27 April 2020 - Did the PBAC give Sanofi the run around?

In March 2020, the PBAC recommended the PBS (Authority required) listing of dupilimab for the treatment of certain patients with atopic dermatitis. It took three submissions to secure a PBAC recommendation.

The initial submission was considered by the PBAC in July 2018.  The target patient population proposed by Sanofi was adults with severe atopic dermatitis who have had an inadequate response or intolerance to cyclosporin, or for whom the use of cyclosporin is contra-indicated.

The PBAC did not recommend the PBS (Authority required) listing of dupilumab for the treatment of adults with severe atopic dermatitis due to uncertainty regarding its appropriate place in therapy and uncertain cost effectiveness.

The PBAC noted that the proposed patient population was narrower than the TGA approved indication for dupilumab and the clinical guidelines which recommend treatment of patients with moderate to severe atopic dermatitis without the requirement for prior intolerance, insufficient response or contraindication to treatment with cyclosporin. The preSubCommittee and prePBAC responses maintained that these patients had the greatest unmet clinical need, and that the restriction was aligned with that of the biological disease-modifying anti-rheumatic drugs for patients with chronic plaque psoriasis. The PBAC noted that prescribers are reluctant to use cyclosporin due to its toxicity and therefore considered that the narrow restriction proposed was not adequately justified. The PBAC requested that expert input be sought to determine if the use of dupilumab by patients with moderate to severe disease regardless of prior cyclosporin use would be more appropriate.

The PBAC considered a major resubmission in July 2019.  The revised proposed target patient population was adults with moderate to severe atopic dermatitis who are inadequately controlled on topical therapies.

The PBAC noted, consistent with its advice from the July 2018 meeting that restricting eligibility to adults with severe atopic dermatitis unable to be effectively treated with cyclosporin may be inappropriately narrower than the TGA indication and the trial data, that the proposed patient population in the resubmission was expanded to moderate-to-severe AD inadequately treated with topical therapies.

The Committee considered that the criteria for defining the patient population for initial and continuing treatment did not appropriately consider the extent of disease in terms of the body surface area affected.

Last month, the PBAC recommended the PBS (Authority required) listing of dupilumab for the treatment of patients aged 12 years and older with severe atopic dermatitis who are inadequately controlled on topical therapies.

The PBAC recommended for the use of dupilumab in adolescents coincides with the recent TGA approval (31 October 2019) for dupilumab for 'moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy.'

In the end, the PBAC has recommended the PBS listing of dupliumab in much the same patient population (i.e patients with severe disease) as first proposed by Sanofi in 2018.