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Pharma’s post-pandemic launch performance problem: what’s the prognosis?

The prescription medicine market has recovered from the wild swings of the early pandemic with renewed growth. COVID
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The prescription medicine market has recovered from the wild swings of the early pandemic with renewed growth.

COVID vaccines and treatments have created a substantial market over and above the existing Rx market- IQVIA estimates that the cumulative value of COVID vaccines could be between $185 and 295bn to 2026. However, this picture of recovery hides a less positive trend – non-COVID innovative launches from 2020 onwards, have, with certain exceptions, under-performed pre-pandemic benchmarks of launch sales performance in the major countries in the market – that is, the US, EU4+UK, China and Japan.

The scope of the problem

Non-COVID prescription medicines didn’t stop launching during the pandemic — approvals by both the FDA and the EMA were, in fact historically high in both 2020 and 2021. Nor did companies choose to delay the launch of approved medicines, which might have been a reasonable response to the early stages of the pandemic; in fact, the non-COVID innovative medicines entered commercial channels, as measured by IQVIA, at rates above or closely similar to pre-pandemic benchmarks, with only three substantial exceptions: France, in 2020, when New Active Substance entries were 19% below the 2016 to 2019 average, and Spain in both 2020 (47% below) and 2021 (20% below).

Launches, therefore, were happening. But were they fulfilling their commercial potential? On average, across the eight countries that provide over 90% of the first five years’ commercial potential for launch medicines, the answer is no. The graphic below shows month-on-month average sales across the US, China, top five Europe and Japan for all New Active Substances, divided into time cohorts. Across the post-pandemic launches, from those that entered in 2020, to those that launched in the third quarter of 2021 (and were then followed for their first six months of sales to Q1 2022) the average six-month sales remain down by 19% from the pre-pandemic benchmark.

There’s no reason to suppose that the innovative launches coming in from 2020 have suddenly become less innovative and significant in terms of commercial potential; most launches are entering the same types of therapy area – oncology, immunology and rare diseases – as before the pandemic, and the unmet need in these areas remains high. Therefore, over $1 billion of innovative launch potential could have been collectively lost to date.

Post-pandemic underperformance appears to be enduring. Breaking down the post-pandemic launches into cohorts each representing six months’ worth of launches (except the most recent, which is for one quarter) reduces the launch numbers and increases the influence of individual launches on the average, but it also allows us to understand how performance is evolving.

On average, launches of 2020’s cohorts both underperformed. The average for the first half of 2021 did seem to revive pre-pandemic levels in the first six months, but that was heavily influenced by the outstandingly positive performance of one launch: Wegovy, an obesity treatment, in the US. The most recent quarter’s worth of launches for which we have six months of sales show significant underperformance: 40% below the pre-pandemic benchmark. Furthermore, the 2020 post-pandemic launches, for which we now have up to 21 months of sales, show continued average underperformance. This performance problem is clearly persistent.

pandemic launches

Why the pandemic hurt launches

Why are we seeing this pattern? Because there’s been a perfect storm of pandemic-initiated factors, which combined (and continue to combine) to create an environment that hurts the sales performance of launches more than inline medicines.

The initial pandemic lockdowns prevented many patients from seeing doctors face-to-face. Telemedicine rose dramatically in many countries, providing a route to managing ongoing care which was a lifeline for many patients. However, most doctors polled by IQVIA consistently state that whilst they are happy to manage many aspects of patient care remotely where possible, they want to see the patient face-to-face to prescribe a newly launched medicine.

This preference leads to fewer opportunities to prescribe new launches in an environment with fewer face-to-face opportunities, and, for many conditions, gaps and backlogs in screening, diagnosis, and check-up. Backlogs and reluctance of patients to present for diagnosis still linger, and for some disease areas a proportion of sufferers may never be diagnosed and treated, or may never be treated with the most recent launches. Launch opportunity is reduced.

Pharma, when launching, needs interaction with doctors to raise awareness, answer questions and build knowledge of and confidence in launches. Whilst it’s well-known that the channel mix of promotion tilted dramatically to remote/digital during 2020 and has remained permanently more hybrid, it’s less well known that in Europe the total amount of interactive promotional time that pharma has with doctors has not yet recovered to pre-pandemic levels in any of the major countries. Pharma simply has less interactive time with doctors. That impacts launches most.

