1

Approximately 1 in 8 pregnant

women is HIV positive and an

estimated 26 infants are infected

with HIV every day in Zambia.

Business case for an improved eMTCT protocol in Zambia

Moving to Option B+

16 November 2012

1 Background Despite evidence that the rate of increase in new HIV infections in Zambia is declining, HIV continues to

pose a serious threat to the health of many Zambians. The transmission of HIV from a HIV positive

mother to her child during pregnancy, delivery or breastfeeding is one of the key drivers of the AIDS

epidemic in Zambia.

Through the implementation of the PMTCT program, Zambia has

made significant progress in preventing mother to child

transmission (MTCT) of HIV (United Nations General Assembly

Special Session on HIV and AIDS, 2012):

The proportion of pregnant women put on prophylaxis to prevent HIV transmission to infants

increased from 61.9% in 2008 to 84.5% in 2011

The risk of children acquiring HIV infection from their mothers in Zambia has gone down from

30%- 45% before the era of antiretroviral treatment (ARV) to 22% in 2010 and 9% in 2011 at age

6 weeks1. However, infants can still acquire HIV infection during the rest of the breastfeeding

period, which is not taken into account in this figure.

At a high level UN political meeting in June 2011, Zambia endorsed the global goal of elimination of

MTCT (eMTCT) of HIV, defined as a 90% reduction of new HIV infections among children by 2015

(Republic of Zambia, Ministry of Health, 2011). For Zambia this would entail reducing the risk of MTCT of

HIV to less than 5% by the end of the breastfeeding period. The Zambian government has taken a step

further and pledged to keep mothers and fathers alive in addition to reducing the number of new HIV

infections in both women and men by 50% by 2015.

This document explores whether a move to a triple-drug antiretroviral combination therapy for all

pregnant women, started as soon as possible during pregnancy and continued for life would help

achieve the HIV MTCT elimination goals.

1 Based on Early Infant Diagnosis (EID) data.

2

The roll out of Option A in Zambia has

been less than optimal. The complexity of

the current program leaves one in seven

HIV pregnant women without the

treatment she needs.

2 The case for change Despite the progress of the eMTCT program in

attaining high coverage rates of ANC attendance and

HIV counseling and testing in ANC settings, Zambia still

faces many challenges further down the cascade

including the continued use of sub-optimal ARV

regimens. This means the country is not on track

towards virtual elimination of MTCT of HIV by 2015.

Implementation of Option A of the 2010 World Health Organization PMTCT recommendations has proven complex. First, the treatment eligibility of an HIV positive woman is determined through CD4 testing. However in 2009, the availability of CD4 testing was limited to just 25% of HIV positive pregnant women in Zambia (Republic of Zambia, Ministry of Health, 2011). Furthermore, it can take as long as two weeks to get the results from the laboratory back to the facility, and even longer to reach the pregnant woman. Second, the current guidelines include provisions for a variety of ARV drug regimens: one before delivery, another at the onset of labor and a third during delivery2. ARV treatment for HIV exposed babies is dependent on whether the mother chooses to breast feed her baby or not. For example ARVs are currently prescribed for 6 weeks for non-breastfeeding infants and for the duration of breastfeeding for breastfeeding infants. With Option A, too many variables have complicated the treatment decision making process; this has led to a situation where in 2011, over 15,000 HIV pregnant women did not receive the antiretroviral regimen that they needed3.

Three PMTCT antiretroviral program options have been acknowledged by the WHO. Both Options B and

B+ provide a single universal regimen to treat the HIV infected pregnant woman for her own health and

to prevent transmission to her child. However, Option B only provides lifelong treatment to ART-eligible

mothers. For mothers with CD4 counts >350, treatment is discontinued one week after breastfeeding.

Option B+ provides all positive pregnant women with immediate and continued treatment for life.

Options A, B and B+ are illustrated in the following figure.

2 Currently, the prophylaxis being used are: 1. Antenatal: AZT 300mg twice daily starting at 14 weeks or as soon as

possible thereafter. 2. Intrapartum: NVP 200mg single dose at onset of labour. 3: Delivery: AZT 300mg/3TC 150mg

during delivery. 4. Postnatal: AZT 300mg/3TC 150mg twice daily for 7 days.

