Acceptability of self-administered antigen test for COVID-19 in the Philippines.

OBJECTIVES: In response to the Omicron surge in early 2022, the HTA Philippines evaluated the acceptability of Filipinos in using self-administered antigen tests (SAAgTs) as part of COVID-19 HTAs in the Philippines. METHODS: Scoping review from literature databases was initially conducted to identify preset codes in the use of SAAgT. Preset codes were used to establish the questions for focus group discussions (FGDs). Semi-structured questionnaires were created through Delphi technique. FGDs with four stakeholder groups (i.e., nine healthcare workers [HCWs], seven representatives of at-risk groups, six economic frontliners, and seven representatives of micro-small-medium-sized enterprises) were conducted. RESULTS: Discomfort in being a target of stigma and being prescribed an "illness identity" when suspected or confirmed COVID-19-positive, along with lack of confidence to perform self-test, caused hesitancy in self-testing among participants. The need for subsidies for test kits from the government or employers was emphasized to increase its accessibility. Having a designated access point and reporting system for SAAgT was highlighted to avoid nepotism (padrino system attributed to debt of gratitude), inequitable distribution, and lapses in reporting. A participatory approach to education was perceived as crucial to reduce any misconceptions associated with the use of SAAgT. CONCLUSIONS: All FGD groups expressed favorable reviews on the implementation of SAAgT because it can potentially reduce the burden of health facility-administered tests. These findings were considered by the HTA Council in the recommendation of SAAgT as part of the overarching national strategies for the diagnosis and screening of COVID-19.

Estimating the EQ-5D-5L value set for the Philippines.

BACKGROUND: The Philippines has recommended the use of Quality-Adjusted Life Years (QALYs) in government health technology assessments (HTA). We aimed to develop a value set for the EQ-5D-5L based on health preferences of the healthy general adult population in the Philippines. METHODS: Healthy, literate adults were recruited from the Philippine general population with quota targets based on age, sex, administrative region, type of residence, education, income, and ethnolinguistic groups. Each participant's preference was elicited by completing Composite Time Trade-Off (C-TTO) and Discrete Choice Experiment (DCE) tasks. Tasks were computer-assisted using the EuroQol Valuation Technology 2.0. To estimate the value set, we explored 20- and 8-parameter models that either use c-TTO-only data or both c-TTO and DCE (also called hybrid models). Final model choice was guided by principles of monotonicity, out-of-sample likelihood, model fit, and parsimony. RESULTS: We recruited 1000 respondents with demographic characteristics that approximate the general population such as 49.6% Female, 82% Roman Catholic, 40% in urban areas, and 55% finished high school. None of the 20-parameter models demonstrated monotonicity (logical worsening of coefficients with increasing severity). From the 8-parameter models, the homoscedastic TTO-only model exhibited the best fit. From this model, mobility and pain/ discomfort had the highest effect on utilities. CONCLUSION: The selected model for representing the Philippine general population preferences for EQ-5D-5L health states was an 8-parameter homoscedastic TTO-only model. This value set is recommended for use in QALY calculations in support of HTA-informed coverage decisions in the Philippines.

Factors associated with the opposition to COVID-19 vaccination certificates: A multi-country observational study from Asia.

BACKGROUND: There are ongoing calls to harmonise and increase the use of COVID-19 vaccination certificates (CVCs) in Asia. Identifying groups in Asian societies who oppose CVCs and understanding their reasons can help formulate an effective CVCs policy in the region. However, no formal studies have explored this issue in Asia. METHOD: The COVID-19 Vaccination Policy Research and Decision-Support Initiative in Asia (CORESIA) was established to address policy questions related to CVCs. An online cross-sectional survey was conducted from June to October 2021 in nine Asian countries. Multivariable logistical regression analyses were performed to identify potential opposers of CVCs. RESULTS: Six groups were identified as potential opposers of CVCs: (i) unvaccinated (Odd Ratio (OR): 2.01, 95% Confidence Interval (CI): 1.65-2.46); vaccine hesitant and those without access to COVID-19 vaccines; (ii) those not wanting existing NPIs to continue (OR: 2.97, 95% CI: 2.51-3.53); (iii) those with low level of trust in governments (OR: 1.25, 95% CI: 1.02-2.52); (iv) those without travel plans (OR: 1.58, 95% CI: 1.31-1.90); (v) those expecting no financial gains from CVCs (OR: 2.35, 95% CI: 1.98-2.78); and (vi) those disagreeing to use CVCs for employment, education, events, hospitality, and domestic travel. CONCLUSIONS: Addressing recurring public health bottlenecks such as vaccine hesitancy and equitable access, adherence to policies, public trust, and changing the narrative from 'societal-benefit' to 'personal-benefit' may be necessary and may help increase wider adoption of CVCs in Asia.

Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward.

There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.

Cost-utility analysis of adjuvant trastuzumab therapy for HER2-positive early-stage breast cancer in the Philippines.

BACKGROUND: Breast cancer is the leading malignancy among Filipino women, with about 23.50% of cases characterized by human epidermal growth factor receptor-2 (HER2) overexpression. Trastuzumab, in addition to standard chemotherapy, is currently recommended as primary treatment for HER2-positive early-stage breast cancer (EBC) in the adjuvant settings, and has been listed in the Philippine National Formulary (PNF) since 2008, but with no current evidence yet on its value for money, to date. Hence, despite several policy enablers, its accessibility remains to be limited in the Philippines. We performed an economic evaluation to assess the cost-effectiveness and budget impact of adjuvant trastuzumab therapy for HER2-positive EBC in the Philippines, using healthcare system and societal perspectives, in aid of guiding coverage decisions. METHODS: A Markov model-based cost-utility and budget impact analyses were conducted to estimate the total costs incurred and outcomes gained in using 1 year of adjuvant trastuzumab added to standard chemotherapy versus standard chemotherapy alone, over a lifetime horizon. We discounted both costs and outcomes at 3.5% per annum. Parameters were estimated using country survival data, systematic review and meta-analysis of the relative treatment effect, local and international cost data, and published utility data. Univariate and probabilistic sensitivity analyses were used to account for parameter uncertainty. RESULTS: Trastuzumab therapy was dominated with an incremental cost-effectiveness ratio (ICER) at PHP 453,505 per QALY gained from a healthcare system perspective or PHP 458,686 per QALY gained from a societal perspective, with 10% cost-effectiveness probability at the country cost-effectiveness threshold of PHP 120,000 per QALY gained. National implementation will cost an additional amount of PHP 13,909 million in year one alone, plus about PHP 2000 to 3000 million annually for the succeeding fiscal years. CONCLUSION: At its current cost, 1 year of adjuvant trastuzumab therapy compared to standard chemotherapy alone for HER2-positive EBC does not represent value for money in the Philippines. Its current cost will have to significantly lower down by one-half to achieve cost-effectiveness.

Incorporating economies of scale in the cost estimation in economic evaluation of PCV and HPV vaccination programmes in the Philippines: a game changer?

BACKGROUND: Many economic evaluations ignore economies of scale in their cost estimation, which means that cost parameters are assumed to have a linear relationship with the level of production. Economies of scale is the situation when the average total cost of producing a product decreases with increasing volume caused by reducing the variable costs due to more efficient operation. This study investigates the significance of applying the economies of scale concept: the saving in costs gained by an increased level of production in economic evaluation of pneumococcal conjugate vaccines (PCV) and human papillomavirus (HPV) vaccinations. METHODS: The fixed and variable costs of providing partial (20% coverage) and universal (100% coverage) vaccination programs in the Philippines were estimated using various methods, including costs of conducting questionnaire survey, focus-group discussion, and analysis of secondary data. Costing parameters were utilised as inputs for the two economic evaluation models for PCV and HPV. Incremental cost-effectiveness ratios (ICERs) and 5-year budget impacts with and without applying economies of scale to the costing parameters for partial and universal coverage were compared in order to determine the effect of these different costing approaches. RESULTS: The program costs of the partial coverage for the two immunisation programs were not very different when applying and not applying the economies of scale concept. Nevertheless, the program costs for universal coverage were 0.26 and 0.32 times lower when applying economies of scale compared to not applying economies of scale for the pneumococcal and human papillomavirus vaccinations, respectively. ICERs varied by up to 98% for pneumococcal vaccinations, whereas the change in ICERs in the human papillomavirus vaccination depended on both the costs of cervical cancer screening and the vaccination program. This results in a significant difference in the 5-year budget impact, accounting for 30 and 40% of reduction in the 5-year budget impact for the pneumococcal and human papillomavirus vaccination programs. CONCLUSIONS: This study demonstrated the feasibility and importance of applying economies of scale in the cost estimation in economic evaluation, which would lead to different conclusions in terms of value for money regarding the interventions, particularly with population-wide interventions such as vaccination programs. The economies of scale approach to costing is recommended for the creation of methodological guidelines for conducting economic evaluations.

