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fsulevine

04/22/21 12:47 PM

#336474 RE: Birdbrain Ideas #336471

The one aspect my opinion differs is that we can sell right now to anyone that desires it and is willing to pay on their own until pricing is set for those that want the government to pay for it. Granted, that number is probably quite low. But do to the need and importance of this drug, I think negotiations will move fairly quickly, especially once and agreement is reached in Germany, most others will probably pay the same or very similar amounts.

lettruthringout

04/22/21 1:46 PM

#336494 RE: Birdbrain Ideas #336471

Shouldn't take long for sales in U.K.

What is the process for securing reimbursement for a new pharmaceutical product?

As noted above, the NHS funds treatments in a number of different ways. This means there is no single pathway to securing NHS reimbursement for a new product. Nonetheless, NICE is often considered the gatekeeper to reimbursement, because a positive recommendation for a product or treatment from NICE obliges the NHS to make funding available for it, usually within three months of the recommendation.

https://www.cov.com/-/media/files/corporate/publications/2020/08/united-kingdom.pdf

NICE’s Standard Assessment Methodology
For most conventional products, NICE will issue a positive recommendation if it assesses a product to have an ICER, usually against an existing reference, of less than £20,000. NICE may apply its discretion to recommend technologies with ICERs between £20,000 and £30,000, where justified on certain grounds, such as the innovative nature of a drug.

U.S. ICER issues positive recommendation for Vascepa

https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-additive-cardiovascular-disease-therapies/