In the UK and France, HTA decision making slowed down. This wasn’t the case in Germany, where a resilient system meant that productivity in terms of HTA decisions was higher in 2020 than the historic average from 2015-2019. Where there have been reductions in overall decision making output, there has also been prioritisation – decisions on cancer treatments have been made at historic levels, whereas for non-cancer treatments, decision output fell.

There clearly has been a bottleneck to effective market access caused by the pandemic in 2020 in some countries. However, a longer term challenge would be if HTA decision making becomes more frequently negative, something that could be driven by a worsening economic situation and tightening healthcare budgets. So far, however, there is little evidence to suggest that HTA decisions are becoming markedly more negative than in previous years.

In the end, approval, availability of a product on the market and its market access are all gateways to the main measure of 2020’s impact on launches – how the product performed in sales terms. Evaluating 2020’s impact on this measure is by no means a completed story; launches in December of 2020 may still have only a few months’ sales to evaluate; those launched in January are now over a year old and should be well established on their launch course. However, preliminary perspective is possible – we have taken two approaches.

First, 2020’s launches can be compared, by country, to the launch cohorts of previous years. To do this, we need to compare like with like, and therefore selected the first six months of continuous sales on the market as the comparison period. This is a completed set for all previous years, but a work in progress for 2020, as a product launched in December 2020 will only have completed its first six months sales in May 2021.

In addition, launch cohorts do perform differently – for example, the years 2015 and 2017 were especially strong in Italy, because those were the years when modern hepatitis C treatments such as Harvoni became available, and high unmet need in Italy combined with healthcare system readiness to fund for a significant number of patients.

Using MIDAS sales data, we compared average monthly sales across the first six months on the market for NAS launched 2015 to 2020. Because we knew that Orphan Medicines, led by the gene therapy Zolgensma and the Cystic Fibrosis treatment Trikafta, had in many cases actually outperformed expectations in 2020, we assessed the first six months of sales for New Active Substance launches with and without Orphan medicines. We also excluded licensed COVID-19 treatments – of which, in the EU, there were only two in 2020, and only one, Veklury (remdesivir) which was a New Active Substance.

Looking at the major European markets, EU4 + UK, we found that 2020 ranked among the lowest of the last six years for launch sales uptake in 3/5 of the leading European countries for all NAS launches, with or without orphan medicines (Figure 2). In no country is 2020 a strong year for the first six months NAS launch. It is important to note here that this is a preliminary assessment that will evolve as more data becomes available and more launches are fed into the model once they reach six months on the market.

Spain was a notable exception in this analysis as the performance of 2020 launches was relatively strong compared to previous years. This is due to delays to pricing and reimbursement decisions in Spain in 2020, which meant that only a small number of NAS actually launched, and those that did were high value, specialty products.

In the UK, performance of 2020 for non-orphan NAS launches ranks fourth worst out of six years, but that relatively strong performance is driven by two launches – Esperoct for haemophilia A and Sarclisa for multiple myeloma, both of which previously held an orphan designation from the EMA that was removed at the request of the MA holder. Therefore, the true picture in the UK is more in line with the low ranking of the 2020 launch cohort in all other countries except for Spain.

Another approach to evaluating how launches did in 2020 is to compare actual achievement with the forecasts made (by analysts) in 2019, before any knowledge of the pandemic. These are global, and may be incomplete as they rely on analysts having made those forecasts and companies publishing 2020 sales figures, but comparison of the launches that outperformed in 2020 versus analyst expectations and those that underperformed shows a stark contrast – all out-performers for which we have data are orphan medicines, whereas only one of the underperformers is.

Key global outperformers are mostly launched in the US alone; we therefore approach generalisations with caution, but the common threads for these launches is that:

• They are orphan medicines, often with an exceptionally strong clinical story. The best outperformer of all, Tepezza, is the first pharmacotherapeutic ever for thyroid eye disease, a rare but debilitating condition. Trikafta (also known as Kaftrio) for cystic fibrosis represents state of the art treatment for 90% of cystic fibrosis sufferers.
• In some cases, they reduce the number of times patients must visit health facilities: Adakveo reduces the number of vaso-occlusive crises that sickle cell anaemia patient suffer – crises which typically land patients in an emergency room. Similarly, Reblozyl treats transfusion dependent anaemia in myelodysplasia, reducing and in some cases eliminating requirements for blood transfusion.

In addition to these characteristics other launches that did well despite the pandemic shared an element of luck – they were already approved in 2019 and had already undertaken most of their launch preparation by the time the pandemic hit. For orphan launches into areas of severe unmet need this meant that a pipeline of patients already existed who could still be moved into treatment despite the pandemic. For other launches it meant a vital few months before the full impact of lockdown hit, although it’s notable that the successful launches pivoted very rapidly to all virtual launch models.

