ISSN 1752-5713 (Print) ISSN 1752-5721 (Email)

Non-alcoholic fatty liver disease (NAFLD) is set to become the most common liver disease worldwide.

Current estimates put NAFLD prevalence at between 20-30% with non-alcoholic steatohepatitis (NASH) affecting 2-3%.

Population-based studies are perceived to provide better prevalence estimates than clinical studies but, to date, few have been conducted in this disease area.

Current challenges include an absence of non-invasive NASH diagnostic measures that are accurate and accessible in real-world practice.

Adelphi’s most recent Diabetes Disease Specific ProgrammeTM found that in a sample

Risk factors for NAFLD/NASH include being male, obese, insulin resistant, diabetic and with conditions such as dyslipidemia and hypertension.

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DSP data1 suggest a typical NASH patient is 59, with five chronic comorbid conditions resulting in five consultations and one hospitalisation a year for reasons other than their diabetes.

6% are co-managed by multiple physicians and complicated drug regimens across multiple

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more than

650 Real World

publications in over

70 distinct disease areas

INCLUDING

Cardiovascular Metabolic

Autoimmune Respiratory Oncology

Pain CNS/Neurology

For further information on our full range of Disease Specific Programmes (DSPs) and/or Bespoke services, please contact: Peter Anderson

email: peter.anderson @adelphigroup.com

Tel: +44 (0)1625 577335

of 9,893 Type 1 and Type 2 Diabetes patients, 13% were tested for NASH with 1% of patients receiving a NASH diagnosis.

In addition, a current lack of NASH-approved therapies offers a limited treatment armamentarium to clinicians.

Among Diabetes-NASH patients, average BMI is 32 with physicians labelling over half of their patients as obese or severely obese.

It is of note that 36% of Diabetes-NASH patients were being managed for their weight loss through their anti-diabetic medication, implying attempts to treat the underlying cause of the disease in the absence of any specific NASH therapy options.

1 Source: Diabetes DSPTM (2016)

conditions affect not only adherence but also outcomes for all conditions.

Anxiety/depression are common and, coupled with current invasive diagnostic measures and lack of effective treatment, the NASH patient has many complex and unmet needs.

As the global obesity epidemic fuels metabolic conditions, not only will prevalence of NAFLD/NASH increase but the clinical and economic burden will be amplified.

34%

36%

13%

1% Real-world NASH

prevalence among T1/T2 diabetes patients

T1/T2 diabetes patients tested for NASH

OF THESE

adelphirealworld.com

Diabetes-NASH patients taking anti-diabetic therapy

as weight loss agent

Diabetes-NASH patients on supervised diet plan

DSP PORTFOLIO

T1DM

T2DM

Heart Failure

Stroke

ACS

AF

NASH

Obesity

CKD

Dyslipidemia

Diabetes Devices

DMO

ACS: Acute Coronary Syndrome AF: Atrial Fibrillation CKD: Chronic Kidney Disease DMO: Diabetic Macular Oedema NASH: Non-alcoholic steatohepatitis T1DM: Type 1 Diabetes Mellitus T2DM: Type 2 Diabetes Mellitus

Benchmark wave fielding Q1 2018

5EU, Canada, UAE, KSA

5th wave: Q2 2016 USA Q1 2017 5EU, Canada,

Brazil, China, Japan

Benchmark wave 2017/2018

14th wave Q1 2018 5EU/US, Japan

Previous: China, Brazil

14th wave Q1 2018 5EU/US, Japan

Previous: China, Brazil

Benchmark wave fielding Q2 2017 5EU

2nd wave fielded Q3 2015 US/5EU/China

2nd wave fielded in Q3 2015 US/China/Japan

2nd wave fielded in

Q2 2012 US/5EU

Benchmark wave fielded in Q1 2010

5EU

Benchmark wave fielded Q4 2015/Q1

2016

3rd wave planned Q1/2 2018

Against the current environment outlined overleaf, the Adelphi team has developed two studies to meet current needs in NASH.

The inaugural NASH Disease Specific ProgrammeTM (DSP) will provide in-depth, real-world disease understanding in a secondary care clinical setting, irrespective of what is advocated in guidelines.

Supporting this, the NASH Presentation in Primary CareTM (PPC) study will address incidence and prevalence of NASH patients in today’s consulting population.

Both studies will provide powerful benchmarks and will be repeated as the market evolves.

Initial data for Europe, North America and the Middle East will be available from Q2 2018.

NASH DSPTM NASH PPCTM

RANDOM: Next 5 NASH patients

(F1-F4)

OVERSAMPLE : Next 2 NASH

patients (F3-F4)

Next 100 consulting patients in primary

care practice

Hepatologists ¦ Gastroenterologists Endocrinologists ¦ Diabetologists

PCPs (survey-only)

MARKET AND DISEASE UNDERSTANDING Secondary Care

Physician and patient viewpoints ¦ Disease understanding ¦ Validated PROs

INCIDENCE & PREVALENCE Primary Care

PCPs Endocrinologists

Diabetologists

At ‘risk’, undiagnosed and diagnosed NASH

529 HCPs ¦ 4,200 NASH Patients 1,240 HCPs ¦ 124,000 Patients

12 Diseases

11 HCP Types

Consulting Population ¦ Europe ¦ North America ¦ Middle East

RA

SpA

Crohn’s/UC

Psoriasis/PsA

Lupus

Sjogren’s Syndrome

Atopic Dermatitis

Impetigo

HIV-AIDS

Hepatitis C

Ophthalmology

Heart Failure

Stroke

Atrial Fibrillation

Dyslipidemia

Diabetes Devices

Diabetes

DMO

NASH

CKD

Hypothyroidism

Endometriosis

Asthma/COPD

Pulm. Hypertension

IPF

Multiple Sclerosis

Dementia

Parkinson’s

Depression/Anxiety

Schizophrenia

Neuropathic/CLBP

Migraine

Osteoporosis

Osteoarthritis

Huntington’s

Hemophilia

Breast Cancer

Prostate Cancer

NSCLC

Gastric Cancer

HCC

Ovarian Cancer

Melanoma

Head/Neck Cancer

Multiple Myeloma

AML

CLL

FL/DLBCL

GBM