Here are excerpts from my post #400276 entitled “UK and Internatioinal Expansion” as well as an addendum I put down today.
PART ONE
QUOTE
{UK and International Expansion
“KM to Michael Yee:
“FROM AN EXPANSION PERSPECTIVE, THE FOCUS IS REALLY TO DEMONSTRATE TRUE COMMERCIAL SUCCESS IN THE U.K. And we hope that, in the next two to three quarters, we will be able to share revenue from the U.K. compared to benchmarks, right, because early on just, you have to see how it compares, and then, from then on, the reimbursement of other markets, but also the international markets” [Jefferies London Healthcare Conference November 16, 2022].
On July 13, 2022 Amarin announced that NICE has issued its FINAL GUIDANCE RECOMMENDING VAZKEPA FOR REIMBURSEMENT and use across the National Health Service [NHS] in England (population 55 million) and Wales (population 3 million) at a price of £144 per 120 soft capsules [the equivalent of approximately 171 EUR or 172 USD]. Noteworthy, “Guidance” does not equate with mandatory. There is no obligation on doctors to prescribe it, but if they consider it to be in the patient’s best interest the NHS must provide it.
Amarin PRed “All local NHS FORMULARIES in England and Wales will NEED TO MAKE VAZKEPA AVAILABLE within 90 and 60 days, respectively.” This is the second step in the process of making the product available to the estimated 480,000 patients.
In Q2 2022 Earnings Conference Call, KM explained to SVB Lerink analyst Roanna Ruiz:
“As a reminder …. we hired every -- you know, our full team in the U.K., I would say, a bit ahead of time”.
“Sweden and the U.K. are in launch mode. In those two countries, once you have national reimbursement, you basically have a phase where you have to get formulary inclusion …. NHS, because they were very excited about the product, committed to have the product listed on NHS formularies within three months, which puts the official launch date for the U.K. for October”.
KM went further to point out that: “we're making every effort to ENSURE that the product will be on the formulary” ... and … THERE IS BUDGET ALLOCATED TO IT, which is the third most important step”.
He also reminded her: “when a product gets approved midyear or toward year-end, it's not that fast that they can allocate budget because of FINANCING CYCLES. So, you tend to have a bit of a slow uptake during the first few months in one year, but in the new year, then there is a budget allocated for you so that physicians know that they can freely prescribe. We're very excited about the launch in the U.K. and Sweden. We now have a full team in the U.K., incredibly talented with very significant cardiometabolic experiences at every level. So, we're very encouraged, and we look forward to share more progress on the launch over the next few quarters. Thank you, Roanna”.
Questions arise:
1. How much of a budget was allocated to VAZKEPA in the UK {England and Wales] and Sweden?
2. On January 25, 2023 Bloomberg made the following assessment: “Britain’s National Health Service needs money, and there is no spare cash to be found. It means officials are facing a brutal reality: either taxes are raised, free NHS are cut, other government departments are scraped – or Britain’s health service breaks”. How is the budget allocation for Vazkepa affected by the dire conditions facing NHS?
3. How come Amarin’s BOLD Global Leadership wasn’t aware of the British Medical Association’s [BMA] repeated views about NHS? Here is a recent review:
“The NHS is experiencing some of the most severe pressures in its 70-year history. The COVID-19 pandemic is just the tip of the iceberg - the health service has been facing years of inadequate planning and chronic under-resourcing.
“Healthcare spending has increased nearly every year since the NHS was established, because the population has grown, and more people are living longer with more complex health issues.
“However, growth in health funding over the past decade, prior to COVID-19, was below the long-term average and did not keep pace with demand.
“Although additional and necessary funding has been provided, the historic lack of funding meant the NHS was unprepared for a major health crisis like COVID-19. It will take time and investment to put the NHS back on a sustainable footing. Additional funding pledged in the Autumn 2022 Statement for the remainder of the SPENDING REVIEW PERIOD (ending 2024/25) is not enough to keep up with record inflation and demand.”
Thus, the “FINANCING CYCLES” KM referred to (above) refer to the Spending Review period that will end in 2024/2025. The question remains: when will there be a budget allocation for Vazkepa????}
PART TWO: ADDENDUM
It is thus evident that:
1. Pricing and national reimbursement decisions do not automatically imply sales. There must be budget allocations first. And this applies to France, which is presently shaken by social demands, Italy, Spain and probably ROW. As a reminder, Boris Johnson had, at the onset of the Covid19 pandemic, opted for a policy of letting old people be taken away by the disease in order to relieve the stress on the NHS system.
2. There is a huge fallacy in KM’s thinking that all European countries (and even the ROW) must align their pricing to that of the UK and Sweden. This simply cannot hold because different countries have disparate development levels and hence national incomes, budgetary constraints, per capita incomes, national economic and social policies etc. They are not monolithic. Already Germany, the richest European nation has rejected KM’s approach because he could not demonstrate that the cost of Vazkepa will be more than offset by savings in the country’s annual expenditures on cardiovascular treatments.
3. The Sarissa “Netflix” approach, already tested by the Novartis-The Medicine Company in the UK, provides an intelligent, original and pragmatic solution to the generation of revenues. It basically requires expertise in operations research with focus on marketing to develop the appropriate system and negotiating arguments – an expertise KM and his supposedly experts in international commercialization utterly lack. Only a PB can handle such a task.
