Download Formulary Decisions August-September 2015

SMC Advice - Formulary Decisions August-September 2015
Scottish Medicines Consortium Recommendations
Date
Product/Manufacturer
August
aflibercept
40mg/mL solution for injection
(Eylea®)
2015
Bayer
1074/15
For adults for the treatment of visual impairment
due to macular oedema secondary to branch
retinal vein occlusion
Comparator Medicines:
The relevant comparators are ranibizumab,
dexamethasone
implants
and
laser
photocoagulation
SMC Advice
aflibercept (Eylea®) is accepted for use within NHS Scotland.
Indication under review: for adults for the treatment of visual
impairment due to macular oedema secondary to branch retinal vein
occlusion.
Decision of ADTC
Included on the Fife
Formulary for this
indication.
Rationale
SMC aflibercept (Eylea)
Hospital use only.
Aflibercept was associated with significant improvements over laser in
visual acuity during a 6-month, randomized, double-masked phase III
study in patients with branch retinal vein occlusion.
This SMC advice takes account of the benefits of a Patient Access
Scheme (PAS) that improves the cost-effectiveness of aflibercept. This
advice is contingent upon the continuing availability of the PAS in NHS
Scotland or a list price that is equivalent or lower.
Aflibercept has previously been accepted by SMC for macular oedema
secondary to central retinal vein occlusion. This advice now extends its
use to patients with macular oedema secondary to branch retinal vein
occlusion
August
2015
1075/15
bortezomib 3.5mg powder for solution for injection
(Velcade®)
Janssen-Cilag Ltd
In combination with rituximab, cyclophosphamide,
doxorubicin and prednisone for the treatment of
adult patients with previously untreated mantle
cell lymphoma who are unsuitable for
haematopoietic stem cell transplantation
lAugust
2015
1084/15
Comparator Medicines:
The bortezomib-containing regimen, VR-CAP
(bortezomib,
rituximab,
cyclophosphamide,
doxorubicin and prednisolone) is similar to RCHOP and in practice it is likely to be used for
patients who would have received R-CHOP
ledipasvir/sofosbuvir 90mg/400mg film-coated
tablet (Harvoni®)
Gilead Sciences Ltd
Treatment of chronic hepatitis C (CHC) in adults.
(The current submission relates to genotype 3
CHC).
Comparator Medicines:
Daclatasvir + sofosbuvir + ribavirin (for 24 weeks);
sofosbuvir + ribavirin (for 24 weeks).
bortezomib (Velcade®) is accepted for use within NHS Scotland.
Indication under
review:
in
combination with
rituximab,
cyclophosphamide, doxorubicin and prednisone for the treatment of adult
patients with previously untreated mantle cell lymphoma who are
unsuitable for haematopoietic stem cell transplantation (HSCT).
Included on the Fife
Formulary for this
indication.
SMC bortezomib (Velcade)
Hospital use only.
Bortezomib in combination with rituximab, cyclophosphamide,
doxorubicin and prednisone significantly improved progression-free
survival compared to a regimen containing rituximab, cyclophosphamide,
doxorubicin, vincristine and prednisone in adults with previously
untreated mantle cell lymphoma who were unsuitable for haematopoietic
stem cell transplantation.
ledipasvir/sofosbuvir (Harvoni®) is accepted for restricted use within
NHS Scotland.
Indication under review: Treatment of genotype 3 chronic hepatitis C
(CHC) in adults.
SMC restriction: patients who are ineligible for or unable to tolerate
interferon.
Included on the Fife
Formulary for use in
genotype 3 patients.
To be prescribed in line
with national Hep. C
guidance.
Hospital use only.
Efficacy data are limited to a phase II open-label study. The addition of
ledipasvir to sofosbuvir plus ribavirin is expected to increase antiviral
activity, although the magnitude of this effect is not well characterised.
