Sovaldi hurdles first drug pricing barrier
pharmafile | June 10, 2014 | News story | Sales and Marketing | Gilead, SMC, Scotland, hep C, sofosbuvir, sovaldi
Scotland’s NHS will pay for Gilead’s new hepatitis C pill Sovaldi despite rising concern over its high cost.
The Scottish Medicines Consortium, which assesses the cost-effectiveness of new medicines in Scotland, will allow Sovaldi (sofosbuvir) to be funded in the country for patients with genotypes of the disease from one to six.
But there are some restrictions, as use in patients who have not yet been treated with genotype 2 is limited to those who are ineligible for – or are unable to tolerate – the older injectable drug made by Roche known as Pegasys (peginterferon alfa).
Use of the 24-week interferon-free regimen of the drug, in combination with Roche’s other ageing hep C treatment Copegus (ribavirin) in patients with genotype 3, also has the same restrictions.
The fact that a health technology assessment body has approved its medicine will be a big lift for Gilead, which has come under attack for its pricing regime for the drug. It is the first body to do so in Europe.
In the US Sovaldi costs $1,000 (£600) a day, or around $84,000 per course of treatment per patient, making it one of the most expensive medicines on the market outside of oncology or rare disease.
In Scotland, the drug is estimated to cost around £37,000 per treatment, per patient.
“We are pleased that the SMC have recognised the significant efficacy and safety profile demonstrated by sofosbuvir in clinical studies and therefore agree it is a valuable use of NHS resources given the high unmet need in hepatitis C,” says Stelios Karagiannoglou, general manager UK of Gilead Sciences.
“We are looking forward to working with Scottish Health Boards to support sofosbuvir’s inclusion on local formulary to ensure patients will be able to benefit from the treatment immediately.”
Petra Wright, the Scottish officer for The Hepatitis C Trust which is partially funded by the pharma industry, adds: “The Trust welcomes the SMC’s advice that sofosbuvir should be made available to NHS patients in Scotland, in what we hope to be the first of many emerging therapies for Hepatitis C.
“The advent of these ‘patient friendly’ medications will reduce treatment duration and the severity of side effects experienced by those affected. This is a step in the right direction which we hope will hasten the elimination of Hepatitis C from Scotland.”
NICE decision looms – but funding in place
NICE is still appraising the medicine and therefore it is not yet available on England’s health service.
The biggest test for the medicine will be whether it can pass this barrier as NICE and the SMC do occasionally make different decisions on the same drug.
But in a highly unusual move NHS England decided in March to pay as much as £18.7 million in a silo fund to treat the 500 patients who could benefit from Gilead’s new treatment here, making NICE’s decision less important for the firm.
This funding stream is the first of its kind for a disease area outside of cancer, with the Hepatitis C Trust a major lobbying force behind its creation.
Whilst the drug’s price has come under intense scrutiny, even in the usually liberal US market, most recognise that it is a highly efficacious drug, and is the best currently available on the market.
Recent clinical trial data show that Sovaldi can effectively cure the disease in over 90% of patients in just 12 weeks. This is compared to other treatments such as Vertex’ Incivek (telaprevir) and Merck’s Victrelis (boceprevir), which take double the amount of time to treat and have cure rates of around 75 per cent.
This efficacy has also translated into astonishing sales – hitting over $2 billion in its first quarter – making it the fastest-selling medicine in the world and on course to break the $10 billion barrier by next year, should this trajectory hold.
A decision by NICE is expected later this year.
Ben Adams
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