Pharmaceutical Commerce - September/October 2017 - 10

Top News
CVS readies a set of outcomes-based contracts for its clients
Oncology, obesity control and respiratory therapy are the first targets
While announcing its annual update
of drugs (now around 36) to be excluded
from its "Standard Control Formulary"
in 2018, the industry-leading pharmacy
benefit manager (PBM) is also hinting at
another cost-control measure: outcomesbased contracting. Such programs have
been occasionally entered into between a
few pharma companies (and a few of their
branded products) and payers or healthcare
providers. With the contract coming from
a national PBM (CVS Caremark manages
nearly 90 million plan members, including
more than 31 million members under
commercial plans), there is the potential
to, in effect, drive a standard of care for a
substantial number of patients-depending

o n h ow C VS Ca re m a r k s e t s u p t h e
contracts, and how rigorously payers choose
to align their members' care.
T h e t h r e e " Tr a n s f o r m Va l u e "
programs are:
* Transform Oncolog y Value: This
program encompasses several cancer types,
including breast cancer and non-small
cell lung cancer. For patients on a certain
breast cancer drug, if a plan's average cost
is above a predetermined threshold, the
manufacturer would be responsible to
add value. If plan members on a certain
non-small cell lung cancer drug progress
to secondary therapy and key lab data has
been obtained, the manufacturer would

contribute additional pre-determined value.
* Tr a n s for m O b e s it y Va lu e : T h e
ma nu fac t u rer wou ld be requ i red to
provide additional value if members do
not achieve a minimum level of weight
reduction within the initial assessment
period. This program is only available
to clients a ligned w it h our Standard
Control Formulary or Advanced Control
Formulary.
* Transform Respiratory Value: For a
certain chronic obstructive pulmonary
disorder controller, if a greater percentage
of members escalate to triple therapy (a
type of combination therapy) compared
t o t h o s e o n o t h e r c o nt r o l l e r s , t h e
manufacturer would need to provide

enhanced value.
These programs will be additions
to other cost-control measures the PBM
has taken: Besides its formulary exclusion
list, the company offers indication-based
pricing (reimbursement based on the
condition being treated); and, for diabetes,
a "Transform" program that combines drug
choices with complementary patient-care
services. A CVS Caremark spokesperson
says that the Transform Value program will
be launched in the near future; it remains
to be seen which drugs will be targeted,
and how successfully CVS Caremark is able
to convince its clients to include the
programs.

HDA's fourth international conference heads to Geneva
Global supply chain issues in distribution bring senior execs together
Although life sciences business leaders
have been overwhelmed this summer
with developments in the all-but-defunct
repeal of O bamacare, and the steps
FDA is taking under new leadership,
the Healthcare Distribution Alliance is
continuing its attention on global issues
of pharmaceutical distr ibution and
healthcare policy. The Fourth International
Pharmaceutical Distribution Conference

will be held in Geneva, Switzerland, on
Oct. 16-17. Co-sponsors are the European
Healthcare Distribution Assn. (GIRP); the
International Federation of Pharmaceutical
Wholesalers (IFPW); and Pharmalog.ch,
the Swiss pharma logistics association.
HDA attracts senior supply chain,
distribution and manufacturing executives,
with educational sessions switching between
US and non-US speakers to provide a global

perspective. Highlighted topics include:
* The evolution of collaborative supply
chain trading partnerships
* Pharmaceutical product traceability/
medicines verification efforts from a global
perspective
* Va l u e - b a s e d o u t c o m e s a n d
reimbursement
* The political and policy landscape
shaping distribution in Europe and the US

* The financial outlook for the global
pharmaceutical market
* T h e d e ve l o pm e nt a n d r o l e o f
biosimilars.
Registration and additional information
is available at the Conference website,
w w w. h e a l t h c a r e d i s t r i b u t i o n . o r g /
events/2017-international-pharmaceuticaldistribution-conference.

'Right to try' programs see renewed legislative attention
PDUFA reauthorization creates new pathways; GAO report notes FDA's 99% acceptance rate for expanded access
Now in place in 37 states, so-called
"right to try" laws seek to remove any
federal obstacle for desperately ill patients to
obtain experimental drugs that have passed
Phase I (the safety step). The topic has been
a legislative priority popular on the right in
the US. One of its main proponents, Sen.
Robert Johnson (R-WI) had threatened to
hold up the Prescription Drug User Fee
Act (PDUFA) legislation unless right-totry language was included, which was done
in limited form when the bill passed the
Senate and then the House on Aug. 3 (at
press time, the bill was awaiting President
Trump's signature).* Paying for the review
of branded and generic drugs, medical
devices and other "UFAs" is essential to
how FDA is funded; the law is expected (by
a Congressional Budget Office estimate)
to generate some $9 billion in fees to fund
FDA's reviews through 2022.
"Right to try" is something of a political
concept; in the regulatory environment of
FDA, allowing sick patients to obtain an
investigational drug is known as "expanded
access," and many manufacturers now have
*http://docs.house.gov/
billsthisweek/20170710/HR2430-1.pdf

