SMC Advice - Formulary Decisions October - November 2013
Scottish Medicines Consortium Recommendations
Date
Product/Manufacturer
atomoxetine 10mg, 18mg, 25mg, 40mg,
October
60mg, 80mg and 100mg capsules
2013
(Strattera®)
909/13
Eli Lilly and Company
Treatment of attention-deficit/hyperactivity
disorder (ADHD) in adults as part of a
comprehensive
treatment
programme.
Treatment must be initiated by a specialist in
the treatment of ADHD, such as a
psychiatrist.
Diagnosis should be made
according to current DSM criteria or the
guidelines in ICD.
SMC Advice
atomoxetine (Strattera®) is accepted for use within NHS
Scotland.
Decision of ADTC
Approved for 2nd
initiation in adults.
Indication under review: treatment of attentiondeficit/hyperactivity disorder (ADHD) in adults as part of a
comprehensive treatment programme. The presence of
symptoms that were pre-existing in childhood should be
confirmed.
Specialist initiation only.
line
use
for
1st
line
choice
Methylphenidate
(off-label for initiating in
adults)
Atomoxetine should
normally be used 2nd line
in patients who do not
respond to
methylphenidate or when
methylphenidate is
contraindicated or not
tolerated.
May be used 1st line in
patients where drug
diversion is a concern or
if substance misuse is
also an issue.
Short term studies in adults have shown that atomoxetine
improves symptoms of ADHD compared to placebo.
The economic case for atomoxetine has
demonstrated for a treatment duration of one year.
Rationale
SMC
atomoxetine
(Strattera)
been
In adults, the presence of symptoms of
ADHD that were pre-existing in childhood
should
be
confirmed.
Third-party
corroboration is desirable and atomoxetine
should not be initiated when the verification
of childhood ADHD symptoms is uncertain.
Diagnosis cannot be made solely on the
presence of one or more symptoms of
ADHD. Based on clinical judgment, patients
should have ADHD of at least moderate
severity as indicated by at least moderate
functional impairment in two or more settings
(for example, social, academic, and/or
occupational functioning), affecting several
aspects of an individual's life.
Comparator Medicines:
No other medicines are licensed for initiation
of treatment for ADHD in adults.
Methylphenidate,
atomoxetine
and
dexamfetamine are licensed for use in
children with ADHD. Methylphenidate has
been widely used for treatment of ADHD in
adults and is recommended by NICE as the
first choice treatment for patients with
moderate to severe ADHD symptoms.
October
2013
907/13
ranibizumab, 10mg/mL, solution
injection (Lucentis®)
Novartis Pharmaceuticals UK Ltd
for
Treatment for visual impairment due to
choroidal neovascularisation secondary to
pathologic myopia in adults.
Comparator Medicines:
ranibizumab (Lucentis®) is accepted for use within NHS
Scotland.
Included on the Fife Formulary for
this indication.
Indication under review: Treatment for visual
impairment due to choroidal neovascularisation
secondary to pathologic myopia in adults.
Specialist hospital use only.
In patients with choroidal neovascularisation secondary to
pathologic myopia, ranibizumab intravitreal injection was
SMC
ranibizumab
(Lucentis)
SMC Advice - Formulary Decisions October - November 2013
vPDT is the only other approved treatment
for choroidal neovascularisation (marketing
authorisation specifies subfoveal only)
secondary to pathological myopia in adults.
October
2013
912/13
ondansetron 4mg, 8mg orodispersible
films (Setofilm®)
Norgine
Product Update
associated with a significant improvement in visual acuity
of 8.4 Early Treatment Diabetic Retinopathy Study letters
at three months compared with photodynamic therapy.
This SMC advice takes account of the benefits of a
Patient Access Scheme (PAS) that improves the costeffectiveness of ranibizumab. This SMC advice is
contingent upon the continuing availability of the patient
access scheme in NHS Scotland or a list price that is
equivalent or lower.
ondansetron orodispersible films (Setofilm®) are
accepted for restricted use within NHS Scotland.
Indication under review:
In adults:

Prophylaxis of acute nausea and vomiting
induced
by
moderately
emetogenic
chemotherapy.

Prophylaxis and treatment of delayed nausea
and vomiting induced by moderately to highly
emetogenic chemotherapy.

Prophylaxis and treatment of acute and delayed
nausea and vomiting induced by highly
emetogenic radiotherapy.

Prophylaxis and treatment of post-operative
nausea and vomiting (PONV).
Not included on the Fife formulary
because clinicians do not support
formulary
inclusion
for
this
formulation.
SMC
ondansetron
(Setofilm)
‘Not preferred’.
Ondansetron tablets are
the
Fife
Formulary
choice.
Specialist
only.
initiation
http://www.fifeadtc.scot.
nhs.uk/formulary/sectio
ns/4%20CNS.pdf
In paediatric populations:

Management of chemotherapy-induced nausea and
vomiting in children aged ≥6 months.

Prophylaxis and treatment of postoperative nausea and vomiting (PONV)
in children aged ≥4 years.
SMC restriction: ondansetron orodispersible films are
restricted to use in patients with an enhanced risk of
aspiration or who experience difficulties in swallowing.
October
2013
914/13
sodium phenylbutyrate granules 483mg/g
(Pheburane®)
Lucane Pharma
Generic preparations of ondansetron are available at a
lower cost than the proprietary products.
sodium phenylbutyrate granules (Pheburane®) are
accepted for use within NHS Scotland.
Indication under review: adjunctive therapy in the
chronic management of urea cycle disorders, involving
deficiencies of carbamylphosphate synthetase, ornithine
transcarbamylase or argininosuccinate synthetase.
It is indicated in all patients with neonatal-onset
presentation (complete enzyme deficiencies, presenting
within the first 28 days of life). It is also indicated in
patients with late-onset disease (partial enzyme
deficiencies, presenting after the first month of life) who
Not included on the Fife Formulary
because clinicians do not support
Formulary inclusion.
SMC
sodium
phenylbutyrate
(Pheburane)
Specialist
centre use.
tertiary
SMC Advice - Formulary Decisions October - November 2013
have a history of hyperammonaemic encephalopathy.
October
2013
855/13
axitinib, 1mg and 5mg, film-coated tablets
(Inlyta®)
Pfizer
For the treatment of adult patients with
advanced renal cell carcinoma (RCC) after
failure of prior treatment with sunitinib or a
cytokine
Comparator Medicines:
Other medicines licensed for second-line use
in RCC include everolimus (after VEGF
receptor therapy), sorafenib, sunitinib (after
cytokines), and pazopanib (first-line but also
second-line after cytokines)
enzalutamide
40mg
(Xtandi®)
Astellas Pharma Ltd
soft
capsules
Treatment of adult men with metastatic
castration-resistant
prostate
cancer
(mCRPC) whose disease has progressed on
or after docetaxel therapy.
Comparator Medicines:
Abiraterone, cabazitaxel (not recommended
by SMC).
Some current guidelines
recommend repeated courses of docetaxel or
mitoxantrone plus prednisolone (unlicensed).
October
2013
910/13
bosutinib 100mg,
tablets (Bosulif®)
Pfizer Ltd
Not included pending protocol
500mg
film-coated
Treatment of adult patients with chronic
phase, accelerated phase, and blast phase
Philadelphia chromosome positive chronic
myelogenous
leukaemia
(Ph+
CML)
previously treated with one or more tyrosine
SMC axitinib (Inlyta)
Await
Lothian
Formulary Committee
decision
following
SCAN submission.
Indication under review: for the treatment of adult
patients with advanced renal cell carcinoma (RCC) after
failure of prior treatment with sunitinib or a cytokine.
Resubmission
October
2013
911/13
Sodium phenylbutyrate granules (Pheburane®) provide an
alternative to sodium phenylbutyrate tablets at no
additional cost but are more expensive than an existing
brand of sodium phenylbutyrate granules
axitinib (Inlyta®) is accepted for use within NHS
Scotland.