3 The UNGASS report states that in 2011 97,118 HIV positive pregnant women required antiretrovirals, but that

only 82,081 women received them.

3

Figure 1. Overview of eMTCT Options

Option B+ makes the elimination of mother to child transmission much simpler and more effective: all

positive pregnant women receive treatment immediately and for life regardless of CD4 count and all

infants are provided with one pill, once a day from birth through four to six weeks regardless of the

feeding method. These simplified and consistent treatment options will help to streamline operations,

procurement and supply management and will strengthen the linkages between the eMTCT and ART

programs at the community level. Option B+ can be a catalyst to decentralize ART care and help Zambia

take a big step in bringing health services closer to the people.

In addition to the operational benefits, there are enhanced health benefits to infants, mothers and the

mothers’ HIV-negative male sexual partners in adopting B+:

- Lower transmission to infants: more women will already be receiving lifelong treatment initiated in

earlier pregnancies, which is likely to lower the total number of new infant infections both during

pregnancy and the breastfeeding period.

- Improved maternal health: the new regimen of triple ARVs is likely to decrease HIV related illnesses

from opportunistic infections (Cohen M. et al, 2011) and increase maternal survival for those who

adhere (Schouten, 2011). This reduces the number of orphans needing support and is likely to have

an indirect impact on reducing under-5 deaths (Anema A. et al, 2010).

- Lower transmission to HIV-negative male sexual partners: The HPTN 052 study demonstrated that

transmission rates to HIV-negative partners are substantially lower for individuals who are initiated

early on ART (Cohen M. et al, 2011).Putting more HIV-positive women on lifelong ART sooner with

Option B+ is therefore expected to avert more adult infections than the other treatment options.

4

The simplicity of Option B+ will lead to

healthier mothers, reduced infant

infections, and a decrease in transmission

to male partners.

Overall, Option B+ is likely to have a greater impact in reducing infant HIV infections, increasing

maternal survival and reducing transmission to HIV

negative male sexual partners than the current eMTCT

program (Option A) and Option B. These benefits will have

a continuing positive impact in the future, both during

future pregnancies and in protecting HIV-negative male

partners. Option B+ is therefore considered the best

available method to eliminate MTCT.

A complementary policy critical to eMTCT is the immediate treatment of the infected partner in a

discordant relationship (where one member of the couple is HIV infected and the other is not). In 2010,

Zambia was a global leader in introducing this policy, but implementation of couples testing and

treatment has been slow. Approximately half of the HIV infected pregnant women have an uninfected

(discordant) partner. Approximately 8% (one in twelve) (Central Statistical Office, 2009) of HIV negative

women have an infected male partner.

Fully implementing the policies of early treatment for discordant couples and Option B+ are critical to

achieve elimination of MTCT. Essentially, these dual policies take Zambia one step further in the

direction of ‘test and treat’ and act as catalysts for bringing healthcare closer to the people.

5

3 Implementation and policy issues

3.1 Drugs

The recommended drugs for maternal treatment in Option B+ are registered, included in the country’s

Adult and Adolescent Treatment Guidelines, and already being prescribed. The difference with Option

B+ is that facilities will have to order larger quantities to ensure that there are sufficient drugs available

for pregnant women to initiate and continue treatment for life. In anticipation of a move to Option B+,

the ARVs forecast team in July 2012 prepared an overview of the additional quantities of drugs that will

be required and factored this into their planning4.

The 2010 ART and PMTCT guidelines in Zambia, prepared with a focus on Option A, discouraged the use

of EFV in the first trimester. However, the WHO has recently released guidance that indicates there is no

compelling evidence to contraindicate use of EFV in pregnancy in Option B+ regimens. Nonetheless, the

WHO has mandated that countries implementing Option B+ contribute toward building knowledge

around the safety of EFV in pregnancy through enhanced birth defects surveillance. At a minimum, one

high volume eMTCT facility, such as the University Teaching Hospital, should gather data through

ongoing surveillance and operations research.

