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How do UK market access prospects look in 2022?

Leela Barham and Neil Grubert look back at what was expected for market access in 2021 and look
The post How do UK market access prospects look in 2022?…

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Leela Barham and Neil Grubert look back at what was expected for market access in 2021 and look ahead at what 2022 could hold. Will all the efforts to speed up market access and ensure that the UK remains attractive to the life sciences industry post-Brexit pay off in 2022?

MHRA gave first Project Orbis approvals in 2021 followed by mixed success for access deals

The 1 January 2021 saw the UK’s regulator, the MHRA, formally join Project Orbis. Project Orbis is a framework for concurrent reviews and approval of promising cancer treatments by regulators in the US, Australia, Canada, Singapore, Switzerland, Brazil and Israel, as well as the MHRA.

By 7 May 2021 the MHRA issued the first authorisation under Project Orbis, for AstraZeneca’s Tagrisso (osimertinib) given post-surgery for lung cancer. In a bonus for AstraZeneca and as proof of the desire for faster access and closer working of agencies in England that shape market access, AstraZeneca also reached an agreement with NHS England and Improvement (NHSE&I) and the HTA body, NICE. Patients were given access to Tagrisso before NICE finished their appraisal on a budget-neutral basis to the NHS.

September 2021 saw another Project Orbis approval from the MHRA, for Amgen’s Lymykras (sotorasib), this time a conditional approval. That gave patients the first access in Europe. Amgen was also able to strike a deal for early access with NHSE&I too.

Gilead’s Trodelvy (sacituzumab) was also given approval under Project Orbis in September. Yet no deal could be struck this time.

More Project Orbis approvals may yet come in 2022, but industry should not expect that deals will always deliver faster access.

Innovative Licensing Access Pathway attracted a lot of interest in 2021, but not yet proven

January 2021 saw another effort to speed up access – this time with closer working between the MHRA and the UK’s HTA bodies, NICE and the SMC – the Innovative Licensing and Access Pathway (ILAP).

By February 2021, details were published for the first Innovation Passport given to MSD’s Welireg (belzutifan) for Von Hippel Lindau disease.

At the end of 2021 the MHRA revealed more details about applications. By 28 December 2021, 71 applications for the first part of ILAP – the Innovation Passport – had been received. Close to 60 percent (41) were successful. Seven times the passport was not given and 22 were still in progress. The MHRA noted that applications have ranged from big to small pharma and from common to rare conditions but the top therapeutic areas were oncology, neurology and respiratory. Products aren’t routinely named.

So far so good, yet the big question remains unanswered: can ILAP really bring faster access? To answer that we need to know which products have got the ILAP treatment and whether they have reached the point where physicians can prescribe to patients across the NHS.

NHS Commercial Framework for New Medicines widely used in 2021 with more deals expected in 2022

Another February 2021 development was the publication of the NHS Commercial Framework for New Medicines. The framework clarified terms for managed entry agreements (MEAs) in England. The framework emphasises the trade-offs that face companies; faster market entry is on the table, but only where companies price fairly and responsibly.

In 2021, NHS England negotiated several high-profile “smart deals,” within that framework (and in practice, long before the framework was published since it wasn’t really new, just consolidating the approach into a single place). 2021 deals have included agreements for:

The features of the deals differ but have included arrangements that see treatments offered to the NHS on a budget-neutral basis whilst more evidence is collected and discounts to secure access faster than would otherwise be the case, with announcements on access before final NICE guidance is published, for example.

NHSE&I continue to highlight the deals that can be struck. On the 12 January 2022 a previously agreed deal from 2020 for Vertex’s Kaftrio (tezacaftor, ivacaftor and elexacaftor) for cystic fibrosis meant that a licence extension from the MHRA to children aged 6 to 11 automatically led to swift access for these younger patients. More deals have followed including for non-small cell lung cancer treatment Tecentriq (atezolizumab) and for the most expensive treatment in the world, gene therapy Libmeldy (atidarsagene autotemcel), to treat metachromatic leukodystrophy (MLD). The latest, announced on 8 February 2020, is for Jemperli (dostarlimab) used in womb and endometrial cancer.

