Vaccine market access pathways in the EU27 and the United Kingdom − analysis and recommendations for improvements

Laigle, Valérie; Postma, Maarten J.; Pavlovic, Mira; Cadeddu, Chiara; Beck, Ekkehard; Kapusniak, A.; Toumi, Mondher

doi:10.1016/j.vaccine.2021.07.040

Cited by 20 publications

(18 citation statements)

References 22 publications

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“…This draws attention to the first criticism of HTA in Italy: the lack of a national agency entrusted to perform HTA and issuing recommendations. Furthermore, it should be pointed out that the procurement of influenza vaccines is tender-based and commissioned to Regional Health Authorities with high heterogeneity in procured types and brands [ 70 , 71 ]. The development of special guidelines on the use of available influenza vaccines could help overcome these regional differences.…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, the regulation moves in the direction of “globalize the evidence, localize the decision” [ 73 ], laying the foundation of shared information at the European level. Shared information, together with early engagement with vaccine stakeholders and improvement of transparency of the decision-making process, was also recommended for improving vaccine market access [ 70 ]. Nevertheless, because of vaccines uniqueness, Vaccines Europe, a specialized vaccines group within the European Federation of Pharmaceutical Industries and Associations, pinpointed some aspects that should be paid attention to in performing future JCA, namely the involvement of public health and vaccines experts as well as vaccines industries in the assessment and the development of specific methodologies and processes for JCA on vaccines [ 74 ].…”

Section: Discussionmentioning

confidence: 99%

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The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment

Calabrò

Boccalini

Panatto

et al. 2022

IJERPH

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Background. The elderly, commonly defined as subjects aged ≥65 years, are among the at-risk subjects recommended for annual influenza vaccination in European countries. Currently, two new vaccines are available for this population: the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose quadrivalent influenza vaccine (hdQIV). Their multidimensional assessment might maximize the results in terms of achievable health benefits. Therefore, we carried out a Health Technology Assessment (HTA) of the aQIV by adopting a multidisciplinary policy-oriented approach to evaluate clinical, economic, organizational, and ethical implications for the Italian elderly. Methods. A HTA was conducted in 2020 to analyze influenza burden; characteristics, efficacy, and safety of aQIV and other available vaccines for the elderly; cost-effectiveness of aQIV; and related organizational and ethical implications. Comprehensive literature reviews/analyses were performed, and a transmission model was developed in order to address the above issues. Results. In Italy, the influenza burden on the elderly is high and from 77.7% to 96.1% of influenza-related deaths occur in the elderly. All available vaccines are effective and safe; however, aQIV, such as the adjuvanted trivalent influenza vaccine (aTIV), has proved more immunogenic and effective in the elderly. From the third payer’s perspective, but also from the societal one, the use of aQIV in comparison with egg-based standard QIV (eQIV) in the elderly population is cost-effective. The appropriateness of the use of available vaccines as well as citizens’ knowledge and attitudes remain a challenge for a successful vaccination campaign. Conclusions. The results of this project provide decision-makers with important evidence on the aQIV and support with scientific evidence on the appropriate use of vaccines in the elderly.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment

Calabrò

Boccalini

Panatto

et al. 2022

IJERPH

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show abstract

“…A recent study identified key features of vaccine market access pathways across the European Union (EU) and the United Kingdom. They included horizon scanning, early advice, initiation of assessment, recommendations from advisory groups for vaccine introduction and funding, final decision, National Immunization Program (NIP) inclusion, and procurement ( 25 ). Drawing on that pathway, we defined decision-making as the process of generating recommendations to include vaccines to the national immunization program and possibly reimbursed by National Immunization Technical Advisory Group (NITAG) and/or Health Technology Assessment Body (HTAB) (or equivalents); and implementation as the process of proceeding with the recommendations including resourcing, making final decisions of vaccine introduction, procurement, and sustainability.…”

