SMC Advice - Formulary Decisions June-July 2015
Scottish Medicines Consortium Recommendations
Date
Product/Manufacturer
June 2015
magnesium aspartate dihydrate equivalent to
1042/15
243mg (10mmol) of magnesium powder for oral
solution (Magnaspartate®)
Kora Corporation Limited
SMC Advice
magnesium aspartate dihydrate (Magnaspartate®) is accepted for use
within NHS Scotland.
Decision of ADTC
Included on the Fife
Formulary.
Indication under review: for the treatment and prevention of
magnesium deficiency, as diagnosed by a doctor
Specialist initiation only.
Product Update
This is the first licensed oral magnesium product to be available in the
UK for the treatment and prevention of magnesium deficiency.
Magnesium supplementation has previously been available as a food
supplement.
Rationale
SMC magnesium
aspartate dehydrate
(Magnaspartate)
Current alternative products
listed on the Fife Formulary
for use for this indication to
be removed.
Request patients currently
prescribed alternative
magnesium supplements are
reviewed and switched to
Magnaspartate where
appropriate with ongoing
monitoring of magnesium
serum levels.
June 2015
1067/15
posaconazole 300mg concentrate for solution for
infusion (Noxafil®)
Merck Sharp & Dohme Limited
Product Update
posaconazole concentrate for solution for infusion (Noxafil®) is
accepted for use within NHS Scotland.
Indication under review: for use in the treatment of the following fungal
infections in adults:

Invasive aspergillosis in patients with disease that is refractory
to amphotericin B or itraconazole or in patients who are
intolerant of these medicinal products;

Fusariosis in patients with disease that is refractory* to
amphotericin B or in patients who are intolerant of
amphotericin B;

Chromoblastomycosis and mycetoma in patients with disease
that is refractory to itraconazole or in patients who are
intolerant of itraconazole;

Coccidioidomycosis in patients with disease that is refractory
to amphotericin B, itraconazole or fluconazole or in patients
who are intolerant of these medicinal products.
For prophylaxis of invasive fungal infections (IFI) in the following
patients:

Patients receiving remission-induction chemotherapy for acute
myelogenous leukaemia (AML) or myelodysplastic syndromes
(MDS) expected to result in prolonged neutropenia and who
are at high risk of developing IFI;

Hematopoietic stem cell transplant (HSCT) recipients who are
undergoing high-dose immunosuppressive therapy for graft
versus host disease (GVHD) and who are at high risk of
developing IFI.
Posaconazole 300mg solution for infusion will generally result in higher
1 of 9
Not included on the Fife
Formulary because clinicians
do not support Formulary
inclusion.
SMC posaconazole
(Noxafil)
Fife Formulary Section
5
Not preferred.
Formulary choice for
prophylaxis is
itraconazole
SMC Advice - Formulary Decisions June-July 2015
plasma concentrations than posaconazole oral suspension and is
expected to result in similar plasma concentrations as the tablet
formulation. Posaconazole solution for infusion is more expensive than
oral preparations. It is intended for patients who are not able to receive
an oral formulation, and should be used for the minimum time required.
Patients should be switched to an oral formulation of posaconazole as
soon as clinically practical.
June 2015
1068/15
adalimumab (Humira®) 40 mg/0.8 ml solution
injection (Humira®)
AbbVie Ltd
Product Update
adalimumab (Humira®) is accepted for restricted use within NHS
Scotland.
Indication under review: Treatment of severe chronic plaque psoriasis
in children and adolescents from 4 years of age who have had an
inadequate response to or are inappropriate candidates for topical
therapy and phototherapies.
Included on the Fife
Formulary for the indication
stated.
SMC adalimumab
(Humira)
Hospital use only.
SMC restriction: Patients with severe disease as defined by a total
Psoriasis Area Severity Index (PASI) score of ≥10 and a Dermatology
Life Quality Index (DLQI) of >10.
Treatment with adalimumab in a paediatric population improves both
signs and symptoms of psoriasis and quality of life.
June 2015
1064/15
vedolizumab 300mg powder for concentrate for
solution for infusion (Entyvio®)
Takeda UK Ltd
For the treatment of adult patients with moderately
to severely active Crohn's disease who have had
an inadequate response with, lost response to, or
were intolerant to either conventional therapy or a
tumour necrosis factor-alpha (TNFα) antagonist.
