UK ovarian cancer survival
Expediting market access of ovariancancer treatments
Systematic review of relevant healthstate utility values & mappingalgorithms• Survival for FIGO stage III/IV epithelial ovariancancer (EOC) worse than in Australia, Canada,Sweden, Norway (1)• 5 yr survival 46.2% (England & Wales)• 2400 deaths would be avoided in 5 years fromdiagnosis if survival rate were same as best rates
in Europe(1) Coleman M, Forman D, Bryant H, et al. Cancer survival in Australia, Canada, Denmark,Norway, Sweden and the UK, 2005-2007 (the International Cancer Benchmarking
Partnership): an analysis of population-based cancer registry data. Lancet 2011
8;377(9760):99-101

Katherine MacGilchrist, MSc
CEO | Systematic Review Director

UK ovarian cancer survival

NICE track record• Bevacizumab• Unequal access to treatments cited as
potentially playing a role (2)– approved by EMA 2005
– rejected by NICE
– only available via Cancer Drugs Fund• Olaparib(2) Maringe, C., S. Walters, J. Butler, M. P. Coleman, N. Hacker, L. Hanna, B. J. Mosgaard, A.
Nordin, B. Rosen, G. Engholm, M. L. Gjerstorff, J. Hatcher, T. B. Johannesen, C. E. McGahan, D.
Meechan, R. Middleton, E. Tracey, D. Turner, M. A. Richards, B. Rachet and Icbp Module 1
Working Group. "Stage at Diagnosis and Ovarian Cancer Survival: Evidence from theInternational Cancer Benchmarking Partnership." Gynecol Oncol 127, no. 1 (2012): 75-82.

– approved by EMA 16-Dec-2014– NICE preliminary decision not to recommend May– final decision expected Sept 2015

• Niraparib? EnAd/ColoAd1? Avelumab?

National Cancer Institute-identified
most important symptoms (3)Question 1
How are we deriving our utilities? How are wemeasuring HRQoL and could the scales beinsensitive to change?

From core set from across cancer types:• Anorexia• Constipation• Diarrhoea• Dyspnea• Fatigue• Nausea• Neuropathy• Pain• Cognitive problems• Insomnia

From ovarian cancer-specific symptoms:• Abdominal pain
• Bloating• Cramping• Fear of recurrence/diseaseprogression• Indigestion• Sexual dysfunction• Vomiting• Weight gain
• Weight loss(3) Donovan, K. A., H. S. Donovan, D. Cella, M. E. Gaines, R. T. Penson, S. C. Plaxe, V. E. von Gruenigen, D. W. Bruner, B. B. Reeve andL. Wenzel. "Recommended Patient-Reported Core Set of Symptoms and Quality-of-Life Domains to Measure in Ovarian Cancer
Treatment Trials." J Natl Cancer Inst 106, no. 7 (2014).

Scales used in phase III trials
QoL

Bevacizumab

Olaparib

Niraparib

AMG
386

Aflibercept

EORTC QLQ-C30‫( ݱ‬AB/GI
symptomscore)
‫ݱ‬

EQ-5D
FACIT-Fatigue‫ݱ‬

FACT-GOG/NTX4‫ݱ‬

FACT-Nausea‫ݱ‬‫ݱ‬‫ݱ‬‫ݱ‬‫ݱ‬

Rucaparib‫ݱ‬

FACT-O‫ݱ‬

‫ݱ‬

‫ݱ‬

‫ݱ‬‫ݱ‬‫(ݱ‬NFOSI18)

FACT-Ovarian
Symptom Index

FACT-O TOIPazopanib‫ݱ‬AIM 4 symptoms

EORTC QLQOV28

Cediranib‫ݱ‬‫(ݱ‬NFOSI-18)

‫ݱ‬

‫ݱ‬

http://clinicaltrials.gov

EORTC QLQ-OV28
From core set from across cancer types:• Anorexia• Constipation• Diarrhoea• Dyspnea• Fatigue• Nausea• Neuropathy• Pain• Cognitive problems• Insomnia

From ovarian cancer-specific symptoms:• Abdominal pain
• Bloating• Cramping• Fear of recurrence/diseaseprogression• Indigestion• Sexual dysfunction• Vomiting• Weight gain
• Weight loss

FOSI-8
From core set from across cancer types:• Anorexia• Constipation• Diarrhoea• Dyspnea• Fatigue• Nausea• Neuropathy• Pain• Cognitive problems• Insomnia

From ovarian cancer-specific symptoms:• Abdominal pain
• Bloating• Cramping• Fear of recurrence/diseaseprogression• Indigestion• Sexual dysfunction• Vomiting• Weight gain
• Weight loss

FACT-Ov4
From core set from across cancer types:• Anorexia• Constipation• Diarrhoea• Dyspnea• Fatigue• Nausea• Neuropathy• Pain• Cognitive problems• Insomnia

From ovarian cancer-specific symptoms:• Abdominal pain
• Bloating• Cramping• Fear of recurrence/diseaseprogression• Indigestion• Sexual dysfunction• Vomiting• Weight gain
• Weight loss

NFOSI-18v2
From core set from across cancer types:• Anorexia• Constipation• Diarrhoea• Dyspnea• Fatigue• Nausea• Neuropathy• Pain• Cognitive problems• Insomnia

From ovarian cancer-specific symptoms:• Abdominal pain
• Bloating• Cramping• Fear of recurrence/diseaseprogression• Indigestion• Sexual dysfunction• Vomiting• Weight gain
• Weight loss

Question 2Do we need a new scale? And validation andmapping algorithm?

How epidemica is contributing

Methods

Conduct an HTA-compliant systematic review of HSUVs& mapping algorithms suitable for ovarian cancer
Consider appropriateness for CEA including degree ofNCI-recommended EOC QoL domain coverage & HTA
requirements
Dataset will be freely available at www.epidemica.eu
Publish in freely accessible manuscriptUpdate annually• Sources: Embase, Medline, HTA Database, NHS EED, EconLit,
PubMed (ahead-of-print), NIHR HTA database, NICE & EQ-5D
websites, CEA Registry, HERC database of mapping studies,
ScHARRHUD database, reference lists of included publications andof SRs.

Resource availability• June/July protocol registration with PROSPERO• July review (comments invited)• Q3 run systematic review• Q4 dataset and manuscript• Inclusion: original HSUVs suitable for ovarian or fallopian tube
cancer (stage I-IV) or primary peritoneal cancer (stage III-IV) where
respondent is a patient or caregiver, or mapping algorithm.
• Exclusion: mixed disease stage; VAS; respondent an expert/HCP orgeneral public.
• Sample size, response, extent & handling of missing data will be
used to assess risk of bias.

What will be in the dataset?
• Data extraction:– HSUV studies; design, country, health state,respondent, instrument, tariff, HSUV estimate &dispersion measure.
– Mapping algorithms; country, instruments, tariff,estimation & validation sample descriptions,model type, coefficients, performance, applicationlimits• Mapping onto Preference-Based Measures ReportingStandards (MaPS) to be published on EQUATOR website
shortlyQuestions
How are we measuring HRQoL in ovarian cancer?
Are we measuring HRQoL accurately enough?
Do we need a new scale on basis of NCI consensus?
Who can do the validation & mapping algorithm work?
Which HTA jurisdictions would you like covered?
Spare some time in July to review protocol?

Support UKovarian cancer survival
katherine@epidemica.eu