Download Formulary Decisions December 2013-January 2014

SMC Advice - Formulary Decisions December 2013-January 2014
Scottish Medicines Consortium Recommendations
Date
Product/Manufacturer
bortezomib 3.5mg powder for solution for
December
injection (Velcade®)
2013
Janssen-Cilag Ltd
927/13
In combination with dexamethasone, or with
dexamethasone and thalidomide, for the induction
treatment of adult patients with previously
untreated multiple myeloma who are eligible for
high-dose chemotherapy with haematopoietic
stem cell transplantation
SMC Advice
bortezomib (Velcade®) is accepted for restricted use within NHS
)
Scotland.
Indication under review: In combination with dexamethasone, or with
dexamethasone and thalidomide, for the induction treatment of adult
patients with previously untreated multiple myeloma who are eligible for
high-dose chemotherapy with haematopoietic stem cell transplantation.
SMC restriction: use as triple
dexamethasone and thalidomide.
therapy
in
combination
with
Decision of ADTC
Included on the Fife
Formulary as a triple
combination
induction therapy.
Rationale
SMC bortezomib (Velcade)
To be used in
combination with
thalidomide +
dexamethasone.
Hospital use only.
Comparator Medicines:
The triple regimen of cyclophosphamide,
thalidomide and dexamethasone (CTD) which is
an unlicensed induction regimen
December
2013
930/13
tocilizumab, 20mg/mL concentrate for infusion
(RoActemra®)
Roche Products Ltd
Product Update
Bortezomib, used in combination with dexamethasone and thalidomide
for the induction treatment of adult patients with previously untreated
multiple myeloma who are eligible for high-dose chemotherapy with
haematopoietic stem cell transplantation improved response rates
compared with a dual combination regimen
tocilizumab (RoActemra®) is accepted for use within NHS Scotland.
Indication under review: tocilizumab in combination with methotrexate
is indicated for the treatment of juvenile idiopathic polyarthritis
(rheumatoid factor positive or negative and extended oligoarthritis) in
patients 2 years of age and older, who have responded inadequately to
previous therapy with methotrexate. Tocilizumab can be given as
monotherapy in case of intolerance to methotrexate or where continued
treatment with methotrexate is inappropriate.
Tocilizumab has previously been accepted by SMC for treatment of adult
rheumatoid arthritis and in active systemic juvenile idiopathic arthritis in
patients from 2 years of age who have responded inadequately to
previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs)
and systemic corticosteroids. Tocilizumab can be given as monotherapy
(in case of intolerance to methotrexate or where treatment with
methotrexate is inappropriate) or in combination with methotrexate.
Included on the Fife
Formulary for the
treatment of
systemic juvenile
idiopathic
polyarthritis.
SMC tocilizumab (RoActerma)
3rd choice after
failure with
etanercept and
infliximab. May be
used 2nd line in
patients unable to
use infliximab.
Hospital use only.
This SMC advice takes account of the benefits of a Patient Access
Scheme (PAS) that improves the cost-effectiveness of tocilizumab. This
SMC advice is contingent upon the continuing availability of the Patient
Access Scheme in NHS Scotland or a list price that is equivalent or
lower.
December
2013
928/13
trastuzumab, 600mg/5mL solution for injection
(Herceptin®)
Roche Products Ltd
Metastatic breast cancer
Trastuzumab is indicated for the treatment of adult
patients with HER2 positive metastatic breast
cancer (MBC):
- as monotherapy for the treatment of those
trastuzumab 600mg/5mL solution for injection (Herceptin®) is
accepted for restricted use within NHS Scotland.
Not included
pending protocol.
Indication under review: treatment of adult patients with HER2 positive
metastatic breast cancer (MBC) and early breast cancer (EBC) in a
range of settings (full details of licensed indication presented later in
advice document).
Await Lothian
Formulary
Committee decision
following SCAN
submission.
Trastuzumab should only be used in patients with metastatic or early
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SMC trastuzumab (Herceptin)
SMC Advice - Formulary Decisions December 2013-January 2014
-
-
-
patients who have received at least two
chemotherapy regimens for their metastatic
disease. Prior chemotherapy must have
included at least an anthracycline and a
taxane unless patients are unsuitable for
these treatments. Hormone receptor positive
patients must also have failed hormonal
therapy, unless patients are unsuitable for
these treatments.
in combination with paclitaxel for the treatment
of those patients who have not received
chemotherapy for their metastatic disease and
for whom an anthracycline is not suitable.
in combination with docetaxel for the
treatment of those patients who have not
received chemotherapy for their metastatic
disease.
in combination with an aromatase inhibitor for
the treatment of postmenopausal patients with
hormone-receptor
positive
MBC,
not
previously treated with trastuzumab.
breast cancer whose tumours have either HER2 overexpression or
HER2 gene amplification as determined by an accurate and validated
assay.
SMC restriction: Subcutaneous trastuzumab injection is accepted for
use in line with previous SMC advice for intravenous trastuzumab (this
excludes its use in combination with an aromatase inhibitor for the
treatment of postmenopausal patients with hormone-receptor positive
MBC, not previously treated with trastuzumab).
In a phase III randomised, open-label clinical study in patients with
HER2-positive early breast cancer, subcutaneous trastuzumab was noninferior to intravenous trastuzumab for the co-primary pharmacokinetic
and efficacy endpoints of serum trough concentration (Ctrough) at pre-dose
cycle 8 before surgery and pathological complete response
Early breast cancer
Trastuzumab is indicated for the treatment of adult
patients with HER2 positive early breast cancer
(EBC).
- following surgery, chemotherapy (neoadjuvant
or adjuvant) and radiotherapy (if applicable).
- following
adjuvant
chemotherapy
with
doxorubicin and cyclophosphamide, in
combination with paclitaxel or docetaxel.
- in combination with adjuvant chemotherapy
consisting of docetaxel and carboplatin.
- in
combination
with
neoadjuvant
chemotherapy
followed
by
adjuvant
trastuzumab therapy, for locally advanced
(including inflammatory) disease or tumours >
2 cm in diameter.
December
2013
929/13
Trastuzumab should only be used in patients with
metastatic or early breast cancer whose tumours
have either HER2 overexpression or HER2 gene
amplification as determined by an accurate and
validated assay.
saxagliptin plus metformin, 2.5mg / 850mg and
2.5mg
/
1000mg
film-coated
tablets
(Komboglyze®)
Bristol-Myers Squibb / AstraZeneca
Product Update
saxagliptin plus metformin (Komboglyze®) is accepted for use within
NHS Scotland.
Indication under review: in combination with a sulphonylurea (i.e. triple
combination therapy) as an adjunct to diet and exercise to improve
glycaemic control in adult patients aged 18 years and older with type 2
diabetes mellitus when the maximally tolerated dose of both metformin
and the sulphonylurea does not provide adequate glycaemic control.
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Not included on the
Fife Formulary
because NHS Fife
decision is that the
medicine does not
represent sufficient
added benefit to
comparator
SMC saxagliptin metformin (Kombogylze)
Both metformin and saxagliptin
(2nd choice gliptin) are included in the Fife
Formulary as single agents.
Fife Formulary Section 6 Endocrine.pdf
SMC Advice - Formulary Decisions December 2013-January 2014
For patients in whom triple combination therapy with metformin, a
sulphonylurea and saxagliptin is appropriate, saxagliptin/metformin has
the potential to reduce the pill burden at a lower cost.
December
2013
946/13
golimumab (Simponi®) 50 mg and 100mg
solution for injection
Merck Sharpe & Dohme Limited
ADVICE: in the absence of a submission from the holder of the
marketing authorisation
golimumab (Simponi®) is not recommended for use within NHS
Scotland.
Indication under review: Treatment of moderately to severely active
ulcerative colitis in adult patients who have had an inadequate response
to conventional therapy including corticosteroids and 6-mercaptopurine
(6-MP) or azathioprine (AZA), or who are intolerant to or have medical
contraindications for such therapies.
medicines to treat
the condition in
question.
Not recommended
for the indication
stated.
Requires submission
and approval of an
IPTR.
SMC golimumab (Simponi)
Company non-submission for the
indication stated.
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.
December
2013
947/13
fentanyl citrate (Breakyl®) 200mcg, 400mcg
and 800mcg buccal film
Meda Pharmaceuticals
ADVICE: in the absence of a submission from the holder of the
marketing authorisation
fentanyl citrate (Breakyl®) is not recommended for use within NHS
Scotland.
Not recommended.
SMC fentanyl citrate (Breakyl)
Requires submission
and approval of an
IPTR.
Fentanyl products are recommended as 3rd
line choices for break through pain when
initiated by palliative care specialists.
Indication under review: Treatment of breakthrough pain (BTP) in
adults with cancer who are already receiving maintenance opioid therapy
for chronic cancer pain.
January
2014
864/13
fluocinolone acetonide 190
intravitreal implant (Iluvien®)
Alimera Sciences Limited
micrograms
Resubmission
Treatment of vision impairment associated with
chronic diabetic macular oedema, considered
insufficiently responsive to available therapies
Comparator Medicines:
The licensed indication only allows the use of
intravitreal fluocinolone as the last line of medical
treatment. Other treatments that have been used
for diabetic DMO in Scotland include laser
photocoagulation, the anti-vascular endothelial
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.
fluocinolone acetonide intravitreal implant (Iluvien®) is accepted for
restricted use within NHS Scotland.
Indication under review: treatment of vision impairment associated with
chronic diabetic macular oedema, considered insufficiently responsive to
available therapies.
SMC restriction:

only in patients in whom the affected eye is pseudophakic (has an
artificial lens after cataract surgery) and;

retreatment would take place only if the patient had previously
responded to treatment with fluocinolone acetonide and
subsequently best corrected visual acuity had deteriorated to less
than 20/32.
The safety and efficacy of fluocinolone intravitreal implant was assessed
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Company non-submission.
Fife formulary choices are sublingual
tablets (Abstral®) and nasal spray
(Pecfent®).
Add to restricted list.
Restricted to use by
trained specialists
after failure with both
laser and
ranibizumab.
Hospital use only.
SMC fluocinolone acetonide (Iluvien)
SMC Advice - Formulary Decisions December 2013-January 2014
growth factor (anti-VEGF) drugs bevacizumab,
(not licensed for intravitreal use), the recently
available ranibizumab and the intravitreal
corticosteroids, triamcinolone and dexamethasone
which are not licensed for this indication.
in two randomised, double-masked, controlled phase III studies in
patients with diabetic macular oedema. Significantly more patients
treated with fluocinolone acetonide had a clinically meaningful
improvement in visual acuity at two and three years versus sham
injection. Subgroup analyses supported this finding in patients with
chronic diabetic macular oedema (median duration at least three years)
and in patients who were pseudophakic at baseline. Raised intraocular
pressure is an important safety issue.
This SMC advice takes account of the benefits of a Patient Access
Scheme (PAS) that improves the cost-effectiveness of fluocinolone. This
SMC advice is contingent upon the continuing availability of the Patient
Access Scheme in NHS Scotland or a list price that is equivalent or
lower.
January
2014
938/14
levonorgestrel
1500microgram
(Upostelle®)
Consilient Healthcare
tablet
levonorgestrel (Upostelle®) is accepted for use within NHS Scotland.
Included on the Fife
Formulary.
Indication under review: emergency contraception within 72 hours of
unprotected sexual intercourse or failure of a contraceptive method.
Replaces Levonelle.
When the use of emergency contraception is indicated this is a slightly
cheaper alternative to an existing preparation.
timolol gel eye drops (Tiopex®) are accepted for restricted use within
NHS Scotland.
Included on the Fife
Formulary.
SMC levonorgestrel (Upostelle)
Product Update
January
2014
941/14
timolol, 1mg/g eye gel for single-dose
container (Tiopex®)
Spectrum Thea Pharmaceuticals Limited
Product Update
Indication under review: reduction of the elevated intraocular pressure
in patients with:
- ocular hypertension,
- chronic open angle glaucoma.
SMC restriction: to use in patients who have proven sensitivity to
Specialist initiation
only.
P/F formulations of timolol should only be
used in patients with known sensitivity to
benzalkonium chloride.
