In order to commercialize a health care product in the USA, the US FDA would need to approve it. But what is the standard process and how early would a company need to be involved and maybe even get advice? Additionally, the core question remains how could US FDA requirements be aligned with potential payer needs - are there any relationships?

The #marketaccess veterans Dr. Stefan Walzer and Dr. Jamie Cross are discussing the principles as well as some very specific details. 

✏️ Take the chance to stay connected and subscribe with your favorite podcast platform: https://lnkd.in/dyTZ3yQb

MAP is the first and only bi-weekly #marketaccesspodcast provided by MArS. For more information about MArS Market Access & Pricing Strategy GmbH visit: https://lnkd.in/db8aQWf

#podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations

#pricing #drugs #medtech #usa #fda

The Inflation Reduction Act in the US will change fundamental how the US pharmaceutical industry works. 

The IRA will negotiate their own prices for Medicare and Medicaid, which will have the result, that they will not pay the same prices in the future anymore.

With Medicare the government directly funds pharmaceuticals for 65+ years old population.

With Medicaid the government fund low income and other vulnerable populations.

Given, that the private insurance sector will follow the lead of government negotiated prices, all prices will decrease.

Revenues in the US will decline, and it will be interesting to see, what that will mean economically and in terms of availability of pharmaceuticals for the US and the global market?

Please enjoy the discussion of market access veterans Dr. Stefan Walzer and Anita Burell MBA on this major change in the major market for pharmaceuticals.

#podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations

#pricing #drugs #medtech #usa #inflationreductionact #inflation #ira

The market access experts Dr. Stefan Walzer and Heather Wellam are discussing the market access process in Japan, one of the largest health care markets in the world!

In Japan not all products need to go through the full process, so an important question is, what the criteria are and what role does cost-effectiveness play in this market? What are the differences in the process between drugs and medical devices?

On top, the two experts are also discussing the opportunity to apply for price premiums in the reimbursement process. 

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 #drugs #medtech #japan