When those medicines are not funded through Pharmac, health insurers often decline coverage because the use of the drug isn’t Medsafe-approved.
The Herald has previously reported on how this affects Kiwis battling multiple myeloma, a common blood cancer.
Pharmac has not funded any new medications for the condition for a decade, forcing desperate families to try and fundraise hundreds of thousands of dollars for life-extending drugs.
One such medicine, daratumumab, has been approved by Medsafe when used in combination with a handful of certain drugs.
Daratumumab is, however, commonly used with other medicines that are not covered by that narrow indication - drug combinations that are safe and effective, and proven through their routine use overseas.
Drug companies can make an application to Medsafe to extend an indication for a medicine, a process that costs money and requires them to provide clinical trial data to demonstrate benefits outweigh the risk of side-effects.
Medsafe has not received such an application from daratumumab’s maker, Janssen, and so the drug is commonly used “off-label”.
That has caused some patients to miss out on health insurance, including retired Porirua GP Dr Logan McLennan, who is privately funding daratumumab to be taken in combination with another medicine, pomalidomide.
McLennan has had health insurance with Southern Cross since 1989, and his policy includes $10,000 a year for oncology drugs not funded by Pharmac, but approved by Medsafe.
Medsafe has approved both daratumumab and pomalidomide, but not in combination - which meant his health insurance didn’t pay out.
The cost of his drugs is much more than $10,000 a year, but in a fight to survive, every dollar counts - the family home is being sold to help pay for his treatment and there is a Givealittle page. McLennan is also aware that other people may miss out on far greater insurance payouts.
Another myeloma patient, who asked not to be named, said his combination of medicine was highly effective and approved by overseas regulators, but not by Medsafe. His health insurer refused cover.
“The fact that insurers refuse to pay for extended indications - which are how most drugs are used around the world - is very unfair to those who pay increasingly expensive premiums for so-called non-Pharmac-approved medicines, especially cancer drugs.
“The drug companies, insurers, and Medsafe need to be held to account for this practice. They are supposed to be there to support [patients] and not restrict access to care.”
Seymour, who has responsibility for Pharmac, said he was unaware of the problem until reading about it in the Herald.
“It’s a valid concern... either medical insurance needs to clean their act up and recognise that as pharmaceuticals change, more and more prescriptions will be off-label, or we need to change the Medicines Act, and it needs to be more flexible.”
A spokeswoman for Janssen, owned by Johnson & Johnson, said Pharmac had been considering funding daratumumab for more than six years, and “given the substantial delays, Janssen has not sought an extension of the current indications” from Medsafe.
Dr Stephen Child, chief medical officer for Southern Cross Health Insurance, which has more than 950,000 members, said medicine, particularly oncology, was rapidly evolving.
“This is why we take the guidance of bodies like Medsafe on which treatments are safe for New Zealanders.”
Child said members could get greater flexibility through add-on policies like “cancer assist” or “critical illness”, which “may enable them to access care and alternative treatments that may not be covered by the public system or health insurance”.
A Medsafe spokesman said the agency wasn’t responsible for health insurance decisions.
“Medical practitioners can use medicines off-label... they’re responsible for ensuring patient consent and meeting the Code of Health and Disability Services Consumers’ Rights.”
Seymour has made other recent changes regarding pharmaceutical access. In March, he announced Pharmac would change its processes so it can assess a funding application at the same time as Medsafe assesses the drug for approval.
Pharmac had previously waited until Medsafe had done its assessment, before it would begin the funding assessment process. (Medsafe assesses medicines to make sure they are safe and work as intended, while Pharmac decides what drugs to fund.)
The new faster, parallel assessment approach is already taken by Pharmac for cancer medicines, and is used in other countries including Australia and Canada.
The Act Party/National coalition agreement also commits to having Medsafe approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.
Seymour said the “off-label” health insurance issue affecting myeloma and other patients would be investigated as part of those reforms.
Nicholas Jones is an investigative reporter at the Herald. He won the best individual investigation and best social issues reporter categories at the 2023 Voyager Media Awards.
