From : Ben Kamarck <Ben.Kamarck@gilead.com>
To : Tamar Gabunia <tgabunia@moh.gov.ge>; Sean Barr <Sean.Barr@gilead.com>
Subject : RE: Georgia HCV Program -Harvoni
Cc : Ben Dunne <Ben.Dunne@gilead.com>; Mariana Miele <mariana.miele@gilead.com>; Graeme Robertson <Graeme.Robertson@gilead.com>; Ekaterine Adamia <eadamia@moh.gov.ge>
Received On : 11.08.2019 12:40
Hi Tamar, Great to know about the testing! Once I have my logistics set for September, we can set a time to meet. Ben -----Original Message----- From: Tamar Gabunia [mailto:tgabunia@moh.gov.ge] Sent: Friday, August 09, 2019 11:40 PM To: Ben Kamarck; Sean Barr Cc: Ben Dunne; Mariana Miele; Graeme Robertson; Ekaterine Adamia 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:Ben.Kamarck@gilead.com] Sent: 7 August, 2019 05:26 To: Sean Barr ; Tamar Gabunia Cc: Ben Dunne ; Mariana Miele ; Graeme Robertson 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:tgabunia@moh.gov.ge] Sent: 06 August 2019 06:24 To: Ben Dunne; David Novoa; Sean Barr; Sopo Belkania Cc: Graeme Robertson; a.gamkrelidze@ncdc.ge; 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:Ben.Dunne@gilead.com] Sent: Tuesday, June 25, 2019 1:23 PM To: Tamar Gabunia >; David Novoa >; Sean Barr >; Sopo Belkania > Cc: Graeme Robertson >; a.gamkrelidze@ncdc.ge; Michael Clancy >; Ekaterine Adamia > 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:tgabunia@moh.gov.ge] Sent: 25 June 2019 10:20 To: Ben Dunne; David Novoa; Sean Barr; Sopo Belkania Cc: Graeme Robertson; a.gamkrelidze@ncdc.ge; 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:Ben.Dunne@gilead.com] Sent: 25 June, 2019 13:18 To: Tamar Gabunia >; David Novoa >; Sean Barr >; Sopo Belkania > Cc: Graeme Robertson >; a.gamkrelidze@ncdc.ge; Michael Clancy >; Ekaterine Adamia > 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:tgabunia@moh.gov.ge] Sent: 25 June 2019 06:48 To: David Novoa; Sean Barr; Sopo Belkania Cc: Graeme Robertson; a.gamkrelidze@ncdc.ge; 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:David.Novoa@gilead.com] Sent: 8 June, 2019 04:57 To: Tamar Gabunia >; Sean Barr >; Sopo Belkania > Cc: Graeme Robertson >; David Sergeenko >; a.gamkrelidze@ncdc.ge; Michael Clancy >; Ben Dunne >; Ekaterine Adamia > 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:tgabunia@moh.gov.ge] Sent: Friday, June 07, 2019 8:55 AM To: David Novoa; Sean Barr; Sopo Belkania Cc: Graeme Robertson; David Sergeenko; a.gamkrelidze@ncdc.ge; 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:David.Novoa@gilead.com] Sent: 7 June, 2019 04:08 To: Tamar Gabunia >; Sean Barr >; Sopo Belkania > Cc: Graeme Robertson >; David Sergeenko >; a.gamkrelidze@ncdc.ge; Michael Clancy >; Ben Dunne >; Ekaterine Adamia > 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:tgabunia@moh.gov.ge] Sent: Thursday, June 06, 2019 10:11 AM To: Sean Barr; Sopo Belkania Cc: Graeme Robertson; David Sergeenko; a.gamkrelidze@ncdc.ge; 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:Sean.Barr@gilead.com] Sent: 18 April, 2019 22:45 To: Tamar Gabunia >; Sopo Belkania > Cc: Graeme Robertson >; David Sergeenko >; a.gamkrelidze@ncdc.ge; David Novoa >; Michael Clancy >; Alina Visnakova >; Ben Dunne > 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:tgabunia@moh.gov.ge] Sent: Wednesday, April 17, 2019 8:53 AM To: Sean Barr; Sopo Belkania Cc: Graeme Robertson; David Sergeenko; a.gamkrelidze@ncdc.ge; 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:Sean.Barr@gilead.com] Sent: 24 March, 2019 19:10 To: Tamar Gabunia >; Sopo Belkania > Cc: Graeme Robertson >; David Sergeenko >; a.gamkrelidze@ncdc.ge; David Novoa >; Michael Clancy >; Alina Visnakova >; Ben Dunne > 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. 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