NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Since every one likes chatGPT here , i asked the question there . Here is the response (copy and pasted”

“ No, if the NHS adds a drug to the High-Cost Drugs (HCD) list, it does not guarantee approval by the MHRA or the granting of a Marketing Authorisation (MAA).

Here’s how the distinction works:

1. MHRA Approval (MAA)
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for evaluating the safety, quality, and efficacy of a drug before it can be legally marketed in the UK.
• A drug must have a valid MAA to be legally supplied outside of clinical trials (except in exceptional access schemes like named patient or compassionate use).

2. NHS HCD List
• The High-Cost Drugs list is a mechanism for funding and reimbursement within the NHS.
• A drug may be provisionally listed on the HCD list for:
• Named patient use
• Specialised commissioning
• Compassionate use
• Pre-approval access (e.g., Early Access to Medicines Scheme)

Key Point:
• Inclusion in the HCD list is often post-approval, not pre-approval, though some exceptions apply for pre-license access under EAMS or similar routes.
• The HCD list is about cost management and budgeting — it does not reflect regulatory endorsement by the MHRA.

Conclusion:

No, inclusion on the NHS HCD list does not imply or guarantee MHRA approval or the granting of an MAA. These are separate processes governed by different agencies with different criteria.

Would you like examples of drugs that were on the HCD list but did not (yet) receive MAA approval?

Yes, there are instances where drugs have been included on the NHS High-Cost Drugs (HCD) list prior to receiving a Marketing Authorisation (MA) from the Medicines and Healthcare products Regulatory Agency (MHRA). This typically occurs under specific access schemes designed to provide patients with early access to promising treatments.

Examples of Drugs on the HCD List Without MHRA Approval
1. Early Access to Medicines Scheme (EAMS):
• The EAMS allows patients with life-threatening or seriously debilitating conditions to access medicines that do not yet have an MA but have demonstrated potential benefits.
• Drugs under EAMS may be listed on the HCD list to facilitate funding and access within the NHS.
• Inclusion in EAMS does not guarantee subsequent MHRA approval, as the full assessment of safety, efficacy, and quality is still pending. ?
2. Named Patient Basis:
• In certain cases, unlicensed medicines can be prescribed for individual patients under the “named patient” provision.
• These drugs may appear on the HCD list to ensure appropriate funding and monitoring, even though they lack formal MHRA approval.
• For example, some antipsychotic medications like Agomelatine and Clozapine IM are available only through named patient requests and are not approved for general use. ? ?
3. Compassionate Use Programs:
• Pharmaceutical companies may provide unlicensed drugs free of charge for compassionate use in specific patient populations.
• These drugs can be included on the HCD list to manage their distribution and monitor outcomes, despite lacking an MA.

Key Takeaways
• Inclusion on the NHS HCD list does not equate to MHRA approval.
• Drugs may be listed to facilitate access under special schemes like EAMS, named patient basis, or compassionate use.
• These mechanisms are designed to provide early access to treatments while the formal approval process is ongoing.

If you need more detailed information on specific drugs or access schemes, feel free to ask.“