Barcelona 2015

Mar 24, 2015 - Mar 26, 2015, CCIB, Barcelona

Your Customer is in Charge.

Turning the launch process on its head

Tom Abbott and Kumar Ramananda from technology specialist HCL discuss how to transform the launch process.



Yes, it’s no secret that pharma companies are facing an increasingly challenging commercial environment, with routine cost containment coupled with longer development cycles among just some of the factors that are eroding profitability. Nevertheless, there are ways that organizations can work smarter in the lead up to the launch of a new offering; however, this involves understanding all the dynamics in play.

For a start, that the offering is unlikely to be just a “pill” – although it is increasingly likely to be a biologic – and services may be integrated rather than simply tacked on; furthermore, the product itself may incorporate technology to make it “smart” and be able to communicate in various ways. Moreover, to get that expensively developed product approved for reimbursement is no easy matter; payers increasingly prefer risk-sharing agreements with pharma companies and are looking for real-world outcomes data, preferably from a relevant dataset; meanwhile, recent trends have seen the innovation focus emphasizing care delivery.

All of which means that it is an increasingly complex landscape in which to launch a new product or solution. In response, Tom Abbott, who has recently joined HCL Technologies as Vice President Global Solutions Lead, Life Sciences and Healthcare, suggests that companies should adopt a comprehensive framework approach to new launches in order to maximize their chances of success.

Indian technology giant HCL has developed a program that it says will enable a pharma company to focus on the launch of a product in a more integrated and market-focused way by “inverting the product lifecycle”. The new framework is designed to help pharma companies address all the issues in the run up to a market launch, using a holistic and integrated model that cuts across silos to deliver the multidisciplinary approach required for a successful launch.

Called “Think Care @ Launch”, the program acts as a toolkit that combines consultancy services and solutions that include data-driven intelligence, insights and decision making. Abbott tells eyeforpharma: “It is a program but it is really more of a philosophy.”

He contrasts today’s world with how drug launches used to be done: “Today, it’s more than just doing a clinical trial and then just throwing it out there. That model used to work 20 years ago. Today, everybody is really focused around value.”

How patients benefit

Abbott emphasizes that pharma companies need to know how patients will benefit, how they will use a product, and also understand how to help them use it in the right way – because these are the kind of answers that payers and healthcare professionals are looking for. Combining stakeholder intelligence and social intelligence is the key.

The Think Care @ Launch program “should help you shrink your launch timeline”, according to Abbott, by enabling pharma companies to process outcomes data and real-world data. “Roadblocks to access can be overcome. The program enables teams to answer the questions patients and providers may have in advance of using the product.”

Focusing on the three major areas of strategic advice, information and providing interactive tools, the Think Care @ Launch framework is designed to help pharma companies find the proof points to support their answers by asking the right questions in the first place, and then identifying roadblocks that could potentially stall the launch process.

Is this a one-size-fits-all program? Not at all, according to Abbott. “Each case will be different and depends on the specific product, patient population and market setting.” It’s more a case of tailored solutions, but with common themes across different products.

Driving a successful launch

So what are the key factors that will help drive a successful launch? Kumar Ramananda, who heads HCL's Life Sciences Commercials Solutions practice globally, identifies three.

Today, launch and market access is not a one time challenge; it is relevant throughout a product’s lifecycle. There is an ever-increasing number of renegotiations on price, and interventions from payers to limit access to certain patient subgroups and increased involvement of patients in treatments, that makes this a priority throughout the drug lifecycle. Because it is a large and complex undertaking, the first component is an “interactive layer that brings clarity and internal alignment to the way team members collaborate”. This will integrate KPIs and track progress. “It should be  a next-generation interaction tool with integrated intelligence– not just a SharePoint system.”

Secondly, you need the ability to understand who your target patient population is. “Pharma understands stakeholders better than it did ten years ago but you also need to understand your population base,” Ramananda argues. It is important to define your information strategy in your therapy areas and be able to make rapid course corrections, should these become necessary.

