SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
Scottish Medicines Consortium Recommendations
Date
Product/Manufacturer
February
fosfomycin 40mg/mL powder for solution for
2015
intravenous infusion (Fomicyt®)
Nordic Pharma
1033/15
Product Update
SMC Advice
fosfomycin (Fomicyt®) is accepted for restricted use within NHS Scotland.
Decision of ADTC
Included on the Fife Formulary.
Indication under review: for the treatment of the following infections in
adults and children including neonates:
- Acute osteomyelitis
- Complicated urinary tract infections
- Nosocomial lower respiratory tract infections
- Bacterial meningitis
- Bacteraemia that occurs in association with, or is suspected to be
associated with, any of the infections listed above
Restricted to use if recommended
by a microbiologist.
Rationale
Scottish Medicines
Consortium fosfomycin
(Fomicyt)
Add to restricted hospital
antimicrobial list.
Hospital use only.
Fosfomycin should be used only when it is considered inappropriate to use
antibacterial agents that are commonly recommended for the initial treatment
of the infections listed above, or when these alternative antibacterial agents
have failed to demonstrate efficacy.
Consideration should be given to national guidance on the appropriate use of
antibacterial agents.
SMC restriction: initiation by microbiologists or infectious disease
specialists.
Unlicensed preparations of intravenous fosfomycin are commonly used in
the NHS in Scotland to treat multi-drug resistant gram negative organisms.
This provides a licensed preparation. Estimated patient numbers are
expected to be small.
February
2015
1030/15
ledipasvir/sofosbuvir, 90mg/400mg, film-coated
tablet (Harvoni®)
Gilead Sciences Ltd
ledipasvir/sofosbuvir (Harvoni®) is accepted for restricted use within NHS
Scotland.
Included on the Fife Formulary.
Indication under review: treatment of chronic hepatitis C (CHC) in adults.
Restricted to use in patients with
genotype 1 and genotype 4.
SMC restriction: genotype 1 and 4 CHC only.
Hospital use only.
Treatment of chronic hepatitis C (CHC) in adults
Comparator Medicines:
Sofosbuvir,
simeprevir,
daclatasvir
in
peginterferon-free regimens or in combination with
peginterferon plus ribavirin.
Telaprevir and
boceprevir in combination with peginterferon plus
ribavirin
In three, uncontrolled phase III studies conducted in treatment-naïve and
treatment-experienced non-cirrhotic and cirrhotic patients with genotype 1
CHC, ledipasvir/sofosbuvir ± ribavirin achieved sustained virological
response (at 12 weeks post treatment) rates of 93% to 99%, which were
significantly superior to historical control rates.
No clinical or economic data were presented for genotype 3 patients with
cirrhosis and/or prior treatment failure.
1 of 9
Scottish Medicines
Consortium ledipasvirsofosbuvir (Harvoni)
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
February
2015
1026/15
idelalisib 100mg and 150mg tablets (Zydelig®)
Gilead Sciences Ltd
In combination with rituximab for the treatment of
adult patients with chronic lymphocytic leukaemia
(CLL):
• who have received at least one prior therapy,
or
• as first line treatment in the presence of 17p
deletion or TP53 mutation in patients
unsuitable for chemo-immunotherapy.
February
2015
867/13
idelalisib (Zydelig®) is accepted for restricted for use within NHS Scotland.
Included on the Fife Formulary.
Indication under review: In combination with rituximab for the treatment of
adult patients with chronic lymphocytic leukaemia (CLL):
• who have received at least one prior therapy, or
• as first line treatment in the presence of 17p deletion or TP53 mutation in
patients unsuitable for chemo-immunotherapy.
Restricted to use in patients with
relapsed
chronic
lymphocytic
leukaemia who are unsuitable for
chemotherapy and treatment naïve
patients with 17p deletion or TP53
mutation who are unsuitable for
chemo-immunotherapy.
SMC restriction: patients with relapsed CLL who are unsuitable for
chemotherapy and treatment naïve patients with 17p deletion or TP53
mutation who are unsuitable for chemo-immunotherapy.
Hospital use only.
