Around one in six people with hepatitis C in four US states
had their prescriptions for direct-acting antivirals refused by insurers, and
almost half of Medicaid recipients were denied reimbursement in 2014 and early
2015, a study by the University of Pennsylvania has found. The findings were presented
on Monday at the 2015 AASLD Liver Meeting in San Francisco.
Restrictions on Medicaid funding of direct-acting antiviral
treatment by state governments in the United States has led the Centers
for Medicare & Medicaid Services to write to state Medicaid directors
to remind them that they are expected to cover new interferon-free antiviral
therapies for hepatitis C without undue restrictions.
Access to direct-acting antiviral treatment may be
restricted by insurers through medical criteria – such as restricting treatment
to people with advanced fibrosis – or by applying requirements such as
abstinence from alcohol or injecting drug use. Insurers may also delay
decisions on treatment, potentially risking a worsening of liver damage or even
The extent to which insurers – including the Medicare system
of publicly-funded insurance for over-65s and the Medicaid publicly-funded
system for people on low incomes – restrict access to hepatitis C treatment was
investigated by researchers from University of Pennsylvania, led by Assistant Professor
of Medicine Vincent Lo Re. The researchers were particularly interested to find
out whether Medicaid recipients faced greater difficulties in obtaining approval
The study used data supplied by Burman’s pharmacy, looking
at all hepatitis C medication prescriptions in four states – Delaware,
Maryland, New Jersey and Pennsylvania – between 1 November 2014 and 30 April
2015. The researchers evaluated what proportion of prescriptions submitted for
insurer approval by the pharmacy were refused, the reason for refusal and how
long it took for prescriptions to be approved. These outcomes were assessed
according to the type of insurer (private insurance, Medicare for over-65s and
the disabled, and Medicaid for people with low-income or special needs).
During the study period 2321 people presented prescriptions
for direct-acting antivirals which were subsequently submitted to an insurer and
were eligible for analysis. The study excluded people with genotypes 4-6,
people whose medication had already been authorised prior to the pharmacy
visit, uninsured people or those who were not permitted to use Burman’s Pharmacy
by their insurer. The majority of people presenting prescriptions were covered
by Medicare (800) or Medicaid (517); 1025 people were privately insured. Most
Medicaid recipients were receiving care through a Medicaid-approved managed
Unsurprisingly, Medicare recipients were significantly older
than other insurance groups, and Medicare and Medicaid recipients were more
likely to be African-American (29% and 33% respectively, compared to 21% of
privately insured, p < 0.001), and to have cirrhosis (35% and 32%
respectively, compared to 26% of the privately insured.
The vast majority of prescriptions were for
sofosbuvir/ledipasvir (Harvoni) (80%
of Medicaid and 86% of other insured persons) or for sofosbuvir (Sovaldi)/ribavirin (11% of Medicaid).
Overall, 16.2% of prescriptions were refused. Recipients of Medicaid
were significantly likely to be refused – 46% of Medicaid recipients were refused
reimbursement, compared to 5% of Medicare recipients and 10% of the privately
insured. Medicaid recipients were ten times more likely to be refused
reimbursement when compared to the privately insured.
Of those refused, lack of data to determine medical need was
the most common reason, accounting for almost half of all Medicaid refusals. Around
one-third of Medicaid denials were on the grounds of lack of medical need. In
comparison, half of all privately insured patients who were denied treatment
were refused on the grounds of lack of medical need.
In each insurance category a disturbing proportion of
patients refused treatment received no formal letter of denial, and the insurer
did not bother to respond. Approximately one in seven Medicaid recipients who
failed to receive insurance authorisation received no letter informing them
that their prescription had been denied.
Drug and alcohol use were not major reasons for denial.
Around 5% of Medicaid recipients were denied treatment on these grounds,
compared to 10% of privately insured patients. However the researchers
emphasised that they lacked information on drug or alcohol history, and that
this information might be a confounding factor.
People without cirrhosis were significantly more likely to
be denied treatment (adjusted odds ratio 2.85), as were people who presented
prescriptions before 31 January 2015 (aOR 3.16).
People insured by Medicaid had to wait significantly longer
than others for their prescription to be approved – a median of 24 days compared
to 14 days for others (p < 0.001), and a quarter had to wait over 49 days.
Denial of treatment and delays in treatment are likely to
result in worse outcomes, the investigators warned.