In a phase III, open-label study, axitinib improved
progression-free survival significantly more than another
targeted therapy when used after first-line sunitinib or a
cytokine. There was no significant improvement in overall
survival.
This SMC advice takes account of the benefits of a
Patient Access Scheme (PAS) that improves the costeffectiveness of axitinib. This SMC advice is contingent
upon the continuing availability of the patient access
scheme in NHS Scotland or a list price that is equivalent
or lower.
enzalutamide (Xtandi®) is accepted for use within NHS
Scotland.
Not included pending protocol
Indication under review: Treatment of adult men with
metastatic castration-resistant prostate cancer (mCRPC)
whose disease has progressed on or after docetaxel
therapy.
SMC
(Xtandi)
enzalutamide
Await
Lothian
Formulary Committee
decision
following
SCAN submission.
In one randomised, double-blind, phase III clinical study,
enzalutamide significantly increased overall survival
compared with placebo.
This SMC advice takes account of the benefits of a
Patient Access Scheme (PAS) that improves the costeffectiveness of enzalutamide. This SMC advice is
contingent upon the continuing availability of the patient
access scheme in NHS Scotland or a list price that is
equivalent or lower.
bosutinib (Bosulif®) is not recommended for use within
NHS Scotland.
Indication under review: Treatment of adult patients with
chronic phase, accelerated phase, and blast phase
Philadelphia chromosome positive chronic myelogenous
leukaemia (Ph+ CML) previously treated with one or more
tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib
and dasatinib are not considered appropriate treatment
Not recommended
SMC bosutinib (Bosulif)
Requires submission and approval
of an IPTR.
Lack of evidence of
clinical and economic
benefits.
SMC Advice - Formulary Decisions October - November 2013
kinase inhibitor(s) and for whom imatinib,
nilotinib and dasatinib are not considered
appropriate treatment options.
Comparator Medicines:
Hydroxycarbamide (considered palliative
treatment), interferon alfa (CP CML only) or
allogenic stem cell transplant.
October
2013
926/13
canakinumab (Ilaris®) 150mg powder for
solution for injection
Novartis Pharmaceuticals UK Limited
options.
Evidence of efficacy for the indication under review comes
from a subgroup of 52 patients who represent “unmet
medical need” in the pivotal study, in which the full
population included 546 patients with chronic, accelerated
and blast phase imatinib pre-treated Ph+ CML.
The submitting company did not present a sufficiently
robust clinical and economic analysis and in addition their
justification of the treatment’s cost in relation to its
benefits was not sufficient to gain acceptance by SMC.
ADVICE: in the absence of a submission from the holder
of the marketing authorisation
canakinumab (Ilaris®) is not recommended for use within
NHS Scotland.
Not recommended
SMC
(llaris)
canakinumab
Requires submission and approval
of an IPTR.
Non-submission
Not recommended
SMC lapatinib (Tyverb)
Requires submission and approval
of an IPTR.
Non-submission
Indication under review: treatment of active Systemic
Juvenile Idiopathic Arthritis (SJIA) in patients aged two
years and older who have responded inadequately to
previous therapy with non-steroidal anti-inflammatory
drugs (NSAIDs) and systemic corticosteroids. Ilaris can
be given as monotherapy or in combination with
methotrexate.
The holder of the marketing authorisation has not made a
submission to SMC regarding this product in this
indication. As a result we cannot recommend its use
within NHSScotland.
October
2013
925/13
lapatinib (Tyverb®) 250 mg film-coated
tablets
GlaxoSmithKline
ADVICE: in the absence of a submission from the holder
of the marketing authorisation
lapatinib (Tyverb ®) is not recommended for use within
NHS Scotland.
Indication under review: treatment of adult patients with
breast cancer, whose tumours overexpress HER2
(ErbB2) in combination with trastuzumab for patients with
hormone receptor-negative metastatic disease that has
progressed on prior trastuzumab therapy(ies) in
combination with chemotherapy.
The holder of the marketing authorisation has not made a
submission to SMC regarding this product in this
indication. As a result we cannot recommend its use
within NHSScotland.
SMC Advice - Formulary Decisions October - November 2013
November
2013
918/13
saxagliptin 2.5mg and 5mg film-coated
tablets (Onglyza®)
Bristol-Myers Squibb/AstraZeneca
In adult patients aged 18 years and older with
type 2 diabetes mellitus to improve glycaemic
control as triple oral therapy in combination
with metformin plus a sulphonylurea when
this regimen alone, with diet and exercise,
does not provide adequate glycaemic control.
Comparator Medicines:
The other DPP-4 inhibitors (linagliptin,
sitagliptin and vildagliptin) are licensed for
use as triple oral therapy in combination with
metformin and a sulphonylurea when this
regimen alone with diet and exercise does
not provide adequate glycaemic control.
November
2013
875/13
saxagliptin (Onglyza®) is accepted for restricted use
within NHS Scotland.
Included on the NHS Fife Formulary
as a 2nd choice gliptin.
Indication under review: in adult patients aged 18 years
and older with type 2 diabetes mellitus to improve
glycaemic control as triple oral therapy in combination
with metformin plus a sulphonylurea when this regimen
alone, with diet and exercise, does not provide adequate
glycaemic control.
Sitagliptin 1st choice.
SMC
(Galvus)
vildagliptin
Treatment with saxagliptin reduces glycosylated
haemoglobin, HbA1c, levels significantly more than
placebo when used in combination with metformin and a
sulphonylurea.
Indirect comparisons demonstrated
similar efficacy to other dipeptidyl peptidase-4 inhibitors.
vildagliptin (Galvus®) is accepted for restricted use
within NHS Scotland.
Treatment of type 2 diabetes mellitus in
adults as triple oral therapy in combination
with a sulphonylurea and metformin when
diet and exercise plus dual therapy with
these medicinal products do not provide
adequate glycaemic control.
Indication under review: Treatment of type 2 diabetes
mellitus in adults as triple oral therapy in combination with
a sulphonylurea and metformin when diet and exercise
plus dual therapy with these medicinal products do not
provide adequate glycaemic control.
The other DPP-4 inhibitors (linagliptin,
saxagliptin and sitagliptin) are licensed for
use as triple oral therapy in combination with
metformin and a sulphonylurea when this
regimen alone with diet and exercise does
not provide adequate glycaemic control
saxagliptin
SMC restriction: as an alternative dipeptidyl peptidase-4
inhibitor option.
vildagliptin 50mg tablets (Galvus®)
Novartis Europharm Limited
Comparator Medicines:
SMC
(Onglyza)
SMC restriction: as an alternative dipeptidyl peptidase-4
inhibitor option.
Treatment with vildagliptin reduces HbA1c levels
significantly more than placebo when used in combination
with metformin and a sulphonylurea. A Bayesian network
meta-analysis suggested similar efficacy to another
dipeptidyl peptidase-4 inhibitor
Not included on the NHS Fife
Formulary because the Board
decision is that the medicine does
not represent sufficient added
benefit
to
other
comparator
medicines to treat the condition in
question.
‘Not preferred’
Formulary choices
1st Sitagliptin
2nd Saxagliptin
http://www.fifeadtc.scot.
nhs.uk/formulary/sectio
ns/6%20Endocrine.pdf
SMC Advice - Formulary Decisions October - November 2013
November
2013
837/13
mannitol 40mg inhalation powder hard
capsule (Bronchitol®)
Pharmaxis Pharmaceuticals Ltd.
Resubmission
Treatment of cystic fibrosis (CF) in adults
aged 18 years and above as an add-on
therapy to best standard of care
Comparator Medicines:
Best supportive care. Dornase alfa and
hypertonic saline (unlicensed) are alternative
treatments for CF, but would not be
considered comparators in the context of the
company’s proposed positioning
November
2013
919/13
eltrombopag, 25mg, 50mg, 75mg filmcoated tablets (Revolade®)
GlaxoSmithKline
In adult patients with chronic hepatitis C virus
infection,
for
the
treatment
of
thrombocytopenia, where the degree of
thrombocytopenia is the main factor
preventing the initiation or limiting the ability
to maintain optimal interferon-based therapy.
