Hi Tamar,

 

Can you send us an order for the donation and help us with the import permit?

 

Thanks!

 

Ben

 

 

Dear Greame,

Many thanks! This is really great. We’ll work with the team on logistics as needed.

 

პატივისცემით,

თამარ გაბუნია

მინისტრის მოადგილე

 

Sincerely,

Tamar Gabunia, MD, MPH

Deputy Minister

 

 

 

 

 

Dear Tamar,

 

I am sure we can supply your requested amounts of Vosevi.

 

Sean, David & Ben,

 

Please can you work with Tamar to facilitate the logistics and supply of 60 bottles of Vosevi as a donation – we will likely need an import waiver and follow the same process that we followed for the emergency supply of Vosevi earlier this year.

 

Thank you and best wishes

 

Graeme

 

 

 

Dear Greame,

 

I hope this email finds you doing well? I am writing to follow up on our communication regarding Vosevi. We are receiving the increasing number of requests from health practitioners for eligible patients. May I  kindly ask if you would be willing to consider provision of the limited amount of medicines for 15-20 patients (about 60 bottles of Vosevi)  to address immediate needs. Detailed procedures are outlined in the e-mail below.

We would be happy to follow up on logistics as needed.

I will look forward to hearing from you.

 

პატივისცემით,

თამარ გაბუნია

მინისტრის მოადგილე

 

Sincerely,

Tamar Gabunia, MD, MPH

Deputy Minister

 

 

 

 

 

Dear Greame,

 

This is to follow up on our earlier communication regarding Vosevi. As you know, we have already sent a forecast for Vosevi for 2019. In this letter, we mentioned that, According to AASLD and EASL guidelines Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) is recommended for the following patient categories:

•             Patients with ALL HCV genotypes with or without cirrhosis who failed on previous treatment with NS5A inhibitors containing regimens

•             Patients with HCV genotype 3 with or without cirrhosis who failed on previous treatment with Sofosbuvir-containing regimens (without NS5A inhibitor) or Pegylated Interferon/Ribavirin regimens

Based on the main international guidelines it remains controversial which regimen:  Sofosbuvir/Velpatasvir (Epclusa) or Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) is treatment of choice for HCV genotype 3 naïve patients with cirrhosis. 

After consultations with Prof. Stephan Zeuzeum (University of Frankfurt) and other experts, we agreed to use Sofosbuvir/Velpatasvir (Epclusa) for treatment of HCV genotype 3 naïve patients with cirrhosis.

Taking into account abovementioned the estimated number of patients requiring treatment with Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) will be around 900 patients  (2 700 bottles of Vosevi).  We may need to adjust this figure later on based on early implementation experience.

At the first stage, we will start Vosevi for already known patients (about 250 patients) with this diagnosis, so we need about 750 bottles of Vosevi, which we can receive after registering the medicine.

As mentioned earlier it is possible to import the limited amount of medicines for 15-20 patients (about 60 bottles of Vosevi)  to address immediate needs.

According to the Georgian legislation unregistered medicinal products may be imported, for non-commercial purposes in the following case:

Under particular circumstances (a natural disaster, mass injury of the population, epidemic, rare disease) for humanitarian purposes, as well as in the case of a special state interest, with the consent of the Ministry. In such cases, the purpose of the import should be clearly stated in the shipping documents.

In order to obtain the consent of the Ministry the following documents should be submitted to the Department of health and LEPL Drug Agency:

1. Application.

2. The application should be accompanied with:

a) A request from the donor's representative organization (if the donor organization is importer) and the electronic version of the list of medicines (on CD)

b) A preliminary confirmation assessment document of medicines issued by World Health Organization and/or a document confirming the registration of medicines issued by the country or interstate pharmaceutical product state regulatory authority, which are recognized by the Georgian Government and/or a document confirming the registration of medicines in the country of manufacture;

c) Distribution timetable of medicines and legal basis of importation of medicines for humanitarian purposes (an agreement, a contract or an official letter, etc.);

d) Patient leaflet of medicine;

e) A copy of the certificate of quality of medicines and/or a document certifying the medicines were manufactured in accordance with international standards, issued by the competent authority (relevant governmental body, recognized international organizations, special regulatory bodies).

On the bases of intermediate decisions by the Drug Agency and Department of Health the consent or refusal for importing unregistered medicines into Georgia will be issued by the Minister.  

If our request is acceptable, we will provide an official order for 60 Vosevi bottles in the next days.

As for the patient currently on Vosevi treatment, the course has not been completed yet. He is clinically stable and takes the drug as indicated. I’ll provide more details once available.

Many thanks and look forward to hearing from you.

With Kind Regards,

 

Tamar Gabunia, MD, MPH

Deputy Minister

Ministry of IDPs from the Occupied Territories, Labour, Health and Social Affairs

Tbilisi, Georgia

 

 

Thank you Ben for confirming the arrival in Georgia.

Tamar,

I hope you are able to arrange collection and safe delivery to the patient. Please do kindly confirm safe receipt.

 

Best wishes

 

Graeme

 

 

 

Dear Tamar,

 

Your order was confirmed on board last night and arrived at 0400hrs this morning as per below.

 

If you require anything further please do not hesitate to ask.

 

Kind Regards

Ben

 

 

Dear Tamar,

 

They have located the shipment and it is rebooked on a flight this evening LH2556 arriving at 0405am tomorrow morning, March 14th.

 

We have opened an investigation with Lufthansa to ascertain what happened, apparently they are having some technical issues, however we are not happy

that we had to be told by you our customer of this delay. We apologize unreservedly on their behalf.

 

I will send you a copy AWB soonest.

 

I wish to thank you for your kind patience and understanding.

 

Kind Regards

Ben

 

 

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