Pharmacoeconomic Guidelines: Philippines
Country/Region: Philippines
PE Guidelines
Philippine HTA Methods Guide - Methodological standards in evaluation of health technologies in the Philippines
PE Guidelines Source:
Republic of the Philippines, DOST- Health Technology Assessment
Information current as of Friday, May 24, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | PE Guidelines |
| Title and year of the document | Philippine HTA Methods Guide, First Edition, 2020 |
| Affiliation of authors | Health Technology Assessment Unit Department of Health - Philippines |
| Purpose of the document | The Philippine HTA Methods Guide is a vital document that aims to provide mandatory guidance to researchers in conducting HTA. Specifically, it endeavors to provide broad guidelines in 1) the conduct of HTA, and more specifically in assessing the clinical, economic, ethical, legal, social and health systems implications of a specific health technology, and 2) the production of standard HTA reports for healthcare decision makers and other target audiences in the health system. This HTA Methods Guide does not aim to cover in detail the specific assessment standards for each classification of health technologies but instead endeavors to provide broad guidelines in the conduct of systematic reviews and economic evaluations and the production of standard HTA reports for healthcare decision makers and other target audiences in the health system. It is expected that guidance will be issued in the future to include more technical aspects and special considerations relevant to other health technologies. |
| Standard reporting format included | Yes. The Philippines ‘reference case’ specifies the methodological standards considered by the HTA Council in making judgments on the value of health technologies to patients and the wider health system. |
| Disclosure | The researchers performing an economic evaluation should declare any conflict of interest to the Ministry of Health. A sample declaration form is available from the website Philippine HTA Methods Guide. |
| Target audience of funding/ author's interests | Researchers aiming to produce an HTA report, whether they are internal or external (e.g., conducted/commissioned independently by topic proponents) to the DOH and PhilHealth. This document also serves as a guide to the HTA Council and decision makers on the methodological standards that are required in HTA to inform their recommendations and decisions. |
| Perspective | The cost-effectiveness analysis should preferably be conducted from a publicly-funded healthcare payer perspective. |
| Indication | Approved indication |
| Target population | Population with a certain disease or health condition that may likely benefit from the introduction of the new technology. Characteristics such as age, sex, ethnicity, disease severity, comorbidities, setting (i.e., in-patient or outpatient) should be included to the extent possible, to further specify the population. |
| Subgroup analysis | Separate calculations should be performed. If applicable, results from subgroup analyses investigating the treatment effect across different subgroups of patients or trials should also be presented, especially when the results are heterogeneous. |
| Choice of comparator | Similar comparator/s used in the clinical assessment (ie, current standard of care or most widely used intervention or no comparator if this is the current practice). Comparators may be the drug/s listed in the PNF, services currently offered by PhilHealth, treatment indicated in clinical practice guidelines by professional societies, or widely accepted treatment among clinicians. Comparators may not always be alternative interventions but can be different ways of administering the same intervention, such as different regimens or treatment sequences. |
| Time horizon | The time horizon for estimating clinical and cost-effectiveness should be sufficiently long to reflect all important differences in costs or outcomes between the technologies compared. A lifetime time horizon is required when alternative technologies lead to differences in survival or benefits that persist for the remainder of a person's life. A time horizon shorter than a patient's lifetime is justified if there is no differential mortality effect between treatment options, and the differences in costs and health-related quality of life relate to a relatively short period (e.g., in the case of an acute infection which has no long-term sequelae). |
| Assumptions required | The description and assumptions of the model used should be clearly stated. Assumptions and mathematical formulas should be aligned with the overall clinical review and size of benefit resulting from the clinical assessment. All assumptions should be subjected to sensitivity analysis. All alternative costs, their sources, and any assumptions should be detailed. |
