Clinton Foundation HIV/AIDS Initiative ARV Procurement Forecast Tool

Version 1.4 March, 2005

User’s Manual

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Index

1. Overview 2. Scale-Up Assumptions

3. Procurement Assumptions

4. Clinical Assumptions

5. ARV Drug Forecasts for Adults (Clinical Assumptions 1)

6. ARV Drug Forecasts for Pediatrics

7. Cost Summary Pages

8. Additional Clinton Foundation HIV/AIDS Initiative Tools

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Abbreviations CHAI – Clinton Foundation HIV/AIDS Initiative CIF – Cost, Insurance and Freight CIP – Carriage and Insurance Paid To DDU – Delivered Duty Unpaid FOB – Free on Board

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1. Overview The CHAI ARV Procurement Forecast Tool 1.4 is intended to assist program managers in quantifying and budgeting for a program’s ARV needs during the initial 12-month phase of scale-up. By combining patient targets with clinical assumptions on single drug toxicity and treatment failure - compiled by the Operations Research team of the CHAI Care Consortium - the tool calculates the total number of units (capsules, tablets, ml of suspensions) required to meet the demand of the program’s projected scale-up. By inserting pricing information from quotations by pharmaceutical companies, the tool can be used to display the total budget for orders as well as generate Purchase Orders to be sent to manufacturers. The tool also allows the user to insert program-specific procurement assumptions, such as emergency buffer stock (based on the projected interval between placement of order and arrival of product) and procurement fees. The CHAI ARV Procurement Forecast Tool 1.4 should be used by program managers planning an initial ARV order for patients who have not previously been on treatment. Programs that have already begun patient roll-out should refer to other available tools (please see 8. Additional Clinton Foundation HIV/AIDS Initiative Tools), as forecasting will be based on both actual consumption and projected uptake. CHAI tools are all currently based on Microsoft Excel software. Although this form limits adaptability, its main advantage lies in accessibility, as MS Excel is included in the basic operating systems of most personal computers. This tool is currently set up to automatically calculate outputs. To facilitate these calculations, the user is required to insert information in cells clearly marked as Input (orange) fields. Cells that are not designated input fields (i.e. marked orange) should not be altered, as they might include formulas that allow the tool to calculate outputs. This user’s manual provides an overview of how the tool functions as well as instructions on how the tool can be adapted if necessary. Please note that figures included in screenshots throughout the user’s manual are designed for illustrative purposes only.

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2. Scale-Up Assumptions The Scale-Up Assumptions can be found at the top of the “Inputs” tab in the CHAI Procurement Forecast Tool 1.4 workbook. It is the first tab to the right of the cover sheet. The Scale-Up Assumptions are separated into patient targets for adults and patient targets for pediatrics.

Scale-Up Assumptions - Adults ADULTS

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

Total Adult Patients (#) 2,750 5,500 8,250 11,000 13,750 16,500 19,250 22,000 24,750 27,500 30,250 33,000

New Patients 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750

The “Scale-Up Assumptions” page shows the number of cumulative patients as well as the number of new patients on a monthly basis. For simplicity, the tool is programmed to assume a linear increase in terms of monthly scale-up. The user is only required to insert the number of cumulative patients to be reached by Month 12; the rest of the figures (cumulative patients by month and new patients by month) are calculated automatically. In cases where the program managers believe that scale-up will look different over 12 months, the cells showing the total number of patients can be manipulated manually without disrupting the flow of the tool.

Note: Figures for New Patients are calculated automatically and are not dependent on whether scale-up figures are inserted manually or calculated by formula. Scale-Up Assumptions – Pediatrics PEDIATRICS

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

Total Pediatric Patients (#) 167 333 500 667 833 1,000 1,167 1,333 1,500 1,667 1,833 2,000

New Patients 167 167 167 167 167 167 167 167 167 167 167 167

Pediatric Patient Weight Distribution

weight % of peds

3-5 kg 14%

5-10 kg 14%

10-15 kg 14%

15 - 20 kg 14%

20 - 25 kg 14%

25 - 30 kg 14%

30 - 40 kg 14%

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The “Scale-Up Assumptions” for children are set up in the same manner as the assumptions for adults. The user may choose to insert a cumulative target for Month 12 or insert monthly targets manually. The Scale-Up Assumptions for children require one additional piece of input for demand forecasting: weight distribution. This information is crucial as dosage assumptions for pediatric patients change based on their body mass. In many cases, this field will be difficult to estimate; however, the more accurate the weight distribution assumptions are, the more accurate the demand forecast will be. In the example above, the program’s goal is to scale up to 2,000 patients by Month 12. Very little information is available for the targeted children’s weight, so an even distribution by weight band has been assumed. Although the initial order might not be the most accurate, follow-up orders will be much more precise as information on children’s weight will be collected as they begin treatment. Note: Please make sure that the weight distribution percentages equal 100%. Currently, CHAI is working on an option that will allow program managers to insert patient distribution by age instead of weight. 3. Order and Inventory Assumptions The Order and Inventory Assumptions can be accessed by selecting the “Inputs” tab in the CHAI Procurement Forecast Tool 1.4 workbook and scrolling down to page 2 of the worksheet. Security Stock Assumptions

Security Stock/Buffer (Number of months per order) 1 The Security Stock cell allows the program manager to decide how many months’ worth of additional stock should be ordered to cover the program’s emergency buffer. It is important to note that the CHAI Procurement Forecast Tool 1.4 divides forecasts into quarterly orders – it is up to the program manager to decide how many months’ worth of stock should be procured. In the example above, the program manager has decided to add 1 additional month’s worth of stock to the order.

