2. The market access mistakes discussed in this presentation
are based on examples we have seen in real life. They are
almost always avoidable. A strategic market access
approach steers you through the complex world of market
access, giving you the best chance of timely, positive,
reimbursement for your drug across Canada..
3. Mistake Waiting until NOC to create a market access plan
4. Don’t wait until the last minute. Start Early!
We can help you PUT THE RIGHT PLANS IN PLACE.
In the ideal world, your company is thinking about market
access issues when designing Phase III trials. But we know
that does not always happen – for a variety of reasons.
Here is a more likely timeline scenario. We can help you
work the plan.
Time
to
NOC
Ac-on
24
Months
Ini-al
Reimbursement
Strategy
18
Months
Tighten
Strategy
Ini-al
Communica-ons
Messages
Payer
Advisory
Board
12
Months
Finalize
Communica-ons
Messages
Ini-al
Payer
Mee-ngs
9
Months
Ini-alize
Submissions
Process
NOC
Dispatch
Submissions
6. 90% of Reimbursement Recommendations involve Criteria.
Take control by proposing a STRONG PLACE IN THERAPY (PIT).
Remember the good old days? Listings were easy. You
just had to send it in. Yep, we can dream about those
days … but they are gone.
Payers demand good value for money. There are often
many alternatives to choose from. If you don’t put
forward a strong Place in Therapy, supported by
evidence, the payers will do it for you … or say “No”.
Do you want to have to explain to your CEO that the
listing doesn’t match the Marketing strategy?
Be proactive! Don’t be afraid to go after a niche
market where you have good data. That will
improve your chances and is good for business!
8. Off-Label Use is a real concern for payers
Mitigate risk. WORK WITH THE REIMBURSEMENT CRITERIA.
Some drugs have a greater potential for off-label use than
others. If your drug has this type of potential, overlooking
the risk is a mistake.
Be proactive and address the issue. Outline how you plan
to mitigate the potential for off-label use. Everyone
wants certainty. Payers included.
We have done programs in this area. Talk to us to help
you avoid problems and boost brand loyalty.
10. Sometimes the “right thing” is the “wrong thing” to do.
We can help you find the way to POSITION YOUR DATA.
Sometimes pharmaceutical companies know an open listing
may break the drug plan bank. They try to do the "right
thing" and ask for some form of restricted reimbursement
without the necessary data to back the request.
Submitting for a Place in Therapy unsupported by
clinical evidence can lead to delays and lost revenue.
Following a meticulous, strategic, evidence-based approach
will give you a competitive advantage.
We’ll provide objective assistance to keep you
away from this trap and strengthen your
request in the process.
12. Many companies try to “Canadianize” a global model
We can help you BUILD A MODEL ACCEPTED BY
CANADIAN PAYERS.
You have done all the right things clinically. Then global builds one PE
model that can be “adapted” for different regions. Why would your
company spend hundreds of millions to develop a drug only to do
pharmacoeconomics on the cheap? It makes no sense at all!
There are many, many examples where payers don’t agree with the
pharmacoeconomic assessment for a variety of reasons. It’s like the
submission goes off topic, leaving payers puzzled. When you are asking
for a specific Place in Therapy, take the time to make sure your
pharmaeconomic model aligns with the clinical Place in Therapy
you’re requesting and it fits the Canadian environment.
We employ Canadian experts that can help!
14. Some companies think some studies are not important
We say OMIT NOTHING!
A common temptation is to omit a study from your submission which does
not strengthen your product story. You have to include and/or
reference all studies that you know about, even if another
organization has done the study. That is a submission requirement.
Plus, the payers do their own literature searches. They will find the
study. Isn’t it better to put all the studies in context rather than try to
avoid any potential negative issue?
Be proactive and communicate clearly. It leads to better results … for
everyone.
16. You love your technology. It’s the best!
But ask yourself, WHAT WOULD I DO IF I HAD TO PAY?
You have a new drug that can bring value to the right patient and you
want the best price possible. Who doesn’t? However, premium prices
these days are really reserved for drugs which bring significant new
value to improve the lives of patients. Many drugs provide moderate
improvement, and that is important because it can benefit a lot of
patients.
Always ask yourself, would I pay more for this product if I had to pay out
of my own pocket?
17. Not developing a contingency plan for a
Mistake DO NOT list recommendation
18. You are positive that everything will work out
Stuff happens! WHAT IS YOUR CONTINGENCY PLAN?
Canada is no longer a reimbursement environment where a simple "yes"
or "no" applies to reimbursement. Product Listing Agreements (PLAs)
are an integral part of the system and they will often turn a "no” into a
"yes”. Some companies even plan for it because they expect to get a
refusal from the expert committee for reasons beyond their control.
Following through on submissions by preparing for PLA negotiations is
essential. You need to prepare for PLA negotiations well in advance
because you might have to negotiate even if the expert committee says
“yes”.
We have helped several clients prepare for what happens
after the submission, so don’t hesitate to contact us to
maximize your chances of success.
20. NOC and launch are approaching fast and you are busy
You can meet the payers but WHAT DO YOU SAY?
Some believe that pre-submission meetings with payers are costly, time
consuming, and not necessary. After all, everything is in the submission,
right? Well maybe, but how do you know what they are thinking or how
they will interpret your message?
Pre-submission meetings give you a reality check on your file. We
have seen several cases where payers have misinterpreted things. They
are human and have a lot to do besides pay full attention to your
submission.
Take the opportunity to put forward your best case and listen.
It’s incredible what you will learn. We have been involved in
numerous meetings and can help you prepare and guide
you through the meeting.
21. Lack of message congruency amongst Market
Mistake Access, Marketing and Clinical
22. Marketing knows what the doctors want to hear.
Do you tell the payers THE SAME THING?
Your submission must be rigorous and evidence-based. The data and
the value proposition have to be well laid out. The message might be
slightly different than what marketing has in mind for doctors and this has
you concerned. That’s normal. Think of it this way, would you talk the
same way to a world-class expert in the disease area the same way
you would talk to a patient who has just discovered that he/she has
the disease that your product can help? Of course not.
Different audiences require different messaging techniques. However,
Clinical, Marketing and Market Access messages must tell a congruent
story to their respective stakeholder audiences. Don’t try to fool them.
They talk with each other.
We have designed many Reimbursement Communication
Plans to get the message across effectively!
23. AVOID MAKING
MARKET ACCESS
MISTAKES
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Cooler Session with George Wyatt
CALL TODAY +1.905.257.5670
Copyright 2004 - 2012 Wyatt Management Consulting Inc.
