Journal of the National Cancer Institute Advance Access originally published online on November 27, 2007
JNCI Journal of the National Cancer Institute 2007 99(23):1750-1752; doi:10.1093/jnci/djm257
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© Oxford University Press 2007.
NEWS |
In Australia, Patients and Government at Odds Over Mesothelioma Treatment Costs
Patient advocates have been lobbying the Australian government to fund a mesothelioma drug that they believe will improve patient quality of life and extend survival. However, the Pharmaceutical Benefits Advisory Committee (PBAC), which makes drug funding decisions for the country's national health care system, has twice rejected pemetrexed for listing on the pharmaceutical benefits scheme, which would ensure universal drug coverage for patients with asbestos-related lung cancer.
As JNCI was going to press, the PBAC overturned those previous decisions to rule that patients will get access to the mesothelioma treatment, much to the delight of the Asbestos Diseases Foundation of Australia and drug manufacturer Eli Lilly, who had been lobbying for the change.
A similar debate between cost effectiveness and access to drugs has been taking place across the world. Other countries, including England and Canada, are working out whether pemetrexed will be available through their national health systems as well.
Mesothelioma is a rare cancer that can develop 20–40 years after exposure to airborne asbestos fibers. The mesothelium—or cells that surround and protect the lung and abdominal organs—are commonly affected, as well as (albeit to a lesser extent) the heart and reproductive organs. People most at risk for this disease include former workers in the asbestos mining, manufacturing, and building industries. Do-it-yourself renovators and their families are also susceptible. It is estimated that one in three Australian homes built before 1987 contains asbestos.
Australia has the highest incidence of mesothelioma in the world, at about 32 cases per million people (about three times higher than the U.S.). These numbers are expected to grow and eventually peak between 2017 and 2020.
Mesothelioma is associated with a poor prognosis. In the Australian state Victoria, for example, the 1-year survival rate is 42% and falls to 5% at 5 years. But chemotherapy can help relieve symptoms, such as pain and breathlessness, and possibly extend survival.
Many chemotherapy drugs have been tested in clinical trials for mesothelioma, from platinum-based treatments with one agent or combination regimens to non–platinum-based alternatives. However, there are limited phase III data upon which to base treatment guidelines. One chemotherapy approach, which is becoming common, is treatment with a combination of pemetrexed and cisplatin.
In 2006, the authors of a Journal of Thoracic Oncology report recommended that patients with an advanced type of mesothelioma be treated with cisplatin and pemetrexed (or, if pemetrexed is not available, with raltitrexed, which is in the same drug class.) The authors reviewed data from 111 phase II trials and eight randomized trials and showed that mesothelioma patients using the combination chemotherapy had substantial cancer shrinkage, and combination treatments with platinum-based drugs were associated with higher response rates than non–platinum-based regimens. Quality of life also appeared to improve. However, the combination is associated with serious side effects, including lowered blood cell (neutrophils and platelets) counts, nausea, vomiting, diarrhea, dehydration, and mouth sores: symptoms that were somewhat relieved by vitamin B12 and folic acid supplements.
The Story Down Under
In Australia, pemetrexed in combination with cisplatin had been approved for the treatment of non–small-cell lung cancer and one type of mesothelioma by the Therapeutic Goods Administration, which has a similar role to that of the U.S. Food and Drug Administration. However, access to the drug combination is an issue because of the costs: 20,000–25,000 Australian dollars (US$18,383–$22,979) for a six-cycle course of pemetrexed with cisplatin. Prior to their recent decision, PBAC had approved the combination only for federal subsidies for non–small-cell lung cancer, not mesothelioma.
That means that, until recently whether Australian patients got treatment depended on where they live. Those in Western Australia were guaranteed treatment, while in New South Wales it was limited to people who were exposed to asbestos on the job. Elsewhere in the country, patients could get compensation through lawsuits, disability insurance, workers’ compensation, or private organizations, all of which can be problematic, says Barry Robson, president of the Asbestos Diseases Foundation of Australia. "You have to prove your case, and not everyone is successful."