Comparator Medicines:
Vedolizumab is the only medicine specifically
licensed for use in patients with Crohn’s disease
after failure, intolerance or contraindication to
TNFα antagonists. TNFα antagonists (infliximab
and adalimumab) licensed for Crohn’s disease do
not specify use after other TNFα antagonists.
vedolizumab (Entyvio®) is accepted for restricted use for use within
NHS Scotland.
Indication under review: for the treatment of adult patients with
moderately to severely active Crohn's disease who have had an
inadequate response with, lost response to, or were intolerant to either
conventional therapy or a tumour necrosis factor-alpha (TNFα)
antagonist.
SMC restriction: for the treatment of adult patients with moderately to
severely active Crohn's disease who have had an inadequate response
with, lost response to, or were intolerant to a TNFα antagonist.
In two clinical studies, more patients treated with vedolizumab achieved
clinical remission at week 6 compared with placebo but the difference
was only statistically significant in one study. One study included a
maintenance phase, and significantly more patients treated with
vedolizumab were in clinical remission at week 52 compared with
placebo.
Patients who continue treatment should be reassessed at least every 12
months to determine whether ongoing treatment is still clinically
appropriate. For people in complete remission at 12 months, consider
stopping vedolizumab, resuming treatment if there is a relapse.
This SMC advice takes account of the benefits of a Patient Access
Scheme (PAS) that improves the cost-effectiveness of vedolizumab. 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.
2 of 9
Not included on the Fife
Formulary because clinicians
have not responded to an
invitation to apply for
Formulary inclusion.
SMC vedolizumab
(Entyvio)
Fife Formulary Section
1
SMC Advice - Formulary Decisions June-July 2015
April 2015
1045/15
vedolizumab 300mg powder for concentrate for
solution for infusion (Entyvio®)
Takeda UK Ltd
The treatment of adult patients with moderately to
severely active ulcerative colitis who have had an
inadequate response with, lost response to, or
were intolerant to either conventional therapy or a
tumour necrosis factor-alpha (TNFα) antagonist
Comparator Medicines:
TNFα antagonists (infliximab, adalimumab,
golimumab)
and
conventional
therapy:
aminosalicylates
(e.g.
mesalazine),
corticosteroids,
immunosuppressants
(e.g.
azathioprine and mercaptopurine). Surgery is an
option for patients who do not respond to medical
interventions
vedolizumab (Entyvio®) is accepted for use within NHS Scotland.
Indication under review: the treatment of adult patients with moderately
to severely active ulcerative colitis who have had an inadequate
response with, lost response to, or were intolerant to either conventional
therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Not included on the Fife
Formulary because clinicians
have not responded to an
invitation to apply for
Formulary inclusion.
SMC vedolizumab
(Entyvio)
Not included on the Fife
Formulary because clinicians
do not support Formulary
inclusion.
SMC ceftobiprole
medocaril (Zevtera)
Fife Formulary Section
1
A higher proportion of patients treated with vedolizumab achieved a
clinical response at week six and clinical remission at week 52 compared
with placebo in a controlled phase III study.
Patients who continue treatment should be reassessed at least every 12
months to determine whether ongoing treatment is still clinically
appropriate. For people in complete remission at 12 months, consider
stopping vedolizumab, resuming treatment if there is a relapse.
This advice takes account of the benefits of a patient access scheme
(PAS) that improves the cost-effectiveness of vedolizumab. 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.
Vedolizumab is also indicated for the treatment of adult patients with
moderately to severely active Crohn's disease who have had an
inadequate response with, lost response to, or were intolerant to either
conventional therapy or a tumour necrosis factor-alpha (TNFα)
antagonist. A submission for this indication is currently undergoing SMC
assessment.
June 2015
943/14
ceftobiprole, 500mg, powder for concentrate for
solution for infusion (Zevtera®)
Basilea Pharmaceutica International Ltd
Resubmission
Ceftobiprole is indicated for the treatment of the
following infections in adults:

Hospital-acquired
pneumonia
(HAP),
excluding ventilator-associated pneumonia
(VAP)

Community-acquired pneumonia (CAP)
Consideration should be given to official guidance
on the appropriate use of antibacterial agents.
