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2021 – UK market access prospects

With a new year comes the opportunity to think ahead for the market access landscape for the coming
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With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. Looking back at key market access news from the last year, Leela Barham takes stock of what the next twelve months could bring for UK market access.

Whilst regulatory approval is only a starting step on market access, the UK has made steps to put the UK on the priority list for companies seeking marketing authorisation. The UK joined two initiatives in October 2020 that should bear fruit in the future: Project Orbis and the Access Consortium.

Project Orbis is coordinated by the US Food and Drug Administration and includes Canada, Australia, Switzerland, Singapore and Brazil and focuses upon review and approval of cancer treatments that offer promise. The Access Consortium includes some of the same players – Australia, Canada, Switzerland and Singapore – and looks more broadly at securing patient access to high-quality, safe and effective medicines. The ABPI has seen these as another way to help the UK deliver faster access.

The promise of faster market access 

Announced in December 2020, and beginning from 1 January 2021, the new licensing and access pathway (ILAP) at the Medicines and Healthcare Regulatory products Agency (MHRA) offers the chance – for a fee – for faster access for medicines that meet the criteria for the scheme. Criteria include that the condition is life-threatening or seriously debilitating or there is a significant patient or public health need.

“The UK has sought to provide incentives for development of new antibiotics by offering a volume neutral deal, also termed a Netflix approach”

Additional criteria include being an innovative medicine, such as an advanced therapy medicinal product (ATMP), significant new indication or a treatment for a rare disease or other special populations such as neonates, children, elderly and pregnant women and aligning with priorities of the UK, be that from the chief medical officer, the Department of Health and Social Care (DHSC) or those from the UK’s Life Sciences Sector Deal.

What is probably most exciting about ILAP is the bringing together of expertise from the MHRA with that of key HTA agencies NICE and the Scottish Medicines Consortium (SMC), as well as NHS England and NHS Improvement (NHSE&I), and, of course, patients too. It’s the first time that all these agencies are working together (much else draws on what has been available for some time; early advice and in parallel between NICE and MHRA).

2021 will reveal just how the ILPA will be operationalised and whichever product will be the first to go through the Innovation Passport stage – a new designation as part of ILAP – will help everyone understand how the criteria for the passport will apply in practice. It’ll also reveal just what the Target Development Profile (TDP) living document will cover and how it can evolve over time. This rolling review features is also another new element on offer under ILAP.

The Netflix approach

Antibiotics are vital to modern health care, yet there have been warnings for years that the economics at play simply don’t incentivise the development of new antibiotics; new antibiotics should be kept in reserve to limit antibiotic resistance and aren’t likely to be used in large volumes. The lack of new antibiotics is a problem when the existing antibiotics stop working.

The UK has sought to provide incentives for development of new antibiotics by offering a volume neutral deal, also termed a Netflix approach. In June 2017, NICE and NHSE&I launched a novel payment approach; offering up to £100 million to companies developing and marketing novel antibiotics based on the value of their products, regardless of volume sold.

2021 will see NICE trialling their adapted HTA approach for assessing the value of new antimicrobials. This will not only interest companies researching and developing new antibiotics, but other countries who will want to see whether the UK approach could work for them too. Where NICE leads, others will want to learn and adapt from.

Key access commitment due to report in VPAS 

The UK has a unique approach to managing the pricing of branded medicines through the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). The deal balances affordability commitments that benefit the UK government – where NHS spend on branded medicines cannot go above a pre-agreed level – with access commitments to industry.

A key commitment in the deal is to reach the upper quartile of uptake in relation to comparator countries for the five highest health gain categories of treatments. A timeline is set for hitting this too; it should be met during the first half of the scheme. That makes it a target for June 2021. Whilst there isn’t a timeline against it, there is also a commitment for the Department of Health and Social Care, NHSE&I and the industry association, the Association of the British Pharmaceutical Industry (ABPI) to better understand national and international variation on uptake and where that is unwarranted.

