Summary Table of Reports on ARV Medications Purchases in 2010 in Russia. Prepared by International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
Purchases of ARV Medications in RF in 2010. Explanatory Note When preparing this document we set a goal of trying to obtain information on the auction held by using only public sources of information and not resorting to consulting agencies, pharmaceutical companies, etc. The results are given below for you to study. Organization and Holding of Auction 1. It is necessary to note an extreme non-transparency of the processes of the auction organization and holding. In 2010 the auction platform was changed from the website www.zakupki.gov.ru to the electronic tendering platform of the Sberbank of Russia (www.sberbank-ast.ru). At the same time the scheme of the auction was modified. In 2009 and 2008 Rospotrebnadzor (Federal Supervision Agency for Customer Protection and Human Welfare) and Roszdrav (Federal Agency for Healthcare and Social Development) held one auction with all ARV medications as a lot, while in 2010 the Ministry of Public Health and Social Development organized a separate auction for each medication (total of 39 auctions). In these circumstances notification of holding an auction and tendering itself took a few weeks. The reports on holding of the auctions were posted on the Sberbank website rather carelessly; besides, soon after the auctions have been held, many of them stopped being displayed by the site search engine. Consequently, in order to look through the report on results for most medications you needed either to have an accurate link available, or to search for it manually by entering the auction ID. An alternative and a more efficient option of information search may be found at the website www.maintender.com, which searches for auction results over all existing websites by the key words and does this much more efficiently than the search engine at the Sberbank website. Thus, more often than not the Sberbank website refuses to give information if the name of the medication is entered in the search field (for instance, “lamivudine” or “etravirine”). At the same time the site www.maintender.com easily finds required auction reports, which proves the fact that creation of an efficient search engine is actually possible and already put into practice. 2. There was no competition for more than a half items. In 24 cases out of 39 the auctions were considered invalid due to the lack of competition, which resulted in conclusion of a contract with the supplier at the maximum price. There were various reasons.
For example, in the cases of the two out of 24 medications (namely “Abacavir + Lamivudine + Zidovudine” and “Fosamprenavir, tablets 700 mg”) only one distributor was allowed to participate in the auction since the committee had identified irregularities in the technical documentation of all other bidders. It is curious that in both cases one and the same supplier - OAO Pharmimex – was allowed to participate in the auction, while its competitors failed to complete the documents properly. The manufacturer of the both medications is the company ViiV Healthcare.
In the case of two other medications (“Lamivudine, tablets 150 mg” manufactured by ViiV Healthcare and “Phosphazide, tablets 200 mg” manufactured by a Russian company AZT-Pharma) all participants themselves recalled their bids, which resulted in only one bid available for examination by the committee by the moment of the auction beginning. In both cases the only participant that hadn’t recalled its bid happened to be ZAO Firm TsV Protech.
Summary Table of Reports on ARV Medications Purchases in 2010 in Russia. Prepared by International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
In 20 cases only one participant claimed to bid in the auction from the very beginning. However, in theory this may be explained by the fact that the manufacturers of the medications have exclusive agreements on supply of these medications concluded with one or another distributor.
3. In the process of organizing the auctions some amendments were made in the documentation for two medications in the part concerning the amount and cost of the medications purchased.
Thus, in the case of lot “Atazanavir, capsules 150 mg” (manufactured by BristolMyers Squibb) it was decided to purchase 2 608 560 capsules 288 819 763 roubles worth instead of initially planned 2 611 320 capsules 289 125 350 roubles worth. At the same time, in terms of the number of yearly medication courses, the difference turned out to be insignificant totalling only 4 courses (3573 courses instead of 3577).
The situation around the medication “Zidovudine, solution 200 ml” (manufactured by ViiV Healthcare) may have other consequences. 35 435 bottles for 29 490 424 roubles were purchased instead of the planned 99 515 bottles for 82 820 364 roubles. Thus, the amount of the medication children’s form purchased decreased practically three times as opposed to the initially planned amount.