Comparator Medicines:
For patients with 17p deletion and/or TP53
mutation unsuitable for chemo-immunotherapy,
first-line treatment would be alemtuzumab
(unlicensed)
plus
pulsed
high
dose
corticosteroids. For patients with relapsed CLL
treatment options include FCR, chlorambucil ±
high dose steroids, chlorambucil ± rituximab,
bendamustine
±
rituximab,
alemtuzumab
(unlicensed) ± high dose steroids, rituximab plus
high dose steroids, or high dose steroids alone.
As noted previously, the marketing authorisation
for alemtuzumab (Mabcampath®) for treatment of
CLL was withdrawn by the company for
commercial reasons. It is now available through a
patient access programme.
Idelalisib in combination with an anti-CD20 antibody significantly improves
progression free survival compared with an anti-CD20 antibody alone in
patients with relapsed CLL. The treatment effect across subgroups with 17p
deletion and/or TP53 mutation was consistent with that of the total study
population.
ruxolitinib (as phosphate), 5mg, 15mg, & 20mg
tablets (Jakavi®)
Novartis Pharmaceuticals UK Ltd
ruxolitinib (Jakavi®) is accepted for use within NHS Scotland.
Included on the Fife Formulary.
Indication under review: the treatment of disease-related splenomegaly or
symptoms in adult patients with primary myelofibrosis (also known as chronic
idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post
essential thrombocythaemia myelofibrosis.
Hospital use only.
The treatment of disease-related splenomegaly or
symptoms in adult patients with primary
myelofibrosis (also known as chronic idiopathic
myelofibrosis),
post
polycythaemia
vera
myelofibrosis or post essential thrombocythaemia
myelofibrosis
Comparator Medicines:
There are no currently available licensed
treatments for myelofibrosis. Hydroxycarbamide is
the predominant pharmacological treatment used
for splenomegaly and other agents such as
anagrelide, thalidomide, danazol are used to
manage
haematological
manifestations
of
myelofibrosis. None are specifically licensed for
use in myelofibrosis.
Scottish Medicines
Consortium idelalisib
(Zydelig)
This SMC advice takes account of the benefits of a Patient Access Scheme
(PAS) that improves the cost-effectiveness of idelalisib. It is contingent upon
the continuing availability of the patient access scheme in NHS Scotland or a
list price that is equivalent or lower
In patients with myelofibrosis, a significantly greater proportion of patients
achieved a spleen response (reduction in spleen volume of at least 35%
from baseline) at 48 weeks when treated with ruxolitinib compared with best
available therapy. Ruxolitinib was also associated with a greater proportion
of patients reporting a clinically significant reduction in myelofibrosis-related
symptoms when compared with placebo.
This advice takes account of the benefits of a Patient Access Scheme (PAS)
that improves the cost effectiveness of ruxolitinib. It 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.
2 of 9
Scottish Medicines
Consortium ruxolitinib
(Jakavi)
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
February
2015
1029/15
apixaban, 2.5mg & 5mg, film-coated tablets
(Eliquis®)
Bristol-Myers Squibb and Pfizer
Treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and prevention of
recurrent DVT and PE in adults
Comparator Medicines:
Dabigatran, rivaroxaban, low molecular weight
heparin and warfarin
February
2015
1023/15
dabrafenib, 50mg and 75mg hard capsules
(Tafinlar®)
GlaxoSmithKline
Dabrafenib monotherapy for the treatment of adult
patients with unresectable or metastatic
melanoma with a BRAF V600 mutation
Comparator Medicines:
Vemurafenib, ipilimumab.
apixaban (Eliquis®) is accepted for use within NHS Scotland.
Indication under review: treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.
Two phase III studies demonstrated efficacy and safety of apixaban. One
study showed non-inferiority of apixaban versus standard anticoagulant
therapy including a low molecular weight heparin in combination with a
vitamin K antagonist for treatment of DVT/PE with a lower rate of major and
clinically relevant non-major bleeding. In a 12 month study apixaban
demonstrated superiority versus placebo for the prevention of recurrent
DVT/PE with a similar bleeding profile to placebo
dabrafenib (Tafinlar®) is accepted for restricted use within NHS Scotland.
Not included on the Fife Formulary
as the medicine does not represent
sufficient added benefit to other
comparator medicines to treat the
condition in question.
Scottish Medicines
Consortium apixaban
(Eliquis)
http://www.fifeadtc.scot.
nhs.uk/formulary/2cardiovascular.aspx
Not preferred.
Not included pending protocol.
Indication under review: monotherapy treatment of adult patients with
unresectable or metastatic melanoma with a BRAF V600 mutation.
Formulary choice NOAC
is rivaroxaban.
Scottish Medicines
Consortium dabrafenib
(Tafinlar)
Await SCAN submission
to Lothian Formulary
Committee.
SMC restriction: for use in patients with unresectable or metastatic
BRAFV600 mutation-positive metastatic melanoma who have received no
prior therapy.
In a phase III randomised open-label study, treatment with dabrafenib
extended median progression free survival by 4.2 months compared with
chemotherapy.
This SMC advice takes account of the benefits of a Patient Access Scheme
(PAS) that improves the cost-effectiveness of dabrafenib. It 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.
February
2015
1022/15
cabozantinib 20mg and 80mg hard capsules
(Cometriq®)
Swedish Orphan Biovitrum Ltd
For the treatment of adult patients with
progressive, unresectable locally advanced or
metastatic medullary thyroid carcinoma. For
patients in whom Rearranged during Transfection
(RET) mutation status is unknown or is negative,
a possible lower benefit should be taken into
account before individual treatment decision
Comparator Medicines:
The only other medicine licensed for use for
medullary thyroid cancer is vandetanib which has
not been recommended for use in NHS Scotland
by SMC
cabozantinib (Cometriq®) is not recommended for use within NHS
Scotland.
Indication under review: for the treatment of adult patients with
progressive, unresectable locally advanced or metastatic medullary thyroid
carcinoma.
In one pivotal, phase III study, cabozantinib was associated with a significant
advantage in progression-free survival over placebo. However, the difference
between cabozantinib and placebo did not reach statistical significance in the
subgroup of patients with Rearranged during Transfection (RET) negative
tumours. The summary of product characteristics therefore notes that for
patients in whom RET mutation status is unknown or is negative, a possible
lower benefit should be taken into account before individual treatment
decision.
The submitting company did not present a sufficiently robust 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.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting.
3 of 9
Not recommended.
Requires submission and approval
of an IPTR before prescribing.
Scottish Medicines
Consortium
cabozantinib (Cometriq)
Lack of evidence of
health benefits
compared to cost.
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
March
2015
1034/15
aclidinium/formoterol fumarate dihydrate 340/12
micrograms inhalation powder (Duaklir Genuair®)
Almirall / AstraZeneca
Maintenance bronchodilator treatment to relieve
symptoms in adult patients with chronic
obstructive pulmonary disease.
Comparator Medicines:
Relevant comparators to umeclidinium/vilanterol
are combination treatments with an inhaled LABA
and an inhaled LAMA: formoterol, indacaterol,
salmeterol (LABAs) and aclidinium, umeclidinium,
glycopyrronium,
tiotropium
(LAMAs).
The
combination products, indacaterol/glycopyrronium
(Ultibro Breezhaler®) and umeclidinium/vilanterol
(Anoro®) are also licensed.
March
2015
1038/15
fingolimod 0.5mg hard capsules (Gilenya®)
Novartis Pharmaceuticals UK
As single disease modifying therapy in highly
active relapsing remitting multiple sclerosis
(RRMS) for the following adult patient groups:
- Patients with high disease activity despite
treatment with at least one disease modifying
therapy (for exceptions and information about
washout periods see sections 4.4 and 5.1 of
summary of product characteristics [SPC]).
