HPV screening test for the early detection of cervical cancer in women assessed in Austria

On the 10th of December 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on the implementation of an HPV screening test for the early detection of cervical cancer in women as a measure of cervical cancer prevention.

The overview of the efficacy and cost-effectiveness is based on a systematic literature search on published reviews, from which 14 systematic reviews or meta-analyses for the efficacy and 2 systematic reviews for the cost-effectiveness were selected. A third systematic review on cost-effectiveness was identified through expert information. International recommendations and actual practice in selected European countries (Sweden, Germany, Portugal) and Austria, as well as organizational and logistical requirements, were assessed and analyzed. The analyses were performed for the years 2019-2021.

Results:

• In comparison to the cytological procedure using the Pap smear, HPV testing has shown better sensitivity but slightly lower specificity. Furthermore, there is robust evidence that with HPV testing, precancerous lesions are more likely detected and treated, leading to decreased cervical cancer incidence. The screening interval can be safely extended within an HPV-based screening program
• Cost-effectiveness studies show that an HPV test can be cost-effective in organized or opportunistic screening programs when the screening interval is extended to at least three years for non-vaccinated women and at least five years for vaccinated women. However, various system parameters (e.g., target age, test prices) can significantly influence the cost-effectiveness results
• In most Western European countries the integration of primary HPV testing into an organized screening program with a starting age between 25 and 30 years and a screening interval between three and five years is recommended and already widely implemented, however deviating in some countries from European guidelines in terms of screening onset age, screening interval, etc.
• In Austria, opportunistic screening is in place, (“Vorsorgeuntersuchung_Neu” and “gynäkologisches Untersuchungsprogramm”) with primary cytological screening using Pap smears for women aged 18 and over. An HPV clarification test after a positive primary result (Pap II and above) is funded to a limited extent. There are no mandatory national guidelines for quality assurance of cervical cancer screening in place in Austria except for the voluntary quality assurance program of the Austrian Society for Cytology
• In the case of implementing HPV primary testing in Austria (alone or combined with Pap), it will be required to transform the opportunistic system into an organized screening program with an exact definition of the target population and the screening interval. Furthermore, installing systematic invitation, monitoring and evaluation systems will be necessary as well as the developing strategies to ensure acceptance within women and practitioners. Changes within human resources and structural changes are to be expected at the laboratory level. Furthermore, HPV primary testing will likely result in increasing numbers of colposcopies. Implementing the HPV test as a clarification test would result in less extensive structural changes or changed workflow (if the current opportunistic screening is continued). However, the second visit of a gynecologist will be required by women with a positive Pap primary test to undergo HPV testing
• Thorough patient information on HPV infections and the testing is required to enable informed decisions as well as training of clinicians and other health professionals involved. Additionally, quality standards need to be implemented (e.g., minimum volume standards for laboratories, quality of smears), and it needs to be ensured that only validated tests are used. Organized screening programs with HPV primary testing for women of 30 years of age and older in a triennial interval were the most effective in terms of cervical cancer cases and deaths per year but were associated with higher costs. However, the most expensive (but not most effective) of the seven pre-defined strategies is the annual HPV-Pap co-testing from the age of 18 years. The current opportunistic screening with Pap primary testing and Pap or HPV test as a clarification test after positive primary findings are among the least expensive strategies but imply significantly more new cervical cancer cases and cervical cancer deaths as other strategies

Conclusions:

• Implementing HPV testing into the Austrian cervical cancer screening is recommended. The greatest health benefit for women can be expected if HPV primary testing is introduced in an organized screening program for women as of age 30 years in a triennial screening interval, which will increase costs. This screening strategy requires extensive structural and health-policy changes which need thorough planning and preparations
• A clear recommendation against annual HPV-Pap co-testing in an opportunistic screening can be made, as it is the most expensive of all options and at the same time is less beneficial for women than other options. The continuation of the existing opportunistic screening is among the least expensive strategies but clearly contradicts acknowledged scientific findings and international recommendations. In any case, training/information and quality assurance measures will be required, including the restriction to use validated tests only
• The implementation of HPV-based primary screening and the associated transformation into an organized screening program requires the participation of all stakeholders involved. The change process can be supported by training for practitioners and decision-makers and information for women, but also by creative reimbursement models for the medical profession during the transition phase

The full report in German (with English summary) can be found here.

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