Naltrexone–bupropion for

managing overweight and

obesity

Technology appraisal guidance

Published: 12 December 2017
www.nice.org.uk/guidance/ta494

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rights).
Naltrexone–bupropion for managing overweight and obesity (TA494)

Your responsibility
The recommendations in this guidance represent the view of NICE, arrived at after careful
consideration of the evidence available. When exercising their judgement, health professionals are
expected to take this guidance fully into account, alongside the individual needs, preferences and
values of their patients. The application of the recommendations in this guidance are at the
discretion of health professionals and their individual patients and do not override the
responsibility of healthcare professionals to make decisions appropriate to the circumstances of
the individual patient, in consultation with the patient and/or their carer or guardian.

Commissioners and/or providers have a responsibility to provide the funding required to enable
the guidance to be applied when individual health professionals and their patients wish to use it, in
accordance with the NHS Constitution. They should do so in light of their duties to have due regard
to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce
health inequalities.

Commissioners and providers have a responsibility to promote an environmentally sustainable

health and care system and should assess and reduce the environmental impact of implementing
NICE recommendations wherever possible.

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Contents
1 Recommendations ...................................................................................................................................................... 4

2 The technology ............................................................................................................................................................. 5

Marketing authorisation ........................................................................................................................................................... 5

Recommended dose and schedule ........................................................................................................................................ 5

Price ................................................................................................................................................................................................... 5

3 Committee discussion ............................................................................................................................................... 6

Current management and comparators ............................................................................................................................. 6

Duration of treatment ................................................................................................................................................................ 7

Analysis ............................................................................................................................................................................................ 8

Trial results ..................................................................................................................................................................................... 8

Company's economic model .................................................................................................................................................... 10

Model assumptions ..................................................................................................................................................................... 11

Cost-effectiveness results ........................................................................................................................................................ 13

Other considerations.................................................................................................................................................................. 14

Conclusion ...................................................................................................................................................................................... 15

4 Appraisal committee members and NICE project team............................................................................... 16

Appraisal committee members............................................................................................................................................... 16

NICE project team ....................................................................................................................................................................... 16

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Naltrexone–bupropion for managing overweight and obesity (TA494)

1 Recommendations
1.1 Naltrexone–bupropion is not recommended within its marketing authorisation
for managing overweight and obesity in adults alongside a reduced-calorie diet
and increased physical activity.

1.2 This recommendation is not intended to affect treatment with

naltrexone–bupropion that was started in the NHS before this guidance was
published. Adults having treatment outside this recommendation may continue
without change to the funding arrangements in place for them before this
guidance was published, until they and their NHS clinician consider it
appropriate to stop.

Why the committee made these recommendations

Obesity is very common in England, affecting about 30% of the population. Current management
for overweight and obesity is lifestyle measures alone, lifestyle measures with orlistat or bariatric
surgery.

Clinical trial evidence shows that naltrexone–bupropion with lifestyle measures is more effective
than lifestyle measures alone, but its long-term effectiveness is unknown.

The estimate of cost effectiveness for naltrexone–bupropion with lifestyle measures, compared
with lifestyle measures alone, is highly uncertain because of uncertainties in the modelling
assumptions. Large numbers of people could be eligible for treatment which could potentially be
long-term, leading to high overall costs for naltrexone–bupropion. Therefore, in these
circumstances more certainty is needed that naltrexone–bupropion will provide value for the NHS.

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2 The technology
Marketing authorisation
2.1 Adjunct to a reduced-calorie diet and increased physical activity,
Naltrexone–bupropion (Mysimba) is indicated for the management of weight in
adult patients (aged 18 and over) with an initial BMI of

• 30 kg/m2 or more (obese) or

• from 27 kg/m2 to 30 kg/m2 (overweight) in the presence of one or more weight-related

co-morbidities (such as type 2 diabetes, dyslipidaemia, or controlled hypertension).

Treatment should be stopped after 16 weeks if the patient has not lost at least 5% of
their initial body weight.

Recommended dose and schedule

2.2 Administered orally in a prolonged-release tablet. Dose is escalated over a
4-week period to a total dose of 32 mg naltrexone and 360 mg bupropion:
week 1, 1 tablet in the morning; week 2, 1 tablet morning and evening; week 3,
2 tablets in the morning and 1 in the evening; from week 4, 2 tablets morning
and evening.

Price
2.3 Acquisition cost (excluding VAT) £73.00 per pack of 112 tablets (source:
company's submission). Costs may vary in different settings because of
negotiated procurement discounts.

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3 Committee discussion
The appraisal committee (section 4) considered evidence submitted by Orexigen Therapeutics and
a review of this submission by the evidence review group (ERG). See the committee papers for full
details of the evidence.

Current management and comparators

Weight management services are tiered but access to these
services varies greatly across England
3.1 The clinical expert explained that weight management should follow current
guidelines such as NICE's clinical guideline on obesity: identification,
assessment and management. The prevalence of the condition is high in England
with about 30% of the population defined as obese. Weight management
services are tiered: tier 1 (healthy lifestyle promotions), tier 2 (lifestyle weight
management programmes), tier 3 (weight management services including
adjunct drug treatment) and tier 4 (bariatric surgery). The committee heard
from the clinical experts that the type and quality of care and access to these
services varies greatly across England. In some parts of the country, the already
patchy tier 3 services are being de-commissioned, with most people not having
access to multi-disciplinary weight management services. A disproportionately
low number of bariatric surgeries are currently being done in the NHS. Only
around 0.1% of people eligible for bariatric surgery actually have it. The patient
expert stressed that limited access to services can be demoralising for patients,
and there is a need for more comprehensive and equitable services across the
country.

Orlistat is not widely used and new pharmacological treatment

options to manage overweight and obesity are needed
3.2 The clinical experts explained that orlistat is the only drug treatment currently
available, after lifestyle measures alone have failed. Its use is limited by
undesirable side-effects, leading to poor adherence and outcomes and so most
people do not want to take it, or stop treatment after a short time. The patient
expert also highlighted that orlistat causes unpleasant and socially unacceptable
gastrointestinal side-effects. The committee heard from the clinical experts that

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there is therefore a high unmet clinical need for novel pharmacological

approaches to treatment. Naltrexone–bupropion provides a new treatment
option with a novel mechanism of action that does not have the same side-
effects as orlistat and may be better tolerated. The committee concluded that
orlistat is not widely used in clinical practice and that there is a need for new
pharmacological treatment options to manage overweight and obesity.

Pharmacological treatment is only effective when it is given with

lifestyle interventions
3.3 The committee heard from the clinical expert that any pharmacological
treatment for weight management should be part of an integrated care pathway
that includes lifestyle management. All pharmacological interventions for
obesity are much less effective without adjunct lifestyle measures. The expert
commented that naltrexone–bupropion should first be available in tier 3
services where comprehensive lifestyle management and monitoring would be
available, but it is highly likely that it would become available in primary care in
the future. The committee recognised that adjunct lifestyle measures alongside
pharmacological treatment are important for treatment success and the
population that may have access to naltrexone–bupropion is likely to be large,
given the high prevalence of obesity (see section 3.1).

Standard management is the relevant comparator

3.4 The committee heard from the clinical experts, and from consultees after
consultation on the appraisal consultation document that standard
management (lifestyle measures) is the relevant comparator because orlistat is
not often used in clinical practice. The committee accepted that orlistat should
not be considered the only comparator for the reasons discussed in section 3.2.
It concluded that standard management was therefore the main comparator in
the appraisal.

Duration of treatment
Treatment for obesity is likely to be recurrent or ongoing
3.5 The patient expert explained that people who are overweight or obese can be
caught in a cycle of weight loss and regain, which can be psychologically
distressing. The clinical expert noted that when people stop treatment they do

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not continue to lose weight and many will regain weight. The clinical expert also
noted that long-term treatment with naltrexone–bupropion is likely to be
necessary for many people, to maximise the likelihood of maintaining weight
loss. The committee concluded that this would likely lead to long-term or
recurrent treatment with naltrexone–bupropion for many people.

Analysis
A full intention-to-treat analysis is more appropriate
3.6 The committee had concerns over the use of a modified intention-to-treat (ITT)
analysis and noted this included people who had at least one post-baseline
measurement of weight while on the study drug. This removed around 20% of
people from the analysis, whereas the full ITT population included as many
people as possible from the point of randomisation into the trial (including all
people who dropped out, whether or not a post-baseline weight measurement
was taken). The ERG explained that a modified ITT analysis could bias results in
favour of naltrexone–bupropion, because drop-out before the first assessment
point could have been as a result of people stopping treatment because of
intolerance or adverse events related to the study drug. The committee agreed
that the full ITT analysis was more appropriate for decision-making.