| Preferred analytical technique | Cost-Utility Analysis (CUA). A cost-effectiveness analysis (CEA) reporting benefits in terms of natural health units should be reported alongside the CUA to further characterize the clinical benefit profile of the health technology. |
| Costs to be included | For CEA, only direct healthcare costs shall be included. In estimating household financial impact, both direct healthcare and non-healthcare costs shall be included. Quantities of resources must be reported separately from their unit costs/prices. All unit prices and costs should be presented in Filipino pesos with a consistent year of analysis (which should be stated and be as close as possible to the evaluation date) by using relevant indexes. |
| Source of costs | Drug Price Reference Index (DPRI) - from DOH Pharmaceutical Division; Electronic Drug Price Monitoring System (EDPMS) and Drug Price Watch- from DOH Pharmaceutical Division; PhilHealth case rates for medical and surgical procedures - from PhilHealth; Database listing cost of catastrophic benefit packages reimbursed by PHIC - from PhilHealth; Salary Grade table of the Department of Health - from PhilHealth; UHC Medium-term Health Expenditure Program - from PhilHealth. List is not exhaustive. |
| Modeling | Yes: decision Tree, Markov, dynamic transmission mode or dynamic model. Model validation is important to see how accurately a model can make relevant predictions. |
| Systematic review of evidences | Systematic reviews with or without meta-analysis are considered the best source of evidence. A study protocol with includes a search strategy should be formulated. Databases to be used include: MEDLINE (OVID) platform, Cochrane Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), EMBASE (OVID), National Health Service Economic Evaluation Database (NHS EED), HERDIN. Data from randomized controlled trials (RCTs) are considered the ‘gold standard’ in evaluating the efficacy of drugs and other therapeutic interventions, although these may not be feasible to conduct for other health technologies. |
| Preference for effectiveness over efficacy | Health outcome must be clinically meaningful. |
| Preferred outcome measure | Preferably QALY; DALY for practical considerations. |
| Preferred method to derive utility | HRQOL from Philippine EQ-5D-5L Study from DOH Pharmaceutical Division; DALY from WHO Global Health Estimates 2016. |
| Equity issues stated | Ethical considerations should include equity and fairness of coverage decisions. Report considerations for special subgroups of patients and the general population, where applicable. The report on equity shall be organized according to PROGRESS-Plus. |
| Discounting costs | Costs occurring in the future should be discounted to the net present value at an annual base case discount rate based on computations from the Ramsey Formula. First 0 to 30 years - 7%. 31 to 75 years - 5.33%. 76+ - 3.66%. |
| Discounting outcomes | Benefits occurring in the future should be discounted to the net present value at an annual base case discount rate based on computations from the Ramsey Formula. First 0 to 30 years - 7%. 31 to 75 years - 5.33%. 76+ - 3.66%. |
| Sensitivity analysis-parameters and range | Sensitivity analysis for costs and benefits should be performed at three and ten percent (3% and 10%) applying the same rate to costs and benefits at a time. All assumptions should be subjected to sensitivity analysis. The sensitivity analysis should point out assumptions or parameters that highly affect cost estimates to provide the decision maker a better picture of the potential impact and allow the decision maker to focus on testing or deciding upon certain assumptions and parameters. |
| Sensitivity analysis-methods | Uncertainties should be explored and quantified where possible through both deterministic and probabilistic sensitivity analyses should be employed. Scenario is preferred over probabilistic analysis. The choice of sensitivity analyses approaches to deal with uncertainty should be clearly stated and a rationale provided for the choice of sensitivity analysis explored. |
| Presenting results | It is recommended that whether or not research costs are included, disaggregation of the research and non-research costs should be clearly presented. Present model results as a tornado graph after varying each parameter in a sensible range, one at a time. |
| Incremental analysis | Yes: incremental costs, outcomes and an incremental cost-effectiveness ratio (ICER). |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes. The result of the cost-effectiveness or cost-utility analysis is best summarized in the form of an incremental cost-effectiveness ratio (ICER). |
| Portability of results (Generalizability) | Yes: social, cultural, religious and other factors which affect the acceptability of the adoption, and use of the health technology in the Philippines for the general population and/or specific subgroups of the population. |
| Financial impact analysis | Yes, with at least a one-year assessment, and ideally up to 3-5 year forecasts. |
| Mandatory or recommended or voluntary | Mandatory |
Acknowledgement: