Thunicia Moodley is Senior Engagement Manager at Syneos Health. Turn the page for more on key trends in pharma launches from Syneos Health.
What are the big trends in pharma and biotech drug launches for 2019?
A key trend is increasing evidence needs, ie, having greater evidence to ensure reimbursement of high prices, even for orphan drugs. Companies also need to adapt to new commercialisation challenges for novel therapeutic modalities like gene and cell therapies. With pharma and biotech looking to become more efficient and agile, and fuel growth, life science leaders will be looking to outsourcing to increase commercial growth, due to greater flexibility of commercial scale and the ability to tap into proven external technological solutions, and fill skill gaps. As data becomes more available and there is better understanding of customer needs and preferences, manufacturers will be able to do more with less.
2018 saw the FDA approve a record number of drugs, as well as an increasing number in orphan disease areas. How is this dynamic and competitive market shaping launch budgets?
The increased competitive landscape has created a dichotomy in how companies are investing for launch. Large companies entering competitive spaces are planning for increased launch budgets to compete and win. Small to mid-sized companies are generally not ‘overspending’ on their launches but instead are seeking ways to be more efficient in how they launch. Regarding orphan launches, we see launch budgets that differ drastically depending on the specific disease. While some rare diseases still require smaller launch budgets (no competitors, already identified patients, etc), there is an increasing set that require larger launch budgets due to increasing competi- tive dynamics.
Multichannel marketing and digital channels seem to be maturing – but Europe remains a very fragmented picture, both regionally and in terms of different therapy areas. How should pharma factor this in?
Pharma should establish a collaborative working approach between regional and local teams; identify a core set of regional channels and support affiliate teams to integrate locally relevant tactics. Fragmentation can be mitigated by tracking user interactions via CRM technologies. Many therapy areas are increasingly international (ie specialists from different markets attend the same congresses, read the same journals and visit the same websites), meaning centralised tracking of interactions across multiple touchpoints can reduce fragmentation and increase marketing efficiency. Although data protection regulations in Europe add complexity, an integrated, data driven approach also allows for delivery of more sophisticated customer experiences through personalisation.
Market access is becoming more complex, with new requirements such as real-world evidence (RWE), conditional marketing authorisation and outcomes-based agreements. What are the best performing companies doing to respond to this?
Successful manufacturers start planning their additional evidence early in clinical development, including health economics endpoints in their phase 2 and 3 clinical trials. In Europe there is a preference for discounts, while in the US there is interest in exploring more complex outcomes-based agreements, due to different healthcare service organisation and reimbursement. Outcomes-based agreements require substantial time investment in analysis and outcome adjudication. RWE of actual drug consumption and efficacy is frequently used in Europe (post-reimbursement) to confirm the initial reimbursement decision and price; planning RWE collection to start as early as possible is crucial for success.
The transformational nature of some new therapies, eg cell and gene therapies, means the whole healthcare system delivery paradigm has to change. How should companies plan and invest in this?
New cell therapies face challenges with manufacturing costs, storage and distribution, overcoming reimbursement hurdles, having multiple touchpoints between the care team and patients, limited sites of care delivery and convincing physicians to change their treatment practices. This requires a shift from a ‘drug company’ to a ‘care delivery’ mindset, and manufacturers should begin planning for the commercialisation considerations early in the development process. Early physician and payer engagement and education are likely to be key to driving access and adoption. A thoughtfully constructed and comprehensive go-to-market strategy, along with a clear en- gagement/communication plan, would ensure that key stakeholders understand the product value proposition, and that the patient gets the drug on time in the right setting.
