TA896/Scope Consultation Comments
Page 1

Summary form

National Institute for Health and Care Excellence

Single Technology Appraisal (STA)

Bulevirtide for treating chronic hepatitis D [ID3732]

Response to consultee and commentator comments on the draft remit and draft scope (pre-referral)

Please note: Comments received in the course of consultations carried out by NICE are published in the interests of openness and transparency, and to promote understanding of how recommendations are developed. The comments are published as a record of the submissions that NICE has received, and are not endorsed by NICE, its officers or advisory committees.

Comment 1: the draft remit

Section Consultee/
Commentator		 Comments [sic] Action
Appropriateness British
Association for
the Study of the
Liver (BASL) &
British Society of
Gastroenterology
(BSG)		 Yes-Hepatitis D has few effective treatment options and any advances in
this field will be very welcome.		 Thank you for your
comment. No action
needed.
Hepatitis B
Foundation UK		 Yes. We have urgently awaited a treatment for hdv population since its
discovery that offers real chances to seroconvert the virus.		 Thank you for your
comment. No action
needed.
MYR GmbH yes Thank you for your
comment. No action
needed.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
NHS England &
Improvement		 Yes, it is appropriate. Thank you for your
comment. No action
needed.
Wording BASL & BSG Yes but I am unclear as to whether the marketing authorisation will include
combination treatment with pegylated interferon.		 Thank you for your
comment. Bulevirtide
received marketing
authorisation in July
2020. No action
needed.
Hepatitis B
Foundation UK		 Partly.
More could be stated about the numbers cured and the cost of failing to
cure the tiny number of hospitals stats recorded does not define the unmet
needs of perhaps 20 to 40,000 HDV patients in the UK and their expected
morbidity and mortality costs.		 Thank you for your
comment. The
background section
provides a brief
summary of the disease
and treatment pathway.
Further details can be
given at the submission
stage. No action
needed.
MYR GmbH Please be aware that changes have been made regarding the wording in
several sections.
Draft remit/appraisal objective: To appraise the clinical and cost
effectiveness of Bulevirtide within its conditional marketing authorisation for
treating chronic hepatitis D in adult patients with compensated liver disease.		 Thank you for your
comment. Bulevirtide
will be appraised within
its marketing
authorisation. No action
needed.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
NHS England &
Improvement		 Yes. Thank you for your
comment. No action
needed.
Timing Issues BASL & BSG In view of the lack of therapeutic options for hepatitis D this should be
prioritised.		 Thank you for your
comment. NICE has
scheduled this topic into
its work programme. No
action needed.
Hepatitis B
Foundation UK		 The urgency is high… no viral hepatitis is as good at killing quickly…
awaiting diagnostic symptoms often means very expensive transplants
resections or deaths.
https://academic.oup.com/gastro/article/7/4/231/5522133		 Thank you for your
comment. NICE has
scheduled this topic into
its work programme. No
action needed.
MYR GmbH Hepcludex is now approved in the European Union (EC decision
31.07.2020) therefore the company seeks a NICE appraisal in a timely
manner in order to enable the treatment of patients with high medical need.
Preparations are underway to be able to submit to NICE and we anticipate
to be ready to submit by late January.		 Thank you for your
comment. NICE has
scheduled this topic into
its work programme. No
action needed.
NHS England &
Improvement		 There are no current effective treatments for Hep D so it would be desirable
to have the final guidance as soon as possible.		 Thank you for your
comment. NICE has
scheduled this topic into
its work programme. No
action needed.

Comment 2: the draft scope

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
Background
information		 BASL & BSG The HES data suggest only 39 bed days - I am not sure how accurate this is
likely to be.
We have performed a liver transplant on a patient in the last 12 months for
Hepatitis D which would contribute. Would be helpful to provide transplant
and mortality data.		 Thank you for your
comments. The
background section
provides a brief
summary of the disease
and treatment pathway.
Further details can be
given at the submission
stage. However, we
have removed the
number of beds from
the background as
suggested.
Hepatitis B
Foundation UK		 The background overlooks that the bulk of chronic Hepatitis B and D is child
acquired and this leads tovast numbers in the UK being asymptomatic or
unaware of their infections and risks of infection.
We feel the background to the approval of this new drug must include the
BME and migrant communities endemic for HBV and that they are clear
targets for its application if co infected with HBV and HDV. To date large
numbers are unaware who is at risk of and infected with HBV and HDV due to
a sex and drugs acquired incidence reportage unbalanced by the fact that
thousands (the bulk) of those diagnosed are migrants and birthing mums with
chronic childhood infections.		 Thank you for your
comments. The
background section
provides a brief
summary of the disease
and treatment pathway.
Further details can be
given at the submission
stage. However, we
have added more
information about
HBV/HDV testing and
prevalence.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
We also feel that the background could balance the Sentinel Surveillance
figures for HBV and therefore HDV possible levels with the Hospital Episode
Statistics.
Sentinel Surveillance noted 2% were HBV infected in 2012 in London
dropping to 1.3% in 2016 seefigure 7
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/
attachment_data/file/801174/London_hepatitis_B_report_2016.pdf point
being an endemic capital is rather more motivating than 21 hospital
admissions nationally in a backgrounding.
Moving on a background study showing ==
In the years 2000–2006 in South London, the prevalence of anti-HD in∼1000
carriers of the HBsAg with chronic liver disease was 8.5% (Cross et al. 2008)
also helps.
MYR GmbH Chronic HDV infection represents the most severe form of viral hepatitis for
millions of patients worldwide (Wedemeyer 2010). Hepatitis delta is liver
inflammation caused by infection with the highly pathogenic Hepatitis delta
virus (HDV) leading to acute and chronic liver disease.
As HDV dissemination and replication strictly depends on the viral surface
proteins of Hepatitis B virus (HBV), HDV prevalence is related to HBV
prevalence. Of the worldwide approximately 257 million chronic HBV carries,
15-25 million subjects are estimated with be infected with HDV (Farci 2003,
Wedemeyer 2010). However, the prevalence of HDV in the EU is below the
Orphan Drug designation threshold. Calculation performed by the company
estimates the prevalence of the chronically HDV infected patients in the EU to
be in the range of 6,909 to maximum 20,492 subjects.		 Thank you for your
comments. The
background section
provides a brief
summary of the disease
and treatment pathway.
Further details can be
given at the submission
stage. However, we
have added more
information about

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
The Hospital Episode Statistics for England 2018/19 recorded 21 admissions,
26 finished consultant episodes and 39 bed days for primary diagnosis of
chronic viral hepatitis B with D virus infection (ICD-10 code B18.0).
Acute HDV infection occurs as either co-infection or super-infection with HBV.
HBV/HDV co-infection results in acute infection and clearance of both viruses
in >90-95% of patients. HBV/HDV co-infection may course a more severe
acute hepatitis compared to HBV monoinfection and is associated with
increased risk of fulminant hepatitis (Rizzetto 2009). Super-infection of an
HBsAg carrier can lead in 70-90% to CHD. Chronic HDV infections are
characterized by persistently high levels of serum ALT and AST and high
HDV viremia along with high titers of anti-HDV antibodies and usually a
suppressed HBV replication (Farci et al. 2012).
Chronic HBV/HDV infection represents the most severe form of viral hepatitis
that rapidly progresses with increased risks towards liver cirrhosis, hepatic
decompensation, and hepatocellular carcinoma (HCC) (Rizzetto 2009,
Wedemeyer et al. 2010).
The liver disease associated with HDV runs a more progressive course than
chronic hepatitis B (CHB) and may lead to cirrhosis within 2 years in 10–15%
of patients (Yurdaydin et al. 2010). If left untreated, chronic HDV infection is
associated with faster progression to fibrosis and cirrhosis, earlier onset of
hepatic complications and likelihood of liver transplantation (Niro et al. 2010,
Buti et al. 2011, Heidrich et al. 2013). Liver cirrhosis and cancer occur 10-15
years earlier in HBV/HDV co-infection and the 5-year mortality of co-infected
individuals is twice that of HBV monoinfection (Cornberg et al. 2007). Chronic
HDV infection causes cirrhosis and HCC with annual rates of 4% and 2.7%,
respectively (Romeo et al. 2009, Gordien 2015).
In the EU, no antiviral drug has been approved for the treatment of HDV until
July 2020 when HEPCLUDEX was approved for the treatment chronic		 HBV/HDV testing and
prevalence.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
hepatitis delta. Pegylated interferon alfa (PEG-IFNα) was used as a de facto
treatment standard based on a very limited number of clinical studies. Current
clinical experience indicates that⁓50% of patients are eligible for interferon
treatment due to contraindications, intolerabilities or advanced liver disease
(Roulot et al. 2020, Kamal et al 2020). 25% thereof achieve a response;
⁓50% of these patient’s relapse (Heidrich et al 2014). In fact, interferon
therapy is only helpful for around 10% of patients and is not approved for
HDV infection treatment.
Clinical guidance 165, recommends a 48-week course of peginterferon alfa-
2a for people co-infected with chronic hepatitis B and hepatitis D infection
who have evidence of significant fibrosis (METAVIR stage greater than or
equal to F2 or Ishak stage greater than or equal to 3).
The aim of treatment is to prevent transmission and viral replication as well as
the progression to cirrhosis, decompensation, hepatocellular carcinoma and
liver failure.
NHS England &
Improvement		 Background information is complete. Thank you for your
comment. Please note,
we have added more
information about
HBV/HDV testing and
prevalence.
The technology/
intervention		 BASL & BSG Yes, frequency of administration should be included and whether combination
therapy needs to addressed.		 Thank you for your
comment. Bulevirtide
will be appraised within
its marketing

