From : Ben Kamarck <Ben.Kamarck@gilead.com>
To : Tamar Gabunia <tgabunia@moh.gov.ge>; Aysan Murtezaoglu <Aysan.Murtezaoglu@gilead.com>; Graeme Robertson <Graeme.Robertson@gilead.com>
Subject : Re: [EXTERNAL] RE: Georgia HCV Program -Harvoni
Received On : 10.09.2019 06:11
Hi Tamar, Aysan and I will be in Tbilisi on Thursday September 26. Will you have time to meet in the afternoon? Ben > On 10 Sep 2019, at 12:54 PM, Tamar Gabunia wrote: > > Dear Sean > > I apologize for late response on this. The national program is still discussing the schemes. We are having a conference call with US CDC colleagues today to decide on Epcluca versus harvoni containing regimens. I'll send the forecast by tomorrow (September 11th) morning US time. > With kind regards > > პატივისცემით, > თამარ გაბუნია > მინისტრის მოადგილე > > Sincerely, > Tamar Gabunia, MD, MPH > Deputy Minister > > > > > > -----Original Message----- > From: Sean Barr [mailto:Sean.Barr@gilead.com] > Sent: 10 September, 2019 04:49 > To: Tamar Gabunia ; Graeme Robertson ; Ben Kamarck > Cc: Ben Dunne ; Mariana Miele ; Ekaterine Adamia ; David Novoa > 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:tgabunia@moh.gov.ge] > 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:Graeme.Robertson@gilead.com] > Sent: 9 August, 2019 20:16 > To: Tamar Gabunia ; Ben Kamarck ; Sean Barr > Cc: Ben Dunne ; Mariana Miele ; Ekaterine Adamia > 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 > Sent: 09 August 2019 16:40 > 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. > > Regards, > Sean > > DISCLAIMER If you have received this message in error, please contact the sender immediately by return e-mail and notify the sender and then delete this message (including any attachments) from your system. This communication and any attachments contain information which is confidential and may also be legally privileged. 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If your e-mail contains any personal information then we will process this according to our Privacy Statement located on Gilead.com. E-mail communications cannot be guaranteed to be secure or error free, as information could be intercepted, corrupted, amended, lost, destroyed, arrive late or incomplete, or contain viruses. Gilead does not accept liability for any such matters or their consequences. Anyone who communicates with Gilead by e-mail is taken to accept the risks in doing so. Gilead has taken every reasonable precaution to ensure that any attachment to this e-mail has been swept for viruses. However, Gilead cannot accept liability for any damage sustained as a result of viruses and would advise that you carry out your own virus checks before opening any attachment. Gilead Sciences Europe Ltd ; Registered as a limited company in England and Wales ; Registered number 5510315 Registered office: South Building ; 2 Roundwood Avenue ; Stockley Park ; Uxbridge ; UB11 1AF ; England DISCLAIMER If you have received this message in error, please contact the sender immediately by return e-mail and notify the sender and then delete this message (including any attachments) from your system. This communication and any attachments contain information which is confidential and may also be legally privileged. It is for the exclusive use of the intended recipient(s). If you are not the intended recipient(s) please note that any form of disclosure, distribution, copying or use of this communication or the information in it or in any attachments is strictly prohibited and may be unlawful. If your e-mail contains any personal information then we will process this according to our Privacy Statement located on Gilead.com. E-mail communications cannot be guaranteed to be secure or error free, as information could be intercepted, corrupted, amended, lost, destroyed, arrive late or incomplete, or contain viruses. Gilead does not accept liability for any such matters or their consequences. Anyone who communicates with Gilead by e-mail is taken to accept the risks in doing so. Gilead has taken every reasonable precaution to ensure that any attachment to this e-mail has been swept for viruses. However, Gilead cannot accept liability for any damage sustained as a result of viruses and would advise that you carry out your own virus checks before opening any attachment. Gilead Sciences Europe Ltd ; Registered as a limited company in England and Wales ; Registered number 5510315 Registered office: South Building ; 2 Roundwood Avenue ; Stockley Park ; Uxbridge ; UB11 1AF ; England