Comparator Medicines:
Various regimens of antibiotics are recommended
in Health Board empirical antibiotic guidelines
including: piperacillin-tazobactam, amoxicillin plus
aztreonam, levofloxacin (usually as an option if
penicillin allergy), and co-amoxiclav plus
gentamicin. In cases where MRSA is suspected
or proven, glycopeptides (vancomycin or
teicoplanin) are added.
Linezolid is often
ceftobiprole (Zevtera®) is accepted for restricted use within NHS
Scotland.
Indication under review: Ceftobiprole is indicated for the treatment of
the following infections in adults:

Hospital-acquired pneumonia (HAP), excluding ventilatorassociated pneumonia (VAP)

Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate use
of antibacterial agents.
SMC restriction: for use in the treatment of HAP (excluding VAP) when
activity
is
required
against
suspected
methicillin-resistant
Staphylococcus aureus (MRSA) and Gram-negative pathogens
(including Pseudomona aeruginosa, Escherichia coli and Klebsiella
pneumoniae) and when combination treatment that includes vancomycin
or teicoplanin is inappropriate or has not been tolerated, or when
treatment modification is required, i.e. as an alternative to linezolidbased regimens.
In a randomised, double-blind phase III study of patients with HAP, the
clinical cure rate for empirical treatment with ceftobiprole was noninferior to the rate associated with intravenous linezolid plus an antipseudomonal cephalosporin
3 of 9
Not preferred
Fife Formulary Section
5
SMC Advice - Formulary Decisions June-July 2015
reserved for second-line use after glycopeptides.
June 2015
1069/15
darunavir 75mg, 150mg, 400mg, 600mg, 800mg
film-coated
tablets
and
oral
suspension
100mg/mL (Prezista®)
Janssen-Cilag Ltd
Product Update
darunavir (Prezista®) is accepted for restricted use within NHS
Scotland.
Indication under review: once daily darunavir co-administered with low
dose ritonavir in combination with other antiretroviral medicinal products
for the treatment of human immunodeficiency virus (HIV-1) infection in
paediatric patients aged 3 to 12 years and ≥15kg who are 1) treatmentnaive or 2) treatment-experienced with no darunavir resistanceassociated mutations, plasma-HIV-1 RNA <100,000 copies/mL, and
CD4+ count >100x106 cells/L.
Not included on the Fife
Formulary for use in patients
from age 3 -12 as clinicians do
not support Formulary
inclusion for this age group.
SMC darunavir
(Prezista)
Tertiary centre use.
Fife Formulary Section
5
SMC restriction: to be prescribed under the supervision of specialists in
paediatric HIV.
Darunavir is listed in the British National Formulary for Children in
combination with other antiretroviral drugs for HIV infection in children
previously treated with antiretrovirals or not previously treated with
antiretroviral therapy.
The Scottish Medicines Consortium has
previously accepted darunavir in this indication in paediatric patients
aged 12 to 17 years and at least 40kg body weight, and in combination
with other antiretroviral medicinal products in antiretroviral (ART)experienced paediatric patients from the age of 3 years and at least 15kg
body weight.
June 2015
1056/15
riociguat 0.5mg, 1mg, 1.5mg, 2mg, 2.5mg filmcoated tablets (Adempas®)
Bayer Plc
Pulmonary arterial hypertension (PAH): as
monotherapy or in combination with endothelin
receptor antagonists, for the treatment of adult
patients with PAH with World Health Organisation
Functional Class (WHO FC) II to III to improve
exercise capacity.
Efficacy has been shown in a PAH population
including aetiologies of idiopathic or heritable PAH
or PAH associated with connective tissue disease.
Comparator Medicines:
Sildenafil, tadalafil, bosentan, ambrisentan,
macitentan, iloprost, and epoprostenol are
licensed for the treatment of PAH in the UK.
Epoprostenol,
administered by continuous
intravenous infusion, has not been included in the
cost table as the mean dose in the only historical
study found was higher than the licensed doses
riociguat (Adempas®) is accepted for use within NHS Scotland.
