Estimating the clinical benefits of vaccinating boys and girls against HPV-related diseases in Europe.

BACKGROUND: HPV is related to a number of cancer types, causing a considerable burden in both genders in Europe. Female vaccination programs can substantially reduce the incidence of HPV-related diseases in women and, to some extent, men through herd immunity. The objective was to estimate the incremental benefit of vaccinating boys and girls using the quadrivalent HPV vaccine in Europe versus girls-only vaccination. Incremental benefits in terms of reduction in the incidence of HPV 6, 11, 16 and 18-related diseases (including cervical, vaginal, vulvar, anal, penile, and head and neck carcinomas and genital warts) were assessed. METHODS: The analysis was performed using a model constructed in Microsoft(®)Excel, based on a previously-published dynamic transmission model of HPV vaccination and published European epidemiological data on incidence of HPV-related diseases. The incremental benefits of vaccinating 12-year old girls and boys versus girls-only vaccination was assessed (70% vaccine coverage were assumed for both). Sensitivity analyses around vaccine coverage and duration of protection were performed. RESULTS: Compared with screening alone, girls-only vaccination led to 84% reduction in HPV 16/18-related carcinomas in females and a 61% reduction in males. Vaccination of girls and boys led to a 90% reduction in HPV 16/18-related carcinomas in females and 86% reduction in males versus screening alone. Relative to a girls-only program, vaccination of girls and boys led to a reduction in female and male HPV-related carcinomas of 40% and 65%, respectively and a reduction in the incidence of HPV 6/11-related genital warts of 58% for females and 71% for males versus girls-only vaccination. CONCLUSIONS: In Europe, the vaccination of 12-year old boys and girls against HPV 6, 11, 16 and 18 would be associated with substantial additional clinical benefits in terms of reduced incidence of HPV-related genital warts and carcinomas versus girls-only vaccination. The incremental benefits of adding boys vaccination are highly dependent on coverage in girls. Therefore, further analyses should be performed taking into account the country-specific situation. In addition to clinical benefits, substantial economic benefits are also anticipated and warrant further investigation as do the social and ethical implications of including boys in vaccination programs.

A comparative analysis of the epidemiological impact and disease cost-savings of HPV vaccines in France.

The aim was to compare the epidemiological and economic impact of 16/18 bivalent and 6/11/16/18 quadrivalent HPV vaccination in France, considering differences in licensed outcomes, protection against non-vaccine HPV types and prevention of HPV-6/11-related diseases. The differential impact of the two vaccines was evaluated using a published model adapted to the French setting. The target population was females aged 14-23 y and the time horizon was 100 y. A total of eight different scenarios compared vaccination impact in terms of reduction in HPV-16/18-associated carcinomas (cervical, vulvar, vaginal, anal, penile and head and neck), HPV-6/11-related genital warts and recurrent respiratory papillomatosis, and incremental reduction in cervical cancer due to potential cross-protection. Quadrivalent vaccine was associated with total discounted cost savings ranging from EUR 544-1,020 million vs. EUR 177-538 million with the bivalent vaccination (100-y time horizon). Genital wart prevention thanks to quadrivalent HPV vaccination accounted for EUR 306-380 million savings (37-56% of costs saved). In contrast, the maximal assumed cross-protection against cervical cancer resulted in EUR 13-33 million savings (4%). Prevention of vulvar, vaginal and anal cancers accounted for additional EUR 71-89 million savings (13%). In France, the quadrivalent HPV vaccination would result in significant incremental epidemiological and economic benefits vs. the bivalent vaccination, driven primarily by prevention of genital. The present analysis is the first in the French setting to consider the impact of HPV vaccination on all HPV diseases and non-vaccine types.

Decision-tree model for health economic comparison of two long-acting somatostatin receptor ligand devices in France, Germany, and the UK.

BACKGROUND: Long-acting somatostatin receptor ligands (SRL) with product-specific formulation and means of administration are injected periodically in patients with acromegaly and neuroendocrine tumors. A simple decision-tree model aimed at comparing cost savings with ready-to-use Somatuline Autogel(®) (lanreotide) and Sandostatin LAR(®) (octreotide) for the UK, France, and Germany. The drivers of cost savings studied were the reduction of time to administer as well as a reduced baseline risk of clogging during product administration reported for Somatuline Autogel(®). METHODS: The decision-tree model assumed two settings for SRL administration, ie, by either hospital-based or community-based nurses. In the case of clogging, the first dose was assumed to be lost and a second injection performed. Successful injection depended on the probability of clogging. Direct medical costs were included. A set of scenarios were run, varying the cost drivers, such as the baseline risk of clogging, SRL administration time, and percentage of patients injected during a hospital stay. RESULTS: Costs per successful injection were less for Somatuline Autogel(®)/Depot, ranging from Euros (EUR) 13-45, EUR 52-108, and EUR 127-151, respectively, for France, Germany, and the UK. The prices for both long-acting SRL were the same in France, and cost savings came to 100% from differences other than drug prices. For Germany and the UK, the proportion of savings due to less clogging and shorter administration time was estimated to be around 32% and 20%, respectively. Based on low and high country-specific patient cohort size estimations of individuals eligible for SRL treatment among the patient population with acromegaly and neuroendocrine tumors, annual savings were estimated to be up to EUR 2,000,000 for France, EUR 6,000,000 for Germany, and EUR 7,000,000 for the UK. CONCLUSION: This model suggests that increasing usage of the Somatuline device for injection of SRL might lead to substantial savings for health care providers across Europe.

Evaluation of the cost per patient per injection of botulinum toxin A in upper limb spasticity: comparison of two preparations in 19 countries.

BACKGROUND: Botulinum toxin A injections are indicated for the management of movement disorders, including upper limb spasticity. The aim of this study was to compare the cost per patient per injection for two botulinum toxin A preparations in 19 countries. METHODS: Doses of botulinum toxin A are expressed in noninterchangeable units (U), ie, Botox(®) in 100 Allergan units (100 U) and Dysport(®) in 500 Speywood units (500 U). Recommended dosages were derived from country-specific summaries of product characteristics or prescribing information. Cost analysis was based on official list prices and expressed in 2011 Euros. The cost per patient per injection was calculated using the recommended dosage in upper limb spasticity combined with price per vial in each country. RESULTS: For upper limb spasticity, the recommended dosage for Dysport in the summary of product characteristics is 1000 U per patient, whereas for Botox the recommended dosage when recommendations were made is 300 U. Allowing for different prices per vial in each country, the cost per patient per injection for upper limb spasticity was less for Dysport than for Botox in 18 (95%) of the 19 countries (mean 17% less across countries). The difference was 20% or higher in nearly half (47%) of the countries. Sensitivity analyses considering available "real-world" dosing showed consistent results, with Dysport being less costly than Botox in all 19 countries. CONCLUSION: Considering costs per patient per injection based on analysis of recommended dosages in the summary of product characteristics, Dysport remains cheaper than Botox in most countries. Thus, when extrapolated to a national level, substantial savings could be realized by using Dysport in the treatment of upper limb spasticity.