Education around PML risk and monitoring at NHNN Queen Square MS Centre

Transcription

1 Audit MS Masterclass, Sheffield, 31 st March 2017 Education around PML risk and monitoring at NHNN Queen Square MS Centre UCL Institute of Neurology Queen Square Multiple Sclerosis Centre National Hospital for Neurology and Neurosurgery, London Dr Cristina Marcoci Honorary Clinical Research Associate

2 129 MS Patients on Natalizumab treatment March % 33.07% 30% 25% 1-12 infusions infusions 20% 15% 10% 7.09% 14.96% 12.60% 8.66% 15.75% 7.87% infusions infusions infusions infusions >72 infusions 5% 0% Patients exposed

3 Blood tests Natalizumab-Treated Patients Monitoring HCG pregnancy tests (prior to infusion) Blood tests (every 3 months in clinic) Positive Negative Haemolysed YES NO Immediate treatment discontinuation Repeat blood test prior to next infusion

4 Natalizumab-Treated Patients - PML Risk Monitoring Anti-JCV Antibody Testing Brain Anti-JCV Antibody Status Positive Negative Treatment duration < 21 months Treatment duration > 21 months Annually brain Anti-JCV antibody testing every 6 months Annually brain Anti-JCV antibody testing every 6 months Every 3 months brain Anti-JCV antibody testing every 6 months PML surveillance protocol (from 1 st July 2016)

5 Anti-JCV Antibody Testing Patients Monitoring (n=129) Re-testing of anti-jcv antibody every 6 months 60% 50% 40% 57% 55% 43% 45% 30% 20% Anti-JCV Negative Anti-JCV Positive 10% 0% July-December 2016 January 2017

6 Anti-JCV Antibody Testing PML Risk Monitoring Changed serostatus (from July - December 2016 to January 2017) Positive Negative 3% Negative Positive 5% Anti-JCV antibody positive patients (n=58) (March 2017) Antibody index 0.9 Antibody index > 0.9. Antibody index > % 7.69% 50%

7 PML Risk estimates (129 patients) March % 45.0% 45.6% 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% 11.2% 12.0% 5.6% 6.4% 4.8% 2.4% 2.4% 1.6% 1.6% 1.6% 2.4% 2.4% PML risk estimates per 1,000 patients

8 Patient 1 QSD01XXX Male, 55 years of age Onset of MS: 1999 First DMT Avonex Commenced on Natalizumab 23/11/2010 (overall 72 infusions) Anti-JCV positive ANTI-JCV ANTIBODY STATUS ( ) JCV stratify Unilab Denmark No NHS consts POS NEG

9 Patient 1 Male, 55 years of age Day care hours stay Infusions / scans (March ) * * * Mar Apr Apr May Jun Jul Aug Aug Sep Nov Nov Dec Dec Jan Feb Mar Mar Mar-2017 scans infusions - 13,560 NHS costs, 14,460 Deferred Unknown reason Deferred Patient did not attend Deferred not reported in time

10 Patient XXXX Male, 44 years of age Onset of MS: 2006 First DMT Rebif 44 mcg Commenced on Natalizumab 20/11/2009 (overall 93 infusions) Anti-JCV positive ANTI-JCV ANTIBODY STATUS ( ) JCV stratify Unilab Denmark No NHS consts POS POS 2.84

11 Patient 2 Male, 44 years of age Day care hours stay Infusions / scans (March ) Mar Apr Apr May Jun Jul Aug Aug Sep Oct Nov Dec Dec Jan Feb Feb Mar-2017 scans, - 1, infusions - 14,690 NHS costs, 9 15,890

12 Patient XXXX Female, 52 years of age Onset of MS: 2009 First DMT Rebif 44 mcg Commenced on Natalizumab 28/02/2011 (overall 75 infusions) Anti-JCV negative ANTI-JCV ANTIBODY STATUS ( ) NEG NEG NEG NEG NEG NEG NEG NEG JCV stratify Unilab Denmark No NHS consts

13 Patient 3 Female, 52 years of age Day care hours stay Infusions / scans (March ) Mar Apr May Jun Jul Aug Sep Oct Oct Nov Dec Jan Feb Mar-2017 scan infusions - 14,690 NHS costs,9 14,990

14 Patient XXXX Male, 28 years of age Onset of MS: 2006 First DMT Rebif 44 mcg Commenced on Natalizumab 01/11/2010 (overall 76 infusions) Anti-JCV negative ANTI-JCV ANTIBODY STATUS ( ) NEG NEG NEG NEG NEG NEG NEG NEG JCV stratify Unilab Denmark No NHS consts

15 Patient 4 Male, 28 years of age Day care hours stay Infusions / scans (March ) Mar Apr Apr May Jun Jul Jun Aug Sep Oct Oct Nov Nov Dec Jan Feb Mar-2017 scans infusions - 15,820 NHS costs, 16,720

16 Patient XXXX Female, 28 years of age Onset of MS: 2007 First DMT Copaxone Commenced on Natalizumab 2008 (overall 97 infusions) Anti-JCV positive JCV stratify Unilab Denmark No NHS consts ANTI-JCV ANTIBODY STATUS ( ) POS NEG NEG NEG NEG

17 Patient 5 Female, 28 years of age Day care hours stay Infusions / scans (March ) Mar Apr May Jun Jul Jul Aug Sep Oct Oct Nov Dec Jan Jan Feb Mar-2017 scans infusions - 14,690 NHS costs, 14,990

18 Conclusions At NHNN Queen Square MS Centre: Patients are educated about PML risk by a well-organized team; A continuous monitoring of PML risk is proved to be on a high level and according to required standards; From the 1 st of July 2016 a new PML surveillance protocol was approved and is applicable to Anti-JCV positive patients who have been on Natalizumab treatment for more than 21 months ( scans: currently every 3 months; previously every 6 months); Anti-JCV Antibody tests are performed every 6 months; Overall, during a period of time March 2016 March 2017, based on the examples of five MS Natalizumab-treated patients, NHS paid approximately 76,950 77,050.

19 Acknowledgements Prof Kenneth Smith Dr Martin Duddy Dr Waqar Rashid Prof Olga Ciccarelli Margaret Vincent Pinar Kara

20 Thank you very much for your attention!