SMC has previously accepted ledipasvir/sofosbuvir for restricted use in
1 of 10
SMC ledipasvir/sofosbuvir
(Harvoni)
SMC Advice - Formulary Decisions August-September 2015
August
2015
1083/15
sitagliptin, 25mg, 50mg and 100mg film-coated
tablets (Januvia®)
Merck Sharpe and Dohme UK Ltd
The treatment of type 2 diabetes mellitus to
improve glycaemic control in adults as add-on to
insulin (with or without metformin) when diet and
exercise plus stable dose of insulin do not provide
adequate glycaemic control
August
2015
1078/15
Comparator Medicines:

DPP-4 inhibitors (i.e. alogliptin, linagliptin,
saxagliptin, vildagliptin)

Thiazolidinediones (i.e. pioglitazone)

GLP-1 receptor agonists (i.e. exenatide,
lixisenatide, liraglutide)

SGLT-2
inhibitors
(i.e.
canagliflozin,
dapagliflozin, empagliflozin)
insulin glargine 300 units/mL solution for injection
in a pre-filled pen (Toujeo®)
Sanofi
Product Update
genotype 1 and 4 CHC; this now extends advice to include use in
genotype 3 CHC
sitagliptin (Januvia®) is accepted for use within NHS Scotland.
Indication under review: the treatment of type 2 diabetes mellitus to
improve glycaemic control in adults as add-on to insulin (with or without
metformin) when diet and exercise plus stable dose of insulin do not
provide adequate glycaemic control.
Included on the Fife
Formulary for this
indication.
SMC sitagliptin (Januvia)
Not included on the Fife
Formulary pending
protocol.
SMC insulin glargine (Toujeo)
Sitagliptin, compared with placebo, improved glycaemic control in adults
with type 2 diabetes mellitus who had inadequate glycaemic control on
an insulin-containing regimen.
SMC has previously accepted sitagliptin for use in combination with a
sulfonylurea (with or without metformin), and for restricted use with
metformin and as monotherapy. This now extends the advice to include
its use in combination with insulin
Insulin glargine (Toujeo®) is accepted for restricted use within NHS
Scotland.
Indication under review: Treatment of type 1 or type 2 diabetes
mellitus in adults aged 18 years and above.
SMC restriction: Its use should be targeted on patients with Type I
diabetes who are at risk of or experience unacceptable frequency and/or
severity of nocturnal hypoglycaemia on attempting to achieve better
hypoglycaemic control during treatment with established insulins. It is
also acceptable as a once daily insulin therapy for patients who require
carer administration of their insulin. In patients with type 2 diabetes it
should be restricted to those who suffer from recurrent episodes of
hypoglycemia or require assistance with their insulin injections.
August
2015
1079/15
lisdexamfetamine dimesylate, 30mg, 50mg and
70mg hard capsules (Elvanse Adult®) Shire
Pharmaceuticals Ltd
As part of a comprehensive treatment programme
for attention deficit/hyperactivity disorder (ADHD)
in adults. Based on clinical judgment, patients
should have ADHD of at least moderate severity.
A comprehensive treatment programme typically
includes psychological, educational, behavioural,
occupational and social measures as well as
pharmacotherapy.
Insulin glargine 300 units/mL (Toujeo®) has similar efficacy but is not
bioequivalent to insulin glargine 100 units/mL and therefore not
interchangeable without dose adjustment. At doses that provide
comparable glycaemic control, Toujeo® is available at a similar cost to
insulin glargine 100 units/mL
lisdexamfetamine dimesylate (Elvanse Adult®) is accepted for use
within NHS Scotland.
Indication under review: as part of a comprehensive treatment
programme for attention deficit/hyperactivity disorder (ADHD) in adults.
Based on clinical judgment, patients should have ADHD of at least
moderate severity.
Three phase III and two phase IV clinical studies in adults with ADHD
demonstrated that lisdexamfetamine improves the symptoms of ADHD
compared with placebo
2 of 10
Formulary choices for insulin
glargine are
Abasaglar® 100 units/ml
Lantus® 100 units/ml
Specialist initiation only.
Not included on the Fife
Formulary pending
protocol.
SMC lisdexamfetamine
dimesylate (Elvanse Adult)
No adult ADHD service
currently established in NHS
Fife.
SMC Advice - Formulary Decisions August-September 2015
Treatment must be under the supervision of a
specialist in behavioural disorders. Refer to the
summary of product characteristics (SPC) for
further information
Comparator Medicines:
Atomoxetine, methylphenidate*, dexamfetamineϮ.
* Methylphenidate is not licensed for treatment
initiation in adults with ADHD.
