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Advocating For Increased Access to MS Treatments

June 14, 2018 | Advocacy, Research, Treatments

On Monday 28th May Multiple Sclerosis New Zealand (MSNZ) with Professor Helmut Butzkueven, of Monash University in Melbourne, met with members of PHARMAC staff to discuss our continued concerns with the very restrictive access criteria for MS disease modifying treatments (DMTs).

Following this meeting we made a further official submission to PHARMAC. This submission followed one made in 2017. PHARMAC’s response to our 2017 submission was a request in February 2018 for further evidence.

Following advice and further research evidence from Professor Butzkueven, we have chosen to concentrate on the two areas that research shows will have the most impact and benefit for people with MS (PwMS);

Stopping Criteria

  1. Expanding the stopping criteria to EDSS 6.0 or 6.5 (there is evidence to support both potential endpoints)
  2. Removing the gradient scale

Starting Criteria

  1. Removing the starting criteria of EDSS 0-4
  2. Amending to include the acceptance of relapse activity demonstrated by clinically confirmed relapse OR new MRI activity in line with modern definition of RRMS instead of the current requirement for both.

Current Criteria

Currently the primary intent of the current criteria is to restrict access to DMT to PwMS who:

  1. Have not transitioned from relapsing remitting MS (RRMS) to secondary progressive MS (SPMS). Currently there is no funded treatment for SPMS.
  2. Definitely have RRMS rather than a clinically isolated syndrome (CIS), which may not progress to RRMS (starting criteria). This avoids misdiagnosis and inappropriate treatment for PwMS who do not have MS at all, but another disease such as migraine with some white matter lesions on MRI and fleeting sensory symptoms (starting criteria).

However, both the stopping and starting criteria are not based on any evidence to support them.

 

Stopping Criteria

Evidence we presented disputes the stopping criteria in two key areas.

  1. The requirement to stop treatment following a 6-month disability progression event. New evidence shows that this is not indicative of treatment failure or SPMS, which is usually classified at EDSS 6.0 and with the absence of a relapse and further progression.
  2. Strong evidence exists to support DMTs being effective for people with RRMS beyond the current two step deterioration on the EDSS scale and up to 6.5, currently a maximum of 4.5.

Historically it was thought that once EDSS 3.0 was reached, progression was uniform. However, newer studies have shown this to be incorrect and the range of progression trajectories for individuals after EDSS 3.0 is in fact very broad particularly with continued use of high efficacy treatments. The disease course after EDSS 3.0 has little to no relationship to the disease course up to EDSS 3.0. It also cannot be assumed that EDSS progression after EDSS 3.0 is uniform or indicative of SPMS. The current requirement for 6 months to improve does not allow enough time for improvement to be truly visible and we have requested that this criterion be altered.

We also highlighted the risks that stopping treatment prematurely is highly likely to cause further and accelerated relapse-associated disability worsening for the individual. In this case, a person is denied access to DMTs when research shows continued access will improve outcomes of disease stability. Their MS is inflammatory (relapse-driven) and thus highly modifiable by DMTs.

 

Starting Criteria

MSNZ submitted further evidence to support the widening of the starting criteria for those who clearly have clinically defined and relapsing MS but do not fit the current starting criteria of having a second episode or relapse from the initial presenting symptoms.

The key areas we provided evidence for reconsideration in relation to the starting criteria are:

  1. Removal of EDSS Score 0-4
  2. Starting criteria be amended to include the acceptance of relapse activity demonstrated by clinically confirmed relapse OR new MRI activity in line with modern definition of RRMS

MSNZ has urged PHARMAC to remove EDSS 0-4 from the criteria as people with RRMS who would benefit, are being denied treatment. According to the PHARMAC criteria, a patient with severe early RRMS, which, following a single relapse, could elevate their EDSS to a point which would not qualify for treatment. This is the type of patient who would benefit most from early treatment.

There is strong evidence, which MSNZ supports, that a person should not begin treatment until confirmation of MS has been confirmed, and not CIS. The criteria in NZ are designed to eliminate the risk of people being prescribed DMTs when they do not in fact have MS. However, the PHARMAC criteria are not in line with the international consensus for the diagnosis of MS as defined in the 2010 and newly revised 2017 MacDonald Criteria. These accept a relapse/second episode OR new MRI activity as the diagnosis of MS. In NZ the requirement is for both.

MSNZ is aware that there are significant issues nationwide with access to MRIs. While the delays in MRI access are not the responsibility of PHARMAC, the criteria impose serious disadvantages for PwMS who may have to wait up to six months for a second MRI. MSNZ will also be advocating to the Ministry of Health, Government and DHBs to address this issue as a priority.

Evidence from the NZ MS Incidence Study, funded by MSNZ, showed that there is a significant delay of 4.4 years between the onset of first symptoms and diagnosis. This demonstrates that people in New Zealand are missing the opportunity to be treated when it is shown to matter. The earlier that treatment is initiated the higher the likelihood of treatment success.

 

Closing Remarks

MSNZ hopes that PHARMAC will look favourably on our submission and that we can work together to make positive changes to benefit the lives of people with MS in New Zealand. We expect to hear the outcomes of both meetings later in 2018 when we will provide an update of the outcomes.

 

Further Reading

A full copy of our submission can be downloaded here:

Submission to PHARMAC from Multiple Sclerosis New Zealand regarding changes to the DMT access criteria June 2018