Barriers to Treatment

Before he passed away in 1999, Charles Buttrose was a seasoned journalist and avid reader – much like his daughter, Ita Buttrose AC OBE, who is also a long-time Macular Disease Foundation Australia (MDFA) Patron.

But if the Government adopts the proposal to cut the MBS rebate, Pastor Ron will be forced to stop receiving eye injections

So, when Ita witnessed her father contorting the newspaper above his head in a bid to read the small print with his peripheral vision, she knew macular disease had robbed Charles of one of his great joys.

Thanks to the arrival of intravitreal anti- VEGF injections in Australia 15 years ago, nAMD has been a very different experience for Charles’ younger brother Gerald.

Diagnosed with nAMD in 2008, within 12 months of this breakthrough treatment being made available locally, Gerald has since received more than 100 anti-VEGF injections.

In fact, intravitreal injection (IVI) has been so effective for Ita’s uncle Gerald, that now, at the age of 98, he can still recognise the faces of his many children and grandchildren, read the newspaper every morning, and even write books – he published a World War Two novel, The Third Movement, only last year.

“I’m quite happy to (have treatment) – I’ll take 200 injections if I can keep my eyesight,” Gerald says.

“It’s worthwhile because your vision is so important.”

Gerald’s story is typical of the many thousands of patients who owe their sight to anti-VEGF treatment.

EVOLUTION OF TREATMENT AVAILABILITY IN AUSTRALIA

Before IVI treatment became widely available in this country in 2007, most people with nAMD lost their vision and often developed legal blindness. Now, in 2022, Australia is a world leader in the management of nAMD.^1,2

Following the discovery that anti-VEGF antibodies used to treat cancer could also treat eye conditions, including nAMD and diabetic retinopathy, Australian ophthalmologists began to use Avastin (bevacizumab) off-label in October 2005.

However, Lucentis (ranibizumab), an antibody fragment of Avastin, became the first drug for the treatment of nAMD to be registered by the Therapeutic Goods Administration (TGA) on 19 February 2007, then subsidised by the Pharmaceutical Benefits Scheme (PBS) on 1 August 2007.

A second drug – Eylea (aflibercept) – was PBS-listed on 1 December 2012, after an advocacy campaign by MDFA and Bayer to remove a restriction that limited use to treatment-naive patients.

On 1 October 2021, Beovu (brolucizumab) became the third anti-VEGF drug to be subsidised by the PBS for the treatment of nAMD; available only for patients who have received Lucentis and/or Eylea for at least six months and have had a suboptimal response to first-line treatment.

EVIDENCE IN SIGHT SAVED

The development, registration and reimbursement of anti-VEGF eye injections has saved the sight of thousands of Australians, including 50,000 currently receiving Lucentis or Eylea for nAMD, plus 11,000 more receiving these drugs for diabetic macular oedema (DMO).³

A 2020 study of patients who completed 10 years of continuous IVI treatment found the average Australian patient maintained vision that was essentially unchanged from their starting vision 10 years earlier (-0.9 logMAR letters change).⁴

The proportion of patients with vision better than 6/12 increased over the 10 years (36% at baseline, 42% at 10 years), but it was also noted that more patients had visual acuity below 6/60 after 10 years (14% versus 7% at baseline).⁴

A/Prof Alex P Hunyor MB BS (Hons), FRANZCO – retinal specialist at Sydney’s Retina Associates, MDFA Board Member and Chair of MDFA’s Medical Committee – said Australia’s standard of care results from a combination of Government-subsidised treatment, patients’ growing awareness of macular disease, and optometrists’ early referral to ophthalmologists.

He said patients with better starting vision – as well as those who are receiving injections for one eye and monitoring for progression in the other – respond particularly well to treatment.

“Catching people early gives you a very good functional outcome, as opposed to just stopping patients from losing their sight,” A/Prof Hunyor says.

“When we catch them at the 6/9, 6/12, 6/18 sort of level, we can often keep them, or get them back into, the right range [for reading and driving].”

Impressively, the study found 28% of Australian patients remained on treatment for at least a decade.⁴

That group includes Gerald Buttrose, who has received eye injections for 14 years.

His first sign of macular disease came in 2008 when he was driving with his wife Colleen, and he noticed the white lines on the road appeared wavy.

The youngest of seven siblings – four of whom developed AMD – Gerald knew to seek urgent treatment.

“Within 24 hours, I was in a doctor’s office – I made sure of that – and he gave me the first injection,” Gerald recalls.

BARRIERS OF COST

Despite the significant evidence of its effect, many patients face barriers to this sight-saving treatment.

