pharmaphorumDecember 25, 2018
Tag: NHS , TSC epilepsy , CDF , Epilepsy
NHS England has reversed a previous decision and will be funding Novartis’ Afinitor (everolimus) for TSC-related refractory epilepsy from April 2019.
The drug has a patchy history with the health service, having been previously rejected on cost effectiveness grounds and moved to the Cancer Drugs Fund (CDF) for conditions including kidney cancer and breast cancer. After the CDF closed, discounts from Novartis and reassessments by NICE convinced the NHS to routinely fund the drug for some of these conditions, but in July 2018 it announced it would not be funding it for TSC-related refractory epilepsy – although it had been approved by the SMC only a week before, sparking outrage from patient groups.
The new decision means that Afinitor will be funded from April 2019 for patients aged two years and older with TSC-related seizures that have not adequately responded to treatment with at least two different anti-epileptic drugs, given at therapeutic doses in addition to their current treatments and where surgical resection has already been considered.
TSC is a rare genetic condition affecting 1 in 6,000 people that can lead to growths in various organs of the body. These growths may be referred to as benign and non-cancerous tumours, with problems from the growths being caused mainly because of their size and where they are in the body.
Epilepsy is the most common neurological feature of TSC, affecting at least eight out of ten people living with the condition. More than 50% of people with TSC who have epilepsy will not respond to standard anti-epilepsy medicines and may need an alternative form of treatment, such as Afinitor. Epilepsy is generally more difficult to control for individuals living with TSC who have moderate or severe learning disabilities.
"NHS England has always recognised that there is enough clinical evidence to commission everolimus for TSC-related refractory epilepsy," said Dr Chris Kingswood, consultant nephrologist and head of research strategy at the Tuberous Sclerosis Association (TSA). "The 20% chance of seizure freedom and 60% chance of significant seizure reduction from treating this group of patients with everolimus is a massive improvement compared to using traditional anti-epileptic drugs. Clinicians supporting people living with TSC will be thrilled to add everolimus to the range of treatments that we can offer to patients with TSC-related refractory epilepsy."
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