Trial results
Trials showed that naltrexone–bupropion is more effective than
placebo
3.7 The committee considered the key clinical evidence presented by the company,
which came from 4 contrave obesity research (COR) trials done in the US. All
were double-blind randomised trials with either placebo or
naltrexone–bupropion given as an adjunct to standard care (lifestyle measures):

• COR-I included people who were obese or overweight. At week 56, the modified ITT
results showed a mean percentage reduction in weight with naltrexone–bupropion of
6.1% compared with 1.3% with placebo.

• COR-II included people who were obese or overweight. At week 28, the modified ITT
results showed a mean percentage reduction in weight of 6.6% with
naltrexone–bupropion compared with 2.1% with placebo.

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• COR-BMOD included people who were obese or overweight but everyone had an
intensive standard management regimen. At week 56, the modified ITT results showed
a mean percentage reduction in weight of 9.7% with naltrexone–bupropion compared
with 5.5% with placebo.

• COR-DM included people who were obese or overweight and who had type 2
diabetes. At week 56, the modified ITT results showed a mean percentage reduction in
weight with naltrexone–bupropion of 5.1% compared with 1.8% with placebo.

The committee considered that the trials were all good quality but were of short
duration. The company presented the results for the modified ITT population and the
committee was aware of the limitations of this analysis (see section 3.6). The
committee noted that in the full ITT analysis in the clarification response,
naltrexone–bupropion was also more effective than placebo in all 4 of the COR trials. It
also noted that there was a smaller effect in the trial of people with type 2 diabetes
(COR-DM). The clinical expert explained that a smaller effect has been shown in
obesity drug trials of patients with type 2 diabetes and the reason is not fully
understood. The committee concluded that the results showed naltrexone–bupropion
to be more effective than placebo in all the COR trials but that the long-term
effectiveness of naltrexone–bupropion was unknown.

Non-intensive standard management alongside pharmacological

treatment is more likely in UK practice
3.8 The committee noted that the trials were done in the US but heard from the
clinical expert that the characteristics of participants in the trials are similar to
those likely to be seen in practice in England. The trials had more female than
male participants, which reflects the population in England who are more likely
to engage with the health service to lose weight. The committee considered the
generalisability of adjunctive standard management regimens in the trials. The
clinical expert explained that the intensive regimen in COR-BMOD was unlikely
to reflect standard practice in England, because of the variation in care in some
regions (see section 3.1). The regimens in the other COR trials would be more
representative of practice in England, where people have general counselling on
lifestyle measures. The committee concluded that standard care in the trials,
other than COR-BMOD, is applicable to practice in England.

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People who are overweight are not well represented in the trials
3.9 The marketing authorisation for naltrexone–bupropion is for people who are
overweight (BMI of 27 kg/m2 to 30 kg/m2) with a comorbidity, and for those who
are obese (BMI over 30 kg/m2). The committee noted that only a small
percentage of patients in the trials were overweight. It heard from the clinical
expert that this is representative of the clinical population most likely to be seen
by the health service in England, because people who are obese are more likely
to seek help. Therefore, the committee concluded that the appraisal should
focus on people who are obese because there is very limited data to inform a
decision on people who are overweight.

Company's economic model

Using a discrete event simulation model was reasonable
3.10 The company presented a discrete event simulation (DES) model that compared
naltrexone–bupropion plus standard management with orlistat plus standard
management and standard management alone. Because standard management
was the main comparator in the appraisal (see section 3.4), the most relevant
analyses were those comparing naltrexone–bupropion plus standard
management with standard management alone. The committee agreed with the
ERG that a DES approach was reasonable, but was concerned that the initial
model did not reflect the full treatment pathway for people with obesity. After
consultation, the company incorporated a transition to bariatric surgery, which
may be a subsequent treatment option for some people (see section 3.1) but it
was unable to capture episodes of retreatment which the committee had
concluded is a likely scenario for many people (see section 3.5). The company
noted that there were limited clinical data to inform such a scenario in the
model and the committee accepted this reasoning.

The model was implemented correctly and is appropriate for

decision-making
3.11 The ERG had concerns about how the initial economic model was implemented
using Discrete Integrated Condition Event (DICE) methodology in Excel, which
caused extremely slow run times. It was also concerned that not enough
simulations were run to produce stable deterministic and probabilistic results
and that the probabilistic analyses did not cover all the main input parameters.