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
authorisation. No action
needed.
Hepatitis B
Foundation UK		 We need to settle a pathway/prescription plan for this drug that is most
**effective.**If Bulevirtide is giving 20% cure rate when combined with interferon
alpha over 2 years, then we need to simply give it to all HBV HDV co infects
as a matter of course. With the caveat that some may need a rest from
interferon monotherapy prior to commencement or some maybe
contraindicated as they react awfully to interferon.
We need to describe what format is getting the best results from Bulevirtide
and prescribe accordingly.		 Thank you for your
comment. Bulevirtide
will be appraised within
its marketing
authorisation. No action
needed.
MYR GmbH Bulevirtide (HEPCLUDEX®) is the lead compound of MYR GmbH, a German
biotech company focusing of the treatment of chronic hepatitis B and D. The
MYR GmbH is the conditional marketing authorization holder and market
HEPCLUDEX® within the European Union and in the United Kingdom. The
European commission approval was granted on 31th of July 2020. From
August/September 2020 Bulevirtide is available for prescription in the
European Union including UK.
Bulevirtide has been designated as an orphan medicinal product
(EU/3/15/1500), is a PRIME-designated product (EMA/PRIME/17/018) and is
intended for the treatment of chronic hepatitis delta virus (HDV) infection in
adult patients with compensated liver disease. (PIM granted on 18.12.2018)
Bulevirtide is the first HBV/HDV entry inhibitor that binds and blocks the jointly
used receptor sodium taurocholate co-transporting polypeptide (NTCP) on
liver cells.
Bulevirtide is a 47-amino acid synthetic peptide and was derived from HBV
envelope protein. By blocking the hepatocyte surface protein (sodium		 Thank you for your
comments. The
technology section was
updated as suggested.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
taurocholate co-transporting polypeptide [NTCP]), it misdirects HBV and co-
infecting HDV to an unproductive pathway and prevents an infection of the
cell.
Bulevirtide is intended for the treatment regimen of patients with CHD as a
subcutaneous injection of 2 mg Bulevirtide per day.
The drug product is a lyophilized powder for injection that is supplied in
single-use vials for reconstitution with 1 ml of sterile water for injection. The
active ingredient is Bulevirtide acetate.
Bulevirtide has been studied in five clinical trials with or without pegylated
interferon alfa or nucleotide analogue therapy in adult patients with chronic
hepatitis D and compensated liver disease. Clinical data on efficacy and
safety of two phase II trials are the basis for the CMA. Currently, one
randomized, multicentre phase III trial investigating the therapy regimen with
Bulevirtide and one multicentre phase II trial study the treatment regimen with
Bulevirtide and PEG-IFN are ongoing.
Intervention(s): HEPCLUDEX® (INN: Bulevirtide)
NHS England &
Improvement		 Yes. Thank you for your
comment. No action
needed.
Population BASL & BSG Yes-are there specific Hepatitis D genotypes likely to be suitable compared to
others?		 Thank you for your
comment. If evidence
allows, subgroups by
disease severity will be
considered.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
Hepatitis B
Foundation UK		 No. Our HDV population needs to be tested far more comprehensively so we
understand where it is. Yes WHO state a 5% of HBV patients have HDV but
many studies have found high prevalences communities and nationalities.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4484953/
We need to test and know if our Pakistani origin and Rumanian origin or
African origin communities harbour pockets of plus 10% levels of co
infection.
Further if genotypes affect death rates and cure rates
https://academic.oup.com/gastro/article/7/4/231/5522133
Regarding the population and the amount of HBV patients accessing a HDV
test and the barriers to accessing a HDV test the study
https://pubmed.ncbi.nlm.nih.gov/25866333/
foundonly 40% of HBV patients obtain a HDV testduring the 2002 2015
period. Since then on our helpline and social media interactions we note that
the majority of HBV patients are quite unaware of their HDV status.		 Thank you for your
comments. The
committee are unlikely
to be able to make
specific
recommendations about
the approaches to
testing specifically but
the issues regarding
access to HDV testing
can be highlighted by
stakeholders in their
evidence submission.
MYR GmbH Bulevirtide is indicated for the treatment of chronic hepatitis delta virus (HDV)
infection in plasma (or serum) HDV-RNA positive adult patients with
compensated liver disease.		 Thank you for your
comment. If evidence
allows, subgroups by
disease severity will be
considered.
NHS England &
Improvement		 The population is difficult to predict but best estimates is less than 100. Thank you for your
comment. During
scoping, variable
estimates have been

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
provided on the number
of people eligible to
have this treatment
were it to be
recommended in a
NICE appraisal.
Stakeholders can make
clear in their evidence
submissions the most
up to date information
on potential eligible
population. No action
needed.
Comparators BASL & BSG Should not pegylated interferon be a comparator? Thank you for your
comment. Pegylated
interferon was added to
the list of comparators.
Hepatitis B
Foundation UK		 Interferon and lifestyle advice is all we offer the co infected to date and
Bulevirtide compares excellently against it. The lifestyle advice can continue
alongside it as it has such vast importance in value.		 Thank you for your
comment. Pegylated
interferon was added to
the list of comparators.
MYR GmbH Best supportive care for the underlying HBV infection. As no drug, except
Bulevirtide, is approved for the therapy of CHD, no best supportive care for a
chronic HDV infection is available.		 Thank you for your
comment. Pegylated
interferon was added to
the list of comparators
because it is currently
used in the NHS for
HDV infection.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
NHS England &
Improvement		 Yes – BSC would be no treatment. Thank you for your
comment. Pegylated
interferon was added to
the list of comparators
because it is currently
used in the NHS for
HDV infection.
Outcomes BASL & BSG Sustained virological response should be defined in terms of duration and
durability.
Are there plans to look at predictors of response in terms of viral kinetics (a
less than 2 log drop had a 95% negative predictive value for virological
response.
Adverse events should specifically include bile acid elevations reported as a
potential problematic side-effect.		 Thank you for your
comments. We have
added virological and
biochemical response
to the list of outcomes.
Hepatitis B
Foundation UK		 A real focus on clearance and functional cure numbers could be highlighted
more.		 Thank you for your
comments. We have
added virological and
biochemical response
to the list of outcomes.
MYR GmbH The outcome measures to be considered include:
•
Sustained virologal response
The company considers the sustained virological response (SVR) as a non-
relevant endpoint, as this virological endpoint for chronic HDV infection
cannot be meaningfully applied as this is highly discussed. Undetectable HDV
RNA at week 24 post-treatment was explored as secondary endpoint in some
clinical studies,with the expectation that it might be associated with sustained		 Thank you for your
comments. We have
updated the outcome
from ‘sustained
virological response’ to
‘sustained response’.
Development of
resistance is a standard

