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learning from our international experiences, looking at preliminary evidence from Thailand,

and considering what these ideas may mean for the future of Thai HTA.

Today, we are very fortunate to have three outstanding speakers with us.

The first speaker is Professor Olivia Wu, William R.

Lindsay Chair of Health Economics at the University of Glasgow,

and also our adjunct professor at the Faculty of Pharmacy, Mahidon University.

Professor Wu brings extensive international experience in HTA,

including 10 years as a member of a NICE Technology Appraisal Committee.

Currently, she is the director of two NIHR research programs,

Better Met Thoughts, Better Research and Program Grants for Applied Research.

She will share her insights on 9th severity modifier from principle to policy.

And our second speaker is our faculty member,

Associate Professor Muntalat Thawan -Jaran -Sap.

From the Faculty of Pharmacy,

my name is Dr. Hwagin.

Mahidong University, she's preliminary results sharing some initial findings on how severity -based weighting might affect HTA decision in the Thai context.

And our last speaker on the third speaker is Professor Darius Lakdawala.

He is a professor of pharmaceutical economics

and public policy from the University of Southern California and holds the Queen Thai Chair in pharmaceutical development and regulatory innovation.

He is one of the key developers of the GRACE model, or we call Generalized Risk Adjusted Cost -Effectiveness.

He will introduce a broader perspective on how we might better

capture the value health gains across patients with different health conditions and levels of risk.

After the presentation, Associate Professor Montalak will lead our panel discussion and Q &A.

I hope today's webinar will give us a new perspective and stimulate a thoughtful discussion.

We are not necessarily looking for a final answer today, but rather to better understand the evidence

and ask for important questions what should Thailand consider before giving greater recognition to the security and equity in HTA.

So without further delay, let me invite our first speaker, Professor Olivia Wu, to begin her presentation.

Professor Olivia, the floor is yours.

Thank you.

thank you dr yusa um

so um i'm going to set the scene for for everybody now um

so this phrase um dr yusa has already mentioned

it a quality is a quality is a quality this is a phrase

that does a great deal of work for hta the assumption as dr yusa has explained is

that a unit of health gain has the same social value to whoever receives it and whenever their starting point is.

So the cost per quality threshold, the willingness to pay threshold that some countries use,

it is only coherent as a decision rule because of this assumption.

And the justification for this is opportunity cost.

When the health system funds a new technology, it displaces health elsewhere.

So equal weighting is how we avoid making arbitrary trade -offs between one group of patients and another.

But equal weighting is a value judgment.

And for more than 15 years, NICE has been under pressure to move away from this.

I'm going to talk about how it has done so.

And first, through the end of life criteria

and then through the severity modifier introduced in 2022 and what we know about it and how the modifier has been behaving.

So end of life criteria, the most important thing to remember is it came out of a political moment.

The end of life criteria wasn't created because of scientific underpinning.

It was because of politics.

In 2008, NICE was undergoing appraisal for several drugs for advanced renal cancer.

cancer.

And NICE was under intense criticism from the Government Review.

And in 2009, NICE introduced supplementary advice to its committee on appraising life -extending end -of -life treatments.

Now, I remember this really well, because 2009 was the year I joined NICE.

And that was when we're trying to grapple with

and understand how to apply this end -of -life criteria in our decision making as a committee.

There are two key features to this.

First, the criteria were drafted with advanced cancer in mind,

because the whole reason why I started thinking about this was because of this appraisal on renal carcinoma.

And this has shaped the design of it. And second,

Now, if you remember, our threshold at that time was £20 ,000 per QALY.

So the end -of -life criteria remained NICE's only explicit modifier for 13 years until 2002,

when the NICE manual, the reference case,

was revised and it was replaced. So, So,

means less than 24 months.

The second element is that there had to be sufficient evidence that it offers an extension to life.

So people have to be living longer with the treatment, normally at least three months compared with the current treatment.

Now, the third element is an element that was added on slightly later on.

The treatment has to be licensed for a small patient population.

And normally that doesn't exceed 7 ,000 people.

Now, if these were met, the committee could take additional account of the quality gain.

