Last year we and others protested against the National Institute for Health and Care Excellence (NICE) guideline (2013) for unexplained infertility, which recommended expectant treatment for up to two years, and then proceeding to IVF if this was unsuccessful, blatantly ruling out the possibility of using intra-uterine insemination (IUI) as a possible intermediate treatment (see BioNews 810).
UK clinical commissioning groups (CCGs), and to some extent international funding agencies, use NICE guidelines to construct and justify funding policies. Even though the guidance was not based on sound evidence, the civil servants in charge of funding disregarded this fact, and all funding for IUI in several London CCGs was immediately stopped.
The preference for the more expensive and intrusive IVF treatment option over IUI raised concerns to such an extent that NICE were pressured to hold an update review. NICE agreed, and identified the need to review IUI (CG156) in June 2015, framing the question: 'What is the effectiveness of intrauterine insemination (IUI) in people with unexplained infertility, mild endometriosis or 'mild' male factor infertility?' (1)
NICE continue in the same guidance notes: 'Additionally a further RCT [randomised controlled trial] (2) on IUI was highlighted by the NICE's Chair of the Evidence Update Advisory Group during sign-off of the completed Evidence Update. This study suggested that IUI is non-inferior to in-vitro fertilisation (IVF). The panel felt that the new study provided new evidence that should be considered in an update and felt that this question should be updated with more urgency than the other questions under consideration.'
So far, so good. But when the update was considered, NICE altered the question by introducing 'expectant management', restricting the evidence which could be used. The question now read: 'What is the evidence for intrauterine insemination, with or without ovarian stimulation, compared with expectant management for people with unexplained infertility, mild endometriosis and mild male-factor infertility, and whether the 2013 recommendations should be updated?'
Among professionals in the fertility area this is seen as a politically manoeuvred 'quick fix' to maintain the status quo and avoid further resource commitment. This is a disservice to evidence-based medicine, to the public purse, CCGs and clinics practising IUI, and for establishing CQC, care quality commission, inspection compliances. The only RCT (3) considered by NICE was as 'very low grade'. However, in the update rebuttal against professionals, NICE avoids using these three words but chooses to refer the reader to the addendum using the following statement several times: 'The lack of high quality evidence available and included in this evidence review is noted in the section 2.6 p.18. No new evidence was identified.'
This technique of burying poor information is often utilised in political circles. Furthermore, they reassure that IUI is not completely banned, stating – in typical civil-servant style – that the committee agreed that a recommendation with a 'do not routinely offer' wording provides 'some flexibility', whereas a 'do not offer' recommendation provided definitive guidance against the use of an intervention. This is worthy of Sir Humphrey from 'Yes, Minister'. NICE informed us that the current wording of the recommendation encouraged consideration of IUI as a treatment option in some categories – for example when people have social, cultural or religious objections to IVF. Such cases are rare and may barely make up one percent of all IUI cases.
Furthermore, they provide no accompanying RCT evidence to support this artificial flexibility. They also disproportionately and incorrectly engaged IUI/CC (clomiphene citrate) RCTs to cover all IUI, including IUI/hMG (human menoposal gonadotrophin) cycles. Framing a narrow question in relation to IUI/CC practice yields limited information, and this cannot be extended to mainstream IUI/hMG protocols. Additionally, NICE allows itself the non-evidence-based liberty to recommend IVF instead. The latter analyses have never been performed but are earmarked for 2017 update. In so doing, NICE displays a plethora of contradictions and inconsistencies, unsupported by evidence, to meet its desired target of retaining the 'status quo' from the previous recommendation, precluding a fair appraisal of IUI practice. Fertility professionals, various professional bodies and societies have peer reviewed CG156 and its update, and have completely rejected this NICE guideline and its recommendation of stopping IUI in favour of IVF (4).
The NICE guidance goes on to look at whether mainstream IUI practice is economically viable. IVF was €43,375 more expensive than IVF, reflecting the additional costs necessary to achieve one additional healthy child from IVF (5). The CCGs are therefore ill informed about the cost effectiveness of IUI against unnecessary and costly IVF treatment if they lean on the NICE guidelines. CCGs are paying over the odds for unnecessary IVF treatments in a highly lucrative fertility industry worth £550 million in the UK, relying on approximately 35–50 percent overuse of IVF procedures to enhance profits (7).
Based on significant professional representations highlighting the lack of evidence against IUI practice, we strongly advise CCGs and clinics to dismiss the NICE guidelines update (6). Furthermore, comparative study of the low-cost, less-intrusive IUI against IVF is only earmarked for 2017, and therefore NICE should not have galloped ahead in its 2013 and 2016 update guidance to recommend IVF instead. Evidence beyond the miserable results from IUI/CC cannot be assumed and extended to IUI/hMG stimulated cycles, let alone taking a leap into comparing IUI with IVF, and recommending IVF instead (7,8). Importantly, the recommendations do not follow the question asked, as highlighted by numerous professionals responding to the update, which is overly constrained by a pre-judged desirable endpoint. In rugby parlance, a swerve, side-step and hand-off. NICE already knows this fact but instead chooses to irresponsibly present ill-considered guidelines to clinics and CCGs.
Finally, NICE needs to validate the guidance by making a risk statement on the limitations of their analyses to ensure that CCGs and clinics are accurately informed. NICE must urgently issue a statement for stakeholders, the NHS and CCGs that practice and funding of IUI/hMG was not covered within its guidance and must therefore be allowed to continue. Efficient and prudent IUI practice will benefit patients, the fertility industry and the healthcare bodies, particularly with cost-saving benefits for the CCGs and NHS, while giving patients choice for the least complicated treatment option.