New medicines must be affordable to all, Minister tells drug companies

Affordability is the major challenge in the evolution of personalised medicine, where therapies are developed for small groups or even for individuals, Minister for Health Stephen Donnelly has said.

Addressing the annual conference of the Irish Pharmaceutical Healthcare Association (Ipha), the industry group representing new drug developers, he said: “We need to make it a reality and we need to make it a reality not just for the wealthy few, because these treatments aren’t cheap, particularly when they are in their infancy. it is important that we make them available for all patients.

“It means that we in Government need to provide adequate funding and it means the industry and Government need to work together to ensure value for money,” he said.

* “We need to avoid situations like we have seen with Kaftrio,” he said, referring to the standoff between drugmaker Vertex and the HSE over the cost of providing the cystic fibrosis medicine already available to 140 other children in Ireland to a 35-strong group of children aged between six and 11. In an open letter last year, 21 consultants treating the children accused Vertex of using the children as “pawns for greater profit”.

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The Minister, who set up a working group last week after publishing a two-year-old report that found more than a third of all new drug approvals take more than two years to complete compared to the six-month window expected, said he wanted to see a more transparent drug approvals process and improved timelines.

“The State has a role to play ... but industry has a role to play too. It is the case that for some applications and some drugs, it can take an awful long time for the applicants to come back with some of the technology assessments that they need. So both sides need to step up to the plate if we are going to improve the time in which this process happens.”

The Minister hailed the dramatic increase in funding for new medicines under the current Government, over the past two years, including 35 orphan drugs — therapies for rare diseases or ones where no treatment is available. He said the success in orphan drugs getting approved showed there was no need for pharma companies to be concerned about value-for-money assessments of what are expensive new drugs.

Earlier, the changing nature of drug discovery was outlined by Amgen’s vice-president of research therapeutic discovery Alan Russell, who described generative artificial intelligence as a game changer that could dramatically shorten the time it takes to develop drugs, reducing cost and getting them to market quicker.

He also spoke about the multispecificity of modern drugs, using the example of an obesity therapy his company is developing, known as AMG133, that is designed to slow the pace of the gastric process and glucose production as well as the formation of fat cells while increasing the feeling of being full and the secretion of insulin.

And Deloitte’s US-based strategy partner Neal Batra warned that the amount spent on reactively treating sickness —effectively what the pharma sector does — will “flatline” over the next couple of decades. In US terms, that means the $2.3 trillion spent on this area of healthcare will rise only to $2.4 trillion by 2040 while overall healthcare will more than double.

He said the experience will be the same in Europe and elsewhere. What this means is the healthcare spending relevant to pharma will account only for 29 per cent of healthcare budgets by 2040, down from 56 per cent now, forcing an increase in cost reduction and market share, unless pharma looks to move more into promoting and restoring health rather than treating illness.

* This story was edited on Wednesday, March 8th, 2023. A statement in the original copy that the 140 children receiving Kaftrio are older than the 35 children excluded from the treatment was incorrect.