Case Study: Market Access

DontBePatient Intelligence was asked to support the market access story of a test developed for the use in women with cervical dysplasia.

Cervical Dysplasia is a condition mainly caused by Infections with Human Papilloma Virus. The Virus causes cell alterations which may develop into cancer, while the majority of the infections will heale without further consequences.

The established testing is based on PAP smears. His technique is simple, cost effective and has shown to reduce the incidence of cervical carcinoma significantly.

The weakness of the Pap smear is the fact, that it mainly describes the degree of inflammatory cell alteration between “normal”(PAP I) and “cancer already developed”(PAP V) without giving any probability information on the further development. So women with a moderate to high grade PAP will have to undergo re-test cycles until a definitive grade – mostly a decrease to PAP I or II – is reached.

This has 2 effects: without a more definitive  prognostic test, women may decide unnecessarily for a surgery of the cervical area (Conisation). This is an invasive procedure with some risks associated and a potential long-term risk of preterm birth due to reduced stability of the lower uterus/cervix. In addition, the re-test cycles may run for years always posing the sword of Damocles above the head of the patient.

The new test works completely different: it tests for the grade of integration of Virus RNA into the genes of the cervical cells. If integration is happening or already fixed, cancer will follow. As long as this is not the case, a restitution to normal is most likely.

In a structured dialogue with >2000 patients, the degree of burden caused by being stuck in retest cycles became clear and measurable. 70% of all women in this cohort were markedly or significantly burdened by the situation and appr. the same number was in fear of developing cancer. 30% of the women with retest cycles lasting three years or longer showed signs of a Post-Traumatic Stress Syndrome (PTSS).

While the reduction of unnecessary Conisations and consecutive  preterm birth events is difficult to measure in monetary dimensions, the psychologic burden and the associated rate of PTSS is an accepted and established cost driver in health care as it is associated with elevated morbidity and mortality.

The introduction of psychological scales into a prospective trial and the focus on this data class leads to an optimized Market Access strategy with a clear cost-benefit correlation.