Realistically it’s seems unlikely that the timetable for the upper quartile target can be met. That’s because so far, based on desk research, there doesn’t appear to be a public list of the five highest health gains, and meeting minutes from operational reviews of the scheme suggest discussions have faced difficulties in agreeing them. It’s difficult both from a methods side (which countries, which treatments, etc) as well as data and time; COVID-19 has been a higher priority for many staffers involved. Expect a delay that may even see this reporting in 2022.

More change at NICE

2020 saw NICE consult on a variety of changes and set out plans on cross-cutting market access issues.

NICE started 2020 with the January publication of their principles; essentially a framework for how the agency goes about its work – from working on national priority areas through to publishing their work and updating as necessary.

NICE followed these in March 2020 with their final statement of intent on increasing the use of health and social data in their guidance. The statement covers one of the buzz phrases in market access – ‘real world data’ – and signals a greater willingness for NICE to consider its use in their work. The agency will keep working on how this will be implemented during 2021; this can only help, as much in the statement is aspirational and there’s not a great deal of clarity on exactly what NICE will accept, or not, as the case may be.

In June 2020, NICE let industry know about their changes to the process used in Single Technology Appraisals (STAs), moving from technical reports from Evidence Review Groups (ERGs) – independent academics – to present issues. That allows for easier engagement but also offers companies a right to reply to ERGs. With this change applied from STAs starting in May 2020, 2021 should see more companies seeing the difference. Efficiencies are the gain NICE hopes to see and that ties in with commitments to make NICE faster set out in VPAS. NICE hadn’t yet reached their targets according to metrics set out in July 2020 relating to appraisals up to Q1 of 2020, so 2021 could see NICE really getting to grips with getting faster.

NICE kept up the pace of consulting in 2020, setting out proposals to change the selection of treatments for evaluation in October 2020. The aim is for simplification as well as confirming promises made in VPAS that NICE will appraise all new active substances and significant new indications.

Arguably the most important consultation from NICE in 2020 was a six week consultation on the evidence and considerations for changing their methods, including those used in Technology Appraisals. According to experts at market access consulting firm, Bresmed, the changes being tabled that are likely to have a high potential impact include the removal of End of Life criteria to be replaced with a severity modifier, a change to the discount rate from 3.5% to 1.5% as well as greater emphasis on real world data.

Yet there is still more work for NICE and all stakeholders who will want to shape the final changes, as the agency plans to consult for another six weeks from February to March 2021 as well as consult with stakeholders on the draft programme manual which will encompass the reformed methods in June to July 2021.

The final changes won’t bear fruit for a little more time; implementation will be for treatments assessed from October 2021. This will also be when changes to selection processes will be implemented too. Companies are going to need to keep refining their inputs to NICE as they consult as well as run scenarios and review strategies to make the most of any opportunities for treatments that will be reviewed under the new approach.

Less clear is the ‘what and when’ of changes to the criteria that determine which treatments are reviewed through the NICE Highly Specialised Technologies (HST) programme, another area that NICE is reviewing. This is of interest as it offers a wider set of value components to be considered, as well as more flexibility on the cost-effectiveness threshold, for ultra-orphan treatments.

It’s likely NICE will set out details on this review during 2021. However, anyone hoping that the door will be open for the rarer end of common treatments could be disappointed as NICE say that they want to make the criteria clearer and more specific but not increase, or decrease, the number of HST topics. NICE is funded to do three a year.

NICE, building on their international links, was one of seven agencies who took part in the first ever World Evidence-based Healthcare Day in October 2020. We can expect to hear more on the global initiative in 2021. It’s also likely that their 2020 agreement with Colombia’s IETS will start to bear fruit, shaping how HTA is done in Colombia.

Pulling all this work together will also be a test of NICE’s 2020 appointed chief executive Gillian Leng. She’ll likely bring a steady hand to the consultation and the next steps, reflecting her over 13 years at NICE. 2021 could see big changes that should provide opportunities for faster NICE appraisals but as ever, the devil is in the detail and the full impact won’t be possible to see until a number of treatments have gone through the new methods and processes.