Ϯ
Dexamfetamine is not licensed for use in adults
with ADHD
August
2015
1048/15
pasireotide (as pamoate), 20mg, 40mg 60mg
powder and solvent for suspension for injection
(Signifor®)
Novartis Pharmaceuticals UK Ltd
Treatment of adult patients with acromegaly for
whom surgery is not an option or has not been
curative and who are inadequately controlled on
treatment with another somatostatin analogue
August
2015
1085/15
pasireotide (as pamoate) (Signifor®) is accepted for use within NHS
Scotland.
Indication under review: Treatment of adult patients with acromegaly
for whom surgery is not an option or has not been curative and who are
inadequately controlled on treatment with another somatostatin
analogue.
Comparator Medicines:
Somatostatin analogues (given monthly),
pegvisomant (not recommended for use by SMC).
Pasireotide administered every four weeks was significantly superior to
an active control group (comprising other somatostatin analogues
administered monthly) for the primary endpoint of biochemical control, in
patients with inadequately controlled acromegaly following treatment with
a somatostatin analogue for at least six months.
tafluprost 15micrograms/mL and timolol 5mg/mL
preservative-free eye drops (Taptiqom®)
Santen GmbH
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting
tafluprost 15 micrograms/mL and timolol 5mg/mL preservative-free
eye drops (Taptiqom®) are accepted for restricted use within NHS
Scotland.
Not included on the Fife
Formulary as clinicians do
not support formulary
inclusion.
SMC pasireotide (as pamoate)
(Signifor)
Fife Formulary Section 8
Tertiary centre use.
Not included on the Fife
Formulary pending
protocol.
SMC tafluprost + timolol
(Taptiqom)
Fife Formulary Section 11 Eye
Product Update
Indication under review: Reduction of intraocular pressure in adult
patients with open angle glaucoma or ocular hypertension who are
insufficiently responsive to topical monotherapy with beta-blockers or
prostaglandin analogues and require a combination therapy, and who
would benefit from preservative-free eye drops.
Fife Formulary choices are
1st choice – latanoprost +
timolol P/F
2nd choiceBimatoprost + timolol P/F
(Ganfort®)
SMC restriction: to use in patients who have proven sensitivity to
preservatives.
August
2015
1063/15
bevacizumab 25mg/mL concentrate for solution
for infusion, (Avastin®)
Roche Products Limited
Bevacizumab in combination with paclitaxel,
topotecan, or pegylated liposomal doxorubicin is
indicated for the treatment of adult patients with
The combination product costs less than preservative-free tafluprost and
timolol eye drops administered separately
bevacizumab (Avastin®) is accepted for restricted use within NHS
Scotland.
Indication under review: in combination with paclitaxel, topotecan, or
pegylated liposomal doxorubicin for the treatment of adult patients with
platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary
peritoneal cancer who received no more than two prior chemotherapy
3 of 10
Not included on the Fife
Formulary pending
protocol.
SMC bevacizumab (Avastin)
Requires SCAN submission
and consideration by Lothian
Formulary Committee.
SMC Advice - Formulary Decisions August-September 2015
platinum-resistant recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who
received no more than two prior chemotherapy
regimens and who have not received prior therapy
with bevacizumab or other vascular endothelial
growth factor (VEGF) inhibitors or VEGF receptortargeted agents.
Comparator Medicines:
Current treatment options for patients with
platinum-resistant ovarian cancer are paclitaxel,
topotecan or pegylated liposomal doxorubicin.
regimens and who have not received prior therapy with bevacizumab or
other vascular endothelial growth factor (VEGF) inhibitors or VEGF
receptor-targeted agents.
SMC restriction: to use in combination with paclitaxel.
The addition of bevacizumab to chemotherapy improved progression
free survival in patients with platinum-resistant ovarian cancer in an
open-label phase III randomised study.
This SMC advice takes account of the benefits of a Patient Access
Scheme (PAS) that improves the cost-effectiveness of bevacizumab.
This advice is contingent upon the continuing availability of the PAS in
NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting.
