March 2021 new listing wrap-up

Dulaglutide 1.5 mg/0.5 mL solution once-weekly injection (TRULICITY) for the treatment of type 2 diabetes is now listed on the PBS General Schedule (Section 85) as Authority Required (Streamlined) with the addition of new clinical criteria:^1,2

• treatment must be in combination with insulin
  and
• treatment must be in combination with metformin unless contraindicated or not tolerated
  and
• patient must have, or have had, an HbA_1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase-4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated
  or
• patient must have, or have had, where HbA_1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.

What is it?

Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist.^3,4

In the presence of elevated glucose concentrations, dulaglutide increases insulin secretion and suppresses glucagon secretion. Dulaglutide also delays gastric emptying, slows glucose absorption and decreases appetite.^3,4

Peak plasma concentrations are reached in 48 hours and the half-life is 4.7 days. This makes dulaglutide suitable for once-weekly injections. Dulaglutide 1.5 mg/0.5 mL solution is given by subcutaneous (SC) injection via a single dose prefilled pen.³

Who is it for?

Dulaglutide is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.⁵

For patients with type 2 diabetes and established cardiovascular disease, dulaglutide reduces the risk of myocardial infarction, stroke and cardiovascular death.⁶

At the November 2019 PBAC meeting, the PBAC noted the potential health benefits associated with the simplified dosing regimen of once-weekly dulaglutide. This was based on improved adherence for some patients with high clinical needs, such as the elderly, indigenous people and people with mental health disorders, compared to twice-daily injection of exenatide 10 micrograms, a GLP-1 receptor agonist that is PBS-listed for type 2 diabetes in combination with insulin and metformin. The PBAC also noted that dulaglutide can be used by patients with severe renal impairment, which may make it a more appropriate choice for some high clinical need populations.⁷

PBAC deferred making a recommendation⁷ until its July 2020 PBAC meeting, when it recommended to extend the listing of dulaglutide based on cost-effectiveness if it were cost-minimised against twice-daily exenatide.⁸

Safety issues

Dulaglutide should not be used by patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.³

Gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea, are typically mild to moderate, occurring during the first 2 weeks of treatment and rapidly declining over the next 4 weeks.³

See the Duglaglutide product information for complete details

For information about reporting adverse reactions see the TGA website.

What else should health professionals know?

The effectiveness and safety of dulaglutide is not inferior compared to exenatide. It is anticipated that some patients currently receiving exenatide twice daily will make the switch to dulaglutide because of the less frequent injections.⁸

The dose of dulaglutide can be administered at any time of the day, with or without meals, and can be injected subcutaneously in the abdomen, thigh or upper arm. It is recommended that the injection occurs on the same day each week if possible.³

Indacaterol + mometasone (Atectura Breezhaler) fixed-dose combination (FDC) is now listed on the PBS General Schedule (Section 85) Authority Required (Streamlined) for the maintenance treatment of asthma.^2,9

There are three dosages for this new medicine:²

• 12269R indacaterol 125 micrograms + mometasone 62.5 micrograms
• 12289T indacaterol 125 micrograms + mometasone 127.5 micrograms
• 12279G indacaterol 125 micrograms + mometasone 260 micrograms

The submission to the PBAC for PBS listing of indacaterol + mometasone FDC was made under the TGA/PBAC Parallel Process. In July 2020 the medicine was both approved for registration by the TGA and recommended by the PBAC for PBS listing.^2,10 

What is it?

Indacaterol + mometasone is a once-daily FDC powder for inhalation in a hard capsule for the treatment of asthma. Indacaterol is a long-acting beta₂ agonist (LABA) that, when inhaled, acts locally in the lungs as a bronchodilator. Mometasone is an inhaled corticosteroid (ICS) with high affinity for glucocorticoid receptors that reduces pulmonary inflammation.¹¹

Who is it for?

Indacaterol + mometasone is indicated as a once-daily maintenance treatment of asthma for adults and adolescents aged 12 years and older.^2,10,11

The PBS restrictions require that:²

• patients must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids
• patients must not be on a concomitant single agent LABA including olodaterol, indacaterol, salmeterol, formoterol or vilanterol
• adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before ‘stepping up’ a patient's medication regimen.

Indacaterol + mometasone is indicated in the product information (PI) for patients whose symptoms are not adequately controlled with an ICS and ‘as needed’ inhaled short-acting beta₂ agonist (SABA) or low dose ICS and LABA, and ‘as needed’ inhaled SABA.¹¹

This medicine is not indicated for the initiation of treatment for asthma, nor for treatment of chronic obstructive pulmonary disease (COPD).¹¹

The dosage recommendations in the PI are indacaterol 125 micrograms + mometasone 62.5 micrograms for patients who require a combination of LABA and low dose ICS, and indacaterol 125 micrograms + mometasone 127.5 micrograms or indacaterol 125 micrograms + mometasone 260 micrograms for patients who require a combination of LABA and medium or high dose ICS.¹¹ These recommendations are consistent with the Australian Asthma Handbook.¹²

The maximum recommended dose is 125 micrograms + mometasone 260 micrograms once daily.¹¹

Safety issues

The most common adverse effects (AEs) of indacaterol + mometasone are headache and musculoskeletal pain. Other common AEs include hypersensitivity reactions, oropharyngeal pain and dysphonia.¹¹

The safety and efficacy of indacaterol + mometasone for paediatric patients less than 12 years of age have not yet been established.¹¹

See indacaterol + mometasone (Atectura Breezhaler) approved PI for complete details.

As a medicine that was recently approved by the TGA, indacaterol + mometasone has been included in the Black Triangle Scheme^a for 5 years from the date the medicine was first supplied in Australia.¹⁰

For information about reporting adverse reactions see the TGA website.

a. The Black Triangle Scheme provides a simple means for practitioners and patients to identify certain types of new prescription medicines, including those being used in new ways and to encourage the reporting of adverse events associated with their use. The Black Triangle does not denote that there are known safety problems, just that the TGA is encouraging adverse event reporting to help us build up the full picture of a medicine's safety profile.

What else should health professionals know?

Guidance on indacaterol + mometasone includes:¹¹

• it should not be used to treat acute asthma symptoms including acute episodes of bronchospasm, for which a SABA is required
• indacaterol + mometasone hard capsules are for inhalation only and must not be swallowed
• patients who don’t experience improvement in asthma control should be asked if they are swallowing the capsule rather than inhaling it
• capsules must be administered only using the Breezhaler inhaler device, which is provided with each new prescription
• after inhalation, patients should rinse their mouth with water without swallowing
• adherence to current treatment and device (inhaler) technique can be assisted with the NPS MedicineWise inhaler checklist and Lung Foundation Australia video on Breezhaler device technique.