Crohn disease: infliximab, adalimumab and vedolizumab
Page last updated: 27 October 2017
Drug utilisation sub-committee (DUSC)
June 2017
Abstract
Purpose
The PBAC considered the February 2015 DUSC review of biological disease modifying drugs (bDMDs) for Crohn disease at its March 2015 meeting. The PBAC noted that a higher than expected proportion of patients was continuing on bDMDs and their use to treat Crohn disease was yet to stabilise. The PBAC also noted that the cost-effectiveness of infliximab and adalimumab may be affected if patients are continuing treatment without achieving remission.
The PBAC requested for its DUSC to assess the utilisation of bDMDs for Crohn disease in another two years.
Listings on the Pharmaceutical Benefits Scheme (PBS)
Infliximab and vedolizumab are Section 100 Authority Required listings. Adalimumab has Authority Required General Schedule listings.
|
PBS first listing date |
Drug |
Listed indication |
|---|---|---|
|
1 October 2007 |
Infliximab |
Patient aged 6 to 17 years inclusive with moderate to severe refractory Crohn disease |
|
1 October 2007 |
Infliximab |
Severe refractory Crohn disease in adults |
|
1 August 2008 |
Adalimumab |
Severe refractory Crohn disease in adults |
|
1 August 2010 |
Infliximab |
Fistulising Crohn disease |
|
1 April 2011 |
Adalimumab |
Fistulising Crohn disease |
|
1 August 2015 |
Infliximab |
Moderate to severe Crohn disease |
|
1 August 2015 |
Vedolizumab |
Severe refractory Crohn disease |
|
1 August 2015 |
Adalimumab |
Patient aged 6 to 17 years inclusive with severe refractory Crohn disease |
The restrictions are complex and patients must meet eligibility criteria regarding disease severity and have failed a prior course of corticosteroids and immunosuppressive therapy with azathioprine or 6-mercaptopurine or methotrexate, unless contraindicated, for non-fistulising disease. Patients also need to achieve a defined response to continue on treatment.
Data Source / methodology
The Department of Human Services (DHS) Authority Approvals database was used for the analyses of continuation on bDMD treatment. The DHS Supplied Prescription database was used to analyse expenditure, derive incident and prevalent patient counts from 2014 to 2016 and to examine prior therapy received by a cohort of first time initiators on a bDMD in 2016. The DUSC Highly Specialised Drugs database was used to analyse the expenditure for infliximab prior to July 2013.
Key Findings
- The number of patients treated with bDMDs for severe refractory adult Crohn disease, fistulising Crohn disease and moderate to severe refractory Crohn disease in children and adolescents had increased steadily from 2007 to 2016.
- In 2016, 7,505 patients received a bDMD for severe adult refractory Crohn disease, 2,135 for fistulising Crohn disease and 824 patients received treatment for paediatric Crohn disease.
- The proportion of patients continuing on bDMD therapy for each of its listed Crohn indications was substantially higher than anticipated.
- bDMDs are being initiated as per their restrictions for prior therapies in the majority of cases.