Access Consortium set out their strategic plan

In December 2020, the UK joined the Access Consortium, which brought the MHRA into partnership with its counterparts from Australia, Canada, Singapore and Switzerland. June 2021 saw more emerge on their ambitions, with the publication of their Strategic Plan 2021-2024 focusing on agility and international alignment, with the aim to speed up regulatory approval. The Consortium signposted its desire to collaborate with HTA agencies too.

The question remains what this means and when it will bear fruit. The Consortium will be measuring progress with a suite of “indicators of success” ranging from the number of applications to the Access Consortium through to time to market.

Disappointing progress on access during 2021 by the Voluntary Scheme

Also in June 2021 was the target timeline for England “to reach the upper quartile (in relation to comparator countries) for the five highest health gain categories during the course of the first half of the Voluntary Scheme.” This was missed according to an analysis published in November 2021.

The target for access is part of the a voluntary agreement – the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) – that was struck between industry and the UK government in 2018. VPAS essentially balances access with scheme members guaranteeing that NHS spend on branded medicines won’t grow by more than 2 percent a year.

Whilst progress on access might be disappointing, for the UK government it seems that the deal is delivering nicely; £1,846 million has been paid back by companies up to November 2021 according to data released in January 2022. A payment percentage of 15 percent of sales will be due for 2022, a rate that is lower that would otherwise have been the case due to essentially an overriding of the previously agreed approach. This adjustment has come about due to a “sharp increase in the calculated payment percentage.” This is stark in comparison to the 5.1 percent rate for 2021.

The VPAS is due to end on the 31 December 2023 and traditionally negotiations on a successor deal begin around 18 months before the end date. 2022 will see both sides assessing scheme performance. Expect lots more positioning messages coming out as each side sets out its stall.

Life Sciences Vision set an ambitious agenda in 2021 with delivery ongoing in 2022

By July 2021, the UK government was laying out how it would try to attract and retain the life sciences industry in the post-Brexit world in the Life Sciences Vision. That vision continues the same policy drives that have shaped all 2021 activity, perhaps best summed up as being smarter and faster in bringing new medicines to patients.

The Life Sciences Vision also identified seven therapeutic areas that are priorities for the government: treatments for neurodegenerative disorders, cancer immunotherapies, novel vaccines, cardiometabolic therapies, treatments for respiratory disorders, therapies for multi-system ageing and treatments for mental illness.

The Vision will continue to shape the access environment but largely will be delivered by specific agencies during 2022 and beyond.

NICE has gotten faster and changes to methods and processes begin from February 2022

The institute has been shown to be faster when it comes to publishing their final guidance through their Technology Appraisal programme, hitting an all-time low of 3.3 months on average from marketing authorisation to final NICE output in 2020/21. Faster is just one of the areas of focus for NICE as set out in their five year strategy, running from 2021 to 2026. It’s also the aim of a 2021 piloted fast track approach used by NICE in appraising UCB’s Bimzelx (bimekizumab) for severe plaque psoriasis.

Stakeholders have been waiting for the final verdict on potential changes at the agency on how they evaluate technologies. The NICE board approved changes on the 19 January and the new manuals were published by NICE on 31 January. The changes range from a new disease severity modifier, greater use of real-world evidence from the lived experience of patients and more flexibility given by NICE’s committees when there are particular challenges in generating evidence, such as in the case of rare diseases. NICE says that the changes will “make the journey for promising new health technologies even faster and patient access fairer.” But as ever, the devil is in the detail in implementation.

NICE will also got a new chief executive: in February 2022, Dr. Samantha Roberts has taken on the job. It’s too soon to know what difference this change in leadership will make. It is however, a (refreshing?) break from the reliance on long-serving NICE staffers to step into key roles.

