Wednesday, July 17, 2024

South Africa Runs Out of Insulin Pens as Global Supply Shifts to Weight-Loss Drugs

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South Africa’s public health care system has run out of the human insulin pens that it provides to people with diabetes, as the pharmaceutical industry shifts production priorities to blockbuster weight-loss drugs that use a similar device for delivery.

Novo Nordisk, the company that has supplied South Africa with human insulin in pens for a decade, opted not to renew its contract, which expired last month. No other company has bid on the contract — to supply 14 million pens for the next three years, at about $2 per pen.

“Current manufacturing capacity limitations mean that patients in some countries, including South Africa, may have limited access to our human insulins in pens,” said Ambre James-Brown, a spokeswoman for Novo Nordisk. The company did not reply to questions about which other countries are affected.

Novo Nordisk’s drugs Ozempic and Wegovy, which are widely prescribed in the U.S. for weight loss, are sold in single-use pens produced by many of the same contracted manufacturers who make the multidose insulin pens. A month’s supply of Ozempic in the United States costs about $1,000, far more than insulin.

Novo Nordisk dominates the global market for insulin in pens and has supplied South Africa since 2014. Eli Lilly, the other major producer, has indicated in recent months that it is struggling to keep up with the significant demand for its weight-loss drug Zepbound.

“This is because of the global demand for Ozempic and these drugs,” said Khadija Jamaloodien, the director of sector-wide procurement for South Africa’s health service. “They’re shifting the focus on the more profitable line.”

Novo Nordisk is continuing to supply human insulin in vials to South Africa, where more than four million people live with diabetes, but pens are considered much easier to use and more precise.

A pen can be set with a dial to dispense a given amount of insulin, and its needle tip can be quickly jabbed into the skin. Insulin from a vial has to be drawn out into a syringe with the patient or a caregiver confirming the dose, and then injecting it.

The vial system was phased out for most South Africans in 2014. But recently, South Africa’s National Department of Health instructed clinicians that they should teach patients how to use vials and syringes of insulin instead of pens.

“Insulin vials and syringes are outdated and difficult to use,” a national association of medical specialists treating diabetes said in a public letter to the government when the switch to vials was announced. “They contribute negatively both to quality of life for people with diabetes, and poor continued medication adherence, which leads to expensive long-term diabetes complications.”

Muhammed Adnan Malek, 19, a teachers’ college student in the town of Zeeland in South Africa’s northwest, has used insulin pens from the public health system to treat his Type 1 diabetes for nine years.

“I’ve never used it in syringes, so when I heard this news, I asked an 80-year-old I know with diabetes what it’s like, and he said it’s very difficult because it’s hard to give the exact dose,” Mr. Malek said. “With insulin, if you’re a unit higher or lower it really has an effect. If you overdose, you go into hypoglycemia and it can lead to coma and death.”

Ms. Jamaloodien’s office has instructed clinicians to reserve the remaining small stock of pens for people who will struggle most with using vials and syringes — small children, the elderly and visually impaired people.

When Boitumelo Molema, 22, a college student, went to her usual clinic in the town of Mafikeng a few days ago to pick up a monthly supply of five pens, she learned they were out of stock. She visited two more clinics, neither of which had supply, before going to a private clinic and buying them for the equivalent of $10 each. She will struggle to cover that cost, she said. (Private clinics purchase small volumes through wholesalers that deal with the companies).

Ms. James-Brown, the Novo Nordisk spokeswoman, said that the company alerted South Africa last year that it would not be bidding on the next contract for human insulin in pens.

Ms. Jamaloodien of the South African health service said that the company told the government only that there would be “supply constraint” but not that it was exiting completely. That, she said, did not become clear until the contracting process ended in January. After that, her department was slow to issue a new tender to try to find another supplier, because of staffing constraints, and it has been scrambling to try to fill the gap, she said.

Novo Nordisk started making pens in 1985, and these, or pumps, are the standard of care for Type 1 diabetics in industrialized countries. They are also used by wealthy people in low-income countries.

But South Africa is a rarity among low-resource countries, the only one that has, until now, supplied insulin pens in the public health service.

Eighty percent of people with diabetes live in low- and middle-income countries.

The drugs known as GLP-1s, such as Ozempic, which are now routinely being used to treat diabetes in high-income countries, are not included in the World Health Organization’s list of essential medicines or the diabetes treatment guidelines of low- and middle-income countries.

Novo Nordisk has an insulin access policy, under which it supplies insulin for $3 a vial to low-and middle-income countries, and for $2 a vial to humanitarian groups such as Médécins Sans Frontières, or MSF. The company signed an agreement last year with the South African drugmaker Aspen Pharmacare to manufacture human insulin there, aiming to produce 60 million vials by 2026.

MSF is also hearing from clinicians in crisis zones including Gaza and Ukraine, where patients who can no longer obtain their usual pens are struggling to return to vials and syringes. In the dark without electricity it is not so difficult to measure insulin in a pen, which clicks to indicate increments it is dispensing, said Leena Menghaney, who works with MSF’s Access campaign, but it is much more challenging to confirm a dosage in a syringe.



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