PBAC accused of ‘bullying’ drug companies into giving free drugs

Uncertainty for migraine patients and pharmacists is likely to persist as Novartis pulls PBS application for Aimovig

This week Novartis decided to no longer proceed with a third Aimovig (erenumab) submission to the PBAC and seek PBS reimbursement for the prevention of migraine in eligible patients.

Richard Tew, general manager of Novartis Pharmaceuticals Australia and New Zealand, said that “This decision has not been taken lightly and follows thorough consideration of recent developments in the reimbursement of innovative migraine treatments in Australia”.

“We acknowledge this will be disappointing news to those living with migraine, as well as healthcare professionals, awaiting a PBS listing to new preventive targeted therapies.

“Novartis is committed to partnering with healthcare professionals and the migraine community to support all patients currently enrolled on Aimovig access programs which will continue until 30 April, 2020.”

Following this time Aimovig will continue to be available via private prescription, at an estimated cost of $750-850/month.

Migraine Australia, a new patient advocacy and support organisation, created by people living with migraine, expressed disappointment at the decision as well as understanding of Novartis’ position.

Chair of Migraine Australia’s organising committee, Raphaella Crosby, says the decision of the PBAC is bullying the drug companies into giving away their drug for free.

 “We just want our lives back, and these drugs can do that,” she said.

 “To deny us a chance at a normal life, confined to welfare or constantly at risk of losing our jobs, unable to have a productive life, simply because there’s too many of us, is cruel and inexplicable,” Ms Crosby said.

The organisation says that the two previous instances where Aimovig was rejected for PBS listing occurred because of the number of migraine patients and that the cost to the Budget would be “high and uncertain”.

The result has been uncertainty for patients and pharmacists alike, Ms Crosby told the AJP.

“We’ve had a number of issues from the community that have been reported back, such as pharmacists complaining that they have too much stock and they can’t fit it in their fridges,” she said.

“I was talking to a pharmacist in Canberra recently about an issue one member was having, and she said, ‘The entire bottom of my fridge is full of Aimovig’.”

This pharmacist’s patients were all accessing the medicine via the trial program, which meant she was only charging a dispensing fee “as though it was on the PBS”.

Different pharmacies charging different fees for trial patients – Ms Crosby says while one pharmacist she knows of charges $175 for dispensing, “a whole lot of others” charge nothing – creates uncertainty for patients which could have been alleviated by a PBS listing.

She said that pharmacists should be aware that many patients who are currently using Aimovig via the trial program are likely to switch following the end of the trial period, to Teva’s Ajovy or Eli Lilly’s Emgality. Both these companies are still applying for listing on the PBS.

Aimovig is a first-in-class monoclonal antibody that blocks the receptor for Calcitonin Gene Related Peptide (CGRP), a chemical which has been found to be a critical component in the sequence of events that results in a migraine attack. Emgality and Ajovy are the first ever medications specifically developed to prevent migraine attacks.

Emgality was recommended on first application in the July 2019 meeting of the PBAC, but with a condition that is has to be under the same cap as currently exists for Botox for migraine. The Botox cap is exhausted each year with the small number of existing Botox patients

The three drugs represent an opportunity for migraine sufferers to break a cycle of medication overuse headaches, Ms Crosby told the AJP – and pharmacists are in a key position to help.

“There’s a lot of people who haven’t ever really treated their migraines saying, ‘Hang on, these new things are around, I might go back to the doctor’,” she said.

“We have a lot of people very unhappy about the codeine upschedule, and this has to do with medicine overuse headache.

“Even if they’re taking a medicine for back pain, if somebody has a history of migraine they need a medicine overuse plan. You may make your migraine condition angry by trying to treat something else.

“Somebody with migraine needs at least three different painkillers. A paracetamol is fine if it’s not too bad, an NSAID for bad days, or a triptan, but you need to rotate them as that’s how you avoid medicine overuse headache.”

It is vital for migraine sufferers to have a plan for managing migraine as well as any other pain they may experience, she said – and for pharmacists to understand the issue.

“If somebody’s buying big bottles of Nurofen and two or three different drugs, if they’re a migraine patient with a plan and the reason they’re getting them is to rotate them, that’s good; if they’re getting a lot of one drug, that’s not good.

“Pharmacists can be very very useful in catching that overuse and informing people about medicine overuse headache.

“That’s the great thing about Aimovig and Emgality and Ajovy: they’re massively busting up that medication overuse headache.”

Meanwhile a spokesperson for the PBAC has denied that it is at fault for Novartis’ decision to withdraw Aimovig from the PBS approval process.

Chair Andrew Wilson has told Pharma In Focus that the decision was Novartis’ alone.

“The Department encouraged them to keep their application in when they first indicated an intention to withdraw,” he told the publication.

A spokesperson for the Department of Health told the AJP that a new medicine cannot be listed by the Australian Government on the PBS unless the PBAC makes a recommendation in favour of listing.

“When considering a medicine proposed for PBS listing, the PBAC is required by legislation to give consideration to the effectiveness and cost of the medicine, including by comparing the effectiveness and cost with that of alternative treatments,” they said.

 “The PBAC  first considered Aimovig (erenumab) at its July 2018 meeting for the treatment of chronic migraine.

“On that occasion the PBAC was unable to recommend Aimovig for PBS listing as the PBAC considered that the submission had neither adequately justified the place in therapy nor justified the proposed PBS listing, which the PBAC considered excluded migraine patients that may benefit from this treatment.

“Further the PBAC considered that the evidence used for the basis of the clinical claim that Aimovig was more effective than botulinum toxin had significant limitations, resulting in a clinical effectiveness and cost-effectiveness estimates that were highly unreliable for decision making.

“The PBAC considered a further application for Aimovig at its March 2019 meeting. On that occasion the PBAC was unable to recommend Aimovig for PBS listing as the PBAC considered the magnitude of the clinical benefit, and the non-inferior efficacy claim versus Botox, were uncertain based on the data presented by Novartis.

“These and other issues identified by the PBAC meant that the PBAC considered that the cost-effectiveness of Aimovig at the price proposed in the resubmission was highly uncertain.

“As an outcome of its consideration in March 2019 the PBAC provided considerable feedback about the matters to be addressed to achieve a positive recommendation.

“Novartis made a further submission for the PBAC’s consideration at its November 2019 meeting, but withdrew the application prior to the PBAC having the opportunity to consider it.”

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