Like Gerald, Pastor Ron Clarke OAM also depends on IVI to maintain his vision. While he’s lived most of his life with only 15-20% vision in his left eye, monthly eye injections for the past 12 years have preserved the vision in his right.

Anti-VEGF injections allow the 90-year-old to maintain a global online ministry of more than 3,000 subscribers.

“But I wouldn’t be able to do it without my sight… I’d be in big trouble,” Pastor Ron says.

“If I ceased having eye injections, I would unquestionably go blind, and I would be unable to continue my ministry work.”

Unfortunately, Pastor Ron can barely afford the cost of treatment. His annual out-of-pocket expenses total $2,000, which he can only just pay out of his pension thanks to some belt-tightening elsewhere in his budget. And that is based on the current level of Medicare and PBS subsidy of his treatment.

Threat of Taskforce Recommendations 

Alarmingly, in December 2019, the Medicare Benefits Schedule (MBS) Review Taskforce for Ophthalmology recommended a 69% cut to the patient rebate for intravitreal injections.

At the time of writing, the Federal Government had not yet responded to the Taskforce report’s 19 recommendations, some of which are supported by MDFA.

But if the Government adopts the proposal to cut the MBS rebate, Pastor Ron will be forced to stop receiving eye injections.

“Without the government subsidy, I wouldn’t be able to afford them, and in that case, I would go blind,” Pastor Ron says.

“If I lose that access to treatment, I will lose my sight. I may as well give up and move into a residential nursing home.”

Pastor Ron wouldn’t be alone.

PricewaterhouseCoopers’ (PwC) modelling commissioned by MDFA discovered that if this recommendation was implemented, out-of-pocket costs for many patients would balloon from $1,900 per year to $3,900 – double for patients with bilateral conditions.⁵ 

That financial burden would force 25% of patients to stop treatment, meaning an extra 47,000 Australians would experience severe vision loss or blindness in one or both eyes over a five-year period.⁵

“That’s the reason that it’s really tragic,” A/Prof Hunyor says.

“If you have someone who has had a good response to treatment, and either had improvement or at least maintained a good level of vision – say 6/12 – if they then drop off treatment, they’re pretty much going to go back to natural history.

“They may not do it as rapidly, and they may not be quite as bad, but the reality is that all of the benefit has been lost.

“If it’s about the economics of vision loss and of saving money from not having people going blind, then what you’ve actually done is thrown this big bucket of money at it, and then it’s essentially as if you’ve just thrown it away, because you lose the benefits.”

Passing on the Costs 

PwC analysis found that whatever savings the Government made from the rebate cut would be passed on, as costs, to other parts of the healthcare system.

The modelling predicts an additional direct cost to Government of $168 million in primary health, mental health care and early admission to residential aged care, plus a further $2.6 billion in indirect costs through loss of patient and family carer productivity.⁵

A 2020 MDFA patient survey revealed 29% of respondents receiving eye injections have considered delaying or stopping treatment due to cost, while 35% have cut down on expenses like food, medicine and even mortgage payments to afford them.⁶

BARRIERS OF ACCESS

As well as cost, access to treatment is another major obstacle.

Many IVI patients in regional Australia struggle to find an ophthalmologist where they live, or they can’t access a public hospital or bulk-billed clinic – an acute problem for people from low socioeconomic or culturally and linguistically diverse backgrounds.

Sometimes barriers are as simple as not having family or friends to drive them to their appointments.

In response, MDFA has developed three costed solutions that could be implemented immediately by leveraging existing systems and infrastructure:

• Establish new low-cost regional clinics enabling patients to access treatment without the need to travel to less affordable metropolitan clinics that are already at capacity,
• Address the maldistribution of ophthalmologists and increase the size of the workforce by using ophthalmology registrars, under supervision of experienced, qualified ophthalmologists, and
• Empower patients to become better informed about ophthalmologists’ fees and to self-advocate for reduced fees where they are unable to afford ongoing treatment.

A/Prof Hunyor says reducing the barriers is possible. “There’s work to be done in terms of trying to make things more affordable for a much larger number of people. But that won’t be achieved by reducing the patient subsidy.”

Tom Smith is the Communications Officer at Macular Disease Foundation Australia. 

References 

1. Rofagha S et al, Ophthalmology 2013;120:2292-9 
2. UK EMR Users Group, Ophthalmology 2014;121:1092 
3. DUSC (2018). Ranibizumab and Aflibercept: Analysis of Use for AMD, DMO, BRVO and CRVO 
4. Gillies et al, Am J Ophthalmol 2020;210 116-124. doi_10.1016_j.ajo.2019.10.007 
5. PwC (2019). Impact of IVI rebate changes 
6. Centre for Social Impact, UNSW (2020). Social impact study into macular disease (longitudinal study of 2169 members of the MDFA community)