Subject: RE: Georgia HCV Program -Harvoni
From: Sean Barr <[email-masked]>
To: Tamar Gabunia <[email-masked]>, Graeme Robertson <[email-masked]>, Ben Kamarck <[email-masked]>
Cc: Ben Dunne <[email-masked]>, Mariana Miele <[email-masked]>, Ekaterine Adamia <[email-masked]>, David Novoa <[email-masked]>
Date: Fri, 20 Sep 2019 17:02:52 +0000

Dear Tamar,

Thank you for sharing the forecast.  Out of the 68,000 - 70,000 bottles of Epclusa needed in 2020, can you let us know when the next shipment will be needed and the preferred quantity so we can lock in the near term production schedule?  Keep in mind the average lot size is 11k.

And just to confirm, the Harvoni shipment planned for Q4 (5,000 bottles), will be the last Harvoni shipment, correct?  Or is there a small possibility that additional Harvoni units will be needed in 2020?

Thank you,
Sean

-----Original Message-----
From: Tamar Gabunia [mailto:[email-masked]] 
Sent: Wednesday, September 11, 2019 9:51 AM
To: Sean Barr; Graeme Robertson; Ben Kamarck
Cc: Ben Dunne; Mariana Miele; Ekaterine Adamia; David Novoa
Subject: [EXTERNAL] RE: Georgia HCV Program -Harvoni

Dear Sean

Based on recent consultations with the National Program please find below estimated needs by the end of 2019 and in 2020. 

From the beginning of the HCV program implementation, more then 60 000 HCV patients have already started treatment and more than 55 000 completed treatment. 
As you know, at this stage, we have patients on both treatment regimens, with Epclusa and with Harvoni; Monthly registration in the program is more or less stable, about 1000 -1100 patient (about 54% of patients are on treatment with Epclusa regimens and 46% on Harvoni regimens). The number of patients enrolled on Harvoni treatment is around 470-500 monthly. We think we will maintain the current enrolment on Harvoni in the coming months. With this picture of the inflow, the required amount of Harvoni for current and new patients (which will be included in the program by the end of 2019) is about 5000 bottles. This amount of Harvoni was order on August 6th. 

Regarding the forecast for 2020, in consultation with US CDC the program experts decided to switch to Epclusa schemes. As, you already know, starting from August 1, the government fully covers cost for all tests including genotyping and treatment monitoring. This should result in greater enrollment in the coming months. It is expected that the flow will increase from 1100 to 1800-2000 patients per month. Out of them about 90% will be on 12-week regimens and 10% on 24-week treatment regimens. To provide medicines for this group of patients, we will need about 68 000-70 000 bottle Epclusa, by the end of the year 2020. We understend this will be delivered via several orders throughout the year.  
We'll get back to you regarding Vosevi-would be good to discuss this when you or other Gilead colleagues are in Tbilisi. 
We would be happy to provide additional information or clarify as needed. 

პატივისცემით,
თამარ გაბუნია
მინისტრის მოადგილე

Sincerely,
Tamar Gabunia, MD, MPH
Deputy Minister

-----Original Message-----
From: Sean Barr [mailto:[email-masked]]
Sent: 10 September, 2019 04:49
To: Tamar Gabunia <[email-masked]>; Graeme Robertson <[email-masked]>; Ben Kamarck <[email-masked]>
Cc: Ben Dunne <[email-masked]>; Mariana Miele <[email-masked]>; Ekaterine Adamia <[email-masked]>; David Novoa <[email-masked]>
Subject: RE: Georgia HCV Program -Harvoni

Dear Tamar,

We're planning our long term Epclusa production this week.  Is your 2020 forecast ready?  How much do you expect to order and when?  Do you think you can let us know this week?

