Migraine Australia welcomes long-awaited PBS listing for Teva’s anti-CGRP therapy

Pharma News: TEVA Pharma Australia secured the long-awaited Pharmaceutical Benefits Scheme (PBS) listing for its anti-CGRP (calcitonin gene-related peptide) monoclonal antibody, Ajovy (fremanezumab), in chronic migraine therapy.

Ajovy was listed on the Australian Register of Therapeutic Goods (ARTG) in September 2019 and has been available for episodic migraine under private prescription.

The long-acting treatment reduces headache and migraine days by 50% in patients with an average of 15 or more headache days, or at least eight migraine days, per month.

At a time when up to 15 million Australians (~62%) are in lockdown due to COVID-19, experts are pointing to emerging studies that suggest people with migraine are experiencing close to a 60% increase in migraine frequency, and 60% increase in migraine severity in comparison to the pre-COVID-19 period.

Associate Professor Susan Tomlinson, Neurologist said “There is real opportunity for migraine-specific preventative anti-CGRP therapies to reduce the burden of difficult to treat migraine. We know that patients living with this debilitating and complex neurological condition respond to different treatments in different ways. The listing of Ajovy offers patients an additional therapy with distinct safety and efficacy profiles. Access to a more comprehensive toolkit of treatment options is timely, as patients are experiencing greater migraine frequency and severity compared to pre-COVID times.”

Migraine Australia stated “Another hard-fought victory for the migraine community as Health Minister Greg Hunt announces that Ajovy is being listed on the PBS. The Momentum program will continue long term for those who are not eligible under the PBS restrictions.”

The reimbursement of Ajovy follows a pivotal Phase III clinical trial demonstrating that the monthly dose (225mg) reduced the mean number of headache days by 4.6 per month (vs. placebo of 2.5 days per month; P<0.001). Significant treatment effects were seen as early as four weeks from baseline from the monthly dose (vs placebo; P<0.001). Furthermore, significantly more patients who received AJOVY achieved at least a 50% reduction in monthly average headache days compared to placebo (monthly dosing; 41% vs 18%; P<0.0001).

The treatment is administered by a monthly (225mg) subcutaneous injection by pre-filled syringe, without the need of a loading dose, and self-injected once patients are trained.

Teva aims to offer patients greater flexibility with an additional autoinjector dosing option for Ajovy soon to be available to patients in Australia.

Benet Irish, General Manager at TEVA Pharma Australia, said “The approval of Ajovy is an important step forward for the Australian migraine community and we congratulate the Government for providing Australians an additional treatment option.”

People living with migraine commonly discontinue preventive treatment due to lack of efficacy and side effects, and most (90%) within one year, leaving them in constant search for new options that will work for them.

After an initial prescription by a neurologist, continuation of Ajovy treatment can be managed by the patient’s GP in regular consultation with the neurologist, if patients achieve and maintain a 50% or greater reduction from baseline in the number of migraine days per month.

Competitor Eli Lilly’s Emgality (galcanezumab) was listed on the PBS earlier this year in June while Novartis withdrew Aimovig from the PBS process in November 2019.