- A top executive at Gilead defended the company's pricing of its blockbuster hepatitis C treatment Sovaldi, penning a point-by-point rebuke to a critical article in a major medical journal.
- The authors of the article, which was published in The BMJ last week, argued Gilead's high list price for Sovaldi (set at $84,000 per treatment course) negatively affected public access to the near-curative treatment.
- Gilead's Gregg Alton, head of commercial and access operations at the California-based drugmaker, fired back in a digital letter to the editor, arguing the authors did not accurately portray Gilead's decision-making process for deciding Sovaldi's price.
Gilead acquired the key compound which makes up Sovaldi when it bought Pharmasset for $11 billion in 2011. After pushing the drug though final clinical testing and regulatory review, Gilead set the wholesale acquisition cost for the drug at $84,000 per 12-week regimen—a price critics have attacked for being excessive. The move was a major catalyst in the pricing debate that has plagued the indsutry over the last few years.
Alton, in his response to The BMJ article, strongly disputed several of the assertions made by the authors and defended Gilead's pricing practices.
"We stand behind the pricing of our therapies because of the benefit they bring to patients and the significant value they represent to payers, providers and our entire healthcare system by reducing the long-term costs associated with managing chronic HCV," Alton wrote.
Alton claimed Gilead conducted "extensive research" with private and public payers to set Sovaldi's price, settling on $84,000 as a price neutral to the cost for standard-of-care treatment at the time it was introduced to the market.
Echoing arguments made by other drugmakers, Alton highlighted the rebates and discounts provided to payers for Sovaldi. The U.S. Department of Veterans Affairs and Medicaid both currently pay less than 50% of Sovaldi's list price, Alton said.
In the article, the authors suggested Pharmasset had considered an initial price of $36,000 for sofosbuvir (the compound which became Sovaldi under Gilead). According to Alton, this is inaccurate.
"Pharmasset anticipated initial pricing of the regimen sofosbuvir would be used in would be priced neutral to the average standard of care regimen at the time. As of late 2011, that cost was approximately $72,000 for up to a 48 week duration of therapy,' Alton said.
The $36,000 figure comes from Pharmasset's consideration that sofosbuvir might be approved in conjunction with other drugs, in which case sofosbuvir would account for a minimum 50% of total treatment value. Sofosbuvir, when approved as Sovaldi under Gilead's sponsorship, was okayed for use with either ribarvirin or a combination of ribavirin and peginterferon-alfa.
Alton also pointed to the "considerable risk" Gilead took when acquiring Pharmasset as data on sofosbuvir's efficacy against the most common type of hep C was limited at the time of the deal.
Gilead's response to The BMJ is an example of the more aggressive approach drugmakers have begun to take to respond to sustained public criticism of pricing practices in the industry. Industry trade groups such as BIO and PhRMA have launched campaigns seeking to tell their side of the story and place drug pricing within the broader context of the healthcare system.
But as the presidential election draws near, drug pricing will likely become a more prominent point of debate.