Health technology assessment (HTA) in England, France and Germany: what do matched drug pairs tell us about recommendations by national HTA agencies?

Schaefer, R.; Hernández, Diego; Selberg, Lorenz; Schlander, Michael

doi:10.2217/cer-2021-0047

Cited by 7 publications

(3 citation statements)

References 29 publications

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“…All ATMPs in this study were being reimbursed in Germany ( Schaefer et al, 2021 ), except for 2 (i.e., ATMP9 and ATMP13), which had been taken off the market by the company ( Qiu et al, 2022 ). In the German market, all new therapies used to be reimbursed at a price freely set by the company during the first year, after which manufacturers negotiate the price of their product with the social insurance providers ( Epstein and Espín, 2020 ).…”

Section: Resultsmentioning

confidence: 99%

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Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries

Rejon-Parrilla,

Espin,

Garner

et al. 2023

Front. Pharmacol.

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Introduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers. While there are many theoretical papers on pricing and reimbursement (P&R) options, original empirical research is very scarce. This paper aims to provide a comprehensive international review of regulatory and P&R decisions taken for all ATMPs with centralized European marketing authorization in March 2022.Methods: A survey was distributed in July 2022 to representatives of 46 countries.Results: Responses were received from 20 countries out of 46 (43.5%). 14 countries reimbursed at least one ATMP. Six countries in this survey reimbursed no ATMPs.Conclusion: Access to ATMPs is uneven across the countries included in this study. This arises from regulatory differences, commercial decisions by marketing authorization holders, and the divergent assessment processes and criteria applied by payers. Moving towards greater equality of access will require cooperation between countries and stakeholders, for example, through the WHO Regional Office for Europe’s Access to Novel Medicines Platform.

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Section: Resultsmentioning

confidence: 99%

“…The law makes an exception for orphan drugs. Added benefit is “assumed” for orphan drugs as soon as they get European central MA if the total expenditure is less than €50 million per year ( Schaefer et al, 2021 ). Hence in these cases the drugs are reimbursed at premium prices.…”

Section: Resultsmentioning

confidence: 99%

Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries

Rejon-Parrilla,

Espin,

Garner

et al. 2023

Front. Pharmacol.

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“…Alternatively, if a marginal benefit for a particular approach is seen, a meta-analysis might help to elucidate the next steps ( 10 ). In addition, Health Technology Assessments (HTA) by national agencies may provide additional information on the potential risks and benefits of adopting new standards of care ( 11 ). In the setting of perioperative NSCLC, the need for an expert consensus is arising from the pace of the above-mentioned pivotal trials, the impact on current clinical diagnostic and therapeutic pathways, and the use of short-term or surrogate outcomes of benefit and often inconsistent biomarkers in some of these studies.…”

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confidence: 99%

From expert recommendations to multidisciplinary team decisions: a way to set out the novel perioperative options for patients with non-small-cell lung cancer

Banna¹,

Naidoo²,

Addeo³

2022

Transl Lung Cancer Res

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How can health technology assessment be improved to optimise access to medicines? Results from a Delphi study in Europe

Fontrier,

Kamphuis,

Kanavos

2023

Eur J Health Econ

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Introduction Access to medicines is a shared goal across healthcare stakeholders. Since health technology assessment (HTA) informs funding decisions, it shapes access to medicines. Despite its wide implementation, significant access variations due to HTA are observed across Europe. This paper elicited the opinions of European stakeholders on how HTA can be improved to facilitate access. Methods A scoping review identified HTA features that influence access to medicines within markets and areas for improvement, while three access dimensions were identified (availability, affordability, timeliness). Using the Delphi method, we elicited the opinions of European stakeholders to validate the literature findings. Results Nineteen participants from 14 countries participated in the Delphi panel. Thirteen HTA features that could be improved to optimise access to medicines in Europe were identified. Of these, 11 recorded a positive impact on at least one of the three access dimensions. HTA features had mostly a positive impact on timeliness and a less clear impact on affordability. ‘Early scientific advice’ and ‘clarity in evidentiary requirements’ showed a positive impact on all access dimensions. 'Established ways to deal with uncertainty during HTA’ could improve medicines’ availability and timeliness, while more ‘reliance on real-world evidence’ could expedite time to market access. Conclusions Our results reiterate that increased transparency during HTA and the decision-making processes is essential; the use of and reliance on new evidence generation such as real-world evidence can optimise the availability of medicines; and better collaborations between regulatory institutions within and between countries are paramount for better access to medicines.

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Health technology assessment (HTA) in England, France and Germany: what do matched drug pairs tell us about recommendations by national HTA agencies?

Cited by 7 publications

References 29 publications

Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries

Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries

From expert recommendations to multidisciplinary team decisions: a way to set out the novel perioperative options for patients with non-small-cell lung cancer

How can health technology assessment be improved to optimise access to medicines? Results from a Delphi study in Europe

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