It was good news for UK drugmaker Archimedes Pharma this week after Scottish cost regulators approved the use of its pain spray PecFent on the National Health Service.
PecFent (formerly known as NasalFent) is an innovative nasal spray formulation of the powerful painkiller fentanyl, and the product received marketing clearance in Europe in September last year for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy.
Following a clinical and cost effectiveness review, the Scottish Medicines Consortium has now endorsed the use of the product in NHS patients experiencing breakthrough cancer pain, but only as an alternative to other fentanyl formulations or for those who cannot take short-acting oral opioids.
Welcoming the decision, the company's president and chief executive Jeffrey Buchalter said the SMC’s "balanced review of PecFent’s clinical effectiveness and health economic value supports Archimedes’ belief that PecFent provides a real opportunity for patients, for healthcare professionals, and for payors to improve the management of breakthrough cancer pain and the cost effectiveness of that management".
The technology behind PecFent allows fentanyl to be delivered in a rapid and controlled manner to better match the timing of a typical episode of breakthrough cancer pain - which can affect up to 95% of patients experiencing chronic cancer pain - compared to conventional approaches.
The Phase III programme for PecFent showed that it can deliver onset of pain relief as early as five minutes following administration, as well as clinically meaningful pain relief from ten minutes, Archimedes noted.
Elsewhere, news was not so positive for Roche, after the SMC rejected the use of Tarceva (erlotinib) as a monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer.
While maintenance treatment with Tarceva provided a statistically significant increase in progression free survival and overall survival in patients treated with standard first-line platinum-based chemotherapy, the manufacturer’s justification of its cost in relation to its health benefits "was not sufficient to gain acceptance by SMC", the cost watchdog said.
For the main comparison of Tarceva with best standard care, Roche's drug was estimated to cost an additional £8,361 for an additional 0.325 years survival and 0.196 quality adjusted life years (QALYs) in patients with stable disease, generating a cost effectiveness estimate of £46,132 per QALY and thus overshooting what cost regulators would normally consider to be value for money.
The decision follows that of sister cost watchdog for England and Wales, the National Institute for Health and Clinical Excellence, which also rejected Tarceva in this setting in preliminary guidelines published late last year.