Comparator Medicines:
There is no active comparator. Current
practice is that this patient population would
receive either no, or suboptimal, antiviral
therapy.
mannitol (Bronchitol®) is accepted for restricted use
within NHS Scotland.
Not included on the Fife Formulary
because clinicians do not support
formulary inclusion.
Indication under review: Treatment of cystic fibrosis
(CF) in adults aged 18 years and above as an add-on
therapy to best standard of care.
SMC
(Bronchitol)
mannitol
Tertiary centre use only.
SMC restriction: As an add-on to best standard of care
in adult patients with CF who are not currently using
dornase alfa due to lack of response, intolerance or
ineligibility and have rapidly declining lung function and in
whom other osmotic agents are considered unsuitable.
In two phase III clinical studies in patients with CF,
inhaled mannitol was superior to a control treatment (a
sub-therapeutic dose of inhaled mannitol) measured by
absolute change in forced expiratory volume in one
second (FEV1) over 26 weeks
eltrombopag (Revolade®) is accepted for use within
NHS Scotland.
Indication under review: In adult patients with chronic
hepatitis C virus infection, for the treatment of
thrombocytopenia, where the degree of thrombocytopenia
is the main factor preventing the initiation or limiting the
ability to maintain optimal interferon-based therapy.
Two double-blind, randomised, controlled studies in
patients with chronic hepatitis C virus infection and
thrombocytopenia demonstrated significantly higher
sustained viral response rates in patients who continued
treatment with eltrombopag during interferon-based
antiviral therapy than in those patients whose
eltrombopag treatment was discontinued on initiation of
antiviral therapy.
This SMC advice takes account of the benefits of a
Patient Access Scheme (PAS) that improves the costeffectiveness of eltrombopag. This SMC advice is
contingent upon the continuing availability of the Patient
Access Scheme in NHS Scotland or a list price that is
equivalent or lower.
Included on the Fife Formulary for
this indication.
Hospital use only.
SMC
eltrombopag
(Revolade)
SMC Advice - Formulary Decisions October - November 2013
November2
013
792/12
vemurafenib 240mg
(Zelboraf®)
Roche Products Ltd
film-coated
tablet
Resubmission
As monotherapy for the treatment of adult
patients with BRAF V600 mutation-positive
unresectable or metastatic melanoma.
vemurafenib (Zelboraf®) is accepted for restricted use
within NHS Scotland.
Not included pending protocol
Indication review: as monotherapy for the treatment of
adult patients with BRAF V600 mutation-positive
unresectable or metastatic melanoma.
SMC
(Zelboraf)
vemurafenib
Await
Lothian
Formulary Committee
decision
following
SCAN submission.
SMC restriction: for use in the first-line treatment of
BRAF V600 mutation-positive unresectable or metastatic
melanoma.
Comparator Medicines:
Dacarbazine is licensed for first-line
treatment of melanoma and ipilimumab is
licensed for use in patients who have
received prior therapy.
November
2013
921/13
azelastine hydrochloride 137micrograms
plus fluticasone propionate 50micrograms
per actuation nasal spray (Dymista® nasal
spray)
Product Update
November2
013
935/13
micronized progesterone (Utrogestan
Vaginal®) 200 mg capsules
Marlborough Pharmaceuticals Ltd
Vemurafenib significantly increases overall survival and
progression-free survival compared with a current
standard chemotherapy for patients with previously
untreated unresectable stage IIIC or stage IV melanoma
with V600 BRAF mutation.
This SMC advice takes account of the benefits of a
Patient Access Scheme (PAS) that improves the costeffectiveness of vemurafenib. This SMC advice is
contingent upon the continuing availability of the Patient
Access Scheme in NHS Scotland or a list price that is
equivalent or lower.
azelastine hydrochloride plus fluticasone propionate
nasal spray (Dymista®) is not recommended for use
within NHS Scotland.
Not recommended
Requires submission and approval
of an IPTR.
Indication under review: for the relief of symptoms of
moderate to severe seasonal and perennial allergic
rhinitis if monotherapy with either intranasal antihistamine
or glucocorticoid is not considered sufficient.
The combined azelastine and fluticasone nasal spray is
significantly more expensive than the components
administered separately.
Micronized progesterone (Utrogestan Vaginal®) is not
recommended for use within NHS Scotland.
Indication under review: Supplementation of the luteal
phase during Assisted Reproductive Technology (ART)
cycles.
The holder of the marketing authorisation has not made a
submission to SMC regarding this product in this
indication. As a result we cannot recommend its use
within NHSScotland
SMC
azelastine
hydrochloride
plus
fluticasone propionate
(Dymista)
More expensive than
single components.
Not recommended
Requires submission and approval
of an IPTR.
SMC
micronized
progesterone
(Utrogestan Vaginal)
Non- submission
SMC Advice - Formulary Decisions October - November 2013
November2
013
934/13
imiquimod (Zyclara®) 3.75% cream
Meda Pharmaceuticals
ADVICE: in the absence of a submission from the holder
of the marketing authorisation
®
imiquimod (Zyclara ) is not recommended for use within
NHS Scotland.
Not recommended
SMC
(Zyclara)
imiquimod
Requires submission and approval
of an IPTR.
Non- submission
Not
recommended
indication.
SMC cefuroxime sodium
(Aprokam)
Indication under review: topical treatment of clinically
typical, nonhyperkeratotic, nonhypertrophic, visible or
palpable actinic keratosis (AK) of the full face or balding
scalp in immunocompetent adults when other topical
treatment options are contraindicated or less appropriate.
The holder of the marketing authorisation has not made a
submission to SMC regarding this product in this
indication. As a result we cannot recommend its use
within NHSScotland.
November2
013
932/13
cefuroxime sodium (Aprokam®) 50 mg
powder for solution for injection
Spectrum Thea Pharmaceuticals Limited
ADVICE: in the absence of a submission from the holder
of the marketing authorisation
cefuroxime sodium (Aprokam®) is not recommended for
use within NHS Scotland.
for
this
Requires submission and approval
of an IPTR.
Non- submission
Not
recommended
indication.
this
SMC botulinum
type A (Botox)
Requires submission and approval
of an IPTR.
Non- submission
Indication under review: Antibiotic prophylaxis of
postoperative endophthalmitis after cataract surgery.
The holder of the marketing authorisation has not made a
submission to SMC regarding this product in this
indication. As a result we cannot recommend its use
within NHSScotland.
November
2013
931/13
botulinum toxin type A 50, 100, 200
Allergan units (Botox®)
Allergan Ltd
ADVICE: in the absence of a submission from the holder
of the marketing authorisation
botulinum toxin type A (Botox®) is not recommended
for use within NHS Scotland.
Indication under review: Management of bladder
dysfunctions in adult patients with overactive bladder with
symptoms of urinary incontinence, urgency and
frequency who are not adequately managed with
anticholinergics.
The holder of the marketing authorisation has not made a
submission to SMC regarding this product in this
indication. As a result we cannot recommend its use
within NHSScotland.
The sponsor company plans to make a submission to
SMC in March 2014.
for
toxin
SMC Advice - Formulary Decisions October - November 2013
Deferred Scottish Medicines Consortium Recommendations
Date
July 2013
835/13
Product/Manufacturer
pirfenidone 267mg capsule (Esbriet®)
InterMune
SMC Advice
pirfenidone (Esbriet®) is accepted for restricted
use within NHS Scotland.
In adults for the treatment of mild to moderate idiopathic
pulmonary fibrosis (IPF)
Indication under review: In adults for the treatment
of mild to moderate idiopathic pulmonary fibrosis
(IPF).
