A quarter of people with HCV initially refused access to sofosbuvir/lepidasvir, says US study, but most successfully appeal

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Insurers deny almost a quarter of requests for sofosbuvir/lepidasvir (Harvoni) to treat people with chronic hepatitis C virus (HCV) infection, investigators from Yale Liver Center report in PLoS One. However, most of those who were initially refused subsequently gained access after appeal. Advanced liver disease and Medicare/Medicaid insurance were associated with earlier decision and approval times, whereas Medicare/Medicaid coverage and high viral load were significant predictors of initial approval.

“We found that nearly one in four were denied initial approval, although most patients eventually obtained drug authorization through the appeals process,” comment the authors. “Fewer than 10% of patients ultimately failed to obtain access to therapy, although the appeals process led to further delay in treatment initiation.”

Treatment of HCV infection has been revolutionised by the development of direct-acting antiviral (DDA) agents. Compared to traditional therapy with pegylated interferon/ribavirin, treatment with DDAs is associated with better tolerability, improved adherence and high cure rates. Because of its efficacy, the combination sofosbuvir/ledipasvir (SOF/LED) is recommended by professional organisations in the US for the treatment of HCV genotype-1 infection.



In the United States, a programme providing health insurance to people on low-incomes of all ages. Provision varies from state to state, although some types of care are covered in all states.


In the United States, a federal health insurance programme that guarantees health coverage for people aged 65 and over and some younger people with disabilities.

retrospective study

A type of longitudinal study in which information is collected on what has previously happened to people - for example, by reviewing their medical notes or by interviewing them about past events. 


Severe fibrosis, or scarring of organs. The structure of the organs is altered, and their function diminished. The term cirrhosis is often used in relation to the liver. 


Thickening and scarring of connective tissue. Often refers to fibrosis of the liver, which can be caused by an inflammatory reaction to long-term hepatitis infection. See also ‘cirrhosis’, which is more severe scarring.

However, it is necessary for insurers to accept that treatment with DAAs is medically necessary and authorise access. A 12-week course of treatment with SOF/LED costs $94,500, or $1,125 per pill. Because of this high cost, insurer authorisation often requires that people have advanced fibrosis (F3 or above) or cirrhosis.

Investigators from Yale Liver Center wanted to see how many people with HCV were obtaining authorisation for therapy with SOF/LED in a “real world’ setting, and also the factors associated with approval, time to decision, and time to approval. They therefore designed a retrospective study involving 129 people prescribed SOF/LED at the centre between October and December 2014.

Their mean age was 57 years, 61% were male and 61% had liver cirrhosis.

Over three-quarters (77.5%) received initial approval. A further 17 (14%) subsequently obtained access to the treatment on appeal. The average time to final appeal was 26 days, and for those who were approved, the average time to decision was 23 days.

Faster approval time was seen for people with Child-Pugh Class B disease (14 vs. 25 days, p = 0.048).

People with Medicaid/Medicare coverage were more likely to be initially approved than those with private insurance (92% vs 71%, p = 0.002). A viral load above 6 million iu/ml was also associated with initial approval (84% vs. 63%, p = 0.04).

Factors associated with shorter decision and approval times were female gender, advanced fibrosis and higher MELD score. Psychiatric disease was a significant predictor of shorter time to approval.

“This is the first study to our knowledge assessing real-world access to interferon-free DAA regimens in established cohorts of patients with chronic HCV seeking antiviral therapy,” write the investigators. “These results contribute to the limited data available addressing the proportion of patients successfully obtaining drug authorization through public and private insurance carriers, time to approval, and predictors of approval.”

They emphasise, “most patients filing a pre-authorization request for SOF/LED are eventually approved, but nearly 1 in 4 were denied access upon initial request, which may represent a barrier within the HCV care cascade.”

A different study design, which looked at insurance approvals in patients presenting prescriptions at a specialty pharmacy chain in four US states, presented at the 2015 Liver Meeting, found that patients with Medicaid insurance were significantly more likely to be refused insurance coverage of their hepatitis C treatment.


Do A et al. Drug authorization for sofosbuvir/ledipasvir (Harvoni) for chronic HCV in a real-world cohort: a new barrier in the HCV care cascade. PLoS ONE 10 (8): e0135645. doi:10.1371/journal.pone.0135645.