August
2015
980/14
avanafil 50mg, 100mg, 200mg tablets (Spedra®)
A Menarini Farmaceutica Internazionale SRL
Treatment of erectile dysfunction in adult men. In
order for avanafil to be effective, sexual
stimulation is required
Comparator Medicines:
For the proposed positioning (second-line to
sildenafil), tadalafil and vardenafil are the relevant
comparators
August
2015
1072/15
elosulfase alfa, 1mg/mL concentrate for solution
for infusion (Vimizim®)
Biomarin Europe Limited
avanafil (Spedra®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of erectile dysfunction (ED) in adult
men. In order for avanafil to be effective, sexual stimulation is required.
The pivotal studies demonstrated a statistically significant improvement
in ED after administration of avanafil compared with placebo in the
general ED population and in patients with ED due to diabetes or
following radical prostatectomy.
The submitting company did not present a sufficiently robust clinical and
economic analysis to gain acceptance by SMC.
elosulfase alfa (Vimizim®) is not recommended for use within NHS
Scotland.
Indication under review: treatment of mucopolysaccharidosis, type IVA
(Morquio A Syndrome, MPS IVA) in patients of all ages.
Treatment of mucopolysaccharidosis, type IVA
(Morquio A Syndrome, MPS IVA) in patients of all
ages
Comparator Medicines:
Supportive care.
August
2015
1100/15
ketoconazole
tablets
HRA Pharma
(Ketoconazole HRA®)
Non SMC Submission
Not recommended.
Requires submission and
approval of an IPTR before
prescribing.
SMC avanafil (Spedra)
Lack of evidence of clinical
and economic benefits.
Not recommended.
SMC elosulfase alfa (Vimizim)
Requires submission and
approval of an IPTR before
prescribing.
Lack of evidence of costeffectiveness and economic
benefits.
Not recommended.
SMC ketoconazole
(Ketoconazole HRA)
In a double-blind placebo-controlled study the difference from baseline in
the mean distance walked in the 6-minute walking test was significantly
longer for elosulfase alfa, given weekly, than placebo at week 24.
The submitting company’s justification of the treatment’s cost in relation
to its health benefits was not sufficient and in addition the company did
not present a sufficiently robust economic analysis to gain acceptance by
SMC.
200mg
This advice takes account of the views from a Patient and Clinician and
Engagement (PACE) meeting
ketoconazole (Ketaconazole HRA®) 200 mg tablets are not
recommended for use within NHS Scotland.
Indication under review: Treatment of endogenous Cushing’s
syndrome in adults and adolescents above the age of 12 years.
4 of 10
Requires submission and
approval of an IPTR before
prescribing.
Company non-submission
SMC Advice - Formulary Decisions August-September 2015
August
2015
1101/15
tigecycline (Tygacil®)
solution for infusion
Pfizer Limited
50
mg
powder
for
Indication under review: Treatment in children from the age of eight
years for the following infections:

complicated skin and soft tissue infections, excluding diabetic
foot infections

complicated intra-abdominal infections
Non SMC Submission
September
2015
1089/15
ciclosporin 1mg/mL (0.1%) eye drops emulsion
(Ikervis®)
Santen GmbH
Treatment of severe keratitis in adult patients with
dry eye disease, which has not improved despite
treatment with tear substitutes
Comparator Medicines:
None. Ciclosporin eye drops are likely to be used
in addition to tear substitutes and ocular
lubricants. Unlicensed preparations of ciclosporin
eye drops are currently in clinical use.
September
2015
1094/15
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
tigecycline (Tygacil®) 50 mg powder for solution for infusion is not
recommended for use within NHS Scotland.
midodrine hydrochloride (Bramox®) 2.5mg, 5mg
tablets
Brancaster Pharma Ltd
Product Update
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.
ciclosporin 1mg/mL (0.1%) eye drops emulsion (Ikervis®) is accepted
for use within NHS Scotland.
Indication under review: treatment of severe keratitis in adult patients
with dry eye disease, which has not improved despite treatment with tear
substitutes.
Ciclosporin eye drops, compared to vehicle, improved signs of corneal
surface damage but not symptoms in patients with severe keratitis
associated with dry eye disease
Not recommended.
Requires submission and
approval of an IPTR before
prescribing.
SMC tigecycline (Tygacil)
Included on the Fife
Formulary for restricted
use.
