Appendix 1. NICE Guidance 1999-2002.NICE Guidance Recommendation Incremental cost per QALY?* Incremental cost per Number of Is an Funding# = official NICE x = not available LYG? people alternative implicationsnumbering; reflects x = not available effected by treatment for NHS ifchronological order of the disease available? procedure/decisions. drug was recommende dRemoval of wisdom teeth No x x 53,372 £5m#1 symptomless Yes Prophylactic removal No cost-effectiveness of pathology free evidence – but the TA impacted (based on impacted molars indicated there was no molars estimated should be evidence of benefit from removed in savings from discontinued. symptom free extraction so the NHS in not removing on cost-effectiveness grounds 1995/96 symptomless the recommendation is clear- wisdom cut. teeth)Selection of hip prostheses Yes, but… x 37,700 total -£8mfor primary total hip x hip Yes Recommended (alternativereplacement #2 prostheses likely to replacements [ie. potential Cost effectiveness based on types of meet benchmark of performed in savings of up comparisons of revision rates prostheses) less than 10% England and to £8m] between types of prostheses. revision rate at 10 Wales years or more. Such 1989/90. evidence favours cemented prostheses.Taxanes for ovarian cancer Yes, but… 5,000 deaths#3 from ovarian Yes £28m gross Recommended (1) as part of combination cancer each (4000 patients treatment for patients (1) TA: £5,273-£11,269 year. at £7000 (1) £6,500 - £10,000 with ovarian cancer (But these figures are not each); £7m (Guidance) after surgery and (2) reported in the Guidance) net
patients with recurrent ovarian cancer (if not * mid-point used * mid-point used previously so treated)Coronary artery stents for Yes, x 120,000 inischaemic heart disease #4 England and Yes Use routinely where The overall pattern suggests uncertain percutaneous a cost per QALY difference Wales with coronary intervention between stents and PTCA of Ischaemic is appropriate for approximately £20,000 - heart disease. patients with either £30,000 (TA p.55) stable or unstable [These figures are not angina or acute reported in the Guidance] myocardial infarction * mid-point usedLiquid based cytology for No, but… 3,000 new Possibly costcervical screening #5 x cases of Yes neutral Could provide £1,100 (5 yr interval) - significant and £2,500 (3 yr interval). cervical because of important benefits . . . cancers improved insufficient evidence Given sensitivity to diagnosed productivity to justify nationwide assumptions, unlikely to each year. and introduction . . . pilot be >£10,000 (5 yr interval) 1,200 deaths improved implementation or >£20,000 (3 yr interval) annually in detection projects should be Guidance p.7 England and rates undertaken. Wales.Taxanes for breast cancer Yes, but… #6 x 33,459 in yes Should be available £7,000 - £24,000 £20m gross for treatment of England and (5000 patients advanced breast Wales with at £4000); cancer where initial breast cancer £16m net cytotoxic (1997 cancer chemotherapy has register). failed or is 14,000 UK inappropriate. women die from breast * mid-point used cancer each year.