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
virological response. However, long-term follow up studies such as the HIDIT-
1 study revealed that more than 50% of patients with undetectable HDV RNA
at 24 weeks post-treatment relapsed and developed detectable HDV RNA at
least once during the follow-up (Heidrich et al. 2014), suggesting that some
form of HDV latency exists in patients.
Therefore, the company believes that no precise statement on the success of
therapy or cure can be given based on the SVR, as CHD patients may
demonstrate high relapse rates in the further course of the disease.
We therefore propose to include the outcome morbidity: virological and
biochemical response for the appraisal.
•
development of resistance to treatment
Resistance development against a drug compound targeting a host protein is
highly unlikely. As Bulevirtide targets the HBV entry receptor it is assumed
that the resistance development, if possible, at all, will need a mutation within
the HBV envelope protein. A selection for mutated subspecies needs active
HBV replication. In practical terms, HBV replication in HDV co-infected
patients will be either suppressed by HDV itself (Wu et al. 1995, Jardi et al.
2001, Heidrich et al. 2013), or by nucleoside/tide analog treatment in
accordance with relevant guidelines.
During both phase II trials, only three virological breakthroughs occurred
during the program, whereas no evidence of resistance was demonstrated.
Importantly, virological breakthroughs were even more common under
interferon. In general, the development of resistance is very unlikely with
Bulevirtide for several reasons: (i) targeting of a host protein, (ii) the necessity
for mutations in HBV, whereas HBV replication can be efficiently controlled by
nucleoside/nucleotide analogues,(iii) the highly conserved NTCP binding
domain within the HBV preS1 domain and (iv) the fact that mutations within		 outcome used in other
technology appraisals
of treatments for
hepatitis infections.
However, we have
added virological and
biochemical response
to the list of outcomes.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
this domain renders HBV/HDV non-infectious. Thus, the company believes
that the respective outcome will not add any meaningful value.
•
morbidity: virological and biochemical response
Instead the company suggests to add the outcome morbidity defined as a
virological and biochemical response. As these outcome measures are
acknowledged surrogate endpoints for the therapy of CHD patients. Both
outcomes are considered to be beneficial.
•
mortality
•
adverse effects of treatment
•
health-related quality of life
NHS England &
Improvement		 Yes. Thank you for your
comment. No action
needed.
Economic
analysis		 BASL & BSG Everyone who has Hepatitis B in the UK should already be tested for
Hepatitis D.		 Thank you for your
comment. No action
needed.
Hepatitis B
Foundation UK		 A step change study in cost effectiveness that includes the value of mass
screening those in high infection level communities could be drawn on to help
seehttps://bmjopen.bmj.com/content/9/6/e030183 akey aspect of this study
is it overturns previous warped notions that migrant communities are not
remaining endemic for the HBV they have migrated from, further it admits that
HBV prevalence may well have tripled as sentinel surveillance figures for ante
natal HBV levels have suggested during the 2000 to 2020 period. See
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/
attachment_data/file/746267/hpr3618_bbv-ss.pdf
Other / Black / Asian groups test 3% HBV positive		 Thank you for your
comments. No action
needed.
National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Comments [sic] Action
MYR GmbH One sentence was adapted:
The use of Bulevirtide is conditional on the presence of HDV. The economic
modelling should include the costs associated with diagnostic testing for HDV
in people with hepatitis B.who would not otherwise have been tested.		 Thank you for your
comment. This is
standard wording. No
action needed.
NHS England &
Improvement		 No comments -
Equality and
Diversity		 BASL & BSG No changes required. Thank you for your
comment. No action
needed.
Hepatitis B
Foundation UK		 We dealt recently with an Essex child excluded from school for the entire
calendar year from sept 1918 to sept 2019. He is now only allowed in school
if he wears a long sleeve dress and avoids the kitchens and uses his special
toilet, with constant one to one surveillance, even if he injures himself his
mum is called to supply plasters or call an ambulance. He is BME and
disabled. Discrimination of HBV is serious!
We feel the advent of a step change cure opportunity for HBV and HDV could
truly start to change this landscape. However if in expediting this medicine we
do not also expedite testing for HBV and HDV, expedite our knowledge of
which communities are afflicted and how they are afflicted in tandem we will
be failing in our efforts for equality.
There are processes that for 16 years we have found need to be borne in
mind when asking people to come forward for testing for HBV/HDV.		 Thank you for your
comments. We have
included your concerns
in our Equality impact
assessment form for
this topic. Equality and
Diversity issues will be
discussed during the
appraisal.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
1. There is a powerful ongoing lobby that present HBV/HDV with a
strong sex or drugs cause it focus. This drives away and underground
the bulk of people at risk of HBV/HDV.
2. There is still a vast array of places that the statement “HBV is a 100
times as infectious as HIV” can be read on NHS websites. This
causes almost limitless pain and shame and is quite sexually untrue
and acts as a barrier to those at risk, or anyone thinking clearly.
3. Many patients are being culture and language barriers that need to be
thought of when creating the new HBV/HDV lexicon. “Easy to
manage when caught early, common child virus” is vastly more
engaging and accurate to such groups.
4. There is often a residual fear of quarantine and deportation in the
most infected groups and again this needs to be thought of when
engaging them in testing and care.
5. With HCV new treatments we had a death reported from reactivated
HBV, we noted that the FDA had a black box warning quicker than
NICE on the issue. With these newer drugs affecting new areas of the
species eg cccDNA, could we perhaps have an international radar for
adverse events? Further with TAF we are seeing heart attack
cholesterol issues and again are we moving fast enough at mandatory
Lipid screenings for TAF users?
6. Large numbers of patients are poorly educated about side effects, the
difference between chemotherapy side effects and peg interferon
needs to be made clear. Many will ask “Ah that's the drug that makes
you bald and infertile.” With a tenofovir plus bulveritide approach
many will say “Ah that's the one that ruins your bones kidneys and
embryos!”