These patients may be defined as those who have
failed to respond to a full and adequate course
(normally at least one year of treatment) of at
least one disease modifying therapy. Patients
should have had at least 1 relapse in the previous
year while on therapy, and have at least 9 T2hyperintense lesions in cranial magnetic
resonance imaging (MRI) or at least 1
Gadolinium-enhancing lesion. A “non-responder”
could also be defined as a patient with an
unchanged or increased relapse rate or ongoing
severe relapses, as compared to the previous
year.
or Patients with rapidly evolving severe RRMS
defined by 2 or more disabling relapses in one
year, and with 1 or more Gadolinium-enhancing
lesions on brain MRI or a significant increase in
T2 lesion load as compared to a previous recent
MRI
Comparator Medicines:
Intramuscular interferon-beta 1a (Avonex,®)
subcutaneous
interferon-beta
1a
(Rebif®);
subcutaneous interferon-beta 1b (Betaferon,®
Extavia®); dimethyl fumarate.
aclidinium/formoterol fumarate dihydrate (Duaklir Genuair®) is accepted
for use within NHS Scotland.
Indication under review: Maintenance bronchodilator treatment to relieve
symptoms in adult patients with chronic obstructive pulmonary disease.
Included on the Fife Formulary.
For use in patients requiring a
LABA/LAMA combination when
treatment with aclidinium or
formoterol has been ineffective.
Scottish Medicines
Consortium
aclidinium/formoterol
fumarate dihydrate
(Duaklir Genuair)
In two 24-week comparator- and placebo-controlled phase III studies,
treatment with aclidinium/formoterol 340/12 microgram resulted in
statistically significant improvements in FEV1 % predicted pre-dose (versus a
LABA) and post-dose (versus a LAMA).
fingolimod (Gilenya®) is accepted for use within NHS Scotland.
Indication under review: as a single disease modifying therapy in highly
active relapsing remitting multiple sclerosis (RRMS) for the following adult
patient groups:
- Patients with high disease activity despite treatment with at least one
disease modifying therapy.
Analysis of a subgroup of patients who had high disease activity despite prior
disease modifying therapy in the year before study entry found that over a 12
month period fingolimod reduced the annualised relapse rate compared with
another disease modifying therapy by 61% in patients who received prior
interferon beta, and by 50% in patients who had received any prior disease
modifying therapy.
This advice takes account of the benefits of a Patient Access Scheme (PAS)
that improves the cost effectiveness of fingolimod. This advice is contingent
upon the continuing availability of the patient access scheme, or a list price
that is equivalent or lower, in NHS Scotland.
4 of 9
Included on the Fife Formulary for
the new indication.
Hospital use only.
Scottish Medicines
Consortium fingolimod
(Gilenya)
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
March
2015
1036/15
levonorgestrel 13.5mg
system (Jaydess®)
Bayer
intrauterine
delivery
Contraception for up to 3 years.
Comparator Medicines:
Progestogen-only LARCS: levonorgestrel 52mg
IUS (Mirena®), medroxyprogesterone acetate
contraceptive injection (Depo-Provera® and
Sayana Press®), etonogestrel contraceptive
implant (Nexplanon®).7
levonorgestrel (Jaydess®) is accepted for use within NHS Scotland.
Included on the Fife Formulary.
Indication under review: Contraception for up to 3 years.
2nd line formulary choice - only for
use in patients where the Mirena®
IUS is considered unsuitable.
A phase III, open-label, randomised study confirmed the contraceptive
efficacy of levonorgestrel 13.5mg intrauterine delivery system according to
the Pearl Index.
Scottish Medicines
Consortium
levonorgestrel (Jaydess)
Other
contraceptives:
combined
hormonal
contraceptives, progestogen-only contraceptives,
intrauterine devices (e.g. copper devices).
March
2015
1032/15
ponatinib 15mg, 45mg film-coated
(Iclusig®)
ARIAD pharmaceuticals, Inc
tablets
Adult patients with
 Chronic phase, accelerated phase, or blast
phase chronic myeloid leukaemia (CML) who
are resistant to dasatinib or nilotinib; who are
intolerant to dasatinib or nilotinib and for
whom subsequent treatment with imatinib is
not clinically appropriate; or who have the
T315I mutation.
 Philadelphia chromosome positive acute
lymphoblastic leukaemia (Ph+ALL) who are
resistant to dasatinib; who are intolerant to
dasatinib and for whom subsequent treatment
with imatinib is not clinically appropriate; or
who have the T315I mutation.
Comparator Medicines:
Current drug treatments for CML include the first
generation tyrosine kinase inhibitor, imatinib
(commonly used first-line) and the second
generation tyrosine kinase inhibitors, nilotinib
(used first- or second-line) and dasatinib (which is
not recommended by National Institute for Health
and Care Excellence [NICE] multiple technology
appraisals [MTA] 241 and 251 and this advice has
been endorsed in Scotland).2,3
Options in patients with CML and the T315I
mutation who are not suitable for allogenic SCT
are considered to be palliative/supportive therapy
and include hydroxycarbamide and interferon alfa.
ponatinib (Iclusig®) is accepted for use within NHS Scotland.
Indication under review: Adult patients with
 Chronic phase, accelerated phase, or blast phase chronic myeloid
leukaemia (CML) who are resistant to dasatinib or nilotinib; who are
intolerant to dasatinib or nilotinib and for whom subsequent treatment with
imatinib is not clinically appropriate; or who have the T315I mutation.
 Philadelphia chromosome positive acute lymphoblastic leukaemia
(Ph+ALL) who are resistant to dasatinib; who are intolerant to dasatinib
and for whom subsequent treatment with imatinib is not clinically
appropriate; or who have the T315I mutation.
A non-comparative phase II study of ponatinib was conducted with primary
outcomes of major cytogenetic response in patients with baseline chronic
phase CML and major haematologic response in patients with baseline
accelerated or blast phase CML or Ph+ALL. Ponatinib demonstrated efficacy
in heavily pre-treated CML and Ph+ALL patients who had received
dasatinib/nilotinib as second line or further line tyrosine kinase inhibitor
therapy or who had the T315I mutation.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting.
5 of 9
Included on the Fife Formulary –
additional list.
Restricted use for patients with a
T3151 mutation or when imatinib,
dasatinib and nilotinib are
unsuitable.
Hospital use only.
Scottish Medicines
Consortium ponatinib
(Iclusig)
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
March
2015
1035/15
sucroferric oxyhydroxide 500mg chewable
tablets (Velphoro®)
Fresenius Medical Care (UK) Ltd.
For the control of serum phosphorus levels in
adult chronic kidney disease (CKD) patients on
haemodialysis (HD) or peritoneal dialysis (PD). It
should be used within the context of a multiple
therapeutic approach, which could include calcium
supplement, 1,25-dihydroxy vitamin D3 or one of
its analogues, or calcimimetics to control the
development of renal bone disease
1007/14
1006/14
November
2014
(Issued
March
2015)
Comparator Medicines:
Medicines licensed to control serum phosphorus
levels include: calcium salts (calcium acetate and
calcium carbonate), lanthanum carbonate,
sevelamer
(hydrochloride
and
carbonate),
aluminium hydroxide and colestilan. Colestilan is
not recommended for use in NHS Scotland by
SMC
infliximab, 100mg, powder for concentrate for
solution for infusion (Inflectra®)
Hospira UK Ltd
infliximab, 100mg, powder for concentrate for
solution for infusion (Remsima®)
Celltrion Healthcare Hungary Kft.
Comparator Medicines:
Infliximab (Remicade®). Other biosimilars may
become available.
sucroferric oxyhydroxide (Velphoro®) is accepted for use within NHS
Scotland.
Not included on the Fife Formulary
as clinicians do not support
formulary inclusion.
Indication under review: For the control of serum phosphorus levels in
adult chronic kidney disease (CKD) patients on haemodialysis (HD) or
peritoneal dialysis (PD). It should be used within the context of a multiple
therapeutic approach, which could include calcium supplement, 1,25dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the
development of renal bone disease.
http://www.fifeadtc.scot.
nhs.uk/formulary/9nutrition-and-blood.aspx
Not preferred.
Current formulary
choices are
Calcium salts
lanthanum
sevelamer.
After 12 weeks, sucroferric oxyhydroxide was non-inferior to a non-calcium,
non-aluminium-based phosphate binder at lowering serum phosphorus
levels in adults with CKD, receiving HD or PD.
infliximab (Inflectra®) / Infliximab (Remsima®) is accepted for restricted
use within NHS Scotland.