Medicines and Medical Devices Bill and a new Innovative Medicines Fund 

The Medicines and Medical Devices Bill is still going through Parliament and should become law in 2021. It’s part of the legal homework necessitated by the UK leaving the EU and covers a range of regulatory issues.

The importance of the Bill from a market access perspective is not however just about regulation but has also seen discussion of the establishment of an Innovative Medicines Fund. Whilst a proposed amendment to the Bill on establishing such a fund was withdrawn during December 2020, the discussions in the House of Lords suggested that NHSE&I and NICE will be engaging during the first quarter of 2021 on the fund.

The fund will replace the Cancer Drugs Fund (CDF), and widen the treatments that can be funded on an interim basis. The CDF as it has been run from 2016 helps generate evidence for treatments that have the potential to be cost-effective but face uncertainties that can be addressed through evidence generation. It’s proved to be a key enabler for market access for cancer drugs and many – although not all – drugs funded under the CDF have gone on to go into routine commissioning, although often with a hefty price cut. Just how the Innovative Medicines Fund will work is something to watch as it may provide new access opportunities previously not available.

More change ahead in 2022

There will be yet more change in the future with major shakeups expected in the way NHS England is structured, with the potential to abolish Clinical Commissioning Groups (CCGs) and Integrated Care Systems to be put on a statutory footing in 2022. That means much planning could be on the cards and, as ever, a need for the pharma industry to keep up to date and ensure that they’re engaging with those that matter for access on a local level.

About the author

Leela Barham is researcher and writer who has worked with all stakeholders across the health care system, both in the UK and internationally, on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).

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There will soon be one million seats on this popular Amtrak route

“More people are taking the train than ever before,” says Amtrak’s Executive Vice President.

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March 11, 2024

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While the size of the United States makes it hard for it to compete with the inter-city train access available in places like Japan and many European countries, Amtrak trains are a very popular transportation option in certain pockets of the country — so much so that the country’s national railway company is expanding its Northeast Corridor by more than one million seats.

Related: This is what it's like to take a 19-hour train from New York to Chicago

Running from Boston all the way south to Washington, D.C., the route is one of the most popular as it passes through the most densely populated part of the country and serves as a commuter train for those who need to go between East Coast cities such as New York and Philadelphia for business.

Veronika Bondarenko captured this photo of New York’s Moynihan Train Hall. 

Veronika Bondarenko

Amtrak launches new routes, promises travelers ‘additional travel options’

Earlier this month, Amtrak announced that it was adding four additional Northeastern routes to its schedule — two more routes between New York’s Penn Station and Union Station in Washington, D.C. on the weekend, a new early-morning weekday route between New York and Philadelphia’s William H. Gray III 30th Street Station and a weekend route between Philadelphia and Boston’s South Station.

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According to Amtrak, these additions will increase Northeast Corridor’s service by 20% on the weekdays and 10% on the weekends for a total of one million additional seats when counted by how many will ride the corridor over the year.

“More people are taking the train than ever before and we’re proud to offer our customers additional travel options when they ride with us on the Northeast Regional,” Amtrak Executive Vice President and Chief Commercial Officer Eliot Hamlisch said in a statement on the new routes. “The Northeast Regional gets you where you want to go comfortably, conveniently and sustainably as you breeze past traffic on I-95 for a more enjoyable travel experience.”

Here are some of the other Amtrak changes you can expect to see

Amtrak also said that, in the 2023 financial year, the Northeast Corridor had nearly 9.2 million riders — 8% more than it had pre-pandemic and a 29% increase from 2022. The higher demand, particularly during both off-peak hours and the time when many business travelers use to get to work, is pushing Amtrak to invest into this corridor in particular.

To reach more customers, Amtrak has also made several changes to both its routes and pricing system. In the fall of 2023, it introduced a type of new “Night Owl Fare” — if traveling during very late or very early hours, one can go between cities like New York and Philadelphia or Philadelphia and Washington. D.C. for $5 to $15.

As travel on the same routes during peak hours can reach as much as $300, this was a deliberate move to reach those who have the flexibility of time and might have otherwise preferred more affordable methods of transportation such as the bus. After seeing strong uptake, Amtrak added this type of fare to more Boston routes.

