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

 

 

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

 

 

 

 

 

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

 

 

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  

 

 

Dear Tamar,

 

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

 

Regards,

Sean