Thursday, December 15, 2022 11:56:33 AM
To: Amarin Corporation
Re: Price & Reimbursement Negotiations with EMA-EC Countries (Specifically, Spain)
Thursday, December 15, 2022
Hello,
Considering the recent discovery that the current recommendation of the ICPM in Spain for P&R of VAZKEPA® will be for “non-inclusion” due to “budgetary” concerns, we would like to propose the following strategies for an Administrative Appeal:
Introduction:
It appears that the perception of doubt on the scientific merits of the IPE molecule that we observed in previous submittals, Germany, and the UK, for example, have finally been put to rest and replaced with “budgetary” concerns that are now endemic throughout Europe and ROW. Although we (the public) are not privy to the full report, we see no issues with “Outcome” measures.
Recommendation:
We, therefore, believe that Amarin needs to focus on the financial “cost effectiveness” argument and what the long-term CVD burden to both patients and the NHS would be when ignoring the rising incidence rate of heart disease and the economic burden associated with this rising population.
CVD Deaths and DALY’s are on the rise again from 2010-2019 according to the Global Burden of Disease Database. Data from the beginning of the COVID pandemic is not yet available. However, due to lockdowns and the unavailable access of patients to their doctors these statistics will be shocking. If not managed, CVD will be the costliest pandemic of all time.
The World Health Organization says, “the key to cardiovascular disease reduction lies in the inclusion of cardiovascular disease management interventions in universal health coverage packages.”
https://vizhub.healthdata.org/gbd-results/.
Attachments: Data Charts
CVD Deaths in Spain 2010-2019
DALY’s in Spain 2010-2019
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