Government puts cystic fibrosis medication on national formulary

Medicine for cystic fibrosis has been added to the government’s formulary list after an agreement was reached with Vertex Pharmaceuticals, Prime Minister Robert Abela announced. 

Speaking at a press conference on Wednesday alongside Health Minister Chris Fearne, Abela said this decision was an investment in the country and its people.

Abela said it would cost the government €3 million a year to import such medicines. 

Abela said that though only a handful of people needed the medicine, the government was still focused on bettering their lives and was determined to “not leave anyone behind”.

Fearne said that for many years cystic fibrosis “has been a condemnation.” He said patients with the condition spend their lives in and out of the hospital. However, in recent years, research has come a long way, with more people with cystic fibrosis living longer.

The health minister said the medicines would reduce the need for hospitalisation of patients by 80%.

Fearne said the best moments in politics are when such decisions bear results and change people’s lives for the better. 

Fearne said that other medicines will be announced in the coming weeks and months, which will be added to the government formulary.

Meanwhile, Vertex Pharmaceuticals’s cystic fibrosis (CF) medicines, licensed by the European Medicines Agency (EMA) announced that it is now available to eligible patients in Malta after an agreement was signed with the Maltese government.

Eligible patients in Malta are now able to access Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor, Symkevi (tezacaftor/ivacaftor) in combination with ivacaftor, Orkambi (lumacaftor/ivacaftor) and Kalydeco (ivacaftor).

The agreement will also allow for reimbursed access to any future indication extensions of these medicines.

Abela had already announced last March that the government will put the life-saving drug for cystic fibrosis patients on the government formulary after cystic fibrosis patient and activist Mandy Vella petitioned for the expensive drug to be provided to sufferers like her.

She has been advocating for the drug to be procured by Maltese authorities since 2018.

Vella had been hospitalised with a chest infection over a complication she has previously said could have been prevented if she had access to the pioneering life-saving drug Trikafta. The drug is used to treat the cells of cystic fibrosis patients and give more strength to their lungs. While it has been a global breakthrough for those with the disease, it comes with a hefty price tag, costing tens of thousands a month for each patient. 

With this announcement, Malta joins the over 25 countries around the world in which Vertex medicines are currently reimbursed, including Australia, France, Germany, the Republic of Ireland, the Netherlands, Spain, Sweden, the UK and the U.S.

“Our medicines have fundamentally changed the way CF is treated and we are very pleased that we have been able to work quickly and collaboratively with authorities in Malta so that eligible people with CF can now get access to our medicines,” said Nicola Massey, Senior Country Manager UK, Ireland & Malta, Vertex.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF.

Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases.