with evidence of "overall survival" with their use, after approval by Health Canada. Of four others of the 17, life was extended by 1.4 to six months. For the remainder no clear conclusion could be reached of their merit in use.

List prices for these drugs? Monthly, $4,700 to $33,000. In the early 1990s when Taxol was introduced and its effect was lauded against several types of advanced cancers, its popularity and huge cost attracted the attention of the pharmaceutical industry to the vast profits waiting to be made. Research and development to produce other successful, best-selling drugs went forward full-steam. Herceptin treatment for aggressive breast cancer; Gleevac to treat adult leukemia; BRAF-inhibitors to treat melanoma; and immunotherapy drugs with their promise in dealing with a variety of cancers, surfaced as true successes.

Dr. Maureen Trudeau, head of medical oncology at Sunnybrook Health Sciences Centre in Toronto cites Opdivo, a new treatment for melanoma, able to retain life for 30 percent more patients than had previous therapy: "It's incredible. Some of these drugs are changing lives", she notes. Those, granted, are the success stories; the list of drugs approved by Health Canada in the past two years appear to fall short of being wonder cures, despite the hype surrounding them, matching their sky-high costs.

The rising cost of cancer

The average monthly cost of newly approved cancer drugs (in 2013 U.S. $)

up to 19801981 - 19891990 - 19951996 - 20002001 - 20052006 - 20102011 - 2013$289$1,113$2,551$3,232$6,948$10,406$10,761
Source: Center for Health Policy & Outcomes, Memorial Sloan Kettering Cancer Center

Still, it is undeniable that people suffering from cancer survive longer now. The number of Canadians alive five years after their dread diagnoses has advanced to 63 percent, an increase from the 56 percent standard of the early 1990s and late 2000s. More screening, allowing cancers to be discovered at an earlier date, along with better treatments are what the Canadian Cancer Society attributes to the growing survival rates.

Preliminary results on new drug treatments are accepted as a quasi-guarantee on longer-life outcomes in recognition that actual survival improvements in short trails are difficult to measure. Health Canada, as well as U.S. and European regulars all accept this. The social pressure to permit what appear to be promising new cancer treatments to enter the market as quickly as possible without waiting to judge whether they may prolong people's lives gives priority to the former and a back seat to the latter.

From the perspective of patients, anxious to prolong their lives, improvements allowing a few months more life may permit a dying person to share their family a little longer, or even buy time during which a superior advance may be on the horizon in care and miracle drugs. Approval of new drugs is a costly affair; Opdivo, a major breakthrough for melanoma comes at a $8,200-per-month pricetag. Yet it was found to be no more effective than existing chemotherapy for lung-cancer patients, and that finding led Biristol-Myers' stock to plummet.

Novartis can produce evidence that it can cost a pharmaceutical company up to $2.6-billion to produce one single, new drug.  Blincyto, found to extend median survival for some late-stage adult leukemia patients by 3.7 months has a cost of $33,000 for 28 days' medication. Six months after its approval, an alert from Health Canada gave warning of mounting evidence it can trigger potentially fatal inflammation of the pancreas.

A high rate of death and lesser but serious side-effects in early stage patients for those using Zydelig which improved overall survival for advanced leukemia sufferers, spurred Health Canada to issue a warning. One analyst claimed the drug was "dead in the water". Its cost was relatively modest, at $4,700 a month. The simple fact is that most of the drugs have a long list of toxic side-effects attached to their use.
Steve Rudaniecki took part in a clinical trial at Hamilton’s Juravinski Cancer Centre. Almost immediately, the lumps and bumps from his chronic lymphocytic leukemia started to disappear.
Steve Rudaniecki took part in a clinical trial at Hamilton’s Juravinski Cancer Centre. Almost immediately, the lumps and bumps from his chronic lymphocytic leukemia started to disappear.  (John Rennison / The Hamilton Spectator)

Novartis charges $7,000 monthly for the drug Afinitor. And that cost is static, irrespective of whether the dose reflects the recommended 10 milligrams, or is reduced to 5 mg or even 2.5 mg. "It is reprehensible in my mind", Sunnybrook oncologist Dr. Maureen Trudeau noted. Little wonder with these sky-high prices, new cancer drugs are placing stress on public and private health plan funders. An estimated 1,800 cancer drugs are in the development stages.

And then there is the fact that a growing number of these new drugs are taken as oral pills or injectables that patients are able themselves to administer in their homes Which translates to the expectation that those people become responsible for the cost of the treatment themselves, while treatment that takes place in hospitals is covered under medicare.  In the United States, many payers remain willing to pay such exorbitant prices; a fact most encouraging to the pharmaceutical manufacturers.

cancer drug costs

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