Implementation of the Innovative Medicines Fund during 2022

Another much talked about an initiative to speed up access is the Innovative Medicines Fund (IMF) for England. Originally promised by the Conservatives back in 2019, 2021 saw NICE and NHSE&I consult on the plans for a £340 million pot of money to provide interim access for the most promising non-cancer treatments. NICE will look again once more evidence becomes available.

The final details aren’t yet known. The consultation runs until February 2022, so perhaps the earliest for the fund to operate could be April 2022. That would neatly fit into a new financial year for the NHS. But even if it does actually get going, can £340 million really make a major difference to access?

Ongoing reforms in the English NHS

Familiar to anyone who has worked in England, there are ongoing reforms to the NHS. The Health and Care Bill reached Committee stage in the House of Lords by the end of 2021. The thrust of the legislation is to enable collaboration between health and care bodies.

Integrated Care Systems (ICSs) are the name of the game and that means that industry needs to keep up their work to ensure that they know just who to engage with, in yet another evolution of the NHS. ICSs won’t be implemented until the 1 July 2022. Trouble is, access to medicines may be down their to-do list against the backdrop of COVID-19 pent-up demand.

A focus on access but not yet delivering at scale?

The UK has delivered an impressive amount of policy and has been innovative itself when it comes to the access environment. Many in the pharmaceutical industry have welcomed these reforms. However, the UK still has some way to go to overcome its reputation for “low and slow” uptake of new medicines. Ensuring wider use of new medicines is what will make the UK market really attractive to pharmaceutical companies. That process of change will likely take years to unfold, but there should be some hope for progress delivering on policies to speed up access in 2022.

About the authors

Leela Barham is a 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).

Neil Grubert is a global market access consultant with more than 20 years’ experience in the field. He posts daily on market access developments around the world and has written more than 150 reports on mature and emerging markets. He was previously Vice-President, Global Market Access Insights at Decision Resources Group.

 

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International

United Airlines adds new flights to faraway destinations

The airline said that it has been working hard to "find hidden gem destinations."

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Since countries started opening up after the pandemic in 2021 and 2022, airlines have been seeing demand soar not just for major global cities and popular routes but also for farther-away destinations.

Numerous reports, including a recent TripAdvisor survey of trending destinations, showed that there has been a rise in U.S. traveler interest in Asian countries such as Japan, South Korea and Vietnam as well as growing tourism traction in off-the-beaten-path European countries such as Slovenia, Estonia and Montenegro.

Related: 'No more flying for you': Travel agency sounds alarm over risk of 'carbon passports'

As a result, airlines have been looking at their networks to include more faraway destinations as well as smaller cities that are growing increasingly popular with tourists and may not be served by their competitors.

The Philippines has been popular among tourists in recent years.

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United brings back more routes, says it is committed to 'finding hidden gems'

This week, United Airlines  (UAL)  announced that it will be launching a new route from Newark Liberty International Airport (EWR) to Morocco's Marrakesh. While it is only the country's fourth-largest city, Marrakesh is a particularly popular place for tourists to seek out the sights and experiences that many associate with the country — colorful souks, gardens with ornate architecture and mosques from the Moorish period.

More Travel:

"We have consistently been ahead of the curve in finding hidden gem destinations for our customers to explore and remain committed to providing the most unique slate of travel options for their adventures abroad," United's SVP of Global Network Planning Patrick Quayle, said in a press statement.

The new route will launch on Oct. 24 and take place three times a week on a Boeing 767-300ER  (BA)  plane that is equipped with 46 Polaris business class and 22 Premium Plus seats. The plane choice was a way to reach a luxury customer customer looking to start their holiday in Marrakesh in the plane.

Along with the new Morocco route, United is also launching a flight between Houston (IAH) and Colombia's Medellín on Oct. 27 as well as a route between Tokyo and Cebu in the Philippines on July 31 — the latter is known as a "fifth freedom" flight in which the airline flies to the larger hub from the mainland U.S. and then goes on to smaller Asian city popular with tourists after some travelers get off (and others get on) in Tokyo.

