Getting Reimbursed. NICE!

Who are they?

The National Institute for Health and Care Excellence (NICE) is an independent organization in England that focuses on improving healthcare quality and consistency. Established in 1999, NICE works to achieve this goal by developing various resources and recommendations.

What do they do?

Here’s a breakdown of their key functions:

• Producing evidence-based guidance: NICE creates guidelines on how to best identify, diagnose, treat, and manage patients with various conditions. These guidelines are based on thorough analysis of scientific research.
• Developing quality standards: They establish quality standards that social care providers and healthcare providers should follow. This ensures a baseline level of quality for healthcare services.
• Technology appraisals: NICE evaluates new medical technologies to determine their effectiveness and cost-efficiency for the National Health Service (NHS).

What does NWBO want?

Northwest Biotherapeutics have been having meetings with NICE, because NICE plays a critical role in determining drug reimbursement for DCVax-L within the National Health Service (NHS) in England, even if MHRA approval comes through soon. Here’s how:

• MHRA Approval: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for approving the safety and efficacy of drugs in the UK. MHRA approval is a crucial first step, but it doesn’t guarantee NHS coverage.
• NICE Appraisal: NICE conducts a separate appraisal process to assess the cost-effectiveness of a new drug for the NHS. They consider factors like:
  • Clinical effectiveness: How well does DCVax-L work compared to existing treatments?
  • Cost-effectiveness: Is the cost of DCVax-L justified by the additional benefits it provides compared to other options?
  • Budgetary impact: How will covering DCVax-L impact the NHS budget?

A positive NICE recommendation is essential for NHS reimbursement. so that doctors in the NHS can prescribe it to patients.

What have NWBO and NICE been doing?

Therefore, Northwest Biotherapeutics have had talks with NICE and …

• Presented data on DCVax-L’s clinical effectiveness: They’ll want to convince NICE that DCVax-L offers significant benefits to patients compared to current treatments.
• Demonstrated cost-effectiveness: This might involve showing that DCVax-L leads to better long-term outcomes, reducing the need for other expensive treatments.
• Negotiated pricing strategy: Finding a price point that balances profitability for Northwest Biotherapeutics with affordability for the NHS is important.

How can NWBO bring down the costs of manufactoring DCVax-l?

If Northwest Biotherapeutics successfully implements their Flaskworks Eden apparatus to automate and scale production of DCVax-L, it will significantly impact the cost of the drug and potentially influence NICE’s decision on reimbursement. Here’s how:

Potential Cost Reduction:

• Economies of scale: Larger-scale production often leads to lower per-unit costs due to efficiencies in material usage, labor, and overhead. With automation, less manpower might be required, and bulk purchasing of materials could become possible, bringing the cost down.
• Streamlined process: Automation can potentially streamline the manufacturing process, reducing waste and errors, leading to cost savings.

Impact on NICE Decision:

A lower cost for DCVax-L could make it even more attractive to NICE for reimbursement within the NHS. Here’s why:

• Improved Cost-Effectiveness: When the price comes down while the clinical effectiveness remains the same, DCVax-L becomes more cost-effective in NICE’s evaluation. This could significantly increase the chances of a positive recommendation.
• Better Budgetary Fit: A lower price tag would also mean less strain on the NHS budget, making it more likely for NICE to approve coverage.

It will also be important to consider these additional factors:

• Initial Investment: Developing and implementing the Flaskworks Eden apparatus likely requires a substantial upfront investment. NICE might consider how these costs are factored into the initial pricing of DCVax-L.
• Evidence of Cost Reduction: NICE will likely require evidence that the new production method translates to actual cost reduction for DCVax-L.

Overall, automating and scaling production with Flaskworks Eden has the potential to be a game-changer for NWBO. If they can successfully demonstrate a significant cost reduction to NICE, it could be a major step towards achieving NHS reimbursement for DCVax-L.

So where is NWBO in the process now?

March 5th. NICE published this:

Process: STA Standard

“STA” stands for Single Technology Appraisal. The STA process is a NICE procedure designed to assess the clinical and cost-effectiveness of a single health technology, usually a pharmaceutical product, medical device, or diagnostic tool. The STA process aims to provide faster guidance to the NHS by streamlining the appraisal process. This is crucial for making new, potentially life-saving treatments available to patients more quickly.

The standard STA process involves several key stages:

1. Scoping: Identifying the exact question the appraisal will answer, including which populations, diseases, and technologies will be considered.
2. Evidence submission: The manufacturer or sponsor of the technology submits evidence about its clinical and cost-effectiveness.
3. Evidence review: An independent Evidence Review Group (ERG) critiques the submitted evidence.
4. Appraisal: An Appraisal Committee, comprising clinicians, health economists, and patient representatives, reviews the evidence and ERG report to develop draft recommendations.
5. Consultation: Stakeholders, including the public, have an opportunity to comment on the draft recommendations.
6. Final guidance: The Appraisal Committee considers the consultation responses and finalizes the recommendations, which NICE then publishes.

Decision: Selected

When NICE uses terms like “selected” or “recommended,” it refers to the outcome of the appraisal process. A decision to recommend a technology means that NICE has found it to be clinically effective and cost-effective for use in the National Health Service (NHS) in England and Wales. Such decisions are crucial because they can influence patient access to treatments, healthcare practices, and funding priorities within the NHS.

A decision might be that a technology is:

• Recommended for use: Indicating it should be available for patients for whom it is deemed appropriate.
• Not recommended: Suggesting it does not offer sufficient clinical benefit relative to its cost.
• Recommended for use within a research context: Sometimes, more evidence on the technology’s effectiveness or cost-effectiveness is needed.

While we wait …

Let’s remember that british politicians through the APPGBT (The All-Party Parliamentary Group on Brain Tumours) published a report and announced it in Westminster February 28th 2023, in which they directly recommended the MHRA to approve and NICE to reimburse DCVax-L.

The wording is impossible to misinterpret, not least knowing that NWBO, was the only company involved in the APPGBT inquiry process, who had a drug that so directly “fitted” the recommendation.