Lastly, the growing economic crisis creates increasing challenge for medicines funding. Health systems have had to spend to address backlogs, make healthcare delivery COVID-resilient and deal with long COVID, as well as addressing COVID itself – and, as previously noted, COVID vaccines constitute a significant incremental global spend. All this means payers are seeking savings from medicines budgets. Managing spend on launch products by controlling price or access is an obvious step – and what we see in some Western European markets is a growing number of restrictions alongside a reimbursement decision, limiting patient opportunity more, a situation which will continue for the duration of the economic crisis.

Properties of resilient launches post-pandemic

Overall, then, there’s a continued launch performance problem – but is this true of all types of launch? There are non-COVID launches that have been resilient to the challenging Pandemic launch environment, and there are emerging common themes.

Orphan medicines and other specialty treatments such as cancer and HIV launches have been among the most consistently resilient over the course of the pandemic and across countries. These launches have in common addressing high unmet need in small, well-defined, and, crucially, mostly pre-identified patient populations. Therefore, the challenge of patient journeys disrupted or abandoned by the pandemic impacted less. Crucially also, healthcare systems remained highly motivated to fund and deliver pharmacotherapy to these patients even at the height of lockdowns. Among launches resilient for these reasons were Tepezza, an orphan thyroid eye disease medication in the US, Zolgensma, a gene therapy for Spinal Muscular atrophy in Germany, and more recently Evrysdi, an oral agent for the same condition.

Some cancer launches also exemplified another trait for post-pandemic launch resilience – drug delivery allowing patients to self-treat at home or minimising the amount of time they spend in healthcare facilities. Thus Phesgo, a sub-cutaneous version of an otherwise IV breast cancer treatment, and the oral cancer agent Calquence, both of which were resilient pandemic launches, demonstrated how minimising health facility visits, once a nice-to-have, is now a significant differentiator for post-pandemic launches.

The type of launch product clearly played an important role in pandemic launch resilience, but a company’s launch go-to-market model could also have a critical role. Here, preparedness and agility in the pivot to a digital engagement model was critical. In the US, where direct-to-consumer advertising meant the patient could be directly engaged even during lockdown, the two oral migraine treatments Nurtec and Ubrelvy did strongly during the first lockdowns, because patient awareness and demand were met by the rapid creation of a fully remote patient journey, from consultations with physicians through to prescription and medication delivery. Lockdowns are no longer; but the more hybrid model of physician and patient engagement is here to stay; the challenge for launching companies is how to optimise engagement impact and patient opportunity within them.

The post-pandemic launch pipeline remains strong in numbers and quality, diverse in launch type, and continues to address severe unmet needs. However, the launch environment they enter will continue to present severe challenges in patient opportunity, physician engagement and market access for the foreseeable future.

To thrive, companies need to plan their launches with different focus. They need to understand early in detail how patient journeys have changed and stall, identifying blocks on the road to diagnosis and treatment, and investing to address them. They must also optimise every single interactive engagement opportunity with doctors, real world or remote, and in some cases grow interactive engagement back to pre-pandemic levels. A fully integrated evidence strategy, driving a strong publication stream, is a door opener for engaging with doctors, and vital to differentiate in an access environment increasingly inclined to restrict access for new launches. These three pillars of post-pandemic launch excellence will be the foundation for post-pandemic launches to recover their potential.

pandemic launches 2

To find out more about the issues discussed in this article, visit www.iqvia.com and search for “Launch Excellence”.

About the author

Sarah Rickwood, VP, EMEA Thought Leadership and Marketing, IQVIA. Sarah Rickwood has 30 years’ experience as a consultant to the pharmaceutical industry. She has an extremely wide experience of international pharmaceutical industry issues, consulting to the world’s leading pharmaceutical companies on global issues. She has been vice resident, European Marketing and Thought Leadership in IQVIA for 12 years. Sarah presents to hundreds of pharmaceutical industry clients every year on a range of global pharmaceutical industry issues, publishing white papers on many topics, including:

  • uptake and impact of innovative medicines, and challenges for Launch Excellence
  • the impact of the pandemic on medicines markets and Rx launch
  • Orphan drugs launch challenges
  • Cell and Gene therapies commercialization challenges and opportunity

Sarah holds a degree in biochemistry from Oxford University.