United's network expansion includes new 'fifth freedom' flight

In the fall of 2023, United became the first U.S. airline to fly to the Philippines with a new Manila-San Francisco flight. It has expanded its service to Asia from different U.S. cities earlier last year. Cebu has been on its radar amid growing tourist interest in the region known for marine parks, rainforests and Spanish-style architecture.

With the summer coming up, United also announced that it plans to run its current flights to Hong Kong, Seoul, and Portugal's Porto more frequently at different points of the week and reach four weekly flights between Los Angeles and Shanghai by August 29.

"This is your normal, exciting network planning team back in action," Quayle told travel website The Points Guy of the airline's plans for the new routes.

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International

Walmart launches clever answer to Target’s new membership program

The retail superstore is adding a new feature to its Walmart+ plan — and customers will be happy.

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It's just been a few days since Target  (TGT)  launched its new Target Circle 360 paid membership plan. 

The plan offers free and fast shipping on many products to customers, initially for $49 a year and then $99 after the initial promotional signup period. It promises to be a success, since many Target customers are loyal to the brand and will go out of their way to shop at one instead of at its two larger peers, Walmart and Amazon.

Related: Walmart makes a major price cut that will delight customers

And stop us if this sounds familiar: Target will rely on its more than 2,000 stores to act as fulfillment hubs. 

This model is a proven winner; Walmart also uses its more than 4,600 stores as fulfillment and shipping locations to get orders to customers as soon as possible.

Sometimes, this means shipping goods from the nearest warehouse. But if a desired product is in-store and closer to a customer, it reduces miles on the road and delivery time. It's a kind of logistical magic that makes any efficiency lover's (or retail nerd's) heart go pitter patter. 

Walmart rolls out answer to Target's new membership tier

Walmart has certainly had more time than Target to develop and work out the kinks in Walmart+. It first launched the paid membership in 2020 during the height of the pandemic, when many shoppers sheltered at home but still required many staples they might ordinarily pick up at a Walmart, like cleaning supplies, personal-care products, pantry goods and, of course, toilet paper. 

It also undercut Amazon  (AMZN)  Prime, which costs customers $139 a year for free and fast shipping (plus several other benefits including access to its streaming service, Amazon Prime Video). 

Walmart+ costs $98 a year, which also gets you free and speedy delivery, plus access to a Paramount+ streaming subscription, fuel savings, and more. 

An employee at a Merida, Mexico, Walmart. (Photo by Jeffrey Greenberg/Universal Images Group via Getty Images)

Jeff Greenberg/Getty Images

If that's not enough to tempt you, however, Walmart+ just added a new benefit to its membership program, ostensibly to compete directly with something Target now has: ultrafast delivery. 

Target Circle 360 particularly attracts customers with free same-day delivery for select orders over $35 and as little as one-hour delivery on select items. Target executes this through its Shipt subsidiary.

We've seen this lightning-fast delivery speed only in snippets from Amazon, the king of delivery efficiency. Who better to take on Target, though, than Walmart, which is using a similar store-as-fulfillment-center model? 

"Walmart is stepping up to save our customers even more time with our latest delivery offering: Express On-Demand Early Morning Delivery," Walmart said in a statement, just a day after Target Circle 360 launched. "Starting at 6 a.m., earlier than ever before, customers can enjoy the convenience of On-Demand delivery."

Walmart  (WMT)  clearly sees consumers' desire for near-instant delivery, which obviously saves time and trips to the store. Rather than waiting a day for your order to show up, it might be on your doorstep when you wake up. 

Consumers also tend to spend more money when they shop online, and they remain stickier as paying annual members. So, to a growing number of retail giants, almost instant gratification like this seems like something worth striving for.

Related: Veteran fund manager picks favorite stocks for 2024

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Government

President Biden Delivers The “Darkest, Most Un-American Speech Given By A President”

President Biden Delivers The "Darkest, Most Un-American Speech Given By A President"

Having successfully raged, ranted, lied, and yelled through…

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President Biden Delivers The "Darkest, Most Un-American Speech Given By A President"

Having successfully raged, ranted, lied, and yelled through the State of The Union, President Biden can go back to his crypt now.

