Wyeth Response to July 2008 Pharmaceutical Benefits Advisory Committee (PBAC) Decision on Enbrel (etanercept) for Treatment of Rheumatoid Arthritis and Psoriatic Arthritis

Background
In December 2002, the PBAC recommended listing of Enbrel (etanercept) for the treatment of patients with severe and active rheumatoid arthritis who have not responded to other available treatments. The listing was implemented on 1 August 2003.

In March 2005, the PBAC recommended listing of Enbrel for the treatment of psoriatic arthritis. The disease severity requirements for treatment eligibility were recommended to be in line with the rheumatoid arthritis disease severity requirements — plus an additional requirement to have the psoriatic component of their disease confirmed by a dermatologist or by biopsy. This listing was implemented on 1 August 2006.

Thus Enbrel is currently PBS-listed for treatment of rheumatoid arthritis and psoriatic arthritis patients who have very severe joint disease (i.e. ≥20 total, or ≥4 major, affected joints) and also have very active disease (i.e. inflammatory marker levels greater than 15 mg per L when measured by C-reactive protein, or greater than 25 mm per hour when measured by erythrocyte sedimentation rate). Psoriatic arthritis patients additionally require a psoriasis diagnosis.

July 2008 PBAC Meeting
Wyeth submitted a request to the PBAC in March 2008 to expand the current PBS listing for rheumatoid arthritis and psoriatic arthritis by reducing the disease severity criteria required to qualify for Enbrel use.

This application was rejected at the July 2008 PBAC meeting. It was rejected because the PBAC was uncertain whether the additional patients, who would be treated if the listing were expanded, would experience sufficient additional clinical benefit. The PBAC also considered the cost-effectiveness of treating these additional patients to be uncertain and high.

What Next
Wyeth is reviewing all available published and unpublished clinical effectiveness data and long-term safety data in order to address the PBAC's clinical effectiveness concerns in the future.

Now that Enbrel has been used in Australia for the treatment of rheumatoid arthritis for over 5 years, and in light of the July 2008 rejection of Wyeth’s submission, Wyeth welcomes ongoing dialogue with the PBAC and other stakeholders to determine a way forward.

Wyeth is committed to trying to expand access to Enbrel for rheumatoid arthritis and psoriatic arthritis patients as these conditions have a significant impact on quality of life. International studies, in which ill patients are asked to score their quality of life, have shown that the impact of arthritic disease on patients’ quality of life is considerable, with RA patients regularly scoring among the lowest compared to other diseases such as cancer (see Figure 1).¹

For further information please contact Dr. Michael Nobes on (02) 8850 8266.

Figure 1.  Quality of Life Scores Compared Between Different Diseases
(A score of 1 represents perfect health; lower scores represent worse health)

Lundkvist 2008 1

RA = rheumatoid arthritis
MS = multiple sclerosis
AMI = acute myocardial infarction
GERD = gastro-esophageal reflux disease
HTN = Hypertension
Ca = Cancer
UC = Ulcerative colitis

References

1. Lundkvist J, Kastang F, Kobelt G. The burden of rheumatoid arthritis and access to treatment: health burden and costs. European Journal of Health Economics 2008;8 (Suppl 2):S49-S60.