Determining the Willingness to Pay for Innovative Oncology Medicines in Malaysia.

OBJECTIVES: Early access to innovative oncology medicine is crucial to provide better treatment alternatives to patients with cancer. However, innovative oncology medicines often come at higher prices, thus limiting the government's ability for its universal coverage. Hence an alternative paying mechanism is needed. This study is intended to determine the willingness to pay (WTP) for innovative oncology medicines among Malaysians. METHODS: A cross-sectional contingent valuation study on 571 Malaysians was conducted to elicit respondents' WTP value via bidding game approach. A double-bounded dichotomous choice was used in 3 hypothetical scenarios: innovative diabetes medicine, innovative oncology medicine one-off (IOMO), and innovative oncology medicine insurance. Univariate logistic regression was used to determine the factors affecting respondent's WTP, whereas the mean WTP value and the factors affecting amount to WTP was determined using a parametric 2-part model. RESULTS: This study received 95% response rate. The mean age of the respondents is 48 years (SD 17) with majority of the respondents female (60.3%) and from ethnic Malay (62%). About 343 (64.7%) of the respondents expressed WTP for IOMO. Those in higher income bracket were willing to pay more for the access of IOMO than the overall WTP mean value (P = .046, coefficient 351.57). CONCLUSIONS: More than half of Malaysian are willing to pay for IOMO at mean value of Malaysian Ringgit 279.10 (US dollar 66.77). Collaborative funding mechanisms and appropriate financial screening among the stakeholders could be introduced as methods to expedite the access of innovative oncology medicine among patients with cancer in Malaysia.

Carbamazepine-Induced Severe Cutaneous Adverse Drug Reactions: A 21-Year Comparison Between Children and Adults in Malaysia.

Severe cutaneous adverse drug reactions (SCARs) are a life-threatening condition. We aimed to identify all carbamazepine-induced SCARs voluntarily reported to the Malaysian pharmacovigilance database and to compare between children and adults. Adverse drug reaction reports for carbamazepine were extracted from 2000 to 2020, and divided into 2 groups, that is, children (aged 0-17 years) and adults (aged 18 years and above). Age, sex, race, and carbamazepine dose were analyzed using multiple logistic regression. Of 1102 carbamazepine adverse drug reaction reports, 416 reports were SCARs (99 children, 317 adults). Stevens-Johnson syndrome and toxic epidermal necrolysis were the main SCAR types for both age groups. Median time-to-onset for any type of SCAR was 13 days, regardless of age. In children, Malay individuals were 3.6 times more likely to report SCARs (95% confidence interval, 1.356-9.546; P = .010) compared to the Chinese population. In adults, carbamazepine-induced SCARs were reported as 3.6 times higher in those with a daily dose of 200 mg or less as compared to a daily dose of 400 mg or more. (95% confidence interval, 2.257-5.758; P < .001) Carbamazepine-induced SCARs reported in Malaysia were predominantly Stevens-Johnson syndrome or toxic epidermal necrolysis, with the majority in Malay individuals. Initiation therapy needs close monitoring between 2 weeks and 1 month.

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study.

BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

Incidence of Antiseizure Medication-Induced Severe Cutaneous Adverse Reactions in Malaysia.