And if it is satisfied that the estimates of life extension were robust

because we're looking for an additional three months and the modelling assumptions are plausible, then we could apply the end of life criteria.

But it's important to also note what is missing here.

There's no measure of quality of life.

There's no measure of how much health is lost relative to normal life.

And there's no formula that turns the criteria into a weight.

So it was all down to our judgment call.

sorry i've moved on too many slides um yes

so the obvious question for us is whether this end of

life criteria allowing a premium reflected what the public actually values because

that was the whole point of it the whole point was the without the end of life criteria before

then it's not we're not reflecting what the public truly values

and so the question for us once the end of life criteria is introduced was whether it does

that job and the honest answer is

that evidence base the evidence base was thin and the evidence

that existed was not actually very supportive of putting more emphasis more weight towards the end of life

so this is one of the big studies

that was done at the time stated preference work using discrete choice experiment

that showed there was very little evidence

that people actually place extra value on the quality gain simply

because it's occurring at the end of life and later studies actually pointed to the same direction

Now what people seem to respond to is severity and prospects.

That's how much health someone stands to lose rather than closeness to death is what people value more.

The length of survival with a poor quality of life matters to people

but the end of life criteria does not really see to that.

And then there are other criticism as well.

Weighting one group's gain means displacing health from patients who don't receive extra weighting.

And if the threshold that we use is already estimated above opportunity cost,

and there's a lot of evidence that's been critical of that.

100

So if you think about the work that

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York University did suggesting that the threshold should be lower than 20 ,000.

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In fact, I think they placed it at 30 ,500.

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then this additional weighting widens the gap.

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So ultimately, this will lead to a net population health cost being lost.

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So by 2019, the end of life criteria had a weak preference base,

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a narrow design and also opportunity cost problem.

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And the question for NICE was whether to abolish this or replace it with something better.

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So 10 years on, after a lot of consultation and work,

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NICE decided that the end -of -life criteria should be replaced. And

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so the 2022 manual introduced a modifier based on the severity

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of the condition defined as the future health lost by people living with it under standard care in the NHS.

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So the nicest reasoning for this is that it aligns with the values held by the society,

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because it extends the premium to conditions that never qualified before.

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And the design has four broad objectives to broaden the eligibility beyond people who are close to death.

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So the short survival cancers to replace a binary grade with weighted with graded weights.

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So if you remember, the end of life criteria was very binary.

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Are people going to live beyond 24 months?

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Can we extend life for three months?

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So it's a very yes or no question.

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And also, the new severity modifier anchors the measure in quantities that can be calculated.

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So it's not purely a judgment call.

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And the final element is that the severity modifier remain approximately opportunity cost neutral.

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So the overall value given under the new rules match the old criteria.

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So there will be no big losers or winners because of this change.

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Now, there are other reasons for replacing the end of life criteria.

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So first of all, the narrow scope, because the criteria focus on just purely short survival and small population.

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So if you think about a child with severe genetic disease

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or an adult with a long term musculoskeletal or mental health condition, they could suffer a very large loss of health,

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but they would still fail to qualify.

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So the narrow scope of the previous end of life criteria was a big problem.

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Secondly, the dichotomous eligibility criteria, which I've just mentioned, the 24 months and the three month threshold were binary.

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So it really, treatment outside these criteria got nothing, regardless of how much health the patient lost.

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Thirdly, these criteria is based on weak societal preference, which I've just described.

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And the policy assumed that, the new policy, the severity modifier assumed that it's reflecting public preference now.

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And then finally, transparency.

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The criteria depended on committee judgment.

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So there's huge criticism on the decision being not transparent because it cannot be clearly calculated.

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So those were the additional reasons for making these changes.

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So how is severity measured?

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So severity is measured as a shortfall.

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So the idea is quite simple.

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If you take the qualities of the people the same age

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and sex would expect to have over the rest of their life,

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and you also take the qualities of the patients with the condition who are expected to have under current care,

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the difference is the health lost to the disease.

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So NICE used two versions of this difference.

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The absolute shortfall is the gap in QALYs

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and the proportional shortfall is a gap as a fraction of the QALYs that the general population would expect.

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And both are discounted at three and a half percent.

