Scottish Medicines Consortium announces latest medicines approved for
use in Scotland
Natalizumab (Tysabri) is now approved for restricted use in NHS Scotland following a resubmission to the Scottish
Medicines Consortium.
The monoclonal antibody can be used as single disease-modifying therapy
in highly active relapsing-remitting multiple sclerosis (RRMS), only
in patients with rapidly evolving severe RRMS defined by two or more
disabling relapses in one year and with one or more gadolinium enhancing
lesion on brain magnetic resonance imaging (MRI) or a significant increase
in T2 lesion load compared with a previous MRI.
In its latest round of assessments the SMC has also accepted oral
capecitabine (Xeloda) for first-line treatment of patients with advanced gastric cancer
in combination with platinum-based chemotherapy. The SMC says that although
capecitabine is more expensive than 5-fluorouracil, the convenience of
oral administration may allow changes to service delivery that benefit
the individual patient or the NHS organisation.
Pioglitazone (Actos) is also approved for use in combination with insulin
for patients with type 2 diabetes who have inadequate glycaemic control
using insulin and who cannot take metformin.
Following abbreviated submissions, the SMC has accepted the new orodispersible
formulation of risperidone (Risperdal Quicklet) for treatment of acute
and chronic schizophrenia and similar psychoses, treatment of mania in
bipolar disorder and treatment of behavioural symptoms of dementia; and
the recently available prolonged release tacrolimus capsules
(Advagraf) for prophylaxis of transplant rejection in adult kidney or liver allograft
recipients and for treatment of adults with allograft rejection resistant
to treatment with other immunosuppressive medicines.
The consortium has rejected the following medicines for use in Scotland
for their licensed indications: abatacept powder for solution for infusion
(Orencia); beclometasone diproprionate tablets (Clipper); levetiracetam
tablets and oral solution (Keppra); sodium oxybate oral solution (Xyrem);
and testosterone transdermal patches (Intrinsa).
The consortium has also advised that celecoxib (Celebrex) should not
be used for ankylosing spondylitis, in the absence of a submission for
that indication from the product’s manufacturer. An SMC spokesman
told The Journal that the SMC asks drug companies for submissions when
a new product or new indication is licensed.
He explained that sometimes a company will not provide information for
the SMC to make an assessment within a reasonable time frame. The SMC
will make an announcement in such cases to curb uptake of the technology
in Scotland until an assessment is made.
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