Posted 26 March 2018
Boehringer Ingelheim boss Wes Cooke has heaped praise on Health Minister Greg Hunt in announcing the PBS listing of his company's combination diabetes treatment Glyxambi, which brings together empagliflozin and linagliptin, on April 1.
But Glyxambi will be battling for market share with AZ's similar treatment, Qtern, which combines dapagliflozin and saxagliptin.
Glyxambi - developed by BI and Eli Lilly - and Qtern are the first GLT2 inhibitor/DPP-4 inhibitor combinations to be PBS listed. Both were recommended at last November's PBAC meeting.
Cook commended the Turnbull government for expanding access to anti-diabetic medication and continuing its support of Australians with type 2 diabetes.
"The PBS changes announced by Health Minister Hunt are a clear indication of the government's willingness to up the ante in the fight against diabetes," he said.
"We are pleased to play our part in supporting government efforts aimed at helping Australians living with type 2 diabetes."
Together the two products that make up Glyxambi, Jardiance and Trajenta, earned $33.6 million in pre-rebate R/PBS benefits in the 12 months to January this year.
The constituent products of Qtern, Forxiga and Onglyza, had combined PBS income of $25 million. Qtern was recommended on a cost-minimisation basis against its constituents in single active form.
In another diabetes win for AZ, Forxiga and Xigduo XR, which combines dapagliflozin and metformin, will be extended to use in triple oral therapy from April 1.
The company said the extension would potentially benefit 120,000 patients.
"I was pleased to hear that combined oral agents of gliptins and SGLT2 inhibitors may soon be accessible under the PBS as triple oral therapy in type 2 diabetes. Such a combination of agents is complementary with demonstrated efficacy and is generally well tolerated. I expect that this new PBS option will help many doctors to support their patients to achieve and maintain blood glucose targets in a durable manner, which can help to prevent diabetic complications," said Professor Stephen Twigg, Endocrinologist, Royal Prince Alfred Hospital and University of Sydney.
In recommending the listing of Glyxambi, the PBAC said it "noted that although the data presented in the submission indicated the empagliflozin with linagliptin was non-inferior to insulin glargine and exenatide, and dapagliflozin with saxagliptin, all in combination with metformin, the incremental benefit of adding a third agent was smaller in magnitude than the benefit observed when adding either agent in the dual therapy setting".
"However, the PBAC considered that the price proposed by the sponsor accounted for this reduction of benefit in triple oral therapy, and any remaining uncertainty," it concluded.
Also included among the additions to diabetes options was Sanofi's Toujeo, which Hunt's office described as "a longer lasting, higher strength insulin [that] provides more options for patients to better manage their treatment through the day and night, reducing night time hypoglycaemia".
"This new treatment option will be available to over 178,000 Australians each year. Without subsidised access, patients would pay around $1,820 each year," it added, while endocrinologist and diabetes specialist Dr Sultan Linjawi said: "Any alternative therapy which offers a lower risk of hypoglycaemia compared to existing options is an important addition for clinicians when considering the appropriate diabetes management for their patients".
Changes were also made to the listings of Jardiance, Jardiamet, Trajentamet, Galvus and Galvumet.
In addition to the diabetes listings, from April 1, acromegaly and carcinoid syndrome patients will have access to Ipsen's Somatuline Autogel through the PBS under a Section 100 (Highly Specialised Drugs Program - Community Access) listing.
"As a result of this change to the PBS listing supply arrangements for Somatuline Autogel, patients will now have greater flexibility and convenience on where they can access their medication, allowing community pharmacists to dispense the treatment for those with an appropriate prescription," Ipsen said.
Other April 1 additions to the PBS include cancer drugs Folotyn, Tecentriq and Odomzo while Ozdurex will be subsidised for non-infectious uveitis.
Nick Lush