Europe contributes to Sovaldi, the overnight blockbuster

New Hepatitis C treatment Sovaldi has enjoyed an unprecedented success in its first three months on the market, producing sales of $2.1 billion for Gilead.

The US pharma company confirmed the record-breaking launch to investors on Tuesday, and predicted further rapid growth ahead. Sovaldi (sofosbuvir) offers a cure to most patients with the potentially life-threatening Hepatitis C infection, and also cuts treatment time and side-effects compared to existing drugs.

This has allowed the drug to set a very high price for the drug in the US, where almost all of its sales so far have been generated. The drug is priced at $84,000 per treatment, which works out as $1,000 per pill. Despite a huge controversy over its cost, the drug's efficacy looks set to fuel its continued growth.

Gilead's executive team confirmed that around 30,000 patients have been prescribed Sovaldi, but none of these have yet finished the 12 week treatment, at which point they are expected to achieve Sustained Viral Response (SVR) when the Hepatitis C virus is no longer detectable in a patient's blood.

Paul Carter, the company's Executive Vice President, Commercial Operations said US prescribing has been driven mainly by hepatologists and gastroenterologists, but that internal medicine specialists and primary care doctors - many of whom also treat HIV patients - have also prescribed the drug.

"Despite the broad spectrum, we estimate that only half of the physicians visited by our therapeutic specialist have prescribed Sovaldi to date," said Carter.

"This leaves us optimistic about the opportunity that lies ahead. In fact, with an estimated 1.7 million diagnosed patients in the U.S. and around 400,000 under treated care, we have to take just a small fraction of those who can benefit from treatments in the future."

Hepatitis C has three main strains or 'genotypes' and 70% of US patients using the drug so far are genotype 1, reflecting its prevalence in the US. These patients must use Sovaldi with pegylated interferon and ribavirin, but Sovaldi allows patients with genotype 2 and 3 to dispense with interferon, a painful injection with causes a number of side effects.

Opposition in the US

Despite its huge success in its first quarter on the market, most US health insurance providers have not yet cleared the drug's reimbursement. Gilead says access to Sovaldi has been as predicted, and that its formulary status is consistent with reimbursement patterns in HIV, the company's existing area of expertise.

However most commercial insurers, 'Part D' and state Medicaid insurance plans take a full six months to review new drugs, and this time lag may give opponents time to block the drug's use.

Earlier this month, Express Scripts, one of the biggest and most powerful pharmacy benefit managers in the US spoke out strongly against the drug's high price.

Express Scripts chief medical officer Steven Miller told Bloomberg: "What they have done with this particular drug will break the country." He added: "It will make pharmacy benefits no longer sustainable. Companies just aren't going to be able to handle paying for this drug."

Express Scripts is reported to be calling on doctors to delay using Sovaldi until new rival drugs hit the market – AbbVie has just filed its Hepatitis C combination with the FDA – with the hope that competition will drive down prices.

The strength of opposition in the US will determine just how much Sovaldi can earn in its first year. Yet the drug already looks on track to eclipse the fastest ever drug launch – currently held by another Hepatitis C drug, Vertex's Incivek, which made $9 billion in its first year.

Europe

Despite gaining marketing approval across the European Union at the end of January, Gilead has only gained reimbursement for the drug in Germany, Austria, Sweden and Finland, with limited reimbursement in France.

The European sales for Sovaldi totalled a $164 million in the quarter – a small fraction of the total earnings for the period, reflecting the gulf between the US and Europe in terms of size of market and speed of reimbursement.

The company says it has filed health economic dossiers with all the major reimbursement agencies and is following the usual price and reimbursement processes.

The limited reimbursement in France is based on the country granting early access to the drug under its 'ATU' programme, which grants accelerated reimbursement for patients with the most acute condition - patients who are either pre or post-liver transplant and also those with advanced liver disease who have failed other HCV treatments or are interferon intolerant. Gilead says this is in line with the ATU scope and will widen when full reimbursement is agreed.

In England, a similar decision has just been made to grant access to early access to these patients with the most acute conditions, around 500 patients in all. NHS England has confirmed that it will spend 18.7 million on supplying the drug to these patients, which works out as £37,400 per 12 week treatment.

NICE, the cost effectiveness watchdog for England and Wales is due to make its initial ruling on the drug in May, with a final decision expected in October. However, as reported by pharmaphorum recently, many expect further negotiations on price in England before the drug can gain wider market access – even if NICE recommends the drug.

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NHS England approves early funding for Sovaldi