Sexual abstinence behavior among never-married youths in a generalized HIV epidemic country: evidence from the 2005 Côte d'Ivoire AIDS indicator survey

Background

Sexual abstinence is the best available option for preventing both pregnancy and sexually transmitted infections, including HIV/AIDS. Identifying the factors associated with sexual abstinence among youths would have meaningful implications in a generalized HIV epidemic country such as the Côte d'Ivoire. Thus, we explored sexual abstinence behavior among never-married individuals aged 15 to 24 in Côte d'Ivoire and assessed factors that predict sexual abstinence.

Methods

We obtained data from the nationally representative and population-based 2005 Côte d'Ivoire AIDS Indicator Survey, conducted from September 2004 to October 2005. Our sample included 3041 never-married people aged 15 to 24. Of these, 990 reported never having sexual intercourse (primary abstinence) and 137 reported sexual experience but not in the 12 months prior to the survey (secondary abstinence). In all, 1127 youths reported sexual abstinence practice.

Results

Of the 3041 never-married youths, 54.4% were male and 45.6% were female. About 33.0%, 6.7%, and 37.1% of them were practicing primary, secondary, and sexual abstinence behavior, respectively. Females of higher education level were significantly 11.14 times as likely as those of no education to practice either primary or secondary abstinence. Males who were animists, had no religion, or were practicing religions other than Christianity or Muslim were significantly less likely than other male youths to practice sexual abstinence (OR = 0.53, 95% CI = 0.30–0.95). Living in the north-west region of the country significantly decreased the odds of sexual abstinence among female youths. Similarly, female youths living in rural areas were significantly 0.42 times as likely as those in the urban zones to practice sexual abstinence.

Conclusion

HIV/AIDS prevention program components could include media campaigns, educational intervention improvement, as well as promoting policies that shape female youth livelihoods. Likewise, youth involvement in initiatives to design appropriate messages, and activities to promote positive behaviors or to change negative perceptions could impact on youths' decision to exert abstinence behavior.

     

Influence of the geriatric oncology consultation on the final therapeutic decision in elderly subjects with cancer: Analysis of 191 patients

Objectives

Evaluate the impact of the Geriatric Oncology Consultation on the final therapeutic management of cancer in elderly patients aged 70 and older.

Design

Retrospective study.

Setting

The Pilot Coordination Unit in Geriatric Oncology of Côte d’Or, Burgundy, France.

Participants

From January 2010 to December 2010, 191 patients with cancer aged 70 and older.

Measurements

The concordance between the treatments proposed following the Tumor Board, those proposed following the Geriatric Evaluation (GE) and those actually given to the patients was evaluated using the Kappa agreement test.

Results

One hundred and ninety-one patients were included. Mean age was 81.5. The most frequent cancer locations were breast (31.9%), colon-rectum (14.1%) and lung (10.5%). Concordance between the cancer treatments proposed by the Tumor Board and those suggested after the GE was excellent except for chemotherapy and targeted therapy, which were recommended less frequently by the geriatrician (Kappa = 0.67), and support care, which was more often proposed after the GE (Kappa = 0.61). However, concordance between treatments proposed by the geriatrician and treatment actually given was not so good for chemotherapy (Kappa = 0.58), and surgery (Kappa = 0.61), since both were often replaced by a less aggressive treatment.

Conclusion

Concordance between the therapies proposed during the Tumor Board or after the Geriatric Oncology Consultation and the treatment actually given was satisfactory. However, the role of the oncologist remains determinant in the final choice, especially for chemotherapy.     

Orphan drugs policies: a suitable case for treatment

Context

Current orphan drug policies are unsatisfactory when viewed from almost all perspectives. Patients find that, although therapies are available for many rare conditions, access to care is sometimes restricted. Pharmaceutical manufacturers have responded to the incentives for research embodied in orphan drug legislation, only to find that funds are not made available to pay for therapies once developed. Those funding health care find that most orphan drugs do not justify funding based on standard value for money criteria, yet that they face political problems if they fail to provide funding for therapy.

