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New HTA Decisions in England
June 2020
Drug name
AJOVY® (fremanezumab)
Teva Pharmaceuticals
Decision date
Therapeutic area
Neurological conditions
Therapeutic sub area
Recommended with restrictions
Fremanezumab is recommended as an option for preventing migraine in adults
Decision Detail
Fremanezumab is recommended only if: the migraine is chronic, that is, 15 or more headache days a month for more than 3 months with at least 8 of those having features of migraine; at least 3 preventive drug treatments have failed and; the company provides it according to the commercial arrangement. Stop fremanezumab if the migraine frequency does not reduce by at least 30% after 12 weeks of treatment.
The company's systematic literature review identified 3 double-blind randomised controlled trials evaluating fremanezumab. All trials compared fremanezumab (dosage of 675 mg every 3 months [quarterly] or 225 mg monthly) with placebo in adults aged 18 to 70 years across multiple international centres. The committee concluded that the subgroup of people from FOCUS for whom 3 preventive treatments had failed provided the most relevant data for the population of interest. The company presented clinical effectiveness results from FOCUS for the subgroup of people for whom 3 or 4 preventive migraine therapies failed to produce clinically meaningful improvement, were not tolerated, or were contraindicated or unsuitable. The baseline to week 12 subgroup results from FOCUS showed fremanezumab reduced the number of monthly migraine days more than placebo for episodic and chronic migraine. The committee concluded that the long-term benefits of fremanezumab compared with best supportive care remained uncertain. There was also a high degree of uncertainty about whether fremanezumab was more clinically effective than botulinum toxin type A for chronic migraine. The committee noted a high level of uncertainty, specifically the lack of long-term natural history data and the simplicity of the model, the sensitivity of the model to the time horizon and the different post-treatment discontinuation scenarios and the sensitivity of the model to alternative utility value assumptions. The committee also considered that the impact of introducing fremanezumab for episodic migraine on NHS resources may be higher than for chronic migraine. This is because episodic migraine is more common than chronic migraine. Therefore, the committee agreed that an acceptable ICER would be towards the lower end of the range normally considered a cost-effective use of NHS resources (£20,000 to £30,000 per QALY gained) for episodic migraine. For chronic migraine, assuming fremanezumab works better than botulinum toxin type A, the most likely cost-effectiveness estimates are within the range NICE normally considers an acceptable use of NHS resources, so it is recommended for chronic migraine. In line with clinical practice, fremanezumab treatment should stop if it is not working well enough after 12 weeks. For episodic migraine, uncertainty in the economic modelling about stopping treatment and quality of life affects the cost-effectiveness estimates. The most likely estimates for fremanezumab are higher than what NICE normally considers an acceptable use of NHS resources, so it is not recommended for episodic migraine.