Indication under review: Rheumatoid arthritis: in combination with
methotrexate, for the reduction of signs and symptoms as well as
improvement in physical function in:

adult patients with active disease when the response to diseasemodifying antirheumatic drugs (DMARDs), including methotrexate
has been inadequate;

adult patients with severe, active and progressive disease not
previously treated with methotrexate or other DMARDs.
Infliximab (Inflectra®) / Infliximab (Remsima®) is also indicated in the
following conditions: adult and paediatric Crohn’s disease and ulcerative
colitis; adult ankylosing spondylitis, psoriatic arthritis and psoriasis.1
SMC restriction: Infliximab (Inflectra®) / Infliximab (Remsima®) is accepted
for use in line with the current SMC and Healthcare Improvement Scotland
advice for the reference product infliximab [Remicade®].
A phase III, randomised, double-blind, parallel-group study demonstrated
similar efficacy and safety of biosimilar infliximab with originator infliximab in
patients with rheumatoid arthritis.
Infliximab (Inflectra®) / Infliximab (Remsima®) is a biosimilar product to a
reference product (infliximab [Remicade®]). The British National Formulary
advises that it is good practice to prescribe biologic medicinal products by
brand name.
6 of 9
Scottish Medicines
Consortium sucroferric
oxyhydroxide (Velphoro)
Not included pending protocol.
Scottish Medicines
Consortium infliximab
(Infectra)
Scottish Medicines
Consortium infliximab
(Remsima)
Await finalisation of
national biosimilar
framework.
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
March
2015
1041/15
tacrolimus (as monohydrate) 0.75mg, 1mg and
4mg prolonged- release tablets (Envarsus®)
Chiesi Ltd
Product Update
tacrolimus (Envarsus®) prolonged release-tablets are accepted for use
within NHS Scotland.
Not included pending protocol.
Indication under review: Prophylaxis of transplant rejection in adult kidney
or liver allograft recipients and treatment of allograft rejection resistant to
treatment with other immunosuppressive medicinal products in adult
patients.
Await Lothian and
Greater Glasgow and
Clyde Formulary
Committee decisions.
Tacrolimus (Envarsus®) is suitable for use by patients for whom tacrolimus is
an appropriate choice of immunosuppressive therapy. It has increased
bioavailability compared with other tacrolimus preparations. Tacrolimus
(Envarsus®) has demonstrated non-inferiority to a tacrolimus immediaterelease capsule and has a similar cost per equivalent dose.
March
2015
1027/15
nintedanib 100mg and 150mg soft capsules
(Vargatef®)
Boehringer Ingelheim International GmbH
In combination with docetaxel for the treatment of
adult patients with locally advanced, metastatic or
locally recurrent non-small cell lung cancer
(NSCLC) of adenocarcinoma tumour histology
after first-line chemotherapy.
Comparator Medicines:
Docetaxel, erlotinib and pemetrexed. Gefitinib is
not recommended by SMC.
March
2015
1031/15
regorafenib 40mg film-coated tablet (Stivarga®)
Bayer plc
Treatment of adult patients with unresectable or
metastatic gastrointestinal stromal tumors (GIST)
who progressed on or are intolerant to prior
treatment with imatinib and sunitinib.
Comparator Medicines:
There are no treatments specifically licensed for
use third-line following imatinib and sunitinib.
Imatinib re-challenge is recommended by Scottish
guidelines for symptomatic relief in the absence of
any suitable clinical study.
nintedanib (Vargatef®) is accepted for use within NHS Scotland.
Scottish Medicines
Consortium tacrolimus
(Envarsus)
Treatment will be
initiated in tertiary
centres.
Not included pending protocol.
Indication under review: in combination with docetaxel for the treatment of
adult patients with locally advanced, metastatic or locally recurrent non-small
cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line
chemotherapy.
Scottish Medicines
Consortium nintedanib
(Vargatef)
Await SCAN submission
to Lothian Formulary
Committee.
Addition of nintedanib to second-line treatment of stage IIIb/IV NSCLC with
docetaxel significantly increased overall survival in the subgroup patients
with adenocarcinoma tumour histology.
