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The latest annual data published by the National Notifiable Diseases Surveillance System (NNDSS) have shown a rebound of invasive pneumococcal disease (IPD) to close to pre-pandemic levels.¹

In the yearly update released on 5 September 2023, IPD cases for 2022, which had fallen during 2020 and 2021, have returned to similar pre-pandemic levels with the highest cases seen in children under the age of 2 years, adults aged 60 to <70 years and children aged 2 to <5 years.¹

Cases in adults >70 years (70-74, 75-79, 80-84, 85+), considered at-risk age groups, have also risen but not to the levels seen in infants.¹

The 2022 data release shows serotypes covered by vaccines currently listed on the National Immunisation Program (NIP) as well as serotypes not covered by currently funded pneumococcal vaccines are contributing to case numbers.¹

Professor Robert Booy, Infectious Diseases Paediatrician, University of Sydney, says the return of disease incidence to pre-pandemic levels is not a surprise, but it is concerning that Streptococcus pneumoniae serotype 3, has once again become the most dominant IPD-causing serotype.¹

“Throughout the first two years of the pandemic, IPD cases fell largely due to COVID non- pharmaceutical intervention (COVID-NPI) and the current resurgence of IPD cases was expected. Serotype 3 has been the most dominant serotype since 2014.¹ In 2022 it remained the most dominant serotype in children <5 years including the most vulnerable cohort of 0 to <2 years. We’ve also seen a rise in serotype 33F to become the second most prevalent serotype in 2022 among infants <2 years followed by serotypes 19F, 15B and 22F together with 38,”¹ Prof Booy said.

The NNDSS 2022 data show that serotype 3 followed by serotype 19F were also the two most dominant serotypes in adults aged > 70 years, however, in contrast to paediatric cohorts, serotypes 23A together with 6C, followed by 22F and 33F rounded off the top six IPD-causing serotypes.¹

Professor Paul Van Buynder, Public Health and Infectious Diseases Epidemiologist, Griffith University, Queensland, says “While it is not known whether these trends are transient or permanent, given the ongoing dominance of serotype 3, a review of the pneumococcal landscape and how to best meet the challenges is required. We have an excellent pneumococcal program in place that to date has served the Australian population well, but we should now look at how we can best optimise the program in response to the evolving landscape.”

“As IPD cases return to pre-pandemic levels it’s advisable young children, Indigenous Australians and older adults keep up with the pneumococcal NIP schedule, that an optimal schedule is implemented,” he added.

The pneumococcal vaccination program for Australia is currently under review with the Government assessing pneumococcal vaccines funded under the National Immunisation Program (NIP) for eligible individuals.³

According to fortnightly data updates on the NNDSS Surveillance Dashboard, overall, 911 cases of IPD were reported nationally in the first two quarters of 2023 compared to 698 cases in the first two quarters of 2022.⁴ In children aged 0 to <5 years, 134 cases of IPD were reported in quarters 1 and 2, 2023 compared to 116 cases in quarters 1 and 2, 2022 while IPD cases in adults aged >70 years has increased from 178 in quarters 1 and 2, 2022 to 243 in quarters 1 and 2, 2023^.4 Reported cases of IPD in 2023 thus far indicated that total cases for 2023 will surpass 2022 totals.⁴

References

1. Australian Government Department of Health and Aged Care. National Notifiable Diseases Surveillance System (NNDSS) Public Dataset. Invasive Pneumococcal Disease Notifications in Australia 2009-2022 (NNDSS data as at 09/09/23). Available at https://www.health.gov.au/resources/publications/national-notifiable-diseases-surveillance- system-nndss-public-dataset-pneumococcal-disease-invasive?language=en. Accessed 9 September 2023.
2. Luck JN et al. Frontiers Cellular & Infection Microbiology. 23 December 2020;10:Article 613287.
3. Australian Government Department of Health and Aged Care. Pneumococcal Disease. https://immunisationhandbook.health.gov.au/contents/vaccine-preventable-diseases/pneumococcal-disease Accessed 25 September 2023.
4. Australian Government Department of Health and Aged Care. National Notifiable Diseases Surveillance System (NNDSS) National Communicable Diseases Surveillance Dashboard. Datasets Quarters 1 and 2, 2022 and Quarters 1 and 2, 2023, Invasive Pneumococcal Disease. Available at https://nindss.health.gov.au/pbi-dashboard/ Data as at 28 August 2023. Accessed 28 August 2023.

