Recommended but not listing any time soon

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The Pharmaceutical Benefits Advisory Committee recommended two biosimilars of AbbVie's HUMIRA (adalimumab) at its July meeting but the timing of their reimbursement is highly uncertain and unlikely to be any time soon because of a global agreement.

HUMIRA is the market-leading PBS-listed biological disease-modifying anti-rheumatic drug (bDMARD). It is reimbursed for nine indications and, according to the 2016-17 PBS Expenditure and Prescription report, over 200,000 prescriptions were dispensed in the year at a total cost to the government of $314 million.

HUMIRA is subject to a special pricing arrangement and its reimbursement would involve the payment of rebates.

The PBAC recommended two adalimumab biosimilars at its July meeting. 

Amgen's AMGEVITA (adalimumab) was recommended for the same nine indications as HUMIRA. MSD's HADLIMA (adalimumab) was only recommended for severe active rheumatoid arthritis.

Yet neither can be listed at this time because of an agreement Amgen and AbbVie negotiated and announced in October last year.

Under the terms of the agreement, AbbVie granted Amgen a non-exclusive license to its intellectual property relating to HUMIRA beginning on certain dates in certain countries.

According to a statement, the license period will begin in the US on 31 January 31 in 2023 and on "other dates in various countries in which AbbVie has intellectual property."

The company confirmed the agreement covers Australia but the date remains undisclosed. The agreement applies directly to Amgen and it is understood it also applies indirectly to MSD. It remains unclear whether it also applies to any other companies.

PharmaDispatch obtained a document late last year through a freedom of information request that suggested the Department of Health was of the understanding HUMIRA will lose exclusivity in December 2018.

The date is critical because it might reflect when the government is anticipating biosimilars. It is fair to assume the government would be expecting biosimilars of adalimumab to contribute a not insignificant portion of budgeted savings.

The government budgeted $880 million in savings from biosimilars as part of its 2015 PBS Access and Sustainability Package. It budgeted a further $335 million in savings from the increased use of generics and biosimilars in the 2018-19 Budget.

Any shortfall in achieving the budgeted savings is likely to increase pressure on the industry and could lead to further measures.