6 Mistakes That Can Kill Your Drug Launch

Despite all the launch experience in the #pharmaindustry , launches today face very different needs than the ones of the past. With the hypercompetitive markets we are now facing, drug launches today have to be focused on value and be able to convince on value – convince physicians, patients, and payers.

You must be able to prove that you are providing the best health outcomes and additional benefits for a price that gives value for what you are offering. This is evident in many markets. The UK introduced value-based pricing in 2014. In the US, the biggest obstacle for new drugs is not FDA approval anymore but access and reimbursement, founded on strong outcomes-based proof of value far beyond simple clinical trials against a control. In Brazil, Russia, India, and China we are seeing the adoption of FDA/EMA standards and market access developments. The Brazilian government already uses its bargaining power to get the best price and also references price to other markets.

You wouldn’t book an airline ticket without knowing the destination, would you? Build a house without a blueprint? Then why are so many brands launched without a solid strategy, one that takes into account the current and future market, and most importantly, the customers’ true needs and what they value most? Nothing, absolutely nothing, could be more important in an age when just 1 in 10 compounds that enter the research and development tunnel actually emerge at the end. The age of the blockbuster is over. Today, if you aren’t successful within the first year, you might as well kiss your drug goodbye.

6 Mistakes That Kill A Traditional Launch

1. Poor Clinical Profile

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.

2. Wrong Price

The product price premium that a drug can command relative to its competitors needs to be realistic and based on something more than a gut sense of what the market will bear.

3. Poor Development

How well did you plan the development of the drug for the marketing of the drug? Did you design the clinical trials against competitors, assess its ability to deliver quality outcomes, and compare its ease of use to others on the market? How about identifying surrogate endpoints and assessing sub-populations to clarify your drug’s benefits for various patient populations, something that’s becoming increasingly important in this age of personalized medicine? You need this level of evidence in order to properly position your drug during launch.

4. Under-investing In Marketing Communications

Even a product with great intrinsic value will not reach its potential market share without solid communications. If your company doesn’t have the resources to launch a deep, multi-layered marketing campaign, then you need to partner with a company that does.

5. Poor Marketing Messages

‘Evidence-based’ marketing messages and themes are increasingly important as market access hurdles make it more difficult to penetrate the market.

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.

Have A Plan For Success

Unless you’ve prepared for the new drug launch by highlighting its value as well as the ability to fill an unmet need, the drug will not sell. For example, 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)? Simply put, they shouldn’t. You now need to ensure you are/have:

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Conclusion

At present, you need to prove more differentiated value and start even earlier in preparing the market and all stakeholders for your launch. One key aspect of this is accurately identifying who those 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 #marketaccess 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 the launches of old.

To learn more about how Eularis can develop the best solutions to the challenges of drug launches today for your #pharma organisation, email Dr. Andree Bates at?[email protected] .