By Judy McKeown, RN (MS Resource Nurse)
PHARMAC’s announcement that it will fund two new treatments for Multiple Sclerosis has been described as “a momentous day for thousands of people” living with the condition by MSNZ Vice President Neil Woodhams.
After years of funding submissions, culminating in a campaign this year led by MSNZ, PHARMAC has approved funding for two new treatments and increased access to those currently funded for New Zealanders diagnosed with relapsing remitting forms of Multiple Sclerosis.
PHARMAC is the New Zealand Crown entity that decides which medicines and pharmaceutical products are subsidised for use in the community and public hospitals.
“This is a big step forward for people with Multiple Sclerosis in New Zealand,” said Mr Woodhams.
“It means that many of those living with MS will no longer be subjected to a level of disability before their treatment is approved… The majority of these people are young women, many of whom are mothers. Earlier access to treatments has shown to greatly reduce relapse rates and halt disease progression”.
Biogen Idec’s Natalizumab (trading as Tysabri) and Novartis Fingolimod (Gilenya) will be funded from 1 November 2014. PHARMAC has also approved increased access to currently funded treatments in today’s announcement. People will be able to switch between drugs if one or other drug doesn’t suit them.
By also allowing general physicians to apply for MS treatments, PHARMAC have taken a more person-centred approach making treatments more accessible and not restricted, Mr Woodhams said.
It is essential, however, that people considering these drugs have accurate information about them and understand that extensive screening needs to take place before commencing treatment.
It is important to note that disease modifying drugs do not cure MS but are designed to modify the course of the disease.
They interact with different parts of the immune system and help to calm down the inflammation that causes relapses, affecting both the rate and the severity of the relapse.
Currently, there are three drugs that are funded for use by PHARMAC in NZ. Some have shown positive results in slowing the disability progression and lengthening the time before secondary progressive MS develops. The remainder of the article will explore in detail the two new drugs Fingolimod (trading as Gilenya) and Natalizumab (trading as Tysabri).
People who wish to switch from injectable treatments to the new treatments must be assessed under the new criteria set out by PHARMAC as being 4 or less on the Expanded Disability Status Scale (EDSS) by a Neurologist. People who are on injectable treatments before November 1, 2014 and do not require switching treatments will continue to be assessed at 5-5.5 on the EDSS.
As is the case with all medications, it is important to weigh the risks and benefits carefully. Talk to your Neurologist/Doctor to determine if either of these treatments is right for you.
How does it work?
A specialised type of immune cell, called a T-cell, is thought to be responsible for much of the damage caused in Relapsing Remitting MS. Gilenya, which is an oral tablet, acts by trapping these T-cells from the bloodstream into organs in the body called lymph nodes. This prevents the T-cells from getting into the brain and causing damage to the protective myelin sheath, which causes the symptoms in MS.
How effective is it?
A two-year study comparing Gilenya to a placebo showed that it reduced relapse rates by 54 to 60 per cent, and reduced disability progression.
What are the side effects?
Gilenya is generally well-tolerated, although some people may experience side effects, some of them potentially quite serious.
Common side effects of Gilenya include headache, diarrhoea, back pain, cough and dizziness. These milder side effects affect around one in ten people taking Gilenya.
When you first take Gilenya it can cause your heart rate to slow down or become irregular. This may make you feel dizzy or tired.
Because of the risk of cardiac toxicity, international requirements are that the administration of the first dose of this drug requires careful in-hospital cardiac monitoring for six hours.
Because this drug is in tablet form the drug can be administered by you at home once it is safe to do so.
Gilenya lowers the numbers of white blood cells in your blood. As white blood cells fight infection, you may find that you pick up illnesses and infections more easily while taking Gilenya.
Very rarely, Gilenya can cause a problem with your vision, known as macular oedema. People taking this medication will routinely require a number of other screening tests, including a specialised eye test known as Ocular Coherence Tomography or OCT.
It is too soon to know about other possible long-term side effects from Gilenya, but people taking the drug are being monitored, which should give a better picture for the future.
How does it work?
Tysabri is administered by IV infusion four weekly in either a hospital or a specially designated clinic in outlying areas of NZ where medical staff are specifically educated to administer and monitor people on this medication.
A monoclonal antibody that works in a different way to injectable therapies, Tysabri is an ‘antibody’, just like those found naturally in the immune system (where antibodies help fight infection). By attaching itself to receptors on the outside of certain immune cells, Tysabri prevents these cells from leaving the blood stream and entering the brain and spinal cord where, in MS, they can cause inflammation and damage.
How effective is it?
According to Michael J Olek, Associate Professor of Neurology Loma Linda University Medical Centre, Tysabri is twice as effective as Copaxone, Avonex and Betaferon in reducing relapses – a 68% reduction over two years, as opposed to one-third reduction. Some experts believe that Tysabri is more effective than any other available MS disease modifying treatment and therefore routinely use it early in the course of RRMS, rather than reserving only it for people who have a high level of early disease activity or for those who are unresponsive to other agents.
What are the side effects?
Most people taking Tysabri tolerate it well, but there can be side effects, including a very rare but potentially fatal infection called PML (progressive multifocal leukoencephalopathy) which is caused by a viral infection in the brain. PML can cause severe neurological symptoms, which may at first be mistaken for MS relapses. Meticulous monitoring for this rare infection will limit the incidents of it occurring.
Monitoring also includes specialised blood tests and regular MRI scans. All nurses will be trained in administration of the drug and infusions occur under the supervision of a Neurologist or in regional centres by General Physicians.
Common side effects include joint pain, fever, fatigue, a runny or blocked nose, sore throat, feeling or being sick, headache or dizziness.
During the infusion of Tysabri, and up to an hour afterwards, some people shiver, or feel sick or dizzy.
Around one in 25 people who take Tysabri may have an allergic reaction to taking it, either during the infusion or in the hour following. In addition, some people might have skin reactions to the infusion.
People on Tysabri may be more susceptible to infections, and should take measures to avoid them, including applying good hand washing habits and avoiding people who are sick, when possible.