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Copyright 2004 - 2012 Wyatt Management Consulting Inc.

BIGGEST MARKET ACCESS

MISTAKES (and how Wyatt Health Helps you avoid them)

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..  

Waiting until NOC to create a market access plan Mistake

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.

Don’t wait until the last minute. Start Early!

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  

Expecting an Open Listing Mistake

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!

90% of Reimbursement Recommendations involve Criteria.

Ignoring Off Label potential Mistake

Mitigate risk. WORK WITH THE REIMBURSEMENT CRITERIA. Off-Label Use is a real concern for payers

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.

Requesting a Place in Therapy unsupported by clinical evidence Mistake

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.

Sometimes the “right thing” is the “wrong thing” to do. We can help you find the way to POSITION YOUR DATA.

Having a pharmacoeconomic model that doesn’t reflect your clinical position Mistake

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!

Many companies try to “Canadianize” a global model We can help you BUILD A MODEL ACCEPTED BY CANADIAN PAYERS.

Not submitting all available data Mistake

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.

Some companies think some studies are not important We say OMIT NOTHING!

Expecting a premium price Mistake

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?

You love your technology. It’s the best! But ask yourself, WHAT WOULD I DO IF I HAD TO PAY?

Not developing a contingency plan for a DO NOT list recommendation Mistake

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.

You are positive that everything will work out Stuff happens! WHAT IS YOUR CONTINGENCY PLAN?

Believing that pre-submission meetings are not critical Mistake

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.

NOC and launch are approaching fast and you are busy You can meet the payers but WHAT DO YOU SAY?

Lack of message congruency amongst Market Access, Marketing and Clinical Mistake

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!

Marketing knows what the doctors want to hear. Do you tell the payers THE SAME THING?

Copyright 2004 - 2012 Wyatt Management Consulting Inc.

MARKET ACCESS

MISTAKES Contact us for a free 15 minute Water

Cooler Session with George Wyatt CALL TODAY +1.905.257.5670

AVOID MAKING