| Infliximab | Crohn's disease (active severe in adults) | Recommended by NICE, not by SMC | SMC (April 2007): manufacturer did not present a sufficiently robust economic case NICE (2010): recommended in patients who have not responded to conventional treatment or have contraindication to conventional treatment, until treatment failure or 12 months. The assessment group estimated the ICER to be £68 000
| No |
| Infliximab | Crohn's disease (fistulising) | Recommended by NICE, not by SMC | SMC (April 2007): manufacturer's justification of the treatment cost in relation to its health benefits was not sufficient NICE (2010): recommended in patients who have not responded to conventional treatment or have contraindication to conventional treatment, until treatment failure or 12 months. NICE assumed the ICER to be £30 000, so a borderline case
| No |
| Infliximab | Acute, severely active ulcerative colitis | Recommended by NICE, but not by SMC | SMC: manufacturer did not present a sufficiently robust economic case NICE: recommended as a possible treatment for people with acute, severely active ulcerative colitis only if ciclosporin could not be used. Otherwise should be used only in trials
| No |
| Infliximab | Severe ankylosing spondylitis (adults) | Restricted by SMC, not recommended by NICE | SMC: in 2004, SMC said that the economics case had not been demonstrated. In 2005, it was approved for very restricted use, as only cost-effective ‘when rigorous stopping rules were applied’. SMC later changed advice in line with the NICE MTA NICE (2008): in an MTA, infliximab was not cost-effective, especially compared with etanercept and adalimumab. SMC had considered infliximab in isolation
| No |
| Pimecrolimus | Atopic dermatitis (eczema) | Recommended by NICE, not by SMC | SMC: no evidence that it has clinical advantage in terms of efficacy or safety when compared with the alternative treatments and the economic case for using this preparation is unproven NICE: recommended for very restricted use for the second-line treatment of moderate atopic eczema on the face and neck in children aged 2–16 years that has not been controlled by topical corticosteroids, and only where serious adverse effects such as irreversible skin atrophy likely
| No |
| Docetaxel (in combination with steroid) | Prostate cancer (hormone-refractory) | Recommended by NICE, not by SMC | SMC: the cost-effectiveness has not been demonstrated NICE: as a treatment option only if Karnofsky performance status score is 60% or more. N.B NICE allowed an ICER of £33000 as being ‘acceptable cost-effective’ N.B SMC have changed their advice in accordance with NICE MTA
| No |
| Cinacalcet | Hyperparathyroidism (refractory) | Use very restricted use by NICE, not recommended by SMC | SMC: the economic case was not demonstrated NICE: recommended for use in ‘extreme situations’: people on dialysis who have very high levels of parathyroid hormone in their blood that cannot be lowered by other treatments and cannot have a parathyroidectomy because of the risks involved. It is not clear from the guidance what the ICER was estimated to be, but in most situations, it was well above £30 000
| No |
| Telbivudine | Chronic hepatitis B | Recommended by SMC, not by NICE | SMC: approved on the grounds that it was cost-effective compared to entecavir and lamivudine NICE: cost-effectiveness not proven. The manufacturer's submission did not include any comparison with entecavir. NICE commented that the complexity and lack of transparency in the manufacturer's model undermined the credibility of the economic results
| No |
| Pegaptanib | Wet age-related macular degeneration | Restricted by SMC, not recommended by NICE | SMC: approved for restricted use in July 2006 NICE: deemed not cost-effective in August 2008 in an MTA along with ranibizumab, which was considered cost-effective N.B SMC have changed their advice in accordance with NICE MTA
| No |
| Sunitinib (first line) | Advanced and/or metastatic renal cell carcinoma | Recommended by NICE, but not by SMC | SMC (July 2007): manufacturer did not present a sufficiently robust economic analysis NICE (March 2009): approved for restricted use in one subgroup, with first cycle free to NHS, and cost per QALY of £54 000 under the ‘end-of-life’ system N.B SMC have changed their advice in accordance with NICE MTA
| Yes |
| Trabectedin Intravenous | Advanced soft tissue sarcoma | Recommended by NICE, but not by SMC | SMC: manufacturer did not present a sufficiently robust economic analysis NICE: restricted use with ICER at £34 000, with a ‘patient access scheme’, in which manufacturer funds the sixth and any further treatments. Approved under end-of-life system
| Yes |
| Adalimumab | Severe active Crohn's disease (adults) | Recommended by NICE, but not by SMC | SMC (October 2007): manufacturer did not present a sufficiently robust economic case NICE (May 2010): restricted use. NICE did not agree with the assessment group assumptions about relapse rates and obtained further analyses from its Decision Support Unit. The final NICE cost per QALY estimate is not clear
| No |
| Efaluzimab | Psoriasis | Restricted use approved by NICE, not recommended by SMC | SMC: cost-effectiveness was not demonstrated NICE: Maybe a treatment option if disease is severe as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of >10. The psoriasis has failed to respond to standard systemic therapies including ciclosporin, methotrexate and PUVA; or the person is intolerant to, or has a contraindication to, these treatments and only if their psoriasis has failed to respond to etanercept or they are shown to be intolerant of, or have contraindications to, treatment with etanercept N.B The license has been withdrawn from EMA due to a possible link with multifocal leukoencephalopathy
| No |