Scottish cost regulators have turned down the use of Mitsubishi Pharma's new blood thinner Exembol on the National Health Service, claiming weaknesses in clinical and economic data presented.
The Scottish Medicines Consortium's decision means that patients with heparin-induced thrombocytopenia type II in need of parenteral antithrombotic therapy will not be able to get access to Exembol (argatroban) on the NHS.
Heparin-induced thrombocytopenia (HIT) is an antibody-mediated adverse drug reaction that causes patients receiving the blood thinner heparin to develop a low platelet count.
But the nature of HIT means that patients are left predisposed to developing blood clots, which can potentially lead to devastating thromboembolic complications, such as pulmonary embolism, acute myocardial infarction and stroke.
According to Mitsubishi, Exembol's anticoagulant effects are "produced rapidly with a predictable dose response effect", and other benefits include a short half- life, "rapidly reversible" anticoagulant effects
But according to the SMC, while "there is limited evidence that [the drug] may be associated with a reduction in thrombosis and deaths due to thrombosis," the company "did not present a sufficiently robust clinical and economic analysis to gain acceptance".
Mitsubishi is, however, intending to resubmit its application, the SMC said.
Eklira Genuair gets OK
Meanwhile, the news was much better for Almirall, after its chronic obstructive pulmonary disease (COPD) treatment Eklira Genuair won favour with the cost watchdog.
Eklira Genuair (aclidinium) was approved for use within NHS Scotland as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
The product is a twice-daily, long-acting muscarinic antagonist (LAMA) offering prescribers a new choice in LAMA therapy that clinical data has shown provide "around the clock symptom control for patients", according to the firm.
The SMC has noted that the NHS list price of aclidinium is lower than that for the traditional LAMA tiotropium, at £343 versus £386, respectively, and that its "economic case was demonstrated."
Its sister body, the National Institute for Health and Clinical Excellence, is expected to publish its assessment of the drug within the next couple of months.