Methods

A literature review was conducted in order to determine the precise nature of the problems and to suggest potential solutions.

Results

Current orphan drug policies are not fit for the purpose and initiatives need to be taken in the areas of (1) clarifying society’s views about the priority to be given to orphan drugs, (2) revising the arrangements for pricing and reimbursement of orphan drugs, (3) defining the priorities for research into rare diseases and (4) developing ‘joined up’ policies to deal with these issues.

Conclusions

Without changes in the current policies, pharmaceutical companies will eventually cease responding to the incentives to develop orphan drugs, because they will increasingly be uncertain whether the drugs, if developed, will be reimbursed.     

Firm- and Drug-Specific Patterns of Generic Drug Payments by US Medicaid Programs: 1991–2008

Background

The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA.

Objectives

Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible.

Methods

The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative ‘price’ for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement.

Results

Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement.

Conclusions

State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.     

Target patient population: how does the regulatory and reimbursement view differ? Insights from the German IQWiG

Aim

This systematic review compares European HTA-agencies (Health Technology Assessment-agencies) for the evaluation of submitted reimbursement dossiers and the acceptance of the by regulatory authorities proven indications (slicing procedure).

Subjects and methods

A Europe-wide literature search and Internet survey from 2000 to 2012 was applied. For 10 market leaders and 4 drugs which were approved in 2009 or 2010, the approved indications were compared to the indications which were eligible for reimbursement in Germany, the United Kingdom (UK) and France.

Results

A slicing procedure could be found for 5 applications (drugs) in UK and France and for 6 applications (out of 14) in Germany. Three drugs out of 16 were referred to a fixed price group. The position of the regulatory authorities remained unchanged for eight compounds. As a final result, it is obvious that indications will be cut off (slicing), market authorizations modified and comparators changed. Scientific reasons are not published.

Conclusion

Slicing (cutting off indications and populations) is well known in European HTA bodies but is applied only in a minority of submissions, which has resulted in a decrease of the population and reimbursement rate. A harmonization process between HTA agencies and regulatory authorities should be initiated.     

Impact of Delisting ARBs, Apart from Losartan, on ARB Utilisation Patterns in Denmark: Implications for Other Countries

Introduction

Renin-angiotensin inhibitor drugs have been a target for health authority initiatives across Europe with the potential for substantial savings once generic angiotensin-converting enzyme inhibitors (ACEIs) became available without compromising care. Recently, losartan was the first angiotensin receptor blocker (ARB) to lose its patent. In Denmark, the authorities removed all other ARBs from the reimbursement list, apart from losartan, as they were all seen as essentially similar for the management of hypertension or congestive heart failure at appropriate doses, but more expensive. Similarly, all other ARB fixed-dose combinations (FDCs), apart from losartan, were removed from the reimbursement list.

Objective

The aims of the study were to (i) assess the impact of these reimbursement changes on the subsequent utilisation of losartan and other ARBs alone or as FDCs; (ii) assess changes in the prices of losartan and other ARBs post-generic losartan to calculate potential savings; and (iii) compare the impact of the policies in Denmark with other European countries to provide guidance.

Methodology

This was a retrospective segmented regression analysis of an interrupted time-series design comparing utilisation patterns before and after the changes in ARB reimbursement status. Utilisation was measured in defined daily doses (DDDs). Changes in total expenditure and expenditure/DDD were also assessed over time.

Results

Losartan utilisation grew from 31 to 33 % of total single ARB utilisation before generic losartan, to 93 % by October 2011. There was a corresponding decrease in the utilisation of all other ARBs. Both changes were significant (p < 0.001). Total expenditure on single ARBs in 2011 was 77 % below 2009 levels despite a 16 % increase in utilisation. Estimated savings were 290.5 million Danish Kroner (DKK). A similar trend was seen for losartan FDCs, which was also significant (p < 0.001).

