Scientific questions usually dominate medical meetings – except for the hepatitis C field, in which a long-awaited drug costs $1,000 a day and has cast a long shadow over global access. So it is with Europe’s main liver disease meeting, where specialists are openly wondering about how to deliver the best treatments to patients in even the richest countries of the West.
Gilead Sciences’ Sovaldi can cure as many as nine out of 10 hep C patients, depending on genotype and stage, but its cost has provoked pushback from payers around the world. With even pharmacy benefit managers in the US objecting, this has raised questions about whether this time rich nations will be able to subsidise delivery of a much-needed new drug to developing nations, as has happened in the past.
“This is based on an old model; the HIV model,” said Jean-Michel Pawlotsky, Director of the French National Reference Centre for Viral Hepatitis B, C and delta. “I think the rich will no longer be able to pay for the poor.”
Hundreds of billions of dollars
Price is always a concern when new drugs are introduced, but the difference in the case of Sovaldi is the sheer volume of potential patients: 3.2 million in the US, which at Sovaldi’s $84,000 price tag would cost payers hundreds of billions of dollars to cure. With US guidelines now calling for the screening of all adults born between 1945 and 1965, many asymptomatic patients could be diagnosed in the coming years, increasing demand for treatment.
Private payers like the pharmacy benefit manager (PBM) Express Scripts have become vocal about this potential budget-buster, and it has even come to the attention of members of the US Congress who have sought an explanation for its price (Gilead price challenge tests the coolest of heads, March 24, 2014).
The US is not alone in raising concerns. At a 12-week price of about $77,000 in France, “Gilead put a price so high that general practitioners and specialists are questioning (it),” said Chloe Forette, hepatitis and HIV risk reduction advocate with Médecins du Monde. “I think it will be very complicated for the French government to provide treatment to all the people who need it right now.”
Globally, 185 million people are estimated to be infected. To its credit, Gilead has taken steps to provide access to cheap pills in some of the world’s poorest countries through a licence to generic manufacturers in India and 99% price discount in Egypt, for example.
Still, the group’s flexibility to provide such discounts is based on the willingness of wealthy nations to pay a premium, which might not be true in the current economic environment, as demonstrated by the US payers’ objections.
“The economy in formerly rich countries is not good. We’re becoming poorer, whereas other economies are emerging,” Dr Pawlotsky said. “We really have to think about a new model together.” Unlike HIV, hepatitis C is an epidemic centred primarily in middle-income countries, and this could alter the willingness of big pharma to open intellectual property to generics or offer steep discounts.
Significantly, while Gilead has signed a 60-country voluntary licensing agreement for Sovaldi, China is not included. Presumably, price negotiations will enter into the discussions in this instance, but it is a sign of the ways in which Gilead is looking to maximise its $11bn payout for Sovaldi through the acquisition of Pharmasset.
However, the evolution of science in the field, it is hoped, might benefit accessibility in developing countries as well as improving cure rates. Competition, for example, could avoid the need to use compulsory licences that mandate generic production in poor and middle-income countries.
“Are there shorter regimens? The data is coming quickly,” said Paata Sabelashvili, from the advocacy group Georgia Harm Reduction Network. “And there are new compounds coming that we hope will generate the competition and it will not be left for compulsory licenses.”