WASHINGTON - Gilead Sciences executives were acutely aware in 2013 that their plan to charge an exorbitantly high price for a powerful new hepatitis C drug would spark public outrage, but they pursued the profit-driven strategy anyway, according to a Senate Finance Committee investigation report released Tuesday.
"Let's not fold to advocacy pressure in 2014," Kevin Young, Gilead's executive vice president for commercial operations, wrote in an internal email. ''Let's hold our position whatever competitors do or whatever the headlines."
Gilead gained federal approval for its drug Sovaldi in late 2013 and ultimately settled on the price of $84,000 for a 12-week course of treatment. To the company, that price seemed to deliver the right balance: value to shareholders while also not so high that insurers would "hinder patient access to uncomfortable levels," according to internal documents. But they also got more than they bargained for: an outpouring of outrage from the public, a backlash from government and private payers, and political scrutiny.
The 18-month Senate committee investigation reviewed more than 20,000 pages of company documents.
"The documents show it was always Gilead's plan to max out revenue, and that accessibility and affordability were pretty much an afterthought," said Sen. Ron Wyden, D-Ore., who co-led the investigation with Sen. Charles Grassley, R-Iowa, in a press conference.
In a statement released Tuesday, Gilead disagreed with the conclusions of the report, saying that the price was "in line with previous standards of care." The company noted that it has programs in place to help uninsured patients and those who need financial assistance access the treatments. More than 600,000 patients around the world had been treated with Gilead's hepatitis C drugs since 2013, according to the company.
Here are four key takeaways from the investigation:
1) It could have been priced at $115,000 for a course of treatment.
Gilead considered a range of prices for Sovaldi and weighed the value to its shareholders against the "reputational risks," meaning the potential outrage from patients, physicians and payers. The potential prices ranged from $50,000 to $115,000.
Executives believed a $50,000 price would build good will and ensure easy access to the drug because it would be covered by most plans. But it would cause "significant foregone revenue," and activists would still critique the price, even at this relatively low level.
At $115,000, executives were concerned about "external considerations" and predicted: "High levels of advocacy group criticism and negative PR/competitive messaging could be expected at $115K and it would be increasingly difficult to manage at these levels."
2) Gilead priced Sovaldi partly based on the expectation it would set a benchmark for the next drugs in the pipeline.
A company presentation noted that Gilead has "considerable pricing potential" for Sovaldi, but that future pricing for next-generation drug launches would be limited by competition -- what it referred to as a second wave of treatments.
"Wave 1 will set a price benchmark against which Wave 2 will ultimately be evaluated," the presentation stated.
"By elevating the price for the new standard of care set by Sovaldi, Gilead intended to raise the price floor for all future hepatitis C treatments, including its follow-on drugs and those of its competitors," the report states.
Its next hepatitis C drug, Harvoni, was priced at $94,500.
3) Patients were warehoused to limit access to Sovaldi.
Facing pent-up demand for a hepatitis C treatment, insurers quickly began to implement restrictions -- essentially, warehousing patients by putting sick people aside until they were even more sick. Medicaid programs in 27 states limited which patients could get access to Sovaldi. Private insurers did, too.
In a letter, the Oregon Health Authority reported that while more than 10,000 Medicare patients were deemed good candidates for Sovaldi and its competitors in fall of 2014, the estimated cost of treating half of them would more than double the entire $600 million spent on all drugs in the previous year. Instead, because treating more advanced patients would be more cost effective, the state implemented a plan to treat at the rate of 500 patients a year for the first six years.
Kentucky's Medicaid program noted that the state's heroin epidemic exacerbated its hepatitis C problem -- people who had injected drugs were being tested for the disease, raising the tricky question of when to start treatment.
"Given the current cost of the newer treatment options and to remain fiscally responsible we will be forced to make difficult decisions regarding who does and does not get access to treatment medications upon diagnosis," Samantha McKinley, pharmacy director of the Kentucky Department for Medicaid Services, wrote in a letter to Grassley and Wyden.
4) Cost-per-cure, not cost of development.
The report suggests that the factors Gilead used to set its price were not based on the research and development needed to bring the drug to market, or on the $11.2 billion it paid for Pharmasset, the company that developed Sovaldi. Instead, Gilead executives looked at what previous treatments had cost and the effect of future waves of competition on the revenue it could bring in.
"Company officials surmised that its drug had a 'value premium' because of increased efficacy and tolerability, shorter treatment duration, and its potential to ultimately be part of an all-oral regimen," the report states.
In its statement Tuesday the company said, "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 [hepatitis C virus]."
With another Senate committee now probing price increases at four other pharmaceutical companies, the final conclusion of the report may be one we see repeated.
"This might be an example that received the most attention in some time, but it won't be the last," Grassley said in a statement.
Alaska Dispatch Publishing