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Transcript:
MARAH: Hello, I'm Marah Walsh from PharmaVOICE. Welcome to the PharmaVOICE Webcast Network and this episode of the Industry Vision. I'm here today with Sarah Rickwood, Senior Principal at IMS.
Welcome Sarah, thank you for joining us.
SARAH: Thank you.
MARAH: Today our conversation is going to focus on insuring launch success and the payer and prescriber considerations in today’s evolving market.
Sarah, can you give us a quick snapshot of the 2008 IMS study on new product launches?
SARAH: We are building on our 2007 landmark study of over 4,000 launches. But this year we looked at 3,000 launches across eight countries. And we only found 21 that were actually deemed excellent. What we found that was different in this study was that there really are four areas where there are fundamental changes in the office based environment. The first being that really the rules for launch success which worked so well in the late 1990s and early 2000s really don’t apply so much these days, and there is reasons for that. And that’s because of the second point we found, that customers are really different now. It used to be the case that the individual prescriber was your most important customer. Now it may well be the payer.
And also we found that there are very different approaches that are needed to the market. Companies may find that they are not actually launching into the entirety of the market these days. They may find that the segment that they can launch into is only a tenth of the actual size of the market.
And lastly, we found different timescales. One thing we find is extremely important is that there is six months on the market to really prepare the long-term launch success for products. And we found, in fact, that some of the key drivers of that first six month success can stop changing in as little as three months onto the market.
MARAH: What’s new or different about today’s launch environment compared to just a few years ago? Are their marked differences depending on which country or region of the world companies are launching in?
SARAH: The old environment was an environment in which the individual prescriber as decision maker was king, and that environment doesn’t exist in many countries today. The new environment that they have is one where non-prescribing decision makers are actually more powerful. And the most powerful non-prescribing decision maker is, in fact, the payer.
The nature of payers really does vary by country and also in terms of their form and influence. In the US, we have a situation where we have private payers in the form of NCOs and federal and state government payers. In the UK, at a country level, you will have the NHS, and at the local level you will have primary care trusts. In Germany, for example, you have the sick funds. But the fact of the matter is across all therapy areas and in all countries, we are seeing payers becoming more powerful. Sometimes change is rapid as it has been in the US from the early 2000s to the late 2000s. Sometimes payer influence is actually growing quite slowly, as it is in Japan.
Individual patients as a non-prescribing payer group can also be extremely important. But their influence varies by country and therapy area. With payers, the message is that they are becoming more important across all therapy areas and all countries.
MARAH: Sarah, what’s the recipe for a future successful launch? What does this imply for a launch in the future?
SARAH: It will have to be new commercial models. They won’t completely replace the traditional prescriber focused approaches, but they will place them in the right structure to make them effective. At a national or a regional or a local level, payers must grant access on the right terms, and this requires compelling evidence of clinical and health economic value. Payers not allowing access for launches is actually the biggest threat to launch success. Companies must build a compelling value case for their new product early in the development of the launch.
MARAH: How do you go about securing payer’s approval?
SARAH: It’s about making sure that you undertake a 7 step process which actually starts before you start to make decisions about your phase 3 clinical trials. The first step in that process, the most fundamental, is that you have to identify and understand the funding flows for the disease area by each country, both now and also at the time that you’re going to be launching the product, which after all, may be five years into the future. You need to identify the decision makers that are actually controlling these funds. And then you need to understand what they want, what motivates those decision makers and the decision criteria for using new products. That’s going to be the basis of how you develop your product through the phase 3 process.
Then you need to adapt product development based on those insights into the decision making criteria. And as you bring the product to market, you’ve actually got to develop value dossiers that are tailored to each type of decision maker and including mostly the payers, both segmented by the type of payer and also by their motivations and decision making criteria.
Before and during launch, you need to make sure that you are segmenting and targeting payers with appropriate messages that they will understand and value. And lastly, you need to monitor the impact of your activity here just as you would monitor the impact of your sales effort when you bring the product to market.
MARAH: Sarah, what do you think are the implications of these changes on commercial planning and implementation? What do companies need to do as a result of this?
SARAH: Launch is probably the lead indicator of how country environments are actually changing. And although new commercial models aren’t simply about launching new products, because existing products also need to come into them, they are often a catalyst for change.
What we’re seeing and what we found in our study in 2008, was that companies in some countries really are changing their commercial models, and Sweden, the UK, and Germany are often countries where this is changing first. So examples of the kinds of things that companies are doing includes structuring the commercial organization around sub-national decision makers. And also doing things like moving pharmacoeconomic experts from being essentially a back office function into a front office function dealing directly with clients at a local level and mirror units which involve both pharmacoeconomic experts and also sales representatives.
Arguments about the value of the product need to be built as a local level in a directly relevant way to individual payers. And there needs to be a seamless coordination of the approval, acceptance, and adoption sequence at a national and a local level.
In addition, on a more technical level, you need to create dedicated, contracting, and tendering units. We found that there were a number of launches that have really managed to take this to heart and build an excellent launch by insuring that they really combine the people and the arguments so that they move seamlessly from a clinical to a social to an economics outcome impact argument. Spiriva is a very good example of a launch that managed that extremely effectively.
MARAH: What is different about what payers are looking for in launch products? Does this differ from what prescribers are looking for?
SARAH: Absolutely. Individual payers are going to vary in terms of their motivations and their decision criteria. For example, some payers will be caring about the timing of budgetary impact, issues of cost containment. Whereas others may be more strategic and be looking at value of holistic improvements in terms of patient outcomes and care.
So the approach that you need to take is going to have to be a segmented approach. One of the things that companies need to consider when they are thinking about launch is the tradeoffs that they must make when they are talking to payers about the way that they wish to launch products. This is especially apparent in the US, because companies must seek to be able to take the right line between earlier penetration and the acceptance of the product to really commensurate with the six month launch windows and the possibility that significant volumes may trigger later pricing or discount challenges.
MARAH: What do companies need to be thinking about when they’re considering launching new products with respect to payers and the environment?
SARAH: They need to define their ideal outcome by customer type and particularly by paired type before, during, and after launch. They need to understand how they need to plan the launch in order to achieve that ideal outcome and how early in advance they need to build launches at a local level in order to achieve the right outcome.
The fact that only 21 launches in the 2008 study were genuinely excellent, clearly shows that there is some considerable room for improvement.
MARAH: Thank you Sarah. We’ve given our viewers a lot to think about and we certainly can’t cover the full study in today’s discussion.
SARAH: Thank you.
MARAH: However, you can download the full discussion from www.IMShealth.com/lifelink.
Thanks for joining us today and please, check out the other episodes in our special marketing excellence series which features new analysis from IMS and covers additional topics related to new product launches and inline brands.
On behalf of all of us here at the PharaVoice Webcast Network, thanks for joining us on today’s episode of the Industry Vision.
Have a great day.
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