SMC timolol eye gel (Tiopex)
Preferred
preservative free
timolol formulation.
preservatives.
The cost of this once daily preservative-free formulation is significantly
cheaper than the twice daily preservative-free preparation and may for
some patients offer advantages in the lower concentration and reduced
applications.
January
2014
939/14
colestilan 1g film-coated tablet, 2g and 3g
granules sachet (BindRen®)
Mitsubishi Pharma Europe
Treatment of hyperphosphataemia in adult
patients with chronic kidney disease (CKD) stage
5 receiving haemodialysis or peritoneal dialysis
Comparator Medicines:
Hyperphosphataemia can be treated with calciumbased phosphate binders (e.g. Calcichew®);
Preserved timolol eye drops are included in the drug tariff and are
significantly cheaper than preservative-free preparations.
colestilan (BindRen®) is not recommended for use within NHS
)
Scotland.
Indication under review: treatment of hyperphosphataemia in adult
patients with chronic kidney disease (CKD) stage 5 receiving
haemodialysis or peritoneal dialysis.
Colestilan, compared to placebo, reduces serum phosphate in dialysis
patients with CKD and hyperphosphataemia. Comparative data with
another non-calcium-based, non-absorbed phosphate binder do not
provide robust evidence of equivalence.
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Not recommended.
Submitting company did not present a
sufficiently robust clinical and economic
analysis.
SMC colestilan (BindRen)
SMC Advice - Formulary Decisions December 2013-January 2014
January
2014
956/14
lanthanum carbonate (Fosrenol®); aluminium
hydroxide (Alu-Cap®); sevelamer hydrochloride
(Renagel®) and sevelamer carbonate (Renvela®).
lomitapide (Lojuxta®) 5mg, 10 mg, 20mg hard
capsules
Aegerion Phamaceuticals
Non SMC Submission
The submitting company did not present a sufficiently robust clinical and
economic analysis to gain acceptance by SMC.
ADVICE:
in the absence of a submission from the holder of the
(No: 956/14)
marketing authorisation
®
lomitapide (Lojuxta ) is not recommended for use within NHS Scotland.
Not recommended.
SMC lomitapide (Lojuxta)
Requires submission
and approval of an
IPTR.
Company non-submission.
Indication under review: Adjunct to a low-fat diet and other lipidlowering medicinal products with or without low density lipoprotein (LDL)
apheresis
in
adult
patients
with
homozygous
familial
hypercholesterolaemia (HoFH).
Genetic confirmation of HoFH should be obtained whenever possible.
Other forms of primary hyperlipoproteinaemia and secondary causes of
hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must
be excluded.
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.
Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines January - February 2014
Product Name
axitinib, 1mg and
5mg, film-coated
tablets (Inlyta®)
SMC Advice
axitinib (Inlyta®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of adult patients with advanced renal cell carcinoma
(RCC) after failure of prior treatment with sunitinib or a cytokine.
Place in therapy
2nd line after failure of one
line of tyrosine kinase
inhibitor or cytokine
irrespective of the choice of
first line TKI
In a phase III, open-label study, axitinib improved progression-free survival significantly more than
another targeted therapy when used after first-line sunitinib or a cytokine. There was no significant
improvement in overall survival.
enzalutamide 40mg
soft capsules
(Xtandi®)
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the
cost-effectiveness of axitinib. This SMC advice is contingent upon the continuing availability of the
patient access scheme in NHS Scotland or a list price that is equivalent or lower.
enzalutamide (Xtandi®) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult men with metastatic castration-resistant prostate
cancer (mCRPC) whose disease has progressed on or after docetaxel therapy.
Lothian formulary Committee Decision
Included on the Additional List
Only approved for use after failure with sunitinib .
2nd line use after pazopanib would be an off-label use
and is not currently approved.
Specialist hospital use only.
2nd line after docetaxel
chemotherapy in men with
ECOG performance status
0-2.
Approved.
Included on the Additional List
Specialist hospital use only
In one randomised, double-blind, phase III clinical study, enzalutamide significantly increased overall
survival compared with placebo.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the
cost-effectiveness of enzalutamide. This SMC advice is contingent upon the continuing availability of
the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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