The National Institute for Health and Care Excellence has issued final guidance recommending Alimera Science’s Iluvien (fluocinolone acetonide intravitreal implant) as an option for patients with chronic diabetic macular oedema, a condition that causes blurred or double vision in about 14% of diabetics.
The drugmaker will be breathing a massive sigh of relief given that NICE initially rejected the product on grounds that it did not offer value for money, but a (confidential) price cut subsequently offered helped sweeten the deal.
Iluvien – a corticosteroid with anti-inflammatory and anti-vascular endothelial growth factor (anti-VEGF) properties – has been endorsed for use in patients when the condition fails to adequately respond to available therapies, and only in an eye with an intraocular (pseudophakiciv) lens.
The implant costs £5,500 and estimates of its incremental cost per QALY ranged from £17,500 to £30,000, but NICE was persuaded that the technology “had been shown to meet a clinical need in people whose disease is unresponsive to available therapies”.
Elsewhere, final guidance has also been published supporting the use of Novartis’ Lucentis (ranibizumab) for certain sight problems in people with a rare form of short-sightedness called pathological myopia.
Specifically, the drug should be considered an option to improve clarity of vision when problems are caused by choroidal neovascularisation, when new blood vessels leak or bleed into the retina, resulting in visual impairment.
The treatment should, however, only be prescribed if Novartis makes it available to the NHS with a patient access scheme (PAS) to improve its cost-effectiveness, says NICE.
The appraisal committee concluded that the drug superior to verteporfin photodynamic therapy, with regard to offering more QALYs (13.19 compared with 12.75) and lower costs (£9,694 versus £12,455).
NICE has also, in its 300th technology appraisal guidance, recommended peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.
Roche’s Pegasys (Peginterferon alfa-2a) and Merck Sharp and Dohme’s ViraferonPeg (peginterferon alfa-2b), in combination with ribavirin, are the only treatments currently licensed in the UK for the treatment of chronic hepatitis C in children and adolescents.
On the downside, the Institute has issued final guidance rejecting Pfizer’s Bosulif (bosutinib) for previously treated chronic myeloid leukaemia.
Even with a proposed patient access scheme to reduce the overall cost of treatment, the drug doesn’t offer enough benefit to justify its price, NICE said, explaining its decision.
It was estimated that the most plausible cost per QALY ranged from £40,000-£50,000 for chronic phase CML, £58,000 for accelerated phase CML, and £60,000 for blast cell CML, and thereby way above that what is normally considered value for money.
