Your 24-month blueprint for market launch success
Pharmaceutical companies should have a market launch strategy at least two years before data from a registrational clinical trial is available.
Once a company has a commercialization blueprint drafted at least two years before market launch, execution should be consistent company-wide to avoid delays. This blueprint can vary between new drugs and previously approved drugs looking to reach more patients or jurisdictions.
- Early decisions need to be made around a company’s commercial plans: Companies will have to juggle multiple considerations: regulatory pathways, pricing strategies, manufacturing plans, engagement with local clinicians, pharmacovigilance reviews, among others.
- Once the company has a commercialization blueprint, execution should be consistent: There should be a single company voice among departments and within departments regardless of geographic location
- Commercialization execution timelines can vary depending on the drug: Decisions around how early certain commercialization approaches will be executed can be based on how confident the company is in terms of the registrational clinical trial delivering positive results
- The impact of digitalization on product launches can vary: In-person education strategies for key opinion leaders (KOL) are still valuable in ensuring drug awareness
Early planning is key to a drug’s commercial success. Broadly, companies should allocate at least 24 months of lead time before launch. To start with, the company needs to decide which aspects of commercialization it would do by itself and which elements it would likely outsource to an external firm. These aspects cover a wide variety of considerations, from what regulatory pathways the drug would be submitted in, to how the company would negotiate with local payers for reimbursement.
As an example, companies looking to market their drugs in Canada need to have a regulatory and importation strategy blueprint around 24 months before launch, as both aspects are key to any company’s filing for drug approval with Health Canada. Pricing and post-approval pharmacovigilance approaches should be reviewed concurrently to avoid delays. Strategies on how the company would engage with local KOLs should also be drafted to ensure clinician awareness as soon as the drug is available.
In general, if a company is yet to enter any country’s local market, it would decide between partnering the drug product to a local company versus establishing itself locally and building its commercial team internally. This decision needs to be reviewed at least two years before launch as it can take months to review and execute.
Regardless of the commercialization strategy, it is imperative for this to be consistent among different departments, as well as within the same department across different geographical locations. For instance, there is value in bringing in research and development colleagues into conversations that relate to market access so that the drug development team can understand what data will be needed to make conversations with payers easier down the line.
Engaging with the UK’s National Institute for Health and Care Excellence (NICE) early can be valuable. While NICE operates only in the UK, many countries nevertheless use the same cost-effectiveness review process and NICE’s advice can be applied to a wide range of jurisdictions.
In general, there are two different commercial strategies a company can take even before it has data from a registrational clinical trial. If the probability of success of a drug’s clinical trial is high, and the company already has existing commercial resources in that disease space, it would be valuable to engage with regional commercial teams as early as possible to allocate resources accordingly.
However, if the drug is yet to be approved anywhere and the trial’s probability of success is less predictable, the global team can devote their efforts to initial market-shaping activities. As the launch prospect of the drug improves, regional teams can join in to provide specific insights into commercialization needs for a specific market.
The impact of digitalization on product launches can vary. If a company is introducing a previously approved product to a new territory or broadening its use, existing digital resources are already available and can be reused or repurposed. However, if it is a new product, a hybrid approach combining in-person educational strategies and digital resources would be ideal to increase brand awareness among clinicians.
Digitalization has made an impact on commercialization in additional ways, such as the establishment of virtual advisory boards, automatic patient recruitment to support programs based on electronic medical records, and digitalization of prior authorizations. The use of artificial intelligence is being investigated as well to allow quicker patient enrollment or prior authorizations. Finally, digitalization allows commercial teams to have easy communication access to internal medical teams.
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Industry Experts Who Contributed:
- Debbie Drane, SVP, Global Commercial Development, CSL Behring
- Sandra Anderson, SVP, Commercialization and Strategy, Innomar Strategies
- Juhana Heinonen, Senior Director, Global Commercial Lead Narcolepsy and Neuroscience, Takeda Pharmaceutical
- Moderator: Brian Mitchell, US Leader, Commercial Agility and Launch Excellence, Merck