Methods and Early Results from AHRQ’s Healthcare Horizon Scanning System

Karen Schoelles MD, SMProject Director, AHRQ Healthcare Horizon

Scanning SystemECRI Institute

AHRQ Annual MeetingSeptember 10, 2012

AHRQ Healthcare Horizon Scanning System

Purpose: – To inform and guide the planning and

prioritization of patient-centered outcomes research investments through the Effective Health Care Program

AHRQ Healthcare Horizon Scanning System

Description: A process– to identify and monitor health care

innovations– to create an inventory of innovations that

address an unmet need and have the highest potential for impact on clinical care, the health care system, patient outcomes and costs

Why Scan the Horizon?

“Horizon scanning aims to help break the element of surprise – shifting our focus earlier along the stages of change to allow proactive planning and decision making.

Without horizon scanning, things seem to “come out of nowhere” but really they are just entering our consciousness at a late point in the stages of change.”

― Jennifer DeLurio, Horizon Scanning Leads Manager

Effective Health Care Website page for Horizon Scanning Overview

http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=881

AHRQ Healthcare Horizon Scanning System

Range of interventions:– Drugs, biologics, medical devices– Procedures– Screening and diagnostic tests, including

imaging– Behavioral health interventions– Care delivery innovations

Includes new uses of existing/diffused interventions

AHRQ Priority Conditions1. Arthritis and nontraumatic joint disease2. Cancer3. Cardiovascular disease4. Dementia (including Alzheimer’s)5. Depression and other mental health disorders6. Developmental delays, attention-deficit hyperactivity

disorder & autism 7. Diabetes mellitus

AHRQ Priority Conditions, continued

8. Functional limitations and disability9. Infectious disease, including HIV/AIDS10.Obesity11. Peptic ulcer disease and dyspepsia12.Pregnancy, including preterm birth13.Pulmonary disease/asthma14.Substance abuse15. (Cross-cutting topics)

Stages of Horizon Scanning

Identify the users Determine the timeframe Conduct horizon scanning and identify

emerging technologies Filter the identified technologies Prioritize the technologies

Stages of Horizon Scanning, continued

Assess technologies of high priority Use peer review to check for quality Disseminate the information Update the information

AHRQ Healthcare Horizon Scanning System: Identified Users

Primarily AHRQ Other CER/PCOR funders Researchers Consumers/patients

AHRQ Horizon Scanning Timeframe

Diffusion into Medical Practice

Initial evaluations in

humans

Approval, clearance, initial

dissemination

7 years 2 years

AHRQ Healthcare Horizon Scanning and Identification of Interventions

Broad scanning and lead selection:– About 100 selected sources plus meeting

abstracts– 12 medical librarians scan these sources

regularly for leads– Leads are selected if they relate to one or

more Priority Conditions– Leads coalesce into specific topics

AHRQ Horizon Scanning: Filtering and Prioritization

Protocol defines criteria Primary question: Does it address an

unmet need?– Gap in effective ways to

Screen Diagnose Treat Monitor Manage Provide or deliver care

Assessing High Priority Topics

Analysts nominate topics based on protocol-defined criteria

Selected topics investigated with specific searches for information

Experts are asked to comment on reports

Horizon Scanning: Assessing Potential for Impact

AHRQ Healthcare Horizon Scanning System - Outputs

AHRQ Horizon Scanning Status Reports

Inventory of topics followed as of prior report new topics added since prior report topics archived since prior report

AHRQ Horizon Scanning Status Reports

Topic Title PotentialPatient

Population

InterventionDeveloper/Manufacturer(s)

Phase of Development

Potential Comparators

Potential Health

or Other Impacts

NS5A inhibitor (IDX-719) for treatment of chronic hepatitis C infection

Patients in whom chronic hepatitis C virus (HCV) infection has been diagnosed

Standard of care for HCV infection has a long dosing schedule and poor tolerability. Better-tolerated treatments with more convenient dosing are needed. IDX-719 is an oral NS5A inhibitor purported to block the ability of the viral NS5A protein to attach to the endoplasmic reticulum of infected hepatocytes, which is thought to be required for the formation of functional viral particles. IDX-719 purportedly inhibits the activity of all HCV genotypes and has been administered up to 50 mg, once daily. Idenix Pharmaceuticals, Inc., Cambridge, MA Phase I/II trial ongoing

BoceprevirNS5A inhibitors in development

Nonnucleoside polymerase inhibitors in development

Nucleoside polymerase inhibitors in development

Pegylated interferon/ribavirin combinationTelaprevir

Slowed or halted disease progression

Sustained virologic response (defined as undetectable virus at 24 weeks)

Decreased need for liver transplant

Improved quality of life

Horizon Scanning: Assessing Potential for Impact

Seven parameters:– Potential importance of the unmet need– Potential to improve patient health – Potential to affect health disparities– Potential to disrupt the health care delivery

system– Potential for adoption by clinicians and/or

patients– Potential impact on cost– Overall potential to meet the unmet need

Input on Potential for Impact

Approximately 350 experts nationwide Experts with a variety of perspectives:

– clinical practice– clinical research– health care delivery– health business– health technology assessment– health facility administration

Input on Potential for Impact

Each expert asked to disclose any potential intellectual or financial conflicts of interest (COI).

Perspectives of an expert with a COI are balanced by perspectives of experts without COIs.

