How-to-guide for successful launching Biopharma drugs
This article offers methodology, best practices, how-to-guidance and project experiences related to successfully launching pharmaceutical drugs.
The need for Biopharma companies to improve their product launch
The product launch has become increasingly complex and difficult due to numerous trends: Target patient size is shrinking. Drugs turn into therapies. Mass-market style launches give way to more targeted group approaches. Country specific regulations evolve and make global launches challenging. Rare diseases make it hard to identify, diagnose and access patients. Regulatory, provider and patient pressures require evidence and value-based outcome modules. Abundance of data and available advanced technologies raise expectations to work more thoroughly and consider more aspects in more detail.
(Read this article to gain more insights on better managing customer data. Click below...)
Companies need to master key areas for product launch success
Initial preparation and launch framework
Good planning starts at least three years before the actual launch. Starting late often lead to lower-quality outcome, delays and overall poor launch. However, if an asset is acquired or in-licensed and/ or the budget limited, this may not be possible.
Good launch planning starts with the end in mind and determines as follow: Size of patient population, ease to identify/ diagnose patients (ex: biomarkers need?), differentiation of product, variability across key markets, objectives & priorities, skills & staffing of global/ local launch teams, timelines, readiness & gaps, evidence required for reimbursement, sourcing & gathering of evidence, advocates & stakeholders to engage, key product dimensions, market & product dynamics, competitive dynamics, R&D/ BD actions & timelines, overall critical success launch factors, KPIs to be measure/ tracked,
The importance and extent of each vary across different product launches.
A launch framework such as LEK's 3-12-50 theme can help organize the various efforts and understand/ mediate the interdependencies among activities:
Roles & Organizational alignment
The launch team must be cross-functional and clearly define individual responsibilities: A brand head or product VP leads the effort. Local launch teams plan and execute efforts locally. They are led by general managers, business unit heads, marketing leaders and supported by cross-functional members. The global team oversees efforts, monitors overall deliverables and intervenes where necessary. Both global and local teams must include R&D, Medical Affairs, marketing, marketing insights, marketing access, health economics and outcomes research (HEOR), and regulatory functions. Other functions may support as required: Manufacturing/ Supply chain, Finance, HR, Compliance, Public Affairs.
Continuous Readiness Assessment
The global team regularly progress and key milestones according to initial plan. Key milestones include: Decision to file, Filing, Marketing Authorization, P&R approval.
The right team, mindset and skillsets are necessary
The overall team requires all necessary cross-functional skill-sets, experience, passion and collaborative mindset. Companies need to plan in advance and start training/ hiring sufficiently in advance.
Biopharma should meet the evolving needs of today's environment in order to be more successful
Engage with access stakeholders prior to launch. Exchange clinical, safety, economic, and financial data as early as possible. Make it easier for health plans, health systems, and PBMs to plan and budget for new products.
Understand the value drivers unique to individual payers and providers. Understand how key customers define value (from therapies). Leverage value drivers to reduce the disease burden, optimize health care resource utilization, meet unmet patient needs in one or more patient sub groups. Identify opportunities for access through innovative arrangements such as value-based contracting.
Share clinical trial data with concerned decision makers. (Read on how to better innovate Clinical trials. Click here...)
Align evidence generation plans with value drivers. Align cross-functionally on desired value claims, proof points and approaches. Address any priority evidence gaps.
Craft customized value stories that resonate with access stakeholders' definition of value. Incorporate clinical, economic and humanistic perspectives on product value to adequately reflect pricing.
Use RWD to identify care gaps & inefficiencies in care delivery. Demonstrate proof of product's clinical superiority versus next best alternatives or standard care.
Demonstrate distinctive outcomes for specific populations and long-term safety to support favorable placement. Customize budgetary impact assessments at the population or cohort level. Supplement budget impact with cost effectiveness models to communicate overall value compared to other or non-drug intervention alternatives. Incorporate market-access endpoints (example: overall clinical cost offsets) into clinical trials to differentiate the economic value of a therapy.
