Management of precancerous anal intraepithelial lesions in human immunodeficiency virus-positive men who have sex with men: Clinical effectiveness and cost-effectiveness.

BACKGROUND: Human immunodeficiency virus (HIV)-positive men who have sex with men (MSM) are at disproportionately high risk for anal cancer. There is no definitive approach to the management of high-grade squamous intraepithelial lesions (HSIL), which are precursors of anal cancer, and evidence suggests that posttreatment adjuvant quadrivalent human papillomavirus (qHPV) vaccination improves HSIL treatment effectiveness. The objectives of this study were to evaluate the optimal HSIL management strategy with respect to clinical effectiveness and cost-effectiveness and to identify the optimal age for initiating HSIL management. METHODS: A decision analytic model of the natural history of anal carcinoma and HSIL management strategies was constructed for HIV-positive MSM who were 27 years old or older. The model was informed by the Surveillance, Epidemiology, and End Results-Medicare database and published studies. Outcomes included the lifetime cost, life expectancy, quality-adjusted life expectancy, cumulative risk of cancer and cancer-related deaths, and cost-effectiveness from a societal perspective. RESULTS: Active monitoring was the most effective approach in patients 29 years or younger; thereafter, HSIL treatment plus adjuvant qHPV vaccination became most effective. When cost-effectiveness was considered (ie, an incremental cost-effectiveness ratio [ICER] < $100,000/quality-adjusted life-year), do nothing was cost-effective until the age of 38 years, and HSIL treatment plus adjuvant qHPV vaccination was cost-effective beyond the age of 38 years (95% confidence interval, 34-43 years). The ICER decreased as the age at HSIL management increased. Outcomes were sensitive to the rate of HSIL regression or progression and the cost of high-resolution anoscopy and biopsy. CONCLUSIONS: The management of HSIL in HIV-positive MSM who are 38 years old or older with treatment plus adjuvant qHPV vaccination is likely to be cost-effective. The conservative approach of no treatment is likely to be cost-effective in younger patients. Cancer 2017;123:4709-4719. © 2017 American Cancer Society.

Adjuvant HPV vaccination for anal cancer prevention in HIV-positive men who have sex with men: The time is now.

IMPORTANCE: Outcomes of treating high-grade squamous intraepithelial lesions (HSIL), a precursor to anal cancer, remain uncertain. Emerging evidence shows that post HSIL treatment adjuvant quadrivalent human papillomavirus (qHPV) vaccination improves the effectiveness of treatment. However, no recommendations exist regarding the use of qHPV vaccine as an adjuvant form of therapy. Our objective was to determine whether post-treatment adjuvant vaccination should be adopted in HIV-infected MSM (individuals at highest risk for anal cancer) on the basis of cost-effectiveness determined using existing evidence or whether future research is needed. METHODS: We developed a Markov (state-transition) cohort model to assess the cost-effectiveness of post-treatment adjuvant HPV vaccination of 27years or older HIV-infected MSM. We first estimated cost-effectiveness and then performed value-of-information (VOI) analysis to determine whether future research is required by estimating the expected value of perfect information (EVPI). We also estimated expected value of partial perfect information (EVPPI) to determine what new evidences should have highest priority. RESULTS: With the incremental cost-effectiveness ratio (ICER) of $71,937/QALY, "treatment plus vaccination" was the most cost-effective HSIL management strategy using the willingness-to-pay threshold of 100,000/QALY. We found that population-level EVPI for conducting future clinical research evaluating HSIL management approaches was US$12 million (range $6-$20 million). The EVPPI associated with adjuvant qHPV vaccination efficacy estimated in terms of hazards of decreasing HSIL recurrence was $0 implying that additional data from a future study evaluating efficacy of adjuvant qHPV vaccination will not change our policy conclusion that "treatment plus vaccination" was cost-effective. Both the ICER and EVPI were sensitive to HSIL treatment compliance. CONCLUSION: Post-treatment adjuvant qHPV vaccination in HIV-infected MSM aged 27 or above is likely to be cost-effective. Use of adjuvant qHPV vaccination could be considered as a potential strategy to reduce rising anal cancer burden among these high-risk individuals.

Are colon and rectal surgeons ready to screen for anal dysplasia? Results of a survey on attitudes and practice.

BACKGROUND: Colorectal surgeons are ideal referral sources to screen for and treat high-grade anal dysplasia (high-grade squamous intraepithelial lesion [HSIL]) and anal cancer. Anal cytology and high-resolution anoscopy (HRA) using acetic acid and magnification are optimal methods for screening. We endeavored to determine US colorectal surgeons' attitudes and practices regarding HSIL screening. METHODS: An Internet-based survey with questions related to clinician demographics and attitudes and practices regarding anal dysplasia was sent to US members of the American Society of Colon and Rectal Surgeons. RESULTS: Of 1655 requests, 290 (18%) eligible participants responded. Most were white (83%), male (76%), board-certified colorectal surgeons (89%), and graduating medical school after 1990 (54%), almost all treated patients at risk for anal cancer and had read research on HSIL. Approximately one-third of respondents had performed anal cytology, and one-third had performed HRA. When evaluating patients for HSIL in surgery, only 31% use acetic acid with magnification. Of 99 participants who perform HRA, 46% were formally trained, 83% primarily do HRA primarily in the operating room, and 82% use acetic acid with magnification. Knowledge of HSIL risk factors was not associated with screening. Women, more recent graduates, and surgeons with higher percentages of HIV-infected patients were more likely to screen. Screening barriers included no training (52%), not a priority (23%), lack of evidence (21%), and cost (8%). CONCLUSIONS: American Society of Colon and Rectal Surgeons members responding to the survey by and large do not screen for anal dysplasia. Those that do are often not formally trained and use inadequate technique.