Antiretroviral drug prices in low- and middle-income countries

The WHO Global Price Reporting Mechanism collects information on the transaction prices of HIV, TB and malaria drugs and diagnostics from a variety of procurement partners and funding agencies, including the Global Fund to Fight AIDS, Tuberculosis and Malaria and the United States President’s Emergency Plan for AIDS Relief. Its broadly representative database currently contains data on the procurement of antiretroviral drugs from 128 countries, including 35 low-income, 51 lower-middle-income and 42 upper-middle-income countries (77). This section reports on price trends based on data accrued up to 1 July 2011.

In low-income countries, the prices of the six most frequently used fi rst-line regimens recommended by WHO declined between 2% and 53% between 2009 and 2010 (Fig. 5.11). Lower-middle-income and upper-middle-income countries had the same downward trend. Regionally, prices tended to be lower in sub-Saharan Africa than in other regions. However, the average prices paid for second-line regimens remain relatively high in all regions. Procurement data show that the number of prequalifi ed generic alternatives available is strongly correlated with the declines in the prices of antiretroviral drugs.

5.3.8.1 Prices of fi rst-line regimens in low-income countries

Table 5.14 Number of people receiving antiretroviral

therapy per laboratory with CD4 cell count or viral load measurement capacity, by geographical region, as of December 2010

Sub-Saharan Africa 20 2 287

[10–10 745]

39 539 [5257–326 241]

Middle East and

North Africa 8 150

[15–439]

the Caribbean 22 1 913

[61–5843]

2 773 [156–20 042]

The median price paid for fi rst-line regimens in low-income countries in 2010 ranged from US$ 64 per person per year for the fixed-dose combination of stavudine + lamivudine + nevirapine¹ (the most widely used combination) to US$ 242 for the most expensive fi xed-dose combination of tenofovir + emtricitabine + efavirenz (Fig. 5.11). The weighted median price² of the 10 most widely used fi rst-line regimens (representing 99% of those prescribed in low-income countries) was US$ 121 per person per year in 2010, 12% lower than the average weighted median price of the six most widely

1 WHO does not recommend stavudine + lamivudine + nevirapine, but it remains the most frequently used fi xed-dose combination based on the 2010 survey of the use of antiretroviral drugs (see section 5.3.7).

2 The weighted median price is the sum of the median prices of the individual regimens multiplied by the percentage of people using that specifi c regimen.

used fi rst-line regimens in 2009 (representing 96% of those prescribed in low-income countries). This decline in prices occurred despite the wider adoption of more expensive tenofovir-based regimens.

These observations are consistent with the price trends observed since 2006: in 2010, the weighted median price of antiretroviral drugs in low-income countries was 60% lower than in 2006. This can be attributed to the sustained scaling up of treatment programmes, leading to growing transaction volumes, greater predictability of demand and more vigorous competition among the various manufacturers.

Fig. 5.11 Median annual cost (in US dollars) of fi rst-line antiretroviral drug regimens for adults in low-income countries,

2008–2010

z 2008 z 2009 z 2010 700

600 500 400 300 200 100

EFV+[3TC+AZT]

600mg+[150+300]mg

EFV+[3TC+d4T]

600mg+[150+30]mg

3TC+NVP+d4T [150+200+30]mg

3TC+NVP+AZT [150+200+300]mg

EFV+FTC+TDF [600mg+200+300]mg

[FTC+ TDF]+NVP [200+300]mg+200mg Median transaction price (US$/per person/per year) 0

d4T: stavudine; 3TC: lamivudine; AZT: zidovudine; NVP: nevirapine; EFV: efavirenz; TDF: tenofovir; FTC: emtricitabine.

450 400 350 300 250 200 150 100 50

Fig. 5.12 Median annual cost (in US dollars) of fi rst-line antiretroviral drug regimens for children (weighing 10 kg or more) in

low-, lower-middle- and upper-middle-income countries, 2008–2010

z 2008 z 2009 z 2010

[3TC+NVP+d4T] [60+100+12]mg (LIC)

Median transaction price (US$/per person/per year) [3TC+NVP+d4T] [60+100+12]mg (LMIC) [3TC+NVP+AZT] [30+50+60mg] (LIC) [3TC+NVP+AZT] [30+50+60mg] (LMIC) AZT(100mg) (LIC) AZT(100mg) (LMIC) AZT(100mg) (UMIC) ZDV(100mg) (LIC) ZDV(100mg) (LMIC) ZDV(100mg) (UMIC)

0

In 2010, the combination of stavudine + lamivudine + nevirapine remained the most commonly prescribed formulation for children, representing 35% of total fi rst-line regimens prescribed for children weighing 10 kg or more. Its average price declined from US$ 57 per person per year in 2006 to US$ 52 in 2009 and early 2010.