Despite the fact that there have been some outstanding successes in 2020, the challenges for innovative launches which lack orphan status or a clear pandemic related advantage (eg in keeping patients out of hospitals or allowing them to self-administer) remain into 2021, and possibly beyond, when they will be joined by increasing economic challenge.  To succeed in this environment, we have identified three critical pillars of post-pandemic launch success:

Understanding and addressing the changed patient journey to effective diagnosis and treatment

Effective launch needs doctors to be able to diagnose patients for the first time and make new prescriptions, or evaluate existing patients and switch prescriptions. For some conditions, face to face meeting is an essential prerequisite for these decisions. In others, it is very much preferred, and will continue to be considered best practice. Patient journeys to effective diagnosis and treatment have been severely disrupted by the pandemic. Telemedicine, remote treatment, altered treatment protocols and missed or sub-optimal treatments have all exacerbated existing challenges on the patient journey or raised new ones. The more complex the patient journey was before the pandemic, the more likely it is to be vulnerable to pandemic disruption. Patient journey challenges have led to patients dropping out, and a “treatment gap” or backlog that needs to be addressed.

Getting as many patients as possible back to effective diagnosis and treatment is something on which the interests of patients, healthcare systems and pharmaceutical companies see alignment. For pharma, the first step is to understand the changed patient journey – how it is impacted, where the bottlenecks are, what impact this has for their product. Understanding how these could be addressed and the appropriate interventions of pharma then follows.

Re-designing commercial model strategy in a more hybrid customer engagement environment

Throughout 2021 and into 2022, we live with the obvious environmental challenges of a socially distanced, uncertain healthcare environment with significantly reduced opportunities for face to face meeting – whether it be between doctor and patient, or pharmaceutical representative and doctor.

Face to face meetings between pharmaceutical reps and doctors have always been an extremely important element of launch introduction. The good news is that the early indicators are that in many major European markets and the US, live e-detailing is not only delivering meetings as long or longer than face to face ones, but ones that are equivalent or even better in terms of doctor intention to prescribe.

With a changed environment here for the longer term, launch strategy as well as tactics have to change. A swift pivot to digital helped tide companies over the immediate impact of lockdowns, but it must now evolve into a long term new commercial strategy, in which a much more hybrid, multichannel approach to launch is key. The good news for the commercial model is that already, pre-pandemic, the most commercially successful launches were also the most digital ones.

During 2020, we have seen encouraging signs that remote e-detailing can not only deliver a detail that is longer in length than face to face details in many countries, but also one that, for most major countries, is as effective or more effective in terms of driving intention to prescribe. Reps, of course, remain central to the hybrid model, where a combination of face to face and remote engagement must be used to optimise on what are likely to be scarcer engagement opportunities.

They will, however, need new skills to be able to engage effectively both in person and remotely, and be deployed in a commercial model which has the right data and platform to optimise all channel opportunities. Whilst reps will continue to be vital, the deployment of reps and other customer facing team members becomes a significantly more challenging choice in the uncertain and risky environment we will continue to see in 2021 and beyond.

Rather than take on permanent employees, pharmaceutical companies may want to make more effective use of contract sales and other customer facing teams, to develop a more agile and locally relevant response, using a combination of appropriately skilled reps, medical and payer liaison, and nurse support teams. As healthcare systems recover, it is difficult to predict what will be needed, when. An approach which combines flexibility on resource to meet rapidly changing needs with capability, in terms of digital and remote skills, may be required.

Building a future fit value proposition backed by a RWE strategy delivering competitive differentiation

Lastly, investment now in an effective and competitive real world evidence (RWE) strategy will yield impact when it is most likely to be needed – as the longer term economic consequences of the pandemic tighten belts on healthcare spending from 2022 onwards. Medicines budgets are unlikely to be able to grow much in times of economic challenge, and the cost relief anticipated from loss of exclusivity for the next five years is smaller than has historically been the case. It is also significantly biologic and biosimilars, although a mature market, do not yet yield cost savings as efficiently as small molecule generics do. Payers are likely to be in a position where they have to prioritise between spends on new launches, and prioritisation will be based on evidence. Launches with superior RWE demonstrating their differentiation and value will be in a more advantageous position. RWE studies take time to set up and run to yield evidence; for the right evidence dossier in 18 months, start investing now.

The launch environment has always evolved – today’s highly specialty product driven environment is a far cry from the primary care, share of voice driven world of the early 2000s. To stay ahead, companies with excellent launches have always planned their launch strategy with the environment that they would be launching their product into firmly in mind. In this sense, the pandemic has not changed the need to understand and anticipate changes in the launch environment, merely made them more complex and disruptive than before. Launches will still succeed, but success will be built on a robust strategic plan with the three pillars of post pandemic launch excellence at its heart.

About the author

Sarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.