3.2 Laboratory Support Adoption of Option B+ will demand regular monitoring of the clinical progress of the patient to assure

optimal performance of the prescribed regimen. In addition, certain tests will need to be administered

before treatment is initiated. At minimum, a hemoglobin test, a urine dipstick for protein and bilirubin

(as proxies for renal and liver functions respectively) and a tuberculosis screening should be performed

before initiation of treatment. Although treatment can be initiated based on the package of tests

described above, a number of tests must be available for patient monitoring and screening purposes,

either on site or through referral. The figure below provides a detailed overview:

4The assumption, based on data from 2010, is that 94% (92,715) of all HIV-infected pregnant women access

antenatal and 85% (78,808) of those would access PMTCT and require ART. Of these, 40% (31,523) with CD4

counts less than 350 are already accounted for in the general population eligible for ART. The 60% (47,285)

remaining are the additional patients needing ART whose CD4 counts are greater than 350.

6

Figure 2: overview of required tests to initiate B+ and for patient monitoring and screening

If survival rates of the HIV positive woman are to improve, access to laboratory monitoring will need to

be enhanced to consistently ascertain the efficacy of the regimen and drug toxicities. Overall, with the

move to B+, a larger number of tests will need to be performed and access to laboratory services will

need to be improved to make this possible.

The use of point of care devices should continue to be encouraged and quality assurance systems for all

point of care diagnostics should be strengthened. Although not yet widely available, viral load tests are

the most suitable tests for patient monitoring. Current efforts underway to make this test available to all

patients in need should be hastened. Due to infrastructural and funding limitations, an immediate cost

effective measure will be the strengthening of current sample referral systems. In the roll out of Option

B+, program planners and implementers will develop a robust national referral system with a

documented quality management plan and a communication strategy targeting the beneficiaries.

3.3 Leadership and Coordination

The overall leadership and technical co-ordination of the PMTCT Option B+ and Pediatric HIV care lies

with the Ministry of Health under the stewardship of the National Antiretroviral Program Coordinator in

the Directorate of Clinical and Diagnostic Services. The eMTCT program is organized along four prongs

for implementation:

Prong 1: Primary prevention of HIV among women of reproductive age

Prong 2: Prevention of unintended pregnancies

Prong 3: Prevention of perinatal transmission from HIV-positive women to their infants

Prong 4: Follow-up for and linkages to long-term prevention, care and support services for

mothers, their children, and their families.

7

Within the Ministry of Health, the Directorate of Clinical Care and Diagnostics is responsible for prong 3

and part of prong 4 and contributes to prong 1 through treatment of male partners. The Directorate of

Public Health and Research is responsible for prongs 1, 2 and part of prong 4.The full involvement of the

Ministry for Community Development, Mother and Child Health in all four prongs is critical to the

success of the eMTCT program. Therefore its active participation in the implementation planning

processes for the roll out of Option B+ is invited and welcome. The National HIV/AIDS/STI/TB Council

(NAC) and civil society organizations are responsible for advocacy and implementation support of the B+

policy.

The PMTCT Technical Working Group (TWG) working in consultation with the ART TWG will review the

eMTCT/ART 2011-2015 strategic plan and develop new health care guidelines and protocols.

3.4 Delivery model

Concerning the delivery model, the key changes with the introduction of Option B+ are:

- Treatment can start earlier: If a pregnant woman tests positive, treatment can be started as soon as

basic tests are performed, see section 3.2

- One ARV regimen for all pregnant women: instead of pregnant women with CD4 >350 being

initiated on short course prophylaxis (Option A), all pregnant women will be initiated on the same

treatment(likely one tablet a day) regardless of CD4 count

- Treatment will be continued for life: more women will be on triple ARVs for a longer period of time

than is currently the case, with an estimate of an additional 47,2855(Republic of Zambia, Ministry of

Health, 2012)pregnant women commencing lifelong treatment in 2013.