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Additional Fees (Shipping/Handling/Distribution) Total additional costs as a % of price per pack

Drugs listed as CIF, CIP, DDU 5%

Drugs listed as FOB 10% Depending on the nature of the quote received by manufacturers, additional fees for shipping, handling and distribution might apply to the price quoted. In the case above, the program manager assumes an additional cost of 5% to the price per pack for products quoted CIF and an additional charge of 10% to the price per pack for products listed FOB. These figures are subject to change depending on a country’s geographic location and domestic infrastructure. Treatment Days/Month CHAI Procurement Forecast Tool 1.4 assumes an average of 30.4 treatment days per month (365 days / 12 months). 4. Clinical Assumptions The Clinical Assumptions can be accessed by scrolling to page 3 on the “Inputs” tab. The Clinical Assumptions page has incorporated data on single drug toxicity and treatment failure rates. This information has been collected by the CHAI from partner organizations and partner countries that have already implemented treatment programs administering ARVs. The CHAI Procurement Forecast Tool 1.4 projects ARV demand patterns over a period of 12 months for treatment naïve patients starting treatment. For adults, the tool projects demand patterns for the two most commonly used 1st line treatment regimens that also form part of the WHO’s International Treatment Guidelines: d4t+3TC+NVP and AZT+3TC+NVP (Scaling Up ARV Therapy in Resource Limited Settings, WHO 2003, http://www.who.int/hiv/pub/prev_care/en/arvrevision2003en.pdf). Based on these two different patterns, the model calculates two sets of forecasts, which are reflected in the “Adult 1” and “Adult 2” tabs. Both demand forecasts are based on the patient targets inserted in the “Scale-Up Assumptions.” The program manager must decide which forecast applies to his/her program and ignore or delete the other page.

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For pediatrics, the tool projects demand patterns for one of the most commonly used 1st line regimens (also recommended by the WHO Treatment Guidelines, 2003): AZT+3TC+NVP. This generates a demand forecast reflected on the “Peds” tab. Clinical Assumptions – Adults (example – d4t+3TC+NVP) Clinical Assumptions 1 - Treatment Initiation Treatment Failure

1st Line Regimen : D4T+3TC+NVP 2nd Line Regimen ABC+DDI+LOP/RIT 80.0%

ABC+DDI+NFV 20.0%

Single Drug Toxicity: D4T+3TC+EFV

AZT+3TC+EFV

AZT+3TC+NVP For illustrative purposes, the tool assumes the following second line regimens: ABC+ddI+Lop/Rit and ABC+ddI+NFV. These assumptions can be changed and adapted if necessary. Please note: This manual should be used as a reference for adapting the tool. The following table summarizes single drug toxicity and treatment failure rates over 12 months for treatment naïve patients starting ARV treatment:

Toxicity Assumptions Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

Single Drug Toxicity D4T 0.25% 0.50% 0.75% 1.00% 1.25% 1.50%

Single Drug Toxicity NVP 1.25% 0.75% 0.50% 0.50% 0.75% 1.00% 1.25%

Treatment Failure Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

1.75% 1.75% 1.75% Single Drug Toxicity – Nevirapine: Within 4 weeks after beginning treatment, ~1.25% of patients suffer toxicity to NVP and have to be moved to an alternative drug (Efavirenz). By the 3rd month an additional 0.75% of the same patient cohort will experience toxicity and by Month 4, an additional 0.5% will have undergone a change to alternative regimens. During Months 5-8, no additional negative

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reactions to NVP are expected, however by Month 9, an additional 0.5% of the original cohort of patients will suffer toxicity to NVP. Months 10-12 should show a steady increase in the % of additional patients switching to alternative drugs. Single Drug Toxicity – Stavudine: During the first 6 months of treatment, toxicity to d4t isn’t expected to occur. By Month 7, a steady increase in the % of patients from the original cohort switching to alternative drugs (e.g. AZT) is projected. This should happen according to the above table. Treatment Failure: According to the data collected by the CHAI Care Consortium, total treatment failure is expected to set in by month 6 of treatment. 1.75% of the original patients are expected to be moved to an entirely different regimen. An additional 1.75% percent of patients are expected to switch by Months 9 and 12. Additional Assumptions: d4t (30) – d4t (40) split. For new patients coming onto treatment, CHAI Procurement Forecast Tool 1.4 assumes that 70% of new patients coming onto treatment will weigh less than 60kg and will thus require d4t (30). Over the course of treatment, a number of patients will gain weight and an increasing percentage of patients that that started treatment in Month 1 will be over 60kg. The percentage will increase to 40% by month 6 and to 50% by Month 9 (thus increasing the number of patients requiring d4t (40)). Note: These assumptions are subject to change as additional data is gathered and analyzed.

