PETALING JAYA, August 22 — The Ministry of Health (MOH) is moving to incorporate real-world data into decisions on drug inclusion in the national formulary, as part of a broader shift towards value-based health care in Malaysia’s public health system.
Health deputy director-general (pharmaceutical services) Azuana Ramli said MOH aims to complement clinical trial findings with real-world evidence (RWE) to better assess the actual performance and patient outcomes of medicines in local settings.
“Sometimes what’s mentioned in clinical trials may not be the end point, which is patient-related outcomes,” Azuana said in her keynote at the Value-Based Healthcare Conference 2025 on July 9 organised by the Pharmaceutical Association of Malaysia (PhAMA) here.
“So, this is to encourage real-world data collection to support the evidence of value for any particular drug.”
Real-world data — such as treatment outcomes collected from hospitals and clinics — are expected to strengthen MOH’s formal health technology assessment (HTA) framework, which guides decisions on listing drugs in the MOH Medicines Formulary, also known as the “Blue Book”.
“In MOH, we have started making decisions for the formulary using formal health technology assessments, so decisions are informed by a formal HTA process to evaluate clinical effectiveness and cost efficiency of treatments,” she said.
“This ensures that only therapies delivering proven value are listed, supporting the optimal use of public health care resources.”
Azuana acknowledged that current HTA evaluations still rely heavily on controlled clinical trial data, but said MOH is exploring how the process can evolve to reflect real-world usage and patient experience in Malaysia.
She noted that industry players, particularly PhAMA members, are already familiar with submitting dossiers to support formulary inclusion, which are assessed for both clinical and economic value. PhAMA represents pharmaceutical multinational companies.
“I think PhAMA members are very familiar because they send their dossiers to the MOH’s Pharmaceutical Services Programme to get evaluated — to ensure whatever we admit to the MOH Medicines Formulary is something that is of value,” she said.
However, Azuana drew a clear line between formulary assessments and pharmaceutical procurement issues, which have come under scrutiny from industry players.
CodeBlue previously reported on July 2 several pharmaceutical industry sources raising concerns about procurement delays, lack of transparency, and MOH’s purchase of local generic drugs at prices higher than off-patent innovator drugs.
Speaking to CodeBlue on the sidelines of the conference, Azuana said these procurement concerns are separate from the HTA-based decisions used for formulary listings.
“That’s a separate issue because purchasing and selection of products into the formulary are two totally different processes. The Blue Book mainly deals with the selection of drugs. Once you’re in there, the decision on whether to purchase or not is still based on the facility’s needs. Sometimes it’s in the Blue Book, but the facility doesn’t need it — so there’s no need for them to purchase it.
“Because in the Blue Book, the products have different categories too. Sometimes they have an ‘A asterisk’, meaning only certain types of consultants can prescribe it.
“In terms of purchasing, it’s a separate issue, because you’d then need to look at things like the current tender, which I’m not in a position to comment on,” Azuana said.
Clinic Trial Data May Not Be Truly Evidence-Based, Generics Underutilised
During a panel discussion at the conference, Azuana said value-based care is not about cutting costs, but about maximising benefit for patients.
“To put it in a sentence, ‘value’ means what is the benefit received by the patient for every ringgit that we spend on the patient – that’s value,” she said.
Prof Kenneth Lee, professor of health economics at Monash University Malaysia, described value-based health care as care that improves outcomes while optimising resource utilisation.
Prof Dr Rohana Abdul Ghani, consultant endocrinologist at the Faculty of Medicine, Universiti Teknologi MARA (UiTM), and president of the Malaysian Society of Obesity (MYOS), expressed frustration over limited access to clinically proven pharmacotherapies.
“My frustration is I want to be a good clinician and I want to give the best for my patients, but I can’t. My pharmacist will say we have no money to buy or there is not enough medication for our patients. Even if I can negotiate a very low price for my patient, then my pharmacist will say, I have to mark it up a bit because we don’t have money for the hospital, and that’s the truth. I’m not sure if I’m supposed to say this.
“So, money, money, money, is still the number one frustration,” Dr Rohana said.
“Other than that, in terms of obesity, which is my area, it’s very difficult to get reimbursement in terms of pharmacotherapy that I want to give to my patients that is backed by scientific evidence that shows very high efficacy, very good long-term outcomes.
