UK Utility Elicitation in Patients with Follicular Lymphoma

VA L U E I N H E A LT H

PCN203 UK Utility Elicitation in Patients with Follicular Lymphoma Wang H1, Smith A1, Yu G1, Aas E2, Bagguley T1, Howell D1, Roman E1, Burton C3, Patmore R4 of York, York, UK, 2University of Oslo, Oslo, Norway, 3Leeds Teaching Hospitals NHS Trust, Leeds, UK, 4Castle Hill Hospital, Hull, UK

20 (2017) A399–A811

A449

QALY gains for InO in comparison to IC.  Conclusions: InO was shown to increase survival and QALYs compared to IC demonstrating it to be an effective treatment for r/r B-ALL; this was demonstrated in all three scenarios explored post-HSCT.

1University

Objectives: Follicular lymphoma (FL) is the most common indolent lymphoma with approximately 1,860 new-cases diagnosed in the UK each year. Clinical management ranges from immediate treatment with chemotherapy and/or radiotherapy, to observation (“watch-and-wait (W&W)”), with treatment initiated if/when symptoms develop. Once a patient has achieved a response to therapy, they are considered to be in remission. Numerous cost-utility analyses on FL management have been conducted over the years; however, the utilities used in these studies were either not derived from published studies or were not specific to FL. The objective of this study was to bridge this gap and present the robust utility values specific to FL for use in future economic evaluations.  Methods: 181 FL patients from the UK’s population-based Haematological Malignancy Research Network (www.hmrn. org) newly diagnosed from 2012 to 2016 completed a EQ-5D-5L questionnaire at diagnosis, at 6 month and at 12 monthly intervals thereafter. Two value sets were used to calculate utility: the EQ-5D-5L value set and the EQ-5D-5L crosswalk index value (mapping to EQ-5D-3L values). Descriptive statistics on utility values were summarized using three aggregated disease states on the treatment pathway: W&W, undergoing treatment, and remission.  Results: Utility score differed with disease state: 0.85 (W&W), 0.83 (Treatment) and 0.88 (Remission) using the EQ-5D-5L value set, and 0.79, 0.74 and 0.83 respectively using the crosswalk value set. Patients in remission had a higher QoL compared to those on W&W (p= 0.182 and p= 0.139 for EQ-5D-5L and EQ-5D-3L values, respectively) and those on treatment (p= 0.016 and p= 0.002 for EQ-5D-5L and EQ-5D-3L values, respectively).  Conclusions: Based on “real-world” contemporary data, this is the first study to measure utility for different phases of the FL pathway, confirming the impact of disease state on QoL. Such robust data should be used in future economic evaluation studies designed to support policy decision making. PCN204 Mapping from SF-36 Trial Data To EQ-5D Utilities in Advanced Basal Cell Carcinoma

PCN206 Utility Values Across Lines of Therapy in Immuno-Oncology Treatments: An Example from Advanced Melanoma Tilden D1, Sierakowski W1, Cottrell S1, Kim H2 Consulting Pty Ltd, Pyrmont, Australia, 2Bristol-Myers Squibb Australia, Mulgrave, Australia

1THEMA

Objectives: Cost utility analyses of oncology treatments are most commonly performed using partitioned survival models, applying health state utilities to progression-free and progressive disease and relative to a specific line of therapy. The objective of this study was to assess utility values across treatments and lines of treatment using data in advanced melanoma for two immuno-oncology agents, nivolumab and ipilimumab.  Methods: Utility values from 1st line (1L) and 2nd line (2L) advanced melanoma populations treated with nivolumab and ipilimumab were extracted from three randomised controlled clinical trials: CheckMate-067 (1L nivolumab and 1L ipilimumab), CheckMate-037 (2L nivolumab) and MDX010-20 (2L ipilimumab). Visual assessment of QoL over time as well as comparisons of baseline and change from baseline values were performed using summary statistics.  Results: Baseline values for 1L and 2L were similar for nivolumab (0.80 vs 0.75, p= 0.001) and ipilimumab (0.79 vs 0.81, p= 0.123). Across all lines of therapy nivolumab use resulted in improvements in utility whilst patients remained progression free. Ipilimumab treatment regimens showed initial declines in utilities in the first 3 months followed by improvements over the remainder of time on treatment. The change in utility from baseline to 12 months was similar for 1L and 2L nivolumab (0.050 v 0.047, p= 0.930). Both these changes were greater than that observed for 1L ipilimumab at 12 months (0.035, p= 0.533 v 1L nivolumab and p= 0.767 v 2L nivolumab). 2L ipilimumab results were limited to short term follow-up, however utility values were comparable to 1L ipilimumab at 5 months (-0.023 v 0.014, p= 0.091).  Conclusions: The quality of life of patients on immune-based therapies appears to be independent of therapy line. Furthermore, economic modelling in an immune-oncology setting should reflect that quality of life looks to be a function of time on treatment.

Loughran T1, Reyes A2, Pletscher M2, Krivasi T2, Hatswell AJ3 Roche Ltd., Welwyn Garden City, UK, 2Hoffmann-La Roche Ltd, Basel, Switzerland, 3BresMed Health Solutions, Sheffield, UK

PCN207 Reported Utilities for Patients with Untreated Advanced/ Metastatic Renal Cell Carcinoma – A Systematic Literature Review

Objectives: Vismodegib is a Hedgehog (Hh) pathway inhibitor indicated for the treatment of adult patients with advanced basal cell carcinoma (aBCC) based on the ERIVANCE [2008-004945-27] Phase II, single-arm trial. ERIVANCE included measurements of health-related quality of life using the SF-36 questionnaire at various timepoints. The objective of this study was to map the SF-36 data onto EQ-5D utilities for use in health economic evaluations. The resulting EQ-5D values were then validated against published utility estimates in aBCC.  Methods: Patient level SF-36 data were used to generate EQ-5D utilities for pre-and post-progression, based upon the best performing algorithm (model 3) reported in a study by Rowen et al (2009). Results were compared to a study by Shingler et al. (2013) which reported utilities associated with various health states in aBCC, stratified by response status and by diameters of lesion. Although the Shingler publication was a vignette study it was believed to be the best available evidence on patients with aBCC.  Results: Mapped utilities [95% CIs] in the locally advanced population amounted to 0.839 [0.810, 0.867] and 0.757 [0.684, 0.830] for PFS and PD (n=  63 at baseline visit), respectively. The mapped PFS utility (0.839) was very close to the raw average of complete response and partial response values reported in Shingler et al. (0.836). The mapped PD utility was considerably lower than the raw average of PD utilities from Shingler et al. (0.705 versus 0.757).  Conclusions: Mapped utilities produce similar estimates to those seen in published literature, though results should be interpreted with caution due to the different methods and small sample sizes. This study is limited by the small sample size of the SF-36 data collected during ERIVANCE - n= 95 at baseline visit.

Mudd A1, Bakker R1, Malcolm B2, Doan J3, Alleman CJ1 1Pharmerit International, Rotterdam, The Netherlands, 2Bristol-Myers Squibb, Uxbridge, UK, 3Bristol-Myers Squibb, Princeton, NJ, USA

1Hoffmann-La

PCN205 Quality-Adjusted Life Years (QALYS) for Inotuzumab Ozogamicin Versus Investigators Choice (IC) for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (R/R B-ALL) Batteson R1, Critchlow S1, Barnes A1, Glah D2, Smith A2, Lang K2, Su Y3 1BresMed, Sheffield, UK, 2Pfizer Ltd, Surrey, UK, 3Pfizer Inc, New York, NY, USA

