New PBS listings from 1 March 2022

The Hon Greg Hunt MP

Minister for Health and Aged Care

Australians will have access to four new medicines through the Pharmaceutical Benefits Scheme (PBS) from March 1 to help fight COVID-19, chronic graft versus host disease, leukaemia and a rare blood disease called paroxysmal nocturnal haemoglobinuria (PNH).

COVID-19 Treatment

From March 1, a prescription-only COVID-19 treatment will be available on the PBS for Australians highest risk of developing severe COVID-19.

Lagevrio® (molnupiravir) is an oral anti-viral medicine which can be used by patients with mild-moderate COVID- 19 who have a high risk for developing severe disease, reducing the need for admission to hospital.

Adults who have mild to moderate COVID-19 confirmed by a PCR or RAT verified by the prescribing doctor and who can start treatment within five days of symptom onset, can be prescribed PBS-subsidised Lagevrio by their doctor if:

  • they are 65 years of age or older, with two other risk factors for severe disease (as increasing age is a risk factor, patients who are 75 years of age of older only need to have one other risk factor); or
  • they identify as Aboriginal or Torres Strait Islander origin, and are 50 years of age or older with two other risk factors for severe disease, or
  • they are moderately to severely immunocompromised.

A PBS listing for Lagevrio means eligible Australians can access this medicine from their local community pharmacy on a prescription from their doctor.

It is important that patients continue to follow local health guidance to isolate if they test positive for COVID-19, including using telehealth to see their doctor and asking their pharmacy to arrange for Lagevrio to be delivered at home, if necessary.

Graft versus host disease

Uvadex® (methoxsalen) is being listed on the PBS for the first time for Australians with chronic graft versus host disease (cGVHD), a complication that can occur when patients undergoing cancer treatment receive transplanted stem cells from a donor.

cGVHD is a complication of allogeneic stem cell transplant, that occurs when donor bone marrow or stem cells start recognising the recipient’s body as foreign and start attacking the recipient’s body cells.

This causes damage in the body, especially to the liver, skin and gut. cGVHD can appear immediately or any time after a patient’s allogeneic transplant.

Uvadex® will be used as part of an integrated, closed system extracorporeal photopheresis (ECP) service for the treatment of cGVHD.

ECP is a type of treatment which removes some of a patient’s blood using a machine. The machine separates the white blood cells-then red blood cells and plasma go back into the body.

The white blood cells are mixed with Uvadex®, then exposed to ultraviolet (UV) light and put back into the patient.

The listing of Uvadex® on the PBS will benefit around 180 Australians a year, who without subsidy could pay more than $9,200 per course of treatment.

Leukaemia

Mylotarg® (gemtuzumab ozogamicin) is also being listed for the first time for Australians with acute myeloid leukaemia (AML)

AML is a cancer of the blood and bone marrow in which the bone marrow makes immature white blood cells in high numbers. These abnormal cells crowd the bone marrow, preventing it from making normal blood cells.

AML is one of the rarer forms of cancer, accounting for 0.8 per cent of all cancers diagnosed, but it can occur at any age and is more common among adults over the age of 60.

Mylotarg® is being listed for the first time for the treatment of patients with previously untreated de novo CD33-positve AML, for use in combination with standard intensive chemotherapy.

Mylotarg® works by stopping the abnormal growth of these cells and destroying them.

The listing of Mylotarg® on the PBS will benefit around 900 Australians a year, who without subsidy may pay around $18,000 per course of treatment.

Paroxysmal nocturnal haemoglobinuria

Australians with paroxysmal nocturnal haemoglobinuria (PNH)-a condition that produces defective blood cells-will have access to a new treatment, Ultomiris® (ravulizumab).

PNH is a rare, potentially life-threatening condition in which red blood cells break apart prematurely. Symptoms occur because of the production of defective blood cells and because the bone marrow does not produce enough blood cells.

The specific symptoms and progression of the disorder vary greatly, and some individuals may have mild symptoms, which remain stable for many years; while others may have serious symptoms, which can progress to cause life-threatening complications. Blood clots are a very serious complication of PNH.

Ultomiris ® protects the red blood cells from damage and destruction by blocking the body’s inflammatory response.

Ultomiris® will be listed for the first time for patients with PNH and will benefit around 160 Australians a year, who without subsidy may pay around $550,000 per year for treatment.

At the same time, Soliris® (eculizumab), which has been available through the Life Savings Drug Program for the treatment of PNH, will move to the PBS.

This PBS listing has been recommended by the independent Pharmaceutical Benefits Advisory Committee.

Minister for Health and Aged Care, Greg Hunt, said the Morrison Government’s commitment to ensuring Australians can access affordable medicines, when they need them, remains rock solid.

“Instead of paying thousands of dollars to access these treatments, from March 1, Australians will pay $42.50 per script, or as little as $6.80 with a concession card,” Minister Hunt said.

“Since 2013, the Coalition Government had approved more than 2,800 new or amended listings on the PBS. This represents an average of around 30 listings or amendments per month – or one each day – at an overall investment by the Government of $14.3 billion.”

/Media Release. View in full here.