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
MYR GmbH No changing needed.
No equality issues anticipated.		 Thank you for your
comment. No action
needed.
NHS England &
Improvement		 Nothing identified. Thank you for your
comment. No action
needed.
Other
considerations		 BASL & BSG How this might fit in with current NICE guidance and in particular the oral
antiviral and pegylated interferon treatments.		 Thank you for your
comments. Pegylated
interferon was added to
the list of comparators.
Bulevirtide will be
appraised within its
marketing authorisation.
Hepatitis B
Foundation UK		 Perhaps we need to study the big barrier to this medicine reaching the tens of
thousands who need it. The lack of national awareness of Hep B and its
causes and risk populations.
During the year 1999 to 2000 WHO noted 20 million people were infected
with HBV via reused medical syringes alone and this figure marches back
annually through a lot of that century. Seehttps://www.who.int/infection-
prevention/publications/is_fact-sheet.pdf?ua=1
Millions and millions and millions of UK citizens in migrant communities and
their onward generations are still unadvised of this catastrophe. Until we
advise people of their exact risk they will not get tested. I am doing an Inquiry
into infections of blood viruses from healthcare and after 60 million has been
spent we are no nearer noticing that the main cause of hundreds of millions
getting HBV was healthcare. “Ah you are from Pakistan/Uganda/Rumania
where millions of unsterile medical injections helped HBV and infect more		 Thank you for your
comments. The
committee may not be
able to address these
wider issues with regard
to access to services
and treatment
specifically in a single
technology appraisal
however these can be
raised in stakeholder
submissions and be
considered by the
committee.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021

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Section Consultee/
Commentator		 Comments [sic] Action
than half the child populations = get tested” Is simply not clear in our UK
lexicon yet.
MYR GmbH Not applicable. Thank you for your
comment. No action
needed.
NHS England &
Improvement		 Consideration should be given to its use in combination with pegylated
interferon as part of the assessment.		 Thank you for your
comment. Bulevirtide
will be appraised within
its marketing
authorisation.
Innovation BASL & BSG Yes, current therapies are poorly effective.
Could the appraisal also consider liver transplant free survival/and or consider
liver transplant costs.		 Thank you for your
comments. The extent
to which the technology
may be innovative will
be considered during
the appraisal.
Hepatitis B
Foundation UK		 Yes this is a step change, we saw a boom in testing for HCV from thousands
to 10’s of thousands when ribavirin and interferon began to offer plus 20%
cure rates in the early Noughties. Rolling this medicine could invigorate the
entire areas of awareness and testing. Further cures are in the pipeline for
HBV, as Professor Williams mentions in his Out of the Shadows Report, we
could begin to out the shadows the whole Pandemic.
The number one question we are asked daily on our platforms is when is a
HBSAG and HDV sero negative opportunity / chance emerging. Many who
know they have HBV but do not admit to their doctors may emerge, many		 Thank you for your
comments. The extent
to which the technology
may be innovative will
be considered during
the appraisal.

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who have fallen out of care may emerge, many who have never checked their
status may emerge to.
These benefits were very real with many ailments when news of functional
curing became general.
MYR GmbH The company considers Bulevirtide as being an innovative medicine with the
potential to make a significant and substantial impact on the health-related
benefits for CHD patients. As there has been no therapeutic regimen or drug
until recently, Bulevirtide being approved as the first and only dedicated
treatment for CHD patients demonstrated substantial antiviral efficacy as well
as a good tolerability and safety profile.		 Thank you for your
comments. The extent
to which the technology
may be innovative will
be considered during
the appraisal.
NHS England &
Improvement		 Yes – likely to supersede pegylated interferon as single agent of choice.
Will be particularly useful in patients with decompensated HDV where
pegylated interferon has poor outcomes.		 Thank you for your
comments. The extent
to which the technology
may be innovative will
be considered during
the appraisal.
Questions for
consultation		 Hepatitis B
Foundation UK		 Have all relevant comparators for bulevirtide been included in the scope?
•
How should best supportive care be defined?
On this subject we tend to be good at defining care along the lines of tests to
be done scans to be done and medicines or surgeries to be done.
But the definition of 10 point counselling needed by each patient, the
definition of patient education in liver care so they become expert in
understanding their HBV panel, Liver Function and scan results and
prognosis therefrom,the definition of what is agreat liver friendlydiet and		 Thank you for your
comments. Please note
that access to testing is
not the remit of this
appraisal. Pegylated
interferon was added to
the list of comparators.
Bulevirtide will be
appraised within its
marketing authorisation.
We have added more
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what is a dangerous liver harming diet. These areas need adding to our
definition. With the bulk of patients still only under monitoring these things are
the bulk of their care.
How many people would you expect to be eligible for treatment with
bulevirtide in the UK?
Anywhere from 20 to 40,000, being 5 to 10% of HBV infections in the UK.
Assuming UK HBV is about 400,000 people after the migration boom of
arriving cases and the onward boom in our unvaccinated youth. See
8.7% of Somali children catching HBV horizontally by 5 see
https://adc.bmj.com/content/86/1/67.3
and 1% of London children testing chronic in 2017 after 15 years of no
vaccinations to endemic community children see Table 3
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/
attachment_data/file/746267/hpr3618_bbv-ss.pdf
What would you expect to be the treatment duration for people who would be
eligible for bulevirtide?
It seems the trials suggest 2 years.
Is testing for hepatitis D virus antibody routine practice in the NHS for all
people with chronic hepatitis B?		 information about
HBV/HDV testing and
prevalence into the
background section.
Thank you for
comment. No action
needed.

