THE biosimilar version of the breast cancer drug trastuzumab was approved by the United States Food and Drug Administration (FDA) in December. Not long after, neighbouring Thailand also registered the drug.
But the Malaysian authorities are dragging their feet in registering the the drug, which could bring some hope to patients who wanted the targeted drug therapy.
This is putting HER2 Positive Metastatic Breast Cancer patients at a disadvantage, prompting Pink Ribbon Wellness (L) Foundation founder and chairman Datuk Dr M. Devanand to urge deputy Health Minister Dr Lee Boon Chye to expedite the approval of the biosimilar drug registration at the recent Excellence in Breast Cancer Therapy and Support Conference.
HER2 patients have aggressive cancer cells and the patients affected make up one-third of the estimated 5,400 breast cancer patients diagnosed every year, says Dr Devanand.
Trastuzumab costs a whopping RM130,000 for a year’s treatment (17 cycles) and the biosimilar version of the drug is expected to bring down the cost by at least half, allowing more patients to gain access to it.
“With limited government funds, we should do generic or biosimilar drugs,” he says, adding that although the price of the drug is still high, it would ultimately be lower as more generic companies compete to produce it.
Following the request to quicken the approval process of the drug, Dr Lee has promised to bring the matter up with the Health Minister.
According to Dr Devanand, trastuzumab can prolong the lives of HER2 patients by an average of three to five years, but one HER2 patient he knew, who was diagnosed at Stage 4, had lived for nine years following the treatment.
Past president of the Malaysian Oncological Society Datuk Dr Ibrahim Wahid points the finger at the National Pharmaceutical Regulatory Agency (NPRA) for the delay in the approval of the drug.
“The paper work is exhaustive. It is taking a long time for drugs to be approved these days,” he says, adding that certain methods of testing required are also time consuming.
Dr Ibrahim says the NPRA should consult with cancer experts to find out which are the priority or important drugs that need to be accelerated in the approval process.
The original drug was introduced more than 20 years ago and the generic version was patented in the United States and approved by the FDA last year.
“But it takes one year to two years for a drug to be approved in Malaysia because of the paper work and testing methods. That is too long.
“Priority drugs should take six months. After all, this drug has been registered and accepted in Europe and the US,” he adds.
Dr Ibrahim says that oncologists face many challenges treating patients as a lot of life-saving cancer drugs are very expensive.
“If patients cannot afford them, there is nothing I can do to save their lives.
“The Government hospitals and Health Ministry will also rarely fund expensive drugs, making it impossible for the poor to have access to good cancer treatment.
“But if I have biosimilar or generic drugs, the cost of the drugs will drop by at least 50%, and more patients can afford it.
“For cancer drugs, we need to bring in more generic drugs or biosimilars to help our patients get easier access to these drugs,” he stresses.
Concurring, Dr Devanand points out that providing a personalised treatment plan will also help reduce healthcare cost and insurance companies should consider introducing the plan.
He says a personalised plan will enable doctors to understand the pathology of the cancer (the DNA of the cancer) and be able to tell if it is a low or high risk cancer.
“If it is a low risk cancer, you need only tablets. If it is a high risk cancer, you need chemotherapy,” he says.
Dr Devanand says that in the US, out of 100 patients in Stage 1 and 2 of cancer, only 25% needed chemotherapy and those who did not need it have been found to be metastatic free for 10 years, based on a 10-year data gathered.
“If we can classify the patients into those who don’t need chemotherapy and those who need chemotherapy, that will save money.
“Insurance companies can save RM30,000 to RM40,000 for each treatment if the patient does not need chemotherapy,” he says.