Managing pharmaceutical launch timelines is a critical step in the journey from clinical development through to market entry.
The last few weeks or even several months between marketing authorisation and launch are a fraction of the average 12 years it takes to progress drugs from the laboratory to the pharmacy shelf. Yet they are absolutely crucial to the effectiveness of launch preparation and the hopes of patients who may have waited years for a better therapeutic option.
Stumbling at the final hurdle of the launch plan is also expensive. An analysis by Deloitte estimated that one year’s delay in drug approval and launch in the US would cut by 1.0% a 14.8% baseline internal rate of return on R&D investment.
Looking at first-to-market advantage for new medicines, in 2014 McKinsey found the average market share 10 years after launch was 40% for first entrants versus 33% for second products to market.
With more demand for real-world data that enable regulators and payers to recalibrate pharmaceutical value throughout the lifecycle, the success curve for new launches is starting to flatten out.
“Companies may need to revise their expectations of launch from high, fast success to steady incremental increases within boundaries negotiated with payers,” Quintiles IMS recently acknowledged.
All the same, it insisted, the first six months of commercialisation remain a key determinant of launch optimisation and market share over the longer term (see Figure 1).
Need to know
Quality of execution depends on all stakeholders knowing what is happening with the launch at every stage of the process.
When TRiBECA® Knowledge asked 450 pharma executives about their biggest challenges in launch tracking and planning, managing timelines and launch status was a recurring theme.
Respondents spoke of the need for “timely visibility of country challenges”, “flexibility to adjust plans at the last minute” or simply “launching with a bang”. Other challenges included:
- lack of predictability around drug reimbursement post-launch;
- clear visibility of tenders;
- capturing and communicating amendments to launch guidelines;
- ensuring all functions started the launch process on time.
These issues multiply when a drug launches globally and sequentially across markets with different economic conditions, pricing and reimbursement systems, advertising and marketing regulations or health-technology assessment (HTA) procedures and post-pricing negotiations with local or regional payers.
Any or all of these factors can have a domino effect in a digitally networked environment, where careful launch scheduling may provide little protection against country-to-country reference pricing or shadowing of HTA decisions.
Results from ongoing clinical trials may necessitate last-minute changes in drug labelling, packaging or positioning. There may be eleventh-hour problems with product sourcing or manufacturing, with inventory management, media coverage or elements of the supply chain.
Making sure stakeholders are on the same page about launch developments is a sine qua non of anticipating and controlling issues that can escalate swiftly from small local hitches to global crises with potential to stop a roll-out in its tracks.
Chasing markets for updates, or collecting and consolidating data from poorly aligned launch readiness tools, also limits the time and effort key personnel can invest in launch strategy and implementation.
The right launch readiness tools will give you a continuous 360˚ view of launch timelines and progress across geographies and functional silos. You can learn from evolving issues in individual markets and, if the launch strays off course, intervene quickly to limit local damage or knock-on effects in other countries.
Launching a new medicine across multiple markets is an iterative process. Global strategy has to bend without breaking to accommodate variations in an ever-evolving regulatory and market-access environment.
You cannot optimise implementation of this strategy if you are always the last to know. A customised tool will ensure timelines stay visible and manageable right through the product roll-out, and at every level of your business.
TRiBECA® Knowledge is a market leader in smart business tools that help pharmaceutical companies successfully launch and commercialise products. Our tools enhance visibility and transparency, streamline processes and drive communication and collaboration across brands, management layers, business functions and countries worldwide.