Objectives: Inotuzumab ozogamicin (InO) is an anti-CD22 antibody-calicheamicin conjugate that has demonstrated superior efficacy in patients with r/r B-ALL compared to IC in the pivotal Phase III INO-VATE ALL trial.1 A UK-based Markov model has been developed based on this study to estimate the mean life year (LY) and QALY gains associated with InO compared to IC. Using a 1.5% discount rate, we explored key QALY drivers and factors influencing long-term survival following haematopoietic stem cell transplant (HSCT).  Methods: Using trial data, parametric survival curves were generated based upon patient’s remission status and whether they received a HSCT. Patients alive 3 years post-HSCT were considered cured and followed general population mortality. Utilities were based on trial EQ-5D scores, and utilities for both post-HSCT and progression states were from the literature. Three scenarios were used to explore post-HSCT survival: (1) using the INO-VATE ALL post-HSCT data split by treatment to estimate treatment effect; (2) pooling the data from both treatment arms and applying survival post-HSCT independent of treatment; and (3) applying a covariate for minimal residual disease negativity, which was shown to be key in determining long-term post-HSCT survival in the treatment of de novo disease and is under investigation as a prognostic factor for survival following relapse.2-4  Results: InO increased survival by 5.18 LYs and 2.23 QALYs versus IC. One-way sensitivity analysis showed utility values in progressive disease and those used 5 years post-HSCT to be most influential. Probabilistic sensitivity analysis showed a large spread in QALYs gained which was a result of postHSCT survival estimates. The first post-HSCT scenario indicated the largest LY and

Objectives: Renal cell carcinoma (RCC) is the most common form of kidney cancer. The aim of this research was to systematically collect quality-of-life (QoL) evidence expressed as utility values for patients with untreated advanced or metastatic RCC.  Methods: A systematic literature review was performed with a pre-defined search strategy and review criteria. Embase, Medline, and the Cochrane Library were included as databases. Conference and Health Technology Assessment (HTA) organization websites were also searched. No language or time limits were applied, except for conference abstracts (≥ 2015).  Results: A total of 2,967 citations were obtained via Embase, Medline, and Cochrane Library, and 362 via conference and HTA organization websites. The review process resulted in the inclusion of 37 publications reporting on utility values. These publications were cost-effectiveness analyses (13 studies), clinical trials (10 studies), HTA reviews (7 studies), and utility studies (7 studies). First-line RCC treatment-specific utilities are those most frequently reported in the included studies, which assigned a specific utility value to treatments such as sunitinib, pazopanib, IFN-α , and temsirolimus. Disease states (pre/post progression), being on or off systemic treatment, and adverse events were also commonly presented as either health-state utilities (e.g., stable disease with grade III diarrhea) or as changes from a baseline utility level (e.g., disutility for grade I/II or grade III/IV events). Utility weights were presented for patient subgroups based on characteristics such as age (< 65 vs. ≥ 65 years), gender, and ECOG status (0 vs. 1), usually when the differences in QoL between patient groups were significant.  Conclusions: The systematic literature review showed that treatment-specific utilities are available and are commonly used in the literature. However, much overlap exists for utility values used in current studies in first-line advanced or metastatic RCC. The main sources for these utilities are the COMPARZ (ClinicalTrials. gov-NCT00720941) and the VEG105192 trial (ClinicalTrials.gov-NCT00334282). PCN208 Correlation Analysis Between Health State Values Derived From EQ-5D-5L And EQ-VAS in Japanese Breast Cancer Patients Iwatani T1, Noto S2, Tsugawa K1 1St.Marianna University School of Medicine, Kawasaki, Japan, 2Niigata University of Health and Welfare, Niigata, Japan

Objectives: The aim of this study is to analyse the correlation of health state values using EQ-5D-5L and visual analogue scale using EQ-VAS as quality of life (QOL) scores in Japanese breast cancer patients.  Methods: A total of 148 patients were enrolled in this study. Of these patients, 120 were primary breast cancer patients, and 28 were metastatic breast cancer patients; data for a total of 612 points of visiting were collected. The study was a longitudinal cohort study conducted from May 2016 to June 2017 in St. Marianna University Hospital. We compared the mean utilities and EQ-VAS scores of primary and metastatic breast cancer patients by using ANOVA. Then, we conducted a correlation analysis between the utilities derived from EQ-5D-5L and the QOL derived from EQ-VAS. All analyses were performed with JMP 13 (SAS Institute., Cary, NC, USA). The study protocol was approved by the Institutional Review Committee of St. Marianna University School of Medicine.  Results: The utilities of primary breast cancer patients were 0.874±0.006, and those of metastatic breast cancer patients were 0.808±0.011 (p< 0.0001). The VAS scores as a QOL indicator of primary breast cancer