Service requirements

The delivery model will need to expand to accommodate a larger number of women initiating treatment

for a longer period of time. The existing ART sites are either too far away for many women in rural areas,

or too congested in urban areas. At a minimum, the following package of interventions should be

available in each Mother and Neo-natal Child Health(MNCH) Clinic to initiate Option B+:

1. All elements of Focused Antenatal Care (FANC), including HIV testing and counseling and syphilis

testing.

– Counseling should include treatment preparation, with a focus on patient comprehension

and the rational and importance of lifelong treatment and adherence

2. Laboratory support for CD4 count, hemoglobin, basic chemistry tests (urine dipstick for Protein and

Bilirubin), Early Infant Diagnosis and TB screening tests either on site or through an established

referral system;

3. The ability to prescribe ARVs and Benzathine Penicillin

5 The Zambia ARV Drug forecasting and quantification report estimates that in 2013 there will be an additional

47,285 pregnant women requiring treatment (these are pregnant women with a CD4 count >350).

8

1200 Sites offering eMTCT

509 sites offering

ART

4. A formal system in place for adherence support, for example through Community Health Workers

(CHWs), lay counselors or adherence support groups such as Safe Motherhood Action Groups

(SMAGs). This system should not be fully dependent on volunteers.

Testing and counseling

Nurses or Counselors, assisted by PMTCT lay counselors, will provide HIV testing and counseling services

for pregnant women and their families at the MNCH clinics. Consistent with current practice, couple

counseling will be encouraged. If a woman is found to be HIV positive, ARVs for PMTCT (Option B+) will

be initiated immediately regardless of CD4 count (and given no counter- indications arise from the on-

site hemoglobin, urine dipstick or TB screening). Likewise, in the case of discordance, the HIV positive

partner will be immediately initiated on ART regardless of CD4 count. This allows same day initiation of

treatment. Other children and family members screened for HIV will be provided further prevention

care and treatment services as appropriate based on current national protocols.

Infrastructure

As more women will be placed on treatment, the provision of an adequately large working space for

group education and interaction during the waiting period for screening and counseling is imperative.

The MNCH clinics must be conducive and able to accommodate males for couples’ counseling and

testing scale up. In addition, pharmacies or storage spaces might need to be expanded to accommodate

the larger volumes of drugs that will be dispensed.

Transition of HIV positive women, their exposed infants and their partners for ongoing care and

treatment after weaning will depend on availability of

dedicated ART services within a defined radius. Ideally,

they should be transitioned to a treatment program

within the facility for chronic care (out-patient

department preferably), in order to decongest MNCH.

However, where the MNCH facility is the only one

offering ART within a defined radius, these MNCH facilities will need to be transitioned to antiretroviral

treatment facilities. As such, an accelerated move to decentralize ART care and integrate facilities to

bring treatment and care closer to families is paramount.

As such, a survey to inform planning as to how many current eMTCT-only facilities need to be up-graded

to ART facilities will be developed. Additionally, Health Professions Council of Zambia (HPCZ) will need to

review its accreditation guidelines and requirements to facilitate the process of transitioning eMTCT-

only facilities into ART facilities.

Human Resources for Health

In order for Option B+ to work, available and appropriately trained human resources are cardinal.

Trained health personnel must be able to prescribe ARVs and there should be at least one nurse or

nurse/midwife per MNCH clinic able to prescribe ARVs. At the start of this program nurses or

nurse/midwives in MNCH clinics should undergo additional on-site training on HIV management with an

9

emphasis on Option B+. In the long term, expansion of the HIV Nurse Practitioner training program with

a focus on strategies to retain these cadres of nurses will be an important investment if this model is to

work. Strengthening the current MOH clinical mentoring program in parallel to the Option B+ roll-outis

another effective measure.

Pregnant positive women will need increased adherence support after delivery. MNCH facilities must

boost their capacity for adherence counseling in order to include comprehensive adherence counseling,

involving an adherence support buddy system of trained Traditional Birth Attendants (tTBA), family

members or groups at each scheduled visit.