This was especially true for patients who cannot prove if, when, or how exposure occurred, he said. Those patients could enroll in a clinical trial or receive subsidized access to pemetrexed as public hospital patients. However, these arrangements are neither guaranteed nor widely available, particularly for people living in rural and regional areas. A report commissioned by the Asbestos Diseases Foundation and Eli Lilly estimated that between 35% and 50% of patients could not get pemetrexed combination chemotherapy. Eli Lilly appears to have a subsidy program for low income patients in the United States but not in Australia.
What upset mesothelioma patient Brian Fegan was that pemetrexed was subsidized for non–small-cell lung cancer but not for mesothelioma. "It's absurd," he said. "If I had tobacco-caused lung cancer, I would have got [pemetrexed] automatically." Instead, Fegan waited 8 months after diagnosis to access pemetrexed treatment only after he received workers’ compensation. Previously, he endured two cheaper chemotherapy courses without pemetrexed. Currently, Fegan is on his second course of pemetrexed treatment.
Why the difference? "The PBAC recommended the listing of [pemetrexed] for the treatment of non–small-cell lung cancer, as it was shown to be as effective as other therapies that are subsidized for this condition and no more expensive," spokesperson Kay McNiece said. The PBAC rejected earlier pemetrexed submissions because of unacceptable cost-effectiveness. The committee also questioned whether pemetrexed improved quality of life, because patients receiving the combination had more serious side effects than patients treated with cisplatin alone.
Costs Around the World
Government agencies across the world are increasingly making drug access decisions from cost–benefit analyses. A similar debate is going on in the U.K. Last year, the National Institute for Health and Clinical Excellence, which performs health assessments in England and Wales, rejected a pemetrexed submission based on cost-effectiveness. Pemetrexed plus cisplatin treatment exceeded the agency's maximum acceptable cost per quality of life year threshold of £30,000 (US$62,423). The best value obtained was for patients with advanced disease and good functional status, almost £38,000 (US$79,070). Currently, pemetrexed plus cisplatin treatment costs on average £8,000 (US$16,646) for a six-cycle course.
In July 2007, the agency changed its position with a draft recommendation that the pemetrexed combination be allowed for one type of mesothelioma patients with advanced disease and low functional impairment. The appraisal committee agreed that pemetrexed treatment might fall within acceptable cost-effectiveness levels if they based their calculations on patients receiving fewer than six cycles of chemotherapy or pemetrexed became available in a smaller dose, options that have also been studied.
"The committee agreed that the incremental cost-effectiveness ratio for pemetrexed–cisplatin in the fully supplemented subgroup with advanced disease, and good performance status was likely to fall within acceptable levels," spokesman Philip Ranson said in an e-mail. However, two undisclosed stakeholders have appealed this finding, and a meeting to discuss the appeal is scheduled for this fall. The final recommendation will be forwarded to the National Health Service, which must allow mesothelioma patients access to the drug within 3 months if it is approved.
Similar decisions are being made in Canada. In the province of Ontario, pemetrexed is not subsidized because its alternative, raltitrexed, is cheaper, with similar clinical benefits. According to a document published by the Ministry of Health and Long-term Care in July, pemetrexed combination therapy costs an average of 30,000 Canadian dollars (US$32,204) for a six-cycle course compared with 3,000 (US$3,220) for raltitrexed with cisplatin.
Canadian mesothelioma patients who were occupationally exposed to asbestos can apply for compensation through the national Workplace Safety and Insurance Board, which will cover pemetrexed treatment. Ineligible patients can pay for pemetrexed themselves, have it subsidized by a private drug plan, or receive raltitrexed treatment, which is subsidized in Ontario. Meanwhile, pemetrexed is covered in British Columbia, Alberta, Manitoba, and Saskatchewan through provincial cancer agencies.
In Australia, PBAC altered its decision to place pemetrexed among approved drugs only after Eli Lilly showed that it is tolerated by most patients, dropped its price by 10% and made the drug available in a lower dose (100 mg versus 500 mg). So now, after three reviews in three years, mesothelioma patients will soon get subsidized access to pemetrexed.
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