Doctors in Scotland now have access to a wider range of treatment options to address high levels of bad cholesterol after cost regulators approved the use of Merck Sharp & Dohme’s Tredaptive for NHS Scotland.

The Scottish Medicines Consortium has endorsed the use of Tredaptive (nicotinic acid/laropiprant) as a monotherapy to cut levels of bad cholesterol in patients with combined mixed dyslipidaemia or primary hypercholesterolaemia - both risk factors for cardiovascular disease - but only when statins are not tolerated or their use is considered inappropriate.

Clinical trials of Tredaptive, which was launched in the UK in September last year, have shown its ability to improve lipid levels, with results from one efficacy study showing that treatment with the drug, with or without a statin, not only reduced low-density lipoprotein cholesterol levels by 18%, but also cut triglycerides by 26% and raised high-density lipoprotein levels by 20% (placebo adjusted) over a 24 week period.

On the back of its strong efficacy, the drug received a licence in Europe as a monotherapy as well as for use in combination with statins when cholesterol levels are not kept under controls with the latter alone. However, the manufacturer’s submission to the Scottish cost regulator was only related to Tredaptive’s role as a stand-alone agent, and therefore the SMC was only able to recommend its use in this setting, it said.

In terms of cost-effectiveness, therapy with Tredaptive has been calculated to carry an incremental cost per QALY gained of £7,759 for patients with established CVD, £9,360 for patients with diabetes only, and £11,980 for those with multiple risk factors only, all of which fall well below the £30,000 ceiling limit used by cost regulators, helping to secure the drug a place on the NHS.

MSD has estimated that the net budget impact for NHS Scotland of therapy with Tredaptive, based on 100% displacement of Merck & Co’s Zetia (ezetimib) in patients unable to take statins, will be £5,800 in the first year and £31,700 in year five.

Revlimid also makes it in
Elsewhere, the SMC also approved the use of Celgene’s Revlimid (lenalidomide) in combination with dexamethasone for the treatment of the blood cancer multiple myeloma, but only when patients have received at least two lines or prior therapy.

The SMC originally rejected the use of Revlimid, an analogue of thalidomide, for use in patients with just one failed treatment, as, despite being widely considered to be ‘breakthrough’ oral drug, its annual price tag of between £36,000 and £69,000 was considered too much for the NHS to bear.

But following a resubmission by the manufacturer, the SMC has followed in the footsteps of its sister organisation for England and Wales, the National Institute for Health and Clinical Excellence, in concluding that there is indeed a plausible economic case for the drug’s use on the NHS, but only under the said restrictions (i.e. two prior therapies instead of ine).

According to Celgene, the net drug budget impact in Scotland will be around £920,000 in year one and £2.9 million in year five, though this figure also includes monitoring, adverse event and medical management costs, the regulator stressed.