Thirdly, social intelligence engines offer the ability to move from planning to actual management of a situation. “Planning is one thing. Putting a plan into action is another,” emphasizes Ramananda.

Failed launches

If you take this approach seriously, you may decide not to launch in a crowded market if you don’t really add significant value. The hope is that, more and more, the industry can focus on innovative products that provide value to patients, payers and providers".

Of course, asking the right questions can also throw up uncomfortable answers, especially in the context of “failed” launches. For example, the 2013 McKinsey & Co report on launch excellence, Beyond the Storm found that two-thirds of a sample of 210 launches failed to meet pre-launch consensus sales expectations for their first year on the market. So surely many launches are bound to be much less successful than anticipated?

Abbott acknowledges the point, asking whether these are, in fact, realistic expectations. “Think Care @ Launch will give you a better sense of what appropriate expectations should be and how to turn them into effective data-driven actions.”

Indeed, market evidence demonstrates how the launch environment is becoming more challenging, especially because, as blockbuster patents expire, many pharma companies are attempting to make up for lost revenues by launching a larger number of incremental products that face more intense competition. Consultants Bain & Company have concluded that 60-90% of European launches are facing access restrictions by payers and governments due to a lack of perceived differentiation or cost-effectiveness.

Abbott is clear: “If you take this approach seriously, you may decide not to launch in a crowded market if you don’t really add significant value. The hope is that, more and more, the industry can focus on innovative products that provide value to patients, payers and providers". He flags this as a key differentiator.

He also argues that the program enables pharma organizations to fill the knowledge gap and reduce their level of uncertainty by understanding the customer better. In addition, the framework helps companies to establish key indicators to trace whether it is on track with a launch. “They can move more quickly to fill the gaps that develop during the launch by identifying them earlier,” he says.

Ramananda discusses the problems around a lack of visibility where a large team with many affiliates is involved. This issue is further compounded by the trend toward smaller and parallel launches. “You can’t miss anything and get it 100% right first time.” The solution lies in preventing the need for course corrections as well as in how rapidly you can respond if they become necessary.

Real-time data

A further aspect of the Think Care @ Launch program is the focus on making various data sources available as near to real time as possible. With typical launch planning, “standard sets of Rx and competitor data are used mostly to check the boxes, which flow into the systems a month later”. New tools enable pharma executives to rely on far more up-to-date stakeholder intelligence data, with insights and overviews provided by dashboards. Ramananda suggests that the differentiator for pharma is “how you can effectively manage this launch process”. The HCL program incorporates a number of tools on the market along with proprietary tools that include social listening and analytics.

Of course, such analysis needs to be sophisticated and based around sound NLP (natural language processing) capability. HCL says that a clear advantage for its approach is its capability to integrate social listening and stakeholder analysis into its platform.

Cost implications

Interestingly, all this know how does not necessarily translate into lower-cost individual offerings but it should result in better healthcare outcomes and improved efficiency overall. Indeed, Abbott suggests that the methodology may actually increase the cost of launching a drug. What’s important, however, is that it translates into better targeting, focusing the product where it can do most good.

For instance, it enables pharma companies to identify specifically which subset of the population will benefit most during phase 3. So, while it may actually increase the cost of development, there will be wider benefits for society by looking at overall health outcomes and avoiding using the products in patients who will not benefit.

Abbott puts this into perspective: wasted treatments are running at about 10-20% of the total, he suggest, with drugs in these cases either ineffective or inappropriately used. “In a $7 trillion healthcare economy, there is a huge saving from ensuring products are used only where they benefit the patients,” he declares.

He continues: “If you can eliminate half the population that doesn’t get the benefit, the average value to those remaining goes up.” So, while this approach may drive up the cost of an individual treatment, the more precise targeting means it is much more effective for those who receive it.