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The assumptions described in the previous paragraphs generate the following demand pattern:

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

D4T+3TC+NVP 100.00% 98.75% 98.01% 97.52% 97.52% 95.81% 95.57% 95.10% 92.24% 90.63% 88.59% 84.60%

D4T(30)+3TC+NVP 70.00% 69.13% 68.61% 68.26% 68.26% 57.49% 57.34% 57.06% 46.12% 45.31% 44.29% 42.30%

D4T(40)+3TC+NVP 30.00% 29.63% 29.40% 29.26% 29.26% 38.33% 38.23% 38.04% 46.12% 45.31% 44.29% 42.30%

D4T+3TC+EFV 0.00% 1.25% 1.99% 2.48% 2.48% 2.44% 2.43% 2.42% 2.83% 3.50% 4.36% 5.33%

D4T(30)+3TC+EFV 0.00% 0.88% 1.39% 1.74% 1.74% 1.46% 1.46% 1.45% 1.42% 1.75% 2.18% 2.66%

D4T(40)+3TC+EFV 0.00% 0.38% 0.60% 0.74% 0.74% 0.97% 0.97% 0.97% 1.42% 1.75% 2.18% 2.66%

AZT+3TC+EFV 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.02% 0.04% 0.06% 0.11% 0.17%

AZT+3TC+NVP 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.24% 0.72% 1.42% 2.34% 3.47% 4.74%

ABC+DDI+LOP/RIT 0.00% 0.00% 0.00% 0.00% 0.00% 1.40% 1.40% 1.40% 2.78% 2.78% 2.78% 4.13%

ABC+DDI(250)+LOP/RIT 0.00% 0.00% 0.00% 0.00% 0.00% 0.84% 0.84% 0.84% 1.39% 1.39% 1.39% 2.06%

ABC+DDI(400)+LOP/RIT 0.00% 0.00% 0.00% 0.00% 0.00% 0.56% 0.56% 0.56% 1.39% 1.39% 1.39% 2.06%

ABC+DDI+NFV 0.00% 0.00% 0.00% 0.00% 0.00% 0.35% 0.35% 0.35% 0.69% 0.69% 0.69% 1.03%

ABC+DDI(250)+NFV 0.00% 0.00% 0.00% 0.00% 0.00% 0.21% 0.21% 0.21% 0.35% 0.35% 0.35% 0.52%

ABC+DDI(400)+NFV 0.00% 0.00% 0.00% 0.00% 0.00% 0.14% 0.14% 0.14% 0.35% 0.35% 0.35% 0.52% Note: The above pattern follows a specific patient cohort over a 12 month period. The above pattern does not reflect cumulative patient projections.

Month 1 Month 2 Month 3 Month 4 Month 5

D4T+3TC+NVP =D93 =B101-B101*C14-B101*C15-B101*C17=C101-C101*D14-C101*D15-C101*D17=D101-D101*E14-D101*E15-D101*E17=E101-E101*F14-E101*F15-E101*F17

D4T(30)+3TC+NVP =B101*D121 =C101*D121 =D101*D121 =E101*D121 =F101*D121

D4T(40)+3TC+NVP =B101*D122 =C101*D122 =D101*D122 =E101*D122 =F101*D122

D4T+3TC+EFV =D96 =(B104+B101*C15-B104*C14)-B104*C17=(C104+C101*D15-C104*D14)-C104*D17=(D104+D101*E15-D104*E14)-D104*E17=(E104+E101*F15-E104*F14)-E104*F17

D4T(30)+3TC+EFV =B104*K93 =C104*K93 =D104*D121 =E104*D121 =F104*D121

D4T(40)+3TC+EFV =B104*K94 =C104*K94 =D104*D122 =E104*D122 =F104*D122

AZT+3TC+EFV =D97 =(B107+B104*C14)*(1-C17) =(C107+C104*D14)*(1-D17) =(D107+D104*E14)*(1-E17) =(E107+E104*F14)*(1-F17)

AZT+3TC+NVP =D98 =(B108+B101*C14)-B108*C17 =(C108+C101*D14)-C108*D17 =(D108+D101*E14)-D108*E17 =(E108+E101*F14)-E108*F17

ABC+DDI+LOP/RIT 0 0 =(C102+C103+C105+C106+C108+C107)*D17*D10+C109=(D102+D103+D105+D106+D108+D107)*E17*D10+D109=(E102+E103+E105+E106+E108+E107)*F17*D10+E109

ABC+DDI(250)+LOP/RIT 0 =C109*D121 =D109*D121 =E109*D121 =F109*D121

ABC+DDI(400)+LOP/RIT 0 =C109*D122 =D109*D122 =E109*D122 =F109*D122

ABC+DDI+NFV 0 0 =(C102+C103+C105+C106+C108+C107)*D17*$D11+C112=(D102+D103+D105+D106+D108+D107)*E17*$D11+D112=(E102+E103+E105+E106+E108+E107)*F17*$D11+E112

ABC+DDI(250)+NFV 0 =C112*D121 =D112*D121 =E112*D121 =F112*D121

ABC+DDI(400)+NFV 0 =C112*D122 =D112*D122 =E112*D122 =F112*D122 Note: If programs are using alternative 2nd line regimens, formulas must be adapted accordingly. See formula table on following page. To examine formulas, go to Excel toolbar, select Tools menu, Formula Auditing, Formula Auditing Mode.

