Feel a lot better now, after a deep dive with AI:
-> It is statistically impossible that NICE/NHS would fund all solid tumor fully for a high cost drug. (obviously, duh)
-> They can (and probably will) switch IFR to fully funded for GBM only. Which could potentially, after selection of patients bring in $100 million - $140 million yearly to NWBO. ~500-800 patient per year. (probably lower $ due to discount)
IFR could remain open for other solid tumour.
That process took 2 years for CAR-T, which now receive aproximately $60-$65 million per year (~230 patient). Amount of $ is probably lower due to discount.
No idea how many years it will take for NWBO to switch from IFR to fully funded (if they get MHRA approval), 2,3,4 years?
But anyway, hopefully NWBO can survive financially until then. Once this fully funded for GBM happen (if it does), then they are good.
The bulls were right, in 5-10 years this stock could actually sky rocket. (hitting a 5-10-15 billion Market Cap) Still risky though, need to survive until getting revenue/profit!!! (2-4 years?)
Some chatgpt explanations/key points, in random order:
Estimated Annual NHS Expenditure on CAR-T Therapy
While exact figures are confidential due to negotiated discounts between the NHS and pharmaceutical companies, we can estimate the annual expenditure based on available data:
• Per-Patient Cost: The list price for CAR-T therapies like Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) is approximately £280,000 to £282,000 per patient. However, the NHS pays a discounted price, the details of which are not publicly disclosed.
• Number of Patients Treated Annually: Estimates suggest that around 15–30 children with acute lymphoblastic leukaemia (ALL) and up to 200 adults with diffuse large B-cell lymphoma (DLBCL) are treated with CAR-T therapies each year in the UK. england.nhs.uk
Using these estimates, the annual expenditure can be approximated as follows:
• Children with ALL: 15–30 patients × £280,000 = £4.2 million to £8.4 millionimperialbrc.nihr.ac.uk+1Imperial blogs+1
• Adults with DLBCL: Up to 200 patients × £280,000 = £56 millionWikipedia+8Imperial blogs+8imperialbrc.nihr.ac.uk+8
Total Estimated Annual Expenditure: £60 million to £65 million
It's important to note that these figures are based on list prices and the actual expenditure is likely lower due to confidential discounts.
Maximum amount of $ NHS/NICE spend on 1 drug/treatment yearly:
(obviously high cost drug cant be in the top receivers due to low amount of patient)
-> For instance, in 2018, adalimumab was the single most expensive drug used in NHS hospitals, costing over £400 million annually for approximately 46,000 patients.
-> In the 2022–23 fiscal year, the NHS in England spent £430 million on apixaban, making it the highest-cost drug for that period.
-> Between 2012 and 2022, the NHS spent approximately £4.62 billion on adalimumab at list prices. After accounting for confidential discounts, the estimated net expenditure was about £2.72 billion ÷ 10 = 272 million.
Estimated Qualification Pool for GBM:
• 3,200 GBM cases
• If we estimate 50% of those are eligible based on age, performance status, and MGMT methylation, we get 1,600 patients.
• After considering recurrent disease and other factors (e.g., rapid progression, resectability), we might end up with a pool of around 500–800 patients/year who could potentially be eligible for Murcidencel, assuming strict clinical trial inclusion criteria are followed.
In Summary:
• Around 500–800 patients per year in the UK might be considered eligible for Murcidencel (or similar therapies), assuming it follows the pattern seen in other high-cost ATMPs for cancer treatment.
• This is a fraction of the total 3,200 GBM cases annually, which aligns with the limited patient pool for expensive treatments like CAR-T.
Potential Practical Steps:
• NICE Assessment for GBM: NICE would likely assess Murcidencel for GBM specifically, considering both cost-effectiveness and clinical outcomes in a targeted patient group.
• Specialised Commissioning by NHS England: If NICE approves it, NHS England would fund Murcidencel for GBM under its specialised commissioning routes, ensuring it is available for eligible patients.
• IFR Process for Other Solid Tumors: For other solid tumors, if the therapy is still showing promise, patients with solid tumors could apply for Murcidencel through the IFR pathway. However, due to the larger patient pool and budget concerns, it would be more limited and subject to review.
Advantages of This Approach:
• Focused Funding for GBM: The NHS would be able to justify full funding for GBM, which is a rare and aggressive cancer with limited treatment options.
• Manageable Patient Pool: Since GBM is rare, the total number of patients needing the treatment is small enough to make full funding feasible.
• Access for Other Solid Tumors via IFR: Patients with solid tumors that do not meet the targeted GBM criteria could still access the treatment on an individual basis, which would allow flexibility while keeping the costs manageable.
Summary Timeline for CAR-T Transition (2017–2019):
2017: Initial EMA approval for CAR-T (Kymriah and Yescarta).
2017–2018: IFR pathway access for individual patients.
Late 2018–Early 2019: NICE cost-effectiveness evaluations and discussions.
July 2019: NICE approval and transition to routine NHS funding for specific indications (DLBCL and ALL).
2019 onwards: Full NHS commissioning and availability.
Conclusion:
The transition from the IFR pathway to routine NHS funding for CAR-T therapies took approximately 2 years from initial approval in 2017 to full routine funding in 2019. This timeline includes the clinical evaluations, cost-effectiveness assessments, and negotiations necessary to make such a high-cost treatment available for a broader group of patient.
Why Murcidencel Have Been Listed Under IFR for All Solid Tumors?
Early-stage access: Sometimes, treatments are listed under IFR for broader indications to allow earlier access to promising therapies, while further data on effectiveness and safety is being collected. This is particularly true when the treatment is innovative and has shown some potential in early trials for multiple types of cancer.
Broader clinical trial data: If Murcidencel has shown efficacy across multiple solid tumors (not just GBM), there may be interest in capturing a wider patient population. However, this can lead to a scenario where the cost burden becomes much harder to manage.
4. The Selection Process Under IFR for All Solid Tumors:
Even though it’s listed under IFR for all solid tumors, it doesn’t mean all patients with solid tumors will receive the treatment.
Selection criteria would still be enforced, likely narrowing the eligible pool based on:
Tumor type
Previous treatments failed
Patient's performance status and overall health
Specific biomarkers that might make the treatment more effective
So, while the patient pool is large, the actual number of people treated may still be relatively low due to these selection criteria.
How This Applies to Murcidencel (CAR-T comparaison):
If Muridencel goes through a similar journey:
It could start under IFR for solid tumors while clinical evidence is being gathered, especially in its early use.
After accumulating enough real-world evidence and clinical trial data demonstrating its benefit, it could potentially transition to routine NHS funding for specific solid tumors (like GBM) or for solid tumors where the treatment shows the best efficacy and cost-effectiveness.
In Summary:
CAR-T therapies were initially available through the IFR pathway due to their high cost and limited initial evidence.
After more data became available and NICE evaluations concluded that the treatments were effective and cost-efficient for certain blood cancers, they were moved to routine funding for specific conditions.
Muridencel might follow a similar path, with initial IFR access for broader solid tumors, eventually transitioning to more targeted NHS funding for certain cancers like GBM.
Crossing fingers for that fully funded GBM patient in 2,3 4 years? 500-800 per year would be enough to keep the lights on!
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