Scottish Medicines
Consortium ciclosporin
(Ikervis)
Company non-submission
Restricted to patients with
severe keratitis who have
responded inadequately to
tear substitutes.
Specialist initiation only.
midodrine hydrochloride (Bramox®) is accepted for use within NHS
Scotland.
Included on the Fife
Formulary.
Indication under review: in adults for the treatment of severe
orthostatic hypotension due to autonomic dysfunction when corrective
factors have been ruled out and other forms of treatment are inadequate.
Specialist initiation only.
Scottish Medicines
Consortium midodrine
hydrochloride (Bramox)
Midodrine hydrochloride (Bramox®) 5mg tablets have been shown to be
bioequivalent to the unlicensed midodrine 5mg product currently in use
in NHS Scotland. The availability of midodrine hydrochloride (Bramox®)
will allow the prescribing of a licensed medicinal product, with a resultant
small net budget impact, based on estimates from primary and
secondary prescribing and expenditure data from 2013/14.
September
2015
1091/15
Travoprost 40 micrograms/mL
(Travatan®)
Alcon Eye Care UK Ltd
Product Update
eye
drops
travoprost (Travatan®) is accepted for use within NHS Scotland.
Indication under review: decrease of elevated intraocular pressure in
paediatric patients aged 2 months to <18 years with ocular hypertension
or paediatric glaucoma.
In a randomised, double-masked study of paediatric patients with
glaucoma or ocular hypertension, travoprost was demonstrated to be
non-inferior to a beta blocker eye drop preparation in terms of mean
reduction in intra-ocular pressure.
5 of 10
Included on the Fife
Formulary for restricted
use.
Restricted to patients with
fair eyes where
pigmentation of the iris
may be a concern.
Specialist initiation only.
Scottish Medicines
Consortium travoprost
(Travatan)
SMC Advice - Formulary Decisions August-September 2015
September
2015
1076/15
nintedanib 100mg and 150mg capsules (Ofev®)
Boehringer Ingelheim
In adults for the treatment of idiopathic pulmonary
fibrosis (IPF).
Comparator Medicines:
The main comparators are pirfenidone and Nacetylcysteine, although the latter is unlicensed
and its use may decline in the future following the
recent publication of the PANTHER study.
Another topical ocular prostaglandin analogue preparation is licensed for
use in children for this indication and is considerably cheaper. In
reducing intra-ocular pressure, travoprost is comparable in effect to other
drugs in its class.
nintedanib (Ofev®) is accepted for restricted use within NHS Scotland.
Indication under review: in adults for the treatment of idiopathic
pulmonary fibrosis (IPF).
Not included on the Fife
Formulary pending
protocol.
Scottish Medicines
Consortium nintedanib (Ofev)
Formulary choice is
Pirfenidone
SMC restriction: For use in patients with a predicted forced vital
capacity (FVC) less than or equal to 80%.
Hospital use only.
Nintedanib, compared to placebo, reduces the decline in pulmonary
function assessed by forced vital capacity in patients with IPF.
This SMC advice takes account of the benefits of a Patient Access
Scheme (PAS) that improves the cost-effectiveness of nintedanib. This
advice is contingent upon the continuing availability of the PAS in NHS
Scotland or a list price that is equivalent or lower.
September
2015
1088/15
insulin degludec/liraglutide 100 units/mL /
3.6mg/mL solution for injection pre-filled pen
(Xultophy®)
Novo Nordisk A/S
Treatment of adults with type 2 diabetes mellitus
to improve glycaemic control in combination with
oral glucose-lowering medicinal products when
these alone or combined with a GLP-1 receptor
agonist or with basal insulin do not provide
adequate glycaemic control
Comparator Medicines:
GLP-1 receptor agonist plus a long-acting insulin.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting
insulin degludec/liraglutide (Xultophy®) is accepted for restricted use
within NHS Scotland.
Indication under review: Treatment of adults with type 2 diabetes
mellitus to improve glycaemic control in combination with oral glucoselowering medicinal products when these alone or combined with a GLP-1
receptor agonist or with basal insulin do not provide adequate glycaemic
control.
Not included on the Fife
Formulary as clinicians do
not support formulary
inclusion.
Fife Formulary Chapter 6
Not preferred.
