New studies which show that patients in some countries can wait years longer than those in others to access potentially life-saving cancer drugs demonstrate the need for better collaboration between doctors and health authorities globally, say researchers.
A comparison of approval times for 41 cancer drugs in Canada, the US and the European Union found the average time to approval to be six months shorter at the US Food and Drug Administration than for the European Medicines Agency and 7.6 months faster than Health Canada.
The greatest delay between FDA and Health Canada approval was 66.1 months for Celgene’s Vidaza (azacitidine); EMA approval came 10.3 months earlier than Health Canada but 55.8 months after the FDA, say researchers Sunil Verma and Nardin Samuel of Sunnybrook Odette Cancer Centre, Toronto, reporting their findings at the European Society of Medical Oncology congress in Madrid.
The fastest approval time among the drugs studied was for Sanofi’s Jevtana (cabazitaxel), which the FDA approved for metastatic prostate cancer just 17 days after the manufacturer filed for approval. In Canada and the EU, the times to approval were 11.63 months and 11.03 months, respectively.
Dr Verma says there is a need for a dialogue amongst industry regulatory agencies, patient groups, the research community and oncology professionals on how best to reduce the time to approval while ensuring safety for approved drugs.
International coordination needed
“We also need a coordinated international approach to reduce the disparity in time to access new drugs around the world,” he said.
Another study presented at ESMO found that patients in eastern Europe had less access to Roche’s HER2-positive breast cancer targeted drug Herceptin (trastuzumab) than those in western Europe and the US, and that these differences can be linked to discrepancies in cancer survival.
Previous research by Felipe Ades Moraes from the Institute Jules Bordet in Brussels and colleagues has shown differences in health spending among EU countries and that these differences are related to discrepancies in cancer survival. In their new study, which tracked how many possible patients could have been treated with the supply of Herceptin within individual countries during 2001-13, they report that eastern European countries acquired insufficient quantities of the drug to treat all patients who would benefit from it.
Eastern Europe procurement levels increased only after 2005 when Herceptin received extended approval for use after surgery to increase the cure rate for breast cancer. Western Europe and the US had a faster uptake, seen since Herceptin’s first approval in the metastatic setting – 2000 and 1998, respectively – and they acquired sufficient accounts to treat virtually all patients, said Dr Ades Moraes.
These findings strengthen the notion that uptake of life-saving drugs is one of the many important factors in improving cancer survival, he said, adding: “as cancer treatment and cancer drugs become more complex and more expensive, a close relationship between health authorities and doctors can dramatically improve patient care and cancer survival by determining priorities in health budget allocation."