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Market Access Advancements and Challenges in "Drug-Companion Diagnostic Test" Co-Development in Europe.

Akhmetov I, Ramaswamy R, Akhmetov I, Thimmaraju PK - J Pers Med (2015)

Bottom Line: However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders.This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution.Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.

View Article: PubMed Central - PubMed

Affiliation: Phamax Analytics Resources Pvt. Ltd. #19, KMJ Ascend 1st Cross, 17th C Main 5th Block, Koramangala Bangalore 560 095, India. ildar.akhmetov@phamax.ch.

ABSTRACT
The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.

No MeSH data available.


Related in: MedlinePlus

This highlights key differences in reimbursement policy approaches for oncology diagnostics and therapeutics. In most of European countries, the coverage for Dx tests occurs at the local and regional levels, while Rx is primarily reimbursed at the national level (except Austria). Such discrepancy creates additional challenges for “therapy-test” producers, as they have to approach miscellaneous payers using different clinical benefit and cost-effectiveness data sets. Adapted from [2,5].
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jpm-05-00213-f003: This highlights key differences in reimbursement policy approaches for oncology diagnostics and therapeutics. In most of European countries, the coverage for Dx tests occurs at the local and regional levels, while Rx is primarily reimbursed at the national level (except Austria). Such discrepancy creates additional challenges for “therapy-test” producers, as they have to approach miscellaneous payers using different clinical benefit and cost-effectiveness data sets. Adapted from [2,5].

Mentions: The diversity in HTA systems of the EU member states is further complicated by centralized versus decentralized assessment and reimbursement processes. In most European states, coverage for prescription medicines is done at the national level, while diagnostic manufacturers have to approach local payers to win reimbursement for their companion tests (Figure 3). For example, Herceptin (tratuzumab) is commonly reimbursed in most of European member states, while its companion diagnostic test HER-2/neu is covered differently in each particular country. Thus, in the UK, Germany and Italy, the test is publicly funded, while in Spain it is a therapeutic partner who covers the expenses related to testing. In France HER-2 test was authorized in 2000, but has only been reimbursed since 2007 [31].


Market Access Advancements and Challenges in "Drug-Companion Diagnostic Test" Co-Development in Europe.

Akhmetov I, Ramaswamy R, Akhmetov I, Thimmaraju PK - J Pers Med (2015)

This highlights key differences in reimbursement policy approaches for oncology diagnostics and therapeutics. In most of European countries, the coverage for Dx tests occurs at the local and regional levels, while Rx is primarily reimbursed at the national level (except Austria). Such discrepancy creates additional challenges for “therapy-test” producers, as they have to approach miscellaneous payers using different clinical benefit and cost-effectiveness data sets. Adapted from [2,5].
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4493497&req=5

jpm-05-00213-f003: This highlights key differences in reimbursement policy approaches for oncology diagnostics and therapeutics. In most of European countries, the coverage for Dx tests occurs at the local and regional levels, while Rx is primarily reimbursed at the national level (except Austria). Such discrepancy creates additional challenges for “therapy-test” producers, as they have to approach miscellaneous payers using different clinical benefit and cost-effectiveness data sets. Adapted from [2,5].
Mentions: The diversity in HTA systems of the EU member states is further complicated by centralized versus decentralized assessment and reimbursement processes. In most European states, coverage for prescription medicines is done at the national level, while diagnostic manufacturers have to approach local payers to win reimbursement for their companion tests (Figure 3). For example, Herceptin (tratuzumab) is commonly reimbursed in most of European member states, while its companion diagnostic test HER-2/neu is covered differently in each particular country. Thus, in the UK, Germany and Italy, the test is publicly funded, while in Spain it is a therapeutic partner who covers the expenses related to testing. In France HER-2 test was authorized in 2000, but has only been reimbursed since 2007 [31].

Bottom Line: However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders.This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution.Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.

View Article: PubMed Central - PubMed

Affiliation: Phamax Analytics Resources Pvt. Ltd. #19, KMJ Ascend 1st Cross, 17th C Main 5th Block, Koramangala Bangalore 560 095, India. ildar.akhmetov@phamax.ch.

ABSTRACT
The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.

No MeSH data available.


Related in: MedlinePlus