“So these are the frustrations that I hope value-based health care will be able to provide, a bit more clarity on what we can do about this.”
In response, Azuana questioned how clinicians can truly know which treatments provide the most value when decisions are based largely on published literature or data provided by pharmaceutical companies.
The MOH official called for a system that monitors real-world patient outcomes to ensure decisions are grounded in actual effectiveness, not just controlled trial settings.
“I think another gap that we have to address is: how do clinicians know that [a drug or therapy] is the best? I think we don’t have an infrastructure that actually monitors the outcomes of patients, which we really, really need.
“Of course, clinicians will base ‘what is the best’ on whatever is being told to them, what the literature says, and so on, but that may not necessarily be true. So I think if we can address the gaps in really monitoring patient outcomes, we can actually focus on using whatever provides the best value,” Azuana said.
“We have to start making decisions based on evidence, based on data. So we have to somehow find a way to be able to monitor all these outcomes, so that we can make good decisions — better than just ingest whatever that may not be truly evidence-based.”
When asked by the moderator whether a major revamp would be needed to build outcomes-based funding models, given the government’s current procurement policies, Azuana said the potential exists, but the system is not there yet.
She explained that Malaysia’s current budgeting structure operates on a yearly cycle, whereas treatment outcomes often take two to three years to emerge. This mismatch makes it difficult to tie funding directly to long-term patient outcomes.
“Probably there is a need to relook at how we actually fund medicines or get these products, because medicines or products are treated like any other items and it’s probably not really an ‘accurate’ way to look at it because medicines give you outcomes.”
She noted that the current model allows mainly for financial-based schemes, such as “buy two, get one free”, which are more about product volume than patient value. Shifting the mindset to view medicines as part of a service would allow funding to be tied to patient outcomes, rather than just paying for the product itself, Azuana said.
“I wouldn’t say that we need a major restructure,” Azuana said, “but probably looking at things in a different way so we can enable a ‘purchase of outcome’ rather than the product.”
Azuana also highlighted the continued underutilisation of generic medicines, particularly in the private sector.
“Many private facilities continue to prescribe high-cost branded medications, as we all know, even when equally effective and more affordable generic options are available,” she said.
She warned that this practice contributes to higher out-of-pocket spending and inefficiencies in health care resources. Promoting evidence-based prescribing and incentivising the use of generics, Azuana said, could reduce costs while maintaining quality of care.
Mind The Gap: Real-World Evidence Can Bridge Research And Reality
Leyla Andrea Hernandez Donoso, senior director of real-world evidence (RWE) for international operations at Novo Nordisk, echoed Azuana’s call for integrating RWE more systematically into health system decision-making, particularly for regulatory approvals, HTA, reimbursement, and evaluating long-term patient outcomes.
“We collect data every day — from registries, from wearable devices, from pharmacy claims — but the impact of real-world evidence is still limited because we are not yet systematically using it to guide health care decisions,” Donoso said during her presentation.
She noted that while randomised controlled trials (RCTs) remain essential for establishing initial safety and efficacy, they often exclude older adults, individuals with multiple comorbidities, and certain ethnic populations.
“RWE fills that gap. It tells us how treatments actually work in people’s lives, not just in labs,” she said.
Donoso said Malaysia could lead the region by strengthening disease registry systems, unlocking siloed datasets, and building local analytical capacity to translate data into actionable insights. Pilot studies and localised modelling could offer immediate value.
“We don’t need national-scale studies to start. Small, focused pilot projects can already demonstrate the value of RWE and open access to innovation,” Donoso said.
Despite growing interest, Donoso observed that RWE is still treated as a “nice-to-have” in many countries, including Malaysia, rather than a “must-have” element of decision-making.
“Even in countries with advanced systems like the US or Switzerland, RWE often struggles to move the needle unless it’s paired with strong stakeholder collaboration, patient engagement, and clear policy alignment,” she said.
Key barriers to adoption include fragmented data systems, lack of standardisation, privacy regulations, and the absence of unique patient identifiers needed for longitudinal tracking and continuity of care.
“The perfect scenario is when we can follow a patient’s entire journey — from the moment they fall ill, to diagnosis, prescription, pharmacy dispensing, and eventual outcomes,” Donoso said. “We are not there yet, but collaboration across sectors — pharma, academia, government — is the only way forward.”