4. Besides, it is impossible not to pay attention to some interesting facts related to the prices offered by the distributors for the medications “Stavudine, capsules 40 mg” and “Fosamprenavir, oral suspension 225 ml”. In the process of tendering for the medication “Stavudine 40 mg” the price offered by one of the bidders (ZAO Firm TsV Protech) was 38 812 203 roubles 67 kopecks for supply of the total batch of goods. The disappointment of the company businessmen must have been great when they found out that only 13 minutes earlier (at least, that is what the reports on the auction results claim) another supplier (OOO Alliance Healthcare Rus) offered the price EXACTLY ONE KOPECK LOWER and in this manner won the auction (38 812 203 roubles and 66 kopecks). For reference: the price offered by the third bidder of the auction (ZAO R-PHARM) totalled 39 455 499. 84 roubles. Almost the same story took place in the case of the medication “Fosamprenavir, suspension”. The only distinction is that the difference in the price for this medication was not 1 kopeck, but almost one rouble. (8 227 661 roubles 07 kopecks bid by OAO Pharmimex versus 8 227 662 roubles bid by the defeated OOO Biotechmed). It would be of interest to mathematically calculate the chance of winning the auction by means of one-kopeck or one-rouble difference at ten-digit order of figures.
Summary Table of Reports on ARV Medications Purchases in 2010 in Russia. Prepared by International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
Financial Aspects The budget allocated for the auction in 2010 totalled 10 252 349 572 roubles. Thanks to the auction the total of 144 049 192 roubles was saved, which is approximately 1.4% of the allocated budget. In general, the budget means were distributed among the suppliers as follows:
Company
Medications
OOO Optimalnoye Zdorovye (Optimal Health) ZAO R-PHARM
Lopinavir/ritonavir (tablets) Darunavir (tablets 400 and 600 mg)
OOO Alliance Healthcare Rus
ZAO Firm TsV Protech
OAO Pharmimex
OAO Pharmstandard
Total Number of Items Won in Auction 3
Won % of without Auction Competition Budget
0
29.7%
Atazanavir (capsules 150 and 200 mg) Didanosine (capsules 250 and 400 mg and solution in bottles 2 g) Lopinavir/ritonavir (solution) Nelfinavir (tablets 250 mg, suspension 240 ml, powder 144 g) Raltegravir (tablets 400) Saquinavir (tablets 500) Stavudine (powder for solution) Enfuvirtide (lyophilizate) Lamivudine+zidovudine, tablets Zidovudine (tablets 300 mg) Nevirapine (tablets 200 mg) Stavudine (capsules 30 and 40 mg)
12
10 times
19.2%
5
1 time
18.4%
Abacavir (solution 240 ml, tablets 300 mg) Zidovudine (capsules 100 mg, solution 200 ml, solution for infusions 20 ml) Lamivudine (solution 240 ml) Lamivudine (tablets 150 mg) Nevirapine (oral suspension 240 ml) Ritonavir (capsules 100 mg) Phosphazide (tablets 200 mg) Abacavir+lamivudine Abacavir+lamivudine+zidovudine Fosamprenavir (tablets 700 mg and suspension 225 ml)
10
7 times
16.4%
4
2 times
10.3%
Didanosine (tablets 100 mg) Etravirine (tablets 100 mg)
2
1 time
3.6%
Summary Table of Reports on ARV Medications Purchases in 2010 in Russia. Prepared by International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
OOO Irvin 2
Indinavir (capsules 400 mg) Efavirenz (tablets 200 and 600 mg) Table 1. Distribution of Budget among Suppliers
3
3 times
2.4%
It was technically impossible to clarify the way the budget means were distributed among the manufacturers of ARV medications based on the tender documentation alone since only a supplier company is always in the picture. In this respect we used the website www.drugreg.org (an Internet version of the State Register of Pharmaceuticals) to identify the manufacturers of the medications. However, even this additional source failed to completely clear up the matter since some medications are manufactured by several companies in the territory of Russia. Thus, it was impossible to identify the manufacturers of 5 items. In this respect the table below contains only minimum values of the manufacturers’ market shares, which may be corrected depending on whose medications exactly were purchased for the five items specified above; however, this correction may not exceed 5% (the last line in Table 2). Table 2. Distribution of Budget among Manufacturers Company Medications Items Won in Auction (Minimum) ViiV Healthcare
