Volume 193 - Issue 9
Improving access for anti-tumour necrosis factor-α therapy in inflammatory bowel disease
Authors: Nicholas A Biehl, Janina Pawlik and Geoffrey M Forbes
Med J Aust 2010; 193 (9): 556-557. || doi: 10.5694/j.1326-5377.2010.tb04052.x
Published online: 1 November 2010
Published online: 1 November 2010
To the Editor: Burger and colleagues reported the limitations of pre-August 2010 Pharmaceutical Benefits Scheme (PBS) criteria for subsidised anti-tumour necrosis factor-α (anti-TNF-α) treatment of perianal Crohn’s disease (CD).1 PBS-subsidised infliximab is now available for CD patients with a Crohn’s Disease Activity Index (CDAI) > 300 who have failed to achieve an adequate response to minimum doses of steroids and immunomodulators, and for patients with fistulising CD.2,4
In contrast with some Australian centres, our hospital has given infliximab to patients who fell outside these restrictions for indications for which clinical efficacy has been shown.1 We report on infliximab use and patient outcomes in patients with CD and ulcerative colitis (UC) since local PBS-subsidised use commenced in October 2008.
Between October 2008 and February 2010, 57 patients at our hospital (44 with CD and 13 with UC) commenced infliximab treatment. Patients were assessed for remission status at 6–8 weeks after commencement of infliximab therapy (ie, after the induction course of three infusions).
Twenty-four CD patients met PBS criteria. Of these, 12 achieved remission (CDAI < 150 [n = 8] or clinical remission on symptomatic grounds [n = 4]), eight showed clinical or endoscopic improvement justifying continued infliximab treatment, and four had no treatment response. Twenty CD patients did not meet PBS criteria. Of these, nine achieved remission (CDAI < 150 [n = 7] or clinical remission on symptomatic grounds [n = 2]), nine showed clinical or endoscopic improvement, and two had no treatment response. Reasons for not meeting PBS criteria were as follows: insufficient trial of prednisolone and an immunomodulator (10 patients, of whom 1 had no treatment response to infliximab); insufficient trial of an immunomodulator alone (7 patients, of whom 1 had no treatment response to infliximab); insufficient trial of prednisolone alone (2 patients); and CDAI < 300 (1 patient, who subsequently achieved clinical remission). Fourteen patients had perianal disease, of whom five did not meet PBS criteria.
Of the 13 patients with UC, none were eligible for PBS-subsidised infliximab treatment. Six achieved, and remained in, clinical remission after a full infliximab induction course of three 5 mg/kg doses. Of the seven patients who did not, two initially responded but failed on reintroduction of treatment after an infliximab-free period. The other five had no response; three required colectomy.
Our audit showed that less than half of patients receiving infliximab for inflammatory bowel disease fulfilled PBS guidelines for subsidised prescription, mostly because of relatively strict requirements for prior steroid and immunomodulator therapy, and the absence of UC as a listed indication. Furthermore, our CD patients who did not meet PBS criteria had similar treatment outcomes to those who did. Thus infliximab treatment can be of major benefit to patients with refractory disease whose only other treatment alternatives are experimental therapies or major surgery.
Further revisions to PBS criteria for anti-TNF-α therapy, including relaxing restrictions for CD and providing access for patients with severe UC, are required.
Acknowledgements
This audit was conducted with support from a Robert Vandongen Vacation Scholarship awarded by Royal Perth Hospital Medical Research Foundation and the University of Western Australia.
References
- Burger DC, Lawrence IC, Bampton PA, et al. Anti-tumour necrosis factor- a treatment for perianal Crohn’s disease in Australia. Med J Aust 2010; 192: 375-377.
- Medicare Australia. Crohn disease. Authority to supply tumour necrosis factor (TNF) alfa antagonist agents through the Pharmaceutical Benefits Scheme (PBS) for patients under section 85 and section 100 of the National Health Act 1953. http://www.medicareaustralia.gov.au/provider/pbs/drugs1/crohns.jsp (accessed Aug 2010).
- Medicare Australia. Fistulising Crohn disease. Initial PBS authority application: supporting information. http://www.medicareaustralia.gov.au/provider/pbs/drugs1/files/4237-initial-fistulising-crohn-disease.pdf (accessed Aug 2010).
- Connell W, Andrews JM, Brown S, Sparrow M. Practical guidelines for treating inflammatory bowel disease safely with anti-tumour necrosis factor therapy in Australia. Intern Med J 2010; 40: 139-149. 0_pgfId-2196615