The average prices of other combinations continued to fall as well (Fig. 5.12). Such price decreases can be attributed to the economies of scale associated with a larger market for formulations for children, especially resulting from UNITAID’s focused programme for children, successful negotiations with major generic manufacturers and the development of fixed-dose combination formulations for children.

5.3.8.2 Prices of fi rst-line regimens in lower-middle-income countries

The median prices in 2010 ranged from US$ 70 per person per year for the least expensive regimen of stavudine + lamivudine + nevirapine to US$ 241 per person per year for the most expensive regimen of tenofovir + emtricitabine + efavirenz. In 2010, the weighted median price of the 10 most widely used combinations in first-line regimens was US$ 124 per person per year, a decrease of 12% from the previous year.

The most commonly used combination among children (weighing 10 kg or more) was stavudine + lamivudine

+ nevirapine, and the price fell from US$ 70 per person per year in 2006 to US$ 52 in 2010.

5.3.8.3 Prices of fi rst-line regimens in upper-middle income countries

In 2010, the median reported prices in upper-middle-income countries ranged from US$ 66 per person per year for the least expensive regimen of stavudine + lamivudine + nevirapine to US$ 242 per person per year for tenofovir + emtricitabine + efavirenz. In the same year, the weighted average median price of the 10 most widely used fi rst-line regimens reported in the Global Price Reporting Mechanism was US$ 121 per person per year – a 40% decrease from the median price recorded in 2009.

The growing use of generic medicines (especially tenofovir- and nevirapine-containing formulations) in upper-middle-income countries is partly responsible for this rapid decline in median prices: in early 2010, about 70% of the transactions recorded in the Global Price Reporting Mechanism involved generic antiretroviral drugs versus about 30% in previous years. In addition, a few lower-middle-income countries became upper-middle-income countries but retained their previous price levels. However, the fall in median prices observed between 2009 and 2010 may not be representative of all upper-middle-income countries, as data captured through the Global Price Reporting Mechanism may not comprehensively include all relevant transactions.

1200 1000 800 600 400 200

Fig. 5.14 Median annual cost (in US dollars) of second-line antiretroviral drug regimens for adults in low-income countries

(LIC), 2008–2010

z 2008 z 2009 z 2010

ABC+ddI+LPV/r+RTV] 300mg+400mg+ [200+50]mg

Median transaction price (US$/per person/per year) [FTC+TDF]+[LPV/r+RTV] [200+300]mg+ [200+50]mg [3TC+AZT]+[LPV/r+RTV] [150+300]mg+ [200+50]mg [3TC+TDF]+[LPV/r+RTV] [300+300]mg+ [200+50]mg [3TC+AZT]+[LPV/r+RTV]+TDF [150+300]mg+ [200+50]mg+300mg [FTC+TDF]+[LPV/r+RTV]+AZT [200+300]mg+ [200+50]mg+300mg AZT+ ddI+LPV/r+RTV] 300mg+400mg+ [200+50]mg

0

d4T: stavudine; 3TC: lamivudine; AZT: zidovudine; NVP: nevirapine; EFV: efavirenz; TDF: tenofovir; FTC: emtricitabine; LPV/r: lopinavir with a ritonavir boost; ddI: didanosine; ABC: abacavir.

Indeed, some price increases have been noted elsewhere (78).

5.3.8.4 Prices of second-line regimens in low- and middle-income countries

The reported prices of second-line regimens also declined in 2010 but remained higher than the prices of fi rst-line regimens across low-income (Fig. 5.13), lower-middle-income and upper-middle-income countries. In 2010, the median reported cost of the most commonly used second-line regimen, lamivudine + tenofovir + ritonavir-boosted lopinavir, was US$ 554 per person per year in low-income-countries, US$ 692 per person per year in lower-middle-income countries and US$ 601 in upper-middle-income countries. The median reported cost of zidovudine + didanosine + ritonavir-boosted lopinavir, the second most commonly used second-line regimen, was US$ 701 per person per year in low-income-countries, US$ 908 per person per year in lower-middle-income countries and US$ 970 in upper-middle-income countries, with important variation across countries (78).

The decline in the prices of second-line drugs between 2006 and 2010 can be attributed to falls in the prices of abacavir, ritonavir-boosted lopinavir and tenofovir, the prequalifi cation of generic versions of ritonavir-boosted lopinavir and tenofovir, the expiry of the patent for didanosine, the scaling up of treatment programmes, new pricing policies by research-based pharmaceutical companies and the efforts of key partners to expand the market for second-line regimens. Although these developments are encouraging, addressing the relative higher cost of second-line regimens remains an important objective as antiretroviral therapy programmes mature and the number of people who need second-line regimens continues to grow.