David Seymour putting the cart before the horse
"A review of the Medicines Act and regulation to get more treatment options approved by Medsafe would be welcomed by nib New Zealand."
Off-label medicines, Medsafe, and the health insurance gap. It’s an issue that’s recently caught the attention of Associate Minister of Health (Pharmac) and Minister of Regulation David Seymour.
He says the gap that causes some New Zealanders with health insurance to miss out on access to life-saving drugs will be closed under his watch and, as a health insurer, we welcome government action to improve Kiwis’ access to safe and effective medicines.
Medical technology is advancing faster than ever before and we’re seeing new and exciting developments across the healthcare sector. This includes developments in pharmaceuticals, meaning doctors around the world now have access to more medicines to treat their patients. Regulation and Medsafe approvals need to be adaptable and fast-moving or Kiwis will miss out on access to the best treatments.
Falling behind our overseas counterparts, between 2011-2023, Medsafe approved only 39 of the 131 modern medicines that are publicly funded in Australia. Medsafe aims for a 100-day initial evaluation for drugs approved elsewhere, but more than half of the drugs assessed between 2022 and 2023 took longer than 176 days.
New Zealand’s public health system can’t meet every demand and many potentially life-saving medications are not funded by Pharmac. Health insurers can help bridge this Pharmac gap, by providing Kiwis with greater access to treatment options through specific products like nib’s non-Pharmac Plus cover, but our hands are tied when it comes to offlabel drugs.
We want to offer the best and latest treatment options to our members, however, as a responsible insurer, we need certainty that off-label medicines won’t put our members’ health at risk.
Member safety is our top priority and we must follow guidance from regulators like Medsafe to ensure treatment options are safe and effective. Like other health insurers, nib is unable to cover off-label drugs prescribed beyond the initial use approved by Medsafe.
It’s been frustrating to watch other countries with similar regulation models, like Australia and the UK, approve life-saving treatments years ahead of us. Meanwhile, we’re faced with stories of Kiwis forced to make sacrifices, from selling their homes to launching crowdfunding campaigns, just to afford essential treatments.
Every pharmaceutical approval system must weigh the risk of releasing unsafe medicines against the risk of delaying access to potentially life-saving (or lifechanging) interventions, and they are understandably cautious.
But with hard evidence that offlabel medicines are safe and effective for patients overseas, there’s a fair argument that Medsafe’s approval times should not be as long and limited as they are today.
Seymour called for change by insurers or a change to the Medicines Act to be more flexible. I believe that rather than an “or,” Seymour’s solution to bridging the health insurance gap needs to be an “and”.
But the cart cannot come before the horse. If Medsafe can first approve off-label medicines, we’ll be able to give our eligible members access to them.
A review of the Medicines Act and regulation to get more treatment options approved by Medsafe would be welcomed by nib New Zealand.
We would support changes that would allow Medsafe to approve drug combinations that are safe and effective and proven through their routine use overseas or approved by recognised regulatory agencies abroad.
Seymour has already made some promising inroads, streamlining Pharmac’s funding process and improving Medsafe’s approval timeframes for medicines already approved by two comparable overseas regulatory agencies.
We would welcome further policy changes to enable Medsafe to approve more off-label medicines.
Private healthcare exists to give people more choice and power over their health. The sector works hard to offer solutions so Kiwis are not left without the healthcare support they need. But to bridge the health insurance gap, we need regulatory processes to move quicker so Kiwis stop missing out on access to the best treatments.