Discussion

Losartan utilisation grew appreciable following the changes. The change was much greater than seen in countries that had eased prescribing restrictions for losartan but not the other ARBs. Active therapeutic switching programmes plus education and financial incentives also significantly enhanced losartan utilisation following generics in two countries and regions; however, the increase in losartan utilisation was less than that seen in Denmark.     

Combining multicriteria decision analysis, ethics and health technology assessment: applying the EVIDEM decisionmaking framework to growth hormone for Turner syndrome patients

Objectives

To test and further develop a healthcare policy and clinical decision support framework using growth hormone (GH) for Turner syndrome (TS) as a complex case study.

Methods

The EVIDEM framework was further developed to complement the multicriteria decision analysis (MCDA) Value Matrix, that includes 15 quantifiable components of decision clustered in four domains (quality of evidence, disease, intervention and economics), with a qualitative tool including six ethical and health system-related components of decision. An extensive review of the literature was performed to develop a health technology assessment report (HTA) tailored to each component of decision, and content was validated by experts. A panel of representative stakeholders then estimated the MCDA value of GH for TS in Canada by assigning weights and scores to each MCDA component of decision and then considered the impact of non-quantifiable components of decision.

Results

Applying the framework revealed significant data gaps and the importance of aligning research questions with data needs to truly inform decision. Panelists estimated the value of GH for TS at 41% of maximum value on the MCDA scale, with good agreement at the individual level (retest value 40%; ICC: 0.687) and large variation across panelists. Main contributors to this panel specific value were "Improvement of efficacy", "Disease severity" and "Quality of evidence". Ethical considerations on utility, efficiency and fairness as well as potential misuse of GH had mixed effects on the perceived value of the treatment.

Conclusions

This framework is proposed as a pragmatic step beyond the current cost-effectiveness model, combining HTA, MCDA, values and ethics. It supports systematic consideration of all components of decision and available evidence for greater transparency. Further testing and validation is needed to build up MCDA approaches combined with pragmatic HTA in healthcare decisionmaking.     

Multi-criteria decision analysis of breast cancer control in low- and middle- income countries: development of a rating tool for policy makers

Background

The objective of this study was to develop a rating tool for policy makers to prioritize breast cancer interventions in low- and middle- income countries (LMICs), based on a simple multi-criteria decision analysis (MCDA) approach. The definition and identification of criteria play a key role in MCDA, and our rating tool could be used as part of a broader priority setting exercise in a local setting. This tool may contribute to a more transparent priority-setting process and fairer decision-making in future breast cancer policy development.

Methods

First, an expert panel (n?=?5) discussed key considerations for tool development. A literature review followed to inventory all relevant criteria and construct an initial set of criteria. A Delphi study was then performed and questionnaires used to discuss a final list of criteria with clear definitions and potential scoring scales. For this Delphi study, multiple breast cancer policy and priority-setting experts from different LMICs were selected and invited by the World Health Organization. Fifteen international experts participated in all three Delphi rounds to assess and evaluate each criterion.

Results

This study resulted in a preliminary rating tool for assessing breast cancer interventions in LMICs. The tool consists of 10 carefully crafted criteria (effectiveness, quality of the evidence, magnitude of individual health impact, acceptability, cost-effectiveness, technical complexity, affordability, safety, geographical coverage, and accessibility), with clear definitions and potential scoring scales.

Conclusions

This study describes the development of a rating tool to assess breast cancer interventions in LMICs. Our tool can offer supporting knowledge for the use or development of rating tools as part of a broader (MCDA based) priority setting exercise in local settings. Further steps for improving the tool are proposed and should lead to its useful adoption in LMICs.

     

Determinants of quality of life among long-term breast cancer survivors

Purpose

To identify the impact of clinical and socio-economic determinants on quality of life (QoL) among breast cancer (BC) survivors 5 years after diagnosis.