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Clinical Assumptions – Pediatrics

Toxicity Assumptions Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

Single Drug Toxicity AZT 2.50% 2.25% 2.00% 1.00%

Single Drug Toxicity NVP 1.25% 0.75% 0.50% 0.50% 0.75% 1.00% 1.25%

Treatment Failure Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

1.75% 1.75% 1.75% Note: Assumptions are subject to change as additional data is gathered and adapted. For Pediatrics, the CHAI Procurement Forecast Tool 1.4 assumes the same single drug toxicity and treatment failure assumptions as for Adults. Single Drug Toxicity – Zidovudine: Within 4 weeks of beginning treatment 2.5% of patients will experience treatment failure. By Month 3, an additional 2.25% of patients will switch to a different regimen. In Month 4, an additional 2% and by Month 5 another 1% of patients experience treatment failure. Single Drug Toxicity – Nevirapine: Same as Adults. The previous assumptions generate the following demand pattern:

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

AZT+3TC+NVP 100.00% 96.25% 93.36% 91.03% 90.12% 88.54% 88.54% 88.54% 86.55% 85.90% 85.04% 82.49%

AZT+3TC+EFV 0.00% 1.25% 1.94% 2.37% 2.35% 2.31% 2.31% 2.31% 2.71% 3.36% 4.22% 5.21%

D4T+3TC+EFV 0.00% 0.00% 0.03% 0.07% 0.09% 0.09% 0.09% 0.09% 0.09% 0.09% 0.09% 0.09%

D4T+3TC+NVP 0.00% 2.50% 4.67% 6.53% 7.44% 7.31% 7.31% 7.31% 7.18% 7.18% 7.18% 7.06%

ABC+DDI+LOP/RIT 0.00% 0.00% 0.00% 0.00% 0.00% 1.40% 1.40% 1.40% 2.78% 2.78% 2.78% 4.13%

ABC+DDI+NFV 0.00% 0.00% 0.00% 0.00% 0.00% 0.35% 0.35% 0.35% 0.69% 0.69% 0.69% 1.03% Note: Please refer to previous pages for changing screen to formula display.

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5. ARV Drug Forecasts for Adults (example – d4t+3TC+NVP) Calculating Number of Patients per Month per drug/formulation

The ARV Drug Forecasts for Adults worksheet (for d4t+3TC+NVP - 1st line regimen) can be accessed by clicking the “Adult 1” tab. This worksheet calculates the number of patients per month that will be taking each formulation. The calculations are based on the inputs from previous worksheets: The worksheet sources the total number of new patients coming onto treatment during Month 1 from the “Scale-Up Assumptions” and multiplies it by the monthly pattern data from the “Clinical Assumptions” for patients beginning treatment In the illustration below, of the 2,750 patients beginning treatment in Month 1, 70%, or 1,925 patients, will be using d4t(30)+3TC+NVP, while 30%, or 825 patients, will be using d4t(40)+3TC+NVP. As monthly patient uptake is modeled linearly in the illustration, an additional 2,750 patients are expected to come onto treatment during Month 2. As in Month 1, out of these new 2,750 patients, 1,925 are projected to use d4t (30)+3TC+NVP, while 825 are expected to use d4t(40)+3TC+NVP. However, out of the 2,750 patients that started treatment in Month 1, several patients will have experienced single drug toxicity to NVP and will have switched to a d4t+3TC+EFV regimen. By Month 2, only 69.13%, or ~1,901 will still be on d4t(30)+3TC+NVP, thus arriving at a total 1,925+1,901 = 3,826 patients. Similarly, of the 825 patients that started treatment on a d4t(40)+3TC+NVP regimen, only 815 patients will remain on this regimen in Month 2, meaning that a total of 825+815=1,640 patients will be on this regimen during Month 2. Of the patients that will have switched to a d4t+3TC+EFV regimen, ~0.9%, or 24 patients, will be on a d4t(30)+3TC+EFV regimen, while ~ 0.4%, or 10 patients, will be on a d4t(40)+3TC+EFV regimen. Unlike d4t+3TC+NVP, which is available in a fixed dose combination, d4t(30), d4t(40), 3TC and EFV must be procured separately. Therefore, in the table below, a total of 24 patients will be on d4t(30), a total of 10 patients will be on d4t(40), 34 patients will be on 3TC (150mg) and 34 patients will be on EFV (600mg).

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Drug

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

D4T(30)+3TC+NVP 1,925 3,826 5,713 7,590 9,467 11,048 12,625 14,194 15,462 16,709 17,927 19,090

D4T(40)+3TC+NVP 825 1,640 2,448 3,253 4,057 5,111 6,163 7,209 8,477 9,723 10,941 12,104

AZT+3TC

(300+150mg) - - - - - - 7 27 67 133 232 367

3TC (150mg) - 34 89 157 226 293 359 426 504 600 720 866

D4T(30) - 24 62 110 158 198 238 278 317 365 425 498

D4T(40) - 10 27 47 68 94 121 148 187 235 295 368

NVP (200mg) - - - - - - 7 26 65 130 225 356

EFV (600mg) - 34 89 157 226 293 360 427 451 604 726 878

ABC (300mg) - - - - - 48 96 144 240 335 431 572

DDI (250mg) - - - - - 29 58 87 134 182 230 301

DDI (400mg) - - - - - 19 39 58 105 153 201 272

Lop/Rit (133/33mg) - - - - - 39 77 116 192 268 344 458

NFV (250mg) - - - - - 10 19 29 48 67 86 114

Starter Packs

3TC 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750 2,750

D4T(30) 1,925 1,925 1,925 1,925 1,925 1,925 1,925 1,925 1,925 1,925 1,925 1,925

D4T(40) 825 825 825 825 825 825 825 825 825 825 825 825

Total Number of Patients Taking Drug

In Month 3, due to the linear growth in new patient numbers, 2,750 new patients are expected to come onto treatment. As in the previous two months, 1,925 of these new patients will be on d4t(30)+3TC+NVP, while 825 patients will be on d4t(40)+3TC+NVP. For patients that began treatment in Month 2, several patients will have experienced single drug toxicity to NVP and will have switched to a d4t+3TC+EFV regimen. Of the patients that started treatment in Month 2, 69 %, or ~1,901, will still be on d4t(30)+3TC+NVP, while only 29%, or 815 patients, will remain on a d4t(40)+3TC+NVP regimen. For patients that began treatment in Month 1, an additional 0.75% of patients on d4t(30)+3TC+NVP and d4t(40)+3TC+NVP will have switched to d4t(30)+3TC+EFV

