The introduction of three new antiretrovirals into ART programmes in low- and middle-income countries (LMIC) -- tenofovir alafenamide fumarate (TAF), low dose efavirenz (EFV400) and dolutegravir (DTG) -- could represent over US $3 billion in savings by the end of 2025.
The Clinton Health Access Initiative (CHAI) presented these potential cost savings at CROI 2016.
CHAI used their forecast for currently available products as baseline and modelled differences in prices of new and current products. They assumed that TAF would displace tenofovir disoproxil fumarate (TDF) and AZT and EFV400 and DTG would displace EFV600 and nevirapine (NVP) in first-line; and DTG would replace TDF and AZT-based backbones in second-line.
They estimated price discounts of new products over time using: costs of raw material (either directly from manufacturers or from the India Import/Export database); API process costs (from patents or literature; and formulation costs (assumed API accounts for 70-90% of the cost formulation and packaging); volumes needed for economies of scale (chemistry inputs based on patents/scientific literature); and manufacturer profit margins (assumed approximately 25%).
CHAI's estimated per patient per year (pppy) price savings at launch and scaled up with new products are shown in Table 1. Market share of new products and cumulative savings to 2025 are shown in Table 2.
|Table 1: Estimated PPPY Savings With New Products|
|ARV||vs||At launch||At scale|
|NVP|| <$1|| $0-2|
|Table 2: Market Share and Cumulative Savings 2025|
|TAF||95% of first-line||$1.8 billion|
|DTG||80-90% of first-line and second line||$1.1 billion|
|EFV400||10-15% of first-line||$0.3 billion|
The authors note that they expect EFV400 expected to peak at approximately 25% market share in 2021 before DTG takes over.
TAF, EFV400, and DTG will enable programmes in LMICs to put more people on ART.
CHAI add that these findings support advocacy for accelerated availability of these products, and they strongly encourage the swift uptake of new antiretrovirals to realise their savings potential. CHAI stress that clear commitments for rapid adoption of the new products by national programmes would encourage more generic manufacturers to produce larger volumes at competitive prices, and help increase the number of people on ART.
DTG and EFV400 based generic products will become available over the next couple of years. TAF, which represents the biggest saving of US$ 1.8 billion by the end of 2025, needs a few more steps.
The potential for savings in generic-accessible LMIC is vast and, as CHAI rightly point out, will enable more people to take ART.
- Prabhu V et al. New ARVs could represent over USD 3 billion in cost savings through 2015. Conference on Retroviruses and Opportunistic Infections. 22-26 February 2016. Boston. Poster abstract 1050.
- Clayden P. WHO 2015 guidelines: newly recommended generic ART products on the way for adults. HTB, 1 February 2016.