HPV testing: IQWiG still sees indications of a benefit in primary screening

The Institute for Quality and Efficiency in Health Care (IQWiG) assessed current study results on the benefit of a test for human papillomavirus (HPV) and examined whether its first assessment from January 2012 is still valid. The rapid report published by the Institute on 11 June 2014 answers this question with “yes”. IQWiG still sees indications that precursors of cervical cancer can be detected and treated earlier and consequently tumours occur less often in women who underwent this testing.

HPV testing is not reimbursed by SHI funds

In screening for cervical cancer, the German statutory health insurance (SHI) funds currently offer an annual cytologic examination of mucosal cells from a smear taken from the neck of the womb (cervix). This test is called a Pap smear. Since it became known that infection with HPV is the main risk factor for developing cervical cancer, experts have been discussing whether HPV testing is also a suitable screening method or is even superior to a cytologic test. The SHI funds currently only reimburse HPV testing in exceptional cases, for example, in cases where the result of a Pap smear is unclear.

New analysis of large study

IQWiG conducted a new search for studies comparing primary screening strategies for cervical cancer based on different screening tests: a strategy including HPV testing alone or in combination with cytology-based testing and a strategy including cytology-based testing alone.

In this update search, they identified no studies that had not already been included in the first assessment. However, they were now able to include the final analysis of one of the largest studies (POBASCAM), for which only an interim analysis had been available in 2011.

Fewer cancer diagnoses in the second screening round

Also under inclusion of the new data, the number of diagnoses for invasive cervical cancer in the second screening round was lower in the HPV group than in the group of women who had only been examined with a cytology-based screening strategy (e.g. Pap smear) in the first screening round. This also applies to the so-called “composite outcome”, which not only comprised tumours, but also advanced precursors of cancer. IQWiG therefore determined an indication of a benefit in each case.

There are still no data or no evaluable data available on mortality, quality of life and potential harm.

As the screening strategies applied in the studies varied greatly and could therefore not be compared with each other, the results still do not allow a recommendation for a specific screening strategy in the German health care system.

Process of report production

The Federal Joint Committee (G-BA) commissioned IQWiG to prepare the report in an accelerated process, known as a “rapid report”. Unlike the normal procedure, no preliminary reports are published in this case. Although a draft version of the report is reviewed by external experts, no hearing at which all interested parties can comment takes place.

IQWiG sent the first benefit assessment to the commissioning agency in November 2011 and published it in January 2012. In October, the G-BA commissioned IQWiG to update its report using the same methodological approach. The present report was sent to the G-BA in mid-May 2014.

An overview of the background, methods and further results of the report is provided in the following executive summary.