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And the committee can apply whichever gives the higher weight.

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So I'm going to just give you a clearer example of how this is done.

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Now, to calculate this, we need three inputs to drive the equation.

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First is the expected qualies in the general population built from life tables, age and sex specific to EQ5D utility norms.

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So if the dark blue bars represent the qualies of a healthy person.

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So in this example, we assume that this is 12 qualies.

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Now, the second calculation is the expected QALYs with current care, which in practice comes from the comparator arm of the economic model.

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So it's basically the light blue bar here, the QALYs for the people with a certain condition.

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So here in my example is one.

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And the third element is discounting.

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So three and a half percent discount is applied to these estimates.

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And so in an absolute shortfall,

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the difference between the qualities for a healthy person and the quality for a person with a condition is the shortfall.

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So here is 12 minus 1 and it gives us 11.

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Now, NICE has given very clear calculation for calculating shortfalls.

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And the decision support unit has published a technical support document together with a calculator now

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but the difficulty is

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that on the patient side of the equation it is actually a modeled output

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so it inherits all the uncertainties and all the limitations from the actual model

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so the survive extrapolation the utility values the baseline age

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and sex mix and the definition of the population

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that all comes from the model so if there are

172

if you're if the model is inaccurate it will then feed into this calculation as well.

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So for proportional shortfall, it's a slightly different calculation.

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So in the same example where a healthy person's QALY is 12,

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and then the QALY for a person with a certain condition is 1, Your loss quali is 11.

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And for proportional shortfall, the calculation is essentially the loss quali divided by the quali of a healthy person.

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So here we get 0 .92.

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So this is how we calculate a proportional shortfall.

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So in terms of decisions, there are two things to think about.

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So first, the weight is applied to the incremental qualis, not the actual threshold.

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So the effect on the decision is equivalent to raising the threshold.

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So the previous 20 to 30 ,000 pounds range,

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a weight of 1 .2 corresponds to the effective threshold of 24 to 36 ,000.

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And the 1 .7 weight corresponds to 34 ,000 to 51 ,000.

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So since April 2026, the standard range has now been raised.

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So this will be raised accordingly as well.

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But in terms of the decision,

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the committee is allowed to pick whichever one gives us the greater benefit between the proportional and the absolute shortfall.

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So what has happened since 2022 since this was introduced?

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Now, this is based on work that NICE has done to review how the severity modifier has been implemented.

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This is a decision support units analysis by Alan Waylu and his colleagues.

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The starting point, their starting point was a surprise that NICE has already noticed.

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In the first year of implementation,

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fewer topics met the one -time anticipation through consultation ahead of applying the disease modifier.

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And so they then had a closer look at how the severity relates to the end of life

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and age in using 555 appraisal decisions between 2009 -2024,

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there were three key findings from this comparison work.

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So firstly, they found that severity weights do not map precisely onto the end -of -life criteria,

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which is what you would expect because the severity weight is supposed to be broader than the end -of -life,

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so it shouldn't be mapping exactly if it's doing its job, so that's fine.

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Secondly, 91 % of the decisions that had met end -of -life criteria would have met a severity weight above one.

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So the majority of previously eligible technologies should still be eligible, which again is good.

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Third, the authors concluded that a change from end -of -life to severity weights has been approximately cost neutral as intended.

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So, in 2024, they concluded that the modifier is working as intended and no change is needed.

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And NICE had also reported that positive recommendations of cancer treatments were somewhat higher under this criteria,

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which is 75%.

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So, NICE is satisfied that this policy is doing what it's intended to do.

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So what does the industry partners think?

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So this is a report from the Association of British Pharmaceutical Industry.

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And so when they looked at what's been applied,

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so this it's from 2022 when it was first introduced all the way to the most recent 2025 to 2026 and

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they they what they argued is they do not disagree

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that the severity modifier it's an improvement in terms of conceptual improvement from the end of life criteria

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but they they have issues with the calibration.

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So they found that 72 % of eligible topics received no severity weighting, and 59 % of those were in oncology.

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NICE's own analysis suggests about 8 % of these topics would receive a 1 .7 modifier, and about 30 % should receive a 1 .2 modifier.

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And so the ABPI interprets this as evidence that the modifier has been applied more conservatively than the opportunity cost neutral requires.

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So they are calling for more work to be done on this.

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And NICE is planning to do more work on whether this is reflecting societal preference.

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And in the meantime, the ABPI has argued that they should have a downward adjustment to this shortfall cutoff.

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So there are still a lot of recognition that there are limitations to this approach.

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Now, of course, there are also methodological challenges.

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So first of all, discounting, the shortfall calculation used discounted qualities.

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And there's always an argument that discounting penalizes chronic diseases because morbidity and mortality accumulate over a long period of time.

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So this is an argument that is not unique to this policy.

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The cutoff, so the proportional shortfall threshold,

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the top weight of 0 .95 is much higher than what other countries use.

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So for example, in the Netherlands, their proportional shortfall is 0 .7.

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The other methodological challenge is related to the borderline estimates.

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So if you remember, we talked about a lot of the estimates from the patient's aspect, especially is fed from the modelling.

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So small changes in assumptions can actually mean a difference in whether you qualify

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or not for the effect for the severity modifier.

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So it's quite challenging.

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The choice of baseline and comparative is also relevant.

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So before 2022, NICE could not calculate shortfall in about a third of the cases, often because there were no committee preferred scenarios.

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And so baseline age or comparative qualities could not be identified.

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So it's quite difficult to make to draw those comparisons.

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And then finally, in terms of reporting,

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there's inconsistent reporting of shortfall calculations limited by transparency and comparability across appraisals.

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So it's not always clear how these calculations were made.

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So I'm just going to finish by saying that the severity modifier,

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I think, is a more coherent instrument than the end of life criteria.

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It is a step forward.

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It's broader, it's graded, and it's more transparent in principle

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but it also but it remains a calibrated compromise

246

if you like rather than a genuine preference based weight um

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so the the next stage of the debate probably will be

248

whether nice choose um a more preference aligned um approach um rather than continue what um making adjustment to this

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or whether there will be further changes ahead.

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But ultimately, I always would like to remind everyone that...

251

The severity modifier is a replacement for the end -of -life criteria.

252

And the end -of -life criteria exists because fundamentally of politics,

253

not really because there was a strong scientific basis to drive this.

254

Thank you.

255

Thank you.

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Woordenschat en spreektips bij deze les

Deze woorden komen het vaakst terug: criteria, severity, modifier, shortfall, weight. Deze video bevat 255 zinnen en 3078 woorden om na te spreken. Het gesproken deel duurt 25:42. De spreker praat in een gelijkmatig tempo van ongeveer 120 woorden per minuut, prettig om te shadowen. Slechts 81% van de woorden hoort bij de 3.000 meest gebruikte Engelse woorden, dus de woordenschat is pittig.

Belangrijke woorden in deze video

15 woorden uit de video die het leren waard zijn, met uitspraak en betekenis:

Woord	Uitspraak	Betekenis
severity zelfstandig naamwoord	/səˈvɛɹ.ə.ti/	ernst, strengheid
threshold zelfstandig naamwoord	/ˈθɹɛʃ(h)oʊld/	drempel
calculation zelfstandig naamwoord	/ˌkælkjuˈleɪʃn̩/	berekening
preference zelfstandig naamwoord	/ˈpɹɛf(ə)ɹ(ə)ns/	voorkeur, preferentie
proportional bijvoeglijk naamwoord		evenredig
discount zelfstandig naamwoord	/ˈdɪskaʊnt/	korting
calculate werkwoord	/ˈkælkjʊleɪt/	berekenen, uitwerken
element zelfstandig naamwoord	/ˈɛləmənt/	element
reflect werkwoord	/ɹɪˈflɛkt/	weerkaatsen
estimate zelfstandig naamwoord	/ˈɛs.tɪ.mət/	schatting
judgment zelfstandig naamwoord	/ˈd͡ʒʌd͡ʒ.mənt/	oordeel
assumption zelfstandig naamwoord	/əˈsʌm(p).ʃ(ə)n/	op zich nemen
topic zelfstandig naamwoord	/ˈtɑpɪk/	onderwerp, thema
narrow bijvoeglijk naamwoord	/ˈnæɹəʊ/	nauw, smal
survival zelfstandig naamwoord	/sɚˈvaɪ.vəl/	overleven, overleving

Grammatica in deze video

De structuren die de spreker het meest gebruikt, met de exacte woorden uit de video:

Structuur	In de video
Present perfect have/has + voltooid deelwoord — iets uit het verleden dat nu nog telt	has already mentioned · has explained · has been
Lijdende vorm be + voltooid deelwoord — het gaat om wat er gebeurt, niet om wie het doet	wasn't created · were drafted · was revised

Uitspraak om op te letten

De spreker gebruikt 15 samentrekkingen en verkorte vormen, zoals I'm, I've, we're. Spreek ze kort uit, zoals je ze hoort.

De “th”-klanken: threshold /ˈθɹɛʃ(h)oʊld/, thin /ˈθɪn/, thoughtful /ˈθɔːtfəl/, methodological /ˌmɛθ.ə.dəˈlɑ.d͡ʒɪ.kəl/
De klanken “sh” en “zh”: threshold /ˈθɹɛʃ(h)oʊld/, calculation /ˌkælkjuˈleɪʃn̩/, assumption /əˈsʌm(p).ʃ(ə)n/, recognition /ˌɹɛkəɡˈnɪʃ(ə)n/, extension /ɪkˈstɛnʃən/
Lange woorden — let op de klemtoon: severity /səˈvɛɹ.ə.ti/, eligible /ˈɛl.ɪ.d͡ʒɪ.bəl/, pharmaceutical /ˌfɑː.məˈs(j)uː.tɪ.kl̩/, recognition /ˌɹɛkəɡˈnɪʃ(ə)n/, economics /ˌiːkəˈnɒmɪks/

Klanken die Nederlandstaligen lastig vinden:

Stemhebbende eindmedeklinker — /b/, /d/, /g/, /z/, /v/ niet verscherpen: threshold /ˈθɹɛʃ(h)oʊld/, extend /ɛkˈstɛnd/, phrase /ˈfɹeɪ̯z/, conclude /kənˈkluːd/, comparative /kəmˈpæɹətɪv/
/æ/ — opener dan de Nederlandse “e”: calculation /ˌkælkjuˈleɪʃn̩/, calculate /ˈkælkjʊleɪt/, narrow /ˈnæɹəʊ/, faculty /ˈfæk.əl.ti/, manual /ˈmæn.j(u)əl/
/g/ — een harde plofklank, geen Nederlandse “g”: recognition /ˌɹɛkəɡˈnɪʃ(ə)n/, argue /ˈɑɹ.ɡju/, regardless /ɹɪˈɡɑɹd.lɪs/, regulatory /ˈɹɛɡ.jʊ.lə.t(ɔː.)ɹi/, disagree /dɪsəˈɡɹi/

Zo oefen je met deze video

Luister de hele video één keer zonder te spreken en noteer de woorden die je niet kent.
Spreek zin voor zin na op normale snelheid en herhaal elke zin tot je ritme gelijk is aan dat van de spreker.
Neem jezelf op en vergelijk met het origineel; let daarbij op woorden als severity, threshold, calculation.

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Shadowing is een wetenschappelijk onderbouwde taalleermethode die oorspronkelijk is ontwikkeld voor professionele tolkentraining en gepopulariseerd door polyglot Dr. Alexander Arguelles. De methode is eenvoudig maar krachtig: je luistert naar native Engelse audio en herhaalt het onmiddellijk hardop — als een schaduw die de spreker volgt met slechts 1–2 seconden vertraging. In tegenstelling tot passief luisteren of grammaticadrills, dwingt shadowing je hersenen en mondspieren om echte spraakpatronen tegelijkertijd te verwerken en te reproduceren. Onderzoek toont aan dat het de uitspraaknauwkeurigheid, intonatie, ritme, verbonden spraak, luisterbegrip en spreekvaardigheid aanzienlijk verbetert — waardoor het een van de meest effectieve methoden is voor IELTS Speaking-voorbereiding en echte Engelse communicatie.

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