January 2021 PBS listings for Janssen, AstraZeneca and Amgen

Pharma News: From 1 January 2021, PBS listing for Janssen, AstraZeneca and Amgen bring new hope for Australians fighting multiple myeloma, non-small cell lung cancer and severe psoriasis.

Janssen’s Darzalex (daratumumab)

Janssen’s Darzalex (daratumumab) is now PBS listed in combination with bortezomib and dexamethasone, as a second-line treatment for patients with multiple myeloma.

According to Myeloma Australia CEO, Steve Roach, Darzalex represents “the first major development in the way multiple myeloma is treated in more than 10 years”.

Professor Andrew Spencer, Head of the Malignant Haematology & Stem Cell Transplantation Service at The Alfred Hospital in Melbourne, and one of the doctors involved in Australian clinical trials of Darzalex, welcomed the new subsidy, citing the serious need for new medicines to combat multiple myeloma.

“Multiple myeloma is a very challenging cancer to treat. It is associated with high rates of relapse, treatment resistance, and poor prognosis,” he said.

“After years of research, we now have an entirely new type of treatment to suppress the cancer during a critical window – when a patient no longer responds to initial treatment or their cancer returns after initial treatment. Myeloma becomes progressively harder to treat after each relapse. The PBS subsidy only applies after a patient has had one prior line of treatment, giving patients access to Darzalex early in their disease course,” he added.

Leukaemia Foundation General Manager of Blood Cancer Partnerships Tim Murphy said “This innovative treatment option is ground-breaking and has the ability to truly turn the tables for some myeloma patients in what can be a long fight against this debilitating blood cancer”.

Around 1,165 patients will benefit from access to Janssen’s treatment, which otherwise ay cost up to $160,000 a year.

In 2020, it was estimated more than 2,300 new cases of multiple myeloma will be diagnosed in Australia. About 18,000 people in Australia are living with this serious condition at any one time.

AstraZeneca’s Tagrisso (osimertinib)

Australians living with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not had prior therapy will benefit from the PBS listing of AstraZeneca’s oral Tagrisso (osimertinib).

Tagrisso is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations with clinical activity against CNS metastases.

Without the PBS subsidy, patients would pay close to $8,000 per script or almost $88,000 per year for this treatment. An average of 1,120 patients per year could benefit.

Interestingly, the FDA approved the use of Tagrisso in early stage NSCLC in late December 2020 based on the phase 3 ADAURA study. Findings showed that Tagrisso reduced the risk of disease recurrence by 83% compared with placebo in the trial that was stopped early because of the high efficacy shown in the treatment arm. The ADAURA results were showcased at last year’s virtual American Society of Clinical Oncology (ASCO) conference.

Amgen’s Otezla (apremilast)

Australians living with severe chronic psoriasis will benefit from the first time listing of Amgen’s Otezla (apremilast) on the PBS.

Associate Professor Peter Foley, Director of Research at the Skin Health Institute, said “The severity of psoriasis is often underemphasised or misrepresented. As psoriasis is a very visible condition, it can take both a physical and mental toll on patients. The availability of new treatment options provides clinicians with greater flexibility to tailor treatment to the needs of individual patients.”

Around 5,000 patients with severe chronic psoriasis might pay more than $7,500 a year for treatment without this listing.

Around 1.6 million Australians live with some form of psoriasis. People who suffer with the most severe and chronic forms of the disease also have an increased risk of developing diabetes and cardiovascular disease.