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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.
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 #EU #EU-Joint-HTA #pharma #healthcare
Cancer care is a challenge in all countries. Now imagine, how difficult it is to organize and manage cancer care in a war zone!
In this special MAP Podcast episode the Ukrainian market access expert Yevgen Brovko explains the situation and market access of cancer care before the Russian invasion and the current state in Ukraine. After a more broad overview, he also explains the Ukrainian health care system in general and explicitly in the oncology area, how new treatments are made available and the steps to launch into the Ukrainian market.
Finally, the market access expert Dr. Stefan Walzer puts the current environment into perspective.
Due to the difficulty in the energy supply in Ukraine, this episode has not been recorded in a one-to-one conversation but was recorded by Yevgen Brovko and sent for finalization to Dr. Stefan Walzer. україна переможе
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 #Ukraine #pharma #healthcare #standwithukraine
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