NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Do you deny that autologous tumor lysate based dendritic cell vaccines (ATL-SC) are in commercial use?

I have listed 3. APCEDEN in India. The German clinic recently discussed. And the Immunocine clinic down in Mexico

IO-VAC® is not commercially available in Germany.
IMO, IO-VAC® is an approved Advanced Therapeutic Medicinal Product (ATMP) in North Rhine-Westphalia, Germany, and is applied to patients at IOZK on a compassionate use basis.

The German legislation framework of the “individueller Heilversuch” (individualized treatment) allows for this state-of-the-art type of clinical treatment of patients. Within this framework, patient and doctor together discuss all possible treatment options, design a mutually agreed-upon treatment plan, and solidify this with an informed consent.

There is no cost-coverage or reimbursement by health insurance companies. The following arguments for declining IO-VAC® treatment reimbursement were given by a German health insurance company (case 11966448):
• This treatment is an experimental application;
• Concrete studies on the combination of the chosen methods are missing;
• Efficacy can only be demonstrated through controlled clinical trials with a large number of patients. Therefore, treatment with new DC vaccines should be carried out exclusively in trials until efficacy is proven. The basic rule here is that these studies should take place in centers, and participation must be voluntary and free of charge as this is an experimental therapy in which the benefits and risks are still unknown.

Therapy costs:
- for an IO-VAC® vaccination cycle between € 23,000 and € 28,000 (At least two vaccination cycles are necessary for one treatment.)




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