Subject patients to genetic tests before starting medication so as to improve the effectiveness of cancer treatments, this is a result of medical advances.  However, Dr Yeh Shih-Peng, Director of the Department of Hematology of the CMUH, pointed out that if genetic tests and the NHI pharmaceutical benefit scheme are not linked, patients may still be denied treatments knowing that such treatments could be effective in them.  It could be devastating.

Dr Yeh expressed that some target treatments for cancers are very costly, and the treatment course usually lasts more than one year until patients’ conditions deteriorate.  Such treatments are not affordable for most families.  Taking lung cancer treatments for example, it is essential that patients take the genetic test before accessing new drugs.  However, if the new drugs suitable for them are not reimbursed by the NHI and are too expensive for the patients, it will place patients and their families in a dilemma. 

Dr Yeh suggested that the authority should consider whether patients are actually able to receive any benefits or treatments after taking the generation gene sequencing testing.

Zhou Mei-Chun form the TFDA pointed out that the TFDA is drafting regulations on governing the laboratory developed tests (LDTs).  Such tests should be precise, reliable and supported by clinical evidence.  The TFDA is now assessing current clinical situations and collecting experts’ comments.

As for companion diagnostics, for example breast cancer patients have to take HER2 genetic tests to justify whether Herceptin is a suitable treatment, the TFDA will engage in cross-departmental communication and collaboration so as to provide clear regulations of the definition of such products and clinical trial designs.

【2017-04-30/ United Daily News】