MS patients suffer side-effects after NHS England switches to cheaper drug | Multiple sclerosis

Scores of people with multiple sclerosis (MS) have suffered debilitating side-effects after being put on to a cheaper new drug as part of an NHS drive to save money.

About 170 MS patients at Charing Cross hospital in London have had complications, including a relapse of their illness, after being switched from Tysabri to a different drug called Tyruko, made by the pharmaceutical company Sandoz.

In a handful of cases, the people affected developed such serious symptoms that they had to be taken to hospital for treatment. Patients have told doctors about side-effects including an inability to use their legs, other mobility problems, fatigue, pain and sudden weight gain.

It is unclear how widespread the adverse reactions to Tyruko are. NHS England said the problem has only been seen at the London hospital. However, one of the patients there claimed to know of people with MS being treated at 15 other hospitals in England who have experienced similar setbacks to their health after being moved on to Tyruko after sometimes years taking Tysabri.

Problems have arisen since NHS England began moving patients across the country with very active relapsing remitting MS from Tysabri on to Tyruko, a “biosimilar” drug, last April. A biosimilar is a version of a drug that has fallen out of patent, allowing other pharmaceutical firms to legally make a medicine that is as safe and effective as the original but on average 72% cheaper.

NHS England hopes to save £1bn over the next five years by expanding its use of off-patent drugs for a range of conditions, including MS. It spends £17bn a year on medicines.

The side-effects from Tyruko are causing so much concern within the health service that NHS England is in discussion with the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) about what to do.

The outcome will be eagerly awaited by MS patients and charities as well as specialists in the disease. Around half of the NHS’s network of hospitals which treat those with MS are already taking part in NHS England’s rollout of switching those on Tysabri on to Tyruko instead.

A spokesperson for Sandoz said: “Patient safety is our first priority. We are seeking to understand the situation at Imperial healthcare NHS trust, which appears to contrast with the experience of patients at other UK hospitals. We believe it’s premature to draw conclusions at this point. We continue to work with the NHS and regulatory authorities to resolve this.”

They added that “Tysabri and Tyruko are considered interchangeable by the MHRA, which has determined that there are no meaningful differences between the two versions”.

Before the switchover began, Imperial College healthcare NHS trust, which runs Charing Cross, had 345 patients on Tysabri – the largest number in the UK. It began giving them Tyruko instead last May. Doctors there expected to see some mild, short-term side-effects as a result of the switchover, as had happened with the introduction of previous biosimilars.

But around half their patients reported “continuing and significant side-effects that worsened over some months, which was not expected”. They have now all been switched back on to Tysabri.

In a letter it sent to MS patients in December, Imperial said: “Clinicians did expect some patients to report side-effects but only relatively mild ones that resolved after a short period.

“However, a number of our patients reported a continuing worsening of their side-effects and/or their MS symptoms following their switch to Tyruko.” All had their treatment reviewed by a doctor or MS clinical nurse specialist.

Drugs expert Dr Andrew Hill, a research fellow in the pharmacology department at Liverpool university, said: “There should be an investigation into why these side-effects are seen, and whether they resolve for people who switch back to the branded formulation.”

Any inquiry should look at whether adverse reactions to Tyruko had been seen in other countries, he added.

An NHS spokesperson said: “We understand that reports of significant side-effects have been focused on patient experience at one trust.

“We are currently in discussions with the MHRA and the Department of Health and Social Care to determine what, if any, steps could be taken by MS centres across the country following the reported experiences of patients under the care of Imperial healthcare NHS trust.”

MS groups said they were aware of the adverse reactions but suggested that only small numbers of patients are affected.

“We are aware of a handful of people who have experienced significant symptoms following the switch,” the Multiple Sclerosis Trust said. But the fact that the patients involved have highly active MS “means their MS may be more difficult to manage, and new symptoms may be a common element of their diagnosis”.

Laura Thomas, head of policy at the MS Society, said: “Some people have told our MS helpline they’ve started experiencing side-effects since switching from Tysabri to Tyruko, and some have told us they’re unsure if Tyruko is as effective. However, there are many others who haven’t reported any issues at all.”