Whatever 'they' gave Biden, every American man, woman, and the other should be allowed to take it - though it seems the cocktail brings out 'dark Brandon'?

Tl;dw: Biden's Speech tonight ...

  • Fund Ukraine.

  • Trump is threat to democracy and America itself.

  • Abortion is good.

  • American Economy is stronger than ever.

  • Inflation wasn't Biden's fault.

  • Illegals are Americans too.

  • Republicans are responsible for the border crisis.

  • Trump is bad.

  • Biden stands with trans-children.

  • J6 was the worst insurrection since the Civil War.

(h/t @TCDMS99)

Tucker Carlson's response sums it all up perfectly:

"that was possibly the darkest, most un-American speech given by an American president. It wasn't a speech, it was a rant..."

Carlson continued: "The true measure of a nation's greatness lies within its capacity to control borders, yet Bid refuses to do it."

"In a fair election, Joe Biden cannot win"

And concluded:

“There was not a meaningful word for the entire duration about the things that actually matter to people who live here.”

Victor Davis Hanson added some excellent color, but this was probably the best line on Biden:

"he doesn't care... he lives in an alternative reality."

*  *  *

Watch SOTU Live here...

*   *   *

Mises' Connor O'Keeffe, warns: "Be on the Lookout for These Lies in Biden's State of the Union Address." 

On Thursday evening, President Joe Biden is set to give his third State of the Union address. The political press has been buzzing with speculation over what the president will say. That speculation, however, is focused more on how Biden will perform, and which issues he will prioritize. Much of the speech is expected to be familiar.

The story Biden will tell about what he has done as president and where the country finds itself as a result will be the same dishonest story he's been telling since at least the summer.

He'll cite government statistics to say the economy is growing, unemployment is low, and inflation is down.

Something that has been frustrating Biden, his team, and his allies in the media is that the American people do not feel as economically well off as the official data says they are. Despite what the White House and establishment-friendly journalists say, the problem lies with the data, not the American people's ability to perceive their own well-being.

As I wrote back in January, the reason for the discrepancy is the lack of distinction made between private economic activity and government spending in the most frequently cited economic indicators. There is an important difference between the two:

  • Government, unlike any other entity in the economy, can simply take money and resources from others to spend on things and hire people. Whether or not the spending brings people value is irrelevant

  • It's the private sector that's responsible for producing goods and services that actually meet people's needs and wants. So, the private components of the economy have the most significant effect on people's economic well-being.

Recently, government spending and hiring has accounted for a larger than normal share of both economic activity and employment. This means the government is propping up these traditional measures, making the economy appear better than it actually is. Also, many of the jobs Biden and his allies take credit for creating will quickly go away once it becomes clear that consumers don't actually want whatever the government encouraged these companies to produce.

On top of all that, the administration is dealing with the consequences of their chosen inflation rhetoric.

Since its peak in the summer of 2022, the president's team has talked about inflation "coming back down," which can easily give the impression that it's prices that will eventually come back down.

But that's not what that phrase means. It would be more honest to say that price increases are slowing down.

Americans are finally waking up to the fact that the cost of living will not return to prepandemic levels, and they're not happy about it.

The president has made some clumsy attempts at damage control, such as a Super Bowl Sunday video attacking food companies for "shrinkflation"—selling smaller portions at the same price instead of simply raising prices.

In his speech Thursday, Biden is expected to play up his desire to crack down on the "corporate greed" he's blaming for high prices.

In the name of "bringing down costs for Americans," the administration wants to implement targeted price ceilings - something anyone who has taken even a single economics class could tell you does more harm than good. Biden would never place the blame for the dramatic price increases we've experienced during his term where it actually belongs—on all the government spending that he and President Donald Trump oversaw during the pandemic, funded by the creation of $6 trillion out of thin air - because that kind of spending is precisely what he hopes to kick back up in a second term.

