KUALA LUMPUR, August 22 — The Ministry of Health’s (MOH) Pharmacy Services Programme (PSP) held a virtual emergency meeting last night with hospital and district health office heads nationwide, among other staff, to discuss the country’s insulin shortage crisis.
CodeBlue understands that nearly 500 participants attended yesterday’s online meeting by the national MOH division that began at around 8pm.
Health director-general Dr Muhammad Radzi Abu Hassan also issued a circular yesterday to all state health directors, as well as the directors of Kuala Lumpur Hospital and National Cancer Institute, to triage diabetes patients and determine patient groups who would be switched from human insulin treatment to far more expensive diabetes drugs, SGLT2 inhibitors and insulin analogs.
“As you are well aware, there is a disruption to the country’s supply of human insulin, due to manufacturing capacity problems with the local insulin manufacturer, as well as supply disruptions for that product at the global level,” Dr Radzi wrote in his circular, as sighted by CodeBlue.
“Various strategies have been implemented at the Ministry level to manage the supply issue from the aspect of management of the contracted supply, including approving the supply of alternative products as well as identifying a new manufacturer as an alternative source of human insulin supply to accommodate domestic needs.”
Dr Radzi’s remarks indicate the unprecedented scale of Malaysia’s current human insulin shortage, to the extent that costlier alternative diabetes treatments and insulin suppliers have to be sourced. The 2020 reported shortage was short term, lasting only a couple of months, and affected just penfill insulin.
PSP’s emergency meeting and the Health DG’s communication occurred yesterday in less than 12 hours after CodeBlue reported on the severe nationwide shortage of human insulin, even though the problem has persisted for months.
Back in February, MOH Putrajaya had already forecast a 21 per cent shortfall in human insulin supply for the year.
Following CodeBlue’s story, complaints have emerged online about some health care facilities, including public health clinics, having already completely run out of insulin, with all their diabetes patients switched back to oral medications that doctors and pharmacists believe are less effective and may affect patient outcomes.
Insulin is a crucial treatment for 3.6 million people living with diabetes in Malaysia with a high 15.6 per cent diabetes prevalence among adults.
CodeBlue reported that the MOH’s human insulin supply is predominantly procured at 80 per cent from Indian biosimilars company Biocon Biologics that operates an insulin manufacturing facility in Johor (the only local manufacturer), whereas the ministry’s remaining supply is obtained from Danish pharmaceutical giant Novo Nordisk.
It is unclear if there really are “global” shortages of insulin as the Health DG claims; there are no news reports on worldwide supply disruptions of the lifesaving diabetes medication, except for an insulin shortage in the United States reported last May and South Africa having run out of human insulin pens supplied by Denmark’s Novo Nordisk, reported last June.
Al Jazeera reported that pharmaceutical multinational companies, including Novo Nordisk, were slashing insulin production in the US in favour of more lucrative weight-loss drugs. The New York Times similarly reported that the pharmaceutical industry was shifting production priorities to blockbuster weight-loss drugs that use a similar device for delivery to insulin pens.
Dr Radzi’s circular did not specify if Novo Nordisk had opted not to renew or bid for a new contract to continue supplying insulin to Malaysia, which would leave India’s Biocon Biologics the sole human insulin supplier for the MOH.
Patient Groups Listed For Insulin Initiation, Switch From Human Insulin Treatment To SGLT2 Inhibitors Or Insulin Analogs
Dr Radzi’s circular listed priority groups for insulin naive patients (those who have not started insulin) to begin insulin treatment:
- Type 1 diabetes patients
- Pregnant women
- Patients with serious kidney failure
Diabetes patients with one daily basal insulin injection, who have an HbA1c reading of less than 8.5 per cent, will be converted from human insulin treatment to SGLT2 inhibitors (Paragraph 3.2).
Additional SGLT2 inhibitors will be given to diabetes patients with high human insulin dosage (more than one unit per kg daily) to reduce (de-intensify) human insulin usage, with the condition that their HbA1c reading is less than 10 per cent, besides having the risk of a cardiovascular event, chronic kidney disease, heart failure, and/or kidney failure.
The following patient groups will be prioritised for conversion from human insulin treatment to insulin analogs (Paragraph 3.4):
- Elderly patients (aged 70 years and above; HbA1c reading of more than 8.5 per cent; and/or comorbidities like hypertension, ischaemic heart disease, hypercholesterolemia; and/or risk of heart complications, and/or kidney complications
- Patients at high risk of hypoglycaemia (low blood sugar)
- Type 1 diabetes patients
- Pregnant women
- Patients with serious kidney failure
“Patients’ current oral therapies must be optimised and referred to specialist doctors first before changing their treatment regimen, including starting insulin treatment (insulin initiation) or changing insulin dosage (insulin intensification or de-intensification),” said Dr Radzi.
“However, these criteria will not replace clinical considerations in treating each individual patient. Therefore, treatment must be tailored according to each patient’s circumstance. Patients must also be advised to adhere to treatment and clinic appointments, including lifestyle changes and periodic blood sugar level checks.”
The Health DG estimated that out of all diabetes patients who are currently treated with human insulin:
- 55 per cent can remain on human insulin treatment, taking into account the contracted supplier’s current supply capacity.
- 18 per cent who fulfil the criteria in Paragraph 3.2 can be considered for a change from oral medication to SGLT2 inhibitors.
- 27 per cent who fulfil the criteria in Paragraph 3.4 can be considered for a change to insulin analog treatment.
“Procurement of SGLT2 inhibitors and insulin analogs must be implemented under the Ministry’s current operational expenditure allocation,” Dr Radzi said in his circular.
As such, the number of patients on human insulin treatment who are identified for eligible conversion to SGLT2 inhibitors and insulin analogs, as well as projected cost implications, must be done at the Responsibility Centre, or Pusat Tanggungjawab (PTJ) level.
The Health DG also instructed a review of the need for the procurement of human insulin under current contracts. Government orders (LPO) that have been issued will be cancelled if the supplier did not acknowledge the LPO by August 21 (yesterday).
Procurement of SGLT2 inhibitors and insulin analogs will be implemented using remaining allocations at the PTJ level.
Applications to coordinate remaining allocations at the PTJ level can be presented for approval from the MOH’s finance division if necessary.
SGLT2 inhibitors and insulin analogs are significantly more expensive than human insulin. CodeBlue reported last December that the Ministry of Finance (MOF) rejected the MOH’s proposal to procure more SGLT2 inhibitors, estimated to cost RM800 million to treat 500,000 people over five years.
The MOH had calculated that SGLT2 inhibitors would actually save the government nearly RM100 million, as the cost of complications would run up to over RM900 million in that period from hospitalisation, heart disease, and dialysis.
Diabetes patients who start with SGLT2 inhibitors will eventually need less insulin; the relatively new class of drugs improves glycaemic control by causing the kidneys to remove sugar from the body through urine. SGLT2 inhibitors are also used in people with chronic kidney disease (CKD) and heart failure to lower the risk of heart attack, stroke, and heart failure flare-ups; some of these inhibitors also aid in slowing the progression of kidney disease.
