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, tenofovir, atazanavir/ritonavir and darunavir/ritonavir 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 markets.
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 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 National Health Service 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 marketplace).
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.
Source: Aidsmap