Proton pump inhibitors for Yes, but… “1 in 10dyspepsia #7 x x people each yes Reduced PPI Healing and maintenance dose year will seek use by at when appropriate GP advice on least 15% (failure to eradicate H dyspepsia could save pylori, ulcers induced symptoms” £40m-£50m by non-steroidal anti- Estimate: in drug costs inflammatory drugs Popn > 16 yrs to heal severe gastro- = 42m. i.e. oesophageal reflux 420,000 disease. Not potentially recommended for suffer non-ulcer dyspepsia dyspepsiaHearing aid technology #8 Yes, but… 8.1m people x x in England yes insufficient evidence Impossible to estimate –but Unknown for digital hearing and Wales evidence suggests ‘potential’ (some aids. Full range of have a to be highly cost-effective potential for analogue devices hearing (Guidance) increase in should be available impairment; purchasing of 2.8m have an analogue impairment devices to of 45 decibels alter price in more than paid by NHS) one ear.Rosiglitazone for type 2 Yes, but… 800,000 withdiabetes mellitus #9 x x type 2 yes Use for patients with No published evidence on Gross £14.5m inadequate blood diabetes. relative cost-effectiveness of glucose control on 70,000 alternative treatment conventional agents eligible for strategies (TA) treatment with a glitzone (see Guidance #21,p.6)Inhaler systems for under Yes, but… Children <5 Possibly cost x x Yes
5s with asthma #10 Recommended where with asthma: neutral if specified good 9% boys and British No cost effectiveness studies practice is not 6% girls. Thoracic available which make direct clinically effective Estimate: Society comparisons between Popn < 5 = guidelines devices. 3.2094m. followed Total <5yrs with asthma = 240,705.Implantable cardioverter Yes, but… 100,000 diedefibrillators (ICDs) for annually Yes Recommended for £21,300 - £108,800 (TA, p.25) £26,000 - £31,000 per life £45m gross,arryhthmias #11 primary and (but noted few good studies year (Guidance) from sudden £25m-30m secondary prevention on QoL and no CUAs using cardiac net in specific patient UK data) £32,400 - £69,600 (TA, events. groups No mention of CUA evidence p.25) in Guidance.: Guidance implicitly rejected TA results in favour of manufacturers’ evidence on CPLYG.Glycoprotein Iib/IIIa Yes, but… 115,000 newinhibitors for acute x patients per Yes Recommended for £34m gross,coronary syndromes #12 high risk patients year with £7,000 - £11,500 per life £29.5m-31m with unstable angina unstable year as part of net or non-Q wave angina or percutaneous coronary non Q-wave myocardial infarction intervention. No data for myocardial and patients use in unstable angina or infarction undergoing non-Q wave myocardial percutaneous infarction. coronary intervention (Guidance)Methylphenidate for Yes, but… 73,200 schoolattention deficit x age children Yes Recommended as £10,000-£15,000 per QALY £7m upperhyperactivity disorder in part of (Guidance) in England limit (gross)childhood #13 comprehensive and Wales Psychotherap programme for £4,700 - £28,200 (TA) with ydiet children with severe hypokinetic
attention deficit disorder. hyperactivity disorderRibavirin and interferon Yes, but… 200,000 – £18, gross,alpha for hepatitis C #14 x 400,000 No lower limit. Recommended for £3,050-£7,000 per QALY for patients with first 6 months treatment; hepatitis C moderate to severe £5,000-£36,000 for second 6 sufferers in disease, depending months England and on experience with (Guidance) Wales. other treatments.Zanamivir in managing No… (1)influenza #15 x 3,000-4,000 Yes (1) not stated Not recommended (1) £38,000 for all adults when for 1999-2000. influenza circulating deaths p.a. in …then Yes, but… (Guidance). high risk recommended for Base case £65,000, range patients. 2000-1 for adults at £18,000 - £107,000 for allThis ‘yes, but’ comprises 2 risk when adults when influenza (2) 12,500decisions: consultations for circulating (TA p45) average(1) ‘No’ to all adults influenza rise above a annual excess (2) £2.3m-(2) ‘Yes’ to at-risk adults certain level (2) £9,300 - £31,500 for at-risk mortality. £11.7m drug adults when influenza cost only circulating (Guidance) * mid-point used Base case £47,000, range -£37,000-£184,000 (TA, p.45).Autologous cartilage No Potentialtransplantation for defects x x annual ACT Yes Not recommended “Not meaningful to make any £3.6m-6.9min knee joints #16 except in clinical operations estimate of cost effectiveness” per year as trials range from - Guidance second line 300-850 p.a. treatment (net).Laparoscopic surgery for No Colorectal Additionalcolorectal cancer #17 x x cancer causes Yes £227 per
