Updated 3.35pm with Commissioner for Health endorsement
Patients who need ADHD medication that is not offered through the government formulary, and suffer mental health repercussions could soon have an alternative.
The plan is to introduce an expert board that will review such requests on a case-by-case basis.
Health Minister Jo Etienne Abela said he would like the board of experts within the psychiatry and psychology fields to assess potential outliers, study the response to the various drugs and then make a recommendation.
The government would then reimburse a set fixed price agreed between the pharma industry and the Medicines Authority, he said.
Last month, Times of Malta reported how a mother with ADHD has no option but to give her own branded medication to her teenage son, who has the same condition but no free access to the drug.
A psychiatrist recommended both Rachel Spiteri and her 18-year-old son to take Concerta, a branded version of methylphenidate, to treat the neurodevelopmental disorder.
It will work well in most, not at all in some, and way too much in a few. Full responders to generics or originators are not at issue- Health Minister Jo Etienne Abela
But whereas Spiteri gets the branded drug free through the Pharmacy of Your Choice (POYC) scheme, the cost of her son’s medication is at least €130 a month.
She spoke out in the hope the government resolves the issue that has been going on for four years despite the Ombudsman finding in her favour and the recommendations of a UK specialist.
Tackling the outliers
Replying to a parliamentary question, Abela announced the setting up of the board in reply to a question by Nationalist MP Charles Azzopardi.
When contacted, Abela said every medication has a bell-curve response in the population.
“It will work well in most, not at all in some, and way too much in a few. Full responders to generics or originators are not at issue. The outliers, however, pose a problem because treatment has to be fine-tuned and treatment can be both costly and logistically problematic due to economy of scale.”
Initiative welcomed
The plan was welcomed by Commissioner for Health Ray Galea. Galea, whose office forms part of the Office of the Ombudsman, noted that he had called for a similar structure in a final opinion of an investigation into a complaint back in May 2023
Pamela Muscat, president of ADHD Malta, welcomed the initiative and hopes it will take immediate effect, and that pro-active action and patient representatives will be part of it, not just professionals.
She added that patient representatives should be consulted on such delicate matters and kept informed about out-of-stock and replacement medication.
The ADHD issue dates back to 2018 when the tender for the branded drug Concerta expired, and since then, Xenidate and other generic versions, which are a lower cost to the health service, have been offered instead.
According to policy, only those who were on Concerta before the tender expired are entitled to get it for free under POYC.
Some ADHD sufferers reported their condition had regressed. Psychiatrists warned that changes in medication provided by the government were having a detrimental effect on children and adults.
Side effects having an impact
The side effects were having an impact on sleeping patterns, appetite, aggression and anxiety, among others.
That was when the government commissioned a UK expert to look into the matter and decided that previous Concerta patients would be given the medicine. The expert doctor Ramzi Nasir, a consultant paediatrician at the Royal Free London NHS Foundation Trust, concluded that, while not all patients warranted a return to Concerta, this should be a clinical decision made jointly by the clinical physician and the patient.
ADHD is the most diagnosed mental disorder in children and is characterised by, among other things, difficulty in sustaining attention and emotion regulation, excessive activity and difficulty in controlling behaviour.
Concerta, Xenidate and the generics that followed are long-acting drugs that essentially do the same thing. They contain the stimulant methylphenidate which works by releasing neurotransmitters (chemical messengers) called norepinephrine and dopamine into the brain. Increasing these neurotransmitter levels helps to stimulate the brain, which can improve the symptoms of ADHD.
Generics are clinically less effective than branded medicines and are effective for a shorter time.