Methods

A cross-sectional survey was conducted in women diagnosed in 2007 for primary invasive non-metastatic BC and identified through the Côte d’Or BC registry. QoL was assessed with the Medical Outcomes Study 12-item Short Form Health Survey (SF-12), the European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) and the breast cancer (EORTC-QLQ-BR23) questionnaires. Social support was assessed with Sarason’s social support questionnaire, and deprivation was assessed by the EPICES questionnaire. Clinical variables were collected through the registry database. Determinants of QoL were identified using multivariable mixed model analysis for each SF-12 dimension. A sensitivity analysis was conducted with multiple imputations on missing data.

Results

Overall, 188 patients on 319 patients (59 %) invited to participate to the survey completed the questionnaires. Five years after breast cancer diagnosis, the disease stages at diagnosis, as well as the treatment received, were not determinants of QoL. Only the age at diagnosis and comorbidities were found to be determinants of QoL.

Conclusions

Five years after BC diagnosis, disease severity and the treatment received did not affect QoL.

     

Access to non-pecuniary benefits: does gender matter? Evidence from six low- and middle-income countries

Background

Gender issues remain a neglected area in most approaches to health workforce policy, planning and research. There is an accumulating body of evidence on gender differences in health workers' employment patterns and pay, but inequalities in access to non-pecuniary benefits between men and women have received little attention. This study investigates empirically whether gender differences can be observed in health workers' access to non-pecuniary benefits across six low- and middle-income countries.

Methods

The analysis draws on cross-nationally comparable data from health facility surveys conducted in Chad, Côte d'Ivoire, Jamaica, Mozambique, Sri Lanka and Zimbabwe. Probit regression models are used to investigate whether female and male physicians, nurses and midwives enjoy the same access to housing allowance, paid vacations, in-service training and other benefits, controlling for other individual and facility-level characteristics.

Results

While the analysis did not uncover any consistent pattern of gender imbalance in access to non-monetary benefits, some important differences were revealed. Notably, female nursing and midwifery personnel (the majority of the sample) are found significantly less likely than their male counterparts to have accessed in-service training, identified not only as an incentive to attract and retain workers but also essential for strengthening workforce quality.

Conclusion

This study sought to mainstream gender considerations by exploring and documenting sex differences in selected employment indicators across health labour markets. Strengthening the global evidence base about the extent to which gender is independently associated with health workforce performance requires improved generation and dissemination of sex-disaggregated data and research with particular attention to gender dimensions.

     

Safety of the yellow fever vaccine during the September 2001 mass vaccination campaign in Abidjan,Ivory Coast

In 2001, a vaccination campaign against yellow fever was carried out in Abidjan, Côte d’Ivoire. During the campaign and 4 weeks after an active surveillance system for adverse events following immunization (AEFI) was set up.More then 2.6 million doses were administered and 87 AEFI were notified. Eight suspected YF cases were reported after vaccination and considered as AEFI. However, none had IgM for YF and all recovered without sequels.This surveillance system provided reassuring data about the safety of the YF vaccine and proved that it is feasible to set up an active surveillance system during a mass campaign.     

Patient-reported outcomes and surgical triage: A gap in patient-centered care?

Purpose

To help address wait times for elective surgery, British Columbia has implemented a triaging system that assigns priority levels to patients based on their diagnoses. The extent to which these priority levels concords with patients’ assessment of their health status is not known. The purpose of this study was to measure the association between the priority levels assigned to patients and their patient-reported outcomes data collected at the time of being enrolled on the surgical wait list.

Methods

Patients waiting for elective surgery in the Vancouver Coastal Health Authority were sampled. Participants completed a set of generic and condition-specific patient-reported outcome instruments, including: the EQ-5D(3L) (general health), PEG (pain), and the PHQ-9 (depression). A multivariate ordered logistic model was used to regress patient-reported outcome values on the priority level assigned at the time of wait list registration.

Results

A total of 2725 participants completed the survey package (response rate 49 %). Using the EQ-5D(3L), 63 % reported having problems with pain or discomfort, 41 % problems performing usual activities, 36 % problems with depression or anxiety, 28 % problems with mobility, and 8 % a problem with self-care. The results from the ordered logistic model indicated very little association between the patient-reported outcomes and wait list priority levels, when adjusted for patient factors.

