Javelin Pharmaceuticals' Dyloject (diclofenac sodium solution for injection) has been accepted by the Scottish Medicines Consortium (SMC) for use within the National Health Service (NHS) Scotland, for the treatment or prevention of postoperative pain by intravenous injection, in supervised healthcare settings at the NHS Tariff Price of GBP 48 per pack (10 x 75mg/2ml vials).
"This is a significant decision" said Derek Gallacher, managing director (European), Javelin. "Not only is Javelin now able to commercialise Dyloject in Scotland which represents approximately eight percent of the UK market, but the SMC assessment is viewed extremely favourably by other Health Technology assessment bodies throughout Europe. Achieving a positive SMC assessment speaks to the strong clinical profile and cost-saving benefits Dyloject brings to the treatment or prevention of postoperative pain."
"The opioid sparing effect of Dyloject, coupled with the ease of simple IV bolus delivery represents a major contribution to the multimodal management of acute postoperative pain. It will be a very useful addition to our postoperative drug portfolio in Scotland" said Dr. Graeme McLeod, consultant anaesthetist at Ninewells Hospital, Dundee, Scotland.
Dyloject is being marketed by Javelin's UK sales force in a convenient ready-to-use injectable formulation that can be administered quickly as an IV bolus at considerable cost savings (up to GBP 50 per treated patient) compared to the current branded diclofenac formulation that requires buffering, dilution and slow infusion over at least 30 minutes.
The SMC provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of newly licensed medicines, new formulations of existing medicines, and new indications for established products. Favourable SMC advice facilitates the introduction of beneficial treatments like Dyloject throughout Scotland.
According to the SMC, the full submission diclofenac (Dyloject) is accepted for restricted use within NHS Scotland for the treatment or prevention of post-operative pain by intravenous injection, in supervised healthcare settings.
When given as an intravenous bolus, it showed non-inferiority to a comparator non-steroidal anti-inflammatory drug infusion at providing pain relief over an initial 4 hour period and caused less thrombophlebitis.
The manufacturer's submission related only to intravenous use of diclofenac (Dyloject) in the post-operative setting. SMC cannot recommend its use by the intramuscular route."
Dyloject is an injectable NSAID with analgesic, anti-inflammatory and antipyretic activity. Diclofenac, the same active ingredient in Dyloject, Voltaren, Cataflam and Voltarol, is a leading analgesic for the treatment of moderate-to-severe post surgical pain and has a demonstrated history of efficacy and safety since its approval in 1981. Historically, diclofenac has been used to treat pain from inflammatory and degenerative forms of osteoarthritis, musculoskeletal conditions, acute attacks of gout, kidney stones, and after surgical operations or trauma.
In October of 2007, Dyloject received Marketing Authorization Application (MAA) approval and favourable pricing in the UK, where it is also being sold. In its pivotal UK registration trial, Dyloject's efficacy and safety were superior to those of the IV formulation of diclofenac currently marketed in the UK. Each dose of the latter product requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has potential to save the UK NHS up to GBP 50 per postoperative patient compared to the currently marketed formulation. This pharmacoeconomic benefit coupled with Dyloject's superior clinical attributes differentiates Dyloject from the currently marketed IV formulation of diclofenac sodium.