Antiseizure medication can potentially cause severe cutaneous adverse reactions, and certain antiseizure medication-induced severe cutaneous adverse reactions are associated with specific human leukocyte antigen alleles. This caused a change in antiseizure medication prescribing patterns, which may influence the incidence of antiseizure medication-induced severe cutaneous adverse reactions. Thus, we aimed to determine the incidence of antiseizure medication-induced severe cutaneous adverse reactions and its change over 15 years (2006-2019) in Malaysia. This retrospective analysis combined antiseizure medication-induced SCAR cases from the national adverse drug reaction database in the National Pharmaceutical Regulatory Agency, antiseizure medication usage data from the Malaysian Statistics of Medicine, and prescribing data from University Malaya Medical Centre, a national-level tertiary hospital to calculate antiseizure medication-induced SCAR incidence in Malaysia. We observed an upward trend in reported antiseizure medication-induced SCAR cases from 28 cases in 2006 to 92 in 2016. The incidence of carbamazepine (CBZ)-induced severe cutaneous adverse reactions increased from 7.5 per 1000 person-years (2006) to 17.8 per 1000 person-years (2016) but dropped to 7.2 per 1000 person-years subsequently (2019). Concurrently, there was an increase in the incidence of severe cutaneous adverse reactions secondary to phenytoin and lamotrigine. The prevalent users of CBZ had reduced from 22.8% (2006) to 14.1% (2016), whereas the levetiracetam and sodium valproate users increased by 5.5% and 4.8%, respectively. The incidence of CBZ-induced severe cutaneous adverse reactions had reduced since 2016, probably related to the implementation of human leukocyte antigen-B*1502 screening in Malaysia or substitution of CBZ with other antiseizure medications. However, this was accompanied by an increase in SCAR incidence related to phenytoin and lamotrigine.

Incidence of allopurinol-induced severe cutaneous adverse drug reaction in Malaysia.

AIMS: Allopurinol is known to cause severe cutaneous adverse drug reactions (SCAR) in Malaysia. However, the incidence of allopurinol-induced SCAR is unknown. Therefore, we aimed to determine the incidence of allopurinol-induced SCAR in Malaysia over 5 years from 2015 to 2019. METHODS: This retrospective analysis was done in collaboration with the National Pharmaceutical Regulatory Agency (NPRA). All allopurinol-induced adverse drug reaction cases reported to NPRA from 2015 to 2019 were extracted. Allopurinol-induced SCAR cases were identified and the incidence over the 5 years was calculated. RESULTS: Incidence of allopurinol-induced SCAR averaged at 2.5 cases per 1000 new users over the 5-year period, with a reducing trend from 3.2 per 1000 new users in 2015 to 2.25 per 1000 in 2019; despite the increasing number of adverse drug reaction cases being reported over the years. Stevens-Johnson syndrome was the commonest form of allopurinol-induced SCAR reported, at 143 cases (46.8% of total SCAR reported). Among Malaysia's 3 main ethnicities, the Chinese had the highest percentages of allopurinol-induced SCAR when compared to the Bumiputera and Indians (3.18 × 10-4 %). CONCLUSION: The estimated incidence of allopurinol-induced SCAR in Malaysia from 2015 to 2019 was 2.5 cases per 1000 new users. This figure is consistent with the incidence reported in other Asian countries, namely Taiwan and Thailand.

National Drug Formulary review of statin therapeutic group using the multiattribute scoring tool.

PURPOSE: HMG-CoA reductase inhibitors (statins) are extensively used in treating hypercholesterolemia. The statins available in Malaysia include atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin, and fluvastatin. Over the years, they have accumulated in the National Drug Formulary; hence, the need for review. Effective selection of the best drugs to remain in the formulary can become complex due to the multiple drug attributes involved, and is made worse by the limited time and resources available. The multiattribute scoring tool (MAST) systematizes the evaluation of the drug attributes to facilitate the drug selection process. In this study, a MAST framework was developed to rank the statins based on their utilities or benefits. METHODS: Published literature on multicriteria decision analysis (MCDA) were studied and five sessions of expert group discussions were conducted to build the MAST framework and to review the evidence. The attributes identified and selected for analysis were efficacy (clinical efficacy, clinical endpoints), safety (drug interactions, serious side effects and documentation), drug applicability (drug strength/formulation, indications, dose frequency, side effects, food-drug interactions, and dose adjustments), and cost. The average weights assigned by the members for efficacy, safety, drug applicability and cost were 32.6%, 26.2%, 24.1%, and 17.1%, respectively. The utility values of the attributes were scored based on the published evidence or/and agreements during the group discussions. The attribute scores were added up to provide the total utility score. RESULTS: Using the MAST, the six statins under review were successfully scored and ranked. Atorvastatin scored the highest total utility score (TUS) of 84.48, followed by simvastatin (83.11). Atorvastatin and simvastatin scored consistently high, even before drug costs were included. The low scores on the side effects for atorvastatin were compensated for by the higher scores on the clinical endpoints resulting in a higher TUS for atorvastatin. Fluvastatin recorded the lowest TUS. CONCLUSION: The multiattribute scoring tool was successfully applied to organize decision variables in reviewing statins for the formulary. Based on the TUS, atorvastatin is recommended to remain in the formulary and be considered as first-line in the treatment of hypercholesterolemia.