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The company recognised the limitations of implementing the model in Excel and
using DICE. After consultation, the company re-implemented the DES model in
Visual Basic for Applications, increased the number of simulations, and
extended the probabilistic analyses to explore the main input parameters. The
committee heard from the ERG that the revised model ran more efficiently and
that the ERG was able to reproduce similar results. The ERG believed that the
company's validation of the model, comparing the old and new implementations
in terms of the incremental cost-effectiveness ratio (ICER) and other outcomes,
gave confidence in the results. The committee concluded it was satisfied that
the model was fit for purpose and the results are appropriate for decision-
making.

Model assumptions
The baseline characteristics reflect the population under
consideration
3.12 The company's initial model used sources other than the trials to estimate some
of the baseline characteristics, such as proportions of current smokers and
people with type 2 diabetes. The ERG preferred the COR trials as its sources for
the baseline characteristics. The committee recalled its earlier conclusion that
the trial population was representative of the population seen in practice in
England (see section 3.8) and therefore agreed with the ERG that the baseline
characteristics in the model should reflect those in the COR trials. In response
to consultation, the company incorporated the committee's preference and the
committee was satisfied that the model reflected a population that would be
seen in England.

Using data from the COR-I and COR-DM trials and a full ITT
analysis to inform time-to-treatment discontinuation is
appropriate
3.13 The company's estimates for time-to-treatment discontinuation (TTD) were
based initially on the results from the pooled COR trials and the indirect
treatment comparison with orlistat, which also used the modified ITT
population. The committee reiterated its views about the inappropriateness of
using a modified ITT population (see section 3.6). The ERG commented that it is
inappropriate to pool the data because of statistical and clinical heterogeneity

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between the trials. COR-II had an earlier assessment point than the other trials
(28 weeks rather than 56 weeks) and COR-BMOD had a more intensive
standard care regimen. Because such intensive standard management is
unlikely to be seen in practice (section 3.8), the committee agreed with the
ERG's view that COR-BMOD should be considered separately to the other
regimens and that it was inappropriate to pool data from the COR trials because
of statistical and clinical heterogeneity. The committee also noted that to derive
the TTD for orlistat, the estimates for naltrexone–bupropion TTD were scaled
to orlistat treatment at an earlier assessment point. It heard from the ERG that
scaling could lead to bias in favour of naltrexone–bupropion and it preferred to
remove the scaling and use the full ITT analysis. The committee agreed with the
ERG's reasoning that applying a scaling factor may lead to bias. In its response to
consultation, the company accepted the committee's preference to use only the
COR-I and COR-DM trials to inform TTD and removed the scaling factor for
naltrexone–bupropion to orlistat. The company also used the full ITT analysis to
estimate TTD. The committee was satisfied that the TTD estimates are
appropriate for decision-making.

It is difficult to predict and model weight regain trajectory after

stopping treatment
3.14 The company's model was based on a previous one by Ara et al. (2012). The ERG
explained that the company had deviated from the assumptions used in Ara et
al. The company assumed that after stopping all treatment, people regained
weight to a predicted BMI (that is, the BMI predicted for the person if they had
not lost weight after having naltrexone–bupropion in the trial) rather than
returning to their baseline weight. In their response to the appraisal
consultation document, the company maintained its preference for its original
approach because it follows evidence from the natural history model
synthesised by Ara et al. that there is a correlation for age and BMI, and it did
not want to deviate from evidence that other factors can influence BMI. The
committee heard that the ERG agreed with the company in part, but because it
found conflicting and implausible predictions for patients whose condition
responded and those whose condition did not respond it preferred to apply the
conservative option of a return to a baseline BMI. The committee heard from
the ERG that a return to a baseline BMI significantly increased the ICER for
naltrexone–bupropion in the company's initial model, and therefore the
company's assumption could favour naltrexone–bupropion. The clinical expert

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explained that it is difficult to predict what an individual's future BMI would be

after treatment had stopped but that, irrespective of treatment for obesity,
there is a natural increase in BMI with time. The committee concluded there is
uncertainty on the most appropriate BMI trajectory after treatment has
stopped and it is difficult to model. It also concluded that the effect of this on the
modelling results was unclear but that the company's approach was likely to
favour naltrexone–bupropion.