SMC restriction: for use in patients who are uncontrolled on basal
insulin analogues (glycosylated haemoglobin [HbA1c] >7.5%
[59mmol/mol]) and for whom a GLP-1 receptor agonist is appropriate as
an add-on intensification therapy to basal insulin to obtain glucose
control.
Formulary choice insulin
analogues are –
Insulin glargine
Insulin detemir
Formulary choice GLP-1
agonists are –
Lixisenatide
Exenatide once weekly
Liraglutide
In two phase III studies treatment with insulin degludec/liraglutide
resulted in a significant reduction from baseline to week 26 in HbA1c
compared with the basal insulin comparators
September
2015
1092/15
empagliflozin
plus
metformin
5mg/85mg,
5mg/1000mg, 12.5mg/850mg, 12.5mg/1000mg
®
film-coated tablets (Synjardy )
Boehringer Ingelheim Ltd
Product Update
empagliflozin/metformin (Synjardy®) is accepted for restricted use
within NHS Scotland.
Indication under review: in adults aged 18 years and older with type 2
diabetes mellitus as an adjunct to diet and exercise to improve glycaemic
control;

in patients inadequately controlled on their maximally tolerated
dose of metformin alone

in patients inadequately controlled with metformin in combination
6 of 10
Scottish Medicines
Consortium insulin
degludec/liraglutide
(Xultophy)
Not included on the Fife
Formulary as clinicians do
not support Formulary
inclusion.
Scottish Medicines
Consortium
empagliflozin/metformin
(Synjardy)
Fife Formulary Chapter 6
Not preferred.
SMC Advice - Formulary Decisions August-September 2015

Formulary choice gliflozin is
Dapagliflozin.
with other glucose-lowering medicinal products, including insulin
in patients already being treated with the combination of
empagliflozin and metformin as separate tablets.
SMC restriction:

for use in patients for whom this fixed dose combination of
empagliflozin and metformin is considered appropriate.

for use as dual therapy (empagliflozin and metformin) when a
sulphonylurea is inappropriate.
September
2015
1077/15
radium-223 dichloride 1000kBq/mL solution for
injection (Xofigo®)
Bayer Pharma AG
For the treatment of adults with castrationresistant prostate cancer, symptomatic bone
metastases and no known visceral metastases
Comparator Medicines:
Since radium-223 can be used in patients with
castration-resistant
prostate
cancer
and
symptomatic bone metastases irrespective of their
previous therapy, it is difficult to define directly
relevant comparators. Other agents that may be
used include docetaxel, cabazitaxel (not
recommended
by
SMC),
abiraterone,
enzalutamide and strontium-89.
September
2015
623/10
trastuzumab 150mg powder for concentrate for
solution for infusion (Herceptin®)
Roche Products Ltd
2nd resubmission
In combination with capecitabine or fluorouracil
and cisplatin for the treatment of patients with
HER2 positive metastatic adenocarcinoma of the
stomach or gastro-oesophageal junction who
have not received prior anti-cancer treatment for
their metastatic disease. Trastuzumab should
only be used in patients with metastatic gastric
cancer
whose
tumours
have
HER2
overexpression as defined by IHC2+ and a
confirmatory FISH+ result, or IHC 3+, as
determined by an accurate and validated assay.
Comparator Medicines:
Triplet chemotherapy regimens consisting of
Empagliflozin/metformin (Synjardy®) has the potential to reduce the pill
burden at no additional cost
radium-223 dichloride (Xofigo®) is accepted for use within NHS
Scotland.
Not included pending
protocol.
Indication under review: for the treatment of adults with castrationresistant prostate cancer, symptomatic bone metastases and no known
visceral metastases.
Scottish Medicines
Consortium radium 223
(Xofigo)
Requires SCAN submission
and consideration by Lothian
Formulary Committee.
In a randomised phase III study of adult men with castration-resistant
prostate cancer with symptomatic bone metastases and no known
visceral metastases, treatment with radium-223 dichloride was
associated with a significant improvement in overall survival compared to
placebo.
This advice takes account of the benefits of a Patient Access Scheme
(PAS) that improves the cost-effectiveness of radium-223 dichloride.
