Launch excellence: new environment, different challenges

Sarah Rickwood

IMS Health

At a time when fewer new pharmaceutical products are coming to market, companies and investors pin extremely high hopes on those that do. The fundamentally altered environment that launches now face, the different customers that wield power over whether a launch succeeds or fails, the different approaches that companies must take to market for excellence, and the different timescales in which success and excellence are measured present new challenges (fig 1).

The environment has now fundamentally and irrevocably changed, in two crucial ways. Payers' control over the use of new medications has increased significantly in most major markets. In almost all primary care therapy classes, and an increasing number of specialist classes, there are now many generic alternatives.

So for launch to achieve excellence today, companies must address four key truths:

1. The environment is different

2. Customers are different

3. There are different approaches to market

4. And different timescales

1. Different environment

Companies have recognised the shift in power from individual prescribers to non-prescribing customers, particularly payors. That’s why they’ve shrunk sales forces – and detailing volumes have declined as well.

Moving to a generic first line treatment paradigm in primary care

Once effective generic therapies are available, they dominate first line treatment. In this environment, launch products are increasingly launching into a second line position.

With this primary care environment, it’s unsurprising that the Excellent Launches are more likely to be specialist-driven. Fewer specialist-lead areas have genericised, and launches with strong first line positions are still possible. This situation will, however, last only as long as the patents do.

A new commercial model

As already noted in the previous article, the changed environment requires a changed business model – principally:

• Greater attention to payers and to gaining market access, in terms of developing evidence, preparation pre-launch, and people focus against payer activity

• Greater investment in outcomes trials before, during and after launch

New markets

The specialty market is the dominant growth driver of the global pharmaceutical industry, and this will continue, with oncology alone forecast to be the world’s leading pharmaceutical sector with some $70-80bn worth of sales by 2011.

2. Different customers

So companies must now address non-prescribing customers, often as a priority over prescribers. They include patient and advocacy groups, HTAs, payers and pharmacists (fig 2).

For excellence in launch companies must define their ideal outcome, by payer type, before, during, and after launch, and plan far enough in advance and effectively to achieve those goals.

What to do: the details of a new commercial model to support launch

• Step 1: Build approval. At national, regional or local levels, payers must grant access on the right terms.

• Step 2: Build acceptance. Payers are not the only advocates crucial to strong product adoption. Clinical opinion leaders, international, national and local, patient groups, and clinical organizations are all important builders of acceptance, and may also influence payer decision making.

• Step 3: Build adoption. Once approval and acceptance have been built, it’s possible to build adoption at the individual prescriber-level.

What to do: Seven steps to address payers effectively

Companies must ensure that they address each of these seven steps in a timely, full and effective fashion.

• Identify, and understand the funding flows for the disease area

• Identify the decision makers controlling these funds – or potential future funds

• Understand what motivates decision makers, and their decision criteria

• Adapt product development based on insights into decision making criteria

• Develop value dossiers tailored to each type of payer, segmented both by group and motivation type

• Before, and during launch, target the segmented payers with appropriate messages

• Monitoring the impact of this activity.

3. Different approaches to market

The new environment will also mean different expectations for peak sales, speed of penetration, and market share for new launches. Future launches, whether specialist or primary care, will enter market environments where the strategic imperative will be countering the restriction of market potential. In this environment, rigorous examination of the potential to grow markets is necessary in the strategic launch plan.

Companies with launches which are effectively entering the second line market must seek to expand this, by improving monitoring of first line therapy, better and early identification of failures, and building a strong case for second line use.

Future successful launches will adopt strategies that combine segment definition with market expansion. In the new launch environment, successful launches must increasingly focus these approaches to expanding diagnosis levels and improving speed to diagnosis in a specific segment within the market.

4. Different timescales

Launches establish their longer term trajectory very early on, and that whilst it is not impossible to improve trajectory after the first six months, it is something that only a minority of launches ever achieve (fig 3). The elements that drive an optimal first six months are complex and inter-dependent. Delivering optimal readiness across all functions and activities is absolutely crucial, and companies must ensure that this is not left to chance.

The prescribers that will drive the first six months of your launch

Not only do innovator doctors prescribe earlier, they also prescribed more, and continued to prescribe more, for up to 20 months post launch.

Innovators and early adopters have significant impact in the first six months of launch, contributing in some cases, more than half of all prescriptions. After the first six months, as the late majority and conservative prescribers start to use the launch, the proportion of total prescriptions from each group more closely matches the number of doctors in that group (fig 4).

The patients that will drive the first six months of your launch

In the first six months, acquisition of new, switch and add-on patients is the key to growth. Most launches grow by a mixture of new plus switch prescriptions, but excellent launches seem to have a higher proportion of switch patients in the first six months than non excellent launches.

Excellent launches are those which are extremely good at preparing the market in such a way that doctors are able to identify pools of existing patients they want to switch, aware of the benefits of the launch medication, and motivated to enact the switch.

What to do: The importance of pre-launch preparation to optimize the first six months and beyond

Delivering optimal readiness across all functions and activities is absolutely crucial. A systematic approach is needed, with comprehensive structures for addressing the following elements - the comprehensiveness of launch readiness, the timeliness of launch readiness, the quality of launch readiness and the relevance of launch readiness.

Conclusion: a new Launch Excellence plan for the next 10 years

We know that we are in a period of transition for the launch environment of the global pharmaceutical industry. What we are transitioning to is not entirely clear, but some themes emerge:

• The specialty market is taking over in growth terms. Getting it right in specialty launch will be an absolutely crucial success factor for excellent companies of the next ten years. But many specialist products will have to succeed in the office based environment, and will find that the same payor pressures exist as exist for primary care launches.

• The primary care market has fundamentally altered, with many disease areas acquiring, effectively, a generic first line treatment paradigm. But this doesn’t mean that disease areas treated in primary care are adequately served, or that there is no opportunity for new launches in primary care. In fact, there continue to be cohorts of new launches coming through in primary care areas such as type II diabetes, osteoporosis, asthma, and others. To be successful, companies with these launches must understand the issues we’ve laid out in this study.

• Payors will increase their power to decide whether launches succeed or fail, becoming more powerful, more complex, and with influence on and interest in a wider set of launch issues. The companies that had excellent launches in the 1990s had huge levels of investment in state of the art approaches to addressing prescribers. The companies with excellent launches in the late 2000s and 2010s will be those that have a similar state of the art approach to payors, whilst not losing site of the continued role of the prescriber.

Companies planning for an excellent launch must take as their starting point the fact that they are in a different environment, with different customers, different approaches to market and different timescales to take account of when planning for their longer term success. Knowing this, they must build a launch with the right patient segmentation strategy, the right approach to payors, both at a strategic and a tactical level, optimal preparation and planning across all aspects of launch readiness, and a plan which explicitly recognizes the extreme importance of the first six months of launch, and plans accordingly against the drivers that are different in this time.

In the future there will still be excellent launches, but the rules they will play by will be very different.

About the author:

Sarah Rickwood is a Senior Principal at IMS Health.

For queries regarding this article please contact IMS Health at netinfo@uk.imshealth.com.