EU Joint HTA will become reality for ATMPs and therapies in oncology by the end of 2024. Anyhow, methods and processes are not yet communicated and established as of March 2023. Furthermore, there are no opportunities for early consultation to plan clinical trials and/or EU joint HTA dossiers. The core question still remains for which endpoints and comparators data would need to be submitted and by when? What would happen if the EMA label changes last minute with an impact on joint HTA assessments. Furthermore, nobody yet knows how these results will be implemented by national payers. More established HTA systems such as France and Germany might only adopt (slightly), others might utilize the full report of the EU joint HTA and directly start with the price negotiations.

Many open questions which have been discussed between the reimbursement veteran Dr. Stefan Walzer and his guests on the podcast Priyanka Kiritharan and Chloe Sheppard. 

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MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy visit: marketaccess-pricingstrategy.de

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Regulatory processes might vary across the world, EMA and FDA are mostly known, but what are drivers by Health Canada? What to consider when expanding e.g. from the US into Canada with a medical device? Are there differences between US FDA and Canadian decisions for drugs? And if so, why? The reimbursement veteran Dr. Stefan Walzer and the regulatory expert for Canada, Fraidianie Sévignè, discuss and recommend steps to consider for medical device and pharmaceutical companies.

Take the chance to stay connected and subscribe with your favorite podcasting platform or directly listen on our website: https://lnkd.in/dZtyKw8B

MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy, visit: marketaccess-pricingstrategy.de

#podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations #pricing #Canada #pharma #healthcare

Companies launching oncology drugs sometimes struggle with existing reimbursement pathways and negotiations with payers, mainly in Europe, but also in other parts of the world. Evidence generation is the start of every drug development, but especially in oncology the design is important – not only that payers want to get a proof of a longer survival, but they also have further needs in their internal assessment. Enjoy the insights shared by the oncology market access veterans Dr. Stefan Walzer and Ed Schoonveld. 

Take the chance to stay connected and subscribe with your favorite podcasting platform or directly listen on our website: https://lnkd.in/dZtyKw8B

MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy visit: marketaccess-pricingstrategy.de

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In this special podcast episode Dr. Stefan Walzer jumps into the latest trends and researches around market access, reimbursement and pricing presented and discussed just beginning of November 2022 at ISPOR Europe. From 6th to 9th of November the leading European experts including Dr. Stefan Walzer have met and discussed in Vienna. Discussion topics ranged widely around market access and pricing including buckets being discussed within this episode:

1) ATMPs

2) EU joint  HTA

3) Digital Health

4) Germany / AMNOG

5) European reimbursement

Please enjoy this compressed summary and let us know your questions that we should cover in the following podcast episodes. 

Take the chance to stay connected and subscribe with your favorite podcasting platform or directly listen on our website: https://lnkd.in/dZtyKw8B

MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy visit: marketaccess-pricingstrategy.de

#podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations #pricing #germany #europe #ispor #isporeurope