Thank you,
sean

-----Original Message-----
From: Tamar Gabunia [mailto:[email-masked]]
Sent: Friday, August 09, 2019 9:34 PM
To: Graeme Robertson; Ben Kamarck; Sean Barr
Cc: Ben Dunne; Mariana Miele; Ekaterine Adamia
Subject: [EXTERNAL] RE: Georgia HCV Program -Harvoni

Dear Greame
Many thanks for your e-mail. Sure, will prepare the 2020 forecast and submit it by August 23rd, latest. Would this fit with your planning schedule? 
With kindest regards

პატივისცემით,
თამარ გაბუნია
მინისტრის მოადგილე

Sincerely,
Tamar Gabunia, MD, MPH
Deputy Minister

-----Original Message-----
From: Graeme Robertson [mailto:[email-masked]]
Sent: 9 August, 2019 20:16
To: Tamar Gabunia <[email-masked]>; Ben Kamarck <[email-masked]>; Sean Barr <[email-masked]>
Cc: Ben Dunne <[email-masked]>; Mariana Miele <[email-masked]>; Ekaterine Adamia <[email-masked]>
Subject: RE: Georgia HCV Program -Harvoni

Dear Tamar,

Would you be able to supply a further forecast for 2020 and the months you would like to have product delivered: Harvoni/Epclusa/Vosevi We need this 2020 forecast quite urgently to put in our plans Thank you and best wishes

Graeme

Graeme.A Robertson
Executive Director,  Africa & CIS
Access Operations & Emerging Markets

--------------------------------------------------------------------------------------------------------------------------------------------------
Gilead Sciences Europe Ltd • Registered as a limited company in England and Wales • Registered number 05510315 Registered office: South Building • 2 Roundwood Avenue • Stockley Park • Uxbridge • UB11 1AZ • England
Telephone: +44(0)208 587 2228 • Mobile: +44(0)7789 268 043 • Fax: +44(0)208 744 6773

-----Original Message-----
From: Tamar Gabunia <[email-masked]>
Sent: 09 August 2019 16:40
To: Ben Kamarck <[email-masked]>; Sean Barr <[email-masked]>
Cc: Ben Dunne <[email-masked]>; Mariana Miele <[email-masked]>; Graeme Robertson <[email-masked]>; Ekaterine Adamia <[email-masked]>
Subject: [EXTERNAL] RE: Georgia HCV Program -Harvoni

Dear Ben,
Many thanks for your reply. Attached is the forecast for the Georgia program provided on June 6th. Based on the latest consumption analysis for Harvoni the needed amount for October-December in 5000 bottles as reflected in the order.
The National Program uses Harvoni containing regimens for treating genotype 1 virus, Epclusa has been used of genotypes 2 and 3. As of now, no decision has yet been made by the scientific committee on switching to exclusively Epclusa regimens. This has been briefly explored at the latest conference call with CDC colleagues a couple of weeks ago, however it will take some time and expert discussion before this is endorsed by the program. We can certainly discuss this during your visit to Tbilisi late September.
Just a quick note on very recent amendments in the Hep C elimination program -starting from August 1st, the government fully covers cost for all tests including genotyping and treatment monitoring. This should result in greater enrollment in the coming months.
Would be happy to address additional questions as needed.
With kind regards
Tamar

-----Original Message-----
From: Ben Kamarck [mailto:[email-masked]]
Sent: 7 August, 2019 05:26
To: Sean Barr <[email-masked]>; Tamar Gabunia <[email-masked]>
Cc: Ben Dunne <[email-masked]>; Mariana Miele <[email-masked]>; Graeme Robertson <[email-masked]>
Subject: Re: Georgia HCV Program -Harvoni

Hi Tamar,

Do you mind sending me your forecast for the Georgia program?

I’m surprised that you’re making another order for Harvoni. I had thought you were making a full switch to Epclusa. It would be helpful for me to understand which products you’ll be needing so that we can ensure we are ready.

Also, I will be in Tbilisi the last week of September. It would be great if we could meet then and discuss.

Thanks!

Ben

From: Tamar Gabunia [mailto:[email-masked]]
Sent: 06 August 2019 06:24
To: Ben Dunne; David Novoa; Sean Barr; Sopo Belkania
Cc: Graeme Robertson; [email-masked]<mailto:[email-masked]>; Michael Clancy; Ekaterine Adamia
Subject: [EXTERNAL] RE: Georgia HCV Program -Harvoni

Dear Ben
I hope all is well with you. With this I would like to place the Harvoni order ( on 5000 bottles). Should you have any questions or require clarification please kindly let me know.