Abbot Jansen Silag\ J&J Bristol Myers
Roche
Merck
Abacavir (solution 240 ml, tablets 300 mg) Abacavir+lamivudine Abacavir+lamivudine+zidovudine Zidovudine (solution 200 ml, solution for infusions 20 ml) Lamivudine (solution 240 ml) Lamivudine+zidovudine, tablets Lamivudine (tablets 150 mg) Fosamprenavir (tablets 700 mg and suspension 225 ml) Lopinavir/ritonavir (tablets 150 mg, oral solution 240 ml) Darunavir (tablets 400 and 600 mg) Etravirine (tablets 100 mg)
11
Without % of Competition Auction (Minimum) Budget (Minimum) 8 times 35.6
2
1
20.4
3
0
13.8
Atazanavir (capsules 150 and 200 mg) Didanosine (tablets 100 mg, capsules 250 and 400 mg, and solution in bottles 2 g) Stavudine (powder for solution) Nelfinavir (tablets 250 mg, suspension 240 ml, powder 144 g) Saquinavir (tablets 500) Enfuvirtide (lyophilizate) Indinavir (capsules 400 mg) Raltegravir (tablets 400) Efavirenz (tablets 200 and 600 mg)
7
5
10.3
4
4
5.4
4
4
5.2
Summary Table of Reports on ARV Medications Purchases in 2010 in Russia. Prepared by International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
AZT-Pharma Hetero Drugs Boeringer Ingelheim Unknown Manufacturer
Phosphazide (tablets 200 mg) Zidovudine (tablets 300 mg) Nevirapine (oral suspension 240 ml) Zidovudine (capsules 100 mg) – ViiV Healthcare, ZAO Bryntsalov, OOO AZT Pharma K.B. Nevirapine (tablets 200 mg) – Abbot, Hetero Drugs (Makiz-Pharma) Ritonavir (capsules 100 mg) – Abbot, Hetero Drugs (Makiz-Pharma) Stavudine (capsules 30 mg) – Hetero Drugs Limited, Bristol-Myers Squibb, OAO Veropharm Stavudine (capsules 40 mg) – Hetero Drugs Limited, Bristol-Myers Squibb
1 1 1
1 0 0
3.8 0.7 0.08
0
4.97
Number of Patients. All purchased medications, except for liquid and infusion forms, were divided into 2 groups based on clinical practice. The first group comprised the medications known as “bases of regimens”, i.e. the medications which are never or extremely seldom indicated in combination with one another (PI, II, NNRTI). The second group included the medications most frequently combined with one another or added to the third medication (“basic medication”). Group I Group II Atazanavir (Reyataz) Abacavir ABC Darunavir (Presista) DRV Abacavir+lamivudine ADC+3TC Indinavir Didanosine DDI Lopinavir/ritonavir (Kaletra) Zidovudine (and Phosphazide) AZT Nevirapine Lamivudine 3TC Nelfinavir Stavudine D4T Raltegravir RAL Saquinavir SQV Fosamprenavir FPV Efavirenz (Stocrin) EFV Etravirine Table 3. Groups of ARV Medications for Calculation of Number of Courses Preliminary calculation of the actual number of full courses (or, in other words, the number of patients to be actually covered with the medications purchased) showed that the medications purchased will suffice for 76 500 yearly courses of Group I medications (the accurate figure obtained is 76135) and for 66 500 courses of Group II medications (the accurate figure obtained is 66254) at most, the children’s forms of the medications not being considered and inaccuracy for post-contact and perinatal prevention not being calculated. However, it should be taken into account that the methodology of this calculation procedure is not perfect and be acknowledged that it enables calculation of the number of ARV medications purchased only up to a specific order. Nevertheless, thanks to this calculation we can affirm for sure that all those in need (that is 120 000 as per Federal AIDS Centre) will definitely not be covered with the ARV medications purchased.
