Pharmac chairman backs early access scheme for new drugs

Originally published on NZ Herald

Pharmac board chairman Steve Maharey is backing an early access scheme that would give patients access to new and emerging drugs faster.

Maharey told the Herald that while Pharmac’s core business was sound, it was a model under stress.

Pharmaceuticals and medical devices were changing with increasing speed and the migration of new ideas around the world was much faster, Maharey said.

“The biggest mega-trend that’s affecting Pharmac is that trend to need to respond more quickly to innovations in new medicines, and will be in medical devices, and to put them into practice once they’ve been evaluated,” he said.

“That process can clearly be, and has been identified by everybody as being, slow and the pressure on that system will get greater and greater.”

Pharmac, the Government’s drug-buying agency with a budget of $985 million, is responsible for the procurement of medicines for district health boards and will soon also take on the management of all medical devices as well.

That includes all consumable from tongue depressors to pacemakers.

A fast-moving issue

Maharey said the logical outcome of the rapidly moving pharmaceutical and device market was speeding up the process, but not all of it because most of Pharmac was working well.

“It would be very difficult simply to speed up the whole lot, spending a billion dollars faster all the time. The other thing is that most things are working just fine.”

Maharey is talking about what he refers to as the edge of the issue, the part of Pharmac that is most often criticised – funding of new and emerging medicines and technology.

“The edge of this issue is fast-moving, so that means early access, the logical thing which is what we are looking at as an agency.”

Labour, while in Opposition, repeatedly called for an early access scheme for patients seeking faster access to new medicines but the proposal has not gone any further.

Prime Minister Jacinda Ardern recently revived the idea when she asked Health Minister David Clark for some advice.

Maharey, whose wife Liz Mackay died of cancer in 2004, said Pharmac was working with the Ministry of Health to look at all the early access processes around the world to try to identify what might be the best way forward.

“Personally, I would very much like to see something like this happen. As I said, we’ve identified that leading edge area as something that we simply must have some policy that will help us address that.”

He cautioned that it was not a policy that should be rushed into.

“I think a pilot would be a better way to go so we don’t lurch into something which may cost a lot of money and not get a lot of progress.

“I would like to think something will happen but that will be a decision made a little higher than my pay grade.”

UK improves early access

The UK has had the Early Access to Medicines Scheme since 2015 which aims to give people access to promising new drugs that are not yet licensed.

Earlier this month, British Health Minister Nicola Blackwood outlined changes that promised even faster access to new medicines through its Accelerated Access Collaborative (AAC).

The AAC would be the single point of contact for innovators keen to get their products into the NHS. The establishment of a “global leading” testing infrastructure was also planned.

Maharey, a former Labour cabinet minister, denied he’d been brought in by the Government as a fixer but said Pharmac was undergoing a “refresh”.

“Are there some things that are causing it some stress? Yes there are.

“It’s got a very prescribed role which is to provide the best health outcomes it possibly can for the wider population of New Zealand. That’s its core role and I think everyone agrees it does that core role very well.”

The board had recently been working on how Pharmac’s core activities could be improved, increasing transparency and addressing the early access issues those for rare diseases.

“Governments all over the world are struggling with this because the prices are astronomical and pharmaceutical companies clearly see this as a major new area of revenue for them so they are pushing those medicines a lot,” Maharey said.

New Zealand behind on new drugs

Medicines New Zealand general manager Graeme Jarvis agreed Pharmac needed to be refreshed in terms of both timeliness and transparency of decision-making.

“As far as getting access to modern medicines for patients and making timely funding decisions, New Zealand has for some years now ranked in last place out of 20 comparable OECD countries including Spain, Italy, the UK and Australia. New Zealand is consistently a long way behind these other countries,” Jarvis said.

On the board of Medicines NZ are representatives of pharmaceutical companies including Sanofi, GSK, Merck, Sharpe and Dohme, Roche, Pfizer and Novartis.

Jarvis said Pharmac’s decision-making processes were far too slow as evidenced by a waiting list of more than 100 medicines which had been recommended for funding by Pharmac’s expert technical committee but not funded.

“These medicines have been sitting on the list for an average of four years,” he said.

A rally will be held today (EDS: TUESDAY) calling for the Government to push Pharmac to fund a number of drugs which patients say could prolong their lives or improve the quality of the lives they had left.

Eight petitions, in addition to an number already presented to Parliament, will be handed over from patient support groups.

A national disgrace

Ken Romeril, a Wellington blood cancer specialist and chief executive of Myeloma NZ, is behind one of the petitions which calls for six myeloma treatments to be funded.

Romeril, who has 40 years’ experience as a haematologist, said myeloma was a significant disease, with 2500 patients and a death every second day, on average.

He said there had been no new drugs funded for the condition since 2014.

“I have a pretty intimate knowledge of the disease, having worked all this time. I have a good knowledge of the deficiencies and issues we have. I just want to be able to speak out on behalf of the patients.

“It’s a national disgrace that our drug budget is so out of kilter with other OECD countries. We’re down at number 19 or 20. I don’t think people in New Zealand have a really good grasp on that, how much behind we are compared with Australia etc.”

He acknowledged that the high prices set by drug companies for their product was an issue but said the problems with Pharmac were systemic.

“The model is broken really, isn’t it.”

More money for Pharmac means less for DHBS

Sarah Fitt, Pharmac’s chief executive, said the agency understood why people wanted access to new drugs for themselves or their loved ones.

“We’ve listened to all their stories, we’ve listened to all their petitions that have been presented to Parliament. We do acknowledge what they’re going through. We go through that ourselves. We have staff, we have family who go through the same thing.

Pharmac’s budget comes from DHBs, which decide themselves how much they will give. But the final decision is made by the Health Minister.

Taking more money from DHBs means less money for hospital services and other costs DHBs have to meet.

“There’s always going to be a trade-off against other demands from the health service, which is never-ending,” Fitt said.

“We feel as though we run a really robust process here where we feel we get really good clinical advice from our advisory committees, we do cost-effective analysis, we look at all the medicines that are waiting to be funded.

Although it was the drugs Pharmac did not fund that received publicity, Pharmac funded many that made a huge difference to people’s lives.

“We funded some new haemophilia treatments last week. We’re the first people in the world to fund these treatments.

“Truvada to prevent HIV, we funded that last year. Again, we were the first country in the world to that.

“The rhetoric very much becomes ‘we’re slow, we’re last’.

“We think our process is flexible so that when something is a good advance and a good technology we can move really quickly. The slower ones are the ones that people hear about but often in those cases they’re slow not because of the process, they’re slow because the evidence is evolving, the price that the company is charging doesn’t tally with the evidence,” she said.

“We feel we deliver really good value for money for the New Zealand taxpayer, we’re making good decisions, evidence-based.”

“For every medicine we fund, then there’s something else we don’t fund. That’s where it becomes difficult because obviously [people] get very frustrated that we’re not funding the medicines that they want for themselves or their family.”

Fitt said early access schemes were not new and Pharmac had been watching their development overseas since 2011.

“There’s been nothing yet to persuade us it’s a good thing to do. But if there’s a better way of doing things then we’ll absolutely go with it but we have to be convinced it’s the right thing to do here.”