This document outlines 12 key challenges that companies may face in market access and how Wyatt Health Management can help address them. The challenges include having an insufficient market access department, tight deadlines for submissions, lack of experience in the Canadian market, making the most of new clinical data, ensuring an objective perspective, launching innovative first-in-class products, understanding competitor approvals, addressing clinical gaps, assessing the likelihood of reimbursement, achieving listings after rejections, negotiating pricing agreements, and effectively communicating with payers. For each challenge, Wyatt Health describes services like virtual support teams, just-in-time partnerships, regulatory expertise, strategic guidance, advisory boards, forecasting tools, and communication planning to
1. IS THIS YOUR
CHALLENGE?
12 Key Challenges in Market
Access and how Wyatt Health
Management can help you!
Copyright 2004 - 2012 Wyatt Management Consulting Inc.
2. WHERE ARE YOU WITH YOUR PAYER REQUEST?
pre-‐noc > noc > POST-‐noc > RESUBMISSION > new indication
Market Access is always a challenge.
Whether you are engaged in early planning for a new
drug, rushing to get your submission ready as you
approach NOC, having to deal in the world of Product
Listing Agreements (PLAs) after the submission or having
to prepare for a new submission with New Information or
a New Indication, Wyatt Health can help you take on the
seemingly impossible. We’re up to the challenge.
3. CHALLENGE
Your market access department is insufficient, stretched
#1 or non-existent
Your team is stretched and you are concerned the new
product won’t get the market access focus it deserves.
Or, your company does not have an in-house market
access department and you are uncertain as to how to give
the new product the best chance of achieving positive
listings in Canada.
4. VIRTUAL MARKET ACCESS DEPARTMENT (VMAD)
Your DEDICATED TEAM ON DEMAND
Instead of hiring new staff, why not hire us as your
Virtual Market Access Department (VMAD)?
For roughly the cost of one or two full-time positions,
you will have wide access to the expertise of a much
larger market access department.
Wyatt Health’s senior consulting staff will offer their
considerable executive insights to help you develop
reimbursement strategies, write submissions,
guide your group through payer negotiations
and much more.
5. CHALLENGE
Your NOC is going to be early and you can’t get the
#2 submissions done on time.
You have just been informed that regulatory approval for your product is
going well and is ahead of schedule. The executive team expects you to
have the submissions ready as soon as the NOC is issued, but you realize
you don’t have the resources you need to complete all the tasks.
6. To the rescue – Filling the gaps when needed
Your JUST IN TIME PARTNER
Market Access needs are often highly variable. For
example, there is a lot of activity around the time of a
submission in terms of activity versus time when you
are planning.
Consider hiring us on a project-by-project basis for a
particularly challenging submission or to help you with
overload.
7. CHALLENGE
You don’t have a presence in Canada, and you need a
#3 Canadian Market Access Specialist
You’re ready to expand your market presence into Canada, but you don’t
have a Canadian partner to help you navigate the environment. You know
Canada has one of the most complex market access environments in the
world and you want the advice of someone with extensive experience.
8. Would you ignore California?
Our complex market is a challenge BUT WORTH IT.
Canada has a stable economy with a GDP about 80% of that
of California. You would not ignore California, would
you? Canada is the 9th largest pharmaceutical market in the
world.
However Canada is not just one market, but a mix of different
provincial and federal public drugs plans, plus a large number
of private drug plans. You want the advice of someone with
extensive experience.
Canada is our home. George Wyatt has over 20 years of
successful experience working in Canadian pharmaceutical
reimbursement. We know what we are doing!
9. CHALLENGE
#4 You want to make the most of a new clinical study
The clinical and regulatory departments did their jobs, but
your product was launched with some gaps that have
affected its market access.
A new long awaited new trial has just been completed.
You want to know how you can take advantage of this
information to improve your drug’s market access.
10. Get the most from your Trial Results.
We help you DEFINE THE BEST PLACE IN THERAPY (PiT)
The good news is that you finally have new
information. Your challenge is to make the most of it.
We always ask; “Does the clinical evidence
support the Place in Therapy (PiT) you request?
We find the Place in Therapy proof that the payers are
looking for.
11. CHALLENGE
You are wondering if your team has the objectivity needed to
#5 anticipate payers’ likely responses.
You’ve been looking at the drug for so long, you may overthink,
overwork, or miss an angle. Despite putting your best people on
the project you still have this sinking feeling that you can’t see
the forest for the trees and you wonder what payers will think.
12. You need a fresh look
And an EXPERIENCED POINT OF VIEW
When you’re too close, even when you try your best, it’s
difficult to be objective. Do you see the the pitfalls payers
might see? Are you missing something important? We
might find a gem in your data that your team missed.
Our goal is to get your drug reimbursed, not reinforce
what you already know, or tell you what you want to
hear.
Seeing beyond the obvious to a more realistic or
promising end is what we do best! We can draw
attention to the potential in your drug that will
make the payers sit up and take notice.
13. CHALLENGE
#6 You have an innovative, first-in-class product
You are charged with launching a truly innovative product, the
first in its therapeutic category. It has the potential to be a huge
win for your organization, and there is no room for error. You’ve
been charged with doing whatever it takes to make a big splash
in the Canadian market.