This approach is all about understanding who benefits and ensuring they get the maximum amount of benefit. “Payers don’t like paying for things, but, even more than that, they really don’t like paying for things that don’t work,” Abbott argues.

Such considerations come sharply into focus in the context of modern biologics – such as stem cell therapy – where pharma companies have only one shot at the target. Such therapies are much more tightly focused – it’s a new era where there are “no repeat prescriptions” or churn in the market. Abbott and Ramananda suggest that tomorrow’s blockbusters will command a much higher price precisely because most of them will be designed to provide permanent solutions.

The HCL framework

This framework encompasses eight major business activities:

1. Collaborative Care – Opportunities for pharma to get involved in patient management activities such as product and treatment guideline training, patient recruitment, non-clinical interventions and other support programs.

2. Patient Support – A range of programs to assist the patient in order to achieve a better health outcome; for example, adherence programs, pill+ services and non-clinical interventions or managed patient care.

3. Social Relationship Management (SRM) – Analysis of social media trends in various channels will improve pharmas’ SRM.

4. Launch Design and Management – Specific launch plans for the payer and the patient. Successful multi-country product launches in an ever changing external, regulatory environment coupled with different value needs of the market stakeholders is a major challenge that needs careful management.

5. Key Account Management & Sales Force Effectiveness – Holistic solutions are required that build flexible and sustainable business models, ensure operational excellence to generate sales and manage costs and focus on both new and existing customers to serve evolving needs.

6. Engagement Planning – Pharmas need to collaborate with payers, providers and also with patients for access to their products and treatments. In-depth knowledge of important influencers is a key competitive advantage.

7. Real World Data (RWD) Analytics – The mash up of PHRs with EHRs to provide useful insights into patient care.

8. Key Opinion Leader/Stakeholder Intelligence – Identifying and engaging the right non-traditional and traditional stakeholders, at the right time for the appropriate cause can have significant impact on time to approval, treatment outcomes and evaluation of trials. Knowing the key stakeholders and country bridge-builders from a 360° perspective along the product lifecycle is key to an efficient and effective PRA approach for pharmaceuticals therapies.

 

Internet of things

HCL has got in early, anticipating among other things the increasing significance of the “Internet of Things”, whereby smart devices will talk to one another as part of a sophisticated health network. However, Abbott acknowledges that the “Internet of Things is still an untapped potential”.

He cites the familiar example of diabetes where, although the market is crowded with products, in many cases patients are not treated effectively. Bluetooth-enabled glucose monitors plus accompanying analytics represent one avenue of innovation, albeit that there is currently “minimalistic device integration”. He suggests that HCL, with its established engineering R&D business that helps customers to conceptualize and prototype devices, can bring a lot of experience and expertise to the table as a partner.

Compliance

Of course, while technology can be a fantastic enabler, it can also throw up huge compliance issues. These are going to vary from project to project, according to Abbott. For example, with websites that link to medical records, “patients need to consent for participation”. What’s more, if information flows back to patients in the form of recommendations, these “programs may officially become medical devices themselves.”

There’s no doubt that regulatory compliance issues will create barriers – “It’s the nature of working in a global environment.” However, there are also efficiency gains. “Most of what we are talking about is scalable and locally configurable.”

The framework encourages companies to “think through all of the things you want to do – to think them through in advance”. Some components can be branded to a specific product or company, while others are more generic. “Generic platforms are likely to be more successful in terms of having an impact on patients and their behavior.”

In conclusion, Abbott acknowledges that there is often some cynicism around when a pharma company launches a new product. However, he stresses: “Most companies I have been talking to want to do something beyond their brand, although the underlying theme is revenue growth.” The likelihood is that, in future, “if a company doesn’t have a product in a therapeutic area, they won’t invest in developing resources in that area.”

He states: “Pharma companies are made of people and people want to do good for society and patients.”

 


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Barcelona 2015

Mar 24, 2015 - Mar 26, 2015, CCIB, Barcelona

Your Customer is in Charge.

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