Dr Hill highlighted the opportunity for reducing the cost of
antiretroviral therapy in Europe, North America and Australasia over the next
few years as many frequently-prescribed antiretroviral drugs go off patent.
Generic competition and pricing transparency have the
potential to drive down treatment costs by 90% – if purchasers are
well-informed about the real costs of manufacture.
Efavirenz and lamivudine are already available as generic
products, while abacavir/lamivudine and lopinavir/ritonavir will become
available as generic products by the end of 2016.
In 2017 generic versions of emtricitabine and tenofovir will all become available – and generic
manufacturers will also be able to sell tenofovir/lamivudine combination pills
already widely used in low- and middle-income countries. In most cases the
products on sale are already prequalified by the World Health Organization or
the US Food and Drug Administration for purchase by the Global Fund to Fight
AIDS or the US President’s Emergency Plan for AIDS Relief (PEPFAR), and have
passed stringent regulatory tests, ensuring rapid approval for developed world
In 2018 atazanavir/ritonavir will become available as a generic and in 2019 darunavir will go off patent, allowing it to be co-formulated with generic ritonavir as a boosting agent.
But, said Dr Hill, few policy-makers or purchasers of
antiretroviral drugs in Europe know just how cheaply antiretroviral drugs can
be manufactured, or are aware of the opportunities for profiteering by
unscrupulous owners of generic products. He highlighted a recent investigation in
the United Kingdom revealing overcharging up to 1000% by one generic
manufacturer as an example of the risk faced by purchasers – such as the
individual National Health Service (NHS) hospitals responsible for drug purchasing in
many parts of England and Wales – when generic replacements for antiretrovirals
begin to appear on the market.
The problem is further exaggerated in the United States
where insurers are liable to pay up to four times the price paid by the UK’s NHS for branded antiretrovirals. In 2016 the US list price
for a year’s prescription of Truvada
was $21,120. The United Kingdom list price for Truvada was $5553. In both cases discounts may apply. A generic
tenofovir/emtricitabine pill is currently available for $67 a year for purchase
by low- and middle-income countries.
“Few national health services know these costs. We need a
lot more pricing transparency, which will have a cascade effect across
therapeutic areas,” he said.
Cancer drugs can also be manufactured cheaply and as these
come off patent, costs can be driven down. For example, the patent on Gleevec (imatinib) for chronic myeloid
leukemia expired in 2016. The current US list price of Gleevec is $146,000, the
drug is currently marketed by Indian manufacturers for $803, and could be made
for $172. However, the first generic entrant to the US market is charging only
10% below the current price of Gleevec
for its formulation of imatinib (see The
ASCO Post for more information on what can go wrong when generics enter the
He also drew attention to the impact that the arrival of
generics might have on the ability of originator companies to negotiate higher
prices for innovative products. Whereas companies could argue that the additional
value of a product in terms of quality of life, virological superiority or convenience
justified a premium compared to existing products, especially previous
formulations of the same drug, companies could now be faced with having to
justify premium pricing compared to low-cost generic products.
Disease elimination – whether of HIV, viral hepatitis or TB –
is only feasible if drugs can be accessed at low prices, within national health
budgets, said Dr Hill. Current global targets for elimination of these diseases
will not be reached without price reductions, and the availability of a growing
range of generic drugs to treat HIV will call into question the prices charged
for branded products, he concluded.