National Institute for Health and Care Excellence

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Sadly it does not seem to be the casesee
https://pubmed.ncbi.nlm.nih.gov/25866333/
and there is a concern that more GP’s are in charge of patients and a system
wherein they non refer or part refer HBV patients is increasing.
Are the outcomes listed appropriate?
Are there any subgroups of people in whom bulevirtide is expected to be
more clinically effective and cost effective or other groups that should be
examined separately?
To an extent those rapidly progressing to end stage liver disease will benefit
most… the fat… the toxic… those with a family history of HCC…. Endemic
communities may be more cost effective to test.
Where do you consider bulevirtide will fit into the existing NICE pathway,
hepatitis B (chronic)?
Early Intervention for co infects prevents sudden onsets of extreme illness.
•
Would bulevirtide be used only after a prior treatment with pegylated
interferon alpha-2a for hepatitis D, and for people in whom treatment
with pegylated interferon alpha-2a is considered inappropriate? If so,
how would people for whom pegylated interferon alpha-2a is not
appropriate be defined?		 Thank you for your
comment. Severity of
disease has been
added to the final scope
as a subgroup for
consideration.
Thank you for your
comment. No action
needed.

National Institute for Health and Care Excellence

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Section Consultee/
Commentator		 Comments [sic] Action
•
Would bulevirtide be used alongside nucleoside/nucleotide analogue
therapy for hepatitis B or would bulevirtide be used alone?
•
Would a combination with pegylated interferon alpha-2a be a
treatment option for some people? If so, please explain who would be
given a combination treatment with pegylated interferon alpha-2a?
•
How do prior treatments for hepatitis B influence the treatment
pathway for hepatitis D?
I feel the cold results of the clinical trials should inform these decisions…. Our
excellent Liver Specialists have no doubt used this medicine and KPI ed
which combo is best for who.
NICE is committed to promoting equality of opportunity, eliminating unlawful
discrimination and fostering good relations between people with particular
protected characteristics and others. Please let us know if you think that the
proposed remit and scope may need changing in order to meet these aims.
In particular, please tell us if the proposed remit and scope:
•
could exclude from full consideration any people protected by the
equality legislation who fall within the patient population for which the
treatment will be licensed;
•
could lead to recommendations that have a different impact on people
protected by the equality legislation than on the wider population, e.g.
by making it more difficult in practice for a specific group to access the
technology;
•
could have any adverse impact on people with a particular disability or
disabilities.		 Thank you for your
comment. No action
needed.

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Please tell us what evidence should be obtained to enable the Committee to
identify and consider such impacts.
During the Infected Blood Inquiry some 2500 patient experiences have been
defined all statements included an answer to the question of side effects from
Interferon usage. I feel that lessons are there to be learnt about mitigating
and managing these from these patient statements. The statements are held
by Judge Langstaff as evidence so I do not understand the protocols for
accessing them. Perhaps an approach could be made? But it would be
remiss of me to have been involved in compiling such a list of 1500 plus
interferon lessons and yet not mention it here as a body of work relevant to
this appraisal .
Do you consider bulevirtide to be innovative in its potential to make a
significant and substantial impact on health-related benefits and how it might
improve the way that current need is met (is this a ‘step-change’ in the
management of the condition)?
Yes, it is a completely new era if we are dealing with offering a sero negative
opportunity that can only improve in time. I can think of no motor to increase
all aspects of HBV and HBV HDV coinfection awareness and testing and
treating.
Do you consider that the use of bulevirtide can result in any potential
significant and substantial health-related benefits that are unlikely to be
included in the QALY calculation?
Please identify the nature of the data which you understand to be available to
enable the Appraisal Committee to take account of these benefits.		 Thank you for your
comments. No action
needed.
Thank you for your
comments. The
company and other
stakeholder
submissions can
expand on the potential
innovative nature of the
technology, in particular
its potential to make a
significant and
substantial impact on
health-related benefits
that are unlikely to be
included in the QALY

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To help NICE prioritise topics for additional adoption support, do you consider
that there will be any barriers to adoption of this technology into practice? If
yes, please describe briefly.
Perhaps we need to study the big barrier to this medicine reaching the tens of
thousands who need it. The lack of national awareness of Hep B and its
causes and risk populations.
During the year 1999 to 2000 WHO noted 20 million people were infected
with HBV via reused medical syringes alone and this figure marches back
annually through that century. See https://www.who.int/infection-
prevention/publications/is_fact-sheet.pdf?ua=1
Millions and millions and millions of UK citizens in migrant communities and
their onward generations are still unadvised of this catastrophe. Until we
advise people of their exact risk they will not get tested. I am doing an Inquiry
into infections of blood viruses from healthcare and after 60 million has been
spent we are no nearer noticing that the main cause of hundreds of millions
getting HBV was healthcare.
NICE intends to appraise this technology through its Single Technology
Appraisal (STA) Process. We welcome comments on the appropriateness of
appraising this topic through this process. (Information on the Institute’s
Technology Appraisal processes is available at
http://www.nice.org.uk/article/pmg19/chapter/1-Introduction).		 calculation during
assessment.
MYR GmbH Have all relevant comparators for Bulevirtide been included in the
scope?
•
How should best supportive care be defined?		 Thank you for your
comments. We have
added more information
about HBV/HDV testing