expanded access programs (EAPs). The
right-to-try measures included in the law
require HHS to hold hearings and issue
guidance on how clinical trial criteria might
be expanded to include more patients
(essentially, enabling more patients who
would otherwise be forced to seek expanded
access use of an investigational drug to
become part of a trial); to evaluate the
EAPs of manufacturers; and to assess the
processes of institutional review boards that
are involved in reviewing trial protocols.
The 21st Century Cures Act, one of
the last laws signed by President Obama
in December, included an obligation for
manufacturers to publish their EAP
policies, in addition to streamlining aspects
of the clinical trials approval process that
could make drugs available more quickly.
In early July, FDA Commissioner Scott
Gottlieb (who has written extensively on a
risk-averse culture at FDA prior to taking its
reins) issued a long list of FDA actions to be
taken in light of the 21st Century Cures Act,
including streamlining trial procedures.
A GAO report reviewing EAPs found
that FDA continues to impose few hurdles
to physicians or their patients in approving
the request (or, at least, not threatening to
impose sanctions on manufacturers who

10 Visit our website at www.PharmaceuticalCommerce.com September | October 2017

would provide the non-approved drug).
For the fiscal years 2012-2015 inclusive,
FDA allowed 5,697 of 5,753 requests to
proceed. GAO's report, "FDA has taken
steps to improve the expanded access
program but should further clarify how
adverse events data are used," summarizes
the pharma industry's perspective as
"[some] manufacturers noted that the lack
of clear information can influence their
decision whether to give patients access to
their drugs because of their concerns that
an adverse event will result in FDA placing
a clinical hold on their drug, which could
delay its development."
This dispute has been going on for
years; FDA's own policies were revamped in
2009 and again in 2016, when the current
streamlined application form (FDA 3926)
was issued. Since around 2014, however, the
Goldwater Institute, a libertarian-leaning
advocacy group, has been pushing state
by state for right-to-try laws. And now it
has the ear of Vice President Mike Pence,
who met with the Institute early this year;
President Trump is also said to be in favor
of the laws. While PDUFA V was being
passed this summer, Sen. Johnson was able
to get a Senate commitment to also pass
his bill, S.204, the Trickett Wendler Right

to Try Act of 2017, which was referred to
the House prior to its August recess. S.204
covers much of the same ground as state
right-to-try laws.
Making a difference?
All this legislating and advocacy work, by
the Goldwater Institute and other right-totry advocates, sounds like real progress has
been made to assist terminally ill patients,
but the end result is still a question mark.
On its website, the Goldwater Institute states
that "While millions of Americans will be
diagnosed with or die of terminal illnesses
each year, compassionate use exceptions
are only granted to about 1,000 patients a
year"-which gives an indication of how
overwhelming expanded access could be
for companies with limited stocks of a drug
that is being produced for trials.
It's not clear, at this point, whether the
right-to-try laws in place in many states
have resulted in any change to patient access.
None of the laws require a manufacturer
to provide an investigations drug; nor is
there any requirement for commercial
or public insurance to pay for expanded
access drugs. There is something of a track
record, going back to the AIDS activist era
in the 1980s, of mobilized groups essentially


http://www.Pharmalog.ch http://www.healthcaredistribution.org/events/2017-international-pharmaceutical-distribution-conference http://www.healthcaredistribution.org/events/2017-international-pharmaceutical-distribution-conference http://docs.house.gov/billsthisweek/20170710/HR2430.pdf http://docs.house.gov/billsthisweek/20170710/HR2430.pdf http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - September/October 2017

Table of Contents
Pharmaceutical Commerce - September/October 2017 - Cover1
Pharmaceutical Commerce - September/October 2017 - Cover2
Pharmaceutical Commerce - September/October 2017 - Table of Contents
Pharmaceutical Commerce - September/October 2017 - 4
Pharmaceutical Commerce - September/October 2017 - 5
Pharmaceutical Commerce - September/October 2017 - 6
Pharmaceutical Commerce - September/October 2017 - 7
Pharmaceutical Commerce - September/October 2017 - 8
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Pharmaceutical Commerce - September/October 2017 - 20
Pharmaceutical Commerce - September/October 2017 - 21
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Pharmaceutical Commerce - September/October 2017 - 24
Pharmaceutical Commerce - September/October 2017 - 25
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Pharmaceutical Commerce - September/October 2017 - 34
Pharmaceutical Commerce - September/October 2017 - Cover3
Pharmaceutical Commerce - September/October 2017 - Cover4
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