Estimates report

• Cancer
• Cardiovascular conditions
• Genetic disorder
• Infections
• Neurological conditions
• Respiratory conditions
• Sleep conditions

• Afatinib
• Alemtuzumab
• Alirocumab
• Atogepant
• Apixaban
• Benralizumab
• Cladribine
• Dabigatran etexilate
• Daridorexant
• Dacomitinib
• Dimethyl fumarate
• Diroximel fumarate
• Dupilumab (200mg)
• Edoxaban
• Elbasvir–grazoprevir
• Eptinezumab
• Erenumab
• Erlotinib
• Evolocumab
• Fingolimod
• Fremanezumab
• Galcanezumab
• Gefitinib
• Glatiramer acetate
• Glecaprevir–pibrentasvir
• Icosapent ethyl
• Inclisiran
• Interferon beta-1a
• Interferon beta-1b
• Ledipasvir–sofosbuvir
• Mepolizumab
• Natalizumab
• Ocrelizumab
• Ofatumumab
• Omalizumab
• Ombitasvir–paritaprevir–ritonavir
• Osimertinib
• Peginterferon beta-1a
• Ponesimod
• Reslizumab
• Rimegepant
• Rivaroxaban
• Siponimod
• Sofosbuvir
• Sofosbuvir–velpatasvir
• Sofosbuvir–velpatasvir–voxilaprevir
• Teriflunomide
• Tezepelumab
• Ublituximab
• Warfarin

NICE guidance TA341 (2015)
NICE guidance TA275 (2013)
SmPC therapeutic indications: apixaban

NICE guidance TA327 (2014)
NICE guidance TA249 (2012)
SmPC therapeutic indications: dabigatran etexilate

NICE guidance TA354 (2015)
NICE guidance TA355 (2015)
SmPC therapeutic indications: Lixiana

NICE guidance TA256 (2012)
NICE guidance TA261 (2012)
NICE guidance TA287 (2012)
SmPC therapeutic indications: rivaroxaban

SmPC therapeutic indications: warfarin

Only use of apixaban, dabigatran etexilate, edoxaban, rivaroxaban and warfarin in primary care is estimated.

1. Population who meet SmPC

The Summaries of Product Characteristics (SmPC) states that these medicines are mostly indicated for an adult population. However due to prevalence data in step 2, the starting population is the whole population in England (2024).

2. Prevalence of atrial fibrillation

The Quality and Outcomes Framework (QOF) reported 2.24% of the England population in 2024/25 have diagnosed atrial fibrillation. Not all people with atrial fibrillation (AF) who are eligible to receive medication will be diagnosed. 

Given this potential unknown population we have used Public Health England’s (2017) estimate of prevalence (and 95% confidence intervals); 2.5% (95% CI 2.4% to 2.6%), which estimates the diagnosed and undiagnosed population. This prevalence estimate is based on a Swedish study and is for the whole population. 

This figure has been applied to the whole population 

3. Proportion of people with atrial fibrillation eligible to receive treatment with apixaban, dabigatran etexilate, edoxaban, rivaroxaban or warfarin

Not all people with atrial fibrillation will be suitable to receive these medications. Reasons for not receiving medicine include lower thromboembolic risk score and weight.

The Quality and Outcomes Framework indicator AF007 records the number of people with diagnosed atrial fibrillation with a record of a CHA2DS2-VASc score of 2 or more, who are treated with anti-coagulation drug therapy, as 89%. This has been used to estimate the proportion of people with atrial fibrillation who are eligible to receive treatment.

This has been applied to the estimate and upper and lower confidence intervals calculated in step 2.

4. People with PE/DVT (VTE) provoked and unprovoked incidence

The incidence (and 95% confidence intervals) of provoked and unprovoked VTE for the whole population have been reported by Martinez (2013) as 131.5 per 100,000 person years (95% CI 130.2 to 132.9).

These proportions have been applied to the population identified in step 1..

5. People with PE/DVT (VTE) and cancer

The estimated incidence of provoked and unprovoked VTE with active cancer is reported by Martinez (2013) as: 18.6%. The inverse of this figure has been used to calculate the proportion of people with VTE who are not known to have cancer.

These figures have been applied to the estimate and upper and lower range calculated in step 4..

6. People with recurrent PE/DVT (VTE)

Martinez calculated 58.1% of people will have unprovoked VTE. This has been used as a proxy for the proportion of the VTE population that should receive long term anti-coagulant treatment.

These figures have been applied to the estimate and upper and lower range calculated in step 4.

7. Treatment duration

The duration of treatment is taken from the British National Formulary (2020). The treatment duration applied here is 3 months for incident VTE, 6 months for incident VTE with cancer, and lifelong for both AF and recurrent VTE.

These treatment durations have been used to estimate the number of people who will receive treatment in a year. For example, if treatment duration is 6 months, the eligible population has been multiplied by 0.5. Where the treatment duration is 3 months, the treatment population has been multiplied by 0.25.

These figures have been applied to the estimate and upper and lower range calculated in steps 3, 5 and 6.

8. Estimated population in England with atrial fibrillation, pulmonary embolism or deep vein thrombosis expected to receive one of apixaban, dabigatran, edoxaban, rivaroxaban and warfarin

The figures calculated in step 7 have been summed together to get a total.

9. Estimated volume

The number of people estimated to receive apixaban, dabigatran, edoxaban, rivaroxaban or warfarin was calculated in step 8. This number has then been multiplied by the number of days in a year to give the annual usage in Assumed Daily Doses (ADD).

10. Estimated usage by quarter per 100,000 population

The estimated annual ADD usage calculated in step 9 was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population and multiplied by 100,000 to give an estimated usage per 100,000 population. This has been applied to the point estimate and upper and lower range calculated in step 9.

References

1. Office for National Statistics (2025) Annual Mid-year Population Estimates, 2024 ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/estimatesofthepopulationforenglandandwales [Accessed: 03/2026].
2. PHE (2017) Technical document for sub-national English atrial fibrillation prevalence estimates: https://www.gov.uk/government/publications/atrial-fibrillation-prevalence-estimates-for-local-populations (Accessed 11/09/2020)
3. Quality and outcomes framework 2021-22 (2022). NHS Digital. Available from https://digital.nhs.uk/data-and-information/publications/statistical/quality-and-outcomes-framework-achievement-prevalence-and-exceptions-data/2021-22 (Accessed 03/01/2023)
4. Martinez (2013). Epidemiology of first and recurrent venous thromboembolism: A population-based cohort study in patients without active cancer https://pdfs.semanticscholar.org/a72e/a02e5d50b2ef7d9f854fb7cdc82d98d59c50.pdf?_ga=2.261870413.1733460998.1602838089-1477011522.1602838089  [Accessed: 11/09/2020].
5. British National Formulary. Available from https://bnf.nice.org.uk/treatment-summary/venous-thromboembolism.html (Accessed 11/09/2020)
6. Datapharm Communications Limited (2016) The Electronic Medicines Compendium [WWW]. Available from: http://www.medicines.org.uk/emc/ [Accessed: 11/09/2020].

NICE guidance TA413 (2016)
SmPC therapeutic indication: ZEPATIER

NICE guidance TA499 (2018)
SmPC therapeutic indication: Maviret

NICE guidance TA363 (2015)
SmPC therapeutic indication: Harvoni

NICE guidance TA365 (2015)

NICE guidance TA330 (2015)
SmPC therapeutic indication: Sovaldi

NICE guidance TA430 (2017)
SmPC therapeutic indication: Epclusa

NICE guidance TA507 (2018)
SmPC therapeutic indication: Vosevi

1. Population who meet SmPC

The Summaries of Product Characteristics (SmPC) for elbasvir–grazoprevir, glecaprevir–pibrentasvir, ledipasvir–sofosbuvir, ombitasvir–paritaprevir–ritonavir, sofosbuvir, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir show they are mostly indicated for an adult population, although some are indicated for people aged 3 years and older. As most patients are likely to be over 18 years the starting population is for this age.

2. Prevalence of chronic hepatitis C

In the resource tool costing template for ombitasvir–paritaprevir–ritonavir (TA365), NICE assume a prevalence rate of 0.4% of the population in England aged 18 and over.

As the population size at the time (ONS mid-year 2014 estimate) was 41,766,418, this gave a prevalent population of 167,066. If the prevalence rate remained the same, given the population increase for the age group, the prevalent population for chronic hepatitis C would now be 185,748.

Public Health England (PHE) publish an annual report on hepatitis C in England. In the accompanying data table, published in 2020, they give the following prevalence figures in 2019 as 89,000. We have used both prevalence figures for an upper and lower range.

3. Number of patients to be initiated with a new course of treatment

All the estimated prevalent population are eligible for treatment. However, the number who would be expected to be treated will depend on the rate at which people present to services or are identified for one of the NHS England hepatitis C programme initiatives. 

TA365 guidance assumes a population treatment of 9%, based on a company submission by Abbvie. This estimate has been applied to the prevalent populations in step 2.

4. Number of people to receive treatment

The upper and lower bound calculated in step 3 and the mid-point have been applied to estimate the number of people who will receive treatment annually.

5. Volume of treatment

The upper and lower bound and the point estimate calculated in step 4 has been multiplied by the number of treatment days. The lower bound multiplied by 56 days (treatment duration of 8 weeks multiplied by 7 days per week) and upper bound multiplied by 84 days (treatment duration of 12 weeks multiplied by 7 days per week). The point estimate is the midpoint between this range.

Assumed Daily Doses (ADD) were used to measure uptake.

6. Estimated usage by quarter per 100,000 population

Estimated annual ADD usage calculated in step 5, was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population and multiplied by 100,000 to give an estimated usage per 100,000 population. This has been applied to the point estimate and upper and lower range calculated in step 5.

References

1. Office for National Statistics (2023) Annual Mid-year Population Estimates, 2022 ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/estimatesofthepopulationforenglandandwales [Accessed: 12/10/2023].
2. NICE (2015) Resource impact assessment template for Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C TA365. Manchester: NICE. Available from: https://www.nice.org.uk/guidance/ta365.
3. Public Health England (2020) Hepatitis C in the England: Annual Report. Available from: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk.
4. Public Health England (2020) Hepatitis C in the England: Headline data table. Available from: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk.
5. Datapharm Communications Ltd (2017) The Electronic Medicines Compendium [WWW]. Available from: https://www.medicines.org.uk/emc/ [Accessed: 16/06/2021].

NICE guidance TA922 (2023)
SmPC therapeutic indication: Quviviq

1. England population

The adult population in England (18+) is taken from the Office for National Statistics’ Annual Mid-Year Population Estimates for 2024.

2. Number of people who have primary care record for insomnia

The prevalence of insomnia varies. The study ‘Insomnia symptom prevalence in England’ (de Lange 2023) used Biobank data from 160,000 people aged 38-71 in the UK. In the Biobank data, the study found 6% of participants’ primary care records contained Read codes for insomnia symptoms at any time.

The 95% confidence interval around this estimated proportion has been calculated using the exact binomial method (Pezzullo, 2009).

These figures have been applied to develop the upper and lower range with the point estimate from step 1.

3. Number of people in whom CBTi is not available or unsuitable

The number of people currently eligible to be treated with cognitive behavioural therapy for insomnia (CBTi) is estimated at 1% in the NICE resource impact template for Sleepio to treat insomnia and insomnia symptoms.  

For 99% of people, CBTi is unsuitable or is not available. This has been applied to the point estimate and upper and lower range calculated in step 2.   

4. Treatment population

The proportion of the eligible population that will receive treatment with daridorexant is estimated in the NICE resource impact template for daridorexant for treating long-term insomnia (TA922, 2023). The estimated treatment population in year 1 up to year 5.  

The year 2 estimate (4.1%) has been applied to the point estimate and upper and lower range calculated in step 3. 

5. Estimated annual volume

The number of people estimated to receive these medicines and continue treatment has been multiplied by the number of days in a year (365) to give the annual usage in ADDs.  

This has been applied to the point estimate and upper and lower range calculated in step 4.

6. Estimated usage by quarter per 100,000 population

Estimated annual Actual Daily Doses (ADD) usage calculated in step 7, was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population (58,620,101) and multiplied by 100,000 to give an estimated usage per 100,000 population.  

This has been applied to the point estimate and upper and lower range calculated in step 5.

References

1. ​​​Office for National Statistics (2025) Annual Mid-year Population Estimates 2024. ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland  [Accessed: 05/06/2024].
2. Lange, Melanie & Richmond, Rebecca & Eastwood, Sophie & Davies, Neil. (2023). Insomnia symptom prevalence in England: A comparison of self-reported data and primary care records in the UK Biobank. 10.1101/2023.09.07.23295191.
3. ​NICE, 2023. Sleepio to treat insomnia and insomnia symptoms (MTG70). Available from NICE guidance Sleepio Tools and Resources webpage.
4. NICE, 2023. Daridorexant for treating long-term insomnia (TA922). Available from https://www.nice.org.uk/guidance/ta922.
5. Pezzullo. (2009) Exact Binomial and Poisson Confidence Intervals calculator. Available from http://statpages.org/confint.html.

NICE guidance TA310 (2014)
SmPC therapeutic indication: Giotrif

NICE guidance TA595 (2019)
SmPC therapeutic indication: Vizimpro

NICE guidance TA258 (2012)
NICE guidance TA374 (2015)
SmPC therapeutic indication: Tarceva

NICE guidance TA192 (2010)
SmPC therapeutic indication: Iressa

NICE guidance TA653 (2020)

NICE guidance TA654 (2020)

NICE guidance TA761 (2022)

NICE guidance TA1043 (2025)

NICE guidance TA1060 (2025)

SmPC therapeutic indication: Tagrisso

The following aims to estimate the expected usage of the NICE positively appraised medicines afatinib, dacomitinib, erlotinib and gefitinib in people with epidermal growth factor receptor (EGFR) positive stage 3b and stage 4 advanced non-small-cell lung cancer (NSCLC), first-line treatment with osimertinib in people with stage Ib to stage IIIa EGFR positive NSCLC and second line use of osimertinib in people with T790 mutation positive EGFR positive NSCLC. 

Where these medicines have a licenced indication not positively appraised by NICE, usage has not been estimated. While this usage is expected to be small, it may result in a lower expected usage when compared to observed usage.

1. Incidence of lung cancer

The national disease registration service (NDRS) Cancer Registration Statistics (2025) reports 42,064 new lung cancer diagnoses in England in 2023.

For the same period, the National Lung Cancer Audit – State of the Nation Report reports 37,750 new lung cancer cases in England.

These values have been used to set the lower and upper bounds.

The midpoint of the two reported figures, 39,907, has been applied as the point estimate.

2. Estimated number of people with non-small-cell lung cancer

The proportion of new lung cancer cases that are non-small‑cell lung cancer (NSCLC) is reported as 91.4% in the National Lung Cancer Audit – State of the Nation Report and 92.2% in the NDRS Cancer Registration Statistics. The midpoint of these proportions, 91.8%, has been applied to the updated incidence values from Step 1.

3. Proportion of people who test positive for EGFR mutation

The observational cross‑sectional study Biomarker Testing for People With Advanced Lung Cancer in England (Adizie 2021) reports that 10% of people with advanced or metastatic lung cancer have an EGFR mutation.

This proportion has been applied to the updated NSCLC population estimates from Step 2.

People with EGFR NSCLC who undergo surgery

NICE TA1043 recommends osimertinib, within its marketing authorisation, as an option for the adjuvant treatment of stage 1b to 3a non‑small‑cell lung cancer (NSCLC) after complete tumour resection. It is for adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or EGFR exon 21 (L858R) substitution mutations.

4a. Proportion of people presenting with stage I – 3a NSCLC

The proportion of new cases of NSCLC that are diagnosed stage 1-3a is reported in the National Lung Cancer Audit State of the Nation Report as 48.5%. This proportion has been applied to the point estimate calculated in step 3.

4b. Proportion of people who undergo surgery

The proportion of new cases of NSCLC that undergo surgery is reported in the National Lung Cancer Audit State of the Nation Report as 20%.

The reported proportion has been applied to the upper and lower range and the point estimate calculated in step 4a.

4c. Proportion of people who had tumour resection surgery and were EGFR positive with exon 19 deletions or exon 21 L858R mutations

Based on data reviewed in Zhang (2016), it is estimated that 90% of people who are EGFR positive have exon 19 deletions or exon 21 L858R mutations. This has been applied to the point estimate for people who had tumour resection surgery and were EGFR positive, calculated in step 4b.

People with untreated locally advanced or metastatic EGFR NSCLC

NICE recommends the following treatments for people with untreated locally advanced or metastatic EGFR NSCLC, afatinib, dacomitinib, erlotinib, gefitinib and osimertinib.

5a. Proportion of people where molecular testing was successful

The proportion of new cases of NSCLC that are diagnosed stage IIIb (advanced), or stage IV (metastatic) is reported in the National Lung Cancer Audit State of the Nation Report as 51.5%.

This proportion has been applied to the point estimate and upper and lower range calculated in step 3.

5b. Proportion of people who receive first line afatinib, dacomitinib, erlotinib, gefitinib or osimertinib

The spotlight audit on molecular testing in advanced lung cancer (2020), 75% of patients with an EGFR mutation received a first-line tyrosine kinase inhibitor (TKI).

The reported proportion has been applied to the upper and lower range and the point estimate for people successfully assessed, calculated in step 5a.

T790M mutation-positive, advanced or metastatic, EGFR NSCLC

NICE TA653 Osimertinib is recommended as an option for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC).

6a. Proportion of people who progress following first line treatment with afatinib, dacomitinib, erlotinib or gefitinib (previously treated EGFR-positive)

Assuming for each of the 6 treatment options, usage is split proportionately, 83.3% of usage will be for afatinib, dacomitinib, erlotinib and gefitinib. The disease will progress in 65% of cases (TA416, NICE 2016) and will then be eligible for osimertinib. These proportions (83.3% and 65%) have been applied successively to the point estimate and the lower and upper range in step 5b.

6b. Proportion of people who harbour T790M mutation at progression (previously treated EGFR-population)

Based on genomic analysis, progression on a first-line EGFR TKI is characterised by an acquired secondary EGFR kinase domain mutation labelled T790M, causing resistance to the first-line EGFR TKI. The proportion of people who harbour T790M mutation at progression is reported in Mazza (2017) to be between 50% and 60%.

The midpoint (55%) has been applied to the point estimate and the proportions (50% and 60%) applied respectively to the lower and upper range calculated in step 6a.

7a. Calculate estimated usage volume – afatinib, erlotinib, dacomitinib and gefitinib

The usage for the first line treatment options afatinib, dacomitinib, erlotinib, gefitinib or osimertinib is assumed to be split evenly. Therefore 80% of usage will be for afatinib, dacomitinib, erlotinib or gefitinib.

This proportion has been applied to point estimate and upper and lower range calculated in step 5b.

The total estimated treatment population for first line afatinib, erlotinib, dacomitinib and gefitinib assumed here that treatment will be for 12 months (365 days). This has been applied to the point estimate and upper and lower range.

7b. Calculate estimated usage volume – first and second line osimertinib

The total estimated treatment population for osimertinib is summed from step 4c, 6b and 16.7% of step 5b.

It has been assumed that treatment will be for 21 months (639 days). 

7c. Total treatment volume – afatinib, dacomitinib, erlotinib, gefitinib and first or second line osimertinib

The total treatment volume (ADD) for afatinib, dacomitinib, erlotinib, gefitinib and first or second line osimertinib has been summed from steps 7a and 7b.

8. Estimated usage by quarter per 100,000 population

Estimated annual ADD usage was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population and multiplied by 100,000 to give an estimated usage per 100,000 population. This has been applied to the point estimate and upper and lower range calculated in step 7c.

References

1. The national disease registration service (NDRS), Cancer Registration Statistics, England, 2023. NHS England Digital. [Accessed: Feb 2026]
2. Office for National Statistics (2025) Annual Mid-year Population Estimates, 2024 ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/estimatesofthepopulationforenglandandwales [Accessed: 03/2026].
3. National lung cancer audit State of the Nation Report - Patient Characteristics Dashboard, 2025. [Accessed: May 2025]
4. Adizie JB, Tweedie J, Khakwani A, Peach E, Hubbard R, Wood N, Gosney JR, Harden SV, Beckett P, Popat S, Navani N. Biomarker Testing for People With Advanced Lung Cancer in England. JTO Clin Res Rep. 2021 Apr 27;2(6):100176. doi: 10.1016/j.jtocrr.2021.100176. PMID: 34590024; PMCID: PMC8474239.
5. Zhang et al (2016). The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016 Nov 29; 7(48): 78985–78993.
6. Spotlight audit on molecular testing in advanced lung cancer (2020). Available from https://www.rcplondon.ac.uk/projects/outputs/spotlight-audit-molecular-testing-advanced-lung-cancer-2019-diagnoses-2017 [accessed 08/11/2021]
7. TA416 (NICE 2016). Manufacturers submission (AstraZeneca 2016) Available from https://www.nice.org.uk/guidance/ta416/evidence [Accessed 29/01/2018]
8. Mazza V, Cappuzzo F. Treating EGFR mutation resistance in non-small cell lung cancer – role of osimertinib. The Application of Clinical Genetics. 2017; 10:49-56. doi:10.2147/TACG.S103471.
9. Datapharm Communications Limited (2017) The Electronic Medicines Compendium [WWW]. Available from: http://www.medicines.org.uk/emc/, [Accessed: 10/11/2021]
10. TA1043 (NICE 2022). Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection. Available from https://www.nice.org.uk/guidance/ta1043 [Accessed May 2025]
11. TA654 (NICE 2020). Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer. Available from https://www.nice.org.uk/guidance/ta654 [Accessed 02/11/2021]
12. TA416 (NICE 2016). Manufacturers submission (AstraZeneca 2016) Available from https://www.nice.org.uk/guidance/ta416/evidence [Accessed 29/01/2018]
13. TA761 (NICE 2022). Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection. Available from https://www.nice.org.uk/guidance/ta761 [Accessed 28/06/2022]
14. TA374 (2015) Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy. Final appraisal determination, section 4.3.6. Available from https://www.nice.org.uk/guidance/ta374[accessed 29/01/2018]

NICE guidance TA805 (2022)
SmPC therapeutic indication: Vazkepa

1.    Population who meet SmPC

The Summary of Product Characteristics (SmPC) states that the medicine is indicated for an adult population only. Office for national statistics population data for England has been used to establish the number of people aged 18 and over (ONS 2025).

2. Secondary prevention of cardiovascular disease

The CVDPREVENT data to September 2025, states the prevalence of GP recorded cardiovascular disease (wide definition) in England for people aged 18 and over is 6.6%. This includes people with a coded diagnosis of at least one of the following cardiovascular diseases (CVD):

• stroke or transient ischaemic attack
• coronary heart disease (CHD) (including myocardial infarction (MI) and acute coronary syndrome)
• heart failure (HF)
• abdominal aortic aneurysm (AAA)
• peripheral arterial disease (PAD)

This proportion has been applied to the England adult population in step 1.

3. Number of people suitable for treatment with statins

Estimates on the proportion of people with CVD who are receiving or who have previously received statins varies. Here we have used a range of between 79% (Steen, 2017) and 90% (Bilitou, 2020).  These have been applied to the population identified in step 2 to calculate the upper and lower range and midpoint (point estimate).

4. Low-density lipoprotein cholesterol concentrations

The estimated number of people who have had at least one recorded instance of a cardiovascular event and whose low-density lipoprotein cholesterol concentrations are above 2.5mmol/L is reported by Danese (2018) to be 21.5%. The remaining 78.5% has been used here as the proportion below 2.5mmol/L. Due to available data the threshold is not an exact match for the threshold stated in the NICE guidance. This threshold has been applied to the point estimate and upper and lower bounds calculated in step 3.

5. Number of people with raised triglycerides

The proportion of people with raised triglycerides (150 mg/dL [1.7 mmol/litre] or more) used here is 20%. This is taken from the resource impact template published alongside the technology appraisal (NICE, 2022). This has been applied to the point estimate and upper and lower bounds calculated in step 4.

6. Number of people who will receive treatment with icosapent ethyl

The resource impact template published alongside the technology appraisal (NICE, 2022) estimates that 1% of the eligible population (step 5) will receive treatment with icosapent ethyl in year 1 rising to 5% in year 5. For the period of this report, it is estimated that 3% will receive treatment. This has been applied to the point estimate and upper and lower bounds calculated in step 5.

7. Calculate estimated usage volume (ADD)

The number of people who are estimated to receive treatment with icosapent ethyl has been multiplied by days in a year to produce an expected volume of medicine per year in Assumed Daily Doses (ADD).

8. Estimated usage by quarter per 100,000 population

Estimated annual ADD usage calculated in step 7, was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population and multiplied by 100,000 to give an estimated usage per 100,000 population. This has been applied to the point estimate and upper and lower range calculated in step 7.

References

1. Office for National Statistics (2025) Annual Mid-year Population Estimates, 2024 ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/estimatesofthepopulationforenglandandwales [Accessed: 03/2026].
2. Datapharm Communications Limited (2015) The electronic Medicines Compendium. Available from: http://www.medicines.org.uk/emc/ [Accessed: April 2023]
3. The Cardiovascular Disease Prevention Audit (CVDPREVENT) available from https://www.cvdprevent.nhs.uk/ [accessed March 2026]
4. Dylan L Steen, Irfan Khan, David Ansell, Robert J Sanchez, Kausik K Ray. Retrospective examination of lipid-lowering treatment patterns in a real-world high-risk cohort in the UK in 2014: comparison with the National Institute for Health and Care Excellence (NICE) 2014 lipid modification guidelines. BMJ Open 2017. Available from https://bmjopen.bmj.com/content/bmjopen/7/2/e013255.full.pdf [accessed April 2023]
5. A Bilitou, A Rabe, L Inema, G Alamgir, K Dunton, The prevalence and patient outcomes of adult primary hypercholesterolaemia and dyslipidaemia in the UK: a longitudinal retrospective study using a primary care dataset from 2008 to 2018, European Heart Journal, Volume 41, Issue Supplement_2, November 2020, ehaa946.3559, https://doi.org/10.1093/ehjci/ehaa946.3559
6. Danese MD, Sidelnikov E, Kutikova L. The prevalence, low-density lipoprotein cholesterol levels, and treatment of patients at very high risk of cardiovascular events in the United Kingdom: a cross-sectional study. Curr Med Res Opin. 2018 Aug;34(8):1441-1447. doi: 10.1080/03007995.2018.1463211. Epub 2018 Apr 20. PMID: 29627994.
7. Resource impact template, Icosapent ethyl with statin therapy for reducing the risk of cardiovascular events in people with raised triglycerides, NICE, 2022. Available from https://www.nice.org.uk/guidance/ta805 [accessed April 2023]

NICE guidance TA937 (2024)
SmPC therapeutic indication: Aquipta

NICE guidance TA871 (2023)
SmPC therapeutic indication: VYEPTI

NICE guidance TA682 (2021)
SmPC therapeutic indication: Aimovig

NICE guidance TA764 (2022)
SmPC therapeutic indication: AJOVY

NICE guidance TA659 (2020)
SmPC therapeutic indication: Emgality

NICE guidance TA906 (2023)
NICE guidance TA919 (2023)
SmPC therapeutic indication: Vydura

The estimated treatment population is calculated for the Calcitonin Gene-Related Peptide (CGRP) receptor antagonists atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab and rimegepant, for treating episodic and chronic migraine. An upper and lower range is calculated, to address the uncertainty in the underlying analyses. 

According to the Summaries of Product Characteristics (SmPC), these medicines are preventative treatments for adults in England who experience at least four migraine days per month and for whom at least three previous preventative treatments have failed.  

Although rimegepant is also indicated for acute treatment (TA919), the acute treatment cohort has not been modelled due to complexities in quantifying treatment duration and expected low utilisation (<10% of the preventative population).  .

1. Prevalence of migraine

Estimates of migraine prevalence vary across data sources. To calculate prevalence in England, a lower bound, upper bound, and point estimate have been established.

• Lower bound: Coppola et al. (2025) report a one‑year migraine prevalence of 10.4% among adults in England. Applied to the adult population (46,437,085; ONS 2025), this equates to 4,829,457 adults with migraine.
• Upper bound: The Lundbeck/Migraine Trust Survey (2021) reports a prevalence of 23%, which corresponds to 10,680,530 adults.
• Point estimate: The midpoint of the two estimates is 7,754,993 adults.

The summary of these estimates is provided in the table below. 

2. Estimated Number of People Experiencing More Than Three Migraine Days per Month 

NICE Technology Appraisals draw upon ICHD‑3 definitions, classifying:

• episodic migraine: fewer than 15 headache days per month
• chronic migraine: 15 or more headache days per month for over 3 months, with 8 or more days meeting migraine criteria

Criteria in NICE TAs for atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, and rimegepant require 4 or more migraine days per month, so the relevant group comprises those with 4 or more migraine days per month.

Data from the Lipton et al. (2015) shows for people with migraine:

• 58% experience less than 4 migraines per month
• 21% experience 4 to 7 migraines per month
• 21% experience 8 or more migraines per month

Thus, 42% of people with migraine experience 4 or more migraine days per month. Coppola et al. (2025) similarly report that 56.2% of people with migraine experience 5 or more monthly headache days, supporting this assumption. This 42% has been applied as a scaling factor. 

3. Number of people who have preventative therapy for migraine 

Coppola et al. (2025) report that 42.4% of individuals with migraine receive preventative therapy. This proportion has been applied to the prevalence estimates from Section 2. 

4. Number of people who had 3 or more prior treatment failures 

A minimum of 3 prior preventative treatment failures is required before initiating the CGRP therapies considered. Coppola et al. (2025) report that 7.7% of people receiving preventative therapy in the UK meet this criterion. This proportion has been applied to the prevalence estimates from Section 3. 

5. Treatment initiation

While NICE guidance does not specify that initiation must be carried out by neurologists, in practice injectable CGRP monoclonal antibodies (erenumab, fremanezumab, galcanezumab, eptinezumab) are often initiated by consultant neurologists due to local formulary restrictions. In contrast, oral treatments (atogepant, rimegepant) may be initiated in primary care. 

Coppola et al. (2025) report that 21.7% of people with migraine are referred to a specialist—these individuals are assumed to receive initiation of biologic injectable therapy.  

In addition, NICE’s resource impact template for atogepant (2024) estimates that 20% people will be initiated in primary care, predominantly on oral CGRP receptor antagonists. 

This proportion has been applied to the population identified in Section 4.

There totals are summed below. 

6. Number of people who continue treatment

The LTS‑302 study (2024), a long‑term safety and tolerability study of atogepant, reports a 3.59% discontinuation rate per cycle. Modelled annually, a 10% discontinuation rate is assumed, meaning 90% continue therapy. This figure has been applied to the treatment population as a scaling factor from section 6.  

7. Estimated annual volume

The number of people continuing treatment has been multiplied by 365 days to calculate the total annual usage in Actual Daily Doses (ADDs).

This figure has been applied as a scaling factor from section 6.  

8. Estimated usage by quarter per 100,000 population

Annual ADD usage has been divided by four to estimate quarterly totals. These have been divided by the England population and expressed per 100,000 population.

This has been applied to the point estimate and upper and lower range calculated in section 7.   

References

1. Coppola, G., Brown, J.D., Mercadante, A.R. et al. (2025) ‘The epidemiology and unmet need of migraine in five European countries: results from the National Health and Wellness Survey’, BMC Public Health, 25, p. 254. Available at: https://doi.org/10.1186/s12889-024-21244-8.
2. Office for National Statistics (ONS) (2025) Annual Midyear Population Estimates 2024. Newport: ONS. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/estimatesofthepopulationforenglandandwales (Accessed: 4 February 2026).
3. Institute for Health Metrics and Evaluation (IHME) (2019; 2021 updates) Global Burden of Disease Study. IHME.
4. Lundbeck/Migraine Trust Survey (2021) State of the Migraine Nation – UK population evidence review.
5. National Institute for Health and Care Excellence (NICE) (2023) Eptinezumab for preventing migraine (TA871). Available at: https://www.nice.org.uk/guidance/ta871/resources.
6. International Headache Society (2026) The International Classification of Headache Disorders, 3rd edition (ICHD3). Available at: https://ichd-3.org/ (Accessed: February 2026).
7. National Institute for Health and Care Excellence (NICE) (2024) Atogepant for preventing migraine (TA973). Available at: https://www.nice.org.uk/guidance/ta973/resources.
8. Blumenfeld, A.M., et al. (2013) ‘Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second International Burden of Migraine Study (IBMSII)’, Headache, 53(4), pp. 644–655.
9. Lipton, R.B., Manack Adams, A., Serrano, D., et al. (2015) The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study – methods and baseline results. Cephalalgia, 35(7), pp. 563–578. 

NICE guidance TA312 (2014)
SmPC therapeutic indication: LEMTRADA

NICE guidance TA616 (2019)
SmPC therapeutic indication: MAVENCLAD

NICE guidance TA320 (2014)
SmPC therapeutic indication: Tecfidera

NICE guidance TA794 (2022)
SmPC therapeutic indication: Vumerityt

NICE guidance TA254 (2012)
SmPC therapeutic indication

NICE guidance TA527 (2018)
SmPC therapeutic indication

NICE guidance TA527 (2018)
SmPC therapeutic indication

NICE guidance TA527 (2018)
SmPC therapeutic indication

NICE guidance TA127 (2007)
SmPC therapeutic indication: TYSABRI

NICE guidance TA533 (2018)
NICE guidance TA585 (2019)
SmPC therapeutic indication: OCREVUS

NICE guidance TA699 (2021)
SmPC therapeutic indication: Kesimpta

NICE guidance TA624 (2020)
SmPC therapeutic indication: Plegridy

NICE guidance TA767 (2022)
SmPC therapeutic indication: Ponvory

NICE guidance TA656 (2020)
SmPC therapeutic indication: Mayzent

NICE guidance TA303 (2014)
SmPC therapeutic indication: AUBAGIO

NICE guidance TA1025 (2024)
SmPC therapeutic indication: Briumvi

The following steps estimate the population of adults with multiple sclerosis who receive treatment with one of the following NICE-approved medicines: alemtuzumab, cladribine, dimethyl fumarate, diroximel fumarate, fingolimod, glatiramer acetate, interferon beta-1a, interferon beta-1b, natalizumab, ocrelizumab, ofatumumab, peginterferon beta-1a, ponesimod, siponimod, teriflunomide, or ublituximab.

1. England Population

The SmPC states that all the above medicines are indicated for an adult population. The following medicines are also indicated for adolescent and paediatric populations: dimethyl fumarate (aged 13+), glatiramer acetate (aged 12+), interferon beta-1a (aged 2+, Rebif only), interferon beta-1b (aged 12-17), and teriflunomide (aged 10+). 

The starting population for this estimate is the total population of England.

2. Estimated prevalence of multiple sclerosis

The proportion of people with multiple sclerosis has been estimated from a study using a representative sample of primary care records in England from The Health Improvement Network (THIN) dataset. The prevalence of multiple sclerosis in England was estimated as 0.19% of the population.

However, had incomplete records not been excluded from this study, the estimated prevalence would have been 0.205%. To account for this uncertainty, both prevalence figures have been applied to the population identified in step 1 to create an estimate range.  

3. People with an Expanded Disability Status Scale (EDSS) score of less than 7

All medicines for multiple sclerosis should be discontinued once a person develops an EDSS score of 7 (an inability to walk) that persists for longer than 6 months. The UK Multiple Sclerosis Register collects clinical data from MS treatment centres, including individuals EDSS score. According to this register 82.42% of people with multiple sclerosis have an EDSS score of less than 7 (correct as of 9 May 2023). To account for error in this estimation, a range between 80% and 85% has been applied to the population identified in step 2 to create an upper and lower estimate. 

This proportion has been applied to the population stated in step 2.

4. Estimated treatment population

Despite evidence that early treatment and adherence to disease modifying therapies results in better outcomes (reduced relapse rates and disease progression), some people with MS may choose to not receive treatment.

A study investigating MS medicine compliance in a Canadian population found that 31.3% of people declined treatment. A similar study on a French population found that 10% of people declined treatment. Some of the most common reasons for this decision were: personal preference, lack of disease activity, wanting to use alternative medicines, or wishing to adopt a conservative approach to treatment. It should be noted that these figures may not directly reflect MS medicine compliance in a UK population. 

To account for these factors when estimating the current treatment population, adherence estimates of 70%, 80% and 90% have been applied to the lower, point and higher estimate, respectively.

5. Calculate estimated usage volume (ADD)

The number of people who are estimated to receive treatment with MS medicines has been multiplied by days in a year to produce an expected volume of medicine per year in ADDs.

6. Estimated usage by quarter per 100,000 population

Estimated annual ADD usage calculated in step 5, was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population and multiplied by 100,000 to give an estimated usage per 100,000 population. This has been applied to the point estimate and upper and lower range calculated in step 5.

References

1. Office for National Statistics (2023) Annual Mid-year Population Estimates, 2022 ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/estimatesofthepopulationforenglandandwales [Accessed: 12/10/2023].
2. Public Health England (2020) Multiple sclerosis: prevalence, incidence and smoking status - data briefing. Available from: https://www.gov.uk/government/publications/multiple-sclerosis-prevalence-incidence-and-smoking-status/multiple-sclerosis-prevalence-incidence-and-smoking-status-data-briefing [Accessed: 30/06/2022].
3. UK MS Register Data (2023) Stats at a glance. Available at: https://ukmsregister.org/Research/OurData [Accessed: 09/05/2023].
4. Zekkat et al., (2012) Multiple sclerosis without treatment: characteristic features of 70 untreated patients in a cohort of 1187 patients. Revue Neurologique. DOI: 10.1016/j.neurol.2011.08.018.
5. Stratos et al., (2020) Non-compliance with disease modifying therapies in patients with Multiple Sclerosis: A qualitative analysis. Multiple Sclerosis and Related Disorders. https://doi.org/10.1016/j.msard.2020.102016.

NICE guidance TA393 (2016)
SmPC therapeutic indication: Praluent

NICE guidance TA394 (2016)
SmPC therapeutic indication: Repatha

NICE guidance TA733 (2021)
SmPC therapeutic indication: Leqvio

The following estimates the population of adults with primary hypercholesterolaemia (familial and non-familial), or mixed dyslipidaemia who receive treatment with a PCSK9 inhibitor (alirocumab or evolocumab) or inclisiran. Bempedoic acid (TA694) is not included in this estimate due to complexities around the eligible populations. .

1. Adult population England

The SmPC states that alirocumab, evolocumab and inclisiran are indicated for an adult population. Evolocumab is also indicated in adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Due to data availability, the eligible adolescent population has not been calculated, however this is not expected to significantly alter the estimated treatment population.

The starting population for this estimate is adults aged 18 years or older in England.

2. Primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia

The proportion of people with primary non-familial hypercholesterolaemia or mixed dyslipidaemia has been estimated from an analysis of primary care practices across the UK. The prevalence of hypercholesterolaemia/mixed dyslipidaemia in the UK was estimated as 23.5% of the adult population. This proportion has been applied to the population identified in step 1. 

3. Estimated number of people receiving or who have previously received lipid lowering therapy

The proportion of people with primary non-familial hypercholesterolaemia or mixed dyslipidaemia who are receiving or who have previously received lipid lowering therapy is estimated at over 90%. To account for error in this estimation, a range between 85% and 95% has been applied to the population identified in step 2 to create an upper and lower estimate.

This proportion has been applied to the adult population stated in step 2.

4. People who have had at least one recorded instance of a cardiovascular event, angina or peripheral arterial disease (secondary prevention)

The proportion of people who have had at least one recorded instance of a cardiovascular event or angina is estimated to be almost 15.9%. This has been applied to the populations calculated in step 3.

5. Low-density lipoprotein cholesterol concentrations

The estimated number of people who have had at least one recorded instance of a cardiovascular event and whose low-density lipoprotein cholesterol concentrations are between 2.5mmol/L and 3.49mmol/L is reported to be 21.5%. Low-density lipoprotein cholesterol concentrations between 3.5mmol/L and 3.99mmol/L is reported to be 3.3% and 3.1% for above 4mmol/L.

Due to available data the thresholds are not an exact match for the thresholds stated in the NICE guidance. These thresholds have been applied to the populations calculated in step 4.

6. Estimated treatment population

There is considerable uncertainty estimating a treatment population for this group of medicines. Based on figures used in the AHSN data toolkit, the trajectory of uptake of inclisiran is estimated to be 9.3% of the eligible population in year 1, 43.9% in year 2 and 61.7% in year 3. The year 3 trajectory has been applied to the point estimate and the upper and lower range calculated in step 5d.

The treatment population for alirocumab and evolocumab is calculated here as the remaining population following year 3 uptake of inclisiran (100-61.7=38.3). This has been applied to the total low-density lipoprotein cholesterol concentrations above 3.5mmol/L calculated in step 5e, for the point estimate and the upper and lower range.

7. Calculate estimated usage volume (ADD)

The number of people who are estimated to receive treatment with alirocumab, evolocumab or inclisiran (step 6c) has been multiplied by days in a year to produce an expected volume of medicine per year in Assumed Daily Doses (ADD).

8. Estimated usage by quarter per 100,000 population

Estimated annual ADD usage calculated in step 7, was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population and multiplied by 100,000 to give an estimated usage per 100,000 population. This has been applied to the point estimate and upper and lower range calculated in step 7.

References

1. Office for National Statistics (2023) Annual Mid-year Population Estimates, 2022 ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/estimatesofthepopulationforenglandandwales [Accessed: 12/10/2023].
2. Datapharm Communications Limited (2021) The Electronic Medicines Compendium [WWW]. Available from: https://www.medicines.org.uk/emc [Accessed: 01/11/2021].
3. A Bilitou, A Rabe, L Inema, G Alamgir, K Dunton, The prevalence and patient outcomes of adult primary hypercholesterolaemia and dyslipidaemia in the UK: a longitudinal retrospective study using a primary care dataset from 2008 to 2018, European Heart Journal, Volume 41, Issue Supplement_2, November 2020, ehaa946.3559, https://doi.org/10.1093/ehjci/ehaa946.3559.
4. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia, TA733, based on estimate provided by NHSE/I, 2021. Available from: https://www.nice.org.uk/guidance/ta733/evidence [Accessed: 01/11/2021].
5. Danese MD, Sidelnikov E, Kutikova L. The prevalence, low-density lipoprotein cholesterol levels, and treatment of patients at very high risk of cardiovascular events in the United Kingdom: a cross-sectional study. Curr Med Res Opin. 2018 Aug;34(8):1441-1447. doi: 10.1080/03007995.2018.1463211. Epub 2018 Apr 20. PMID: 29627994.
6. Calculation based on data supplied to the AHSN data toolkit by the inclisiran medicine manufacturer (Novartis), 2021.

NICE guidance TA565 (2019)
SmPC therapeutic indication: Fasenra

NICE guidance TA751 (2021)
SmPC therapeutic indication: Dupixent

NICE guidance TA671 (2021)
SmPC therapeutic indication: Nucala

NICE guidance TA278 (2013)
NICE guidance TA339 (2015)
SmPC therapeutic indications: Xolair

NICE guidance TA479 (2017)
SmPC therapeutic indication: Cinqaero

NICE guidance TA880 (2023)
SmPC therapeutic indications: Tezpire

Benralizumab, dupilumab (200mg only), mepolizumab, reslizumab and tezepelumab are add-on therapies, and are recommended by NICE as options for treating severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta-agonists.

Omalizumab is recommended by NICE as an optional add-on therapy for treating severe persistent confirmed allergic IgE mediated asthma as an add on to optimised standard therapy. The Summary of Product Characteristics (SmPC) states omalizumab is indicated for allergic asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria. Only usage for allergic asthma has been calculated here. This will mean we have underestimated total use of omalizumab. 

1. England population

The Summary of Product Characteristics (SmPC) states the starting age for the medicines benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab and tezepelumab ranges from 6 to 12 years of age. For the purpose of this estimate the whole population has been selected. The population England is taken from the Office for National Statistics Annual Mid-Year Population Estimates. 

2. Number of people who have been diagnosed with asthma

The Quality and Outcomes Framework (QOF) reported the number of people on the asthma register (NHS Digital, 2025) as 3,944,639. 

The 95% confidence interval around this has been calculated using the exact binomial method (Pezzullo, 2009).

The prevalence and confidence interval has been applied to the population in England in step 1.

3a. Number of people with asthma and a blood eosinophil count of 300 cells per microlitre or more

A cohort study (Price 2015) using anonymised UK medical record data to identify primary care patients with asthma aged 12-80 years and their eosinophil count and exacerbation rates.   

A cohort which included blood eosinophil count to 2 decimal places showed that 31% (16,602 out of 54,072) have blood eosinophil count greater than 300 cells per microlitre (μL).

This has been applied to the point estimate and upper and lower range calculated in step 2.

3b. Number of people with asthma and a blood eosinophil count of 300 cells per microlitre or more and 4 or more exacerbations in the last 12 months

People with a blood eosinophil count of 300 cells per microlitre or more (step 3a) who have 4 or more exacerbations in the last 12 months are not included in the cohort study (Price 2015).  

For this estimate the percentage of people with a blood eosinophil count of less than 400 cells per microlitre and 4 or more exacerbations in the last 12 months has been used, at 2.5%.  

This has been applied to the point estimate and upper and lower range calculated in step 3a.   

3c. Number of people with asthma and a blood eosinophil count of 300 cells per microlitre or more and 3 or more exacerbations in the last 12 months

People with a blood eosinophil count of 300 cells per microlitre or more (step 3a) who have 3 or more exacerbations in the last 12 months are not included in the cohort study (Price 2015).  

For this estimate the percentage of people with a blood eosinophil count of less than 400 cells per microlitre and 2-3 exacerbations in the last 12 months has been used, at 6.2%.

This has been applied to the point estimate and upper and lower range calculated in step 3a.

4a. Number of people asthma and a blood eosinophil count of 400 cells per microlitre or more

A cohort study (Price 2015) using anonymised UK medical record data to identify primary care patients with asthma aged between 12 and 80 years and their eosinophil count and exacerbation rates.   

The study showed that 16% (20,929 out of 130,248) have blood eosinophil count greater than or equal to 400 cells per μL.

This has been applied to the point estimate and upper and lower range calculated in step 2.

4b. Number of people with asthma and a blood eosinophil count of 400 cells per microlitre or more and 3 or more exacerbations in the last 12 months

People with a blood eosinophil count of greater than or equal to 400 cells per microlitre or more (step 4a) who have 3 exacerbations in the last 12 months is not included in the cohort study (Price 2015).  

For this estimate the percentage of people with a blood eosinophil count of greater than or equal to 400 cells per microlitre and 2-3 or more exacerbations in the last 12 months has been used, at 4.3%.  

This has been applied to the point estimate and upper and lower range calculated in step 4a.

5. Total eligible population for mepolizumab, reslizumab or benralizumab

The eligible population has been summed from step 3b and step 4b.

6a. Treatment population for benralizumab, mepolizumab and reslizumab

Benralizumab, mepolizumab and reslizumab are add on therapies that are initiated in secondary care, requiring clinical consultation, where capacity may act as a barrier to treatment initiation.

The NICE resource impact template for TA565 (benralizumab, 2019) estimates the proportion of the eligible population (step 5) that will receive treatment with benralizumab to be 4%.

The NICE resource impact template for TA431 (mepolizumab, 2017) estimates the proportion of the eligible population (step 5) that will receive treatment with mepolizumab to be 15%. Alternatively, the NICE resource impact template for TA565 (benralizumab, 2019) estimates the proportion of the eligible population (step 5) that will receive treatment with mepolizumab to be 6%. These have been used to inform the lower and upper range and midpoint (10.5%) the point estimate.

The NICE resource impact template for TA479 (reslizumab, 2017) estimates the proportion of the eligible population (step 5) that will receive treatment with reslizumab to be 10%. Alternatively the NICE resource impact template for TA565 (benralizumab, 2019) estimates the proportion of the eligible population (step 5) that will receive treatment with reslizumab to be 1%. These have been used to inform the lower and upper range and midpoint (5.5%) the point estimate.

These proportions have been applied to the point estimate and lower and upper range calculated in step 5.

6b. Treatment population for dupilumab

Number of people who have had mepolizumab, reslizumab or benralizumab but whose asthma had not responded adequately (NICE, TA751) is 20%. Of this eligible for dupilumab population around 20% are expected to receive dupilumab (200mg) in year 1.

These proportions have been applied to the point estimate and lower and upper range calculated in step 6a.

7. Total eligible population for tezepelumab

The number of people asthma and a blood eosinophil count of 300 cells per microlitre or more and 2-3 exacerbations in the last 12 months is taken from step 3c. The clinical and patient experts (NICE, TA880) explained that about 5% of people with severe asthma who have regular treatment cannot have existing biological treatments.

This proportion has been applied to the point estimate and lower and upper range calculated in step 3c.

8. Total eligible population for omalizumab, severe asthma

The number of people with severe asthma is reported in in the United Kingdom is reported to be around 200,000 people (Asthma UK, 2022). This equates to around 169,000 people in England, as 84.5% of the total UK population is England.

9. Total eligible population for omalizumab

The IDEAL study (Albers, 2018) estimates that 30.6% (CI 27.1 – 34.2%) of people with severe asthma will be eligible for omalizumab. This proportion has been applied to the point estimate and lower and upper range calculated in step 8.

10. Overlap with other biologics

The IDEAL study (Albers, 2018) estimates that around 25% of the eligible population for omalizumab will overlap with other treatment options. The eligible population for omalizumab (step 9) has been reduced proportionately to adjust for this overlap.

11. Treatment population for omalizumab

The NICE resource impact report for omalizumab for treating severe persistent allergic asthma (2013), estimated that around 2,000 people would receive omalizumab for treating severe persistent allergic asthma. This is around 4% of the eligible population.

12. Treatment population for benralizumab for treating relapsing or refractory eosinophilic granulomatosis with polyangiitis  

Benralizumab is also recommended by NICE for a separate indication - relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) (NICE, TA1096). The accompanying resource impact assessment predicts that approximately 268 people in England will receive benralizumab for EGPA in year 1. This population is distinct from the severe asthma pathways modelled above, so it is added as a separate step prior to calculating the total treatment population.

13. Total treatment population

The treatment populations in step 6, step 7 and step 11 have been summed.

14. Proportion discontinuing treatment each year

The proportion of people discontinuing add-on therapy each year is reported in the manufacturer’s submission to NICE for benralizumab (TA565) to be 11.8% for benralizumab, mepolizumab and reslizumab. This has been applied to the total estimated treatment population for benralizumab, mepolizumab, omalizumab, reslizumab and tezepelumab.

This proportion has been subtracted from the point estimate and lower and upper range calculated in step 12.

15. Estimated annual volume

The number of people estimated to receive these medicines and continue treatment has been multiplied by the number of days in a year (365) to give the annual usage in ADDs. This has been applied to the point estimate and upper and lower range calculated in step 13.

16. Estimated usage by quarter per 100,000 population

The estimated annual Actual Daily Doses (ADD) usage calculated in step 14 was divided by 4 to show quarterly ADD usage. This was then divided by the whole England population and multiplied by 100,000 to give an estimated usage per 100,000 population. This has been applied to the point estimate and upper and lower range calculated in step 5.

References

1. ​​​Office for National Statistics (2025) Annual Mid-year Population Estimates 2024. ONS: Newport. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland  [Accessed: 04/03/2026]
2. ​Quality and outcomes framework 2024-2025. NHS Digital. Available from https://digital.nhs.uk/data-and-information/publications/statistical/quality-and-outcomes-framework-achievement-prevalence-and-exceptions-data/ (Accessed 04/03/2026)
3. Pezzullo. (2009) Exact Binomial and Poisson Confidence Intervals calculator. Available from http://statpages.org/confint.html
4. Price DB, Rigazio A, Campbell JD, Bleecker ER, Corrigan CJ, Thomas M, Wenzel SE, Wilson AM, Small MB, Gopalan G, Ashton VL, Burden A, Hillyer EV, Kerkhof M, Pavord ID. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015 Nov;3(11):849-58. doi: 10.1016/S2213-2600(15)00367-7. Epub 2015 Oct 19. PMID: 26493938.
5. NICE (2019) Resource impact assessment template for TA565 benralizumab (2019). Manchester: NICE. Available from: https://www.nice.org.uk/guidance/ta565. [Accessed: 23/10/2019].
6. NICE (2017) Resource impact assessment template for TA431 mepolizumab (2017). Manchester: NICE. Available from: https://www.nice.org.uk/guidance/ta431 . [Accessed: 23/10/2019].
7. NICE (2017) Resource impact assessment template for TA479 reslizumab (2017). Manchester: NICE. Available from: https://www.nice.org.uk/guidance/ta479 . [Accessed: 23/10/2019].
8. NICE, 2023. Tezepelumab for treating severe asthma (TA880). Available from https://www.nice.org.uk/guidance/ta565 [Accessed: 28/06/2024].
9. Asthma UK (2020) Do no harm. Available from: https://www.asthmaandlung.org.uk/about-us/our-latest-work/our-asthma-reports [Accessed 28/06/2024]
10. Frank C. Albers, Hana Müllerová, Necdet B. Gunsoy, Ji-Yeon Shin, Linda M. Nelsen, Eric S. Bradford, Sarah M. Cockle & Robert Y. Suruki (2018) Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study, Journal of Asthma, 55:2, 152-160, DOI: 10.1080/02770903.2017.1322611 Available from https://doi.org/10.1080/02770903.2017.1322611 [Accessed: 28/06/2024).
11. NICE (2013) Resource impact assessment report for Omalizumab for treating severe persistent allergic asthma. TA278. Manchester: NICE. Available from: https://www.nice.org.uk/guidance/ta278. Based on manufacturer submission to NICE for TA278 (TA133-TA201) https://www.nice.org.uk/guidance/ta278/documents/asthma-severe-persistent-patients-aged-6-adults-omalizumab-rev-ta133-ta201-novartis2 [Accessed: 11/10/2020].
12. NICE, 2019. Benralizumab for treating severe eosinophilic asthma (TA565). Available from https://www.nice.org.uk/guidance/ta565 [Accessed: 25/06/2024].
13. NICE, 2021. Dupilumab for treating severe asthma with type 2 inflammation (TA751). Available from https://www.nice.org.uk/guidance/ta751 [Accessed: 10/03/2025].
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