HCV Therapy Management Now and in the Near Future
Why a Specialty Pharmacist Intervention and Continued
Support is Critical
Christa Bigham, RPh, PharmD
Christine Anderson, BSPharm
Orchard Specialty
The authors report no financial conflicts with any products discussed in this paper.
Triple therapy with interferon, ribavirin and a protease
inhibitor introduced mid 2011 followed by interferonfree regimens in 2013 marked a new era for the
treatment of chronic Hepatitis C (HCV). By 2015,
several more therapeutic options and combination
regimens to treat HCV-infected patients are expected
to be available. Rapid changes in treatment options
and evidence-based guidelines require pharmacists
to maintain updated training as well as regular
revision of patient management pathways.
Therapy selection was once a very simple process in
which a prescriber identified a patient with the virus,
measured the impact of the disease and prescribed
several months of interferon and ribavirin therapy.
The explosion of new drugs to market will present the
healthcare industry with several efficacious therapy
options, different combinations of competitive
products, and rapidly evolving guidelines.1 This
significant advancement in efficacy and safety is
expected to come with a steep cost. It has now
become a necessity for all provider types to take a
proactive approach before the next agent is available.
A pharmacist should be a valuable asset to both
the payor and the healthcare provider by evaluating
clinical appropriateness prior to any HCV therapy
initiation.
Gastroenterologists and other HCV specialists have
done their research, followed studies and have
preselected candidates for these new regimens even
before they are FDA approved. Health plans and
payors need to respond quickly to the warehoused
demand for the new agent. Rapid changes and
increasing treatment cost with HCV therapies
have forced formulary and utilization managers to
rethink their traditional approach of waiting several
months before developing formal approval criteria.
Pharmacists can play an important role in the precertification process by complimenting the payors
utilization management (UM) strategies. Pharmacists
can also use their expertise to fill in any information
gaps to ensure the regimen, safety and efficacy
profiles and length of therapy meet published
guidelines.
New FDA approved agents have helped to reduce
pill burden, remove the need for self-injection and
are reported to reduce risk of intolerable side effects
while increasing Sustained Viral Response (SVR)
rates. A SVR is achieved when a patient remains virus
free 12 weeks after completing any HCV regimen.
These newer agents have added to the complexity
of developing defined first line therapies and have
significant cost implications to health plan and
payors.
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