Kirstie works in IQVIA’s EMEA Thought Leadership team, and has experience preparing white papers on priority healthcare topics such as the impact of biosimilars in Europe, the availability of medicines and product shortages. Kirstie has over 5 years’ experience in healthcare and life sciences, previously working to provide industry expertise and analytics which support industry associations to influence health policy, and providing clinical and commercial competitive insights for pharmaceutical companies. She holds a degree in Neuroscience from the University of Nottingham.

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Sex work is real work: Global COVID-19 recovery needs to include sex workers

Societally, we need to recognize that sex workers have agency and deserve the same respect, dignity and aid as any other person selling their labour.

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Globally, sex workers have been left to fend for themselves during the pandemic with little to no support from the government. (AP Photo/Bikas Das)

During the pandemic, business shifted from in person to work-from-home, which quickly became the new normal. However, it left many workers high and dry, especially those with less “socially acceptable” occupations.

The pandemic has adversely impacted sex workers globally and substantially increased the precariousness of their profession. And public health measures put in place made it almost impossible for sex workers to provide any in-person service.

Although many people depend on sex work for survival, its criminalization and policing stigmatizes sex workers.

Research shows that globally, sex workers have been left behind and in most cases excluded from government economic support initiatives and social policies. There needs to be an intersectional approach to global COVID-19 recovery that considers everyone’s lived realities. We propose policy recommendations that treat sex work as decent work and that centre around the lived experiences and rights of those in the profession.

Sex work and the pandemic

The United Nations Population Fund (UNFPA) recently reported that apart from income-loss, the pandemic has increased pre-existing inequalities for sex workers.

In a survey conducted in Eastern and Southern Africa, the UNFPA found that during the pandemic, 49 per cent of sex workers experienced police violence (including sexual violence) while 36 per cent reported arbitrary arrests. The same survey reported that more than 50 per cent of respondents experienced food and housing crises.

Lockdowns and border closures adversely impacted Thailand’s tourism industry which relies partially on the labour of sex workers.


Read more: Sex workers are criminalized and left without government support during the coronavirus pandemic


In the Asia Pacific, sex workers reported having limited access to contraceptives and lubricants along with reduced access to harm reduction resources. Lockdowns also disrupted STI or HIV testing services, limiting sex workers’ access to necessary healthcare.

In North America, sex workers have been excluded from the government’s recovery response. And many began offering online services to sustain themselves.

A woman stands backlit next to a dimly lit bus that reads 'Thailand' with green lighting.
Sex workers stand in a largely shut-down red light area in Bangkok, Thailand on March 26, 2020. (AP Photo/Gemunu Amarasinghe)

Government vs. community response

Globally, sex workers have been left to fend for themselves during the pandemic with little to no support from the government. But communities themselves have been rallying.

Elene Lam, founder of Butterfly, an Asian migrant sex organization in Canada, talks about the resilience of sex wokers during the pandemic.

She says organizations like the Canadian Alliance for Sex Work Law Reform are working in collaboration with Amnesty International to mobilize income support and resources to help sex workers in Canada.

Organizations in the United Kingdom, Germany, India and Spain have also set up emergency support funds. And some sex worker organizations have developed community-specific resources for providing services both in person and online during the pandemic.

Global recovery needs to include sex workers

The International Labour Organization’s “Decent Work Agenda” emphasizes productive employment and decent working conditions as being the driving force behind poverty reduction.

Sociologist Cecilia Benoit explains that sex work often becomes a “livelihood strategy” in the face of income and employment instability. She says that like other personal service workers, sex workers also should be able to practice without any interference or violence.

In order to have an inclusive COVID-19 recovery for all, governments need to work to extend social guarantees to sex workers — so far they haven’t.

As pandemic restrictions disappear, it is crucial to ensure that everyone involved in sex work is protected under the law and has access to accountability measures.

A woman stands wearing a mask with a safety vest on in front of a collage of scantily clad women and a sign that reads 'nude women non stop'
A volunteer helps out at Zanzibar strip club during a low-barrier vaccination clinic for sex workers in Toronto in June 2021. THE CANADIAN PRESS/Frank Gunn

Recommendations

As feminist researchers, we propose that sex work be brought under the broader agenda of decent work so that the people offering services are protected.

  1. Governments need to have a legal mandate for preventing sexual exploitation.

  2. Law enforcement staff need to be trained in better responding to the needs of sex workers. To intervene in and address situations of abuse or violence is critical to ensure workplace safety and harm reduction.

