Drugs with a poor clinical profile fail to deliver benefits on the primary product attributes of efficacy, safety and ease of administration. Even the best launch strategy can’t compensate for these deficiencies. The solution, therefore, lies in producing an honest assessment of this prior to launch and, if poor, then seriously considering whether it’s worth the budget to launch it at all.
3. Poor development
4. Under-investing in marketing communications
5. Poor marketing messages
6. Lack of market
This refers to overestimating the market potential. In other words, the launch ‘fails’ to meet an unrealistic forecast, but is it the forecast itself that is wrong? That’s why the data that goes into such forecasts is so important. Now, on top of these, we have more things in today’s environment that are required. Part of being successful is getting your brand out in front of the rest of the ‘me-too’ pack. If you haven’t developed a drug that brings added value to providers and patients, then all the slick marketing in the world won’t get it sold.
After all, with around 100 new Diabetes compounds in mid-late stage clinical trials currently, why should physicians switch from the plethora of Diabetes drugs they’ve got at their disposal – most of which are generic and work pretty well – to your new, relatively untested, not-sure-how-to-use-it, expensive, branded molecule, particularly now that they’re sharing risk for outcomes and costs, and being paid based on the quality of care they provide (as well as its cost)? They shouldn’t . . . unless you’ve prepared them for the new drug by highlighting its value to them as well as the ability to fill an unmet need before it even launches. You now need to also ensure you are or have:
1. A strong differentiated value proposition that includes additional benefit and value for money.
2. Gaining market access and then expanding that market.
3. Redefining therapy guidelines.
4. Strong cross-functional collaboration.
5. Stronger pre-launch planning with increased investment in earlier phases.
6. Stronger stakeholder preparation and engagement so they are waiting for the launch.
7. Creating multi-stakeholder value.
8. Communications focus on key value-added drivers to each stakeholder group.
9. Better resource allocation.
10. Stronger cost efficiency of all activities.
11. Post-launch demonstration of superior health outcomes in the real world.
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Conclusion
At present you need to prove more differentiated value, and start even earlier in preparing the market and all key stakeholders for your launch. One key aspect of this is accurately identifying who the key stakeholders will be, and then fully understanding their needs and drivers. The team needs a consistent yet customized message to different stakeholders in different countries that focus on the values important to them. Soon most markets will be doing cost-benefit analyses on new drugs to determine whether to give them access or not. This means that closing the gap between registration and access is even more critical. The entire team must focus early on proving the strong differentiated value with well-constructed clinical trials with valuable endpoints.
The market access team must use this to assemble a strong case for the added value for patients, physicians and payers as well as which comparators, biomarkers and endpoints are required. This needs to be given to the clinical trial teams to ensure the relevant data is collected. They also need to know about sub-indications, conditions for acceptance of new drugs in that therapeutic area, the competitive environment, and the needs and drivers of all stakeholders. This cross-functional collaboration is an important change from launches of old.
To learn more, please contact the author, Dr Andree Bates, at Eularis.
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To learn more about how Eularis can help you find the best solutions to the challenges faced by healthcare teams, please drop us a note or email the author at abates@eularis.com.