Pharmaceutical Commerce - May/June 2017 - 17

Market Access
important part of our responsibility is to
help them understand what they have seen
or read, and its possible relevance to their
treatment options."
Another I/O modality that is different
from checkpoint inhibition is the use of
modified T cells (CAR-T)-which thus
far has no approved therapies yet, but is
eagerly anticipated as regulatory approval
of the leading candidate is expected in the
near future. "This modality is generating
significant interest and excitement from
all stakeholders as CAR-Ts have shown
activity in relapsed lymphomas, acute
lymphoblastic leukemias, and chronic
lymphocytic leukemia," say Nabhan of
Cardinal Health. However, he notes that
"the toxicity of CAR-Ts can be severe and
careful attention to how these adverse
events should be managed is essential to
assure favorable outcomes to patients."
Will competition moderate costs?
Worldwide spending on cancer medicines
will exceed $150 billion by 2020, up from
$107 billion in 2015 according to recent data
from IMS. "Cost is clearly the most pressing
issue associated with I/O therapies, and
stakeholders agree that manufacturers need
to demonstrate the value of this modality in
a changing reimbursement landscape where
cost containment and maximizing efficacy
is a paramount concern to payers," says
Nabhan of Cardinal Health.
"The best way to position a new agent

among its competitors and maximize payer
coverage is to know which patients are most
likely to receive response with the agent, and
then gearing studies toward that population.
This requires good science and thoughtful
trial design, and is certainly one of the main
challenges facing the I/O community over the
next decade," says Cowey of Texas Oncology.
Today, cancer researchers are pursuing both
traditional and non-traditional biomarkers,
including "tumor neoantigen profiling,"
"mutational load analysis," and identifying
certain infiltrating immune cells within
tumors, to improve the deployment of
checkpoint inhibitors.
"Combining checkpoint inhibitors
with older or generic chemotherapy may
not drive up costs as dramatically, but once
you combine two immune therapies, with
a biologic or a newer non-biologic specialty
drug-so-called stacking-that's going to
create enormous cost issues," adds Evans of
Genentech.
Clearly the argument can be made that
using a combination of therapies in search
of the most advantageous synergistic effects
to drastically improve outcomes represents
money well spent, to get the patient into
remission or even cured and back into
their productive lives, where they are living
longer lives, supporting their families and
so on. Many believe that there will always
be a tipping point where really effective
treatment-or even cures-can help justify
huge price tags. But it helps to back up such

claims with real-world evidence.
"Consider the use of Yervoy and Opdivo
in combination to treat melanoma-
the cost can easily run to $200,000. While
Bristol-Myers Squibb is offering a discount
for patients who use both therapies
simultaneously, it's important to note
that the costs aren't necessarily hitting the
patients-they are falling on the backs of
the payers and the drug companies, who
shoulder much of the high cost," says
Sanchez of Trinity Consultants. That's why
there's keen interest in making sure only
the right patients are getting these costly
therapy options, and helping to manage the
affordability. "Drug makers do not want
to risk headlines of patients abandoning
promising therapy options because of the
cost, so RWE data (which is always messy
due to poor adherence and tolerability
issues) must be developed to drive the most
appropriate utilization."
Despite the hurdles, some expect
growing competition in I/O to help keep
costs down. "We now have a lot of different
I/O products being pursued. This is already
seeming to bend the cost curve for new drugs
developed under the bio umbrella, where we
may be seeing a 10% price premium, over
traditional therapy options-not a 25%
price premium," says Sanchez. "As multiple
I/O drugs are racing to the finish line, the
competition should favorably impact the
starting costs that were common just a few
years ago."

One promising combination is the use of
ADCs (to shrink or "de-bulk" the tumor and
prime the immune system) in conjunction
with I/O therapies. "When the promise of
this combination is realized, then the length
and quality of life that patients might achieve
should justify that cost," says Gregory of
ImmunoGen.
More than ever, reimbursement is
contingent on showing value of a particular
therapy where value is broadly defined as
outcomes divided by cost. "RWE studies and
patient-reported outcomes that can show
how efficacy and quality of life are potentially
improved for patients when I/O therapies
are administered and used under real-world
conditions are becoming essential in payers'
determination of favorable coverage," adds
Nabhan of Cardinal Health.
"Due to the high cost of immunotherapies,
manufacturers need to proactively engage
payers and other stakeholders early on
in cost-effective discussions and leverage
various value frameworks to communicate
a comprehensive value story of these
innovative therapies," says Shields of Xcenda.
"Similarly, patients may face exorbitant outof-pocket costs, so in addition to traditional
foundation programs, it will be imperative
for pharma companies to establish farreaching patient-assistance programs (PAPs)
that can help to offset those costs."
Value frameworks
"Oncologists are already overwhelmed.

Avella pitches specialty
pharmacy's benefits in
managing cancer care
Less drug waste, fewer ER visits can offset high drug costs
For years, some observers have called the trend in cancer therapy "unsustainable"
as cancer cases rise, and the number-and cost-of drug therapies rise even faster. In a
just-released white paper, Avella Specialty Pharmacy doesn't address these trends directly,
but does offer that specialty pharmacies like itself can moderate rising healthcare costs.
The paper's argument, based largely on existing studies, positions specialty pharmacies as
a key member of the care team: payer, physician and patient.
On a per-member, per-month basis, cancer care has risen from 9.4% of overall cost
for commercial plans in 2004, to 10.7% (most analyses expect this proportion to jump
higher in the next few years). Oncology drug sales have nearly doubled from $28 billion
in 2008 to $50 billion in 2016, and are on pace to reach $75 billion in 2024, according
to cited Datamonitor Healthcare statistics. And in 2016, while there were 21 oncology
drugs approved by FDA, 12 were oral oncolytics-and therein lies the patient-support
problem, since oral products are typically consumed at home by the patient (and are
often dispensed from specialty pharmacies). Adherence for such therapies is sub-optimal;
it dropped, in one study, from 91% during a clinical trial, to 56% when the drug was
commercialized.
Two prime reasons for non-adherence are drug cost and unmanaged side effects. To
address these, Avella touts its role in helping patients obtain financial assistance (claiming
$54 million in such support during 2016), and patient support through education and
such tools as starter kits containing OTC products to address side effects. It also provides
treatment data back to healthcare providers and payers, and looks toward integrating its
data resources with the electronic medical record (EMR) systems at health facilities for a
higher level of care coordination.
The free white paper is available at Avella's website at
https://info.avella.com/outlook-oncology-whitepaper.
May | June 2017 Visit our website at www.PharmaceuticalCommerce.com 17


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Pharmaceutical Commerce - May/June 2017 - Table of Contents
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