Indication under review: Pulmonary arterial hypertension (PAH): as
monotherapy or in combination with endothelin receptor antagonists, for
the treatment of adult patients with PAH with World Health Organisation
Functional Class (WHO FC) II to III to improve exercise capacity.
Efficacy has been shown in a PAH population including aetiologies of
idiopathic or heritable PAH or PAH associated with connective tissue
disease.
SMC restriction: for use as a PAH-specific monotherapy as an
alternative treatment option to endothelin receptor antagonist (ERA)
monotherapy in adult patients with PAH of WHO FC II to III. It is
restricted to initiation and prescribing by specialists in the Scottish
Pulmonary Vascular Unit or by similar specialists.
Riociguat demonstrated significant improvement compared with placebo
in exercise capacity, in terms of six-minute walking distance, in patients
with symptomatic PAH in a phase III study.
This advice takes account of the benefits of a Patient Access Scheme
(PAS) that improves the cost-effectiveness of riociguat. 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
4 of 9
Not included on the Fife
Formulary as clinicians do not
support Formulary inclusion.
SMC riociguat
(Adempas)
Tertiary centre use.
Fife Formulary Section
2
SMC Advice - Formulary Decisions June-July 2015
Engagement (PACE) meeting.
June 2015
1055/15
sorafenib 200mg film-coated tablets (Nexavar®)
Bayer Plc
sorafenib (Nexavar®) is accepted for use within NHS Scotland.
Not included pending
protocol.
Indication under review: treatment of patients with progressive, locally
advanced or metastatic, differentiated thyroid carcinoma, refractory to
radioactive iodine.
SMC sorafenib
(Nexavar)
Requires SCAN
submission to Lothian
Formulary Committee.
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.
June 2015
1061/15
tinzaparin 20,000 IU/ml 0.4ml, 0.5ml, 0.6ml, 0.7ml,
0.8ml and 0.9ml pre-filled syringe (Innohep
Syringe®)
Leo Pharma
Patients with solid tumours: Extended treatment of
symptomatic venous thrombo-embolism and
prevention of its recurrence
Comparator Medicines:
The relevant comparator is the other LMWH
licensed for this indication, dalteparin.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting
tinzaparin (Innohep Syringe®) is accepted for use within NHS Scotland.
Indication under review: Patients with solid tumours: Extended
treatment of symptomatic venous thrombo-embolism (VTE) and
prevention of its recurrence.
Not included on the Fife
Formulary as clinicians do not
support Formulary inclusion.
SMC tinzaparin sodium
(Innohep)
Not preferred.
Fife Formulary choice
for this indication is
Dalteparin.
In patients with cancer and VTE, tinzaparin was associated with rates of
VTE recurrence that were not significantly different from those with a
vitamin K antagonist (VKA). In a large study it was not significantly
different from a VKA for a composite outcome that included symptomatic
deep vein thrombosis (DVT), non-fatal and fatal pulmonary embolism
(PE), incidental DVT and PE.
Fife Formulary Section
2
This advice takes account of the benefits of a Patient Access Scheme
(PAS) that improves the cost-effectiveness of tinzaparin. 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.
June 2015
1062/15
rivaroxaban 2.5mg film-coated tablets (Xarelto®)
Bayer plc
rivaroxaban (Xarelto®) is not recommended for use within NHS
Scotland.
Not recommended for this
indication.
Rivaroxaban co-administered with aspirin alone or
with aspirin plus clopidogrel or ticlopidine, is
indicated for the prevention of atherothrombotic
events in adult patients after an acute coronary
syndrome (ACS) with elevated cardiac biomarkers
Indication under review: rivaroxaban co-administered with aspirin
alone or with aspirin plus clopidogrel or ticlopidine, is indicated for the
prevention of atherothrombotic events in adult patients after an acute
coronary syndrome (ACS) with elevated cardiac biomarkers.
Rivaroxaban in addition to standard care significantly reduced the
occurrence of the primary composite endpoint: death from
cardiovascular causes, myocardial infarction, or stroke, compared to
standard care alone.
The submitting company did not present a sufficiently robust economic
analysis to gain acceptance by SMC
Requires submission and
approval of an IPTR before
prescribing.
Comparator Medicines:
Aspirin ± clopidogrel, ticagrelor (+ aspirin),
prasugrel (+ aspirin).