  3. Awareness and educational campaigns need to focus on destigmatizing sex work.

  4. Policy-makers need to incorporate intersectionality as a working principle in identifying and responding to the different axes of oppression and marginalization impacting LGBTQ+ and racialized sex workers.

  5. Engagement with sex workers and human rights organizations need to happen when designing aid support to ensure that an inclusive pathway for recovery is created.

  6. Globally, there needs to be a steady commitment towards destigmatizing sex workers and their services.

Despite the gradual waning of pandemic restrictions, sex workers continue to face the dual insecurity of social discrimination and loss of income support. Many are still finding it difficult to stay afloat and sustain themselves.

Societally, we need to recognize that sex workers have agency and deserve the same respect, dignity and aid as any other person selling their labour.

The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

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OU researchers award two NSF pandemic prediction and prevention projects

Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its…

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Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its Predictive Intelligence for Pandemic Prevention initiative, which focuses on fundamental research and capabilities needed to tackle grand challenges in infectious disease pandemics through prediction and prevention.

Credit: Photo provided by the University of Oklahoma.

Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its Predictive Intelligence for Pandemic Prevention initiative, which focuses on fundamental research and capabilities needed to tackle grand challenges in infectious disease pandemics through prediction and prevention.

To date, researchers from 20 institutions nationwide were selected to receive an NSF PIPP Award. OU is the only university to receive two grants to the same institution.

“The next pandemic isn’t a question of ‘if,’ but ‘when,’” said OU Vice President for Research and Partnerships Tomás Díaz de la Rubia. “Research at the University of Oklahoma is going to help society be better prepared and responsive to future health challenges.”

Next-Generation Surveillance

David Ebert, Ph.D., professor of computer science and electrical and computer engineering in the Gallogly College of Engineering, is the principal investigator on one of the projects, which explores new ways of sharing, integrating and analyzing data using new and traditional data sources. Ebert is also the director of the Data Institute for Societal Challenges at OU, which applies OU expertise in data science, artificial intelligence, machine learning and data-enabled research to solving societal challenges.

While emerging pathogens can circulate among wild or domestic animals before crossing over to humans, the delayed response to the COVID-19 pandemic has highlighted the need for new early detection methods, more effective data management, and integration and information sharing between officials in both public and animal health.

Ebert’s team, composed of experts in data science, computer engineering, public health, veterinary sciences, microbiology and other areas, will look to examine data from multiple sources, such as veterinarians, agriculture, wastewater, health departments, and outpatient and inpatient clinics, to potentially build algorithms to detect the spread of signals from one source to another. The team will develop a comprehensive animal and public health surveillance, planning and response roadmap that can be tailored to the unique needs of communities.

“Integrating and developing new sources of data with existing data sources combined with new tools for detection, localization and response planning using a One Health approach could enable local and state public health partners to respond more quickly and effectively to reduce illness and death,” Ebert said. “This planning grant will develop proof-of-concept techniques and systems in partnership with local, state and regional public health officials and create a multistate partner network and design for a center to prevent the next pandemic.”

The Centers for Disease Control and Prevention describes One Health as an approach that bridges the interconnections between people, animals, plants and their shared environment to achieve optimal health outcomes.

Co-principal investigators on the project include Michael Wimberly, Ph.D., professor in the College of Atmospheric and Geographic Sciences; Jason Vogel, Ph.D., director of the Oklahoma Water Survey and professor in the Gallogly College of Engineering School of Civil Engineering and Environmental Science; Thirumalai Venkatesan, director of the Center for Quantum Research and Technology in the Dodge Family College of Arts and Sciences; and Aaron Wendelboe, Ph.D., professor in the Hudson College of Public Health at the OU Health Sciences Center.

Predicting and Preventing the Next Avian Influenza Pandemic

Several countries have experienced deadly outbreaks of avian influenza, commonly known as bird flu, that have resulted in the loss of billions of poultry, thousands of wild waterfowl and hundreds of humans. Researchers at the University of Oklahoma are taking a unique approach to predicting and preventing the next avian influenza pandemic.

Xiangming Xiao, Ph.D., professor in the Department of Microbiology and Plant Biology and director of the Center for Earth Observation and Modeling in the Dodge Family College of Arts and Sciences, is leading a project to assemble a multi-institutional team that will explore pathways for establishing an International Center for Avian Influenza Pandemic Prediction and Prevention.

