Global Insight Perspective | |
Significance | According to the study, cost effectiveness for patients of up to 21 years is optimised, but the financial benefits start to shrink for vaccinations in patients aged 21-26. |
Implications | The report touts the overall cost benefits of Gardasil, which will be viewed positively in the backdrop of recent reports on marketing efforts and adverse event incidents related to the vaccine in the United States. |
Outlook | With the debate also evaluating economic benefits, the clinical significance of cervical cancer vaccines is expected to be entrenched, bolstering arguments for further immunisation in the United States. |
A joint study entitled "Health and Economic Implications of HPV Vaccination in the United States", carried out by researchers at the Harvard School of Public Health, has been published in the New England Journal of Medicines (NEJM). It examines the benefits of prevention from cancers associated with human papillomavirus (HPV) strains HPV-16 and HPV-18, genital warts associated with HPV-6 and HPV-11, and immunity duration and screening practices. The findings of the study are as follows:
- The cost-effectiveness ratio of routine vaccinations for 12-year-old girls remained optimised at US$43,600 per quality-adjusted life year (QALY) for HPV-6 and HPV-11, which cause genital warts.
- Catch-up programmes for girls aged 13–18 are at US$97,300 per QALY, with US$81,000 per QALY for genital warts. Extension to 21 years brings up the cost to US$120,400 per QALY.
- However, costs per QALY for the 21–26 age group at US$152,700 per QALY have been deemed not as cost effective. The researchers contend that the cost of extending the catch-up programme in this age group is less than US$100,000 per QALY if one assumes life long immunity, but the cost increases to more than US$200,000 per QALY on the addition of a booster dose to maintain that life long immunity.
- Hence, the study has found that the cost effectiveness of cervical cancer vaccines will be maximised at the pre-adolescent age of the target population with high coverage, and the most important factor is the duration of vaccine immunity. The researchers also indicate a revision in screening policies, with emphasis on "sensitive tests".
The study also builds a strong case for sustained surveillance after vaccination. The research found that high risk strains of HPV that are not targeted by the vaccine could emerge, impressing upon potential change in sexual behaviour, and adding that it could result in lower uptake in screening opportunities.
Outlook and Implications
The research study's findings generally support the clinical benefits of the cervical cancer vaccine in terms of cost. However, the findings related to the 21–26 age group increases challenges faced by the vaccine in terms of reimbursement, primarily from private insurers. It also brings to context the relative success of U.K. firm GlaxoSmithKline's (GSK) Cervarix in gaining reimbursement in five European nations, including the United Kingdom. Notably, Cervarix's costs have won preference despite the prevention of just two strains of HPV, as opposed to Merck & Co.'s (U.S.) Gardasil's four strains, which have primarily contributed to a premium in the latter's cost structure.
This survey is the first instance whereby HPV vaccines' cost effectiveness have been examined, indicating a potential progress in the lifecycle of the only vaccine brand marketed in the United States—Gardasil. This follows reports over the past month on the implementation of marketing tools associated with the vaccine—namely a free dose if reimbursement from private insurers is not forthcoming (see United States: 20 August 2008: Merck's Gardasil Marketing Efforts Fall under Spotlight). Additionally, in July Gardasil was associated with 7,802 reports of adverse events reports, and further evaluation of the perceived risks associated with the vaccine is likely to be carried out (see United States: 8 July 2008: Uncertainty over Merck's Gardasil Following Emergence of Adverse Events). So far, Merck has gained approval for the vaccine as a prevention for cervical cancer, genital warts, vaginal intraepithelial neoplasia, and cervical intraepithelial neoplasia for patients aged up to 27 years in the United States, but its application to extend it beyond that age group was rejected. However, Cervarix is still facing delays in obtaining approval from the U.S. FDA.