{"id":38949,"date":"2017-04-18T15:40:24","date_gmt":"2017-04-18T14:40:24","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=38949"},"modified":"2017-04-18T16:02:56","modified_gmt":"2017-04-18T15:02:56","slug":"nices-proposed-new-qaly-modifier-for-appraising-highly-specialised-technologies","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2017\/04\/18\/nices-proposed-new-qaly-modifier-for-appraising-highly-specialised-technologies\/","title":{"rendered":"James Raftery: NICE\u2019s proposed new QALY modifier for appraising highly specialised technologies"},"content":{"rendered":"

After\u00a0a\u00a0consultation on changes to its methods for appraising health technologies, the National Institute for Health and Care Excellence (NICE) has gone public\u00a0with its way forward<\/a>. As discussed previously<\/a>, the consultation sought views on four items:<\/p>\n

    \n
  1. Introduce a “fast track” NICE technology appraisal process for the most promising new technologies, which fall below an incremental cost effectiveness ratio of \u00a310 000 per quality adjusted life years (QALY).<\/li>\n
  2. Operate a “budget impact threshold” of \u00a320 million, set by NHS England, to signal the need for a dialogue with companies to agree special arrangements to better manage the introduction of new technologies recommended by NICE.<\/li>\n
  3. Vary the timescale for the funding requirement when the budget impact threshold is reached or exceeded, risking disruption to the funding of other services.<\/li>\n
  4. Automatically fund, from routine commissioning budgets, treatments for very rare conditions (highly specialised technologies (HSTs)) up to \u00a3100 000 per QALY, and provide the opportunity for treatments above this range to be considered through NHS England\u2019s process for prioritising other highly specialised technologies.\u00a0<\/strong><\/li>\n<\/ol>\n

    According to the papers from NICE’s public board meeting of 15 March 2017<\/a>, minimal change is proposed on items 1 to 3, but 4 is subject to change.\u00a0On highly specialised technologies (usually less than one thousand patients), the consultation found considerable opposition, particularly from companies and patient\/carer organisations (77% of whom said they had received payments from industry).\u00a0<\/strong><\/p>\n

    NICE now proposes to introduce \u201ca QALY modifier,\u201d which could raise the threshold to
    \n\u00a3300 000 for some highly specialised technologies. This modifier involves weighting lifetime QALY gains by size of gain, with a standard weight of 1 for less than or equal to 10 QALYs, 2 for 11-29 QALYs, and 3 for greater than or equal to 30 QALYs\u00a0(Table 1).\u00a0<\/strong><\/p>\n

    Table 1:\u00a0<\/strong>NICE\u2019s new w<\/strong>eighting of QALYs in HST by incremental QALY gain<\/strong><\/p>\n\n\n\n\n\n\n
    Incremental QALYs gained (per patient, using lifetime horizon)<\/strong><\/td>\nWeight versus 100k\/QALY<\/strong><\/td>\n<\/tr>\n
    Less than or equal to 10<\/td>\n1<\/td>\n<\/tr>\n
    11 \u2013 29<\/td>\nBetween 1 and 3 (using equal increments)<\/td>\n<\/tr>\n
    Greater than or equal to 30<\/td>\n3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

     <\/p>\n

    Source<\/strong>: <\/strong>NICE and NHS England consultation of changes to the arrangements for evaluating and funding drugs and other health technologies assessed through NICE’s technology appraisal and highly specialised technologies programmes. Copied from table 1: Weighting of QALYs in HST. Para 21. Item 9.2. in Agenda and Papers. Public Board Meeting, 15 March. <\/a><\/p>\n

    Some points are worth making on highly specialised technologies and the proposed changes.<\/p>\n

    Firstly, on HSTs, NHS England\u2019s budget covers the commissioning of both services and medicines and is not ringfenced. The budget allocated for highly specialised services (HSTs) in 2013\u201314 was \u00a3544\u00a0million, of which the spend on high cost drugs was \u00a3156\u00a0million. HSTs thus account for a small (around 0.5%) share of NHS spending, most of which is not (yet, at least) on drugs.<\/p>\n

    Secondly, the report notes that in its appraisals of HSTs, QALY large gains are common and that perhaps three recent HST appraisals would have received some weight. A quick check shows that NICE has appraised only four HST topics (Table 2). Of these, the guidance on eculizumab for atypical hemolytic-uremic syndrome (<\/em>aHUS) cited a QALY gain of just over 10. No estimates of QALY gains were reported in the guidance on the other three topics, and the relevant figures were redacted in the reports of the evidence review groups. NICE acknowledges that the future relevance of the QALY modifier cannot be predicted.\u00a0<\/strong><\/p>\n

