international registers – how an hta organisation can contribute

International registers – how an HTA organisation can contribute

Hannah Patrick

Consultant clinical advisor to the Interventional Procedures Programme,

National Institute for Health and Clinical Excellence

HTAi conference, Bilbao

June 2012

The purpose of NICE Interventional Procedure Guidance

• inform patients and clinicians of uncertainties in Safety and Efficacy of novel procedures

• give conditions for safe use eg surgeon training, specialist centres etc

“Special arrangements”

• Inform the clinical governance leads in their hospitals

• Audit outcomes

• Ensure that patients understand the uncertainty about the safety and efficacy

Arterio–venous extracorporeal membrane carbon dioxide removal

• Key efficacy outcomes:– survival without disability– reduction in mechanical ventilation– improvement in arterial blood gases

• Key safety issues:– Bleeding, vascular injury, limb amputation – Gas/ clot embolism, clotting within the device

First assessment (2008)

Special arrangements

Data collection/ research to provide evidence on

thresholds for intervention and criteria

for patient selection.

Essentially…use / coverage with evidence development

Second assessment (2011)

Special arrangements

Enter patients into trials, data collection.

Document patient selection criteria,

thresholds for intervention, and clinical

benefits.

Essentially…use / coverage with evidence development

Issues to address in establishing a register

• 3 professional societies; Clinical Perfusionists, Cardiothoracic Surgeons, Intensivists

• Other registers; Novalung, European register, Extracorporeal Life Support Organisation (ECMO database)

Extracorporeal life support organisationAcknowledgment: http://www.elso.med.umich.edu/

More issues and the way forward

Some hospitals provide ECC02R but not ECMO

Who should pay and how?

Role of the HTA organisation:

Project management

Recommend data submission

Endoscopic balloon dilatation for subglottic or tracheal stenosis

• Key efficacy outcomes: avoidance of tracheostomy, improve lung function and exercise tolerance, reduce stridor

• Key safety issues: laryngeal or airway scarring, bleeding and inadequate reduction of papillomas

First assessment (2012)

Special arrangements

Data submission to the International Register for Airway

Stenosis (www.airwaystenosis.net).

Essentially…use / coverage with evidence development

Radiofrequency cold ablation for respiratory papillomatosis

• Key efficacy outcomes: reduce frequency of microlaryngoscopy procedures

• Key safety issues: laryngeal or airway scarring and bleeding

First assessment (2012)

Special arrangements

Data submission to the International Register for Airway

Stenosis (www.airwaystenosis.net).

Essentially…use / coverage with evidence development

International Registry for Airway Stenosis

Issues - Rare condition affecting children and adults- Funding of dataset development?

Role of the HTA organisation:- Recommend data submission

- Project management

International collaboration – lessons learnt

• Especially important for uncommon procedures

• Work through professional societies

• Develop existing databases wherever possible

• Active surveillance essential

• Learn from collaborative initiatives