Launching in Today’s Cut-Throat Pharma Environment

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



You must be able to prove that you are providing the best health outcome and additional benefits for a price that gives value for what you are offering. This is evident in many markets. The UK introduces 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 trial against a control. In Brazil, Russia, India and China we are seeing 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 customer’s 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.

Here are 6 things that can 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, 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. 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. 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 prelaunch 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

 

Conclusions

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 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: http://www.eularis.com


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