პატივისცემით,
თამარ გაბუნია
მინისტრის მოადგილე

Sincerely,
Tamar Gabunia, MD, MPH
Deputy Minister

From: Ben Dunne [mailto:[email-masked]]
Sent: Tuesday, June 25, 2019 1:23 PM
To: Tamar Gabunia <[email-masked]<mailto:[email-masked]>>; David Novoa <[email-masked]<mailto:[email-masked]>>; Sean Barr <[email-masked]<mailto:[email-masked]>>; Sopo Belkania <[email-masked]<mailto:[email-masked]>>
Cc: Graeme Robertson <[email-masked]<mailto:[email-masked]>>; [email-masked]<mailto:[email-masked]>; Michael Clancy <[email-masked]<mailto:[email-masked]>>; Ekaterine Adamia <[email-masked]<mailto:[email-masked]>>
Subject: RE: Georgia HCV Program -Epclusa

Hi Tamar,

We have approx. 7200 units in stock. Would a partial shipment of 7200 units this week suffice and we can ship the balance next week?

Ive just heard there is a small delay on the line running the balance of approx. 2800 units.

Thanks
Ben

From: Tamar Gabunia [mailto:[email-masked]]
Sent: 25 June 2019 10:20
To: Ben Dunne; David Novoa; Sean Barr; Sopo Belkania
Cc: Graeme Robertson; [email-masked]<mailto:[email-masked]>; Michael Clancy; Ekaterine Adamia
Subject: [EXTERNAL] RE: Georgia HCV Program -Epclusa

Dear Ben
Many thanks for your prompt reply. Much appreciated!

პატივისცემით,
თამარ გაბუნია
მინისტრის მოადგილე

Sincerely,
Tamar Gabunia, MD, MPH
Deputy Minister

From: Ben Dunne [mailto:[email-masked]]
Sent: 25 June, 2019 13:18
To: Tamar Gabunia <[email-masked]<mailto:[email-masked]>>; David Novoa <[email-masked]<mailto:[email-masked]>>; Sean Barr <[email-masked]<mailto:[email-masked]>>; Sopo Belkania <[email-masked]<mailto:[email-masked]>>
Cc: Graeme Robertson <[email-masked]<mailto:[email-masked]>>; [email-masked]<mailto:[email-masked]>; Michael Clancy <[email-masked]<mailto:[email-masked]>>; Ekaterine Adamia <[email-masked]<mailto:[email-masked]>>
Subject: RE: Georgia HCV Program -Epclusa

Hello Tamar,

We are planning to dispatch on Friday (we are expecting the balance of stock from our manufacturing site tomorrow), i have requested flight details and will forward them to you later today.

Best Regards
Ben

From: Tamar Gabunia [mailto:[email-masked]]
Sent: 25 June 2019 06:48
To: David Novoa; Sean Barr; Sopo Belkania
Cc: Graeme Robertson; [email-masked]<mailto:[email-masked]>; Michael Clancy; Ben Dunne; Ekaterine Adamia
Subject: [EXTERNAL] Georgia HCV Program -Epclusa
Importance: High

Dear David

I am writing back regarding the Epclusa order status. May I kindly ask what’s an estimated delivery date to Georgia? Our current stock of the drug is really low and we need to plan carefully before drugs arrive.
Many thanks for your understanding and cooperation.

პატივისცემით,
თამარ გაბუნია
მინისტრის მოადგილე

Sincerely,
Tamar Gabunia, MD, MPH
Deputy Minister

From: David Novoa [mailto:[email-masked]]
Sent: 8 June, 2019 04:57
To: Tamar Gabunia <[email-masked]<mailto:[email-masked]>>; Sean Barr <[email-masked]<mailto:[email-masked]>>; Sopo Belkania <[email-masked]<mailto:[email-masked]>>
Cc: Graeme Robertson <[email-masked]<mailto:[email-masked]>>; David Sergeenko <[email-masked]<mailto:[email-masked]>>; [email-masked]<mailto:[email-masked]>; Michael Clancy <[email-masked]<mailto:[email-masked]>>; Ben Dunne <[email-masked]<mailto:[email-masked]>>; Ekaterine Adamia <[email-masked]<mailto:[email-masked]>>
Subject: RE: Georgia HCV Program - Harvoni

Dear Tamar,

This is excellent news.
We will check the status of Epclusa and get back to you.