Supply Chain Management

With the introduction of B+, there will be an estimated 12%6 increase in the amount of drugs that will

have to be distributed to the facilities in the short run. This in turn will have implications for the supply

chain management system. MOH in conjunction with MSL will need to develop and put in place a well

thought out Procurement Supply Management (PSM) plan that includes ARV logistics standard

operating procedures. This plan should address issues related to quantification of needs (particularly in

relation to existing supply and procurement), procurement and distribution and management of the

drugs and other HIV related commodities at national, sub national and facility level. The continued

monitoring of this system will help to strengthen facility level logistics management.

Patient Retention and Transition

In order to mitigate the risk of primary resistance in the population, specific attention should be given to

patient retention and drug adherence issues; at each follow up visit, adherence counseling including

patient education and pill counts should take place. Working with the trained facility health center staff,

Option B+ oriented Neighborhood Health Committees (NHCs) can monitor the performance of CHWs in

the follow up of HIV positive women and HIV exposed infants. NHCs will enhance community

mobilization and implement a robust adherence support mechanism both at the facility and within the

community.

Patient retention and drug adherence is likely to be a more complicated issue with the transition to

Option B+, as women with high CD4 counts generally feel healthy and might be reluctant to take

treatment for the rest of their lives. Further work is required to ensure that the right messages are

communicated to pregnant women and to ensure that they are willing to continue treatment after the

breastfeeding period.

6 The Zambia ARV Drug forecasting and quantification report estimates that in 2013 there will be an additional

47,285 pregnant women requiring treatment (these are pregnant women with a CD4 count >350). In 2012 there are 382,581 people on ARVs. The additional pregnant women who will remain on treatment under Option B+ (and would have otherwise not remained on treatment) therefore represents a 12% increase (47,285/382,581).

10

Community engagement

With a larger number of patients on ARVs, the role of the community to monitor, retain and increase

adherence among stable patients is increasingly important. As communities begin to take on this role,

facilities can then focus primarily on patient initiation and management of more complicated cases.

Districts and facilities should develop robust adherence support services for early identification and

follow-up of pregnant women to prevent losses to follow up. These services should include a community

level Monitoring & Evaluation (M&E) component that feeds into the facility M&E system. All PMTCT

implementing partner programs must reflect funded community level adherence support activities as

part of their overall PMTCT portfolios, keeping in mind that the best interventions are developed by and

for the communities they are intended to serve. The following interventions and systems should be

further developed and implemented:

Community structures to provide psychosocial support and follow-up care, such as peer support

groups, neighborhood health committees.

Community-based models for ART delivery, patient tracking, adherence support and home

based care

Approaches that engage the whole family in delivering care and support

Strategies to promote and support male partners’ involvement at the health facility as well as in

the community

Follow-up and referral mechanisms with M&E tools to measure utility

On-site, routine analysis of records to identify trends in missed ANC appointments for action.

Coordinated scheduling that combines the 6-week infant immunization visit with the mother-

infant pair follow-up visit.

Community capacity building on eMTCT services and support systems.

11

4 Cost implications

4.1 Short term costs

The costing model assumes that the scale up to Option B+ will happen gradually over the next four

years. This is illustrated in the graph below, which provides an overview of the number of HIV positive

pregnant women who are receiving Option B+7, Option A prophylaxis, are on treatment eligible8or no

ARVs. Women who are already receiving treatment for their own health are included in the Option B+

category below.

A preliminary costing analysis has shown that the incremental cost of providing eMTCT through Option

B+ compared to the current Option A, is expected to be in the range of $50 million to $70 million during

the three year period from 2013 to 2015. The majority (90%) of the incremental costs are associated

with the costs for drugs, including drugs for women who are no longer pregnant or breastfeeding9. The

remaining incremental costs cover the additional human resources and laboratory commodities

required under Option B+. The chart below illustrates the difference in costs between Option A and

Option B+.

7 Including women with a CD4 count below 350 who are receiving ART for their own health and would be eligible

for treatment under the current guidelines even if they were not pregnant and part of the PMTCT program. These are counted in the B+ category as their treatment is the same as the treatment under Option B+. 8 These are women with CD4 counts below 350 and are already on treatment before pregnancy.

9 These estimates are based on models developed by CHAI and by PEPFAR. More information can be found in

Annex I. The cost of treatment of women with CD4<350 and treatment for infants over 6 weeks are not included in this estimate, as they are already included in the ART program budget. The focus of this costing is the incremental or additional costs to the program with this policy shift.

Treatment eligible Treatment eligible Treatment eligible

Option A prophylaxisOption A prophylaxis

Option A prophylaxis

Option B+Option B+ Option B+

No ARVs No ARVs No ARVs

0

20000

40000

60000

80000

100000

120000

2013 2014 2015

12

Figure 2. Estimated costs of Option A and Option B+ from 2013 to 2015.

Rather than providing prophylaxis to the infant, positive mothers will initiate treatment sooner and

continue on the regimen through breastfeeding. This and other key operational simplifications are

expected to reduce the number of infected infants by18,000 over the 3 years (2013 to 2015). The main

objective of the policy change is to save lives by preventing infections. However, the policy change will

reduce other costs to the system. The most obvious are the averted pediatric HIV treatment costs for

drugs and human resources: roughly $ 6.7million before 2015, which will increase to savings of around

$38 million by 2025 just for the 18,000 infants protected from HIV during 2013 to 201510.

Table 1 presents an overview of the estimated total costs to provide Option B+. Drugs followed by

human resources are the main drivers.

Table1: total costs of providing Option B+

2013 2014 2015 Total As % Drug commodity &

shipping costs11 $ 29,344,149 $ 43,187,127 $ 51,703,973 $ 124,235,249 57%

Human Resources $ 17,110,639 $ 18,970,059 $ 20,339,825 $ 56,420,523 26%

Lab commodity costs $ 5,828,729 $ 6,766,418 $ 7,210,610 $ 19,805,756 9%

Operational costs $ 6,013,759 $ 6,519,830 $ 5,867,891 $ 18,401,480 8%

Total $ 58,297,276 $ 75,443,433 $ 85,122,299 $ 218,863,008 100%

Table 2 shows the incremental costs of providing Option B+ as opposed to Option A and illustrates that

drug costs are the main component at 87% of all incremental costs.

10

Calculated using a discount rate of 5%, current costs of drugs and estimates for the costs of human resources 11

There is a difference between the estimated cost that is recorded here and in the Drug Forecasting and Quantification Report. The difference is caused by the use of different assumptions regarding the scale up of the implementation of B+.

$-

$10

$20

$30

$40

$50

$60

$70

$80

$90

$100

2012 2013 2014 2015

Mill

ion

s

Option A

Incremental cost

of Option B+

over 2013 to

2015: $50m –

$70m

Option B+

13

Table 2: incremental costs of providing Option B+ versus Option A

Breakdown into

categories 2013 2014 2015 Total As % Drug commodity &

shipping costs $ 7,490,707 $ 18,210,294 $ 24,879,072 $ 50,580,073 87%

Human Resources $ 990,271 $ 2,067,013 $ 2,696,868 $ 5,754,152 10%

Lab commodity & shipping

costs $ 271,723 $ 567,173 $ 740,001 $ 1,578,897 3%

Operational costs $ - $ - $ - $ - 0%

Total $ 8,752,701 $ 20,844,481 $ 28,315,941 $ 57,913,122 100%

Please see Annex I for further detail on the short term costing of the move to B+.

4.2 Long term impact Although Option B+ leads to higher costs in the short run, it is expected that more infant infections will

be averted through simplifying operations and that fewer males are expected to become infected with

HIV because of the viral load suppression of a triple-combination ARV regimen.It is also expected that

women will initiate their own treatment earlier, improving their health outcomes, and averting their in-

patient hospital costs, and other expenses such as drugs for opportunistic infections.

The following graph illustrates the difference between the expected infant infections under Options A

and B+1213.The difference in infection rates is caused by the expectation that Option B+ is simpler to

implement – women will therefore start ARVs earlier in the first pregnancy when they are initiated, and

remain on so that they will be preventing transmission to their child from the start of their subsequent

pregnancies.

