SMC announces latest approvals and rejections
Protein kinase inhibitor dasatinib (Sprycel; Bristol-Myers Squibb) has been approved by the Scottish
Medicines Consortium for use in NHS Scotland for the treatment of adults with chronic myeloid leukaemia (CML) with resistance or intolerance to previous therapy including imatinib mesylate.
However, the SMC rejected the drug’s use for patients with the
accelerated or blast phases of CML.
It also rejected the use of dasatinib for adults with acute lymphoblastic
leukaemia with resistance or intolerance to previous therapy, saying
that the economic case was not sufficiently robust.
Infliximab (Remicade; Schering-Plough) was accepted for patients with
severe plaque psoriasis who have failed to respond to or are unsuitable
for other systemic therapies. But it recommended that infliximab should
not be used for maintenance treatment of fistulating active Crohn’s
disease or severe active Crohn’s disease, or to treat adults with
moderate to severe active ulcerative colitis.
The SMC also accepted the following products:
• Azelaic acid gel (Finacea; Valeant) for the topical treatment of papulopustular
rosacea
• Desmopressin oral lyophilisate (DDAVP Melt; Ferring) for the treatment
of
vasopressin-sensitive cranial diabetes insipidus, and post-hypophysectomy
polyuria and polydipsia
• Desmopressin oral lyophilisate (DesmoMelt; Ferring) for the treatment
of primary nocturnal enuresis
• Dibotermin alfa implant kit (InductOs; Wyeth) for the treatment of
acute tibia fractures, as an adjunct to standard care using open fracture
reduction and intramedullary nail fixation, in adults for whom there
is risk of non-union
• Docetaxel (Taxotere; sanofi-aventis) for the induction treatment of
patients with unresectable locally advanced squamous cell carcinoma of
the head and neck in combination with cisplatin and 5-fluorouracil, restricted
to patients for whom induction chemotherapy is appropriate
• Lanthanum carbonate chewable tablets (Fosrenol; Shire) for use as a
phosphate-binding agent in the control of hyperphosphataemia in chronic
renal failure patients on haemodialysis or continuous ambulatory peritoneal
dialysis
• Sitaxentan sodium (Thelin; Encysive) for the treatment of patients
with pulmonary arterial hypertension classified as WHO functional class
III, to improve exercise capacity (restricted to specialists in the Scottish
Pulmonary Vascular Unit)
Products rejected by the SMC on economic grounds were buprenorphine
transdermal patches (BuTrans; Napp), dexrazoxane (Savene; TopoTarget),
standardised allergen extract of grass pollen (Grazax; ALK-Abelló)
and topotecan (Hycamtin; Merck). |
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