What is MaHTAS?
MaHTAS, stand for Malaysian Health Technology Assessment, is a section under Medical Development Division Ministry of Health Malaysia. MaHTAS is tasked to provide evidence-based input on health health technology and clinical practice. We conduct horizon scanning, health technology assessment (HTA), develop and implement Clinical Practice Guidelines (CPG).
What is Health Technology?
It refers to intervention that may be used to promote health, to prevent, diagnose or treat acute or chronic disease, or for rehabilitation and long term care. This includes healthcare devices and equipment, medical and surgical procedures, pharmaceuticals, vaccines and blood products, preventive and psychological interventions, and organizational systems used in healthcare.
What is Health Technology Assessment (HTA)?
HTA is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.
What is the purpose of HTA?
The main purpose of HTA is to provide input for decision / policymaking related to health technology in health care such as decision on acquisition, adoption and implementation of new health technology, continued use of existing technology, disengage use of obsolete technology, pricing and reimbursement
What type of HTA reports being produced by MaHTAS?
- Health Technology Assessment Report (HTA):
- Comprehensive report.
- Evaluate safety, effectiveness issues, cost-effectiveness/financial impact, organizational considerations. May also address ethical, social and legal implications.
- Expert committee and externally reviewed
- Preparation time: 8 -18 months after approval of issues by HTA CPG Council
- Technology Review Report (Mini-HTA):
- Less comprehensive report
- Smaller scope of assessment (evaluate safety, effectiveness issues, costs/ financial impact)
- May be externally reviewed
- Preparation time: 2 - 4 months after receiving request
- Information Brief (Rapid Review):
- Very rapid information response
- Evaluate safety and effectiveness issues
- Look for high level of evidence, may restrict the literature search to 1 or 2 database
- Preparation time: 2 – 4 weeks
Who can apply for HTA?
It can be requested only by health personnel in Ministry of Health (MoH). Requests can be made through Heads of Department at hospital level, Hospital or Institutional Directors, State Health Directors, District Health Officers, District Dental Officers, Heads of Section, Heads of Division, Heads of Service or Heads of Allied Health Profession and other government agencies. National Heads of Clinical Services (when relevant) will give advice if health technology assessment is required for a health technology that has been requested for the conduct of HTA. For the time being, MaHTAS DO NOT accept request for the conduct of HTA from industries.
How to apply for HTA?
HTA can be requested through:
- Manually using Request for Health Technology Assessment (HTA) Form PTK-BOR-01 Pindaan 2/11. This form can be obtained from URL link (coming soon) or from MoH / MaHTAS portal.
- Online service at the MaHTAS portal at URL link (coming soon)
- Request to be directly submitted through a letter / email to the Director, Medical Development Division, Ministry of Health or Head of MaHTAS.
What types of HT that can be requested for HTA?
Issues requested for the conduct of HTA must be of interest / importance at National Level. HTA can be requested for:
- New Health Technologies which is defined as health technologies that have never been introduced in Ministry of Health Facilities
- Existing Health Technologies where there are concerns about safety, efficacy or effectiveness, and economic implications
What is CPG?
Clinical Practice Guidelines (CPG) are “statements that include recommendations intended to optimise patient care that is informed by a systematic review of evidence and, an assessment of the benefits and harms of alternative care options”. A CPG is not intended to be prescriptive, menu-driven or cookbook where the healthcare provider has no discretion in managing his/her patient or a medical textbook that provides in-depth background clinical knowledge of a medical condition. It does not replace the knowledge and skills of the healthcare providers but aids their case management.
What is the purpose of CPG?
They are designed to help healthcare providers making clinical decisions in an effective and safe way based on the best and current available evidence. The CPG development also takes into account values, experiences and preferences of both healthcare providers and patients and, availability of local resources/resource implications.
What are the CPG implementation strategies?
CPG implementation is strongly advocated worldwide to enhance its utilisation. All CPGs developed by MaHTAS will be implemented using effective implementation strategies such as Quick Reference and Training Module. The implementation documents are downloadable from the MoH and Academy of Medicine websites. Other strategies include launching event, publication in peer-review journal and patient information leaflet. Description of these strategies as below:
|
Type of activities |
Details |
|
Quick Reference |
· A pocket-size easy reference document · Aims to provide key messages and summary of the main recommendations of the CPG |
|
Training Module & Training of Core Trainers |
· Developed based on the CPG · Aims to disseminate contents of the CPG and train healthcare providers nationwide in delivering echo-training of the CPG systematicaly and effectively · Monitoring of echo-training is done at the end of the year |
|
Launching |
· Can be either a standalone or a piggy-back event · Aims to create awareness of CPG existence among the relevant stakeholders by officially launching the CPG and disseminating key messages to them |
|
Publication |
· In scientific journal or possibly mainstream media · Aim to increase dissemination of the CPG contents to healthcare providers and public |
|
Patient Information Leaflets |
· A user friendly simple document using plain language · Aim to share contents of the CPG with the public (including patients and carers) and empower them to be involved in the disease management |
Who can propose a topic for CPG development?
