Experts consider risk, safety and cost effectiveness of drugs for government subsidies.
As cases and deaths of the dominant strain of meningococcal disease in Australia, meningococcal B, rise, experts are again questioning why a vaccine which can help prevent a majority of cases is not available free to all Australian children and adolescents.
The New South Wales state government has recently issued a health warning following the death of an 18-year-old woman, who died from meningococcal B after attending the Canberra music festival, Spilt Milk. She is the third in NSW to die from meningococcal disease this year (most of which have been caused by strain B) and the 29th known case of infection.
Four other cases were associated with the Splendour in the Grass music festival, which took place near Byron Bay in August. All were caused by the B-strain of the disease.
Victoria also issued a health alert in November after another teenager, an 18-year-old who recently returned from “Schoolies” in Maroochydore, Queensland, was diagnosed with meningococcal B in early December. Victoria reported 14 cases of meningococcal disease in 2022.
The deaths highlight a thorny economic and ethical issue for the government: how much is a life worth?
What is meningococcal disease, and how can you get it?
Meningococcal disease is caused by the bacterium Neisseria meningitidis, of which there are several strains. The bacteria live naturally in the back of the nose and throat in about 10% of the population (called carriers) without causing any illness.
There are five strains of meningococcal: A, B, C, W-135, and Y.
Meningococcal is transmitted by close, prolonged household and intimate contact. Infections arise when a particular strain of the bacteria is able to get through the lining of the throat and enter the bloodstream, which usually takes the form of a blood infection (septicaemia) or infection of the membranes covering the brain and spinal cord (meningitis).
The bacteria can only survive a few seconds outside the body so cannot be picked up from surfaces, swimming pools, buildings or animals.
After infection, it usually takes one to 10 days for symptoms to appear, which can include a sudden onset of fever, rash of red-purple pin pricks or bruises, headache, neck stiffness, photophobia, muscle aches, cold hands and feet, confusion, irritability, joint pain, nausea and vomiting.
The highest incidence of meningococcal occurs in two age groups: 0 to 4 years, and 15 to 25 years. Teenagers have the highest carriage rates, peaking in 19-year-olds, and so play an important role in transmission.
Before the start of a National Meningococcal C Vaccination Program in 2003 (which aimed to deliver free vaccinations to all children up to 19 years) most fatalities in Australia were caused by the group C strain. In 2016, strain W emerged as dominant, making up almost half of the Australian cases.
In 2017, B strain increased to levels similar to W and in 2018, following widespread meningococcal ACWY school vaccination programs, strain B became dominant.
While rare, meningococcal disease is extremely dangerous and can cause death in as little as 24 hours. Among vaccine preventable diseases, meningococcal has the second highest fatality rate after rabies, at a little above 10%, and up to 40% in the case of meningococcal septicaemia, which occurs when the bacteria enter the bloodstream and multiply, damaging the walls of the blood vessels.
For those who survive , up to a fifth exhibit permanent life-long disabilities, such as brain damage, deafness, kidney failure, and limb amputation. And while all age groups are susceptible to meningococcal disease, infants are 17 times more likely to be infected compared to the general population.
Meningococcal B is the only strain not covered by a free combination vaccine for all Australian children under the National Immunisation Program (NIP), costing families about $115 per shot, per child. Two doses are needed.
Meningitis Centre Australia CEO, Karen Quick, says the expense and time-consuming process is a deterrent to families who want to vaccinate their children.
“There are two doses needed, a doctor’s script, pharmacy visit, doctor’s visits – it is not easy,” she tells Cosmos Weekly. And while it is difficult to find out exactly how many people are vaccinated against meningococcal B, Quick says the numbers are low.
Why isn’t the vaccine free for all Australian children and teens?
In August 2013, a vaccine against a broad spectrum of meningococcal B strains, also known as Bexsero, was registered in Australia. Since August 2014, this vaccine has been available in Australia through private prescription, and the Australian Technical Advisory Group on Immunisation (ATAGI) has recommended targeting at-risk age groups and populations.
(Bexsero is manufactured by Glaxo Smith Kline (GSK) and is currently free for Aboriginal and Torres Strait Islander children aged up to 12 months, as well as for some immunocompromised people.)