5 of 9
SMC rivaroxaban
(Xarelto)
SMC Advice - Formulary Decisions June-July 2015
June 2015
1047/15
olaparib, 50mg, hard capsules (Lynparza®)
AstraZeneca UK
Olaparib is indicated as monotherapy for the
maintenance treatment of adult patients with
platinum-sensitive
relapsed
BRCA-mutated
(germline and/or somatic) high grade serous
epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in response (complete
response or partial response) to platinum-based
chemotherapy
Comparator Medicines:
Bevacizumab is indicated for platinum-sensitive
recurrent disease for which it is administered in
combination with carboplatin and gemcitabine for
six to 10 cycles and then as monotherapy until
disease
progression;
it
has
not
been
recommended for use in NHS Scotland by SMC
olaparib (Lynparza®) is not recommended for use within NHS Scotland.
Not recommended.
Indication under review: monotherapy for the maintenance treatment
of adult patients with platinum-sensitive relapsed BRCA-mutated
(germline and/or somatic) high grade serous epithelial ovarian, fallopian
tube, or primary peritoneal cancer who are in response (complete
response or partial response) to platinum-based chemotherapy.
Requires submission and
approval of an IPTR before
prescribing.
SMC olaparib
(Lynparza)
Olaparib was assessed in a phase II randomised, placebo-controlled
study of patients with high grade serous, recurrent, platinum-sensitive
ovarian, fallopian-tube or primary peritoneal cancer in which there had
been an objective response to the most recent platinum-based
chemotherapy regimen. In the sub-group of patients with BRCA
mutation, olaparib was associated with a significantly improved
progression-free survival compared with placebo. Analysis of mature
overall survival data is awaited.
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.
This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting.
June 2015
1082/15
panitumumab (Vectibix®)
Amgen Ltd
panitumumab (Vectibix®) is not recommended for use within NHS
Scotland.
Non SMC Submission
Indication under review: Treatment of adult patients with wild-type RAS
metastatic colorectal cancer first-line in combination with FOLFIRI.
Not recommended.
SMC panitumumab
(Vectibix)
Requires submission and
approval of an IPTR before
prescribing.
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.
NICE (National Institute for Health and Clinical Excellence) is currently
undertaking a multiple technology appraisal (MTA) that includes the use
of panitumumab in this indication. However, due to the significant time
interval between product availability and the expected date of NICE
guidance, not recommended advice has been issued.
June 2015
686/11
vinflunine (as ditartrate), 25mg/mL, concentrate
for solution for infusion (Javlor®)
Pierre Fabre Limited
vinflunine (Javlor®) is not recommended for use within NHS Scotland.
Not recommended.
Indication under review: monotherapy for the treatment of adult
Resubmission
patients with advanced or metastatic transitional cell carcinoma of the
Requires submission and
approval of an IPTR before
prescribing.
Monotherapy for the treatment of adult patients
with advanced or metastatic transitional cell
carcinoma of the urothelial tract after failure of a
prior platinum-containing regimen.
Efficacy and safety of vinflunine have not been
urothelial tract after failure of a prior platinum-containing regimen.
Efficacy and safety of vinflunine have not been studied in patients with
performance status ≥ 2.
Vinflunine plus best supportive care was associated with improved
6 of 9
SMC vinflunine
(Javlor)
SMC Advice - Formulary Decisions June-July 2015
studied in patients with performance status ≥2.
Comparator Medicines:
Whilst there are no standard second-line
therapies, other chemotherapeutic agents may be
used including re-treatment with the first-line
platinum-containing regimen if it produced an
initial durable response. Other second-line options
depend on first-line therapy and may include
gemcitabine (plus cisplatin) or unlicensed use of
taxanes (e.g. paclitaxel).
July 2015
1028/15
tiotropium, 2.5 microgram, solution for inhalation
(Spiriva® Respimat®)
Boehringer-Ingelheim Limited
As add-on maintenance bronchodilator treatment
in adult patients with asthma who are currently
treated with the maintenance combination of
inhaled corticosteroid (ICS) (≥800 micrograms
budesonide/day or equivalent) and long-acting
beta2 agonists (LABA) and who experienced one
or more severe exacerbations in the previous year
Comparator Medicines:
Other treatments that may be used in the
population under review are leukotriene receptor
antagonists
(montelukast,
zafirlukast),
SR
theophylline (e.g. Slo-Phyllin®)and oral LABAs
(e.g.
modified release salbutamol and
bambuterol).