No more than two experts with a possible COI are considered out of a total of the seven or eight experts who are sought to provide comment for each topic

Horizon Scanning: Assessing Potential for Impact

Eligible topics:– Within 0–4 years of potential diffusion (e.g.,

in phase III trials or preliminary efficacy data in the target population) in the United States

– Or in very early diffusion Comments received from at least 6 – 8

experts

Sample Potential High Impact Report: Priority Condition 9 – Infectious Diseases

June 2012 107 Infectious Disease topics tracked in the

system as of May 2012 11 topics eligible for Potential High Impact

assessment and comments received from 6 – 8 experts

9 of 11 selected as having potential for high impact based on comments received– 6 at higher end of “high”– 2 in moderately high range– 1 at lower end of “high”

Sample Topics Selected for Potential High Impact Report

Hepatitis C Virus Infection Interventions– NS3/4A Protease Inhibitors (Boceprevir and

Telaprevir) for Treatment of Chronic Hepatitis C Infection - HIGH

HIV/AIDS Interventions– Collaborative Care Model for Treatment of HIV

and Comorbid Depression – LOWER END OF HIGH

– Emtricitabine/Tenofovir (Truvada) for Prevention of HIV Infection - HIGH

– Routine Anal Pap Smear Screening at HIV Clinics to Prevent Anal Cancer – MODERATATLEY HIGH

Sample Topics Selected for Potential High Impact Report, continued

Healthcare-Acquired and Bacterial Infection Interventions– Antimicrobial Copper Surfaces in the ICU for

Prevention of Healthcare-Acquired Infections - HIGH

– Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection - HIGH

– Fidaxomicin (Dificid) for Treatment of Clostridium difficile Infection - HIGH

– Xpert MTB/RIF Test for Simultaneous Detection and Drug Sensitivity Testing of Mycobacterium Tuberculosis – MODERATELY HIGH

Topics Eligible for Assessment

*Controlled release phentermine/topiramate (Qnexa®) for treatment of obesity*EndoBarrier Endoluminal Sleeve for treatment of obesity

Full Sense Bariatric Device for treatment of morbid obesity

Liraglutide (Victoza®) for treatment of obesity

Lorcaserin (Lorgess®) for treatment of obesity

Maestro vagus nerve block system for treatment of morbid obesity

Methionine aminopeptidase 2 inhibitor (ZGN-433) for treatment of obesity

Naltrexone and bupropion HCL (Contrave®) for treatment of obesity

Tesofensine for treatment of obesity

Potential High Impact Report: Obesity

Obesity – Potential High Impact

19 topics were in the system 9 topics met eligibility criteria for high impact

assessment and 6 – 8 sets of expert comments were provided

Experts thought 7 of the 9 had no potential for high impact at this time

Phentermine/topiramate (Qnexa®): HIGH end of the high impact range

EndoBarrier endoluminal sleeve for excess weight loss – LOW end of high impact range

Leads for new topics

Trials fail to meet endpoints

Developer cannot procure

funding

FDA issues a negative decision

Intervention doesn’t diffuse

Safety issues appear

Better alternative developed

New trial results

become available

Topics already in the

system

Intervention reappears with new developer

Formulations, delivery

routes and combinations

change

Arthritis

Cancer

Cardiovascular

Dementia

Depression

Developmental Delay

Diabetes

Functional Limitations

Infectious Diseases

Obesity

Peptic Ulcer

Pregnancy

Pulmonary

Substance Abuse

Cross-Cutting

0% 20% 40% 60% 80% 100%

50%

84%

28%

80%

57%

17%

83%

76%

62%

75%

30%

10%

8%

69%

20%

43%

67%

15%

25%

60%

67%

17%

18%

33%67%

33%

Development StoppedNegative FDA DecisionExpert CommentsLittle UptakeDiffused Past 2 YrNot Meeting HS Criteria

Reasons for Archiving by Priority Area (as % of Archived Topics)

Reasons for Archiving by Priority Condition as Percentage of Topics in that Priority Condition

Arthrit

is

Cance

r

Cardi

ovas

cula

r

Demen

tia

Depre

ssio

n

Devel

opm

enta

l Del

ay

Diabe

tes

Funct

iona

l Lim

itatio

ns

Infe

ctio

us D

iseas

es

Obesit

y

Peptic

Ulce

r

Pregn

ancy

Pulm

onar

y

Subst

ance

Abu

se

Cross

-Cut

ting

0%

10%

20%

30%

40%

50%

60%

Not Meeting HS Criteria

Diffused Past 2 Yr

Little Uptake

Expert Comments

Negative FDA Decision

Development Stopped

Horizon Scanning Challenges

Drinking from the fire hose: – large volume of leads and topics

Tracking developments on 1000 topics already in the system and updating across all outputs

Fast pace of change Difficulty finding innovations in care delivery Difficulty getting broader input, including from

patients and clinicians, given PWRA requirements

Horizon Scanning Team

AHRQ: Elise Berliner, COTR ECRI:

– Diane Robertson, Project Manager– Randy Hulshizer, Content Team Leader– Eileen Erinoff, Director, Information Center– Jennifer DeLurio, Leads Manager– Marna Sanders, and 11 more fabulous medical

librarians, a.k.a. lead finders– Brian Wilkinson, and Abigail Dean - Senior

Horizon Scanning Analysts– Vladimir Cadet, Mike Leshinski, Marcus Lynch -

Horizon Scanning Analysts– And many more helping hands!

"Everything that can be invented has been invented."

Charles H. Duell, Commissioner, U.S. Office of Patents, 1899