Not recommended around admission. except in clinical 16,000 deaths 34,000 new trials annually. cases p.a., 80% receive surgery. £6.2mLaparoscopic surgery for Yes, but… 105,000 Unknowninguinal hernias #18 x people Yes Recommended only (1) £50 000 per QALY for recurrent and if used generally. develop bilateral inguinal inguinalThis ‘yes, but’ comprises 2 hernia. Totally (2) <£50,000 if restricted to hernias eachdecisions: extraperitoneal bilateral and recurrent hernia year.(1) No to laparoscopic procedure preferred. repair. (Guidance)surgery for primary Restrict tohernias appropriately trained(2) Yes to laparoscopic teamssurgery for recurrent andbilateral.Donepezil, rivastigmine, Yes, but… 400,000 with /x x Noand galantamine for Recommended as one AD in £42m perAlzheimers disease #19 component for England and “Main benefits cannot be year managing mild and Wales. reliably or easily estimated (gross) moderate from existing evidence." Alzheimers disease, Mild-to- Guidance: cost per QALY if mini-mental state moderate: zero to somewhere over examination >12 250,000 £30,000. points and ongoing Manufacturers’ evidence improvement cited by Guidance as £10,000Riluzole for motor neurone Yes, but… 2,000 peopledisease #20 x effected by No Recommended for £34,000- £43,500 per QALY Various £7.5m gross, treatment of patients reported in the Guidance. ALS interventions £5m net with amyotrophic for lateral sclerosis form Original TA base case
of MND £58,000; range - £62,000- symptomatic [i.e. current £107,000; later revisions to the relief but no NHS TA in the light of new treatment spending on evidence suggest a base case alternative. this treatment of either £16,500 or £20,000, for ALS = depending on which model is £2m] used.Pioglitazone for type 2 Yes, but… 800,000 withdiabetes mellitus #21 x x type 2 Yes Recommended as Eventual cost possible alternative to diabetes. savings of rosiglitazone (see Those £12m per above) eligible for year treatment with a glitazone = 70,000Orlistat for obesity in Yes, but… 1998: 17%adults #22 x adult males Yes Recommended only £46,000 (range: £19,000 - £15-16m (but for people who have £55,000) [independent and 21% does not lost at least 2.5 kg by review, cited by the adult females include dietary control and Guidance] are obese resource physical activity (BMI >30) savings from alone in previous Estimate: reductions in month and who meet Popn > 16 yrs obesity co- body mass index = 41.9957m. morbidity) criteria. To be Total obese = restricted to adults 7,979,183 who show specified improvements, for up to three monthsTemozolomide for Yes, but… 3,500 newrecurrent malignant x cases of brain No “Patients who have “Estimating cost per QALY is Cost per LYG of Survival rates (1) £1mglioma (brain cancer) #23 failed first-line tumours in difficult because the temozolomide against are extremely chemotherapy with the UK each extension of median survival prozarbazine is estimated poor; current
This ‘yes, but’ comprises other agents may be time is not statistically to be £35,000 [Guidance] year. treatmentstwo decisions: considered for significant, and the QoL data not curative(1) Yes to second-line treatment”. “Not are limited” [Guidance]treatment. recommended for(2) No to first line first-linetreatment. chemotherapy treatment for patients who have failed primary therapy.”Wound care #24 Yes, but… From a x x population of Yes ? “No evidence from “The quality of the economic ‘difficult to RCTs, but studies 300,000, 120 analyses and the clinical data estimate’ suggest modern (0.04% on which they were based dressings and bio- require were on the whole poor” – surgical techniques wound Guidance may reduce pain and treatment. be more acceptable to Estimate: patients” - Guidance Total popn 52,690 =2,108Gemcitabine for pancreatic Yes, but… 5,730cancer #25 X diagnosed Yes (1) “May be £7,200 to £18,700 per LYG. £816,000 - considered as p.a. (Guidance) £3m (net) treatments for (1) No CQG evidence but patients with assessment of QoL willThis ‘yes, but’ comprises advanced or almost certainly mean CQGtwo decisions: metatastic cancer, will be markedly higher than(1) Yes to first-line where first-line CPLYG (TA, p.37)treatment patients with chemotherapy is toadvanced disease be used; (2) not(2) No for patients suitable recommended forfor curative surgery patients who are suitable for curative surgery or patients with a Karnofsky score less than 50”