July 2015
1081/15
darunavir 800mg, cobicistat 150mg film-coated
tablet (Rezolsta®)
Janssen-Cilag Ltd
In combination with other antiretroviral medicinal
products
for
the
treatment
of
human
immunodeficiency virus-1 (HIV-1) infection in
adults aged 18 years or older. Genotypic testing
should guide the use of Rezolsta®.
July 2015
1073/15
Comparator Medicines:
There are many antiretroviral agents licensed for
the treatment of adults with HIV infection.
Protease inhibitors recommended in UK
guidelines
include:
darunavir/ritonavir,
atazanavir/ritonavir,
lopinavir/ritonavir,
and
fosamprenavir/ritonavir
palonosetron, 250 micrograms solution for
injection (Aloxi®)
Chugai Pharma UK Limited
survival when compared with best supportive care alone in the secondline treatment of advanced or metastatic transitional cell carcinoma of
the urothelial tract in patients with good performance status.
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.
tiotropium (Spiriva® Respimat®) is accepted for use within NHS
Scotland.
Included on the Fife
Formulary for this indication.
Indication under review: As add-on maintenance bronchodilator
treatment in adult patients with asthma who are currently treated with the
maintenance combination of inhaled corticosteroids (≥800 micrograms
budesonide/day or equivalent) and long-acting beta2 agonists and who
experienced one or more severe exacerbations in the previous year.
As add on therapy at Step 4 in
the management of asthma.
Two phase III RCTs demonstrated that the addition of tiotropium
significantly improved lung function and increased the time to the first
severe exacerbation compared with placebo in patients with uncontrolled
asthma despite treatment with high dose inhaled corticosteroid and a
long acting beta2 agonist
SMC tiotropium
(Spiriva)
Only the Respimat device is
licensed for this indication
and not use via the
Handihaler.
darunavir/cobicistat (Rezolsta®) is accepted for use within NHS
Scotland.
Included on the Fife
Formulary.
Indication under review: In combination with other antiretroviral
Hospital use only.
SMC
darunavir/cobicistat
(Rezolsta)
medicinal products for the treatment of human immunodeficiency virus-1
(HIV-1) infection in adults aged 18 years or older. Genotypic testing
should guide its use.
Pharmacokinetic studies have demonstrated that darunavir/cobicistat is
bioequivalent (in terms of darunavir exposure) to ritonavir-boosted
darunavir. No comparative efficacy studies have been reported.
palonosetron (Aloxi®) is accepted for use within NHS Scotland.
Indication under review: prevention of acute nausea and vomiting
7 of 9
Not included on the Fife
Formulary as clinicians do not
support Formulary inclusion
SMC palonosetron
(Aloxi)
SMC Advice - Formulary Decisions June-July 2015
associated with highly emetogenic cancer chemotherapy and prevention
of nausea and vomiting associated with moderately emetogenic cancer
chemotherapy, in paediatric patients 1 month of age and older.
Product Update
July 2015
1080/15
tedizolid phosphate 200mg film-coated tablets and
200mg powder for concentrate for solution for
infusion (Sivextro®)
Cubist (UK) Limited/Merck Sharp & Dohme
Limited
The treatment of acute bacterial skin and skin
structure infections (ABSSSI) in adults.
Consideration should be given to official guidance
on the appropriate use of antibacterial agents.
Comparator Medicines:
Vancomycin, teicoplanin, linezolid, ceftaroline,
tigecycline and daptomycin are licensed for the
treatment of complicated skin and soft-tissue
infections.
A phase III double blind study demonstrated non-inferiority of
palonosetron to another 5-HT3 antagonist in paediatric patients.
tedizolid phosphate (Sivextro®) is accepted for restricted use within
NHS Scotland.
for this patient group.
Tertiary centre use.
Fife Formulary Section
4
Not included on the Fife
Formulary as clinicians do not
support Formulary inclusion.
Indication under review: The treatment of acute bacterial skin and skin
structure infections (ABSSSI) in adults.