Conclusions

This study observed no relationship between patients’ self-reported health status and their assigned priority level for elective surgery. A more patient-centered approach to triaging patients for surgical treatment would incorporate patients’ perspective in surgical wait list prioritization systems.

     

Reducing uncertainty in value-based pricing using evidence development agreements

Background

Value-based pricing (VBP), whereby prices are set according to the perceived benefits offered to the consumer at a time when costs and benefits are characterized by considerable uncertainty and are then reviewed ex post, is a much discussed topic in pharmaceutical reimbursement. It is usually combined with coverage with evidence development (CED), a tool in which manufacturers are granted temporary reimbursement but are required to collect and submit additional health economic data at review. Many countries, including the UK, are signalling shifts in this direction. Several countries, including Sweden, have already adopted this approach and offer good insight into the benefits and pitfalls in actual practice.

Objective

To describe VBP reimbursement decision making using CED in actual practice in Sweden.

Methods

Decision making by The Dental and Pharmaceutical Benefits Agency (TLV) in Sweden was reviewed using a case study of continuous intraduodenal infusion of levodopa/carbidopa (Duodopa®) in the treatment of advanced Parkinson’s disease (PD) with severe motor fluctuations.

Results

The manufacturer of Duodopa® applied for reimbursement in late 2003. While the proper economic data were not included in the submission, TLV granted reimbursement until early 2005 to provide time for the manufacturer to submit a formal economic evaluation. The re-submission with economic data was considered inadequate to judge cost effectiveness, so TLV granted an additional extension of reimbursement until August 2007, at which time conclusive data were expected. The manufacturer initiated a 3-year, prospective health economic study and a formal economic model. Data from a pre-planned interim analysis of the data were loaded into the model and the cost-effectiveness ratio was the basis of the next re-submission. TLV concluded that the data were suitable for making a definite decision and that the drug was not cost effective, deciding to discontinue reimbursement for any new patients (current patients were unaffected). The manufacturer continued to collect data and to improve the economic model and re-submitted in 2008. New data and the improved model resulted in reduced uncertainty and a lower cost-effectiveness ratio in the range of Swedish kronor (SEK)430 000 per QALY gained in the base-case analysis, ranging up to SEK900 000 in the most conservative sensitivity analysis, resulting in reimbursement being granted.

Discussion

The case of Duodopa® provides excellent insight into VBP reimbursement decision making in combination with CED and ex post review in actual practice. Publicly available decisions document the rigorous, time-consuming process (four iterations were required before a final decision could be reached). The data generated as part of the risk-sharing agreement proved correct the initial decision to grant limited coverage despite lack of economic data. Access was provided to 100 patients while evidence was generated.

Conclusions

Economic appraisal differs from clinical assessment, and decision makers benefit from analysis of naturalistic, actual practice data. Despite reviewing the initial trial-based, ‘piggy-back’ economic analysis, TLV was uncertain of the cost effectiveness in actual practice and deferred a final decision until observational data from the DAPHNE study became available. Second, acceptance of economic modelling and use of temporary reimbursement conditional on additional evidence development provide a mechanism for risk sharing between TLV and manufacturers, which enabled patient access to a drug with proven clinical benefit while necessary evidence to support claims of cost effectiveness could be generated.     

Economic implications of in vitro fertilization using willingness to pay

Introduction

Fertility levels are determined by social, religious, and cultural factors on one hand, and by financial considerations that affect the demand for children as well as the supply of children on the other. Using theoretical and empirical models we examine the private and social benefit of children, and the private and social welfare differences that are generated by technological innovation in fertility technology.

Subjects and methods

A theoretical model measures the marginal private and social benefit when the children’s potential output depends on the natural potential fertility combined with medical fertility technology. It is followed by an empirical model that focuses on the evaluation of the general public’s, and in vitro fertilization patients’ “willingness to pay” for fertility treatments. The economic evaluation method is based on willingness to pay, which is derived from answers to hypothetical questions.

Results

Based on questionnaires distributed between in vitro fertilization actual patients and the general public, the empirical model’s findings are that the average willingness to pay amongst patients is $5,482, whereas for the general public it is $4,398. Both the general public as well the actual patients are willing to pay more than the actual average cost of an in vitro fertilization treatment, which is $3,257.

Conclusion

We find that when considering the appropriate allocation of limited resources, subsidizing fertilization should receive high priority since the net benefits for both patients and society are high.     

Priority to End of Life Treatments? Views of the Public in the Netherlands

Objectives

Recent debates in the Netherlands on health care priority setting have focused on the relative value of gains generated by life-extending medicines for people with a terminal illness, mostly new cancer drugs. These treatments are generally expensive, provide relatively small health gains, and therefore usually do not meet common cost per QALY thresholds. Nevertheless, these drugs may be provided under the assumption that there is public support for making a special case for treatments for people with a terminal illness. This study investigated the views of the public in the Netherlands on a range of equity and efficiency considerations relevant to priority setting and examines whether there is public support for making such a special case.

Incorporating MCDA into HTA: challenges and potential solutions,with a focus on lower income settings

Background

Multicriteria decision analysis (MCDA) has the potential to bring more structure and transparency to health technology assessment (HTA). The objective of this paper is to highlight key methodological and practical challenges facing the use of MCDA for HTA, with a particular focus on lower and middle-income countries (LMICs), and to highlight potential solutions to these challenges.

Methodological challenges

Key lessons from existing applications of MCDA to HTA are summarized, including: that the socio-technical design of the MCDA reflect the local decision problem; the criteria set properties of additive models are understood and applied; and the alternative approaches for estimating opportunity cost, and the challenges with these approaches are understood.

Practical challenges

Existing efforts to implement HTA in LMICs suggest a number of lessons that can help overcome the practical challenges facing the implementation of MCDA in LMICs, including: adapting inputs from other settings and from expert opinion; investing in technical capacity; embedding the MCDA in the decision-making process; and ensuring that the MCDA design reflects local cultural and social factors.

Conclusion

MCDA has the potential to improve decision making in LMICs. For this potential to be achieved, it is important that the lessons from existing applications of MCDA are learned.

     

Impact of Cross-Reference Pricing on Pharmaceutical Prices

Objective

Several EU countries are determining reimbursement prices of pharmaceuticals by cross-referencing prices of foreign countries. Our objective is to quantify the theoretical cross-border spill-over effects of cross-reference pricing schemes on pharmaceutical prices in the former EU-15 countries.

Methods

An analytical model was developed estimating the impact of pharmaceutical price changes in Germany on pharmaceutical prices in other countries in the former EU-15 using cross-reference pricing. We differentiated between the direct impact (from referencing to Germany directly) and the indirect impact (from referencing to other countries that conduct their own cross-reference pricing schemes).

Results

The relationship between the direct and indirect impact of a price change depends mainly on the method applied to set reimbursement prices. When applying cross-reference pricing, the reimbursement price is either determined by the lowest of foreign prices (e.g. Portugal), the average of foreign prices (e.g. Ireland) or a weighted average of foreign prices (e.g. Italy). If the respective drug is marketed in all referenced countries and prices are regularly updated, a price reduction of € 1.00 in Germany will reduce maximum reimbursement prices in the former EU-15 countries from €0.15 in Austria to €0.36 in Italy.

Discussion

On one side, the cross-border spill-over effects of price reductions are undoubtedly welcomed by decision makers and may be favourable to the healthcare system in general. On the other side, these cross-border spill-over effects also provide strong incentives for strategic product launches, launch delays and lobbying activities, and can affect the effectiveness of regulation.

Conclusions

To avoid the negative effects of cross-reference pricing, a weighted index of prices from as many countries as possible should be used to determine reimbursement prices in order to reduce the direct and indirect impact of individual countries.