Medication adherence in patients with type 2 diabetes mellitus treated at primary health clinics in Malaysia.

PURPOSE: Diabetes mellitus is a growing global health problem that affects patients of all ages. Even though diabetes mellitus is recognized as a major chronic illness, adherence to antidiabetic medicines has often been found to be unsatisfactory. This study was conducted to assess adherence to medications and to identify factors that are associated with nonadherence in type 2 diabetes mellitus (T2DM) patients at Primary Health Clinics of the Ministry of Health in Malaysia. MATERIALS AND METHODS: The cross-sectional survey was carried out among T2DM patients to assess adherence to medication in primary health clinics. Adherence was measured by using the Medication Compliance Questionnaire that consists of a total of seven questions. Other data, such as patient demographics, treatment, outcome, and comorbidities were also collected from patient medical records. RESULTS: A total of 557 patients were recruited in the study. Approximately 53% of patients in the study population were nonadherent. Logistic regression analysis was performed to predict the factors associated with nonadherence. Variables associated with nonadherence were age, odds ratio 0.967 (95% confidence interval [CI]: 0.948-0.986); medication knowledge, odds ratio 0.965 (95% CI: 0.946-0.984); and comorbidities, odds ratio 1.781 (95% CI: 1.064-2.981). CONCLUSION: Adherence to medication in T2DM patients in the primary health clinics was found to be poor. This is a cause of concern, because nonadherence could lead to a worsening of disease. Improving medication knowledge by paying particular attention to different age groups and patients with comorbidities could help improve adherence.

Medication adherence among hypertensive patients of primary health clinics in Malaysia.

PURPOSE: Poor adherence to prescribed medications is a major cause for treatment failure, particularly in chronic diseases such as hypertension. This study was conducted to assess adherence to medications in patients undergoing hypertensive treatment in the Primary Health Clinics of the Ministry of Health in Malaysia. Factors affecting adherence to medications were studied, and the effect of nonadherence to blood pressure control was assessed. PATIENTS AND METHODS: This was a cross-sectional study to assess adherence to medications by adult patients undergoing hypertensive treatment in primary care. Adherence was measured using a validated survey form for medication adherence consisting of seven questions. A retrospective medication record review was conducted to collect and confirm data on patients' demographics, diagnosis, treatments, and outcomes. RESULTS: Good adherence was observed in 53.4% of the 653 patients sampled. Female patients were found to be more likely to adhere to their medication regime, compared to their male counterparts (odds ratio 1.46 [95% confidence intervals [CI]: 1.05-2.04; P < 0.05]). Patients in the ethnic Chinese were twice as likely (95% CI: 1.14-3.6; P < 0.05) to adhere, compared to those in the Indian ethnic group. An increase in the score for medicine knowledge was also found to increase the odds of adherence. On the other hand, increasing the number of drugs the patient was taking and the daily dose frequencies of the medications prescribed were found to negatively affect adherence. Blood pressure control was also found to be worse in noncompliers. CONCLUSION: The medication adherence rate was found to be low among primary care hypertensive patients. A poor adherence rate was found to negatively affect blood pressure control. Developing multidisciplinary intervention programs to address the factors identified is necessary to improve adherence and, in turn, to improve blood pressure control.