The largest distances, such as the ones between Boston and New York or New York and Washington, are available at the lowest rate for $20.

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The next pandemic? It’s already here for Earth’s wildlife

Bird flu is decimating species already threatened by climate change and habitat loss.

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March 11, 2024

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I am a conservation biologist who studies emerging infectious diseases. When people ask me what I think the next pandemic will be I often say that we are in the midst of one – it’s just afflicting a great many species more than ours.

I am referring to the highly pathogenic strain of avian influenza H5N1 (HPAI H5N1), otherwise known as bird flu, which has killed millions of birds and unknown numbers of mammals, particularly during the past three years.

This is the strain that emerged in domestic geese in China in 1997 and quickly jumped to humans in south-east Asia with a mortality rate of around 40-50%. My research group encountered the virus when it killed a mammal, an endangered Owston’s palm civet, in a captive breeding programme in Cuc Phuong National Park Vietnam in 2005.

How these animals caught bird flu was never confirmed. Their diet is mainly earthworms, so they had not been infected by eating diseased poultry like many captive tigers in the region.

This discovery prompted us to collate all confirmed reports of fatal infection with bird flu to assess just how broad a threat to wildlife this virus might pose.

This is how a newly discovered virus in Chinese poultry came to threaten so much of the world’s biodiversity.

H5N1 originated on a Chinese poultry farm in 1997. ChameleonsEye/Shutterstock

The first signs

Until December 2005, most confirmed infections had been found in a few zoos and rescue centres in Thailand and Cambodia. Our analysis in 2006 showed that nearly half (48%) of all the different groups of birds (known to taxonomists as “orders”) contained a species in which a fatal infection of bird flu had been reported. These 13 orders comprised 84% of all bird species.

We reasoned 20 years ago that the strains of H5N1 circulating were probably highly pathogenic to all bird orders. We also showed that the list of confirmed infected species included those that were globally threatened and that important habitats, such as Vietnam’s Mekong delta, lay close to reported poultry outbreaks.

Mammals known to be susceptible to bird flu during the early 2000s included primates, rodents, pigs and rabbits. Large carnivores such as Bengal tigers and clouded leopards were reported to have been killed, as well as domestic cats.

Our 2006 paper showed the ease with which this virus crossed species barriers and suggested it might one day produce a pandemic-scale threat to global biodiversity.

Unfortunately, our warnings were correct.

A roving sickness

Two decades on, bird flu is killing species from the high Arctic to mainland Antarctica.

In the past couple of years, bird flu has spread rapidly across Europe and infiltrated North and South America, killing millions of poultry and a variety of bird and mammal species. A recent paper found that 26 countries have reported at least 48 mammal species that have died from the virus since 2020, when the latest increase in reported infections started.

Not even the ocean is safe. Since 2020, 13 species of aquatic mammal have succumbed, including American sea lions, porpoises and dolphins, often dying in their thousands in South America. A wide range of scavenging and predatory mammals that live on land are now also confirmed to be susceptible, including mountain lions, lynx, brown, black and polar bears.

The UK alone has lost over 75% of its great skuas and seen a 25% decline in northern gannets. Recent declines in sandwich terns (35%) and common terns (42%) were also largely driven by the virus.

Scientists haven’t managed to completely sequence the virus in all affected species. Research and continuous surveillance could tell us how adaptable it ultimately becomes, and whether it can jump to even more species. We know it can already infect humans – one or more genetic mutations may make it more infectious.

At the crossroads

Between January 1 2003 and December 21 2023, 882 cases of human infection with the H5N1 virus were reported from 23 countries, of which 461 (52%) were fatal.

Of these fatal cases, more than half were in Vietnam, China, Cambodia and Laos. Poultry-to-human infections were first recorded in Cambodia in December 2003. Intermittent cases were reported until 2014, followed by a gap until 2023, yielding 41 deaths from 64 cases. The subtype of H5N1 virus responsible has been detected in poultry in Cambodia since 2014. In the early 2000s, the H5N1 virus circulating had a high human mortality rate, so it is worrying that we are now starting to see people dying after contact with poultry again.