National Institute for Health and Care Excellence

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Section Consultee/
Commentator		 Comments [sic] Action
All relevant comparators for Bulevirtide with respect to the underlying
HBV infection have been considered for the scope, including PEG-IFN
and NUCs. As no drug, except Bulevirtide, is approved for the therapy
of CHD, no best supportive care for a chronic HDV infection is
available and could be considered for the appraisal.
How many people would you expect to be eligible for treatment with
Bulevirtide in the UK?
Treatment will be eligible for patients with chronic HDV and compensated
liver disease.
In line with the ODD and OMAR the theoretical mean HDV patient pool is
estimated to be around 5812. Of this population the diagnosed HDV patient
pool is estimated to be around 2325 (40%) of which 1627 (70%) will be
compensated and therefore in line with the indication and eligible for
treatment (see illustration below). If all patients of the theoretical mean HDV
patient pool will be diagnosed, it is calculated that the compensated HDV
patient pool and therefore eligible for treatment will be 4068 (70%) (see
illustration below). It is assumed that with increasing diagnosis rate the
patient pool will also increase.
Note: illustration and references not included in the form – see MYR
consultation comments for more information.
What would you expect to be the treatment duration for people who
would be eligible for Bulevirtide?
The optimal treatment duration is unknown. Treatment should be continued
as long as associated with clinical benefit.
Consideration to discontinue the treatment should be given in case of
sustained (6 months) HBsAg seroconversion or loss of virological and
biochemical response.		 and prevalence into the
background section and
updated the outcomes
section.

National Institute for Health and Care Excellence

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Commentator		 Comments [sic] Action
Is testing for hepatitis D virus antibody routine practice in the NHS for
all people with chronic hepatitis B?
In general, routine diagnostic testing for anti-HDV antibodies should be
implemented for all patients with chronic hepatitis B as well as for patients
being positive for HBsAg/HBcAg as well as HBV DNA. According to personal
communication of the company, common HDV testing is not implemented
routinely in all health facilities.
Are the outcomes listed appropriate?
The outcomes listed are appropriate with the expectations of sustained
virological response and development of resistance to treatment.
As described above the company considers the sustained virological
response (SVR) as a non-relevant endpoint, as this virological endpoint for
chronic HDV infection cannot be meaningfully applied as this is highly
discussed. Undetectable HDV RNA at week 24 post-treatment was explored
as secondary endpoint in some clinical studies, with the expectation that it
might be associated with sustained virological response. However, long-term
follow up studies such as the HIDIT-1 study revealed that more than 50% of
patients with undetectable HDV RNA at 24 weeks post-treatment relapsed
and developed detectable HDV RNA at least once during the follow- up
(Heidrich et al. 2014). The occurrence of viral relapse suggest that some form
of HDV latency exists in patients where HDV RNA was transiently
undetectable in blood.
Therefore, the company believes that no precise statement on the success of
therapy or cure can be given based on the SVR, as CHD patients may
demonstrate high relapse rates in the further course of the disease.
We therefore propose to include the outcome morbidity: virological and
biochemical response for the appraisal. In this context virological response is
defined as a more than 2 log10reduction in serum HDV RNA or undetectable
HDV RNA at the end of treatment. A decline of 2 logs or more logs of HDV

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Section Consultee/
Commentator		 Comments [sic] Action
RNA at the end of treatment was recently acknowledged and recommended
as a surrogate marker for treatment efficacy in clinical trials. Researcher as
well as clinicians have widely agreed upon this endpoint (Yurdaydin et al.
2018).
Biochemical response is defined at normalization of serum alanine
aminotransferase (ALT) levels, a liver enzyme indicating the damage of the
liver. Decline in ALT levels is an established surrogate marker for impact on
necroinflammation, and thereby clinical benefit in viral hepatitis (EMA parallel
consultation meeting 2018 between EMA and company).
Furthermore, that company would like to remove the outcome resistance
development, as resistance development against a drug compound targeting
a host protein is highly unlikely. The outcome resistance development to
treatment originates from treatment regimens for HBV infections unlike HBV
therapies targeting a viral protein required for viral replication,Bulevirtide
targets the host protein NTCP used by HBV/HDV as entry receptor.
Bulevirtide does not target any viral protein needed for viral replication
and/or dissemination. This has been acknowledged and agreed upon by
EMAs safety advisory group meeting (SAG meeting between EMA and
company).
It is assumed that the resistance development, if possible, at all, will need
a mutation within the HBV envelope protein. A selection for mutated
subspecies needs active HBV replication. In practical terms, HBV
replication in HDV co-infected patients will be either suppressed by HDV
itself (Wu et al. 1995, Jardi et al. 2001, Heidrich et al. 2013), or by
nucleoside/tide analogue treatment in accordance with relevant
guidelines.
During both phase II trials, only three virological breakthroughs occurred
during the program, whereas no evidence of resistance was demonstrated.
Importantly, virological breakthroughs were even more common under

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Section Consultee/
Commentator		 Comments [sic] Action
interferon. In general, the development of resistance is very unlikely with
Bulevirtide for several reasons: (i) targeting of a host protein, (ii) the necessity
for mutations in HBV, whereas HBV replication can be efficiently controlled by
nucleoside/nucleotide analogues,(iii) the highly conserved NTCP binding
domain within the HBV preS1 domain and (iv) the fact that mutations within
this domain renders HBV/HDV non-infectious. Thus, the company believes
that the respective outcome will not add any meaningful value.
Are there any subgroups of people in whom Bulevirtide is expected to
be more clinically effective and cost effective or other groups that
should be examined separately?
There are currently no subgroups of patients in whom Bulevirtide is expected
to be more clinical effective
Where do you consider Bulevirtide will fit into the existing NICE
pathway,hepatitis B (chronic)?
•
Would Bulevirtide be used only after a prior treatment with
pegylated interferon alpha-2a for hepatitis D, and for people in
whom treatment with pegylated interferon alpha-2a is considered
inappropriate? If so, how would people for whom pegylated
interferon alpha-2a is not appropriate be defined?
Buleviritde is the first and only approved therapy for CHD patients. Bulevirtide
can be prescribed to patients independently of a prior treatment with PEG-
IFN. Within the clinical studies efficacy and safety results demonstrate
comparable results between naïve, previously treated, non-responders and
patients with contraindications.		 Thank you for your
comment. Severity of
disease has been
added to the final scope
as a subgroup for
consideration.
Thank you for
comments. No action
needed.