The goal of the project is to incorporate and understand the status and major challenges of data, models and decision support tools for preventing pandemics. Researchers hope to identify future possible research and pathways that will help to strengthen and improve the capability and capacity to predict and prevent avian influenza pandemics.

“This grant is a milestone in our long-term effort for interdisciplinary and convergent research in the areas of One Health (human-animal-environment health) and big data science,” Xiao said. “This is an international project with geographical coverage from North America, Europe and Asia; thus, it will enable OU faculty and students to develop greater ability, capability, capacity and leaderships in prediction and prevention of global avian influenza pandemic.”

Other researchers on Xiao’s project include co-principal investigators A. Townsend Peterson, Ph.D., professor at the University of Kansas; Diann Prosser, Ph.D., research wildlife ecologist for the U.S. Geological Survey; and Richard Webby, Ph.D., director of the World Health Organization Collaborating Centre for Studies on the Ecology of Influenza in Animals and Birds with St. Jude Children’s Research Hospital. Wayne Marcus Getz, professor at the University of California, Berkeley, is also assisting on the project.

The National Science Foundation grant for Ebert’s research is set to end Jan. 31, 2024, while Xiao’s grant will end Dec. 31, 2023.


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Pfizer vaults into sickle cell market as GBT deal confirmed

Pfizer’s reported interest in acquiring sickle cell disease specialist Global Blood Therapeutics (GBT)  has been confirmed, with the
The post Pfizer…

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Pfizer’s reported interest in acquiring sickle cell disease specialist Global Blood Therapeutics (GBT)  has been confirmed, with the $68.50-per-share deal valuing GBT at $5.4 billion.

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

Oxbryta is the main asset in the deal, with Evaluate predicting sales could reach $1.5 billion in 2028 – a leap forward from the $195 million it made last year and $127 million in the first half of 2022.

Pfizer is expecting big things from the takeover , predicting that the company’s SCD franchise will bring in combined peak sales of more than $3 billion.

The boards of both companies have recommended the deal to shareholders, and the two companies suggested it should close before the end of the year – assuming of course it doesn’t fall foul of any antitrust issues raised by financial regulators.

The GBT deal comes at a time when the market for SCD therapies is undergoing significant change, with multiple new drugs reaching the market after years of stagnation and progress also being made with genetic therapies from the likes of bluebird bio, Vertex Pharma/CRISPR Therapeutics and Precision Bio/Novartis.

Oxbryta came to market in 2019, a few days after Novartis’ injectable anti-P-selectin antibody Adakveo (crizanlizumab), which is also tipped for blockbuster sales but like Oxbryta has suffered from a slow rollout.

CRISPR Therapeutics and Vertex are also in the running with their gene-editing candidate CTX001, in phase 1/2 trials which are due to generate final results later this year. If those results are positive the partners have said they could file for approval in the US before year-end.

Meanwhile, bluebird bio’s one-time gene therapy  lovotibeglogene autotemcel is supposed to be heading for regulatory filing in the US next year, although it has been delayed by an FDA partial clinical hold implemented after a persistent case of anaemia was seen in one adolescent patient in a clinical trial.

GBT’s inclacumab – another P-selectin antibody that could encroach on Adakveo – is in a pair of phase 3 trials due to generate results next year.

Meanwhile, there are a couple of orally-active pyruvate kinase R activators from Forma Therapeutics and Agios – etavopivat and mitapivat, respectively – in mid-stage development, and Pfizer has its own SCD candidate in PF-07209326, an E-selectin anatomist in phase 1.

It’s worth noting that this isn’t Pfizer’s first deal in SCD. In 2011 it paid $340 million for rights to rivipansel, a pan-selectin antagonist developed by GlycoMimetics, which failed a phase 3 test in 2019 and was jettisoned by Pfizer the following year.

The deal is another example of Pfizer splashing out on business development thanks to windfall cash generated by its COVID-19 vaccine Comirnaty and oral antiviral therapy Paxlovid. It comes shortly after the group closed a $6.7 billion acquisition of Arena Pharma, bringing on board etrasimod in late-stage testing for ulcerative colitis, and made an $11.6 billion takeover bid for Biohaven and its migraine therapy Nurtec ODT (rimegepant).

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