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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.
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.
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.
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.
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.
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.
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.
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!
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.
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.
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.
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.
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.
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!
CHALLENGE
            You need to know how your CDR approvals
 #7         compare to competitors
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.
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?
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!
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?
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?
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.
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?
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.
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.
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?
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!
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

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Is this Your Challenge

  • 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