Have a great weekend,
David

From: Tamar Gabunia [mailto:[email-masked]]
Sent: Friday, June 07, 2019 8:55 AM
To: David Novoa; Sean Barr; Sopo Belkania
Cc: Graeme Robertson; David Sergeenko; [email-masked]<mailto:[email-masked]>; Michael Clancy; Ben Dunne; Ekaterine Adamia
Subject: [EXTERNAL] RE: Georgia HCV Program - Harvoni

Dear David,
Thanks for your reply. We expect to utilize the existing Harvoni stock before its expiry date, based on the assumption that the current enrollment rate is maintained/increased. Will provide the order as advised and can received the order as it becomes available.
I would like to take this opportunity and check with you the Epclusa order status. We are hoping to receive it by the end of June.
Many thanks for all your assistance.

პატივისცემით,
თამარ გაბუნია
მინისტრის მოადგილე

Sincerely,
Tamar Gabunia, MD, MPH
Deputy Minister

From: David Novoa [mailto:[email-masked]]
Sent: 7 June, 2019 04:08
To: Tamar Gabunia <[email-masked]<mailto:[email-masked]>>; Sean Barr <[email-masked]<mailto:[email-masked]>>; Sopo Belkania <[email-masked]<mailto:[email-masked]>>
Cc: Graeme Robertson <[email-masked]<mailto:[email-masked]>>; David Sergeenko <[email-masked]<mailto:[email-masked]>>; [email-masked]<mailto:[email-masked]>; Michael Clancy <[email-masked]<mailto:[email-masked]>>; Ben Dunne <[email-masked]<mailto:[email-masked]>>; Ekaterine Adamia <[email-masked]<mailto:[email-masked]>>
Subject: RE: Georgia HCV Program - Harvoni

Dear Tamar,

Thank you very much for the detailed update.
If I understand correctly, you might be able to fully use the existing Harvoni stock before its expiry date?

Please place the Harvoni order for the additional 7220 bottles, we will trigger the appropriate activities once received.
In case the product becomes available earlier, would you like to receive it before September?

Best regards,
David

From: Tamar Gabunia [mailto:[email-masked]]
Sent: Thursday, June 06, 2019 10:11 AM
To: Sean Barr; Sopo Belkania
Cc: Graeme Robertson; David Sergeenko; [email-masked]<mailto:[email-masked]>; David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne; Ekaterine Adamia
Subject: [EXTERNAL] Georgia HCV Program - Harvoni

Dear Sean
I hope all is well with you. With this I would like to provide you with updated information on HCV Program implementation and share our estimates on the needed amount of Harvoni.
In general, from the beginning of the HCV program implementation more then 55 000 HCV patients were registered, more then 54 000 out of registered patients have already started treatment and more than 51 000 completed treatment.
As you have already been informed, at this stage, we have patients on both treatment regimens, with Epclusa and with Harvoni; monthly registration in the program is stable, with about 1000 -1100 patient (about 54% of patients are on treatment with epclusa regimens and 46% on harvoni regimens). The number of patients enrolled on Harvoni treatment is around 470-500 monthly. We think we will maintain the current enrolment on Harvoni in the coming months.
With this picture of inflow, from June, until the end of the year, about 3500 new patients will be included in HCV program with Harvoni regimens. The needed amount of Harvoni for current and new patients is around  11150 bottles. It should be noted that the current stock of Harvoni is 6930 bottles with the expiry date on December 31st. The total need of Harvoni (including the three months buffer stock (additional 3000 bottles)) by the end of 2019 amounts to 7220 bottles.
Please kindly let us know if you have any questions or concerns on these estimates. If acceptable, we will provide an official order for 7220 Harvoni bottles in the next few days.
Many thanks and look forward to hearing from you.
With Kind Regards,