This advice takes account of the benefits of a Patient Access Scheme (PAS)
that improves the cost effectiveness of nintedanib and 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.
regorafenib (Stivarga®) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult patients with unresectable or
metastatic gastrointestinal stromal tumors (GIST) who progressed on or are
intolerant to prior treatment with imatinib and sunitinib.
In a study of patients with metastatic or unresectable GIST who had prior
treatment with imatinib and sunitinib, treatment with regorafenib prolonged
the median progression free survival by 3.9 months when compared with
placebo.
This advice takes account of the benefits of a Patient Access Scheme (PAS)
that improves the cost-effectiveness of regorafenib and 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.
7 of 9
Not included pending protocol.
Scottish Medicines
Consortium regorafenib
(Stivarga)
Await SCAN submission
to Lothian Formulary
Committee.
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
SMC Advice - Deferred Formulary Decisions
Date
December
2014
753/12
Product/Manufacturer
aztreonam lysine, 75mg, powder and solvent for
nebuliser solution (Cayston®)
Gilead Life Sciences Limited
Re-submission
Suppressive therapy of chronic pulmonary
infections due to Pseudomonas aeruginosa in
patients with cystic fibrosis aged six years and
older.
Consideration should be given to official guidance
on the appropriate use of antibacterial agents.
Comparator Medicines:
Inhaled colistimethate sodium and tobramycin.
SMC Advice
aztreonam lysine (Cayston®) is accepted for restricted use within NHS
Scotland.
Indication under review: Suppressive therapy of chronic pulmonary
infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
aged six years and older.
SMC restriction: When inhaled colistimethate sodium and inhaled
tobramycin are not tolerated or not providing satisfactory therapeutic benefit
(measured as ≥2% decline in forced expiratory volume in 1 second [FEV1]).
Aztreonam lysine has demonstrated superiority in improving lung function
and respiratory symptoms in one active-controlled study and two 28-day
placebo-controlled studies in patients with cystic fibrosis and chronic
Pseudomonas aeruginosa infection.
This advice takes account of the benefits of a Patient Access Scheme (PAS)
that improves the cost effectiveness of aztreonam lysine. It 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.
8 of 9
Decision of ADTC
Included on the Fife Formulary for
restricted use in patients where
alternative treatments
(colistimethate sodium, inhaled
tobramycin) are ineffective or not
tolerated.
Specialist initiation only.
Formulary status of inhaled
tobramycin and colistimethate
sodium changed to specialist
initiation.
Rationale
Scottish Medicines
Consortium aztreonam
lysine (Cayston)
SMC Advice - Formulary Decisions February-March 2015
CONFIDENTIAL
Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines February 2015 - March 2015
Product Name
SMC Advice
Place in therapy
Pemetrexed
(Alimta®)
Indication under review: monotherapy for the maintenance
treatment of locally advanced or metastatic non-small cell lung cancer
other than predominantly squamous cell histology in patients whose
disease has not progressed immediately following platinum-based
chemotherapy.
Will be used in patients with performance status
0 or1, non-progression patients of advanced
non-squamous non-small cell lung
cancer after 4 cycles of cisplatin and pemetrexed
first-line
chemotherapy. There are no existing treatments
currently used for maintenance therapy in this
setting.
In patients with locally advanced or metastatic non-squamous nonsmall cell lung cancer, maintenance treatment with pemetrexed,
following completion of first-line platinum-based chemotherapy, was
associated with prolonged overall survival and progression-free
survival when compared with placebo.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting
The use of pemetrexed maintenance
monotherapy has been shown to slightly reduce
the use of second-line systemic therapy for
NSCLC from 72% to 64%.
Evidence showed increased survival and added
benefit.
Response to therapy will be assessed by CT
scan every 12 weeks (4 cycles).
Patient will attend for bloods (incld. FBC, U&E’s,
LFT’s) and treatment administration every 3
weeks.
Patients will receive the following supportive
treatments:
Dexamethasone PO 4mg BD for 3 days each
cycle;
Folic acid PO 400mcg daily throughout
treatment,
Vit B12 1mg IM every 9 weeks
9 of 9
Lothian formulary Committee
Decision
Include on the Additional List, for
Specialist Hospital Use only, for the
indication in question.
Add to Fife Formulary
Yes / No
Yes
Hospital use only.