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Fulltext Quality of life in parents of autistic children: A transcultural perspective

Eapen V, Karlov L, John JR, Beneytez C, Grimes PZ, Kang YQ, et al.

Front Psychol, 2023;14:1022094.
PMID: 36910746 DOI: 10.3389/fpsyg.2023.1022094

INTRODUCTION: The concepts of health, illness, and disability as well as the perceptions of autism and quality of life (QoL) vary greatly across cultures and across time. This study sought to explore the interplay of culture on QoL and impact on parents caring for autistic children.
METHODS: We used a transcultural dataset from seven countries (Australia, Hungary, Malaysia, Romania, Singapore, Spain, and the United Kingdom) with participating parents/carers reporting on the Quality of Life in Autism (QoLA) questionnaire. The QoLA questionnaire is a validated measure of QoL for parents of autistic children, with Part A subscale measuring parental QoL and part B subscale assessing the parental impact of the child's autism spectrum disorder (ASD) symptoms or features. We used the Quade's ranked analysis of covariance to determine significant differences between the countries in relation to QoLA Part A and Part B scores while adjusting for baseline differences using covariates such as parents' gender, child's age, and gender. Additionally, a post-hoc analysis with Bonferroni correction was also conducted to examine multiple pairwise comparisons.
RESULTS AND CONCLUSION: We found that while the effect of features of ASD (Part B subscale) stayed strongly comparable between cultures, the self-reported parental QoL was most likely determined by different aspects of culture in different countries. It is concluded that while the ASD symptoms or features appear to affect parents in the same way across different countries, the parental QoL may be a culturally informed construct.
Fulltext Evidence-based public policy making for medicines across countries: findings and implications for the future

Godman B, Fadare J, Kwon HY, Dias CZ, Kurdi A, Dias Godói IP, et al.

J Comp Eff Res, 2021 Aug;10(12):1019-1052.
PMID: 34241546 DOI: 10.2217/cer-2020-0273

Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.
Fulltext Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications

Godman B, Wladysiuk M, McTaggart S, Kurdi A, Allocati E, Jakovljevic M, et al.

Biomed Res Int, 2021;2021:9996193.
PMID: 34676266 DOI: 10.1155/2021/9996193

BACKGROUND: Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology. Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel.
RESULTS: Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups.
CONCLUSIONS: There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed.
Fulltext Corrigendum to "Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications"

Godman B, Wladysiuk M, McTaggart S, Kurdi A, Allocati E, Jakovljevic M, et al.

Biomed Res Int, 2023;2023:9757348.
PMID: 37065720 DOI: 10.1155/2023/9757348

[This corrects the article DOI: 10.1155/2021/9996193.].
Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

Godman B, Hill A, Simoens S, Selke G, Selke Krulichová I, Zampirolli Dias C, et al.

Expert Rev Pharmacoecon Outcomes Res, 2021 Aug;21(4):527-540.
PMID: 33535841 DOI: 10.1080/14737167.2021.1884546

Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems.Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines.Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments.
Fixed dose drug combinations - are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries

Godman B, McCabe H, D Leong T, Mueller D, Martin AP, Hoxha I, et al.

Expert Rev Pharmacoecon Outcomes Res, 2020 Apr 01.
PMID: 32237953 DOI: 10.1080/14737167.2020.1734456

Introduction: There are positive aspects regarding the prescribing of fixed dose combinations (FDCs) versus prescribing the medicines separately. However, these have to be balanced against concerns including increased costs and their irrationality in some cases. Consequently, there is a need to review their value among lower- and middle-income countries (LMICs) which have the greatest prevalence of both infectious and noninfectious diseases and issues of affordability.Areas covered: Review of potential advantages, disadvantages, cost-effectiveness, and availability of FDCs in high priority disease areas in LMICs and possible initiatives to enhance the prescribing of valued FDCs and limit their use where there are concerns with their value.Expert commentary: FDCs are valued across LMICs. Advantages include potentially improved response rates, reduced adverse reactions, increased adherence rates, and reduced costs. Concerns include increased chances of drug:drug interactions, reduced effectiveness, potential for imprecise diagnoses and higher unjustified prices. Overall certain FDCs including those for malaria, tuberculosis, and hypertension are valued and listed in the country's essential medicine lists, with initiatives needed to enhance their prescribing where currently low prescribing rates. Proposed initiatives include robust clinical and economic data to address the current paucity of pharmacoeconomic data. Irrational FDCs persists in some countries which are being addressed.
Fulltext The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future

Godman B, Haque M, Leong T, Allocati E, Kumar S, Islam S, et al.

Front Public Health, 2021;9:671961.
PMID: 34249838 DOI: 10.3389/fpubh.2021.671961

Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers. Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders. Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries. Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production. Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities.