4 Committee discussion

The Appraisal Committee reviewed the data available on the clinical and cost effectiveness of nintedanib, having considered evidence on the nature of idiopathic pulmonary fibrosis and the value placed on the benefits of nintedanib by people with the condition, those who represent them, and clinical experts. It also took into account the effective use of NHS resources.

Clinical management

4.1 The Committee understood that idiopathic pulmonary fibrosis is a distressing illness that limits physical activity because of breathlessness, and can lead to hypoxia, pulmonary hypertension, heart failure and death. The Committee heard from clinical experts that 80% of people with idiopathic pulmonary fibrosis die from the condition or from respiratory failure. The median overall survival in the clinical trials, which excluded people with the most severe disease, was 3 to 4 years. It heard that there is no cure for idiopathic pulmonary fibrosis, although the Committee acknowledged that pirfenidone and lung transplant (when drug treatment is not appropriate) are options available to manage the condition. It heard however that these are not appropriate for many people because of the tolerability of pirfenidone, the severity of the person's condition, or other comorbidities. Patient experts explained that a key aim of treatment is to slow the progression of disease. They stated that people with idiopathic pulmonary fibrosis would benefit from alternative treatment options. The Committee concluded that idiopathic pulmonary fibrosis is associated with substantial morbidity and mortality, and that there are few treatment options.

4.2 The Committee discussed the effect of acute exacerbations in idiopathic pulmonary fibrosis, which it understood to be more serious than exacerbations in other respiratory diseases. It heard from clinical experts that half of people with idiopathic pulmonary fibrosis will die within 30 days of an acute exacerbation. People who survive an exacerbation have permanent and substantially reduced lung function (up to a 20% decline in percent predicted forced vital capacity [FVC]). Clinical experts explained that acute exacerbations can be difficult to define in clinical trials, because they can be confused with respiratory infections, but are clearly recognised in clinical practice by experienced clinicians. The Committee heard from patient experts that preventing or delaying acute exacerbations is an important way to maintain quality of life. The Committee concluded that exacerbations are an important clinical event, but can be difficult to define, particularly in clinical trials.

4.3 The Committee considered how clinicians assess lung function in people with idiopathic pulmonary fibrosis. It understood that clinicians use a number of measures of lung function, and heard that they routinely use percent predicted FVC to guide clinical decision‑making. Clinical experts noted some disadvantages with using percent predicted FVC. For example, the equations used to calculate percent predicted FVC (adjusting for age, sex and height) extrapolate data from a middle‑aged white male population and may under‑ or overestimate the expected lung volume for current clinical practice in England. Clinical experts explained that it is difficult to know how a person's lung function would have progressed without treatment. However, the Committee acknowledged that this is not unique to idiopathic pulmonary fibrosis. The Committee heard from clinical experts that other measures of lung function (such as the 6‑minute walk test distance and diffusion capacity of the lung for carbon monoxide) are less reliable than FVC. The company stated that emphysema commonly co‑exists with idiopathic pulmonary fibrosis, and that in people with both conditions, percent predicted FVC can be less sensitive (that is, it could be high despite significant pulmonary disease) and can change from one day to the next. The Committee recognised the limitations of FVC but understood that in clinical practice the wider patient characteristics would be taken into account in interpreting percent predicted FVC. Clinical experts noted that they follow the stopping rule in NICE's technology appraisal guidance on pirfenidone for treating idiopathic pulmonary fibrosis, but explained that before withdrawing treatment they retest FVC to confirm that the 10% drop is not temporary, which might happen with an infection. The Committee concluded that, although it has some limitations, percent predicted FVC is the most reliable and widely used measure of lung function in clinical practice.

4.4 The Committee discussed the treatment options for people with idiopathic pulmonary fibrosis.

  • It heard that pirfenidone is normally offered to people whose disease meets the criteria in the NICE guidance for pirfenidone: that is, people with a percent predicted FVC of 50–80%. It heard that this group represents around half of the population with idiopathic pulmonary fibrosis in the UK, but that around 30% of people could not tolerate pirfenidone.

  • The Committee heard that people with a percent predicted FVC of more than 80% represent around one third of people with idiopathic pulmonary fibrosis. It heard from clinical experts that this group would be offered best supportive care because pirfenidone is not recommended in this population.

  • Clinical experts explained that drug treatment might not be appropriate for people with a percent predicted FVC of less than 50% (more severe disease). The aim of treatment in this population is to maintain quality of life, and lung transplant might be explored as an option.

    The Committee concluded that in clinical practice nintedanib would be appropriate for treating people with a percent predicted FVC of more than 50%.

Clinical effectiveness

4.5 The Committee discussed the clinical trial evidence for nintedanib and heard that the trials reflected current clinical practice. It understood that there were inconsistencies in some of the results across the 2 phase III trials. However, it noted that a pre‑planned pooled analysis showed statistically significant differences between nintedanib and placebo for loss of lung function and a non‑significant benefit in favour of nintedanib for reducing acute exacerbations. The Committee heard that, based on pre‑planned and post‑hoc subgroup analyses, nintedanib was effective regardless of the baseline FVC. It noted that the mean baseline percent predicted FVC was approximately 80% across all 3 nintedanib trials, indicating that the trials provided evidence for treating idiopathic pulmonary fibrosis in people with a percent predicted FVC above 80%. The Committee concluded that the trials provided an appropriate basis for its decision‑making, and showed that nintedanib is more effective than placebo in all subgroups.

4.6 The Committee considered whether the company network meta‑analysis was robust. It heard from the ERG that the company had included all relevant trials, but had explored heterogeneity in the results by excluding trials in sensitivity analyses. The Committee understood that the results of the network meta‑analysis informed the relative effectiveness of nintedanib and pirfenidone in the company model. It heard that the company used the results of different sensitivity analyses (that is, using data from different sets of trials) for different outcomes in the model (see section 3.4). The Committee agreed that this introduced a potential bias in favour of nintedanib because the results of the analyses chosen by the company were more favourable to nintedanib than the results from analyses including all trials. It concluded that the same trials should be included for all outcomes. The Committee agreed with excluding one of the Japanese studies (SP2) because it considered it to be an outlier. The company clarified that not all trials reported evidence for all outcomes considered in the model, and presented an updated analysis excluding the SP2 study from the relevant outcomes (overall survival and acute exacerbations). The Committee concluded that the updated network meta‑analysis provided a more appropriate basis for its decision‑making. The Committee considered the effectiveness of nintedanib and discussed the results of the company network meta‑analysis and concluded that the clinical effectiveness of nintedanib is similar to pirfenidone.

Cost effectiveness

4.7 The Committee considered whether the company model, in which health states were based on percent predicted FVC and occurrence of acute exacerbations, accurately represents the progression of idiopathic pulmonary fibrosis. It heard from patient experts that idiopathic pulmonary fibrosis is a progressive disease which does not improve, and noted that the model reflects this. The Committee heard from the company that exacerbations increased the rate of disease progression (that is, loss of lung function) in the model, which the Committee considered appropriate. However, taking into account the clinical experts' comments about the substantial impact of exacerbations on quality of life (see section 4.2), the Committee was concerned that the results of the model were not sensitive to changes in the rate of exacerbations. The ERG stated that it considered the methods applied in the company's economic analyses to be generally appropriate. The Committee concluded that a model based on percent predicted FVC and exacerbations was appropriate for decision‑making.

4.8 The Committee discussed the population included in the economic model. The Committee appreciated that its remit was to compare nintedanib with current NHS treatment which, for people with percent predicted FVC of 50–80%, is pirfenidone or best supportive care. For people with percent predicted FVC of more than 80%, current NHS treatment is best supportive care. It noted that the company analyses included a population with a percent predicted FVC of more than 50%, and that the ERG modelled a restricted population with a percent predicted FVC of 50–79.9%. The Committee recognised that the ERG had assumed that people with a percent predicted FVC of 80% or more do not present in clinical practice. However, the Committee heard from the clinical experts that people with a percent predicted FVC of 80% or more represent a third of people with idiopathic pulmonary fibrosis in specialist clinical practice (see section 4.4), and that the relevant comparator for this population is best supportive care. The Committee agreed that to compare nintedanib with best supportive care, it would have preferred to see a model representing only people with a percent predicted FVC of 80% or more. After consultation, the ERG provided an analysis in people with a percent predicted FVC of 80% or more. The Committee noted the ERG's concerns that subgroup analyses were subject to limitations because parameters such as hazard ratios, mortality rates, and rates of stopping treatment may differ between the subgroups and the whole population. In the absence of subgroup‑specific parameters, the Committee concluded that the company model was appropriate for its decision‑making.

4.9 The Committee considered the extrapolations of overall survival based on the company model. It noted that the company and the ERG had used the log logistic curve in their base‑case analyses. The Committee discussed whether this curve was appropriate given that it has a long tail, meaning that the model might overestimate life expectancy and therefore underestimate the incremental cost‑effectiveness ratio (ICER) for nintedanib. The Committee noted that using other methods to extrapolate survival substantially increased the ICER for nintedanib compared with best supportive care. The Committee heard from the clinical experts that the median survival estimated with the log logistic curve generally reflects the natural history of treated disease. The Committee agreed that the survival modelling was uncertain, but noted that it had little effect on the ICER when comparing nintedanib with pirfenidone because the company had assumed equal survival with these drugs. Any differences in quality‑adjusted life year (QALY) gain between nintedanib and pirfenidone were therefore derived from differences in quality of life. The Committee concluded that the log logistic curve was sufficient for decision‑making, but recognised that the ICER for nintedanib compared with best supportive care, when using the log logistic curve, may be an underestimate.

4.10 The Committee discussed the utility values in the company's model. It approved of the company using trial‑based EQ‑5D data to estimate health‑state utility values. The Committee expressed some concern that the company did not include a disutility for diarrhoea in the model, because this is a common adverse event with nintedanib that it considered would worsen quality of life. It heard from the company that including a diarrhoea‑related disutility would not affect the model results because the event was mild‑to‑moderate and led to less than 5% of people stopping treatment in the nintedanib clinical trials. However, the Committee did not agree that diarrhoea would have no clinical impact.

4.11 The Committee considered the changes to adverse‑event‑related disutilities suggested by the ERG. It heard from clinical experts that the ERG's preferred estimate of rash‑related disutility (based on data from the RECAP study) was inaccurate because the RECAP study underestimated the incidence of rash by 50%. Clinical experts agreed with the ERG's choice of a lower incidence of photosensitivity with pirfenidone, and stated that it was reasonable to assume people have adverse events in the model for approximately 1 month rather than for 1 year (as in the company base case). The Committee concluded that the estimate of rash‑related disutility in the company's original base case was more appropriate than the ERG's estimate, but that the ERG provided more accurate estimates of other disutilities which the company incorporated in its revised base case (see sections 3.21 and 3.22).

4.12 The Committee compared the company model with the model submitted for NICE's technology appraisal guidance on pirfenidone for treating idiopathic pulmonary fibrosis, for external validation. It noted that the nintedanib model produced different results from the pirfenidone model, when comparing pirfenidone with best supportive care. The ERG could not fully compare the 2 models because of confidentiality, but explained some key differences. For example, treatment effect in the pirfenidone model was based on FVC and the 6‑minute walk test distance. However, the Committee understood from clinicians that the 6‑minute walk test distance was an unreliable measure. The pirfenidone model did not include acute exacerbations, which the Committee understood to be an important clinical event in idiopathic pulmonary fibrosis. The pirfenidone model used a mapping algorithm to calculate utility values, whereas the nintedanib model included trial‑based EQ‑5D data. The Committee concluded that it could not compare the models fully, but that the current model for nintedanib was robust, and appropriate for decision‑making.

4.13 The Committee considered whether it should take into account the consequences of the Pharmaceutical Price Regulation Scheme (PPRS) 2014, and in particular the PPRS payment mechanism, when appraising nintedanib. The Appraisal Committee noted NICE's position statement in this regard, and accepted the conclusion 'that the 2014 PPRS payment mechanism should not, as a matter of course, be regarded as a relevant consideration in its assessment of the cost effectiveness of branded medicines'. The Committee heard nothing to suggest that there is any basis for taking a different view with regard to the relevance of the PPRS to this appraisal of nintedanib. It therefore concluded that the PPRS payment mechanism was not applicable for considering the cost effectiveness of nintedanib.

4.14 The Committee discussed the most plausible ICER. It noted that the most plausible scenario would include its preferred assumptions for:

  • disutilities for adverse events (see section 4.11)

  • estimates of overall survival, acute exacerbations, loss of lung function, adverse events, and stopping treatment odds ratios for nintedanib compared with pirfenidone (see section 4.6).

    The Committee considered the population for which pirfenidone and best supportive care were comparators (that is, people with a percent predicted FVC of 50–80%). The Committee was aware that the company presented a revised base case incorporating the Committee's preferred assumptions but without stopping rules for nintedanib or pirfenidone. The Committee understood that current NICE guidance for pirfenidone recommends that pirfenidone treatment should be stopped if there is evidence of disease progression (a decline in percent predicted FVC of 10% or more in any 12‑month period). The Committee noted comments from consultation that there was no clinical basis for applying a stopping rule for nintedanib. However, the Committee appreciated that stopping rules generally improve cost effectiveness by minimising continued treatment in people for whom a drug is not effective, and understood that the 10% value was determined during the pirfenidone appraisal. The Committee heard that when the ERG included this stopping rule and the patient access schemes for both nintedanib and pirfenidone in the company's revised base case, nintedanib dominated pirfenidone (meaning that nintedanib was cost saving and more effective than pirfenidone). Applying this stopping rule for pirfenidone but not nintedanib resulted in an ICER of between £20,000 and £30,000 for nintedanib compared with pirfenidone. The Committee noted that the exact ICER was towards the upper end of the £20,000–£30,000 range. The Committee was mindful of its consideration that the clinical effectiveness of nintedanib is similar to pirfenidone (see section 4.6) and was aware that not including a stopping rule for nintedanib would make it more costly than pirfenidone for similar benefits. The Committee was also mindful that compared with best supportive care, the ICERs for both nintedanib (see section 4.15) and pirfenidone (see sections 3.21 and 3.22) were substantially higher than the range considered a cost‑effective use of NHS resources. For these reasons, the Committee agreed that nintedanib could not be considered cost effective without a stopping rule. The Committee concluded that nintedanib could be considered cost effective compared with pirfenidone in people with a percent predicted FVC of 50–80% when the stopping rule for nintedanib was applied.

4.15 The Committee considered the population with a percent predicted FVC of more than 80%, for whom the comparator is best supportive care. The Committee would have preferred to see a model only of people with a percent predicted FVC of more than 80%, but in the absence of appropriate subgroup‑specific parameters (see section 4.8) the Committee considered that the company model of people with a percent predicted FVC of more than 50% was appropriate for decision‑making. It noted that the ICER for nintedanib compared with best supportive care was substantially greater than £30,000 per QALY gained. The Committee acknowledged that the ICER based on the ERG's exploratory analysis including only people with a percent predicted FVC of 80% or more was also substantially greater than £30,000 per QALY gained. NICE cannot report the ICERs because the patient access schemes are confidential. The Committee noted comments that nintedanib is clinically effective in all subgroups and that it is not clinically beneficial to delay treatment until the condition worsens. However, the Committee was aware of the high ICERs estimated for nintedanib compared with best supportive care. The Committee concluded that the ICERs for nintedanib compared with best supportive care in people with a percent predicted FVC of more than 80% were not within the range considered to be a cost‑effective use of NHS resources.

4.16 The Committee heard from patient experts and Committee members that nintedanib was innovative in its potential to make a significant and substantial impact on health‑related benefits. The patient expert emphasised the better tolerability profile associated with nintedanib which significantly improved their quality of life. For example, the patient expert valued their opportunity to pursue outdoor activities while receiving nintedanib, which they had been unable to do when receiving pirfenidone because of the associated photosensitivity. The Committee acknowledged that nintedanib is associated with adverse events that are not commonly associated with pirfenidone, such as serious gastrointestinal events, and that diarrhoea is more common with nintedanib than pirfenidone, but heard from clinical and patient experts that people may tolerate nintedanib better than pirfenidone. The Committee also noted that people do not need to take nintedanib as often as pirfenidone but heard differing views about the value of this, and considered this a small advantage. On balance, the Committee concluded that there are benefits associated with nintedanib that the economic model does not fully capture, such as the impact on patients' lives of nintedanib's better tolerability profile and reduced dosing frequency, compared with pirfenidone. The Committee concluded that there may be some additional gains in health‑related quality of life over those already included in the QALY calculations, supporting its recommendation that nintedanib should be offered to people as an alternative to pirfenidone.

Summary of Appraisal Committee's key conclusions

TA379

Appraisal title: Nintedanib for treating idiopathic pulmonary fibrosis

Section

Key conclusion

Nintedanib is recommended as an option for treating idiopathic pulmonary fibrosis, only if:

  • the person has a forced vital capacity (FVC) between 50% and 80% of predicted

  • the company provides nintedanib with the discount agreed in the patient access scheme

  • treatment is stopped if disease progresses (a confirmed decline in percent predicted FVC of 10% or more) in any 12‑month period.

The Committee agreed that nintedanib could only be considered cost effective compared with pirfenidone, but not compared with best supportive care. The incremental cost‑effectiveness ratios (ICERs) for nintedanib as a replacement for best supportive care were not within the range considered to be a cost‑effective use of NHS resources. Nintedanib had similar cost effectiveness to pirfenidone. The Committee therefore could only recommend nintedanib for the subgroup in which pirfenidone, when provided with the discount agreed in the patient access scheme, is currently recommended in NICE's technology appraisal guidance: those with a percent predicted FVC of 50–80%.

When considering the application of a treatment stopping rule for nintedanib, the Committee was mindful of its consideration that the clinical effectiveness of nintedanib is similar to pirfenidone, and was aware that not including a stopping rule for nintedanib would make it more costly than pirfenidone for similar benefits. The Committee therefore agreed nintedanib could not be considered cost effective without a stopping rule.

The Committee concluded that, although it has some limitations, percent predicted FVC is the most reliable and widely used measure of lung function in clinical practice and understood that in clinical practice the wider patient characteristics (such as the presence of emphysema or a possible infection) would be taken into account in interpreting a person's FVC.

1.1, 4.3, 4.14, 4.15

Current practice

Clinical need of patients, including the availability of alternative treatments

There is no cure for idiopathic pulmonary fibrosis; median overall survival is 3–4 years and 80% of patients die from the disease or respiratory failure. Lung transplant can improve survival but few people are eligible. Pirfenidone is normally offered to people whose disease meets the criteria in the NICE guidance for pirfenidone: that is, people with a percent predicted FVC of 50–80%. But 30% of people with idiopathic pulmonary fibrosis in the UK cannot tolerate pirfenidone. People with a percent predicted FVC of more than 80% (who represent around one third of people with the disease) are offered best supportive care. Drug treatment may not be appropriate for people with more severe disease (a percent predicted FVC of less than 50%).

4.1, 4.4

The technology

Proposed benefits of the technology

How innovative is the technology in its potential to make a significant and substantial impact on health‑related benefits?

There are benefits associated with nintedanib that the economic model does not fully capture, such as the impact on patients' lives of nintedanib's better tolerability profile and reduced dosing frequency, compared with pirfenidone.

3.5, 4.16

What is the position of the treatment in the pathway of care for the condition?

Nintedanib is an option for people with a percent predicted FVC of 50% or more.

4.4

Adverse reactions

The most frequently reported adverse reaction associated with using nintedanib is diarrhoea. Clinical and patient experts indicated that people may tolerate nintedanib better than pirfenidone.

2.2, 4.16

Evidence for clinical effectiveness

Availability, nature and quality of evidence

The clinical evidence for nintedanib came from 3 multicentre, double‑blind, placebo‑controlled randomised trials comprising 2 phase III trials (INPULSIS 1 and INPULSIS 2) and a phase IIb dose‑ranging trial (TOMORROW). In the absence of head‑to‑head trials of nintedanib and pirfenidone, the company submitted a network meta‑analysis, which generally provided an appropriate basis for decision‑making.

3.1, 4.5, 4.6

Relevance to general clinical practice in the NHS

The 3 nintedanib trials enrolled people with a percent predicted FVC of at least 50% and therefore provided an appropriate basis for decision‑making because clinical experts stated that drug treatment may not be appropriate for people with severe disease (a percent predicted FVC of less than 50%).

3.6, 4.4, 4.5

Uncertainties generated by the evidence

The company used the results of different sensitivity analyses from its network meta‑analysis (using data from different sets of trials) for different outcomes in the model. The trials selected by the company potentially biased the results in favour of nintedanib. The Committee would have preferred the company to have used the same trials for all end points in the model, excluding only the SP2 study of pirfenidone (to reduce heterogeneity). After consultation, the company updated its analysis in line with the Committee's preferred assumptions on the network meta‑analysis.

3.4, 3.21, 4.6

Are there any clinically relevant subgroups for which there is evidence of differential effectiveness?

There are no subgroups for which there is evidence of differential effectiveness.

3.3, 4.5

Estimate of the size of the clinical effectiveness including strength of supporting evidence

Clinical trials showed that nintedanib is more effective than placebo in all subgroups. There were inconsistencies in some of the results across the 2 phase III trials. However, a pre‑planned pooled analysis showed statistically significant differences between nintedanib and placebo for loss of lung function and a non‑significant benefit in favour of nintedanib for reducing acute exacerbations. The clinical effectiveness of nintedanib is similar to pirfenidone based on the results of the network meta‑analysis.

4.5, 4.6

Evidence for cost effectiveness

Availability and nature of evidence

The company model (based on percent predicted FVC and occurrence of acute exacerbations) was appropriate for decision‑making. It was appropriate not to include people with a percent predicted FVC of less than 50% in the model.

4.4, 4.7, 4.8

Uncertainties around and plausibility of assumptions and inputs in the economic model

The Committee was concerned that:

  • the results of the model were not sensitive to changes in the rate of exacerbations

  • using the log logistic curve to extrapolate survival data could underestimate the true ICER for nintedanib compared with best supportive care

  • the company did not include a disutility for diarrhoea in the model

  • the company had overestimated some adverse event‑related disutilities (this was amended in the company's additional analyses)

  • the company's use of different network meta‑analysis scenarios for different outcomes in the model could bias the results in favour of nintedanib (this was amended in the company's additional analyses)

  • neither the company nor the ERG provided a model using subgroup‑specific parameters only for people with percent predicted FVC of over 80%, when comparing nintedanib with best supportive care in people for whom pirfenidone is not recommended; the ERG had concerns that its subgroup analyses were subject to limitations.

4.6, 4.7–4.11

Incorporation of health‑related quality‑of‑life benefits and utility values

Have any potential significant and substantial health‑related benefits been identified that were not included in the economic model, and how have they been considered?

The Committee was concerned that the company did not include a disutility for diarrhoea in the model, because this is a common adverse event with nintedanib that the Committee considered would worsen quality of life. The company overestimated some adverse‑event‑related disutilities, but these were amended in the company's additional analyses.

The Committee concluded that there may be some additional gains in health‑related quality of life over those already included in the quality‑adjusted life year (QALY) calculations (its tolerability profile and reduced dosing frequency). These further supported the Committee's recommendation that nintedanib should be offered as an alternative to pirfenidone.

3.21, 4.10, 4.11, 4.16

Are there specific groups of people for whom the technology is particularly cost effective?

Nintedanib had different comparators (either pirfenidone or best supportive care) for different subgroups according to percent predicted FVC. Nintedanib was cost effective compared with pirfenidone, but not when compared with best supportive care. Because pirfenidone is a comparator for a subgroup (people with a percent predicted FVC of 50–80%), nintedanib was cost effective only for this group.

4.8, 4.14, 4.15

What are the key drivers of cost effectiveness?

Any differences in QALY gain between nintedanib and pirfenidone were derived from differences in quality of life (because the modelled survival gain with each drug was the same).

The cost effectiveness of nintedanib compared with best supportive care was sensitive to survival rates.

4.9

Most likely cost‑effectiveness estimate (given as an ICER)

For people with a percent predicted FVC of 50–80%, including price discounts for nintedanib and pirfenidone:

  • nintedanib dominated pirfenidone (that is, nintedanib was cost saving and more effective than pirfenidone). The Committee was aware that not including a stopping rule for nintedanib would make it more costly than pirfenidone for similar benefits.

For people with a percent predicted FVC of more than 80%, including the patient access scheme for nintedanib:

  • the ICER for nintedanib compared with best supportive care (with patient access schemes applied) was substantially over £30,000 per QALY gained. NICE cannot report the exact ICERs because of the confidentiality of the patient access schemes.

4.14, 4.15

Additional factors taken into account

Patient access schemes (PPRS)

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of nintedanib, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.

The Committee concluded that the Pharmaceutical Price Regulation Scheme (PPRS) payment mechanism was irrelevant for the consideration of the cost effectiveness of nintedanib.

2.3, 3.21, 4.13

End‑of‑life considerations

Not applicable.

Equalities considerations and social value judgements

Not applicable – no equality issues raised.

  • National Institute for Health and Care Excellence (NICE)