10 Biggest Market Access Mistakes

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Transcript of 10 Biggest Market Access Mistakes

  • 1. 10 BIGGESTMARKET ACCESSMISTAKES(and how Wyatt HealthHelps you avoid them) Copyright 2004 - 2012 Wyatt Management Consulting Inc.

2. The market access mistakes discussed in this presentationare based on examples we have seen in real life. They arealmost always avoidable. A strategic market accessapproach steers you through the complex world of marketaccess, 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. Dont 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 marketaccess issues when designing Phase III trials. But we knowthat does not always happen for a variety of reasons.Here is a more likely timeline scenario. We can help youwork 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 5. Mistake Expecting an Open Listing 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. Youjust had to send it in. Yep, we can dream about thosedays but they are gone.Payers demand good value for money. There are oftenmany alternatives to choose from. If you dont putforward a strong Place in Therapy, supported byevidence, the payers will do it for you or say No.Do you want to have to explain to your CEO that thelisting doesnt match the Marketing strategy?Be proactive! Dont be afraid to go after a nichemarket where you have good data. That willimprove your chances and is good for business! 7. Mistake Ignoring Off Label potential 8. Off-Label Use is a real concern for payersMitigate risk. WORK WITH THE REIMBURSEMENT CRITERIA.Some drugs have a greater potential for off-label use thanothers. If your drug has this type of potential, overlookingthe risk is a mistake.Be proactive and address the issue. Outline how you planto mitigate the potential for off-label use. Everyonewants certainty. Payers included.We have done programs in this area. Talk to us to helpyou avoid problems and boost brand loyalty. 9. Requesting a Place in Therapy unsupportedMistake by clinical evidence 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 listingmay break the drug plan bank. They try to do the "rightthing" and ask for some form of restricted reimbursementwithout the necessary data to back the request.Submitting for a Place in Therapy unsupported byclinical evidence can lead to delays and lost revenue.Following a meticulous, strategic, evidence-based approachwill give you a competitive advantage.Well provide objective assistance to keep youaway from this trap and strengthen yourrequest in the process. 11. Having a pharmacoeconomic model that doesntMistake reflect your clinical position 12. Many companies try to Canadianize a global modelWe can help you BUILD A MODEL ACCEPTED BYCANADIAN PAYERS.You have done all the right things clinically. Then global builds one PEmodel that can be adapted for different regions. Why would yourcompany spend hundreds of millions to develop a drug only to dopharmacoeconomics on the cheap? It makes no sense at all!There are many, many examples where payers dont agree with thepharmacoeconomic assessment for a variety of reasons. Its like thesubmission goes off topic, leaving payers puzzled. When you are askingfor a specific Place in Therapy, take the time to make sure yourpharmaeconomic model aligns with the clinical Place in Therapyyoure requesting and it fits the Canadian environment.We employ Canadian experts that can help! 13. Mistake Not submitting all available data 14. Some companies think some studies are not importantWe say OMIT NOTHING!A common temptation is to omit a study from your submission which doesnot strengthen your product story. You have to include and/orreference all studies that you know about, even if anotherorganization has done the study. That is a submission requirement.Plus, the payers do their own literature searches. They will find thestudy. Isnt it better to put all the studies in context rather than try toavoid any potential negative issue?Be proactive and communicate clearly. It leads to better results foreveryone. 15. Mistake Expecting a premium price 16. You love your technology. Its 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 youwant the best price possible. Who doesnt? However, premium pricesthese days are really reserved for drugs which bring significant newvalue to improve the lives of patients. Many drugs provide moderateimprovement, and that is important because it can benefit a lot ofpatients.Always ask yourself, would I pay more for this product if I had to pay outof my own pocket? 17. Not developing a contingency plan for aMistake DO NOT list recommendation 18. You are positive that everything will work outStuff 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 isessential. You need to prepare for PLA negotiations well in advancebecause you might have to negotiate even if the expert committee saysyes.We have helped several clients prepare for what happensafter the submission, so dont hesitate to contact us tomaximize your chances of success. 19. Believing that pre-submission meetingsMistake are not critical 20. NOC and launch are approaching fast and you are busyYou can meet the payers but WHAT DO YOU SAY?Some believe that pre-submission meetings with payers are costly, timeconsuming, and not necessary. After all, everything is in the submission,right? Well maybe, but how do you know what they are thinking or howthey will interpret your message?Pre-submission meetings give you a reality check on your file. Wehave seen several cases where payers have misinterpreted things. Theyare human and have a lot to do besides pay full attention to yoursubmission.Take the opportunity to put forward your best case and listen.Its incredible what you will learn. We have been involved innumerous meetings and can help you prepare and guideyou through the meeting. 21. Lack of message congruency amongst MarketMistake 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 andthe value proposition have to be well laid out. The message might beslightly different than what marketing has in mind for doctors and this hasyou concerned. Thats normal. Think of it this way, would you talk thesame way to a world-class expert in the disease area the same wayyou would talk to a patient who has just discovered that he/she hasthe 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 congruentstory to their respective stakeholder audiences. Dont try to fool them.They talk with each other.We have designed many Reimbursement CommunicationPlans to get the message across effectively! 23. AVOID MAKING MARKET ACCESSMISTAKESContact us for a free 15 minute Water Cooler Session with George Wyatt CALL TODAY +1.905.257.5670 Copyright 2004 - 2012 Wyatt Management Consulting Inc.