Share evidence beyond clinical trial endpoints, such as patient reported outcomes, details on patient support programs, and implications of the product on quality of life for patients suffering from the disease. Do so especially where approved novel products have limited clinical information (example: rare disease treatments).
Leverage data and advanced analytics to power risk-based value modelling, identify target reimbursable patient population and other analysis to build customized value stories. Leverage RWD with analytics to identify potential value drivers. Actuarial analytics applied to RWD on disease burden can help identify new sources of clinical and economic value for value stories.
Read how to leverage Artificial Intelligence and Advanced Analytics for the Drug development life cycle. Click here...
Provide transparent information with draft models, rational, parameters/ assumptions to health plan decision makers to build trust. Avoid black box budget impact models.
Collaborate with payers and providers to exchange data, build tools to map the patient journey and generate RWE. Collaborate with technology companies to gain deeper insights into data. Leverage platforms and tools to collect, validate and analyze RWD.
Deploy pilots to focus on improve outcomes and develop early value-based contracting roadmap(s).
What can go wrong and what to do...
Insights and Learning lessons from previous client engagements & projects
It takes much more than creating an innovative product. It is important to help patients to get an appropriate diagnosis. On average, it takes patients five to seven years to get a right diagnosis of a rare diseases and involves visits to about eight different physicians.
Access and payers have become very important to the success of a launch. The role of medical affairs has further increased in importance.
The patient's voice is central when launching a drug and working with patient-advocacy groups. It requires much thoughtfulness about the environment. There is only one shot to get it right.
It is important to consider product features, such as mode of administrating the drug (example injections by doctors or common nurses).
Consistency is of utmost importance. Spend sufficient time to differentiate your product. Do not assume to off-set lack of focus with frontline marketing and sales.
The positioning statement is the most powerful document, internally, for aligning teams on what the drug should accomplish. Keep it simple and maintain a long-term positioning.
Respect and support the value proposition across all strategies, tactics and communication channels. It applies for sales field force, medical affairs, communications and development. Focus on simplicity. KOLs and other physicians need to get the idea quickly or else will dismiss it.
Read how Pharma companies should better engage with health care professionals. Click here...
Differentiation is all about customer intimacy. Pharmaceutical brands should focus more on building brands, rather than selling products.
It is important to get the culture right and manage natural biases within the organization. People tend to assume that their product is the best. Need to do more competitive analysis.
Foster an environment for people to raise their opinions. Play devil advocate. Challenge team assumptions to examine vulnerability to competitive pressures.
Pay sufficient attention to details. Do not underestimate less attractive, but important duties such as risk management plans.
Operate in an agile governing model. Define a clear product strategy underscored by strong product planning. Demonstrate value across the evolving stakeholder landscape. Develop new approaches to maximize launch opportunities.
Read more on how Biopharma companies should reconsider their business models. Click here...
Conclusion
If you are interested in more Health Care and Life Sciences related content, you can refer to my other publications or reach out to me directly at [email protected] or WeChat (ID: alexwsteinberg2 )
About the author: Alex Steinberg comes out of a family of doctors, scientists and other health care professionals who have sacrificed their lives to improve the health & well-being of people around the world. Alex drives digital transformation, innovation and intelligent automation efforts for the largest brand companies in China.
Special credits: This article leverages text, content and graphics of LEK, McKinsey and Deloitte. Their Life Science and Healthcare expertise & thought leadership positively impact the lives of millions of people. Thank you!
Legal disclaimer: This article represents my personal opinion and does not reflect that of my current/ previous employer(s) or clients. The article intends to increase awareness, understanding and dialog about Health Care and Life Science issues. It does not present any offer or advice in a legal sense. Markets and technology change quickly and information gets out-of-date. The reader is advised to always seek individual analysis & consultation.