“NHLS bringing New Technology to Market”

SAMED 2015 CONFERENCE

Sarvashni Moodliar

Outline

• Introduction

• Background

• Current role of Health Technology Assessment Unit

• Overview of Invitro Diagnostic Device Assessments

• Review of HTA Projects

• Challenges

• In Summary

Introduction

Health Technology Assessment (HTA) is a multi-

disciplinary field of policy analysis that examines

the

• medical

• economic

• social

• ethical implications

of the incremental value, diffusion and use of

medical technology in health care1,2.

NHLS Laboratory Footprint

HTA Management Cycle

Velasco-Garrido M, Busse R. Policy brief – Health Technology Assessment: An Introduction to objectives, role of

evidence and structure in Europe. European observatory on Health Systems and Policies, 2005. (http://

www.euro.who.int/_data/assets/pdf_file/0018/90432, accesses 15 April 2011).

HTA processes:

• The process of HTA requests are interdependent

on the following phases:

• identification and priority setting,

• laboratory/clinic based performance evaluations and

• the dissemination of the information to the appropriate

persons.

Background

• The establishment of HTA Unit within the NHLS,

Quality Assurance Division in 2012 was funded by

PEPFAR/CDC

• To adhere to the following :

The MEDICAL AND RELATED SUBSTANCES ACT R.

586 in South Africa 3,5

Accreditation requirements ( ISO 15189)

National Treasury Requirements for procurement

• Membership to INAHTA and HTAi

• International benchmark - HTA bodies

• Members of the PAHWP6

Current role of the HTA Unit

• To screen all medical diagnostic IVD’s introduced

to the NHLS by monitoring the introduction of new

IVD’s and selecting those technologies in need of

assessment.

• The screening is limited to

POCT

Medical diagnostic kits

Analysers (small/medium/large)

Reagents

Overview

Performance evaluations Completed

Review of HTA project proposals

• Over the period 2012 to 2014 the HTA unit had

documented 113 performance evaluations; of which

30% of these requests were POCT.

• These included :

• HIV RDT’s for NDOH

• Malaria RDT’s

• Glucometers

• Blood gas analysers

• CD4 / Viral load

• Other

• Post market surveillance – lot to lot verification for

NHLS and NDOH

Challenges

In summary

• The availability of good diagnostic evidence

regarding the performance of IVD tests and

interpreting its value for practice is important for the

quality of results issued by the NHLS.

• At the same time the process is challenging and

time consuming.

• It is therefore the intent of the unit to strike a

balance by prioritising project requests and

developing a streamline processes to address the

influx of IVD performance evaluations requests.

References

1. Battista RN. Towards a paradigm for technology assessment. In: Peckham M, Smith R,

eds. The scientific basis of health services. London, BMJ Publishing Group. 1996.

2. Busse R et al. Best practice in undertaking and reporting health technology

assessments. International Journal of Technology Assessment in Health Care, 2002,

18:361–422.

3. Govender M et al. Health technology assessment – a new initiative in South Africa.

South African Medical Journal, 2010, 10(6):334

4. Velasco-Garrido M, Busse R. Policy brief – Health Technology Assessment: An

Introduction to objectives, role of evidence and structure in Europe. European

observatory on Health Systems and Policies, 2005. (http://

www.euro.who.int/_data/assets/pdf_file/0018/90432, accesses 15 April 2011).

5. WHO: Medical Devices: Managing the Mismatch - Clinical Evidence for medical devises:

regulatory processes focusing on Europe and the United States of America. Background

paper 3, August 2010. (http:// www.WHO_HSS_EHT_DIM_10.3_eng.pdf , assessed 12

May 2011).

6. Peeling, R.W. & Mcnerney,R.2014. Emerging technologies in point-of-care molecular

diagnostics for resource –limited settings. Expert Review of Molecular Diagnostics,14,

525-534

•

•

Acknowledgment

• NHLS Management – formation of the unit

• NHLS Laboratory staff

• SAMED

• Co-Authors: Ribisi A, Sekano M, Moletsane T, Dabula P , Van Heerden A.J

This activity has been supported by the President’s Emergency Plan for

AIDS Relief (PEPFAR) through CDC under the terms of

[5U2GPS001328].”

Thank you