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and d4t(40)+3TC+EFV. Thus, of the original 1,925 patients on d4t(30)+3TC+NVP from Month 1, only 1,887 remain on that regimen, which equals a total of 1,887+1,901+1,925=5,713 patients on d4t(30)+3TC+NVP. In the same way, the number of patients on d4t(40)+3TC+NVP is 809+815+825=2,448 patients. For the following months, the calculations are set up in the same way. As one moves to the right of the spreadsheet towards Month 12, the formulas become longer, as a new “patient cohort” is added each month. The calculations described in the above paragraphs do not require any additional input. However, should the program use different second line regimens in its treatment guidelines or different formulations of ARVs than the ones currently used in the tool, both the demand pattern data as well as the monthly patient number data will have to be adapted, following the same logic as in the above paragraphs. Starter Packs: For patients beginning treatment on a d4t+3TC+NVP regimen, starter packs are assumed to be required for the first two weeks of treatment. Calculating Number of Pills needed per Month The calculations for number of pills required per month are based on multiplying the number of patients per formulation per month by the number of pills required per day. This product is then multiplied by the average number of days per month (30.4) to arrive at the number of required pills per month. Should the tool be adapted to forecast for drugs/formulations different from the ones listed in the illustration, the program manager must make sure that the correct daily dosage assumptions are used. For patients beginning treatment on a d4t+3TC+NVP 1st line regimen, the tool assumes that for the first 14 days, patients will be taking 1 pill of 3TC and d4t (30) / (40) for 14 days and 1 pill of d4t+3TC+NVP fixed dose combination. After the initial 2 week period, patients will continue therapy by taking 2 pills of fixed dose combination per day. To adjust the number of pills ordered of d4t(30)+3TC+NVP and d4t(40)+3TC+NVP, the number of these pills/month is reduced by the number of d4t(30) or d4t(40) pills used in starter packs.

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Drug Pills/Day

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

D4T(30)+3TC+NVP 2 117,104 232,745 347,518 461,717 575,916 672,088 768,020 863,472 940,629 1,016,435 1,090,536 1,161,303

D4T(40)+3TC+NVP 2 50,188 99,748 148,936 197,879 246,821 310,936 374,890 438,525 515,682 591,489 665,590 736,356

AZT+3TC

(300+150mg) 2 - - - - - - 411 1,642 4,074 8,097 14,089 22,308

3TC (150mg) 2 - 2,091 5,421 9,571 13,721 17,799 21,866 25,912 30,654 36,505 43,799 52,708

D4T(30) 2 - 1,464 3,795 6,700 9,605 12,051 14,492 16,920 19,290 22,216 25,863 30,317

D4T(40) 2 - 627 1,626 2,871 4,116 5,747 7,374 8,993 11,363 14,289 17,936 22,391

NVP (200mg) 2 - - - - - - 401 1,601 3,973 7,889 13,699 21,631

EFV (600mg) 1 - 1,046 2,711 4,786 6,861 8,899 10,938 12,977 13,712 18,357 22,094 26,692

ABC (300mg) 2 - - - - - 2,928 5,855 8,783 14,587 20,391 26,195 34,825

DDI (250mg) 1 - - - - - 878 1,757 2,635 4,086 5,537 6,988 9,145

DDI (400mg) 1 - - - - - 586 1,171 1,757 3,208 4,659 6,110 8,267

Lop/Rit (133/33mg) 6 - - - - - 7,026 14,053 21,079 35,008 48,938 62,867 83,579

NFV (250mg) 10 - - - - - 2,928 5,855 8,783 14,587 20,391 26,195 34,825

3TC 1 38,500 38,500 38,500 38,500 38,500 38,500 38,500 38,500 38,500 38,500 38,500 38,500

D4T(30) 1 26,950 26,950 26,950 26,950 26,950 26,950 26,950 26,950 26,950 26,950 26,950 26,950

D4T(40) 1 11,550 11,550 11,550 11,550 11,550 11,550 11,550 11,550 11,550 11,550 11,550 11,550

Starter Packs

Pills Needed / Month

Calculating Total Number of Packages and Total Cost of the Order

The main page of the “ARV Drug Forecasts for Adults” worksheet consists of summarizing the program’s ARV demand into four quarterly orders. The additional security stock buffer from the “Order and Inventory Assumptions” worksheet is automatically added to each quarterly order.

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On this page, the program manager is required to incorporate price quotes received from suppliers (or from other resources, e.g. MSF report) as well as the pack sizes. Once this information has been inserted, the tool can translate the number of pills per quarterly order into number of boxes required per quarterly order, cost of each quarterly order and the total cost of the entire order.