A cost-utility analysis of cervical cancer screening and human papillomavirus vaccination in the Philippines.

BACKGROUND: Cervical cancer is the second leading cause of cancer cases and deaths among Filipino women because of inadequate access to screening and treatment services. This study aims to evaluate the health and economic benefits of HPV vaccination and its combination with different screening strategies to find the most optimal preventive strategy in the Philippines. METHODS: A cost-utility analysis was conducted using an existing semi-Markov model to evaluate different screening (i.e., Pap smear, visual inspection with acetic acid) and vaccination strategies against HPV infection implemented alone or as part of a combination strategy at different coverage scenarios. The model was run using country-specific epidemiologic, cost and clinical parameters from a health system perspective. Sensitivity analysis was performed for vaccine efficacy, duration of protection and costs of vaccination, screening and treatment. RESULTS: Across all coverage scenarios, VIA has been shown to be a dominant and cost-saving screening strategy with incremental cost-effectiveness ratio (ICER) ranging from dominant to Php 61,059 (1443 USD) per QALY gained. VIA can reduce cervical cancer cases and deaths by 25%. Pap smear screening was found to be not cost-effective due to its high cost in the Philippines. Adding HPV vaccination at a cost of 54 USD per vaccinated girl on top of VIA screening was found to be potentially cost-effective using a threshold of 1 GDP per capita (i.e., Php 120,000 or 2835 USD/ QALY) with the most favorable assumption of providing lifelong immunity against high-risk oncogenic HPV types 16/18. The highest incremental QALY gain was achieved with 80% coverage of the combined strategy of VIA at 35 to 45 years old done every five years following vaccination at 11 years of age with an ICER of Php 33,126 (783 USD). This strategy may result in a two-thirds reduction in cervical cancer burden. HPV vaccination is not cost-effective when vaccine protection lasts for less than 20 years. CONCLUSION: High VIA coverage targeting women aged 35-45 years old at five-year intervals is the most efficient and cost-saving strategy in reducing cervical cancer burden in the Philippines. Adding a vaccination program at high coverage among 11-year-old girls is potentially cost-effective in the Philippines assuming a life-long duration of vaccine efficacy.

Medicines management in the Philippine public sector during the response to Haiyan.

INTRODUCTION: Health service delivery in the Philippines is constantly challenged by disasters and emergencies. This descriptive study documented existing policies for medicines management in the Philippines and then assessed these in the public sector response post-Haiyan. METHOD: We used desk a review of existing laws, regulations and related issuances and a series of interviews of key informants from various national and local health agencies. RESULTS: We found that while numerous national policies covered critical aspects of medicines management, implementation post-Haiyan was problematic at all levels of the decentralized health-care system. We identified issues of quantification, warehousing, distribution, utilization monitoring and disposal. Donated medicines also added additional burden for storage and disposal, especially for expired and unwanted medicines. DISCUSSION: While the process of managing medicines during disasters did not differ greatly from non-emergency situations, the Haiyan experience highlighted the system's weaknesses. With the current gaps in implementation, as well as the logistical obstacles brought about by disasters, there is a need to have integrated mechanisms for medicines management in the Philippines. This assessment provided an important opportunity to review the medicines management policies at national and local levels.

Immunohistochemical profile, pattern of recurrence, and time to progression of non-metastatic breast cancer patients of the Department of Health-Breast Cancer Medicines Access Program

