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IS THIS YOUR CHALLENGE? 12 Key Challenges in Market Access and how Wyatt Health Management can help you!

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.  

pre-‐noc new indicationRESUBMISSIONPOST-‐nocnoc >>> >

WHERE ARE YOU WITH YOUR PAYER REQUEST?

Your market access department is insufficient, stretched or non-existent #1

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.

CHALLENGE

Your DEDICATED TEAM ON DEMAND VIRTUAL MARKET ACCESS DEPARTMENT (VMAD)

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.

Your NOC is going to be early and you can’t get the 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.

#2 CHALLENGE

Your JUST IN TIME PARTNER To the rescue – Filling the gaps when needed

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.

You don’t have a presence in Canada, and you need a 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.

#3 CHALLENGE

Our complex market is a challenge BUT WORTH IT. Would you ignore California?

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!

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.

#4 CHALLENGE

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.

Get the most from your Trial Results.

You are wondering if your team has the objectivity needed to 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.

#5 CHALLENGE

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.

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.

#6 CHALLENGE

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!

You need to know how your CDR approvals compare to competitors #7

CHALLENGE

CDR Tracker® - For what you really need to know!

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.

UNDERSTANDING THE ENVIRONMENT is the first step.

-­‐  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?

#8 CHALLENGE

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!

Find out what payers think with a Payer Advisory Board LEARN FROM THOSE WHO HAVE BEEN THERE

You need to know: What is the likelihood of a positive 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?

Senior management often wants to know, “What is the likelihood of our product receiving a positive CDR / pCODR recommendation?”

#9 CHALLENGE

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?

Trust our CDR Forecaster™ or pCODR Forecaster™ UNCOVER WHAT IS IMPORTANT FOR YOUR DRUG.

You need to know how to achieve a listing breakthrough 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.

#10 CHALLENGE

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?

Rejections are not uncommon. We are PERSISTENT IN LOOKING FOR THE RIGHT ANSWER.

You need to negotiate pricing with a drug plan

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.

#11 CHALLENGE

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.

Product Listing Agreements (PLAs) are here to stay. We help you find a WIN-WIN SOLUTION.

You need to get the message across to payers

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?

#12 CHALLENGE

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 CHALLENGE!

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Contact us for a free 15 minute Water Cooler Session with George Wyatt CALL TODAY +1.905.257.5670