Model Registration: A Call to Action

Sampson, Chris; Wrightson, Tim

doi:10.1007/s41669-017-0019-2

Cited by 23 publications

(19 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Computer decision models serve as the analytic foundation for most health economic evaluations, the prominence of which continues to grow. Cohen et al [1], Cohen and Wong [2], and Sampson and Wrightson [3] have argued that authors should publish the decision model ‘source code’, by which we mean the model’s human-readable computer instructions or its underlying component files with formulas in the case of spreadsheet-implemented models. They explained that releasing source code would boost model credibility and allow other researchers to adapt existing computer code to answer similar and related questions, thus increasing the efficiency of health economics.…”

mentioning

confidence: 99%

Publication of Decision Model Source Code: Attitudes of Health Economics Authors

et al. 2019

View full text Add to dashboard Cite

mentioning

confidence: 99%

Publication of Decision Model Source Code: Attitudes of Health Economics Authors

et al. 2019

View full text Add to dashboard Cite

“…Even so, for sponsoremployed scientists and clinicians, they are qualified enough to participate as authors of company-sponsored research publications [8]. As proposed by Sampson and Wrightson, it could be a good strategy the creation of a registry and linked database of model-based economic evaluations [9]. Several mechanisms, such us publication bias, methodological errors, miss-interpretation of findings and fraud, might jeopardized Health Technology Assessment (HTA).…”

Section: Discussionmentioning

confidence: 99%

The use of medicines in exceptional circumstances in Spain: adding perspective to early access

Pérez-Surio

Ortíz

2018

Drugs Ther Perspect

View full text Add to dashboard Cite

The use of medicines in exceptional circumstances refers to the use of non authorized medicines, or which are used outside the authorized conditions, and includes three different situations: (a) The use of medication in research or compassionate use; (b) The use of foreign medicines (medicines unauthorized in one country but authorized in others), and; (c) Off-label use (medicines outside the authorized conditions of use, or use out of indication). In Spain we intend to govern the period between authorization and price, with standard criteria, through Therapeutic Positioning Reports. The keys to manage this situation, in our opinion, could be: (1) A restrictive interpretation of access that can be made through the Therapeutic Positioning Reports, (2) with an agreement so that the medication is paid at the price at which finally it is financed, and (3) restricting this period of time to only a few months or less (e.g. orphan medicines). Introduction Access to medicines in exceptional circumstances (compassionate use, off-label use, and foreign drugs) is a health need. Many of these non-covered pharmacological needs are given in committed clinical situations, understanding such as chronic or severely debilitating diseases or those that they place patient's life in danger, and cannot be satisfactorily addressed with one authorized and commercialized medication. The use of medicines in exceptional circumstances refers to the use of non authorized medicines, or which are used outside the authorized conditions, and includes three situations different well delimited in the Spanish Royal Decree (RD) 1015/2009 regulating the availability of medicinal products in special situations: (a) The use of medication in research or compassionate use; (b) The use of foreign medicines (medicines unauthorized in Spain but authorized in other countries, and; (c) Off-label use (medicines outside the authorized conditions of use or use out of indication). The legislation limits the use of each one of them for those exceptional circumstances in which there is no other commercial therapeutic alternative and describe two different situations for each one, the individual use or those situations in which there may be a collective use (which the legislation states, respectively, temporary use authorization, use protocol or recommendations of use). The Spanish procedure is absolutely guarantor [1], requiring for its authorization: 1) the informed consent of the patient; 2) the request of a specialist physician; 3) the conformity of the Medical Chief Director of the healthcare center; 4) the conformity of the promoter or pharmaceutical company, and, finally; 5) the authorization by the Spanish Agency of Medicines and Medical Devices.

show abstract

“…Experts agreed that transparency in decision-making is beneficial to the public and should be implemented wherever possible. The panel suggested that making mathematical models available for critique may both increase transparency and improve any given model [56]. Inclusion of stakeholder input into the evaluation process may also enhance transparency.…”

Section: Consistency and Transparency In Vaccine Decision-makingmentioning

confidence: 99%

Economic evaluation of meningococcal vaccines: considerations for the future

et al. 2019

View full text Add to dashboard Cite

In 2018, a panel of health economics and meningococcal disease experts convened to review methodologies, frameworks, and decision-making processes for economic evaluations of vaccines, with a focus on evaluation of vaccines targeting invasive meningococcal disease (IMD). The panel discussed vaccine evaluation methods across countries; IMD prevention benefits that are well quantified using current methods, not well quantified, or missing in current cost-effectiveness methodologies; and development of recommendations for future evaluation methods. Consensus was reached on a number of points and further consideration was deemed necessary for some topics. Experts agreed that the unpredictability of IMD complicates an accurate evaluation of meningococcal vaccine benefits and that vaccine cost-effectiveness evaluations should encompass indirect benefits, both for meningococcal vaccines and vaccines in general. In addition, the panel agreed that transparency in the vaccine decision-making process is beneficial and should be implemented when possible. Further discussion is required to ascertain: how enhancing consistency of frameworks for evaluating outcomes of vaccine introduction can be improved; reviews of existing tools used to capture quality of life; how indirect costs are considered within models; and whether and how the weighting of quality-adjusted life-years (QALY), application of QALY adjustment factors, or use of altered costeffectiveness thresholds should be used in the economic evaluation of vaccines.

show abstract

Model Registration: A Call to Action

Cited by 23 publications

References 29 publications

Publication of Decision Model Source Code: Attitudes of Health Economics Authors

Publication of Decision Model Source Code: Attitudes of Health Economics Authors

The use of medicines in exceptional circumstances in Spain: adding perspective to early access

Economic evaluation of meningococcal vaccines: considerations for the future

Contact Info

Product

Resources

About