Cost-effectiveness results
Naltrexone–bupropion may not be an appropriate use of NHS
resources
3.15 The committee noted that the ICER for naltrexone–bupropion with standard
management compared with standard management alone is £23,750 per
quality-adjusted life year (QALY) gained. It also noted that the model showed a
small incremental benefit for naltrexone–bupropion (a QALY gain of 0.0434).
Because of the small QALY gain, the committee expected that the ICER would
be very sensitive to changes in the QALY estimate. It noted the company
estimated that an additional 0.009 incremental QALY benefit would reduce the
ICER to below £20,000 per QALY gained, and it considered that this showed the
sensitivity of the ICER to small changes in the QALYs. The committee considered
that the ICER was uncertain for a number of reasons. It recalled that the model
was unable to capture episodes of retreatment, which the committee had
concluded is a likely scenario for many people (see section 3.5), and it was
unclear how this would affect the ICER. It also recalled that there is uncertainty
about how to model weight regain after treatment has stopped (see
section 3.14) and that the effect of different approaches on the modelling
results was unclear, but the company's approach was likely to favour
naltrexone–bupropion (see section 3.14). The committee concluded that the
combination of these factors means that there is considerable uncertainty
about the true ICER for naltrexone–bupropion.

3.16 The committee referred to section 6.3.3 of NICE's guide to the methods of
technology appraisal. This states that above a most plausible ICER of £20,000
per QALY gained, judgements about the acceptability of the technology as an
effective use of NHS resources take into account a number of factors including
the degree of certainty around the ICER. The committee concluded that there is

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substantial uncertainty around the ICER for the reasons outlined in

section 3.15.

3.17 The committee also referred to section 6.2.14 of the guide, which states that the
committee 'will want to be increasingly certain of the cost effectiveness of a
technology as the impact of the adoption of the technology on NHS resources
increases. Therefore, the committee may require more robust evidence on the
effectiveness and cost effectiveness of technologies that are expected to have a
large impact on NHS resources.' The committee recalled the high prevalence of
obesity (see section 3.1) and that, as a consequence, there was potential for the
impact of introducing the treatment to be large. The committee recognised the
high unmet need for pharmacological treatments but, recognising the
potentially large impact on NHS resources, it took a cautious approach in
making its recommendations. Because of the uncertainty around the ICER, the
potentially large patient population and long duration of treatment, the
committee needed to be certain that naltrexone–bupropion will provide value
to the NHS. Therefore, it was unable to recommend naltrexone–bupropion as a
cost-effective treatment for use in the NHS.

3.18 The committee was aware that the company believed that the cost
effectiveness of naltrexone–bupropion was inherently underestimated because
its model captured only 3 obesity-related diseases (myocardial infarction, stroke
and type 2 diabetes), whereas weight is a known risk factor for many other
diseases. Also, the company's model did not include the increased risk of death
after a myocardial infarction or stroke or the relationship between BMI and
mortality risk beyond the first 15 years of the time horizon. The committee
accepted that the effects of these on the cost-effectiveness estimates were
unknown and ideally would have been included in the company's model.
However, the committee was not persuaded that this would change its
conclusions about the cost effectiveness of naltrexone–bupropion.

Other considerations
Naltrexone–bupropion is considered an innovative technology
3.19 The committee recalled that naltrexone–bupropion offers a different
mechanism of action to current treatment (orlistat) and may be better tolerated
than orlistat (see section 3.2). The committee accepted that

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naltrexone–bupropion could be considered innovative but, for the reasons

discussed in sections 3.15 to 3.18, it was unable to recommend
naltrexone–bupropion for use in the NHS.

Conclusion
3.20 The committee noted that the ICER for naltrexone–bupropion with standard
management compared with standard management alone was £23,750 per
QALY gained. It identified a number of uncertainties around the modelling
assumptions and considered that there is considerable uncertainty about the
true ICER for naltrexone–bupropion. It noted that the patient population is
potentially very large and treatment is long-term. Because of the uncertainty
about the true ICER and the potentially high impact on NHS resources, the
committee needed to be certain that naltrexone–bupropion will provide value
to the NHS. Therefore it was unable to recommend naltrexone–bupropion as a
cost-effective treatment for use in the NHS.

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4 Appraisal committee members and NICE

project team
Appraisal committee members
The 4 technology appraisal committees are standing advisory committees of NICE. This topic was
considered by committee A.

Committee members are asked to declare any interests in the technology to be appraised. If it is
considered there is a conflict of interest, the member is excluded from participating further in that
appraisal.

The minutes of each appraisal committee meeting, which include the names of the members who
attended and their declarations of interests, are posted on the NICE website.

NICE project team

Each technology appraisal is assigned to a team consisting of 1 or more health technology analysts
(who act as technical leads for the appraisal), a technical adviser and a project manager.

Hamish Lunagaria
Technical Lead

Zoe Charles
Technical Adviser

Liv Gualda and Marcia Miller

Project Managers

ISBN: 978-1-4731-2649-7

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Accreditation

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