SMC tedizolid
phosphate (Sivextro)
Not preferred
Fife Formulary choice
is linezolid.
SMC restriction:

Use in patients with ABSSSI caused by Gram-positive
Staphylococcus
aureus (specifically
methicillin-resistant
Staphylococcus aureus [MRSA] isolates)

Use of tedizolid phosphate is restricted to use as an alternative
oxazolidinone antibacterial on the specific advice of local
microbiologists or specialists in infectious disease.
Fife Formulary Section
5
In two randomised, double-blind clinical studies, tedizolid phosphate was
non-inferior to another oxazolidinone antibacterial in adult patients with
ABSSSI.
The presenting company did not submit any evidence for SMC to
consider around the use of tedizolid phosphate in “mixed infections”,
where the infection involves both Gram-positive and Gram-negative
organisms.
July 2015
1066/15
enzalutamide, 40mg soft capsules (Xtandi®)
Astellas Pharma Ltd
enzalutamide (Xtandi®) is not recommended for use within NHS
Scotland.
Not recommended for this
indication.
Treatment of adult men with metastatic castrationresistant prostate cancer who are asymptomatic
or mildly symptomatic after failure of androgen
deprivation therapy (ADT) in whom chemotherapy
is not yet clinically indicated.
Indication under review: Treatment of adult men with metastatic
castration-resistant prostate cancer (mCRPC) who are asymptomatic or
mildly symptomatic after failure of androgen deprivation therapy in whom
chemotherapy is not yet clinically indicated.
In a randomised phase III study of adult men with chemotherapy naive
mCRPC treatment with enzalutamide was associated with an extended
radiographic progression free survival and overall survival compared to
placebo.
The submitting company did not present a sufficiently robust economic
analysis to gain acceptance by SMC 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.
Requires submission and
approval of an IPTR before
prescribing for this indication.
eribulin (Halaven®) is not recommended for use within NHS Scotland.
Not recommended for this
indication.
Comparator Medicines:
Watchful waiting.
July 2015
1065/15
eribulin (mesilate),
injection (Halaven®)
Eisai Ltd
0.44mg/mL,
solution
for
For the treatment of patients with locally advanced
Indication under review: for the treatment of patients with locally
advanced or metastatic breast cancer who have progressed after at least
one chemotherapeutic regimen for advanced disease. Prior therapy
8 of 9
Requires submission and
approval of an IPTR before
SMC enzalutamide
(Xtandi)
SMC eribulin (Halaven)
SMC Advice - Formulary Decisions June-July 2015
or metastatic breast cancer who have progressed
after at least one chemotherapeutic regimen for
advanced disease. Prior therapy should have
included an anthracycline and a taxane in either
the adjuvant or metastatic setting unless patients
were not suitable for these treatments.
Comparator Medicines:
Chemotherapy
(including
vinorelbine,
capecitabine, or a taxane [e.g. docetaxel,
paclitaxel]) or hormonal therapy (including
letrozole or exemestane).
should have included an anthracycline and a taxane in either the
adjuvant or metastatic setting unless patients were not suitable for these
treatments.
prescribing for this indication.
In a randomised, phase III, open-label study, patients treated with
eribulin gained 2.5 months additional overall survival compared with the
comparator, treatment of physicians choice, which included a range of
single agent chemotherapy treatments.
The submitting company’s 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.
This supersedes previous advice for eribulin (SMC No. 726/11).
Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines June 2015 – August 2015
Product Name
SMC Advice
nintedanib
100mg
and 150mg soft
capsules (Vargatef®)
Boehringer
Ingelheim
International GmbH
nintedanib (Vargatef®) is accepted for use within NHS
Scotland.
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 firstline chemotherapy.
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.
Place in therapy
To be used in combination with
docetaxel as 2nd line systemic anticancer
therapy.
Lothian formulary Committee
Decision
Added to the additional list for use
in combination with docetaxel as a
2nd line therapy.
Specialist use only.
Treatment will be continued until disease
progression or unacceptable toxicity.
Nintedanib monotherapy can be
continued if patients have received at
least 4 cycles of docetaxel
chemotherapy.
This advice takes account of the views from a Patient and
Clinician Engagement (PACE) meeting.
9 of 9
Added to Fife Formulary
Yes / No
Rationale
Yes