This advice is contingent upon the continuing availability of the patient
access scheme in NHS Scotland or a list price that is equivalent or
lower.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting
trastuzumab (Herceptin®) is accepted for restricted use within NHS
Scotland.
Indication under review: in combination with capecitabine or
fluorouracil and cisplatin for the treatment of patients with HER2 positive
metastatic adenocarcinoma of the stomach or gastro-oesophageal
junction who have not received prior anti-cancer treatment for their
metastatic disease. It is indicated for use only in patients with metastatic
gastric cancer whose tumours have HER2 overexpression as defined by
IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an
accurate and validated assay.
SMC restriction: for use in patients whose tumours have HER2
overexpression defined by immunohistochemistry (IHC) 3+ (“HER2 high
expresser”).
The addition of trastuzumab to doublet chemotherapy improved overall
and progression-free survival and tumour response.
This advice takes account of the views from a Patient and Clinician
7 of 10
Not included pending
protocol.
Scottish Medicines
Consortium trastuzumab
(Herceptin)
Requires SCAN submission
and consideration by Lothian
Formulary Committee.
SMC Advice - Formulary Decisions August-September 2015
epirubicin, a platinum-based agent and a
fluoropyrimidine are used in the treatment of
metastatic gastric cancer. SMC clinical experts
have advised that EOX is the most commonly
used chemotherapy regimen in NHS Scotland.
Epirubicin, cisplatin and capecitabine (ECX);
epirubicin, cisplatin, and fluorouracil (ECF); and
epirubicin, oxaliplatin and fluorouracil (EOF) may
also be used.
Engagement (PACE) meeting
Docetaxel in combination with cisplatin and
fluorouracil is licensed for the same indication;
however, SMC has issued advice that it is not
recommended for use within NHS Scotland as the
marketing authorisation holder has not made a
submission to SMC.
September
2015
873/13
abiraterone acetate 250mg tablets (Zytiga®)
Janssen-Cilag Ltd
abiraterone acetate (Zytiga®) is accepted for use within NHS Scotland.
Abiraterone acetate is indicated with prednisone
or prednisolone for the treatment of metastatic
castration resistant prostate cancer in adult men
who are asymptomatic or mildly symptomatic after
failure of androgen deprivation therapy in whom
chemotherapy is not yet clinically indicated
Comparator Medicines:
Watch and wait.
Not included pending
protocol.
Indication under review: abiraterone acetate is indicated with
prednisone or prednisolone for the treatment of metastatic castration
resistant prostate cancer (mCRPC) in adult men who are asymptomatic
or mildly symptomatic after failure of androgen deprivation therapy in
whom chemotherapy is not yet clinically indicated.
Scottish Medicines
Consortium abiraterone
(Zytiga)
Requires SCAN submission
and consideration by Lothian
Formulary Committee.
In a randomised, double-blind phase III study of adult men with
chemotherapy-naive mCRPC, treatment with abiraterone acetate in
combination with corticosteroid was associated with a statistically
significant extended progression-free survival and overall survival when
compared with placebo plus corticosteroid.
This advice takes account of the benefits of a Patient Access Scheme
(PAS) that improves the cost-effectiveness of abiraterone acetate. This
advice is contingent upon the continuing availability of the patient access
scheme in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting.
September
2015
872/13
everolimus 2.5mg, 5mg
(Afinitor®)
Biomarin Europe Limited
and
10mg
tablet
Resubmission
For the treatment of hormone receptor-positive,
HER2/neu negative advanced breast cancer, in
combination with exemestane, in postmenopausal
women without symptomatic visceral disease after
recurrence or progression following a nonsteroidal aromatase inhibitor
everolimus (Afinitor®) is not recommended for use within NHS
Scotland.
Indication under review: For the treatment of hormone receptorpositive, HER2/neu negative advanced breast cancer, in combination
with exemestane, in postmenopausal women without symptomatic
visceral disease after recurrence or progression following a non-steroidal
aromatase inhibitor.
The addition of everolimus to exemestane treatment significantly
increased progression free survival compared with exemestane alone in
postmenopausal women with disease progression following a nonsteroidal aromatase inhibitor.
Comparator Medicines:
8 of 10
Not recommended.
Requires submission and
approval of an IPTR before
prescribing.
