Please contact us if you have a question which we’ve not yet answered: info@cfbuyersclub.org
Who are the generic manufacturers?
We have identified a small number of companies that are manufacturing generic versions of cystic fibrosis drugs. One in particular, Gador, who is based in Argentina, has provided us with current prices for their generic version of CFTR modulators.
How much will the medicines cost?
At the beginning of November 2020, we received confirmation from Gador as to the prices of their generic modulators:
If you are in a position to purchase any of these medicines from Gador/their designated pharmacy, please email us so that we can provide further information: info@cfbuyersclub.org
How do we know the generic is safe and effective?
The generic manufacturer’s labs have been inspected by a number of stringent regulatory authorities including the FDA and a number of other regulatory authorities, and it has achieved the World Health Organisation’s certification for Good Manufacturing Practice. They already supply other medicines to the US and EU health systems.
In order to secure regulatory approval they have conducted bio-equivalence tests which prove that their product has the same biological effect in patients as the Vertex product. This is the methodology used to ascertain if any generic drug is the same as the original product.
Furthermore, the CF Buyers Club have worked with a leading London university and a London NHS Hospital Trust to test one of Gador’s generic products, Lucaftor (generic Orkambi®), in their academic lab. This facility has extensive experience of undertaking pharmacokinetic testing, and they analysed the active pharmaceutical ingredients in the originator (Vertex) product and the generic product to ensure they have comparable levels of ivacaftor and lumacaftor. These independent test results confirm the bio-equivalence tests conducted by the generic manufacturer.
What CF drugs are available generically?
The supplier we are working with currently has ivacaftor for 6 years and older, and ivacaftor-lumacaftor for 6 years and older and ivacaftor-tezacaftor for 12 years and older.
The 2-5 year old formulation made by Vertex is dosed according to weight in the form of granules designed to make them easier to consume. The generic is not available in granule form. Some children with CF within this age bracket will already be taking other kinds of tablets, so taking the 6-11 tablet may be an option for some patients. Please email us at info@cfbuyersclub.org if you need further information about this.
As with all decisions on treatment we advise you to speak to your clinical team.
Gador are currently developing a generic elexacaftor, enabling them to produce a generic Trikafta®/Kaftrio®. They forecast that this will be ready to launch in Q3 2021.
Do you have any information on the generic drugs for clinicians?
Gador have provided these datasheets on both of their current generic drugs, feel free to share these with your CF team:
Lucaftor (generic Orkambi™) 6-11 years
Tezacar (generic Symdeco™/Symkevi™)
How are they able to produce generic versions of these drugs?
Patents are granted at a national level. Vertex has not secured patents on their products in the country where the generic supplier is based so there is no legal barrier to them producing the medicines. Beyond this they undertook extensive scientific research and development to produce the active pharmaceutical ingredients in the medicines and testing to ensure their medicines are safe and efficacious.
Is it legal to purchase from them?
What follows is not legal advice. You may however find it useful in making an assessment about the legality of importing CF medications into your country.
UK law - like domestic laws in many countries around the world - includes a personal use exemption allowing patients to bring medicines into the country for personal use. In the UK this is understood as up to a three month supply and can be either brought in on your person when you are travelling into the country, or it can be bought from an overseas supplier and delivered to a patient or their family member in the mail.
This may not be the same in all countries and it is the responsibility of each buyer to understand and adhere to the rules around personal importation and taxation in the country where they live.
This is still very expensive - how can I cover the cost?
We realise that for most people, despite being much cheaper than the Vertex price, the cost of the generic treatment is still an unaffordable amount of money. Nonetheless, for some people this may be an option so we felt obliged to share information on the generic’s availability in the knowledge that some patients could benefit.
The CF Buyers Club, along with patient advocacy group Vertex Save Us, will continue to explore ways of ensuring that all patients will one day have access to CFTR modulators.