Docetaxel, Paclitaxel, Yes, but… 33,000 newGemcitabine and X cases of lung Yes (1) should be Treatment maintains and (1) £2,250 - £16,700 per (1) EstimatedVinorelbine for non-small considered as part of cancer p.a. probably modestly improves LYG as a netcell lung cancer #26 front-line QoL; CQG probably similar (2) Docetaxel as a second- increase of chemotherapy to CPLYG (TA, p.57) line therapy estimates at £3.8 to options for advanced just over £14,000 per LYG £15.3m, but cancers. (2) Docetaxel subject to ‘a should be considered degree of where second-line uncertainty’. treatment is appropriate for patients with locally advanced or metatastic disease when relapse has occurred after prior chemotherapy. (Guidance)Cox II selective inhibitors No, but… 1.3m – 1.75mof osteoarthritis and X with OA and Yes Not recommended Evidence on CQG from (1) £6,842 - £15,647 per (1) OA: £50mrheumatoid arthritis #27 for routine use in 250,000 – CCOHTA deleted from the LYG (manufacturers); - £112m patients with 500,000 with TA (as being confidential) > £150,000 (CCOHTA) RA: £9.5m - rheumatoid arthritis RA (Guidance) £35.6m (TA, or osteoarthritis. p.81)This ‘no, but’ comprises To be used onlytwo decisions: when ‘clearly (2) £25m(1) No to routine use indicated’, after (Guidance)(2) Yes to use by high-risk careful considerationpatients. of the risks and benefitsTopotecan for advanced Yes, but… 6,000 casesovarian cancer #28 x diagnosed Yes (1) “Recommended (1) £7m (net) £1,000 per LYG … but as one option for each year. ‘cost effectiveness analysis second-line treatment unsound’ (Guidance) where disease is 4,500 die
resistant”. each yearThis ‘no, but’ comprises (2) “Nottwo decisions. recommended in patients with poor performance status, bowel obstruction or after previous exposure to topecan or similar drugs” – GuidanceFludarabine for B-cell Yes, but… 2.7 peoplechronic lymphocytic x x per 100,000 Yes “Recommended as “The assessment of cost Results reported ‘per year Not expectedlaukaemia #29 second-line therapy effectiveness … is subject to of remission’ rather than to result in a for patients who have Estimate: considerable uncertainty” LYG net increase. either failed, or are 142 (Guidance) intolerant of, first-line ‘Robust estimates of cost chemotherapy. Oral utility cannot be obtained formulation with the current information preferred” – available’ (TA, p.33) GuidanceBreast Cancer – taxanes – Yes, but…review #30 x 1. £7,000 - £23,500 14,000 Yes Guidance remains (1) £20m (net) unchanged from #6. (second line, which NICE women die 1. Docetaxel and recommended) from breastThis ‘yes, but’ comprises 2 paclitaxel are cancer in thedecisions: recommended as an UK each(1) Yes to use as second- option for the 2. £11,000 - £27,000 (first year.line treatment. treatment of line, which NICE rejected)(2) No to use as first-line advanced breast (1) 5,000treatment. cancer where initial No change in the evidence cases pa. … chemotherapy … base since Guidance #6 has failed or is inappropriate. 2. Use of docetaxel in combination with a
anthracycline in first- line treatment of advanced breast cancer is not currently recommended.Sibutramine for obesity in Yes, but… 20% of thoseadults #31 Guidance: manufacturers’ x aged >16 Yes Net £19.2m should be considered evidence £10,000, but £15,000 (surgery, only for people years are by year 3 (but - £30,000 ‘more realistic’. other drugs) meeting specified obese ie. may be a criteria. * mid-point used have a BMI > conservative 30 Estimate: estimate). Popn >16 = Initial HTA £7,900, with an 41.9957m update based on higher Obese = prices for the drug £10,500. 8,399,140 45,100 patients by year 3 (Guidance)Multiple Sclerosis: beta No 63,000 £91minterferon and glatiramer x No (£73m - (manufacturers submission)acetate #32 £118m) £10,000. net. Sensitive to extrapolation of benefit: 5 yrs: £380,000-£780,000 10 yrs: £190,000 - £425,000 * mid-point used 20 yrs: £40,000 - £90,000Advanced Colorectal Yes, but … X (1) Irinotecan first line 28,900 newCancer: irinotecan, therapy = £29,000 LYG, cases p.a. Yes (1) Irinotecan and (2) £21m netoxaliplatin and raltitrixed oxaliplatin in “The Committee believed the (oxaliplatin)#33 combination with central estimate of £39,000 (3) Irinotecan second line
