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PBAC Outcomes – November 2019

The November 2019 PBAC Meeting Outcomes were published recently

With 61 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making for this meeting, compared to the past 5 years of outcomes.

Of note, the November 2019 meeting had the highest recommendation rate of any of the major PBAC meetings (March, July or November) for the past 5 years.  Overall, 74% of the 61 submissions were recommended. This compares to an average of 60% between March 2015 and the November 2019 meeting.

Fourteen Sponsors made more than one submission to the PBAC, with Roche and Orpharma topping the list with four submissions each. One submission came from the National Aboriginal Community Controlled Health Organisation (NACCHO) for Prednefrin® Forte eye drops (Allergan Australia Pty Limited) indicated for severe inflammation of the eye. NACCHO, the national peak body representing Aboriginal Community Controlled Health Services, were given a positive recommendation by the PBAC with a Restricted Benefit listing for severe eye inflammation following cataract surgery for patients who identify as Aboriginal and Torres Strait Islander.

The majority of positive recommendations were based on cost-minimisation economic analyses (n=19), as reported by the PBAC. Thirteen of 45 positive recommendations related to oncology indications, while two positive recommendations were for biosimilars.

One third of rejected submissions related to oncology indications. Reasons for rejection were varied, and related to the uncertain cost-effectiveness of the intervention, financial estimates that were unacceptably high, uncertain and/or inadequately justified, unclear or immature clinical evidence and in one case, an unacceptable nominated comparator (Polivy® for diffuse large B-cell lymphoma).

Two out of four deferred outcomes were related to oncology indications. Deferred submissions were related to requests for revisions to economic models, estimated financial implications and/or proposed Risk Sharing Arrangements, one unacceptable price advantage (Trulicity® for type 2 diabetes mellitus) and one cost-minimisation analysis unable to proceed until the comparator is listed (Keytruda® for melanoma).

Of the 61 submissions assessed by the PBAC in November 2019, 15 (25%) were resubmissions of which 74% were recommended, compared to a 5-year average recommendation rate for resubmissions of 50%. Oncology medicines accounted for nine (60%) resubmissions.

Publication of the Public Summary Documents from the November meeting on 6th March 2020 (for positive and subsequent rejections) and 20th March 2020 (for first time rejections and deferrals) will provide some additional context for the implications for PBS expenditure from this meeting.

 

The Commercial Eyes Market Access & Pricing team can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

This article was written by Michelle Yassa and Ian Teichert, from our Market Access & Pricing team

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