In the United States, the chemotherapy standard of care for pleural mesothelioma is combination therapy using pemetrexed, marketed as Alimta^® by Eli Lilly, and cisplatin. The USFDA approved this treatment—the only one officially approved for mesothelioma in the U.S.—in 2004 due to the successful results of a number of clinical trials showing the combination provided better tumor response and additional survival time than other treatments. However, not all countries initially approved the use of pemetrexed and cisplatin for the treatment of mesothelioma.

In Australia, pemetrexed had been previously approved only for the treatment of non-small cell lung cancer. The Pharmaceutical Benefits Advisory Committee (PBAC), which is the authority that approves funding for the drugs that will be distributed through the nation’s national health care system, had twice rejected listing pemetrexed for mesothelioma treatment due to the high cost of the drug, which at 20,000–25,000 Australian dollars (US$18,383–22,979) was more expensive than other treatments. The PBAC was also concerned that the side effects associated with pemetrexed were too great for the benefits it offered and that the dosing regimen was too strong.

Similar reactions were seen in England and Canada as well. Both national health care systems at first rejected pemetrexed due to its high cost and the side effects associated with treatment. In July of 2007, the UK finally approved the use of pemetrexed. In Canada, the individual provinces have different rules, but pemetrexed or raltitrexed, a drug in the same class as pemetrexed, is now available through a number of means.

Back in Australia, patient groups, such as the Asbestos Diseases Foundation of Australia, have been fighting for approval of pemetrexed. The drug has been available in some parts of the country, but because it was not been offered as part of the national health care system, it was not available universally. The Asbestos Diseases Foundation estimates that 35%–50% of all mesothelioma patients do not have access to the drug.

Recently, however, the PBAC reversed positions and has now approved pemetrexed for mesothelioma treatment, much to the approval of the Asbestos Diseases Foundation and for mesothelioma patients all over the country. In fact, Australia has the highest incidence rate of mesothelioma in the world. At 32 cases per million, it’s incidence rate is nearly three times that of the United States and is expected to grow until 2017. The PBAC changed their positions after Eli Lilly presented data showing pemetrexed was well-tolerated in most patients, and because Eli Lilly reduced the price by 10% and offered the drug in a smaller 50mg dose as compared to the traditional dose of 100mg.

Labels: mesothelioma