It’s not just H5 subtypes of bird flu that concern humans. The H10N1 virus was originally isolated from wild birds in South Korea, but has also been reported in samples from China and Mongolia.

Recent research found that these particular virus subtypes may be able to jump to humans after they were found to be pathogenic in laboratory mice and ferrets. The first person who was confirmed to be infected with H10N5 died in China on January 27 2024, but this patient was also suffering from seasonal flu (H3N2). They had been exposed to live poultry which also tested positive for H10N5.

Species already threatened with extinction are among those which have died due to bird flu in the past three years. The first deaths from the virus in mainland Antarctica have just been confirmed in skuas, highlighting a looming threat to penguin colonies whose eggs and chicks skuas prey on. Humboldt penguins have already been killed by the virus in Chile.

A colony of king penguins.
Remote penguin colonies are already threatened by climate change. AndreAnita/Shutterstock

How can we stem this tsunami of H5N1 and other avian influenzas? Completely overhaul poultry production on a global scale. Make farms self-sufficient in rearing eggs and chicks instead of exporting them internationally. The trend towards megafarms containing over a million birds must be stopped in its tracks.

To prevent the worst outcomes for this virus, we must revisit its primary source: the incubator of intensive poultry farms.

Diana Bell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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This is the biggest money mistake you’re making during travel

A retail expert talks of some common money mistakes travelers make on their trips.

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March 11, 2024

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Travel is expensive. Despite the explosion of travel demand in the two years since the world opened up from the pandemic, survey after survey shows that financial reasons are the biggest factor keeping some from taking their desired trips.

Airfare, accommodation as well as food and entertainment during the trip have all outpaced inflation over the last four years.

Related: This is why we're still spending an insane amount of money on travel

But while there are multiple tricks and “travel hacks” for finding cheaper plane tickets and accommodation, the biggest financial mistake that leads to blown travel budgets is much smaller and more insidious.

A traveler watches a plane takeoff at an airport gate.

Jeshoots on Unsplash

This is what you should (and shouldn’t) spend your money on while abroad

“When it comes to traveling, it's hard to resist buying items so you can have a piece of that memory at home,” Kristen Gall, a retail expert who heads the financial planning section at points-back platform Rakuten, told Travel + Leisure in an interview. “However, it's important to remember that you don't need every souvenir that catches your eye.”

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According to Gall, souvenirs not only have a tendency to add up in price but also weight which can in turn require one to pay for extra weight or even another suitcase at the airport — over the last two months, airlines like Delta  (DAL) , American Airlines  (AAL)  and JetBlue Airways  (JBLU)  have all followed each other in increasing baggage prices to in some cases as much as $60 for a first bag and $100 for a second one.

While such extras may not seem like a lot compared to the thousands one might have spent on the hotel and ticket, they all have what is sometimes known as a “coffee” or “takeout effect” in which small expenses can lead one to overspend by a large amount.

‘Save up for one special thing rather than a bunch of trinkets…’

“When traveling abroad, I recommend only purchasing items that you can't get back at home, or that are small enough to not impact your luggage weight,” Gall said. “If you’re set on bringing home a souvenir, save up for one special thing, rather than wasting your money on a bunch of trinkets you may not think twice about once you return home.”

Along with the immediate costs, there is also the risk of purchasing things that go to waste when returning home from an international vacation. Alcohol is subject to airlines’ liquid rules while certain types of foods, particularly meat and other animal products, can be confiscated by customs. 

While one incident of losing an expensive bottle of liquor or cheese brought back from a country like France will often make travelers forever careful, those who travel internationally less frequently will often be unaware of specific rules and be forced to part with something they spent money on at the airport.

“It's important to keep in mind that you're going to have to travel back with everything you purchased,” Gall continued. “[…] Be careful when buying food or wine, as it may not make it through customs. Foods like chocolate are typically fine, but items like meat and produce are likely prohibited to come back into the country.

Related: Veteran fund manager picks favorite stocks for 2024

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