Drug Pills/BoxEstimated cost

per pack

Import duties

and freight

costs

(US $) (US $) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2

D4T(30)+3TC+NVP 60 10.8 13.50 667,893 1,764,610 2,698,876 3,453,043 11,132 29,410 44,981 57,551 150,276 397,037

D4T(40)+3TC+NVP 60 11.4 14.25 286,240 781,068 1,402,318 2,122,017 4,771 13,018 23,372 35,367 67,982 185,504

AZT+3TC

(300+150mg) 60 16.02 20.03 - - 6,637 48,202 - - 111 803 - -

3TC (150mg) 60 4.85 6.06 8,138 44,515 84,968 144,095 136 742 1,416 2,402 822 4,498

D4T(30) 60 2.96 3.70 5,697 30,719 54,926 84,929 95 512 915 1,415 351 1,894

D4T(40) 60 3.7 4.63 2,442 13,796 30,041 59,167 41 230 501 986 188 1,063

NVP (200mg) 60 4.8 6.00 - - 6,473 46,821 - - 108 780 - -

EFV (600mg) 60 57 71.25 4,069 22,258 40,762 72,739 68 371 679 1,212 4,832 26,431

ABC (300mg) 60 72.9 82.01 - 3,172 31,660 88,194 - 53 528 1,470 - 4,335

DDI (250mg) 60 31.8 35.78 - 951 9,184 23,476 - 16 153 391 - 567

DDI (400mg) 60 50.88 57.24 - 634 6,646 20,621 - 11 111 344 - 605

Lop/Rit (133/33mg) 180 41.04 46.17 - 7,612 75,985 211,667 - 42 422 1,176 - 1,952

NFV (250mg) 60 15.48 17.42 - 3,172 31,660 88,194 - 53 528 1,470 - 921

3TC 60 4.85 6.06 125,125 125,125 125,125 125,125 2,085 2,085 2,085 2,085 12,643 12,643

D4T(30) 60 2.96 3.70 87,588 87,588 87,588 87,588 1,460 1,460 1,460 1,460 5,401 5,401

D4T(40) 60 3.7 4.63 37,538 37,538 37,538 37,538 626 626 626 626 2,894 2,894

TOTAL 245,389 645,746

Starter Packs

(US $)

Total Pills Per Quarter (includes Security Stock) Total Cost Per Quarter (includes Security Stock)Total Boxes Per Quarter (includes Security Stock)

Note: Pack sizes and prices used in the tool are included for illustrative purposes.

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6. ARV Drug Forecasts for Pediatrics The “ARV Drug Forecasts for Pediatrics” worksheet can be accessed by clicking the “Peds” tab. This worksheet calculates the number of pediatric formulations of ARVs (suspension, capsules, tablets) that will have to be procured to meet the demand for the number of pediatric patients projected to be put on treatment over the course of twelve months (based on inputs from “Scale-Up Assumptions” worksheet). The CHAI ARV Procurement Forecast Tool 1.4 is currently set up to quantify needs based on the most commonly used 1st line regimen for pediatrics: AZT+3TC+NVP. Drugs/Formulations currently included in the pediatric forecasting tool:

Liquid Formulations Capsules Tablets Stavudine 1mg/ml Lamivudine 10mg/ml Nevirapine 10mg/ml Zidovudine 10mg/ml Didanosine 10mg/ml Lopinavir/Ritonavir 80/20mg/ml Abacavir 20mg/ml Nelfinavir 50mg/g Cotrimoxazole 40mg/5ml

Stavudine (15mg) Stavudine (20mg) Stavudine (30mg) Zidovudine (100mg) Efavirenz (50mg) Efavirenz (200mg)

Lamivudine (150mg) Nevirapine (200mg) Zidovudine (300mg) Didanosine (25mg) Didanosine (50mg) Didanosine (100mg) Didanosine (200mg) Lopinavir/Ritonavir (133/33mg) Abacavir (300mg) Nelfinavir (250mg) Cotrimoxazole (480mg)

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Assumptions for the use of liquid vs. solid formulations The CHAI ARV Procurement Forecast Tool 1.4 currently uses the assumptions displayed below for pediatric patients regarding the use of liquid vs. solid formulations based on a patient’s weight. These assumptions can be changed by the program manager according to a program’s needs. 3-5kg: 100% liquid formulations 5-10kg: 100% liquid formulation 10-15kg: 100% liquid formulation 15-20kg: 50% liquid formulation, 50% solid formulation 20-25kg: 20% liquid formulation, 80% solid formulation 25-30kg: 20% liquid formulation, 80% solid formulation Note: For some drugs, these rules do not apply as dosing information for both liquid and solid formulations might not exist for all weight bands. In the case of stavudine, 100% of patients 25-30kg and 30-40kg are projected to be on solid formulations (capsules), as no dosing information exists for patients in these weight bands for liquid formulations. The tool’s current assumptions can be found on the “Inputs” worksheet, under “Pediatric Forecasting Assumptions: Liquid vs. Solid Formulations.” Calculating Number of Patients per Month per drug/formulation

This worksheet calculates the number of patients per month using each formulation of each drug in the above list. As with “ARV Drug Forecasts for Adults,” the “ARV Drug Forecasts for Pediatrics” worksheet sources the total number of new patients coming onto treatment during Month 1 from the “Scale-Up Assumptions” worksheet and multiplies it by the monthly pattern data coming from the “Clinical Assumptions” worksheet for patients that will begin treatment. For pediatrics, this product is also multiplied by the data inserted in the “Scale-Up Assumptions” worksheet that shows the distribution of new patients by weight band. Finally, this product is multiplied by the assumptions above regarding the use of solid vs. liquid formulations.