National Institute for Health and Care Excellence

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Section Consultee/
Commentator		 Comments [sic] Action
PEG-IFN is a non-approved therapy for the treatment of CHD patients (for
efficacy of PEG-IFN in HDV treatment please see background section).
•
Would Bulevirtide be used alongside nucleoside/nucleotide
analogue therapy for hepatitis B or would Bulevirtide be used
alone?
Bulevirtide can be used alongside with NUC therapy for the underlying HBV
infection if indicated according to the current treatment guidelines (EASL
2017, Terrault et al. 2018). Our clinical program demonstrated that Bulevirtide
and NUC can be safely administered together in patients with CHD and
treatment was well tolerated**.**
•
Would a combination with pegylated interferon alpha-2a be a
treatment option for some people? If so, please explain who
would be given a combination treatment with pegylated
interferon alpha-2a?
As approved be the European Commission and recommended by the CHMP
Bulevirtide can be used for the treatment of adult patients with chronic HDV
infection and compensated liver disease. Co-administration with PEG-IFN for
treatment of the underlying chronic HBV infection lies in the discretion of the
attending physician. Clinical data of our phase II program demonstrated that
co-administration of Bulevirtide and PEG-IFN is well tolerated and safe.
•
How do prior treatments for hepatitis B influence the treatment
pathway for hepatitis D?
Until recently, no therapeutic regimen or drug was approved for the dedicated
treatment of CHD.
PEG-IFNα was used as a_de facto_treatment standard and was the only		 Thank you for
comments. No action
needed.
Thank you for
comments. No action
needed.
Thank you for
comments. No action
needed.

National Institute for Health and Care Excellence

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available off-label therapeutic option recommended by treatment guidelines
(EASL 2017). However, current clinical experience indicates that only⁓50%
of patients are eligible for interferon treatment. Approx. 25% thereof achieve a
response;⁓50% of these patient’s relapse. In fact, interferon therapy is only
helpful for around 10% of patients and the benefit-risk in chronic HDV
infection is not established.
In CHD patients with ongoing HBV DNA replication therapy with nucleos(t)ide
analogue (NA) should be considered (EASL 2017, AASLD 2018). NAs
approved for treatment of HBV infection show negligible antiviral effects on
HDV since they neither affect HDV replication nor suppress HBsAg
production (Wedemeyer et al. 2011), which was further confirmed by the
company in its phase II program.
Thus, prior treatment for HBV will not impact the treatment pathway for HDV**.**
Do you consider Bulevirtide to be innovative in its potential to make a
significant and substantial impact on health-related benefits and how it
might improve the way that current need is met (is this a ‘step-change’
in the management of the condition)?
The company considers Bulevirtide as being an innovative medicine with the
potential to make a significant and substantial impact on the health-related
benefits for CHD patients. As there has been no therapeutic regimen or drug
until recently Bulevirtide being approved as the first and only dedicated
treatment for CHD patients demonstrated substantial antiviral efficacy as well
as a good tolerability and safety profile.
Do you consider that the use of Bulevirtide can result in any potential
significant and substantial health-related benefits that are unlikely to be
included in the QALY calculation?		 Thank you for your
comments. The
company and other
stakeholder
submissions can
expand on the potential
innovative nature of the
technology, in particular
its potential to make a
significant and
substantial impact on
health-related benefits
that are unlikely to be
included in the QALY

National Institute for Health and Care Excellence

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Section Consultee/
Commentator		 Comments [sic] Action
We are in the process of analysing available data and colleting QALY data
from our ongoing clinical program phase II and phase III trials. These data will
become available in the near future and may be part of the upcoming
submission.
Please identify the nature of the data which you understand to be
available to enable the Appraisal Committee to take account of these
benefits.
The following data will be available for the Appraisal Committee:
Phase II data (MYR202 and MYR203).
Interim data on week 24 from phase III and phase II data (MYR301 and
MYR204; Nov/Dec. 2020).
To help NICE prioritise topics for additional adoption support, do you
consider that there will be any barriers to adoption of this technology
into practice? If yes, please describe briefly.
No barriers = no treatment option for HDV, high unmet medical need.		 calculation during
assessment.
Thank you for your
comments. No action
needed.
NHS England &
Improvement		 Implementation will be via the existing HCV ODNs if approved and this should
be part of the guidance recommendation.
Currently HCD testing is recommended but poorly implemented.		 Thank you for your
comments. We have
added more information
about HBV/HDV testing
and prevalence into the
background section.

National Institute for Health and Care Excellence

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The following consultees/commentators indicated that they had no comments on the draft remit and/or the draft scope

None.

National Institute for Health and Care Excellence

Consultation comments on the draft remit and draft scope for the technology appraisal of bulevirtide for treating chronic hepatitis D [ID3732] Issue date: March 2021