Archives for August 2015

Personalized cancer treatment requires complex clinical laboratory testing to determine a tumour’s genetic profile. The Princess Margaret Cancer Centre, a leader in providing this testing for its patients, and LifeLabs Medical Laboratory Services have begun working together to expand this testing capacity to more Canadians.

The Princess Margaret Cancer Centre (PMCC) has teamed up with Ontario-based LifeLabs Medical Laboratory Services (LifeLabs) to expand the availability of cancer genome profiling across Canada, with funding from Genome Canada. This will improve access to personalized cancer treatment for patients across the country.

Cancer genome profiling is emerging as an essential step in modern cancer care. The percentage of patients whose tumours were driven by genetic mutations that could be targets for tailored cancer therapeutics range from 21% (head and neck tumours) up to 73% (melanoma), according to a Personalized Medicine Coalition report. In fact, tumour classification is changing from being based on the tissue of origin to being based on the underlying genomic alterations, making it critical that patients across the country have equal and timely access to appropriate testing. And as discussed in an accompanying article “Can personalized cancer care be cost-effective?” this type of testing can lead to better outcomes as well as save healthcare dollars.

Major treatment centres such as the PMCC have been at the forefront of developing and applying new tumour genetic profiling tests for their patients. However, access to these tests outside such major cancer centres is difficult due to the complexity of the tests.

For this project, Dr. Suzanne Kamel-Reid at the PMCC and team will combine their expertise in next-generation sequencing for clinical tumour profiling with LifeLabs’ expertise in specimen collection, their transportation network and logistics capabilities. They will also develop a secure cloud-based cancer genome analysis infrastructure to be able to store and share information between the two groups. The combined expertise and resources will expand the availability of such tests across Canada including rural areas and community hospitals.

By: Kathryn Deuchars, Director, Ontario Personalized Medicine Network

One cancer drug alone could wipe out Canada’s total budget of $12B for prescription drugs. Can this last?

Drug companies bringing out new targeted therapies for rare disorders are asking, and getting, eye-popping prices. Examples include Kalydeco® for one type of Cystic Fibrosis, reported to cost CAD$300,000 per year, or the recently marketed Solaris® for which Alexion tried to get CAD$700,000 per year for Canadian patients (even higher than it was charging U.S. patients). Drug companies argue that these costs are justified because the drugs are showing dramatic results for patients. But because these are for a very small number of patients, and only a few have been marketed so far, our healthcare system may be able to absorb the cost – there are only 90 patients in Canada that might benefit from Solaris, for example. But this won’t always be the case – there are 7,000 rare disorders that may be amenable to drug treatment, and treatments are typically needed life-long.

What really brings it home are the escalating prices for some new targeted therapies for cancer.

Prominent oncologist Dr. Leornard Saltz of the Memorial Sloan Kettering Cancer Center took aim at these at the recent American Society of Clinical Oncology (ASCO) meeting. At the plenary speech, Dr. Saltz focused on the expected high cost of new combination treatment for metastatic melanoma from Bristol-Myers Squibb Co. Although he welcomed the arrival of a “truly, truly remarkable” new therapy, “he said that combining the drugs would cost around $295,000 a patient over nearly one year, which he called unsustainable. If all U.S. patients with metastatic cancer took drugs priced at $295,000 a year, it would cost $174 billion to treat them all for just one year” reports the Wall Street Journal.

Given that Canada’s total public spend on prescription drugs is about $12B, and adjusting for Canada’s population size, that would pretty much wipe out Canada’s total budget for prescription drugs.

Not all new drug pricing seems so far out of line. Although the recently released Hepatitis C drug Harvoni® costs over $1,000 per pill, and a complete course of treatment costs approximately CAD$85,000, this is a one-time treatment with near 100% cure rate for a potentially lethal disease with a very high cost burden (see our July 2015 article about this new treatment). And as outlined in an accompanying article, “Can personalized cancer care be cost-effective?” selecting the best targeted treatment for a patient’s cancer by genetic analysis of their tumour has been shown to be both cost effective and to give better outcomes.