Scottish Medicines Consortium
everolimus (Afinitor)
The submitting company did not
present a sufficiently robust
economic analysis to gain
acceptance by SMC.
SMC Advice - Formulary Decisions August-September 2015
Endocrine therapies used after non-steroidal AIs
include: exemestane, tamoxifen, megestrol and
fulvestrant.
Fulvestrant has been not
recommended for use by SMC.
September
2015
1093/15
budesonide 9mg prolonged
(Cortiment®)
Ferring Pharmaceuticals
Product Update
release
tablets
The submitting company did not present a sufficiently robust economic
analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting
budesonide (Cortiment®) is not recommended for use within NHS
Scotland.
Indication under review: in adults for induction of remission in patients
with mild to moderate active ulcerative colitis (UC) where 5-ASA
treatment is not sufficient.
In two, phase III, placebo-controlled studies, significantly higher
proportions of patients achieved clinical and colonoscopic remission at
week 8 with budesonide (Cortiment®) 9mg once daily compared to
placebo. However, similar clinical effectiveness with the reference
product, a rectal formulation of budesonide, has not been demonstrated.
9 of 10
Not recommended.
Requires submission and
approval of an IPTR before
prescribing.
Scottish Medicines
Consortium budesonide
(Cortiment)
Lack of evidence of clinical
effectiveness.
SMC Advice - Formulary Decisions August-September 2015
Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines August - October 2015
Product Name
SMC Advice
Place in therapy
sorafenib
film-coated
(Nexavar®)
Bayer Plc
sorafenib (Nexavar®) is accepted for use within NHS Scotland.
Sorafenib is indicated for the treatment of patients with
progressive, locally advanced or metastatic
differentiated thyroid carcinoma (DTC) refractory to
radioactive iodine.
200mg
tablets
Indication under review: treatment of patients with progressive,
locally advanced or metastatic, differentiated thyroid carcinoma,
refractory to radioactive iodine.
Treatment with sorafenib demonstrated a significant, clinically
relevant five-month improvement in median progression free
survival compared with placebo in patients with progressive,
locally advanced or metastatic, differentiated thyroid carcinoma,
refractory to radioactive iodine.
This SMC advice takes account of the benefits of a Patient
Access Scheme (PAS) that improves the cost-effectiveness of
sorafenib. This advice is contingent upon the continuing
availability of the PAS in NHS Scotland or a list price that is
equivalent or lower.
docetaxel
This advice takes account of the views from a Patient and
Clinician Engagement (PACE) meeting.
Submission for off-label use.
Lothian formulary
Committee
Decision
Add to additional list,
Specialist use only.
Added to Fife Formulary
Yes / No
Rationale
No.
Patients will be treated
in Lothian.
Starting dose is 400mg twice daily taken continuously until
disease progression (broken down into 28-day cycles).
All patients will be discussed at the thyroid MDT prior to
offering sorafenib
There are currently no active anti-cancer medicines in
routine use for this patient group.
Monitoring requirements
Monthly blood tests for a median of 11 months.
Monthly clinic visits for a median of 11 months
3 monthly CT scans for a median of 11 months.
Baseline ECG before each cycle .
Early use of docetaxel upon diagnosis of metastatic or
locally advanced prostate
cancer.
Patients with newly diagnosed (within 3 months of starting
LHRH analogue or antagonist therapy)
metastatic or locally advanced (TanyN1M0 or T3-4N0M0)
prostate cancer with a performance status of 0 -1
and no contraindication to chemotherapy (e.g. marrow
failure).
Docetaxel will be offered upfront at diagnoses alongside
standard hormonal therapy. It is anticipated that
this will displace docetaxel currently used at later stages of
treatment. It is possible that some patients
with a long progression free survival may be re-challenged
with docetaxel in the hormone refractory
setting. Clinician experience is that this will only apply to a
very small patient group (may be around 10
patients per year) due to the emergence of new treatment
options in this therapeutic area and lack of
fitness to receive chemotherapy in later stages of disease.
Treatment will be repeated every 21 days for 6 cycles.
10 of 10
Off label use
approved.
Off-label use for this indication
approved.
Specialist use only.
Already listed
on the Fife Formulary.