November 26, 2014
DC Department of Health Care Finance
Attn: Charlene Fairfax, RPh, CDE
441 4th Street NW, Suite 900 South
Washington, DC 20001
RE: District of Columbia DHCF P&T Committee Preferred Drug List Review – Hepatitis B and Hepatitis C Agents
Hepatitis B Agents
 We recommend Tenofovir (Viread) and entecavir (Baraclude or generic) both be considered first line therapies
for chronic hepatitis B infection.
 Preauthorization for any HBV therapy is discouraged as it presents an additional challenge for both providers
and their patients who largely represent a population already disproportionately impacted by health care access
barriers.
 We recommend that the generic names be used for all chronic hepatitis B therapies, rather than the trade
names: Entecavir (Baraclude), Tenofovir (Viread), Lamivudine (Epivir), Adefovir (Hepsera), Telbivudine (Tyzeka).
Hepatitis C Agents
 Harvoni, recently approved by the FDA, represents a significant advancement in the treatment of hepatitis C
genotype 1 (see bullet #2). As such, we strongly recommend that Harvoni be designated as a “preferred” drug
on the District of Columbia Department of Health Care Finance Pharmacy Preferred Drug List.
 If Harvoni is determined to require prior authorization, we strongly urge the DHCF P&T Committee to reconsider
its clinical criteria for hepatitis C treatment. We believe such reconsideration is warranted as Harvoni is:
o The first FDA-approved treatment for hepatitis C which requires neither interferon nor ribavirin.
o The first treatment with labeling to support a shortened duration of only eight (8) weeks of treatment in
select patients.
o Consistently reported to yield high sustained virologic response (SVR) rates exceeding 90%, regardless of
prior treatment experience or cirrhosis, with a remarkably low rate of side effects and adverse events,
and few clinically relevant drug-drug interactions.
 Specifically, we urge the DHCF P&T Committee to align clinical criteria with the best available evidence, with
substantial deference to patient-provider decision-making. We highlight a recent clarification to the AASLD/IDSA
Hepatitis C Guidance:
o “Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to
virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence
clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less
than 12 months) due to non–liver-related comorbid conditions.” [hepcguidelines.org, emphasis added]
 In addition, AASLD released a policy statement clarifying that the Guidelines’ prioritization of patients in highest
and high need of HCV treatment was intended solely as a guide to patient-provider decision making, and not as
a rationale for denial of coverage of treatment by payers:
o “Our Guidance is not intended to be used by payers to deny access to treatment. In no way does this
position contradict the evidence evaluated to produce the Guidance and the recommendation made in
the Guidance to treat the sickest first, but recognizes need to treat all.”
 The following highlights aspects of the clinical criteria for sofosbuvir which appear to be in conflict with the
AASLD/IDSA Hepatitis C Guidance, are not otherwise supported by evidence, and/or inflict undue and unethical
burden on patients:
o Restricting treatment to one course of therapy per DC Medicaid lifetime
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
Despite high cure rates, even with 100% adherence a proportion of the population will still not
achieve SVR, as evidenced by clinical trials. This population will require additional treatment to
achieve SVR and avoid future, highly costly sequelae.
 It is highly unethical, therefore, to enact a blanket restriction of one course of treatment
per DC Medicaid lifetime.
 Further, clinical trial and real-world evidence suggests low rates of reinfection across a variety of
sub-populations, making the need for such a restriction superfluous in clinical criteria for
treatment.
 In instances of reinfection, it is also unethical and poor public health practice to deny curative
treatment for a communicable, chronic, and life-threatening virus such as hepatitis C.
o Restricting replacement of lost or stolen medication
 Requiring “legitimate documented evidence” of loss or stolen medication offers not only a
vague requirement without a clear avenue for appeal, but places gratuitous hardship on
patients who are otherwise committed to therapy and adherent.
 This restriction is particularly concerning for vulnerable populations, including the homeless and
unstably or transitionally housed, particularly given the once-in-a-DC-Medicaid-lifetime criteria.
o Restrictions related to illicit drug and alcohol abstention
 Clinical evidence does not support the denial of treatment to active drug users – this prohibition
is based on non-medical, discriminatory thinking. Active users can and have been successfully
treated; this is a decision more appropriately decided within the provider-patient relationship.
 Given the lack of evidence to support such denial of treatment, it is highly unethical to
categorically exclude drug users from the opportunity for curative treatment.
 Further, this restriction denies treatment to a population with some of the highest rates of
hepatitis C, presenting a missed opportunity to significantly reduce both the District’s
prevalence and continuing transmission of hepatitis C.
 Alcohol use is not accurately detected with monthly urine screening, making this restriction not
only unnecessary and ineffective, but costly to the system and DC taxpayers.
 We believe patient counseling and education, already included in clinical criteria, in
combination with guidance within the provider-patient relationship is sufficient.
 This restriction further imposes undue hardship on the District’s medicinal marijuana patients
who legally access this treatment in consultation with their medical provider.
District patients have been waiting, hopeful, for many years for this new era in hepatitis C treatment. While the
Affordable Care Act recently helped millions of Americans gain access to health coverage, many for the first
time, its mandate that no individual be denied insurance based on a pre-existing condition is meaningless if that
coverage restricts access to the treatment needed to cure that condition.
Thank you for the opportunity to submit these comments; please contact us if you have questions or require additional
information.
Sincerely,
Christine Rodriguez, MPH
National Viral Hepatitis Roundtable
crodriguez@nvhr.org
Chari Cohen, MPH, DrPH(c)
Hepatitis B Foundation / Hep B United
chari.cohen@hepb.org