1. IS THIS YOURCHALLENGE?12 Key Challenges in MarketAccess and how Wyatt HealthManagement 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 ProductListing Agreements (PLAs) after the submission or havingto prepare for a new submission with New Information ora 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 DEMANDInstead of hiring new staff, why not hire us as yourVirtual 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 muchlarger market access department.Wyatt Health’s senior consulting staff will offer theirconsiderable executive insights to help you developreimbursement strategies, write submissions,guide your group through payer negotiationsand 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 neededYour JUST IN TIME PARTNERMarket Access needs are often highly variable. Forexample, there is a lot of activity around the time of asubmission in terms of activity versus time when youare planning.Consider hiring us on a project-by-project basis for aparticularly challenging submission or to help you withoverload.
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 thatof California. You would not ignore California, wouldyou? Canada is the 9th largest pharmaceutical market in theworld.However Canada is not just one market, but a mix of differentprovincial and federal public drugs plans, plus a large numberof private drug plans. You want the advice of someone withextensive experience.Canada is our home. George Wyatt has over 20 years ofsuccessful experience working in Canadian pharmaceuticalreimbursement. 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 newinformation. Your challenge is to make the most of it.We always ask; “Does the clinical evidencesupport the Place in Therapy (PiT) you request?We find the Place in Therapy proof that the payers arelooking 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 lookAnd an EXPERIENCED POINT OF VIEWWhen you’re too close, even when you try your best, it’sdifficult to be objective. Do you see the the pitfalls payersmight see? Are you missing something important? Wemight find a gem in your data that your team missed.Our goal is to get your drug reimbursed, not reinforcewhat you already know, or tell you what you want tohear.Seeing beyond the obvious to a more realistic orpromising end is what we do best! We can drawattention to the potential in your drug that willmake 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 makesthings more difficult when seeking reimbursement.What is your anchor point? If there is nothing tocompare 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. Wewill never give up until we find the ideal Place inTherapy (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 themost comprehensive information on all drugs that areor have been part of the Common Drug Review (CDR)reimbursement approval process in Canada. We trackeverything from the CDR submission to public planreimbursement funding decisions.Subscribers have access to this critical information asthey need it.If you don’t have time to work with the database,we can create custom reports for you. Just callus 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 BoardLEARN FROM THOSE WHO HAVE BEEN THEREWyatt Health has broad expertise in developing,managing, and operating advisory boards, round tables,focus groups, and other types of market researchprojects. We help you get the advice you need and wecan also publish findings, if applicable.Take advantage of our expertise in running projects andour experience in getting to the people who havemanaged and advised drug plans. They are terrific andprovide 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 thatwill go through the public reimbursement process. Theseanalyses are based on all the past recommendationsissued by the Expert Committees of Canada’s CommonDrug Review (CDR) and pan Canadian Oncology DrugReview (pCODR).We produce a reliable forecast of success based on yourproducts current profile and a Gap Analysis that allowsclients to address issues in advance of the submission.With so much at stake, can you afford not to trythis 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 immediatelyapparent. Many of the great successes in life havecome through trial and error. You may think you havedone all the right things, but it is possible thatsomething was missed. And in today’s environment, anegative reimbursement recommendation is not the kissof death it used to be. There are alternatives.Wyatt Health will work closely with you to establish newsets 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 orPatient Access Schemes, or by some other name. InCanada, we call them Product Listing Agreements(PLAs). There are hundreds of PLAs in place in thepublic and private drug plan markets in Canada andwe have plenty of experience negotiating them.We will work with you to help you determine “what’s inthe box” and “what’s not in the box”, when it comesto establishing terms. We support win-win solutionsbecause it is likely that you will have another drugthat will be subject to this process and you wantthe 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 clinicaland the focus gets concentrated on doing a goodsubmission. Yes, that is important, but it’s not theonly thing.Payers are people too and they need to understandyour product, not just read about it in the submission.Talk with us about our ReimbursementCommunications Plans and how we can help you getyour messages out!
27. WE’RE UP to theCHALLENGE!Contact us for a free 15 minute Water Cooler Session with George Wyatt CALL TODAY +1.905.257.5670