The proposed 2016 NCSP changes: the case for uncoupling the known from the unknown
The proposed changes to the cervical screening program in Australia as detailed in the article by Prof Ian Hammond (O&G Magazine Vol 16 No 3 Spring 2014 p26) makes interesting and informative reading. These changes consist of two broad elements:
- discontinuation of screening for women under 25 years of age; and
- the replacement of the two-yearly cervical smears with five yearly HPV genotype (and cervical cytology where indicated) in women aged 25–74 years.
In the article, these two elements were coupled together as a single package, which is yet to be given approval by policy makers. It would appear, however, that these two elements though related, are separate matters and there might be some benefit in uncoupling and presenting them as two separate proposals to policy makers.
As pointed out in the article, there is overwhelming evidence for not screening women under 25 years of age and this has been the standard in many countries for years. This is because screening such women only inflicts unnecessary morbidity on them without any clinical benefit and at a huge cost. As an example, to see teenagers and women under 25 years of age who have undergone multiple loop excisions and even cone biopsy for CIN changes, as a result of the current screening program, is quite disheartening; even more so when these women are nulliparous.
There is no question in regards to the benefits of discontinuing screening for those under 25 years of age, but the same cannot yet be said for the other component of this proposal: five-yearly HPV genotype in women aged 25–74 years. As good as the evidence in support of this latter component might be, it remains in part an unknown quantity in regards to its real benefits and cost. This is because the potential benefits identified from it are mostly derived from clinical trials and it remains to be seen how things will play out when it is rolled out into the general population. There is also the possibility that some of the pitfalls associated with this component may turn out to be more than expected. For example, to state that it will lead to a 20 per cent increase in colposcopy referrals, but no increase in treatments may not materialise in clinical practice. Given the subjective nature of colposcopy, the likelihood is that more colposcopy will typically result in more cervical biopsy, which in turn will lead to more treatment (especially among those offering ablative treatment at the time of cervical biopsy) and this in turn would lead to further colposcopy and follow up appointments. As the two proposals are currently being presented to policy makers as a single package, there is always the danger (albeit small) that rejection of one component implies rejection of all. This will then leave clinicians in a place where they will continue to subject younger women to unnecessary Pap smear, colposcopy and treatment.
It may therefore be beneficial to consider separating and presenting discontinuation of screening for the under 25 years as a separate entity, for earlier implementation, to policy makers. Given what is known about this, there is little to be gained by waiting till 2016 to implement this aspect of the proposal. It is inconceivable that policy makers will not immediately embrace such a proposal on the advice of experts in this field given the immediate cost savings and prevention of further unnecessary morbidity to such women.
I thank Dr Onyeka for his comments and interest in the Renewal of the National Cervical Screening Program. I am pleased to note his support for the new age of commencement starting at 25 years. He has suggested that we might consider ‘uncoupling’ the other MSAC recommendations from the age of commencement, as in his opinion Primary HPV screening ‘remains in part an unknown quantity’.
It is important to point out that the Renewal is a package and the objectives as documented in the MSAC report1 and elsewhere2 are listed below:
- assess the evidence for screening tests and pathways, the screening interval, age range and commencement for both vaccinated and non-vaccinated women;
- determine a cost-effective screening pathway and program model;
- investigate options for improved national data collection systems and registry functions to enable policy, planning, service delivery and quality management; and
- assess the feasibility and acceptability of the renewed program.
The MSAC recommendations primarily deal with points 1 and 2, but have included a recommendation for an invitation to screening.
Integral to the Renewal is the move from a Register ‘reminder’ system to an ‘invitation and reminder’ system, for both joining and exiting the program. Also of importance is the new later age for exiting the program. Enabling the registers to perform these expanded functions including receiving and storing data regarding HPV status, cytology, histology, colposcopy results and date of last contact, is a major process and a blueprint for these improved functions has been developed and is being considered by government committees. It is also hoped that the renewed Register will be national (virtual or real) and will allow for each woman to have one record, facilitating ease of access and data transfer across all jurisdictions for all concerned.
He would like us to move immediately to a delayed starting age of screening, but not move to HPV screening at the same time. Key to the policy decision is the operational aspect of the program including an upgraded and renewed register, not to mention the quality and safety monitoring and changes to workforce and laboratory practice. The register is needed to invite women at 25 years of age before we can change the policy and this is not a quick or easy process.
In addition, there is overwhelming evidence supporting primary HPV screening and this in concert with the other aspects of the renewal will lead to at least 15 per cent fewer cases of cervical cancer and similar reduction in mortality. To delay introduction of this innovative strategy will lead to unnecessary morbidity and mortality. I note that the Netherlands is introducing a primary HPV screening program in 20163, the NHS in England has six pilot sites assessing primary HPV testing4 and that in Australia the Compass trial5 has commenced and this will further inform the Renewal.
He has also raised concerns regarding the projected increase in colposcopy and feels that increase in treatment is inevitable. He has stated that an increase in cervical biopsy is likely and that this will in turn lead to more treatment ‘especially among those offering ablative treatment at the time of cervical biopsy’. I would point out that our current NHMRC guidelines6 state that ablative treatment should not be carried out in the absence of histologic diagnosis and treatment of low-grade lesions is specifically not recommended and high-grade lesions should only be treated (ablative or excisional) when a histologic diagnosis is available.6 Furthermore, it is anticipated that the projected increase in colposcopy will be transient as the impact of HPV vaccination continues to reduce the at risk population.
Finally, I note that the Australian Health Ministers Advisory Council met on the 19 September and has approved the MSAC recommendations and endorsed the Interim Implementation Plan for the Renewal.
Prof Ian Hammond
Chair, Steering Committee for the Renewal Implementation Project National Cervical Screening Program