BACKGROUND: Breast cancer remains to be the leading cause of malignancy among women and survival rates vary worldwide. Molecular and immunohistochemical (NC) profiling of breast cancer has emerged to improve treatment, which led to 6 different breast cancer subtypes luminal-A, luminal-B, Her-2 enriched, basal-like, daudin low, and normal breast. Essentially, this guides clinicians as to the choice of treatment and prognostication of disease. This study evaluates the characteristics of the different IHC subtypes of breast cancer among Filipinos as to pattern of recurrence and time to progression (TIP) within their 1st 2 years of follow-up.METHODS: This is a retrospective cohort study, approved by the University of the Philippines Manila Research Ethics Board (UPMREB). Study population included breast cancer patients enrolled in the DOH-BCMAP and managed at the medical oncology clinics of the Philippine General Hospital (PGH) and Jose R. Reyes Memorial Medical Center (JRRMMC) from 1 May 2011 to 31 December 2013. Patients' demographics, disease and treatment profile were gathered from the medical charts. Patients were grouped into 12 different IHC subtypes utilizing only IHC staining results of Her2neu, ER and PR. Disease progression/ relapse and time to progression (UP) were primary outcomes analyzed and compared between subtypes using SPSS.RESULTS: There were 368 eligible patients; 50% were >50 years old, 48% postmenopausal, 34% stage IIA, and 94% had invasive ductal carcinoma. About 88% completed their chemotherapy regimen, mostly AC-T. At 1 to 2 years follow-up, 18% had disease progression, mostly distant metastasis, with HER2neu(-)/ER(-)/PR(-), HER2(+), and HER2neu(-)/ER(+)/PR(+) subtypes having the most number of disease progression. The HER2neu(-)/ER(-)/PR(-) subtype had the shortest median TTP (11 months 9sd). HER2(+) subtype had median TTP of 14±8 sd, while HER2neu(-)/ER(+)/PR(+) had median TTP at 11.6±7.41 sd. The median TTPs among the different IHC subtypes were statistically comparable. CONCLUSION: Filipinas with non-metastatic breast cancer after surgery and mainly on adjuvant chemotherapy started to develop disease progression/ relapse within the first 2 years of follow-up; 82% had no relapse. At these early years of follow-up, the median TTPs among the different breast cancer IHC subtypes who went into relapse were comparable, although HER2neu(+) regardless of ER/PR subtype tended to have more disease progression, followed by HER2neu(-)/ ER(-)/ regardless of PR subtype, and then HER2neu(-)/ ER(+)/ regardless of PR subtype. IHC resultant HER2neu(+) regardless of ER/PR and HER2neu(-)/ER(-)/PR(-/+) subtypes can serve as early prognosticators of breast cancer relapse.  

Impact of histopathological profile on disease progression of breast cancer patients during the 1st 1-2 years follow-up: Evidence from the Philippine DOH-Breast Cancer Medicine Access Program

INTRODUCTION: Current international consensus confirms that certain histopathologic factors such as tumor morphology, histologic grade and presence of lymphovascular invasion are correlated with prognosis. This retrospective cohort study evaluated the correlation between histopathologic profile and time to disease progression (UP) within the first 1-2 years follow-up of Filipino Stage I-Ill early breast cancer patients.METHODS: This is a retrospective cohort study which included breast cancer patients enrolled in the Department of Health¬Breast Cancer Medicine Access Program (DOH-BCMAP) at the medical oncology clinics of two tertiary hospitals in Manila. Clinical and histopathologic factors were gathered from patient records, and the patients were grouped according to the modified St. Gallen definition of risk categories for patients with breast cancer. Kaplan-Meier survival analysis determined the average UP as well as progression-free survival (PFS). Multivariate logistic regression determined factors contributing to disease progression.RESULTS AND CONCLUSION: Of the 326 patients enrolled in this study, 18% showed progression, with a median HP of 14 months. UP was comparable among the low-, intermediate- and high-risk groups. PFS during the 1st 1-2 years follow-up was estimated to be at 78% for the high-risk group, 83% for the intermediate-risk group, and 86% for the low-risk group. During this 1st 1-2 years follow-up, no studied factors of interest were shown to be significantly correlated with outcome among this predominantly intermediate to high risk for recurrence breast cancer patients. Follow-up of this patients up to 5 or more years would define sustained gains from the DOH-BCMAP.

The effect of DOH-PCSI patient navigation access program for breast cancer on quality of care at the Medical Oncology Clinic at the Philippine General Hospital: The 1st 6 months

INTRODUCTION: Cost has become a limiting factor for indigent breast cancer patients at the Philippine General Hospital (PGH). The Department of Health-Philippine Cancer Society Inc (DOH¬PCSI) Access Program for Breast Cancer Medicine provided free chemotherapy through a patient navigation system in PGH starting January 2012 to improve breast cancer treatment quality. This study looked into the differences of quality care in the non-metastatic setting among enrolled patients in the first 6 months compared to patients outside of the program from 2011-2012.METHODS: This retrospective cohort used follow-up rates and 19 quality care indicators linked to improved outcomes to look into quality of care among patients who were enrolled (n=58) and those who were not (n=118 for 2011 and 2012). Subgroup analyses compared patients in the program and those who were not included in the same period (n=28). Another analysis compared 2011 patients (n= 90) with those in 2012 (n=86). Z¬test for the difference of proportions was done.RESULTS: Attrition rate decreased from 62% in 2011 to 18% in 2012 (pConclusion. The DOH-PCSI Access Program for Breast Cancer Medicine program improved care among breast cancer patients in PGH, noted as early as within its first six months.