5FUA/FA not CPLYG would translate into a therapy = £17,000-£28,000 (3) £20m net recommended for significantly higher CQG as LYG (irinotecan) routine first-line QoL associated withThis ‘yes, but’ comprises 4 therapy for advanced advanced colorectal cancer is (2) Oxaliplatin and (4)decisions: colorectal cancer (2) below perfect health” raltitrexel = either no(1) no Oxiplatin should be (Guidance, p.9) estimates, or estimates for(2) yes considered as first progression-free life year(3) yes line treatment in(4) no specified clinical circumstances. (3) Irinotecan is recommended as a second-line treatment (4) Raltitrexed not recommended for the treatment of advanced colorectal cancer.Breast Cancer – Yes, but … 16-20% oftrastuzumab #34 x women with Yes recommended for 1. £37,500 per QALY in £17m net (but specified clinical breast cancer combination therapy. for both circumstances: have decisions 1 & 1. Combination advanced 2. £19,000 as monotherapy 2) therapy: for patients disease; 50%This ‘yes, but’ comprises 2 with HER2>3 who of patients Estimate,decisions: have not received with early based on(1) Yes to use as chemotherapy and in symptoms Guidance costcombination therapy whom anthracyclin will figures:(2) Yes to use as inappropriate. eventually (1) £9.6mmonotherapy 2. Monotherapy: for progress to (2)£7.5m patients with advanced HER2>3 who have disease. had 2 previous Estimate: chemotherapy 1997: 33,459 regimes. women with breast cancer.
5,353 – 6,692 have advanced disease.Rheumatoid Arthritis: Yes, but … 10,000 with £3m (net)Juvenile Idiopathic x JIA in Yes Etanercept Manufacturers’ evidence onlyArthritis – etanercept and recommended for England and (£16,082). TA suggested thisinfliximab. children 4-17 whose Wales. was questionable and that#35 condition has not “construction of a JIA model responded with greater validity presents adequately to considerable problems” methotrexate Guidance: suggests “likely to be in the region of £15,000 to £30,000”. * mid-point usedRheumatoid Arthritis: Yes, but … TA: etanercept £63,974, 420,000 £55 - £75metanercept and infliximab infliximab £99,373 (but does x people with Yes (gross – not Recommended forfor adults. adults with RA who not include non-drug costs RA. net i.e. does#36 have not responded averted) not deduct adequately to at least the cost of 2 disease modifying Guidance: £27,000 - £35,000 existing drugs. (for ‘these therapies’) prescriptions * mid-point used for these drugs)Lymphona – Rituximab. No, but… 9,000 new Unknown#37 x x cases each Yes Not recommended as 3rd line or subsequent year in the treatment. UK Recommended as last line treatment only, for patients for whom all other treatment options exhausted, as a means of collecting
‘case series’ data.Asthma inhaler devices for Recommended a 10-20% of £1.2m netchildren specific type of x children aged Yes <£5,000. TA reports a (alternative#38 inhaler ( press and 5-15. ‘threshold analysis’: at either devices) breathe and spacer) Estimate: £5,000 or £20,000 per QALY Popn 5-15 = the gain in QALYs necessary 7.4848m. to make any one intervention 748,480 – cost effective is very small. 1,496,960 “No intervention can be with asthma. dismissed as not being cost- effective”Smoking cessation – Yes Evidence QoL improved by 120,000 £20m - £56mnicotine replacement quitting – so by implication deaths of Yes (gross: drug £4,500 (1992 prices, costs#39 Recommended for the cost per QALY will be those >35 costs relating and benefits discounted at those who wish to lower than the cost per LYG. years to smoking 6%); £350 - £800 (1998 quit smoking. QALYs gained one third attributable cessation prices, costs discounted at greater than LYG per quitter to smoking only) 6% and benefits at 1.5%) (TA) annually. Independent model cited by Guidance: <£2,500 in comparison to advice alone; <£1,000 in comparison with counselling.Source: Guidance and supporting Technical Appraisals available on NICE’s web page (www.nice.org.uk).* £ cost per QALY are those reported in the Guidance. Where there are disparities between those in the Guidance and those in the Technical Appraisal (TA),the TA results are also shown.