Posted 20 September 2017
With a queue of drugs dating back to March 2015 awaiting PBS listing, the media fanfare surrounding the fortunate few announced each month as making it onto the PBS seems somewhat misplaced.
Research by Pharma in Focus has revealed at least 13 drugs recommended for listing since the beginning of 2015 that are still waiting for the Health Minister to give them the go ahead.
In the fast-paced world of modern medicine, getting a positive recommendation from the PBAC only to then wait years for PBS access is like winning the lottery and not having it paid out.
Sitting longest in the queue is Novartis' inflammatory diseases biologic Ilaris (canakinumab), positively recommended by the PBAC on a cost-minimisation basis at its March 2015 meeting for systemic juvenile idiopathic arthritis.
Tipped at the time to cost less than $10 million, the drug remains unlisted more than two and a half years later.
Next longest in the queue is Sanofi's diabetes drug Toujeo (insulin glargine [rDNA origin]), recommended by the PBAC in July 2015.
After almost a year of negotiations, the Department of Health and Sanofi said last year they had failed to reach an agreement, leaving Australian diabetics without access to a therapy recommended for listing on its first attempt more than two years ago.
Left over from the November 2015 PBAC meeting was GSK's asthma drug Arnuity Ellipta (fluticasone furoate), with GSK returning to the PBAC in March this year to request it be declared a drug worthy of listing. GSK again walked away with a positive recommendation but the minister still has not seen fit to reward the company's enduring patience with a PBS-listing more than six months later.
Last year was a good year for PBAC recommendations - Pharma in Focus found no recommended drugs still waiting for listing, whereas eight drugs given the green light by the PBAC in March this year and a further five from its July meeting are still in limbo.
Medicines Australia said in 2015 the government was taking on average 12 months for drugs positively recommended to gain access to the PBS, and it appears many new drugs are still struggling to jump the final hurdle in the long and winding road to reimbursement.
With only two new drugs making it onto the PBS this month - Gilead's Zydelig (idelalisib) which waited 14 months for the privilege and Pfizer's Somavert (pegvisomant) which waited 10 months, the path to reimbursement in Australia remains an uncertain one and for some unfortunate drugs, it is a road to nowhere.
Megan Brodie
megan.brodie@lushmedia.com.au
Research assisted by Yajun Ma