14. Find the value for payers – the Place in Therapy (PiT)
You need laser focus and a PIN-POINT STRATEGY.
True innovation is the holy grail, but often makes
things more difficult when seeking reimbursement.
What is your anchor point? If there is nothing to
compare your product to, it could get lost, or rejected.
Payers might not see its value, even if it is brilliant.
Timing, positioning and communication are critical. We
will never give up until we find the ideal Place in
Therapy (PiT) and help you get the message across.
They don’t call us PiT Bulls for nothing!
15. CHALLENGE
You need to know how your CDR approvals
#7 compare to competitors
16. CDR Tracker® - For what you really need to know!
UNDERSTANDING THE ENVIRONMENT is the first step.
CDR Tracker® is an online database that provides the
most comprehensive information on all drugs that are
or have been part of the Common Drug Review (CDR)
reimbursement approval process in Canada. We track
everything from the CDR submission to public plan
reimbursement funding decisions.
Subscribers have access to this critical information as
they need it.
If you don’t have time to work with the database,
we can create custom reports for you. Just call
us at +1.905.257.5670.
17. CHALLENGE
#8 Your product has clinical gaps. How will the payers respond?
-‐
You know your product has some gaps, but you want to give it the
best chance of success. You have physicians covered, but are
wondering about reimbursement. You wish you could talk with
payers, to present your product story for their advice before
submitting. What is the best way to do this?
18. Find out what payers think with a Payer Advisory Board
LEARN FROM THOSE WHO HAVE BEEN THERE
Wyatt Health has broad expertise in developing,
managing, and operating advisory boards, round tables,
focus groups, and other types of market research
projects. We help you get the advice you need and we
can also publish findings, if applicable.
Take advantage of our expertise in running projects and
our experience in getting to the people who have
managed and advised drug plans. They are terrific and
provide great advice that can be very beneficial to you!
19. CHALLENGE
You need to know: What is the likelihood of a
#9 positive recommendation?
Senior management often wants
to know, “What is the likelihood
of our product receiving a
positive CDR / pCODR
recommendation?”
You know that pCODR
is new and CDR has a 50/50
track record, but how can you get a
realistic assessment for YOUR product?
20. Trust our CDR Forecaster™ or pCODR Forecaster™
UNCOVER WHAT IS IMPORTANT FOR YOUR DRUG.
Our Forecasters are another Wyatt Health innovation.
We apply objective behavioural analyses to drugs that
will go through the public reimbursement process. These
analyses are based on all the past recommendations
issued by the Expert Committees of Canada’s Common
Drug Review (CDR) and pan Canadian Oncology Drug
Review (pCODR).
We produce a reliable forecast of success based on your
product's current profile and a Gap Analysis that allows
clients to address issues in advance of the submission.
With so much at stake, can you afford not to try
this exercise with your drug?
21. CHALLENGE
You need to know how to achieve a listing breakthrough
#10 after multiple rejections.
Confuscius said “the key to success is persistence”, but, you are
becoming frustrated by repeated rejections. You believe in your
product and want to know how to achieve the desired
listing breakthrough.
22. Rejections are not uncommon.
We are PERSISTENT IN LOOKING FOR THE RIGHT ANSWER.
Often, the right path to success is not immediately
apparent. Many of the great successes in life have
come through trial and error. You may think you have
done all the right things, but it is possible that
something was missed. And in today’s environment, a
negative reimbursement recommendation is not the kiss
of death it used to be. There are alternatives.
Wyatt Health will work closely with you to establish new
sets of alternatives that will give your product a chance.
Did we mention we love a challenge?
23. CHALLENGE
You need to negotiate pricing with a drug plan
#11
You need to reach a listing agreement that provides cost
certainty over a period of time in one province with competitors
when you have an established price in another.
24. Product Listing Agreements (PLAs) are here to stay.
We help you find a WIN-WIN SOLUTION.
You may know them as Risk-Sharing Arrangements or
Patient Access Schemes, or by some other name. In
Canada, we call them Product Listing Agreements
(PLAs). There are hundreds of PLAs in place in the
public and private drug plan markets in Canada and
we have plenty of experience negotiating them.
We will work with you to help you determine “what’s in
the box” and “what’s not in the box”, when it comes
to establishing terms. We support win-win solutions
because it is likely that you will have another drug
that will be subject to this process and you want
the payers to know that you act in good faith.
25. CHALLENGE
You need to get the message across to payers
#12
The clinical results are good and you are ready to start your
submission. You want to make sure that payers understand the
importance of what your product delivers, but how do you do it?
26. You have the greatest product – how will they know?
You need to COMMUNICATE YOUR MESSAGE.
We see this quite a bit. A product has great clinical
and the focus gets concentrated on doing a good
submission. Yes, that is important, but it’s not the
only thing.
Payers are people too and they need to understand
your product, not just read about it in the submission.
Talk with us about our Reimbursement
Communications Plans and how we can help you get
your messages out!
27. WE’RE UP to the
CHALLENGE!
Contact us for a free 15 minute Water
Cooler Session with George Wyatt
CALL TODAY +1.905.257.5670