Clinical And Cost Impact of A Novel Non-Invasive Approach For The Treatment of Cervical Dysplasia From A US Payer Perspective

OBJECTIVES: Current treatments for cervical dysplasia involve removal of affected cervical tissue. This may lead to side effects such as bleeding, infection and preterm delivery. This analysis sought to determine the clinical and cost impact of a tissue-preserving procedure using a novel photodynamic therapy under investigation for treatment of cervical dysplasia (Cevira®, Photocure, Oslo, Norway) as compared to loop electrosurgical excision procedure (LEEP) and cold knife conization (CKC). METHODS: A budget impact model was developed from the perspective of a US payer with 5 million covered lives. The model captured Medicare allowable costs for cervical cancer screening, subsequent colposcopy with biopsy for abnormal screening results, treatment of cervical dysplasia, and side effects from treatment using 2016 reimbursement rates. Clinical data for screening, follow-up biopsy and treatment outcomes were from published data. A scenario analysis determined the impact of treatment modality, including a non-surgical method like Cevira®, on preterm birth and associated costs. RESULTS: In a US health plan with 5 million covered lives, 810,525 women 18 -44 years would present for cervical cancer screening. Of those, 7,972 women would have abnormal screening and subsequent biopsy that is CIN2/3.The per patient cost to screen and treat at 24 months follow-up was $222 for photodynamic therapy, compared to $220 for LEEP and $222 for CKC. When incorporating costs related to the increased risk of preterm birth for LEEP and CKC, per patient costs were lowest for photodynamic therapy ($268) as compared to LEEP ($322) and CKC ($378). CONCLUSIONS:The per patient cost to screen and treat using tissue-preserving procedures like Cevira® is similar to current treatment strategies but has the clinical benefit of sparing normal cervical tissue, leading to lower rates of procedure-related side effects. Further benefit maybe derived from reduction in preterm births and its associated costs and intangible impact on morbidity.