López Noelia, Torné Aureli, Franco Agustín, San-Martin María, Viayna Elisabet, Barrull Carmen, Perulero Nuria
1Medical Affairs, MSD, Madrid, Spain.
2Gynecologic Oncology Unit, Institut Clinic of Gynecology, Obstetrics and Neonatology (ICGON), Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Faculty of Medicine, University of Barcelona, Barcelona, Spain.
Infect Agent Cancer. 2018 May 2;13:15. doi: 10.1186/s13027-018-0187-4. eCollection 2018.
A new nonavalent human papillomavirus (HPV) vaccine that includes genotypes 6/11/16/18/31/33/45/52/58 has been recently approved in Spain. A previous study has shown that attributable fraction of HPV related diseases in Spain is consistent with that reported in European and global studies. The aim of the present study was to estimate the annual direct costs associated to the following HPV-related diseases: genital warts, high grade precancerous lesions and cancer of cervix, vulva, vagina, anus and penis and head and neck cancer, caused by genotypes included in the nonavalent (9vHPV) and quadrivalent vaccines (4vHPV), in Spanish men and women.
Cancer registries and epidemiological studies were used to estimate the number of new annual cases of genital warts, anogenital precancerous lesions and cancer of cervix, vulva, vagina, anus, penis and head and neck, as well as the fraction attributable to HPV infection and to genotypes targeted by both vaccines in Spain. Costs per patient for each disease were obtained from the literature. In addition, 142 specialists were surveyed to estimate cost per patient of vulvar, vaginal, anal and penile precancerous lesions. The annual burden of diseases attributable to types targeted by both vaccines was estimated and compared. All results were validated by a panel of experts.
In 2016, new genital warts, precancerous lesions and cancers attributable to types targeted by the 9vHPV were estimated at 49,251, 29,405 and 3381, respectively. Among them, 12,597 new precancerous lesions and 530 new cancers were related to the 5 additional types covered by the 9vHPV. Annual cost of new cases of these diseases associated to types targeted by the 4vHPV and 9vHPV were estimated at 116.7 and 150.9 million € for the Spanish National Health Service (NHS), respectively (2017 €).
HPV-related diseases represent a major burden for the Spanish NHS. Annual new cases and costs related to the 5 additional types from the 9vHPV represent a significant burden compared with that associated to types included in the 4vHPV.
一种包含6/11/16/18/31/33/45/52/58型的新型九价人乳头瘤病毒(HPV)疫苗最近在西班牙获批。此前一项研究表明,西班牙HPV相关疾病的归因比例与欧洲及全球研究报告的一致。本研究的目的是估算与以下HPV相关疾病相关的年度直接成本:由九价(9vHPV)和四价疫苗(4vHPV)所包含的基因型引起的尖锐湿疣、高级别癌前病变以及子宫颈、外阴、阴道、肛门、阴茎癌和头颈癌,涉及西班牙男性和女性。
利用癌症登记处和流行病学研究来估算每年尖锐湿疣、肛门生殖器癌前病变以及子宫颈、外阴、阴道、肛门、阴茎和头颈癌的新发病例数,以及西班牙HPV感染和两种疫苗所针对基因型的归因比例。每种疾病的患者人均成本从文献中获取。此外,对142名专家进行了调查,以估算外阴、阴道、肛门和阴茎癌前病变的患者人均成本。估算并比较了两种疫苗所针对类型导致的疾病年度负担。所有结果均由专家小组进行了验证。
2016年,估计9vHPV所针对类型导致的新尖锐湿疣、癌前病变和癌症病例分别为49251例、29405例和3381例。其中,12597例新癌前病变和530例新癌症与9vHPV涵盖的另外5种类型有关。西班牙国家卫生服务体系(NHS)中,4vHPV和9vHPV所针对类型导致的这些疾病新病例的年度成本分别估计为1.167亿欧元和1.509亿欧元(2017年欧元)。
HPV相关疾病给西班牙NHS带来了重大负担。与4vHPV所包含类型相比,9vHPV另外5种类型导致的年度新病例和成本构成了重大负担。