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Drug

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12

Suspension

D4T - 2 6 12 19 25 32 38 45 51 58 64

3TC 98 195 293 390 464 584 680 776 870 964 1,059 1,151

3-5 kg 24 48 71 95 95 142 166 189 212 235 258 281

5-10 kg 24 48 71 95 119 142 166 189 212 235 258 281

10-15 kg 24 48 71 95 119 142 166 189 212 235 258 281

15 - 20 kg 12 24 36 48 60 71 83 95 106 118 129 140

20 - 25 kg 5 10 14 19 24 28 33 38 42 47 52 56

25 - 30 kg 5 10 14 19 24 28 33 38 42 47 52 56

30 - 40 kg 5 10 14 19 24 28 33 38 42 47 52 56

NVP 98 194 290 385 480 574 667 761 852 943 1,033 1,121

AZT 98 193 286 377 467 556 645 733 820 908 995 1,080

DDI - - - - - 2 3 5 8 11 15 19

Lop/Rit - - - - - 1 2 3 5 7 9 12

ABC - - - - - 2 4 6 10 13 17 23

NFV - - - - - 0 1 1 1 2 2 3

Capsules

D4T (15mg) - - - - - - - - - - - -

D4T (20mg) - 1 2 4 7 9 11 13 16 18 19 20

Patients Per Month Taking Drug

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The total number of patients per month per drug/formulation is calculated by adding the number of patients per weight band. In the above illustration, for 3TC suspension in Month 1, 98 total patients on 3TC suspension is the result of 24 patients in the 3-5 kg weight band+ 24 in the 5-10kg weight band + 24 in the 10-15kg weight band + 12 in the 15-20kg weight band + 5 in the 20-25kg weight band + 5 in the 25-30kg weight band + 5 in the 30-40kg weight band. In the above illustration, in Month 1, in the 3-5kg weight band, the Forecasting tool arrives at 24 patients by multiplying 167 new patients (from “Scale-Up Assumptions” worksheet) by the 14% weight band distribution for 3-5kg which =~24 patients. This product is multiplied by the demand pattern information generated by the “Clinical Assumptions” (all new patients will be on a formulation of 3TC as 100% of new patients are on a AZT+3TC+NVP 1st line regimen). This product is multiplied by the “Liquid vs. Solid” assumption that all patients in the 3-5kg weight band must take liquid formulations. Thus, the total number of new patients on 3TC liquid formulation in Month 1 is ~24 patients. The same calculation is repeated for the other weight bands. In Month 2, due to the fact that the number of new patients coming onto treatment is projected linearly in the “Scale-Up Assumptions”, 167 new patients are expected to start treatment. As in Month 1, 24 of these patients are expected to be on liquid 3TC as they all start on an AZT+3TC+NVP 1st line regimen. Of the ~24 patients that started treatment in Month 1, all are still on a 3TC liquid formulation, which is shown in the above total of ~48 patients on 3TC for the 3-5kg weight band for Month 2. Of the patients that started treatment in Month 1, only 96% have remained on an AZT+3TC+NVP regimen, 1.25 will have switched to an AZT+3TC+EFV regimen, and 2.5% will have switched to a d4t+3TC+NVP regimen. However, all of these regimens require 3TC liquid formulation for the 3-5kg weight band which means that even though not all patients from Month 1 are expected to be on the same regimen, they are expected to be using 3TC liquid formulation for ARV therapy. As is the case for adults, in the following months, the “ARV Forecasting Tool for Pediatrics” takes the number of new patients coming onto treatment and multiplies it by the clinical assumptions for new patients. This figure is added to the number of patients that started treatment in each previous month multiplied by the corresponding figure in the clinical assumptions 12-month cycle. For programs that use different 1st or 2nd line regimens than the ones assumed in the tool, the formulas should be adjusted as described in the above paragraphs. Note: For Opportunistic Infection Prophylaxis, it is assumed that all patients coming onto treatment will also receive Cotrimoxazole.

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Calculating Number of units needed per Month

The “ARV Drug Forecasts for Pediatrics” calculates the number of units (ml, capsules or tablets) by multiplying the average daily dosage requirements per weight band by the number of patients per weight band. This product is multiplied by the average number of treatment days per month (30.4) to arrive at the total number of units per weight band. The total number of units per month is the sum of the total number of units per weight band.

Drug Formulation

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11

Suspension

D4T ml - 1,349 3,881 7,442 11,507 15,501 19,494 23,488 27,412 31,335 35,259

3TC ml 28,679 57,357 86,036 114,714 141,075 171,570 199,746 227,923 255,607 283,290 310,974

3-5 kg 3 2,317 4,635 6,952 9,270 9,270 13,864 16,141 18,418 20,655 22,892 25,129

5-10 kg 6 4,345 8,690 13,036 17,381 21,726 25,995 30,265 34,534 38,728 42,923 47,117

10-15 kg 10 7,242 14,484 21,726 28,968 36,210 43,326 50,441 57,556 64,547 71,538 78,529

15 - 20 kg 14 5,069 10,139 15,208 20,278 25,347 30,328 35,309 40,289 45,183 50,077 54,970

20 - 25 kg 18 2,607 5,214 7,821 10,429 13,036 15,597 18,159 20,720 23,237 25,754 28,270

25 - 30 kg 22 3,187 6,373 9,560 12,746 15,933 19,063 22,194 25,325 28,401 31,477 34,553

30 - 40 kg 27 3,911 7,821 11,732 15,643 19,554 23,396 27,238 31,080 34,855 38,630 42,406

NVP ml 47,254 93,918 140,241 186,343 232,445 277,740 323,036 368,331 412,624 456,611 500,192

AZT ml 70,791 139,813 207,281 273,400 338,858 403,170 467,483 531,795 594,982 658,169 721,356

DDI ml - - - - - 563 1,126 1,690 2,806 3,923 5,039

Lop/Rit ml - - - - - 130 261 391 650 908 1,167

ABC ml - - - - - 591 1,181 1,772 2,943 4,113 5,284

NFV mg - - - - - 10,323 20,645 20,645 41,110 61,575 71,897

Capsules

D4T (15mg) Caps - - - - - - - - - -

D4T (20mg) Caps - 47 135 260 402 541 680 820 957 1,094 1,183

Units Needed Per Month

Note: The daily dosage assumptions are based on HIV Drug Dose Ranges, Harvard AIDS Institute, MSF, ACHAP; (May 2003) and Pediatric ARV & Cotrimoxazole Dosing, CDC, Baylor, Columbia; (March 2004). Dosage Assumptions are displayed on the “Inputs” worksheet, under “Pediatric Forecasting Assumptions: Dosing Guidelines.”

