Guest editor: Chris Skedgel | Director
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The idea of unmet need is central to many healthcare, regulatory, and
investment decisions. In principle, an unmet need is seen as deserving some special priority, but there is little agreement amongst stakeholders in how to recognise or define such needs. Some medical needs are unmet because we do not have the treatments; other medical needs are unmet because we do not have the capacity.
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OHE recently presented a free to attend webinar on the concept of unmet need and its role in driving pharmaceutical development. Despite the importance of this concept to multiple aspects of pharmaceutical decision-making, there is little agreement between stakeholders on how to distinguish "genuine" unmet needs from less pressing concerns.
This lack of agreement is not simply a philosophical matter. Although the European Commission's Pharmaceutical Strategy for Europe highlights the role of safe, effective, and affordable medicines in promoting and maintaining health, it also points out that many medical needs remain unmet. In response, they have proposed "more tailored incentives" to encourage innovation around unmet needs – the effectiveness of these incentives will depend on alignment between stakeholders. In a recent Commentary, OHE argues that a new understanding of unmet need is required to overcome tensions between stakeholders.
In a different vein, research from the Health Foundation shows that since the start of the Covid pandemic, the NHS is 'missing' 7.5 million patients that would have been expected to have been referred for routine hospital care. Those patients who were diagnosed during the pandemic, have joined a record waiting list of more than 5.6 million patients. Although there are effective treatments available for most of these patients, these substantial backlogs represent a different form of unmet need.
The government has not committed to a timetable for clearing Covid backlogs. OHE estimates suggest that even without accounting for seasonal pressures on the NHS, that will draw resources away from addressing backlogs, it is likely to take well over two years to address backlogs in cancer alone, unless substantial new resources are dedicated to this issue.
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“…quite a lot of people need to be treated to prevent one hospitalisation or death. This means the drug needs to be very safe and affordable. The safety data also look good, so again this is encouraging."
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Staying with the theme of COVID-19 pressure on the NHS, the BMJ has reported that the antiviral molnupiravir, from MSD, reduces the risk of hospital admission in patients with COVID-19 around 50%. This product is not currently approved in the UK, but if proven effective, it could reduce COVID-19 deaths as well as the strain the pandemic puts on the NHS over the winter period.
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However, the baseline risk of hospitalisation without the drug was only 14%, meaning that most patients who received the medicine on a preventative basis would not have been hospitalised anyway (86% of those treated) and therefore receive no direct benefit from treatment. Treating a lot of patients who aren't likely to benefit to prevent a few bad outcomes emphasises the importance of safety and affordability in preventative treatments with a relatively small absolute risk reduction.
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Combining the themes of care backlogs and avoiding preventable hospital admissions, OHE has just published a Consulting Report demonstrating the value of vaccines in maintaining health system capacity. This report shows a double benefit to vaccines: 1) direct cost-savings due to avoided hospitalisations stemming from infectious disease, and 2) enabling indirect health gains to other patients by preserving health system capacity. In the worst stages of the pandemic, a tremendous degree of health system capacity have been devoted to COVID-19, 'crowding out' patients with other conditions. This healthcare 'opportunity cost' represents a substantial proportion of the excess mortality observed over the course of the pandemic.
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OHE researchers led the analysis of patient-reported outcomes data collected in an observational study of enzalutamide in metastatic castration-resistant prostate cancer (mCRPC), recently published in the International Journal of Cancer. Patients completed the EQ-5D-5L, FACT-P, and the BPI whilst enrolled in the study. The study confirmed enzalutamide's clinical efficacy and tolerability whilst patients reported improved quality of life and pain with treatment.
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Our panel of experts explore the role of unmet need at specific points in the development pathway and discuss outstanding challenges to its use in promoting innovation in areas of genuine health need. These challenges include:
1) Balancing incentives for
development
2) Balancing consistency and
transparency
3) Balancing the needs in rare
diseases alongside needs in
more prevalent conditions
4) Balancing patient and clinical
perceptions
Watch here.
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The Hill reports that the latest version of US President Biden's social spending package does not include a provision to allow Medicare to negotiate drug prices with pharmaceutical manufacturers. Such a provision was supported by most Democrats but opposed by a key Democratic senator and all Republicans. The pharmaceutical industry argues that lower drug prices will harm innovation, including around addressing unmet needs.
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As reported by the BBC, the UK government has announced in last week's budget that NHS England will receive £5.9 billion to address waiting lists and treatment backlogs. However, this funding is earmarked for physical infrastructure and equipment, including CT and MRI scanners, and will not be used for day-to-day operations. The NHS welcomed the announcement but said that problems of staff shortages remain.
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30 November | OHE is presenting research where we've examined how different types of Product Development Partnerships (PDPs) are associated with the likelihood of product approval, i.e., successful pharmaceutical innovation, and whether some types of PDPs stimulate drug development effectively in the early stages.
POSA213 13:30-16:00 (CET) Virtual ISPOR Europe 2021
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2 December | OHE is moderating and speaking in an ISPOR workshop presenting the differences in health economics when applied to digital health technologies (DHTs) and pharmaceuticals, and comparing the English and German processes for bringing DHTs to market.
309WK 12.30-13.30 (CET) Virtual ISPOR Europe 2021
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9 December | Join OHE’s global thought-leaders and industry experts to discuss the highly controversial issue of value and prices of orphan medicines, and how to set a fair reward to private R&D investments. We will be exploring patient perspective on medicine access challenges, collaborative solutions to address uncertainty and data gaps to accelerate access to promising therapies.
£375
Early Bird discount valid until 09.11.2021
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