New research into levels of use across England of drugs which have been appraised by the National Institute for Health and Clinical Excellence (NICE) shows that, out of 13 treatments, such use appears to be higher than expected for six, and lower than expected for another six.The third annual review of the use of NICE-appraised medicines shows that, during 2010 and 2011, actual levels of use in England seemed to be higher than expected for:
- Merck & Co's Temodar (temozolomide), licensed for the treatment of newly-diagnosed brain cancer in adults and also for second-line treatment of brain cancer in adults and children over three:
- Pfizer's Champix (varenicline), used to aid smoking cessation;
- Sanofi's Lantus (insulin glargine) and Novo Nordisk's Levemir (detemir), a treatment for people with type I diabetes;
- osteoporosis treatments Merck & Co's Fosamax (alendronate), Procter & Gamble's Didronel (etidronate) and Actonel (risedronate), Eli Lilly's Evista (raloxifene) and Forteo (teriparatine), Servier's Protelos (strontium ranelate) and Amgen's Prolia (denosumab);- statins for adults with clinical evidence of cardiovascular disease (CVD); and
- Eisai's Gliadel Wafer (carmustine implant), for the treatment of recurrent glioblastoma multiformeThe drugs whose use was lower than expected were:
- acute coronary syndrome (ACS) treatments Eli Lilly's ReoPro (abciximab), Angiomax (eptifibatide) and Iroko Cardio's Aggrastat (tirofiban);
- Sanofi's Rilutek (riluzole), used to extend life in patients with amyotrophic lateral sclerosis (ALS);
- naltrexone, for recovering heroin addicts;
- Roche's Herceptin (trastuzumab), used in the treatment of advanced breast cancer and gastric cancer;
- Shire's Resolor (prucalopride), for the treatment of chronic constipation in women; and
- Takeda's Uloric (febuxostat), for chronic hyperuricaemia in gout.
For Novartis' Lucentis (ranibizumab), used in the treatment of age-related macular degeneration (AMD), the outcome was inconclusive and depended on the assumptions in the methodology used, says the report, which was commissioned by the Department of Health and produced by the NHS Health and Social Care Information Centre (HSCIC) in collaboration with NICE and with the involvement of the pharmaceutical industry.Commenting on this latest research, HSCIC chief executive Tim Straughan pointed out that the work continues to be badged as experimental because it relies on deriving estimates for the numbers of eligible patients and expected use of medicine. This "requires a number of assumptions for things such as average length of treatments - and these are extremely difficult to produce,” he said.
"Anyone interpreting the figures needs to be clear about the limitations of what the data show and it would certainly be wrong to think they definitively show drugs are being either 'under' or 'over' prescribed," Mr Straughan cautioned.
Similarly, the regional variation could be due to various factors, including gaps in data, differences in demography and disease prevalence across the country and the fact that figures may be based on small numbers of patients for each of the drugs considered, he went on. Moreover, "users of the figures should also remember that many of the medicines considered are only one of a number of treatment options available to clinicians. This means some variation in use should be expected, and may be due to the prescribing preferences of clinicians in local areas."
The report is the result of a 2009 agreement between the government and the Association of the British Pharmaceutical Industry (ABPI). The industry group commented that, after nearly four years, these latest figures show that patients are still not getting access to NICE-recommended medicines at the expected level. Half of the disease groups are showing lower-than-expected use, the industry group points out, adding that, in fact, the picture for some medicines showing under-use in 2010 had actually worsened in 2011.
The NHS is required to fund NICE-approved medicines, and the NHS Constitution gives patients the legal right to them if their clinicians deems it appropriate, but the report shows how little progress has been made on the uptake and access of medicines, where the UK consistently lags behind international counterparts, says the ABPI.The industry is also concerned at how few of the newest medicine have been included in the report, the group notes, adding: "we know there are a number of innovative medicines that are difficult for patients to access."
And finally, the data shows that doctors are prescribing older generic drugs at a higher level than NICE expectations. "This is a result of the very long time it takes for some medicines to reach or exceed NICE-estimated levels, by which time they have lost their patent and can be prescribed cheaply by the NHS," the ABPI concludes.