The three key stages to a successful specialty drug launch


Craig Caceci, Managing Director at Terebellum, offers guidance to pharmaceutical companies that are in the position to take their drugs to market. 

In today’s competitive environment, a winning, fail-safe drug launch strategy is more important than ever, especially with increased NHS and private payer influence, steep standards for coverage and ongoing issues such as safety, efficacy and pricing.

The challenges are even greater in the case of orphan drugs where patients need to be identified; therefore, emphasis is on diagnosis. Market access is more difficult and supply is focused on smaller patient populations which brings its own set of challenges. 

So what does an effective launch strategy look like and when should a drug manufacturer start considering it? 

Here’s an outline of steps that can be taken to clear hurdles, dispel unpredictability and importantly avoid costly mistakes to ensure market acceptance and product uptake.

Preparation is key

12-18 months prior to launch is when you should start preparing to go to market, if not sooner. 

Questions to ask include, what does the launch timeline look like, who do we need to hire, what publications do we need to reach out to, where is the funding coming from and have we got enough of it? 

You’ll also need to develop brand materials, get your supply chain in place, ensure medical affairs are ready to go, build reimbursement dossiers and have pricing strategy set. 

It’s a busy time so it’s understandable that many companies struggle balancing resources, timescales and budgets. Especially when there are many important elements to get right and big decisions to make. 

While commercialisation should always be in mind as the ultimate end game, as soon as the molecule is discovered in fact, we understand that it’s often not the first thing that is considered. It is certainly wise to create a commercial, medical affairs and market access strategy, and obtain epidemiology data, earlier on ie. before 18 months. Early strategies make you aware of any gaps, some of which may take longer than 18 months to fill – for example certain endpoints may need to be implemented in the clinical trials, so advice needs be given to clinical teams as soon as possible. However, if starting earlier is not an option, then organisations should place express focus on communicating why treatment of the disease matters. 

Identifying and engaging key opinion leaders (KOLs) and patient opinion leaders (POLs) will enable you to develop and demonstrate strategies that truly reflect therapeutic needs. Meanwhile, determining key performance indicators (KPIs) aligned with your commercial goals and the needs of stakeholders will support smart business decisions and transparency. Regulators, payers and other stakeholders (not to mention you and your team) will want to see that you have an infrastructure in place and are ready to go. So, raising capital and getting your supply chain in order is critical. 

Ideally, these preparation activities should commence 12-18 months prior to launch and slowly ramp up, as required over the following months. Engaging a third-party partner that understands the complexities of the market and can provide strategic advice, will be invaluable in helping you navigate challenges and spot opportunities.

Three to six months before launch: be ready to pivot

With a launch date fast approaching, things can develop or change quickly. 

But there’s still time to make sure you have your house in order. 

Ideally, you’ll now be working on the finer details so that you’re ready to flip the switch the day your product is approved to go-to-market. These include making sure your team are hired, trained and prepared, appropriate financial and logistical systems are in place, brand positioning is clear, promotional materials are prepared, reimbursement dossiers are ready and (local) pricing negotiation strategies are clear. Plus, appropriate representatives are interfacing in the field. 

Whilst having a game plan and timeline is good, you’ll also need to be ready to adapt and accept that things don’t always go the way you expect or plan for. Waiting for your product to get its all-important seal of approval is the riskiest time. Demand on resources is high and a future income stream is not guaranteed. 

Astute drug development companies have a contingency plan determined and additional capital ready to purchase another asset if that’s what’s needed to keep the lights on business-wise whilst an alternative path is explored. A plan B is particularly important if your fate relies on one molecule. 

And, finally let’s not forget the importance of activities you’ve been working on for the past 12 months or so to communicate why treatment of the disease matters and how you will deliver. Now is not the time to step back on this, in fact ramping up such activity at this stage is advised.  

Robust data capture will be invaluable in terms of real-world reporting that can be shared through publications or abstracts. Different segments to target may require different product education approaches so be aligned and up to speed with the changing roles of payers and patient advocacy organisations with influence. 

Competitive analysis is also increasingly important at this stage to understand your position in the market and you’ll no doubt have a direct line of contact to your regulatory consultancy.

Post launch: show value

As soon as the product is launched, start collecting data and insights.

There are many questions to ask. How is the market receiving the drug, who’s using it, are some segments more receptive than others, what’s working, is reimbursement where it needs to be, what could be improved, do you need to take a different path?

Most importantly, speak with your payers, as the importance of engaging with them on product value to ensure launch success cannot be overstated. Through this you’ll be able to convert price-based conversations into value-based discussions around health outcomes, comparative effectiveness and most value attributes.

As well as collecting data, it’ll come as no surprise that now more than ever is the time for sharing data. Plan your publication abstract and conference schedule with military precision. Hopefully you’ll have started this prior to launch, and data pushing from the clinical trial post-launch is more important than ever to support your sales reps.

Consider what data you need to present, when and where – and taper it so that you don’t throw everything at one promotional opportunity or conference.  Have a strategy in place as there’ll be limitations in place in terms of what you’re allowed to say and abstracts can only be used for a limited period of time. By being smart you’ll be able to keep the message going for quite some time about the value of your product and how you will deliver.

What does a good launch strategy look like?

So, what are the benefits you can gain if you put this advice into action? 

The ultimate objective is to have a flawless launch. One where there are no major issues or setbacks, sufficient funding is in place, the product is approved, dosing is right, supply is in order, messaging is well-received and field sales teams are in place. If you have a product that quickly becomes the gold standard it’s clear that you’ve anticipated the market and put the right things in place to meet that need.

Planning and preparation is good, but a footnote to this is that you also need to be flexible and agile – the two work together. Be realistic that not everything will go to plan and you will need to pivot to achieve success.

Effective planning provides more space to adapt and change plans where needed. Alternatively, if you’re already working on everything else and fighting deadlines, and then something happens which requires you to redirect course, it’s a bit harder to do if you’re already not meeting your launch milestones.

DDW Volume 24 – Issue 1, Winter 2022/2023

Craig CaceciAbout the author

Craig Caceci, Managing Director, Terebellum. With over 25 years’ experience in the pharmaceuticals sector, Craig drives the growth and operations of global specialty pharmacy and healthcare services provider, Terebellum.

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