The focus needs to be on how to appropriately price new drugs. The CBC looked into the Solaris story, pointing out that the cost of such drugs has little to do with the development and manufacturing costs. The CBC article also pointed out that much of the basic discovery costs came out of the public purse in the form of academic research funding, which drug companies do not factor into their pricing. Barry Werth of the MIT Technology Review looked into the high prices for two new drugs, Kalydeco® and Zaltrap®, and cites veteran drug maker and former Genzyme CEO Henri Termeer as saying “In determining the price for a drug, companies ask themselves questions that have next to nothing to do with the drugs’ costs. It is not a science […] It is a feel.”

Two efforts underway in Canada should help realign drug pricing. Ontario’s MaRS EXCITE program helps companies develop the evidentiary bundle, including an economic analysis, that a company can bring to the bargaining table to provide a more rational approach to drug pricing. The project “PACE-‘Omics,” led by Alberta’s Drs. Christopher McCabe and Tania Bubela, funded by Genome Canada, aims to develop better decision-making tools “to give policymakers and investors the tools they need to make the right investment decisions on technology development, regulatory pathways, cost-effectiveness and benefit to the Canadian healthcare system.” Together these approaches should help bring a better informed approach to establishing sustainable prices for new drugs.

By: Kathryn Deuchars, Director, Ontario Personalized Medicine Network

A study of personalized cancer care in action found that this approach not only saved money but resulted in better outcomes. Such personalized cancer treatment is available here in Ontario.

A small study by Intermountain Healthcare, in Salt Lake City, compared the costs of using personalized medicine in cancer patients with late stage, metastatic disease. Patients whose therapy selection was based on next-generation tumour profiling testing rather than using standard chemotherapy options have lower costs per week and longer progression-free survival.

Personalized approaches to cancer treatment are being tested at many centers, including Ontario’s Princess Margaret Cancer Centre, which launched the “IMPACT” trial (for “Integrated Molecular Profiling in Advanced Cancer Trial”) in March, 2012. This trial is described as “the first Canadian comprehensive molecular profiling program that seeks to provide doctors with specific cancer gene information so that each patient’s treatment can be tailored to his/her specific form of the disease” and aims to test 1,000 patients.

Intermountain Healthcare has been offering a similar type of test, a 98-gene cancer panel test for genes commonly altered in solid tumours. The test involves sequencing over 1200 regions of these 98 genes. The results can be used to identify the appropriate targeted therapeutic specific to the genetic profile of a patient’s tumour. In a retrospective matched cohort study of 72 patients with metastatic cancer, patients at Intermountain Healthcare that received the gene panel test had an average progression-free survival of 22.9 weeks compared to 12 weeks for the group that received standard chemotherapy treatment. The respective costs per week were slightly lower in the gene panel group, at US$3,204 vs. US$3,501. The $6,000 price of the test was included in the cost analysis.

The key contributors to the costs in chemotherapy arm “were more and longer hospital stays and emergency room visits.” In addition to avoiding such hospital visits, “targeted therapies offer other benefits. Many of the targeted drugs are oral agents, which allow patients to take them at home or work, while continuing to be productive at work and go about their daily life. They don\’t have to take time off work to go into the hospital for chemotherapy treatment” according to the authors of the study. These ancillary benefits were not factored into the above cost analysis, suggesting that the overall cost benefit is even higher.

Full details of the Intermountain Healthcare study are yet to be released (the work was presented in abstract form in conjunction with the recent annual meeting of the American Society of Clinical Oncology). Yet they suggest that the promise of personalized medicine of reducing costs while improving care can be realized. A key influencer of this, however, will be the cost of targeted therapeutics. As discussed in the accompanying article “Rising prices for new targeted therapeutics threatens their own success” new approaches are needed to ensure that high costs don’t derail the potential of personalized medicine.

By: Kathryn Deuchars, Director, Ontario Personalized Medicine Network