In August 2012, the big news in the hepatitis community was a new set of CDC guidelines recommending that all Baby Boomers (those born between 1945 and 1965) receive a hepatitis C test. According to the CDC, at that time, more than two million U.S. baby boomers were infected with hepatitis C (HCV), representing approximately 75% of all HCV-infected individuals and the vast majority of the 15,000 people who would die of HCV-related causes that year.
The goal of universal testing for this age cohort was to help identify more than 800,000 additional HCV-infected individuals, who had not yet been diagnosed.
HCV treatment in the pre-Sovaldi era
Before the introduction of Gilead’s Sovaldi (sofosbuvir) HCV treatment was no easy task, especially for the patient. Treatment consisted of combination therapy with injectable pegylated interferon alfa and ribavarin (RBV) for 24 to 48 weeks. Although this regimen was relatively effective for patients with HCV genotypes 2 or 3—the average sustained virological response (SVR) rate was 80%—it was less effective for patients with HCV genotype 1.
Moreover, the interferon-based regimens had some serious side effects, including increased risk of depression and flu-like symptoms. Given the complexity, cost and side effects of this regimen, adherence was a problem, leading many patients to not achieve sufficient SVR.
On December 6, 2013, the FDA approved once-daily, oral Sovaldi (400 mg) for treatment of genotypes 1,2,3, and 4. As part of its announcement, Gilead heralded the availability of a series of firsts: The first-ever oral treatment for HCV genotypes 2 or 3, high cure rates, a shortened 12-week regimen (for most patients) and the first-ever regimen for patients awaiting liver transplantation to prevent HCV recurrence.
Though the news of Sovaldi’s arrival was enthusiastically received by patients, physicians and and the larger hep C community, payers immediately expressed their concerns about the $1,000-per-pill cost of Sovaldi, resulting in an overall cost of $84,000.
In fact, within three months, Sovaldi was generating roughly 6,500 prescriptions per week, and payers were starting to impose restrictions. Everyone from members of Congress to state governments started to question pricing. Then the pharmacy benefits manager, Express Scripts, ratcheted up the level of hysteria, when it estimated that if every eligible Medicaid patient or prisoner were to take Sovaldi, it would end up costing states a total of $55 billion.
Expanding the treatment pool
When Harvoni (sofosbuvir/ledipasvir) was approved by the FDA in October 2014, it broadened the scope of HCV treatment options, and the uptake rate was even quicker than with Sovaldi. Within three months, Harvoni was generating 7,000 prescriptions per week. Then in December 2014, AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir) was approved, further expanding the potential treatment pool.
A lot has changed in the last two and a half years. "With the new treatments, people are excited about being treated and cured," Alan Franciscus, founder and executive director of the Hepatitis C Support Project and editor-in-chief of the HCV Advocate, told BioPharma Dive in an interview. "Prior to the approval of interferon-free therapies, there was usually a reluctance from patients—maybe a better word is fear—of treatment."
However, despite the seismic shift in the hepatitis C treatment landscape, there are still roughly 1.5 million patients who have been diagnosed with hepatitis C, who remain untreated, as well as a large population of undiagnosed HCV-infected individuals. Even worse, every day, 26 people are still dying from HCV-related causes, according to the National Medical Association. There are a number of reasons, largely related to lack of awareness and diagnosis, as well as social and cultural barriers, but access is still a major challenge.
Big data insights from Treato and the challenge of coverage
Leveraging the power of Big Data, Treato, which aggregates patient experiences from the Internet, analyzed online conversations among people in the hepatitis C community. Treato analysts found that Harvoni was the most popular treatment option, mentioned positively online twice as much as Sovaldi. They also found that 26% of those online discussing hep C treatment options fall into the 50- to 64-year-old age category.
One thing that has become clear through Treato's insights is that getting coverage for one of the new hep C treatments is challenging. When Treato looked at the insurance issue, they found that many patients were concerned about how to navigate the appeals process after being denied coverage. Also, a large part of the conversation around getting coverage was related to how sick a person needs to be to be approved for treatment with Sovaldi or Harvoni.
These observations from Treato echo a cost-management strategy outlined by CVS Health in December 2014, when the company included “evaluation of severity of illness” as a major decision-making factor in who could be covered.
Franciscus finds this trend disturbing. "We know that many insurance companies and state Medicaid insurance funds are denying coverage to patients unless their HCV liver disease is severe," he said. "One person denied coverage said to me, ‘Maybe I should start drinking a lot of alcohol.’ While this statement is extreme, I think it highlights the frustration some patients feel, because these ‘miracle’ treatments are here, but there are so many obstacles to access them."
Product uptake continues
Despite barriers to access, the IMS Institute for Healthcare Informatics estimates that between 2014 and 2108, roughly 450,000 people will be treated with one of the new hep C treatment regimens. Francisus conceded that although access has been a challenge, the availability of Sovaldi, Harvoni and VieKira Pak—the so-called "miracle" drugs, has increased awareness "dramatically." And that, undoubtedly, is a good thing.