Hundreds with multiple sclerosis ‘abandoned’ due to Pharmac drug access criteria

There’s concern that a Pharmac decision to fund the drug Ocrelizumab (Ocrevus) for certain patients with multiple sclerosis from December 1st will still see hundreds missing out due to the national drug-buying agency’s ‘inhumanely strict’ treatment access criteria.

“While Multiple Sclerosis New Zealand (MSNZ) absolutely welcomes the news that Pharmac will now fund Ocrelizumab for a sub-group of patients with the most common form of the disease, Relapsing Remitting Multiple Sclerosis (RRMS), we remain disappointed that Pharmac’s out-dated access criteria will deny around 600 further New Zealanders suffering from this and other forms of the disease the chance to improve their lives and limit the impact of their condition” says MSNZ National Manager Amanda Rose.

Around 4000 New Zealanders currently live with Multiple Sclerosis or MS. Over half (around 2000) suffer from RRMS which sees symptoms and “attacks” come and go, with disability increasing over time. Around 15% (around 600 patients) are diagnosed with another form of the disease, Primary Progressive MS (PPMS), in which the symptoms are constant, with continual decline.

Pharmac has decided to only fund Ocrelizumab for RRMS patients who, as part of the MS Special Authority Criteria, must have an annually-tested disability score of 4 or less out of 10 on the Expanded Disability Status Scale (EDSS), proving they are able to walk 500m continuously and unaided. The current criteria leaves several groups of patients out in the cold and denied access; including those with RRMS whose disability score is greater than 4 or who have progressed by two points from their initial starting point for a period of 6 months or more, as well as the 600-odd patients with PPMS. Ocrelizumab is fully funded for a much wider and more disease-advanced group of RRMS patients in Australia, the UK, Europe and the USA, while the drug is readily available to patients with PPMS in both the USA and UK. Ocrelizumab is the ONLY disease-modifying treatment shown in clinical trials to halt disease progression in people with PPMS and has been approved for use by Medsafe, the FDA, NICE and the European Commission.

MSNZ has been lobbying Pharmac for some time to widen its Special Authority Criteria for New Zealanders and has also requested the agency provide evidence to support its current limited access rules.

“Pharmac’s access criteria for all MS treatments is not evidence-based” says Amanda Rose. “Several leading international experts have expressed astonishment at the strict criteria MS patients here in NZ are subjected to. Clinical evidence clearly demonstrates that for all forms of MS patients benefit from earlier drug access for a longer, more sustained period of time”. MSNZ says around 20 New Zealanders with PPMS have until now managed to get private access to Ocrelizumab through Roche’s Compassionate Programme. Some report having zero or limited regression of their condition or any new lesions since starting treatment.

“For people with Progressive MS, being able to halt the condition in its tracks is monumental” says Rose. “These people are continuing to remain active, contributing to the economy, their families and their communities”.

MSNZ President Malcolm Rickerby says Pharmac’s decision to fund Ocrelizumab came after more than two years of MSNZ lobbying.

“MSNZ has been strongly advocating for Ocrelizumab to be funded since May 2017” says Rickerby. “We stepped up this pressure after receiving a positive indication for funding from Pharmac’s own Pharmaceutical Technical Advisory Committee (PTAC) in November 2018, demanding action and an explanation as to why the process was taking so long. While we very much welcome Pharmac’s eventual decision, it’s possible that without this sustained pressure, people with MS would still be waiting.”

MSNZ acknowledges that Pharmac’s PTAC committee will be reviewing the access criteria for all MS treatments at its November meeting this year. It says it welcomes this review and hope it results in more patients being given access to treatments earlier and staying on them longer.

Motueka grandmother Lesley Jackson was diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS) seven years ago, aged 52. The businesswoman was, at the time, running her own vineyard.

“I struggled for the first two years, suffered some nasty falls and gradually started to get worse” says Lesley. “Suddenly your business is gone, your income is gone. From being an independent earner I’m now financially reliant on my husband”.

At initial diagnosis Lesley was assessed as being 2 points on the internationally recognised Expanded Disability Status Scale (EDSS), which Pharmac uses to determine access to treatment. She therefore qualified for drug treatment under Pharmac’s MS Special Authority Criteria. She’s been on five different drugs for her MS over the ensuing years. “You hold onto hope they’re working for you but then have to face the truth that your MS is getting worse and they aren’t helping any more” she says. “Suddenly, easy tasks become tough and pain and fatigue grips you”.

A GP visit three years ago to get another supply of the last drug she was prescribed, delivered the worst news yet. “My MS nurse said they could no longer give it to me because my RRMS had now deteriorated to Secondary Progressive MS. She told me that this meant I was no longer eligible for any MS drugs as none would help me. When I asked if I might be a candidate for the up and coming release of Ocrelizumab she told me I’d be ruled out, not just for having Secondary Progressive MS, but for also being over 55”.

While pleased for the cohort of MS patients who will now get Pharmac-funded access to Ocrelizumab, Lesley is devastated not just for herself, but for the hundreds of other patients denied free access under Pharmac’s strict MS Special Authority Criteria scheme.

“Pharmac’s out-dated rules mean hundreds like me, many much younger, are being denied a life – a life from a drug being offered to thousands of patients like us with MS in nearly all other OECD countries”.

At $24,085 per year, Lesley says Ocrelizumab is just too expensive for most. “We can’t afford it and I feel like I’ve just been thrown on the scrapheap” she says. “I do understand Pharmac can’t fund every single drug out there. However, Ocrelizumab has been well-proven in major international trials to hold back MS progression”.

Lesley, who now relies on a mobility aid to get around the house, also takes issue with what she calls the “Pharmac walk of shame” – the 500 metre unaided walking test all MS patients are forced to pass at regular intervals to continue getting drug treatment. She says anxiety is a known trigger for MS “flares” and the ordeal sets many up to fail. “I vomited the last time I lined up for the walk and was unable to even start it” says Lesley. “I’ve seen grown men cry having to face it. Nowhere else in the OECD is anyone made to sit this test - it’s inhumane”.