Section: Introductionmentioning

confidence: 99%

“…A recent study identified key features of vaccine market access pathways across the European Union (EU) and the United Kingdom. They included horizon scanning, early advice, initiation of assessment, recommendations from advisory groups for vaccine introduction and funding, final decision, National Immunization Program (NIP) inclusion, and procurement (25). Drawing on that pathway, we defined decision-making as the process of generating recommendations to include Various published works exist that help to assess a country's readiness with regards to immunization programs; however, there are limitations in terms of target diseases, population, and transferability in different European contexts.…”

Section: Introductionmentioning

confidence: 99%

Country score tool to assess readiness and guide evidence generation of immunization programs in aging adults in Europe

Pham

Beck²,

Postma³

et al. 2023

Front. Public Health

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ObjectivesDelaying of policies for immunization of aging adults, low vaccine uptake, and the lack of supportive evidence at the national level could diminish the value in health and economics of such programs. This study aims to develop a “country score tool” to assess readiness and to facilitate evidence generation for aging adult immunization programs in Europe, and examine the comprehensiveness, relevance, acceptability, and feasibility of the tool.MethodsThe tool was developed in two phases. First, a modified Delphi process was used to construct the tool. The process included a literature review, stakeholder consultations, and a three-round Delphi study. The Delphi panel included researchers, supra-national and national decision-makers of immunization programs recruited from five countries, using snowball sampling method. The consensus was predefined at the agreement rate of 70%. Pilot testing of the tool was conducted in the Netherlands, Germany, Serbia, and Hungary involving researchers in the field of health technology assessment. After assessing the countries' readiness, researchers evaluated four features, namely comprehensiveness, relevance, acceptability, and feasibility of the tool via an online survey that included 5-scale Likert questions. The percentages of affirmative answers including “agree” and “totally agree” choices were presented.ResultsThe review identified 16 tools and frameworks that formed the first version of our tool with 14 items. Eight experts were involved in the Delphi panel. Through three Delphi rounds, four items were added, one was dropped, and all others were amended. The consensus was achieved on the tool with 17 items divided into decision-making and implementation parts. Each item has a guiding question, corresponding to explanations and rationales to inform assessment with readiness scores. Eight researchers completed the pilot testing. The tool was rated as comprehensive (75%), relevant (100%), acceptable (75%), and feasible (88%) by participants.ConclusionThrough a thorough and transparent process, a country score tool was developed helping to identify strengths, weaknesses, and evidential requirements for decision-making and implementation of immunization programs of aging adults. The tool is relevant for different European contexts and shows good comprehensiveness, acceptability, and feasibility.

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“…In most cases, inclusion of a vaccine into the NIP grants nation-wide reimbursement, facilitating adequate and equal uptake. However, studies have indicated high variability in the time to accessing new vaccines in Europe, with a range of 2 to 6 years following marketing authorization [7] . National assessments underlying immunisation policy decisions are a significant contributor to this access delay.…”

Section: Introductionmentioning

confidence: 99%

A review of the sustainability of vaccine funding across Europe and implications for post-COVID policymaking

Lawlor

Wilsdon²,

Rémy-Blanc³

et al. 2022

Health Policy

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Vaccine market access pathways in the EU27 and the United Kingdom − analysis and recommendations for improvements

Cited by 20 publications

References 22 publications

The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment

The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment

Country score tool to assess readiness and guide evidence generation of immunization programs in aging adults in Europe

A review of the sustainability of vaccine funding across Europe and implications for post-COVID policymaking

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Vaccine market access pathways in the EU27 and the United Kingdom − analysis and recommendations for improvements

Cited by 20 publications

References 22 publications

The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment

The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment

Country score tool to assess readiness and guide evidence generation of immunization programs in aging adults in Europe

A review of the sustainability of vaccine funding across Europe and implications for post-COVID policymaking

Contact Info

Product

Resources

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Vaccine market access pathways in the EU27 and the United Kingdom − analysis and recommendations for improvements