Comparator Medicines:
There are no medicines licensed for treatment of IPF.
The main current treatment is mainly best supportive
care with some patients receiving off-label Nacetylcysteine and/or low dose corticosteroid
SMC restriction: For use in patient with a predicted
forced vital capacity (FVC) less than or equal to
80%.
Pirfenidone reduced the decline in lung function
parameters associated with IPF compared to
placebo in a pooled analysis of two similarly
designed phase lll studies.
September
2013
917/13
nalmefene 18mg film-coated tablets (Selincro®)
Lundbeck Limited
The reduction of alcohol consumption in adult patients
with alcohol dependence who have a high drinking risk
level (DRL), without physical withdrawal symptoms and
who do not require immediate detoxification.
Nalmefene should only be prescribed in conjunction with
continuous psychosocial support focused on treatment
adherence and reducing alcohol consumption.
Nalmefene should be initiated only in patients who
continue to have a high DRL two weeks after initial
assessment.
Comparator Medicines:
No other medicines are specifically licensed for reducing
alcohol consumption. Other medicines, acamprosate,
naltrexone and disulfiram are licensed for maintenance of
abstinence after alcohol withdrawal.
This SMC advice takes account of the benefits of a
Patient Access Scheme (PAS) that improves the
cost-effectiveness of pirfenidone. This SMC advice
is contingent upon the continuing availability of the
Patient Access Scheme in NHS Scotland or a list
price that is equivalent or lower.
nalmefene 18mg film-coated tablets (Selincro®)
are accepted for use within NHS Scotland.
Indication under review: the reduction of alcohol
consumption in adult patients with alcohol
dependence who have a high drinking risk level
(DRL), without physical withdrawal symptoms and
who do not require immediate detoxification.
Nalmefene should only be prescribed in conjunction
with continuous psychosocial support focused on
treatment adherence and reducing alcohol
consumption. Nalmefene should be initiated only in
patients who continue to have a high DRL two
weeks after initial assessment.
In a post hoc analysis of two pivotal phase III studies
representing the licensed population, nalmefene was
shown to significantly reduce alcohol intake
compared with placebo, measured as a reduction in
heavy drinking days and total alcohol consumption
over a six month period.
ADTC Decision
Included
on
the
Fife
Formulary for the treatment
of adults with mild to
moderate
idiopathic
pulmonary fibrosis with a
forced vital capacity ≤ 80%
predicted.
Rationale
SMC
835/13
pirfenidone_Esbriet
Treatment should be in line
with
the
NHS
Fife
Pirfenidone Protocol.
Hospital use only.
Not included on the Fife
Formulary as clinicians do
not
support
formulary
inclusion.
SMC 917/13
http://www.fifeadtc.scot.
nhs.uk/formulary/section
s/4%20CNS.pdf
SMC Advice - Formulary Decisions October - November 2013
Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines November 2013
Product Name
crizotinib,
200mg
and
250mg,
hard
capsule
(Xalkori®)
SMC Advice
crizotinib (Xalkori®) is accepted for treatment of adults with
previously treated anaplastic lymphoma kinase (ALK)-positive
advanced non-small cell lung cancer (NSCLC).
In a phase III clinical study in patients with previously treated
anaplastic lymphoma kinase (ALK)-positive advanced NSCLC,
crizotinib significantly increased progression-free survival compared
with standard chemotherapy.
This SMC advice takes account of the benefits of a Patient Access
Scheme (PAS) that improves the cost-effectiveness of crizotinib.
This SMC advice is contingent upon the continuing availability of
the patient access scheme in NHS Scotland or a list price that is
equivalent or lower.
Place in therapy
Treatment of adults with previously treated
anaplastic lymphoma kinase (ALK)-positive
advanced non-small cell lung cancer
(NSCLC).
Crizotinib would replace current second-line
treatment docetaxel chemotherapy
1st line treatment would be a platinum based
chemotherapy regimen..
Lothian formulary Committee Decision
Included on the Additional List
Specialist hospital use only.