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From:
Published online 2012 January 30. doi: 10.1136/bmjopen-2011-000671

Table 3

Differences between NICE and SMC appraisals

NICE productConditionDecisionsReasonPAS
InfliximabCrohn'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
InfliximabCrohn'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
InfliximabAcute, severely active ulcerative colitisRecommended 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
InfliximabSevere 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
PimecrolimusAtopic 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
CinacalcetHyperparathyroidism (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
TelbivudineChronic hepatitis BRecommended 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
PegaptanibWet age-related macular degenerationRestricted 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 carcinomaRecommended 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 IntravenousAdvanced soft tissue sarcomaRecommended 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
AdalimumabSevere 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
EfaluzimabPsoriasisRestricted 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

EMA, European Medicines Agency; ICER, incremental cost-effectiveness ratio; MTA, multiple technology assessments; NICE, National Institute of Health and Clinical Excellence; PAS, Patient Access Scheme; PUVA, Psoralen and Ultraviolet Light A; SMC, Scottish Medicines Consortium.