Cosmos Weekly described in a two part series late last year how a drug gets on the Pharmaceutical Benefits Scheme (PBS). A new medicine first has to be approved by Australia’s drug regulator, the Therapeutic Goods Administration (TGA), before it is assessed by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert advisory body made up of clinicians, health economists, and consumer representatives, who make recommendations to the government about drug listings.
PBAC Chair since 2015, Professor Andrew Wilson, who oversaw the most recent submission by GSK, told Cosmos Weekly it is not surprising that meningococcal B is the dominant strain in Australia as the rest have been vaccinated against, and questioned whether “commercial considerations” stand in the way of B being part of the combination meningococcal ACWY vaccine.
In the company’s first Bexsero submission in 2013, PBAC noted that GSK estimated that “over 4 million children would be vaccinated over the first 5 years of a full 4CMenB vaccination programme (including catch ups), at a net cost to the government of greater than $400 million”.
PBAC wrote in its public decision statement: “This vaccination programme would prevent 224 cases of invasive meningococcal disease, 9 deaths due to meningococcal B disease, and 93 patients with sequelae after 5 years.”.
It concluded that “the rarity of invasive meningococcal B disease compared to the large number of vaccinations that are required was the primary driver of the unfavourable incremental cost-effectiveness ratio, and that … given the clinical uncertainties of a population wide prevention, there was high financial risk to the government and reduced opportunity to fund other interventions which are acceptably cost-effective.”
In 2019, PBAC upheld its decision, despite noting that “over a period of years, the model predicted a total of 1,134 cases in the no vaccination scenario and 941 cases in the vaccinated scenario which led to approximately 193 cases and 6 deaths potentially avoided”. It did, however, propose to the Government that it should make the vaccine free for at-risk groups.
In a table provided to Cosmos by the federal health department, in 2022 alone there have been 111 cases of meningococcal across Australia, 90 of them strain B.
Wilson says PBAC considers whether the proposed vaccine will protect individuals, and whether it will stop transmission and the benefits relative to the overall risk in the community “One hundred, 200 cases a year is important, nobody is denying that,” says Wilson. “But when you have a disease at that rate, the risk of transmission in the community is low. Compare that to Covid, the flu or measles, which are highly infectious and spread quickly.”
Wilson says meningococcal tends to appear in clusters, like the one we are seeing now. And while he stands by PBAC’s most recent decision, he says the committee is open to changing circumstances or a new submission.
“So far, the company hasn’t decided to come back with an application,” he says. “Either that happens or the government may reconsider if cases go up.”
Another way the vaccine can become more cost effective is if the company drops its prices or a competitor comes into the field, Wilson adds. PBAC could not reach a price agreement with GSK which would make the drug cost effective for a national immunisation program.
“There is another MenB vaccine that is marketed in the US that we haven’t seen here — for some reason, it never comes to us,” he says.
“Either way, it’s difficult to weigh these things up — these are small numbers, how do you weigh up those benefits?
Advocates still fighting
That’s not to say that advocates such as Meningitis Centre Australia, haven’t tried to get the vaccine on the National Immunisation Program.
In 2019, GSK put forward a submission to include Bexsero in the National Immunisation Program (NIP) for all Australian infants under two years of age, as well as adolescents. The submission included detailed economic modelling showing how the “vaccine would represent a value for money investment in the Australian health system”, a GSK spokeswoman says.
“Yet, despite four submissions to the Federal Government to date, GSK has been unsuccessful in securing access for all Australian children to our meningococcal B vaccine … because our health system uses a funding model that undervalues prevention,” she adds.
When Cosmos Weekly asked Health Minister Mark Butler to explain why Bexsero remains costly when it vaccinates against the most common strain of meningococcal in Australia, we were referred to a federal Health Department spokesperson.
For Meningitis Centre’s Quick, change can’t happen quickly enough — and she says state governments also have a role to play. South Australia is the only state in Australia to offer Bexsero to its infants for free, enacted as a response to higher local rates.
“What we need is for all state governments to step up and draw a line and say ‘no more under my watch, we want to save lives and disability’,” says Quick. “They need to make it clear that this is vaccine preventable disease, and make a commitment that no more children and teenagers in their state will be put at risk.
“This will make the federal government stand up and listen and consider placing on the NIP.”
Caroline Zielinski is a freelance journalist based in Melbourne. She writes on health, science, social affairs and all issues related to women