Figure 3. Averted infant HIV infections: A vs. B+ 2013-2025

12

To estimate the potential impact of Option B+, it was assumed that from 2013 all HIV positive women would receive Option B+. 13

Due to the long term nature of the modeling exercise, these estimates need to be treated with caution and should be used for illustrative purposes only.

-

5,000

10,000

15,000

20,000

25,000

30,000

35,000

Option B+

Option A

B+ vs. A: estimated

~100,000 averted

infant infections

14

Infant HIV infections under Option A are expected to have reached 390,000 by 2025, whereas under

Option B+ it is expected that around 290,000 infants will be HIV infected: a difference of 100,000 infant

infections averted. B+ is simpler to implement and more pregnant women will receive the treatment

they need sooner and for a longer period. In the absence of any ARV intervention, we would expect

around 570,000 infections. In total, Option B+ is expected to prevent around 280,000 infections by 2025

compared to a scenario where nothing is done to prevent infection.

Women who are on Option B+ are expected to have less opportunistic infections and have an increased

life expectancy compared to Option A, leading to dramatically improved maternal and infant health

outcomes, higher economic productivity and fewer orphans. In addition, male HIV infections are

expected to be significantly lower in Option B+ compared to Option A. Further modeling is required to

estimate the potential male infections averted.

4.3 Resource mobilization The previous section has shown that the move towards Option B+ is expected to cost around $ 50

million to $ 70 million more than the current implementation costs between 2013 and 2015. The

Ministry of Health has calculated the resource gap for drugs and ARVs in this time frame. Based on this,

an estimate of the available funding for drugs for eMTCT has been made. This is highlighted in the table

below.

15

Table 3: Estimated resource gap for implementing Option B+

2013 2014 2015

Total estimated costs to implement Option B+

14

$58,297,276 $75,443,433 $85,122,299

Budgeted funds – drugs

MOH $4,239,885 $6,975,424 $9,972,392

USG $3,821,943 $6,111,451 $5,318,109

Global Fund $8,148,198 $7,473,669 $11,368,526

Total budgeted funds for drugs $16,210,027 $20,560,543 $26,659,027

Budgeted funds non-drugs

MOH15

$17,110,639 TBC TBC

USG16

$ 20,906,370 $25,938,141 $31,450,787

Global Fund17

$3,618,119 $1,533,953

Total budgeted funds for non-drugs $ 41,635,129 $27,472,094 $31,450,787

Resource gap $ 452,120 $27,410,796 $27,012,485

The Zambian Government is committed to treating HIV positive patients and has announced that the

budget for ARVs in 2013 will triple to a total of $35 million18. In terms of partner support, advocacy for

resource mobilization needs to be intensified. The key partners that support MOH in the area of eMTCT

are CDC, PEPFAR, UNICEF, Global Fund and CHAZ. Discussions with each organization on future support

to the implementation of Option B+ are ongoing.

14

Information from JSI deliver indicates that in 2013-2015 respectively 12%, 20% and 28% of all ARVs will be consumed by the eMTCT program. The calculation for the gap analysis uses these ratios to calculate the available funding for the eMTCT program requirements for ARVs. 15

This figure is based on the estimate for costs for human resources used in the costing model. The estimate is based on the actual salaries and allowances of cadres used in eMTCT. It represents 3.5% of the total HR budget from MOH. 16

This data is based on COP 2012 data and assumes that funding flatlines after 2012. It includes the line item for eMTCT and for 2013, 2014, 2015 respectively 12%, 20% and 28% of the line items ‘Adult Treatment’, ‘Laboratory Infrastructure’ and ‘Strategic Information’. The budgeted funds include pipeline funding and exclude funds that are focused on prongs 1, 2 and 4. These resource estimates need to be further refined for future implementation decisions. 17

This figure is based on information from CHAZ on Global Fund’s Single Stream of Funding, focused on eMTCT. 18

This figure needs to be approved by parliament.

16

Bibliography Anema A. et al. (2010). Estimating the impact of expanded access to antiretroviral therapy on maternal,

paternal and double orphans in sub-Saharan Arica 2009-2020. AIDS Research and Therapy.

Cohen M. et al. (2011). Prevention of HIV-1 Infection with Early Antiretroviral Therapy. The New England

Journal of Medicine.

Republic of Zambia, Ministry of Health. (2011). Joint eMTCT and ART National Strategy & Operational

Plan 2011-2015.

Republic of Zambia, Ministry of Health. (2012). Zambia ARV Drug Forecasting and Quantification Report.

Schouten, E. (2011). Prevention of mother-to-child transmission of HIV and the health-related

Millennium Development Goals: time for a public health approach. The Lancet(378), 282-284.

United Nations General Assembly Special Session on HIV and AIDS. (2012). Zambia Country Report .

World Health Organization. (2012). Programmatic Update: Use of Antiretroviral Drugs for Treating

Pregnant Women and Preventing HIV Infection in Infants.

17

ANNEX I

Key assumptions to estimate the costs of Option B+

Short term costs: 2013 - 2015

The cost estimates presented in this business case include those costs associated with mother/infant

pairs to prevent HIV transmission from an HIV-positive mother to her child during pregnancy,

breastfeeding and until her next pregnancy, also referred to as prong 3. This includes the following:

– Drug costs (ARVs, CTX, penicillin for syphilis)

– Health worker costs

– Laboratory commodities

– Shipping and in-country distribution of commodities

– Operational costs: training costs, monitoring and evaluation, infrastructure and other

operational costs such as printed materials, software and transport.

– Allowance for overhead costs as a 20% markup on the operational costs

In addition, the following table outlines the key assumptions that were used to calculate the short term

cost estimates for implementing Option B+.

2012 2013 2014 2015

HIV positive pregnant women 98,000 98,663 100,901 103,222

% HIV positive pregnant women receiving ARVs 90.13% 93.93% 95.85% 97.80%

Percent of enrolled women receiving Option A

prophylaxis19

100% 67% 33% 17%

Percent of enrolled women receiving Option B+ prophylaxis 0% 33% 67% 83%

Regimen TDF – FTC - EFV

Discount rate (used for estimating the averted costs) 5%

19

The denominator used is the number of HIV positive pregnant women with CD4 counts over 350, and are thus not on treatment already.

18

Long term estimates: 2013 – 2025

The following table lists the key assumptions used to estimate the impact and costs of implementing B+ over a longer term.

Assumptions for long term impact 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

Expected pregnancies

616,352

620,522 634,597

649,195

663,792

678,718

693,979

709,584

725,539

741,853

758,534

775,590

793,030

810,862

HIV prevalence among pregnant women 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90% 15.90%

% HIV positive pregnant women receiving ARVS

90.13% 93.93% 95.85% 97.80% 97.80% 97.80% 97.80% 97.80% 97.80% 97.80% 97.80% 97.80% 97.80% 97.80%

% Of those on Option B+ prophylaxis, who were already receiving ARVs as prophylaxis at start of pregnancy 0% 0% 15% 20% 25% 30% 35% 40% 45% 50% 55% 55% 55% 55%

19

In addition, key assumptions were made around the impacts of the simpler implementation of Option

B+. These assumptions define the difference in estimating the averted infant infections, and are listed in

the table below.

Option A Option B+

Week of commencing treatment 20 weeks 14 weeks

% of women who start ARVs late and are on ARVs for less than 4 weeks during pregnancy (and deliver on ARVs) 60% 10%

% of women who start (or continue) ARVs, stop and then start again during pregnancy (received >4 weeks) 15% 13%

% of women who start ARVs and stop during pregnancy, do not deliver or breastfeed while on ARVs 18% 15%

Monthly drop out rate 5% 1%

Limitations

The cost estimates for the short and the long term are both based on a set of assumptions. These

assumptions can change over time and as such, the estimates have to be treated with caution, especially

as the model considers a long time frame and the effect of assumptions multiplies. In addition, the value

of lives saved and improved quality of life are not included in the costing.