Japanese drugs manufacturer Eisai have pulled their new epilepsy drug Fycompa after wrangling with a government body over price. The move potentially sets a worrying precedent that may affect future drug development
Fycompa is the brand name for perampanel, an epilepsy medicine released for use in Europe in September 2012. Less than a year later, its manufacturer – Japanese pharmaceuticals giant Eisai – has decided to pull the medicine from Germany.
The reason for their decision relates to the controversial ‘AMNOG’ pricing structure that came out of 2010’s Act on the Reform of the Market for Medical Products. The AMNOG act aims to limit how much public money is spent on drugs. Spiralling drug costs have contributed to increased national health bills all over the world in recent years.
The act requires that any new drug should be assessed after its launch. This assessment compares the new drug to those already available and then assigns it a ‘price group’. Whatever group a drug is assigned determines how much the government will pay the manufacturer.
Perampanel was assessed earlier this year. One of the problems seems to be that the drug is a ‘first-in-class’ treatment. This means that no other drug works in the same way. Permapanel is the first epilepsy drug to target AMPA receptors in the brain – which are thought to play a key role in generating seizures.
Because no similar drug is currently available, perampanel had to be compared against other epilepsy drugs that work in different ways. The AMNOG assessment compared perampanel to lamotrigine and topiramate – and placed it in the same pricing group.
Eisai are said to be ‘appalled’ at the German Federal Joint Committee (G-BA) ruling, which states that perampanel’s benefit to patients is unproven. Eisai had previously submitted a detailed folio of evidence to the G-BA, designed to demonstrate its clinical value. However, assessors insist that perampanel’s therapeutic value is no greater than that of the two medicines it was assessed against.
Speaking to Pharma Times, Nick Burgin, European director of market access at Eisai, spoke out about the ruling. He states that the G-BA decision "failed to take into account the patient need for new innovative treatments. Further they did not acknowledge the patient-value of perampanel that was demonstrated in the comprehensive analyses submitted".
The manufacturer has publicly pointed out that around 30 per cent of people with epilepsy do not become seizure-free with existing medications. As such, new ‘first-in-class’ drugs like perampanel may represent a significant advance for people whose seizures have not responded to other drugs.
Since Eisai have been severely limited in what profit can be made in the German drugs market, they have taken the decision to pull the drug from Germany at the end of the year. They have stated that patients already taking the drug will still have access to it.
Cases like this may set a worrying trend that might affect the development of new epilepsy drugs in the future. Concerns are based around the costs of developing a drug and how drug licences work.
While the profits made by drug companies might seem astronomical, the process of developing a new drug is extremely expensive. Manufacturers like Eisai must make a new drug profitable after its launch in order to get back the costs of developing it. The problem is to do with the length of a licence.
A drugs manufacturer can patent the formula for a new drug – being granted a licence to be the only company selling that drug for around 10 years. After that time, other companies can copy the formula and make money selling it – but without having to pay the development costs. That means that companies like Eisai only have 10 years to make their money back before other companies can ‘cash in’ on their formula.
Government bodies in many countries are having to be more careful about how much money is spent on healthcare. It is understandable that they are trying to limit the money spent on medicines. However, if the drugs manufacturers cannot make a profit on their drugs, they may not continue to develop them. Ultimately, this means that people with conditions like epilepsy may not get the best possible treatment – only the most cost-effective.