პატივისცემით,
თამარ გაბუნია
მინისტრის მოადგილე

Sincerely,
Tamar Gabunia, MD, MPH
Deputy Minister

From: Sean Barr [mailto:[email-masked]]
Sent: 18 April, 2019 22:45
To: Tamar Gabunia <[email-masked]<mailto:[email-masked]>>; Sopo Belkania <[email-masked]<mailto:[email-masked]>>
Cc: Graeme Robertson <[email-masked]<mailto:[email-masked]>>; David Sergeenko <[email-masked]<mailto:[email-masked]>>; [email-masked]<mailto:[email-masked]>; David Novoa <[email-masked]<mailto:[email-masked]>>; Michael Clancy <[email-masked]<mailto:[email-masked]>>; Alina Visnakova <[email-masked]<mailto:[email-masked]>>; Ben Dunne <[email-masked]<mailto:[email-masked]>>
Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Tamar,

Greetings to you as well and many thanks for this comprehensive update.  I’m glad to see the Epclusa rollout is progressing as planned.  Yes, please go ahead and place an order for 11,000 Epclusa bottles.

Regarding Harvoni, I suggest we tentatively plan a packaging run of 3,000 to 5,000 bottles for delivery in September, to give you enough time to replace the expiring product in November.  Let’s try to make sure you have enough to cover Q1 ’20 demand as well.  For all bottles expiring, we’ll need proof of destruction when the time comes.

Regards,
Sean

From: Tamar Gabunia [mailto:[email-masked]]
Sent: Wednesday, April 17, 2019 8:53 AM
To: Sean Barr; Sopo Belkania
Cc: Graeme Robertson; David Sergeenko; [email-masked]<mailto:[email-masked]>; David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne
Subject: [EXTERNAL] Georgia HCV Program - Current Stock and Future Supply

Dear Sean
Greetings! With this I would like to provide you with updated information on HCV Program and adjusted plan on treatment.
From the beginning of the HCV program implementation more then 55 000 HCV patients were registered, more then 54 000 out of registered patients have already started treatment and more than 50 000 completed treatment.
As you have already been informed, at this moment, we have patients on both treatment regimens, with Epclusa and with Harvoni;

•         From December 2018, we included Epclusa in treatment regimens for all untreated (treatment naïve) or already treated (treatment experienced) patients with genotype 2 and 3, also, for already treated (treatment experienced) patients with genotype 1 and 4. For all other patients we used Harvoni regimens.

•         Currently, the number of patients receiving Epclusa treatment regimens is about 550 per month and with Harvoni treatment regimens - about 500 per month.

•         With this picture of inflow, from now, until the end of the year, about 4950 new patients will be enrolled in HCV program on Epclusa containing regimens, out of them about 88% will be on 12-week regimens and 12% on 24-week treatment regimens. To provide medicines for this group of patients, we will need about 17 400-bottles of Epclusa, by the end of the year. It should be noted that at the moment the number of Epclusa bottles remaining in central warehouse is about 6400, so the total number of required bottles is 11 000 bottles (=17400-6400).
If our request is acceptable, we will provide an official order for 11000 Epclusa bottles in the next few days.

As for Harvoni, at the moment number of bottles, remaining at the warehouse is enough for about 6 months (the estimated number of patients 500 per month on average). We estimate that 14000 bottles of Harvoni will be needed in April-December. Currently the available stock includes 10550 bottles with the expiry date on December 31, 2019. We would appreciate your guidance on managing the available stock  given the anticipated expiry by the end of 2019.
Many thanks and look forward to hearing from you.
With Kind Regards,
Tamar Gabunia
Deputy Minister

From: Sean Barr [mailto:[email-masked]]
Sent: 24 March, 2019 19:10
To: Tamar Gabunia <[email-masked]<mailto:[email-masked]>>; Sopo Belkania <[email-masked]<mailto:[email-masked]>>
Cc: Graeme Robertson <[email-masked]<mailto:[email-masked]>>; David Sergeenko <[email-masked]<mailto:[email-masked]>>; [email-masked]<mailto:[email-masked]>; David Novoa <[email-masked]<mailto:[email-masked]>>; Michael Clancy <[email-masked]<mailto:[email-masked]>>; Alina Visnakova <[email-masked]<mailto:[email-masked]>>; Ben Dunne <[email-masked]<mailto:[email-masked]>>
Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Tamar,

Thank you and nice to meet you.  I look forward to the update.

Regards,
Sean

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