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Calculating quarterly order summaries and number of packs

The “ARV Forecast Tool for Pediatrics” worksheet calculates quarterly orders and the required number of packs in the same manner as the “ARV Forecast Tool for Adults” worksheet. The tool summarizes the demand requirements in quarterly orders and adds in the additional buffer stock established in the “Procurement Assumptions” worksheet.

The program manager is required to insert the number of units per package and the cost per package based on quotations by manufacturers or other sources. Based on this information, the tool calculates the number of packs needed per quarter and the total cost of each quarterly order.

DrugUnits per

Bottle/Box

Estimated Cost

Per Box/Bottle

Import Duties

and Freight

Costs

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

(US$) (US$)

Suspension

D4T 200 3.140 3.53 5,666 37,320 76,260 114,518 28 187 381 573 100 659 1,347 2,023

3TC 100 0.91 1.14 186,411 462,973 740,215 1,010,140 1,864 4,630 7,402 10,101 2,120 5,266 8,420 11,490

3-5 kg

5-10 kg

10-15 kg

15 - 20 kg

20 - 25 kg

25 - 30 kg

30 - 40 kg

NVP 100 0.93 1.05 304,865 754,572 1,195,990 1,624,253 3,049 7,546 11,960 16,243 3,190 7,895 12,513 16,994

AZT 100 1.14 1.43 452,708 1,100,047 1,727,114 2,343,207 4,527 11,000 17,271 23,432 6,451 15,676 24,611 33,391

DDI 200 14.74 16.58 - 610 6,091 16,967 - 3 30 85 - 51 505 1,407

Lop/Rit 200 14.74 16.58 - 141 1,410 3,928 - 1 7 20 - 12 117 326

ABC 240 34.80 39.15 - 640 6,387 17,792 - 3 27 74 - 104 1,042 2,902

NFV 7,200 35.37 39.79 - 11,183 89,267 255,448 - 2 12 35 - 62 493 1,412

Capsules

D4T (15mg) 60 2.90 3.26 - - - - - - - - - - - -

D4T (20mg) 60 3.00 3.38 198 1,302 2,661 3,799 3 22 44 63 11 73 150 214

Total units per quarter (includes Security Stock) Total Cost Per Quarter (includes Security Stock)

(US $)

Total Boxes/Bottles per Quarter (includes

Security Stock)

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7. Cost Summary Pages The final two worksheets of the tool (please see “Cost Summary 1” and “Cost Summary 2” tabs) include an overall display of the total cost of the budget. “Cost Summary 1” shows the program’s total cost using a d4t+3TC+NVP 1st line/1st choice regimen, while “Cost Summary 2” shows the program’s total cost using an AZT+3TC+NVP 1st line/1st choice regimen. The $ figures in the screen shot below are illustrative; however, they clearly show the cost differential of using an AZT+3TC+NVP 1st line regimen vs. a d4t+3TC+NVP first line regimen for adults. Total Cost (Adults 1 + Pediatric)

Q1 Q2 Q3 Q4 Total

Adults 245,389$ 645,746$ 1,110,562$ 1,667,468$ 3,669,165$

Pediatrics 23,065$ 57,949$ 94,977$ 134,662$ 310,653$

Total 268,454$ 703,694$ 1,205,539$ 1,802,130$ 3,979,818$ Total Cost (Adults 2 + Pediatric)

Q1 Q2 Q3 Q4 Total

Adults 473,218$ 1,192,106$ 1,966,612$ 2,813,601$ 6,445,537$

Pediatrics 23,065$ 57,949$ 94,977$ 134,662$ 310,653$

Total 496,283$ 1,250,054$ 2,061,590$ 2,948,264$ 6,756,190$ Note: Patient Scale-Up assumptions are the same for both cost summaries.

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8. Additional Tools Available from the Clinton Foundation HIV/AIDS Initiative The CHAI ARV Procurement Forecast Tool 1.4 is intended to assist program managers quantify and budget for a program’s ARV needs during the initial 12-month phase of scale-up. After the initial procurement of ARVs, subsequent forecasting must be modified to reflect actual consumption at sites as well as inventory levels. CHAI has developed several tools that can assist program managers as well as site mangers to track ARV consumption by patient, monitor stock levels and project forward demand based on scale-up assumptions. These tools currently are available in an MS Excel format and can be adapted to meet a program’s need. If you have any questions or comments about the CHAI ARV Procurement Forecast Tool 1.4, or would like to receive additional information on Clinton Foundation HIV/AIDS Initiative Procurement and Supply Management Tools, please contact us at:

Clinton Foundation HIV/AIDS Initiative 225 Water St

Quincy, MA 02169 Tel: 617-774-0110 Fax: 617-774-0220

procurement@hivaidsinitiative.org