A formal request for development of new CPG topic is sent out biennially to the Heads of Clinical Services of MoH, as well as the Master, Academy of Medicine Malaysia and Deans of the main Medical Schools. The new CPG proposals should be sent in to the CPG Secretariat at MaHTAS using a special form (PTK – BOR – 03 Pindaan 1/09) which is available on MaHTAS portal. The list of new topics would then be prioritised by the CPG Technical Advisory Committee for certain number of CPG to be developed by MaHTAS. Informal request received will undergo similar process if MaHTAS is to conduct the CPG development. All those involved with the development of a CPG has to fill a form on declaration of conflicting interest.
How can one participate in a CPG development?
- CPG Development Group (DG)
CPG DG is the working group of a CPG. It is formed specifically for each CPG topic/project and the members are essentially multidisciplinary in nature. The chairman of a new/updated CPG is chosen by the relevant National Advisor. The chairman of a CPG has the liberty to select other members of the DG with the advice from MaHTAS. Sometimes, National Advisors or Directors of Division are requested to nominate members for the purpose. DG members are chosen for their expertise and ability to work together in a team in developing and implementing a CPG. They will be trained on CPG development by MaHTAS before embarking on a CPG project.
- CPG Review Committee (RC)
CPG RC is also formed specifically for each CPG topic/project. The members are multidisciplinary and comprise of senior consultants in public and private sectors, patients/carers/non-governmental organisation members and other relevant stakeholders from different disciplines/programmes in MoH. They oversee the work of DG and give their expert advices from time to time throughout the CPG development.
- CPG External Reviewers (ER) & Public Consultation
When a draft CPG is completed, it will be sent for external (peer) review by experts in the field, both local and foreign. An ER is identified and suggested by both DG and RC. The draft will also be posted on the MoH website for a month for anyone interested in it to give their comment (public consultation) to improve the document. All feedbacks will be addressed by the DG accordingly.
What is Horizon Scanning?
Horizon Scanning is an activity that identifies innovations in the field of health technology likely to have a significant impact; and disseminates information relevant to the needs of the customer which is timely, so as to enable appropriate decision making (such as resource allocation), facilitate appropriate adoption, and identify further research requirements.
What is the purpose of Horizon Scanning?
The purpose is to provide timely advice to allow appropriate implementation and/or adoption of health technologies, and to facilitate timely budgetary planning. The system will help with decisions on undertaking primary and secondary researches. Emerging technologies identified will also be monitored when the evidence is inadequate.
What type of HS reports being used by MaHTAS?
- Rapid Assessment (TechScan)
- Assessment period: around one week
- Length: 1 to 2 pages
- Purpose: a brief assessment in order to respond stakeholders about specific new/emerging technology
- Brief Assessment (TechBrief)
- Assessment period: 2 months
- Length: 4 to 10 pages
- Purpose: more in-depth but still brief overview using a structured search strategy
- In-depth Assessment (Horizon Scanning report)
- Assessment period: 4 to 6 months
- Length: > 40 pages
- Purpose: in-depth assessment using a structured search strategy
How to apply for HS?
HS can be requested through (which is also known as reactive identification):
- Manually using proforma forms (PTK-Bor-13 for Pharmaceutical Information Proforma and PTK-Bor-14 for Medical Technology Information Proforma). This form can be obtained from or from MoH / MaHTAS portal.
- Online service at the MaHTAS portal
Request to be directly submitted through a letter / email to the Director, Medical Development Division, Ministry of Health or Head of MaHTAS.
What types of health technologies that can be assessed through horizon scanning?
The system covers all health technologies which are planned to be marketed within the next 24 months. The type of technology covered are:
- Medical devices
- Diagnostics
- Biologics,
- Regenerative technologies
- Procedures
- Pharmaceuticals
- Traditional & Complementary Medicine
- Public health interventions
How do we request for health technology assessment pertaining to our product(s)?
MaHTAS conduct assessment based on request from policy / decision makers within MOH or other government agencies. We do not conduct assessment for industries.
Do we need to have approval letter from MaHTAS for us to market our product(s)?
MaHTAS conduct evidence-based health technology assessments and provide report or input to the policy/decision makers. We do not provide any approval letter for health technologies that have been assessed.
Can we send samples of our product(s) for MaHTAS to try and do assessment on them?
MaHTAS does not accept any samples or products for assessment, test and validation.
What should we provide in order to help MaHTAS to verify/approve our product(s)?
Unfortunately, we do not conduct product verification or certification. Assessment by MaHTAS is conducted through evidence-based systematic review process.
Can MaHTAS help us to arrange for product(s) presentation?
MaHTAS does not arrange for product(s) presentation, however, we may attend to any presentations or invitations based on request from policy/decision makers with MoH or other goverment agencies. This is to avoid any issues related to conflict of interest.
Who should we contact to propose our product(s) to Ministry of Health, Malaysia?
You may send your proposal to Secretary-General of the Ministry of Health Malaysia or other relevent departments within MoH that specifically involve with any indications of your product(s).
How could we get our product(s) certified by Ministry of Health?
Product certification will depend on the specific health technologies and under purview of other agencies. For example:
-All drugs and medicines : National Pharmaceuticals Control Bureau. Further information can be obtained from the official website http://www.bpfk.gov.my
-Medical devices: Medical Device Authority. Any registration and licensing purposes, please refer to https://www.mda.gov.my/