    Table 2:\u00a0<\/strong>Topics appraised by NICE\u2019s HST programme<\/strong><\/p>\n\n\n\n\n\n\n\n
    Guidance<\/strong><\/td>\nDrug<\/strong><\/td>\nDisease<\/strong><\/td>\nCost per patient year<\/strong><\/td>\nEstimated eligible patients<\/strong><\/td>\nNICE Recommendation<\/strong><\/td>\n<\/tr>\n
    HST1<\/strong><\/td>\nEculizumab<\/td>\nAtypical haemolytic uraemic syndrome (aHUS)<\/td>\n\u00a3340 200<\/td>\n74 (highly uncertain)<\/strong><\/td>\nYes with PAS<\/strong><\/td>\n<\/tr>\n
    HST2<\/strong><\/td>\nElosulfase alfa,<\/td>\nMucopolysaccharidosis type\u00a0IVa (MPS\u00a0IVa)<\/td>\n\u00a3394 680<\/td>\n74-77\u00a0 eligible (co est)<\/strong><\/td>\nYes as managed access<\/strong><\/td>\n<\/tr>\n
    HST3<\/strong><\/td>\nAtaluren,<\/td>\nDuchenne muscular dystrophy (dystrophin gene)<\/td>\n\u00a3220 256<\/td>\nNot known<\/strong><\/td>\nYes with PAS<\/strong><\/td>\n<\/tr>\n
    HST4 <\/strong><\/td>\nMigalastat<\/td>\nTreating Fabry disease in people over\u00a016 years of age with an amenable mutation,<\/td>\n\u00a3210 000<\/td>\n142<\/strong><\/td>\nYes with PAS<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

     <\/p>\n

    Notes:<\/strong> Eligible patient numbers for HST4 cited in guidance, with authors’ best estimates for others.<\/p>\n

    Source:<\/strong>\u00a0Table derived from NICE\u2019s published HST appraisals<\/a><\/p>\n

    Thirdly, estimating the lifetime QALY gain is difficult, requiring extrapolation from sparse data. Estimates of lifetime QALY gain seem more likely to rely on mortality rather than morbidity, in turn implying that patients must be young enough to accrue higher QALYs. QALY gain has some resemblance to previous suggestions by NICE, such as \u201cQALY shortfall,\u201d but differs in being linked to the health gain due to particular technologies.<\/p>\n

    Fourthly, more generally, while there may be an advantage of continuing to frame the argument within the QALY framework, no rationale has been provided for either the \u00a3100 000 or the new \u00a3300 000 thresholds. Any such justification would need to justify first, the increase by a factor of 5 for HSTs to get from the basic \u00a320 000 threshold to \u00a3100 000, and then justify an additional increase by a factor of 3 to reach the \u00a3300 000 threshold, making a multiple of 15.<\/p>\n

    Fifthly, the QALY modifier appears to enable NICE to appraise all HSTs, thus killing off the proposal that topics that NICE could not recommend would be \u201cmigrated\u201d to NHS England\u2019s Clinical Priorities Advisory Group.<\/p>\n

    Finally, the proposed QALY modifier\u2019s increasing weight with magnitude of QALY gain conflicts with what little evidence we have about what the public might prefer. In the largest study yet<\/a> on the topic, commissioned to inform NICE, public views were found to favour technologies with large QALY gains but at a diminishing rate. The new QALY modifier may not only lack a rationale, but also seems to move in the opposite direction to the evidence.<\/p>\n

    James Raftery<\/strong> is a health economist with several decades’ experience of the NHS. He is professor of health technology assessment at Southampton University. A keen \u201cNICE watcher,\u201d he has provided economic input to technical assessment reports for NICE, but has never been a member of any of its committees. The opinions expressed here are his personal views.<\/em><\/p>\n

    Competing interests<\/strong>: The author has no further interests to declare.<\/p>\n","protected":false},"excerpt":{"rendered":"

    After\u00a0a\u00a0consultation on changes to its methods for appraising health technologies, the National Institute for Health and Care Excellence (NICE) has gone public\u00a0with its way forward. As discussed previously, the consultation […]<\/p>\n

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