If reelected, the president wants to "revive" parts of his so-called Build Back Better agenda, which he tried and failed to pass in his first year. That would bring a significant expansion of domestic spending. And Biden remains committed to the idea that Americans must be forced to continue funding the war in Ukraine. That's another topic Biden is expected to highlight in the State of the Union, likely accompanied by the lie that Ukraine spending is good for the American economy. It isn't.

It's not possible to predict all the ways President Biden will exaggerate, mislead, and outright lie in his speech on Thursday. But we can be sure of two things. The "state of the Union" is not as strong as Biden will say it is. And his policy ambitions risk making it much worse.

*  *  *

The American people will be tuning in on their smartphones, laptops, and televisions on Thursday evening to see if 'sloppy joe' 81-year-old President Joe Biden can coherently put together more than two sentences (even with a teleprompter) as he gives his third State of the Union in front of a divided Congress. 

President Biden will speak on various topics to convince voters why he shouldn't be sent to a retirement home.

According to CNN sources, here are some of the topics Biden will discuss tonight:

  • Economic issues: Biden and his team have been drafting a speech heavy on economic populism, aides said, with calls for higher taxes on corporations and the wealthy – an attempt to draw a sharp contrast with Republicans and their likely presidential nominee, Donald Trump.

  • Health care expenses: Biden will also push for lowering health care costs and discuss his efforts to go after drug manufacturers to lower the cost of prescription medications — all issues his advisers believe can help buoy what have been sagging economic approval ratings.

  • Israel's war with Hamas: Also looming large over Biden's primetime address is the ongoing Israel-Hamas war, which has consumed much of the president's time and attention over the past few months. The president's top national security advisers have been working around the clock to try to finalize a ceasefire-hostages release deal by Ramadan, the Muslim holy month that begins next week.

  • An argument for reelection: Aides view Thursday's speech as a critical opportunity for the president to tout his accomplishments in office and lay out his plans for another four years in the nation's top job. Even though viewership has declined over the years, the yearly speech reliably draws tens of millions of households.

Sources provided more color on Biden's SOTU address: 

The speech is expected to be heavy on economic populism. The president will talk about raising taxes on corporations and the wealthy. He'll highlight efforts to cut costs for the American people, including pushing Congress to help make prescription drugs more affordable.

Biden will talk about the need to preserve democracy and freedom, a cornerstone of his re-election bid. That includes protecting and bolstering reproductive rights, an issue Democrats believe will energize voters in November. Biden is also expected to promote his unity agenda, a key feature of each of his addresses to Congress while in office.

Biden is also expected to give remarks on border security while the invasion of illegals has become one of the most heated topics among American voters. A majority of voters are frustrated with radical progressives in the White House facilitating the illegal migrant invasion. 

It is probable that the president will attribute the failure of the Senate border bill to the Republicans, a claim many voters view as unfounded. This is because the White House has the option to issue an executive order to restore border security, yet opts not to do so

Maybe this is why? 

While Biden addresses the nation, the Biden administration will be armed with a social media team to pump propaganda to at least 100 million Americans. 

"The White House hosted about 70 creators, digital publishers, and influencers across three separate events" on Wednesday and Thursday, a White House official told CNN. 

Not a very capable social media team... 

The administration's move to ramp up social media operations comes as users on X are mostly free from government censorship with Elon Musk at the helm. This infuriates Democrats, who can no longer censor their political enemies on X. 

Meanwhile, Democratic lawmakers tell Axios that the president's SOTU performance will be critical as he tries to dispel voter concerns about his elderly age. The address reached as many as 27 million people in 2023. 

"We are all nervous," said one House Democrat, citing concerns about the president's "ability to speak without blowing things."

The SOTU address comes as Biden's polling data is in the dumps

BetOnline has created several money-making opportunities for gamblers tonight, such as betting on what word Biden mentions the most. 

As well as...

We will update you when Tucker Carlson's live feed of SOTU is published. 

Tyler Durden Fri, 03/08/2024 - 07:44

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