Real-World Data and Real-World Evidence: Current status in the APAC region (Focus: Malaysia)
Our senior analyst Shimi Manayath Panakkal discussed about the usage of Real-World Data and Real-World Evidence in Malaysia with Dr. Sattian Kollanthavelu from Hospital Selayang, Malaysia. This is our fourth post in our interview series on Real-World Data.
. . . will help in understanding the overall trends in terms of disease burden and help in allocating funds accordingly
Considering the rapidly transforming healthcare space, what are your overall views on the usage of Real-World Data (RWD) in healthcare decision making?
Dr. Sattian: Real-world evidence, is the way to go. Without using the term ‘Real-world’ specifically, we have been using it in one way or other in the form of treatment guidelines or randomised controlled trials (RCTs).
In my view, it is a very practical thing to use Real-world data. RCTs are conducted in an ideal environment under uniform conditions but in the real-world scenario there will be lot a variation. Real-world evidence can provide us with a localized perspective accounting for such variations. For example, when I worked in Sabah (East Malaysia) earlier, while handling malaria cases, we used to start the treatment immediately with high dose options. We do this as we know due to the poor road access, lack of proper transportation options, the patient usually reaches the facility with a severe disease. In such cases, I cannot start a patient with a low dose medication from RCT based evidence. Whereas in West Malaysia, which has proper transportation and good coverage of hospitals, malaria patients are treated with oral medications as they can always be upgraded to the next line of medications and can be admitted to the tertiary hospitals.
We know that with the introduction of 21st Century Cures Act in 2016, USFDA has placed additional focus on using RWE in regulatory decision making. Coming to Malaysia, how is the regulatory landscape evolving in terms of usage of RWD?
Dr. Sattian: I don’t think we have any specific act similar to USFDA, but we have been practicing it to some extent based on our own evidence. Let me explain you with an example.
In Malaysia, we have been treating patients with Hepatitis C virus (HCV) under clinical trial with generic version of sofosbuvir and ravidasvir in collaboration with DNDi (Drugs for Neglected Diseases Initiative). Ravidasvir is pan-genotypic, you can use for all the HCV genotypes and it is manufactured in collaboration with an Egyptian company. In the United States, they have certain law that restricts the availability of generic version of these medications, due to both economic reason and the potency of generic drugs. But our evidence, points out that if we treat the patient early, the disease progression will be slower, and overall treatment cost is cheaper as well. So based on our data, we start treatment at early stage using the generic versions.
With respect to decision making by regulatory bodies in Malaysia, we do use real-world data to some extent. For instance, to establish Dengue vaccination guidelines, there were trials performed and we studied some biological prevention measures also. But as per my knowledge, there are no written rules.
In the U.S., a draft guidance on the appropriate use of RWD in regulatory decision-making is expected to be published by 2021. Are there any such measures in pipeline for Malaysia as well? Dr. Sattian: In my knowledge we do not have anything at the moment.
Dr Sattian Kollanthavelu MD (UMS) MRCP (UK) Senior Gastroenterology & Hepatology Fellow Department of Hepatology Hospital Selayang, Malaysia
How are the key stakeholders of the healthcare value chain responding to the use of real-world evidence in decision making?
Dr. Sattian: The term ‘Real-world data’ may not be familiar to everyone, but it has been utilised to treat patients. For example, we have our colorectal cancer screening programme, and Malaysian GI registry(MGIR). So, for the last ten years we have been using online system to update all our colonoscopy and OGDS (oesophagogastroduodenoscopy) findings. So, based on that information we understood that the incidence of colorectal cancer has increased since the use of colonoscopy. Keeping this in view, the clinical practice guideline and the colorectal cancer screening programme was modified to suit our population rather than using international guidelines.
What are the common sources of RWD? Are there any specific indications or areas in which RWD is utilized more in Malaysia?
Dr. Sattian: We have the disease specific registries like Malaysian GI registry, Malaysia Cancer registry, Infectious Disease registries. Tuberculosis and Malaria registries are compulsory, and cases must be notified as per law requirements. Also, from the hospitals, we have electronic medical records (EMRs), student and employment health check-up data. Insurance database is also an important source.
What are the key barriers to increased use of RWD?
Dr. Sattian: Data is available in abundancy but as clinicians we are limited by time. Most of the time goes into clinical work, but if we have a designated time for research it could be helpful. At the same time, fixing specific time might not be practical when we consider the enormity of RWE.
Is quality an issue with RWD? Dr. Sattian: Quality is not an issue. For example, MGIR has very high-quality data as it captures very specific information that is well regulated and periodically updated.
Coming to privacy, all the data is protected under PDPA (Personal Data Protection Act) in Malaysia.
What is the outlook for the usage of Real-World Data (RWD) in the future?
Dr. Sattian: As a system, we are going towards increased adoption of EMRs, so that patient’s information is easily accessible to the HCPs. Also, as more and more hospitals use EMR, a detailed patient health history will be available for the clinicians. So, we are moving towards using real-world evidence to tailor the treatment for patients.
Also, our discharge summary captures pertinent data regarding disease diagnosis (under ICD-10 coding system), treatment duration, prognosis, etc. This in turn will help in understanding the overall trends in terms of disease burden and help in allocating funds accordingly.
It was an insightful discussion. Thank you for your time!