Pharmacoeconomic Guidelines: Malaysia
Country/Region: Malaysia
Submission Guidelines
Guidelines on Submission of Dossier for Listing Into the Ministry of Health Medicines Formulary, 2024
Submission Guidelines Source:
Ministry of Health of Malaysia
Additional Information:
Pharmacoeconomic Guideline for Malaysia, 2019
Information current as of Monday, May 20, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Submission Guidelines |
| Title and year of the document | Guidelines on Submission of Dossier for Listing Into The Ministry of Health Medicines Formulary, 2024 |
| Affiliation of authors | Pharmaceutical Services Programme, Ministry of Health Malaysia; Universiti Sains Malaysia; Universiti Teknologi MARA; Universiti Malaya; Azmi Burhani Consulting Sdn Bhd; Pharmaceutical Association of Malaysia |
| Purpose of the document | Dossier submission (local PE evidence is not mandatory). |
| Standard reporting format included | Yes. |
| Disclosure | Yes. |
| Target audience of funding/ author's interests | Product registration holders, Ministry of Health personnel |
| Perspective | Primary: MOH. Secondary: Societal. |
| Indication | Must be approved by the Malaysia Drug Control Authority. |
| Target population | For whom the intervention is intended, in the clinical practice. |
| Subgroup analysis | To be included as part of the Economic Evaluation report if applicable. |
| Choice of comparator | Direct comparative effectiveness and safety of the proposed medicine to the current standard practice are highly preferred, especially studies conducted in Malaysia. Must include all relevant comparators--both formulary or non-formulary medicines--which have the same or similar indications as the proposed medicine into the budget impact analysis. Comparator can also be a non-drug therapy. |
| Time horizon | Should be five-years long for all projections in budget impact analysis. |
| Assumptions required | Yes. Should be clearly stated. |
| Preferred analytical technique | Cost-utility analysis (CUA) is strongly preferred. Cost-effectiveness analysis (CEA) may be acceptable in some circumstances. The economic analysis should be conducted from the perspective of Ministry of Health (MOH) Malaysia and can be supplemented with an analysis conducted from the societal perspective. |
| Costs to be included | Yes. Medicine and related treatment costs which are required: Price per unit (SKU), Number of dosage units per day or per cycle, Average duration of treatment in days or cycles per year, Total cost of medicine per patient per year, Additional cost per patient per year, Total annual cost per patient. |
| Source of costs | Yes. Data sources must be reported. Data sources not limited to the MOH facilities (Example: Ministry of High Education [MOHE], Ministry of Defense [MOD] or private setting). If no published data is available, estimates can be used. However, estimates need to be justified. Malaysian data should be used. If local data is not available, other sources may be used if justification is provided, sources are adequately referenced, and assumptions stated. |
| Modeling | Yes. Complete disclosure of methodology including calculation and uncertainty should be provided in a live spreadsheet of MS Excel format. Calculation should be accessible to the user and allow replication of analysis. Abbreviations or legends used in the economic model must be clearly defined. |
| Systematic review of evidences | Yes. High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias are preferred. |
| Preference for effectiveness over efficacy | Not mentioned or distinguished between the two. |
| Preferred outcome measure | Not specified, but the choice of health outcome should be justified. Preference-based outcomes can be reported only if applicable. |
| Preferred method to derive utility | Not specified, but the choice of health outcome should be justified. Preference-based outcomes can be reported only if applicable. |
| Equity issues stated | N/A |
| Discounting costs | 3% (according to Pharmacoeconomics Guidelines for Malaysia 2019) |
| Discounting outcomes | 3% (according to Pharmacoeconomics Guidelines for Malaysia 2019) |
| Sensitivity analysis-parameters and range | It should systematically examine the influence of different variables/parameters and assumptions to identify the key parameters with greatest effect on the results. Sensitivity analysis with higher and lower discount rates (for example 0% and 5%) should be conducted. (according to Pharmacoeconomics Guidelines for Malaysia 2019) |
| Sensitivity analysis-methods | Several sensitivity analysis methods can be used such as the one-way, multi-way, scenario and probabilistic sensitivity analysis. (according to Pharmacoeconomics Guidelines for Malaysia 2019) |
| Presenting results | Results should include: study parameters, incremental costs and outcomes, characterising uncertainty, characterising heterogeneity. |
| Incremental analysis | ICER (according to Pharmacoeconomics Guidelines for Malaysia 2019) |
| Total costs vs effectiveness (cost/effectiveness ratio) | ICER (according to Pharmacoeconomics Guidelines for Malaysia 2019) |
| Portability of results (Generalizability) | Yes. To be included in the discussion of the Evidence Table of the dossier. Should contain details that allow readers to appraise whether the results of the study are applicable to their settings. (according to Pharmacoeconomics Guidelines for Malaysia 2019) |
| Financial impact analysis | Yes. A full write-up (report) of budget impact analysis (BIA) must be submitted together with MS Excel live worksheet. Complete disclosure of methodology including calculation and uncertainty should be provided in a live spreadsheet of MS Excel format. Calculation should be accessible to the user and allow replication of analysis. Abbreviations or legends used in the BIA model must be clearly defined. • Malaysian data (Example: prevalence of disease states, projected market shares from the MOH perspective or payer perspective) should be used, where possible. If local data is not available, other sources may be used if justification is provided, sources are adequately referenced, and assumptions stated. • Five-year time horizon is required for all projections. • Treatment mix must include all relevant comparators, formulary or non-formulary medicines, which have same/similar indication as the proposed medicine. |
| Mandatory or recommended or voluntary | Mandatory. |
Acknowledgement:
Kah Woon Teoh, PhD Candidate, PhD in Pharmacy, Monash University Malaysia
Yee Vern Yong, MPharm, MSc (Pharmacoeconomics), Ministry of Health Malaysia