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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.

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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

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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.

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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Pfizer begins study of oral drug for prevention of COVID-19

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Pfizer Inc (PFE.N) said on Monday (27 September) it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.

The drugmaker and its rivals, including US-based Merck & Co Inc (MRK.N) and Swiss pharmaceutical Roche Holding AG (ROG.S), have been racing to develop an easy-to-administer antiviral pill for COVID-19. Read more.

The mid-to-late-stage study will test Pfizer's drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection.

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In the trial, PF-07321332, designed to block the activity of a key enzyme needed for the coronavirus to multiply, will be administered along with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection.

To date, Gilead Sciences Inc's (GILD.O) intravenous drug remdesivir is the only approved antiviral treatment for COVID-19 in the United States.

Pfizer has also started another study of PF-07321332 in non-hospitalized, symptomatic adult patients.

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Merck and partner Ridgeback Biotherapeutics recently launched a late-stage trial of their experimental drug molnupiravir for prevention of the COVID-19 infection. Read more.

Molnupiravir is also being studied in a late-stage trial in non-hospitalized patients to see if it reduces the risk of hospitalization or death.Reporting by Manojna Maddipatla and Amruta Khandekar

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EU Digital COVID Certificate: Commission awards €95 million to boost access to tests

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The Commission has awarded grants to 20 member states totalling €95 million to purchase COVID-19 diagnostic tests to facilitate the delivery of the EU Digital COVID Certificate. This goes hand-in-hand with the continued roll-out of COVID-19 vaccinations and is part of the Commission's commitment to support affordable access to fast and accurate testing for those citizens who have not yet been fully vaccinated, in particular those who cannot get vaccinated due to medical reasons.

The grants, financed through its Emergency Support Instrument (ESI), will allow member states to provide tests. This support, channelled through the national authorities, will cater for the various needs in the different member states. Health and Food Safety Commissioner Stella Kyriakides said: “The EU Digital COVID Certificate allowed Europeans to resume safe travelling over the summer and has become a symbol of an open and safe Europe. Whilst vaccination is key and our strongest asset to put an end to the pandemic, fast and accurate testing remains important to tackle the spread of COVID-19. The 20 million rapid tests we purchased for member states earlier this year and today's announcements of additional funds prove that we stand firm on our commitment to ensure that citizens have access to tests and that our digital certificates are available for everyone, in particular those who cannot get vaccinated.”

Justice Commissioner Didier Reynders said: “Over 400 million Europeans have so far benefited from the Certificate, and 42 countries are already linked to the EU certificate system. This is a major European achievement which has been highly valued by our citizens. Today's grants will further contribute to the use of the certificates and ensure that people can continue to move freely and safely. I welcome this decision and I call on the 20 member states to make the best use of those additional tests.”

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The ESI provides a needs‐based, co-ordinated emergency response to help member states address needs related to the immediate acute phase of the COVID-19 pandemic, as well as the exit, recovery and prevention of any resurgence.

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US-EU agenda for beating the global pandemic: Vaccinating the world, saving lives now, and building back better health security

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Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Co-ordinated US and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and US-EU Summits in June, and on the upcoming G20 Summit, the US and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.  

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Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organisations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

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Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization.  The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through HERA and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world's capacity to deliver these vaccines in real time. 

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back and Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

More information

Joint statement on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce

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