Summary Table of Reports on ARV Medications Purchases in 2010 in Russia. Prepared by International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru) Number of Price for 1 Price for 1 Tablets Cost of Cost of Yearly Manufacture Initial Price, Tablets Purchase Saved Tablet, Tablet, per Yearly Yearly Courses Name of Medication r RUR Purchased Price RUR USD* Day Course, RUR Course, USD Purchased Money Abacavir + Lamivudine ViiV 698521438 1267320 688043616 542.91 17.51 1 198163 6390 3472 10477822 Abacavir + Lamivudine + Zidovudine ViiV 141105240 389589 141105240 362.19 11.72 2 264399 8557 534 0 Abacavir, solution 240 ml ViiV 24224421 8845 24224421 2738.77 87.08 NA 0 Abacavir, tablets 300 mg ViiV 311458788 3962580 311458788 78.60 2.50 2 57378 1824 5428 0 Atazanavir, capsules 150 mg BMS 288819763 2608560 287375664 110.17 3.53 2 80421 2578 3573 1444099 Atazanavir, capsules 200 mg BMS 494001300 3365590 494001300 146.78 4.67 1 53575 1703 9221 0
Auction Winner OAO Pharmimex
Market Share *** 6.81
Darunavir, tablets 400 mg
JS|JJ
122259029
454140
121647734
267.86
8.59
2
195541
6269
622
611295
Darunavir, tablets 600 mg Didanosine, capsules 250 mg Didanosine, capsules 400 mg Didanosine, tablets 100 mg Didanosine, bottles 2 g (2.0) Zidovudine, capsules 100 mg Zidovudine, solution 200 ml Zidovudine, tablets 300 mg Zidovudine, solution for infusions 20 ml Indinavir, capsules 400 mg Lamivudine + Zidovudine, tablets Lamivudine, solution 240 ml Lamivudine, tablets 150 mg Lopinavir + Ritonavir, oral solution 60 ml
JS|JJ BMS BMS BMS BMS ???** ViiV Hetero
927542234 48927888 174921846 11289485 8586006 11207520 29490424 67675660
2296920 729070 2035395 311520 8509 1448000 35435 2263400
922904523 48927888 174921846 11289485 8543076 11036755 29490424 67337282
401.80 67.11 85.94 36.24 1004.00 7.62 832.24 29.75
12.88 2.17 2.77 1.15 32.19 0.24 26.67 0.95
1 1 1 4 NA 6 NA 2
146657 24495 31368 52910
4702 791 1013 1682
6293 1997 5576 213
16692
535
661
21718
696
3101
4637711 0 0 0 42930 170765 0 338378
OAO Pharmimex ZAO Firm TsV Protech ZAO Firm TsV Protech ZAO R-PHARM ZAO R-PHARM OOO Optimalnoye Zdorovye (Optimal Health) OOO Optimalnoye Zdorovye (Optimal Health) ZAO R-PHARM ZAO R-PHARM OAO Pharmstandard ZAO R-PHARM ZAO Firm TsV Protech ZAO Firm TsV Protech OOO Alliance Healthcare Rus
ViiV Merck ViiV ViiV ViiV
13329355 1427306 1669389810 64002237 447190162
32630 119340 28000500 45665 14827260
13329355 1427306 1669389810 64002237 447190162
408.50 11.96 59.62 1401.56 30.16
13.10 0.39 1.93 45.39 0.97
NA 4 2 NA 2
17462 43523
564 1405
82 38357
22017
711
20311
0 0 0 0 0
ZAO Firm TsV Protech OOO Irvin 2 OOO Alliance Healthcare Rus ZAO Firm TsV Protech ZAO Firm TsV Protech
0.13 0.01 16.52 0.63 4.42
Abbott
76869824
51904
76869824
1481.00
48.19
NA
0
0.76
