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#EAPM – From HTA to IHI

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Greetings, and a warm welcome to all our health correspondents who are not yet
en route for the jolly hols – the European Alliance for Personalised Medicine (EAPM) is still here to keep you updated on the personalised health related events that are ongoing, as health does not stop for the holidays, writes EAPM Executive Director Denis Horgan.

ESMO Virtual Congress 2020

First up, make sure you register in good time for the ESMO Virtual Congress 2020, at which EAPM will be organizing a round table on 18 September, bringing its stellar cast of specialists from the patients network, as well as experts from the oncology community and the European Medicine Agency (EMA) and European Parliament, The agenda is available here, and you can already register here.

HTA after COVID-19

As England and the devolved nations emerge from COVID-19 lockdown at varying rates, so too their respective health technology assessment (HTA) bodies are taking a similarly varied approach to returning to business as usual. While some normal business is resuming across the medicines landscape, many are now looking at how we can create a new normal – being more ambitious than before in how we make HTA work better for patients and for the system.

Challenges

Prior to the emergence of the pandemic, there were already challenges facing the UK and EU’s HTA bodies. The National Institute of Health and Care Excellence (NICE), which was due to take on all new indications by April 2020, (including those that would have been covered by NHS England), needed to boost capacity in an already overstretched programme. As the pandemic unfolded, NICE, SMC and the All Wales Medicines Strategy Group (AWMSG) set out their programmes of suspended operations due to COVID-19.

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NICE prioritised its activities to focus on therapeutically critical topics (including ‘appraisals involving a cancer medicine’) and guidance addressing COVID-19 diagnostic or therapeutic interventions, and meanwhile, NHS England Specialised Commissioning Clinical Priorities Advisory Group (CPAG) delayed its May 2020 round until late July, in further evidence that NICE is not yet ready to absorb CPAG’s activities as planned, by April 2020.

Very little information was made public on the prioritisation process of topics, making it difficult to establish accountability for these decisions. While NICE has now started publishing guidance not related to COVID-19, moving closer towards ‘business as usual’, recent NICE Board papers suggest that prioritisation of some sort will have to continue. It is crucial that justification for prioritized topic selection is made transparent. The most clear and present challenge HTA bodies will face following the resumption of operations is a backlog in appraisals – this may lead to decision outcome delays, further hindering patient access to latest treatments.

The future

COVID-19 has brought some uncertainty about the direction of the HTA space in the UK, as it has with the majority of sectors. Will an overburdened NICE lead to more innovative commercial deals being carved out at NHS England? Might this lay a precedent for a novel twist in the relationship between pharma and payers?

Innovative Health Initiative

Leaders from across the health sector have released a joint statement underlining the potential of the recently-published draft proposal for a European Partnership for Health Innovation, or Innovative Health Initiative (IHI), released by the European Commission. The statement – which accounts for COCIR, EFPIA, EuropaBio, MedTech Europe and Vaccines Europe, all partners in the initiative – acknowledge how the proposal envisions Europe as “a world-leader in collaborative research and development”, centring technology, connectivity and interoperability as key areas of investment. IHI is a multi-sector public-private partnership intended to share and excel knowledge and innovation in the European health sector regardless of the socio-economic conditions of individual locations. It brings together experts from medtech and pharma in a collaborative effort to produce person-centred healthcare. There is a particular emphasis on advancing pre-competitive research in a way that benefits not only small and big companies but also scientists, researchers and healthcare professionals to provide the highest quality of care to patients. The initiative, which was originally proposed in July 2019, is expected to be draft legislation by autumn of this year. With such a large and potentially-impactful collaboration as IHI, there must be significant regulation in place to ensure the safety of patients, which could significantly alter the way that health care is conducted across Europe.

Acupuncture could be ‘NICE’ for chronic pain

According to The National Institute of Health and Care Excellence (NICE), a number of commonly used drug treatments for chronic primary pain have little or no evidence that they work and shouldn’t be prescribed. NICE has stated in its draft clinical guideline published on 3 August, on the assessment and management of chronic pain in over 16s, that people with a type of chronic pain called chronic primary pain should be offered supervised group exercise programmes, some types of psychological therapy, or acupuncture. The guideline further states that paracetamol, non-steroidal anti-inflammatory drugs (these include aspirin and ibuprofen), benzodiazepines or opioids should not be offered. This is because, while there was little or no evidence that they made any difference to people’s quality of life, pain or psychological distress, there was evidence that they can cause harm, including possible addiction. The draft guideline is now open to public consultation until 14 September 2020.

Spanish government launches coronavirus contact tracing app

The Spanish government has launched Radar COVID, its coronavirus contract tracing app. The app works via Bluetooth and people when entering places of work or establishments can log in to show where they have been so if any outbreaks occur the government and health services as well as the individual person can know if they were in that vicinity at the time. A test app for the Spanish nation was sent to the isolated island of La Gomera, between 29 June and 31 July, who had two cases of COVID-19, and a population of 22,000 people. The aim was to test the populace on the island in the Canaries and reach 3,000 downloads to see how efficient the app is. Radar COVID is based on the API that Google and Apple developed jointly to enable its use in devices running on Android or iOS software. The app requires users to activate their phone’s Bluetooth and use the app frequently to check their level of exposure to the coronavirus. The government wants the app to be downloaded in the Canary and Balearic Islands in particular, both tourist hotspots, and is working on an English version.

Worrying coronavirus trend in Poland

Despite the fact that Poland has had one of the EU’s mildest brushes with coronavirus thus far, the number of new cases in the country is bringing cause for concern. New cases hit record levels on three days last week (with the highest being 658 new cases on Saturday (1 August). The situation has brought sterner measures from the Polish health ministry, which has warned of a crackdown on people not wearing masks in shops, and ensuring that weddings stay smaller than 150 people – and three Polish senators have come down with the disease. Senator Artur Dunin told Polish television “everything hurts”. 

UK government urges drug stockpiles for end-of-Brexit transition

The government has urged pharmaceutical firms to have six weeks' worth of drugs stockpiled, ready for the end of the Brexit transition period. In a letter to medical suppliers, the Department of Health said there would be no extension to the transition period after 31 December. The department acknowledged that global supply chains were under pressure because of the coronavirus crisis. But it said having reserve stocks would provide a buffer against disruption.

A final reminder for the ESMO Virtual Congress 2020 – register here and check out the agenda here. And bon voyage if you are now about to set off on your travels, stay safe and well, and look out for further EAPM updates during August.

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EU Reporter publishes articles from a variety of outside sources which express a wide range of viewpoints. The positions taken in these articles are not necessarily those of EU Reporter.

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