Scottish cost regulators have issued seals of approval for the use of Sanofi-Aventis’ heart drug Multaq, Novartis’ cancer therapy Glivec, and AstraZeneca’s reflux drug Nexium on the National Health Service.
Specifically, the Scottish Medicines Consortium has voted in Multaq (dronedarone) as an option for preventing the recurrence of atrial fibrillation in patients, when conventional first-line anti-arrhythmic drugs don’t work, cannot be taken or are not tolerated.
According to Sanofi, Multaq is the first heart rhythm drug shown in clinical studies to maintain normal heart rhythm as well as help cut hospital admissions and risk of death due to cardiovascular-related causes when added to standard therapy, and so offers patients an important new treatment option.
The SMC’s decision to fund the drug on the NHS in Scotland has been welcomed by clinicians and patients groups alike, particularly as there have been no new treatment options in 20 years, and Multaq was recently endorsed by the European Society of Cardiology in new Guidelines for the Management of Atrial Fibrillation after recognising it as a “beneficial, useful and effective” medicine.
“Treating AF is about improving quality of life for patients and their families and it is good news that the SMC has made available this new drug which can reduce the morbidity, mortality and hospitalisations associated with AF,” noted Professor Andrew Rankin, Professor of Cardiology at the University of Glasgow.
Sanofi will also be breathing a sigh of relief on the Scottish approval given that the National Institute for Health and Clinical Excellence is currently leaning towards rejecting the drug’s use on the NHS in England and Wales, highlighting once again the stark postcode lottery of treatment across Great Britain.
Glivec and Nexium nods
Also in direct contrast to NICE, which turned down the drug last month, the SMC has also given the green light to Novartis’ Glivec (imatinib) for Gastrointestinal Stromal Tumours (GISTs), but only in those patients who are considered to be at a high risk of disease recurrence following surgery.
Novartis noted that one-year treatment with the drug, which it says is the first and only treatment licensed as an adjuvant therapy to delay the recurrence of GIST, “significantly improved one year recurrence-free survival compared with placebo and was associated with an increase of 16.4 months in median time to recurrence in patients at high risk of relapse”.
In addition, data from a core registration trial showed that 99% of high-risk patients given Glivec were alive at 12 months and tumour free versus 56% of patients treated with placebo, the firm stressed.
Understandably the company said it is delighted with the SMC’s decision, but Panos Alexakos, Oncology General Manager, Novartis UK and Ireland, also said “it is disappointing for patients in England and Wales who cannot benefit from access to the same clinically and cost effective treatment option now available to people in Scotland”.
AstraZeneca was also celebrating news that the Scottish regulator has given the nod to its gastro-oesophageal reflux disease therapy Nexium (esomeprazole; 10mg gastro-resistant granules for oral solution) sachets for use in for use in children aged one to 11 years old, when patients in whom licensed doses of a generic proton pump inhibitor have been ineffective.
Around four in ten children in the UK are diagnosed with the disease which, left untreated, can lead to serious complications including weight loss, dehydration and oesophagitis.
According to AZ, the availability of paediatric sachets will make treatment easier to administer and thereby reduces the likelihood of disease complications, especially for those who find current therapies hard to swallow.