Lopinavir + Ritonavir, tablets Nevirapine 200 mg Nevirapine, oral suspension 240 ml Nelfinavir, powder 144 g (bottle) Nelfinavir, tablets 250 mg Raltegravir, tablets 400 mg Ritonavir (capsules) 100 mg Saquinavir, tablets 500 mg Stavudine (capsules) 30 mg Stavudine (capsules) 40 mg Stavudine, powder for oral solution 1 mg/ml – 260 ml Fosamprenavir, oral suspension 225 ml Fosamprenavir, tablets 700 mg
Abbott ???**
1966780483 68144751
34541280 2893620
1956946580 58937145
56.66 20.37
1.83 0.66
4 2
19.36 0.58
BI Roche Roche Merck ???** Roche ???** ???**
9051968 6078955 60610176 285972515 371123092 248794164 119278560 42886412
13178 3485 1434900 560280 6319140 2505480 2866584 1011472
7990906 6078955 60610176 285972515 365556245 248794164 28146917 38812204
606.38 1744.32 42.24 510.41 57.85 99.30 9.82 38.37
19.64 56.49 1.37 16.46 1.86 3.22 0.32 1.23
NA NA 10 2 2 4 2 2
BMS
18000356
16686
18000356
1078.77
34.71
NA
8310768 201178743
2897 1051860
8227661 201178743
2840.06 191.26
91.97 6.17
NA 2
139620
4502
383404804 232024770 357854396 10901709 229713214
10644220 212040 1747080 835380 8192340
383404804 232024770 352486580 10901709 229713214
36.02 1094.25 201.76 13.05 28.04
1.16 35.29 6.51 0.42 0.90
3 2 4 3 1
39442 798803 294566 14290 10235
1269 25760 9499 461 330
Phosphazide, tablets 200 mg Enfuvirtide lyophilizate 90 mg/ml Etravirine, tablets 100 mg Efavirenz, tablets 200 mg Efavirenz, tablets 600 mg TOTAL
ViiV ViiV AZTpharma Roche JS|JJ Merck Merck
10252349572
10108300380
82717 14869
154176 372599 42230 144978 7168 28012
2667 481
4993 12015 1359 4695 232 901
1.40 0.24 3.08 2.84 4.89 1.20 9.13 0.48 1.73 0.11 0.08 0.11 0.29 0.67
23658 3964
9833903 9207606
ZAO R-PHARM OOO Optimalnoye Zdorovye (Optimal Health) OOO Alliance Healthcare Rus
393 768 8656 1716 3927 1386
1061062 0 0 0 5566847 0 91131643 4074208
ZAO Firm TsV Protech ZAO R-PHARM ZAO R-PHARM ZAO R-PHARM ZAO Firm TsV Protech ZAO R-PHARM OOO Alliance Healthcare Rus OOO Alliance Healthcare Rus
0.08 0.06 0.60 2.83 3.62 2.46 0.28 0.38
0
ZAO R-PHARM
0.18
1441
83107 0
OAO Pharmimex OAO Pharmimex
0.08 1.99
9721 290 1197 763 22445
0 0 5367816 0 0
ZAO Firm TsV Protech ZAO R-PHARM OAO Pharmstandard OOO Irvin 2 OOO Irvin 2
3.79 2.30 3.49 0.11 2.27
144049192
Summary Table of Reports on ARV Medications Purchases in 2010 in Russia. Prepared by International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
* The price of one tablet in dollars was calculated based on the dollar/rouble exchange rate as of the date of the auction ** The auction documentation lacks information on who exactly is the manufacturer, since this form of the medication is manufactured by several companies *** The market share is calculated based on the actual cost of the medication (purchase price). Liquid form - solution/powder/infusion – number of doses, courses and their cost are not calculated, since dosage must be calculated based on the child’s weight. The auction is considered to be invalid, one participant, the medication was purchased at the maximum price