2 August 2018

PBS-listing a boost for combination insulin

Diabetes PBS

A new soluble co-formulation of insulin that may reduce the risk of hypoglycaemia in some patients with type 2 diabetes has been PBS-listed.

Ryzodeg is a combination of the short-acting insulin, aspart, and the ultra-long-acting insulin, degludec.

Degludec has a flat, stable and long action profile beyond 24 hours, meaning that a single daily injection will provide a constant basal insulin coverage in adults.

The addition of 30% aspart, to the 70% degludec in Ryzodeg given at the time of the patient’s largest meal of the day, allows availability of the more rapid-acting insulin required for the mealtime coverage, while also providing the more continuous and slowly released insulin required for the remaining 24 hours.

If required, Ryzodeg can be given twice daily, at the two largest meals of the day, if more intensive glycaemic control is required.

Proponents of Ryzodeg say the main advantage that this combination has over some existing insulins is its reduced likelihood of causing hypoglycaemia.

Patients on insulin often feared a sudden crash in blood sugar levels, which might cause them to become unconscious, Professor Greg Fulcher, a diabetologist and the clinical director of chronic medicine for Northern Sydney Local Health District, said.

“Of all the different side effects that they might get, this is the one that scares them the most,” he said.

Professor Fulcher’s 2016 analysis of two RCTs comparing Ryzodeg with another commonly prescribed premixed biphasic insulin, BIAsp 30, showed that Ryzodeg was associated with a significantly lower risk of hypoglycaemia, particularly nocturnal hypoglycaemia. “So, it does have a tangible benefit for patients,” he said.

“There aren’t any obvious downsides … of this specific [combination] insulin compared to any other [combination] insulin.”

The PBS listing drops the cost of Ryzodeg from around $930 per year per patient to a maximum of $39.50 per script or $6.40 per script for concessional patients, including pensioners.

Professor Glen Maberly, a senior endocrinologist at Western Sydney Diabetes, said his patients with complicated type 2 diabetes had responded well to Ryzodeg.

“We were given the opportunity to use Ryzodeg before it came out, so I’ve used it in about 14 or so patients so far,” he said. “The old mixed insulin had problems with causing low blood sugar levels in the middle of the day and the middle of the night, and now with Ryzodeg we’re not seeing that that much.”

Professor Maberly said Ryzodeg might be appealing to patients because it could potentially reduce the number of daily injections.

It might also be helpful for patients with renal disease who were prone to hypoglycaemia, he said. While Ryzodeg had some proven benefits over other combination insulins, this was not true for all comparisons.

For instance, once-daily injections of Ryzodeg in patients with type 2 diabetes had higher rates of hypoglycaemia compared against once-daily injections of insulin glargine in two clinical trials, according to Novo Nordisk’s product information sheet.

“I’m not trying to tell you that it’s the be-and-end-all, and I’m not from the pharma company that makes it,” Professor Professor Maberly said. “I just think it’s good and it’s got a place.”