Novartis Withdraws PBS Submission

The cost of CGRP treatments without PBS support is approximately $800 per month. This is beyond the affordability of most people living with chronic migraine. The nature of chronic migraine makes work difficult or impossible for many patients who experience severe pain and symptoms like nausea, vomiting, visual impairment, light sensitivity, fatigue, and brain fog.

The new treatments have been described by some as “life-changing”. It has provided hope to many Australians living with frequent migraine. Disappointingly it has been rejected twice by the PBAC.

The PBAC is the committee responsible for making recommendations to the government who typically implement the recommendation.

Limited information is available from the PBAC or from Novartis as to the details regarding its withdrawal. Richard Tew, General Manager Novartis Pharmaceuticals Australia and New Zealand said: “This decision has not been taken lightly and follows thorough consideration of recent developments in the reimbursement of innovative migraine treatments in Australia.”

A current migraine preventive treatment covered by the PBS is Botox. Botox treats numerous medical conditions and may also be used to help prevent migraine when a specific migraine injection protocol is followed. When used for migraine treatment, patients do not receive the typical cosmetic benefits for which Botox is well known.

Botox can be an effective treatment for migraine but there is no one treatment that works for everyone. Botox is manufactured by Allergan which receives limited support from the PBS. There are conditions attached with the PBS coverage. One condition is a “cap” or limit to the amount covered by the PBS. If that cap is reached then no further funding support is provided by the PBS to the manufacturer and the organisation essentially funds the treatment itself for the patient.

The PBAC has suggested that this new class of CGRP treatment for migraine prevention share the same cap currently used by Botox. Details about the amount set in the cap are limited, however, Migraine and Headache Australia understands that this amount is so small that the cap budget set for the entire year is reached by Botox alone within a few months.

Not only is this cap insufficient for Botox currently, but the PBAC has indicated that the CGRPs are to share this same cap with Botox.

Migraine today is underdiagnosed, undertreated and poorly managed. Studies report that less than one third of patients who qualify for preventive treatment are currently using them. Without expanding the cap to provide adequate support for Australians living with chronic migraine, people will continue to suffer.

Migraine and Headache Australia’s CEO Trevor Thompson said: “We are disappointed that despite over 2,000 unique and written submissions from the migraine community to the PBAC, little has changed. Migraine still does not appear to be a priority nor has the level of support changed with the arrival this new generation treatment.”

Patients have a fundamental human right to access effective treatments at a fair price. The Australian government has put in place the PBS system for exactly this purpose yet appears to have turned its back on this life-changing treatment.