Immuno-oncology therapy KEYTRUDA (pembrolizumab) has been listed on the Pharmaceutical Benefits Scheme (PBS) in combination with certain other cancer treatments for the treatment of eligible patients with persistent, recurrent, or metastatic cervical cancer and who are unsuitable for surgery or radiation.¹

Australia is a long-standing world leader in cervical cancer prevention and control with nationwide screening introduced in 1991; and the adoption of the first national human papillomavirus (HPV) vaccination program in 2007.²

Despite the success of these initiatives, inequities in cervical cancer outcomes remain with indigenous women three times more likely to die of the disease than non-Indigenous women.^2,3,4

More than 70% of cervical cancer occurs in women who had never screened or who were lapsed screeners.5 With participation in cervical screening programs lower amongst some CALD (culturally and linguistically diverse) women, more remains to be done to address these disparities.^3,5

Women with metastatic cervical cancer face a poor prognosis with only 17.6% expected to be alive 5 years after diagnosis.⁶

Professor Linda Mileshkin, Director of Medical Oncology at the Peter MacCallum Cancer Centre, says, “In Australia there have been no new funded treatments introduced since 2016 for advanced cervical cancer. Combining immunotherapy with chemotherapy for the treatment of certain patients with advanced cervical cancer provides a treatment option for these women in an area of high unmet need.”

Australia is expected to be the first country to achieve WHO’s definition of cervical cancer
elimination as a public health problem, potentially as early as 2030.²

Cervical cancer indication.⁷ KEYTRUDA (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.

Minimum Consumer Medicine Information.⁸ KEYTRUDA contains the active ingredient pembrolizumab. KEYTRUDA is a medicine that may treat certain cancers by working with the immune system. KEYTRUDA may be given in combination with other anticancer medicines. Not everybody is suitable to have KEYTRUDA as a treatment for their cancer. Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn’s, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage. If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby. Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed. Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. Sometimes these problems can become severe or life-threatening. More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended. These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening. Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur. Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, low levels of thyroid hormone, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma. These are not the only side effects that occur with KEYTRUDA.

For further information read the KEYTRUDA Consumer Medicine Information or speak with your healthcare professional.

PBS information: Authority required STREAMLINED. KEYTRUDA is available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of persistent, recurrent, or metastatic (Stage IVB) cervical cancer. Further criteria apply. Consult the Pharmaceutical Benefits Scheme at www.pbs.gov.au for full information.

A new report titled “A Neglected Burden: The Ongoing Economic Costs of COVID-19 in Australia” reveals the economic costs of COVID-19 in Australia are substantial^1,2 and highlights the need for Government to keep in place countermeasures that could mitigate the ongoing and future economic impact of the virus.²

Findings from the report suggest the future economic cost of COVID-19 in Australia could range from AUD ~17 billion p.a. (~0.6% of GDP) to AUD ~56 billion p.a. (~2.2% of GDP), depending on the scenario that evolves.²

COVID-19 could impose substantial economic costs, including direct costs on the healthcare system and productivity losses from missed work.²

• Around AUD 17.8 billion in annual productivity losses may occur due to infections in working age adults, which is equivalent to around 0.7% of Australian GDP per year.²
• Infections in children may result in productivity losses in Australia of around AUD 1.7 billion per year.²
• COVID-19’s impact on vulnerable Australians – older Australians, those with comorbidities and Indigenous Australians may cost approximately AUD 12.4 billion per year.²
• 46 workdays could be lost for each person with long COVID. This will potentially cost the Australian economy around AUD 8,058 per person per year.²
• At least AUD 2.3 billion in productivity losses per year in relation to healthcare workers infected with COVID-19. Frontline healthcare workers taking time off to recover from COVID-19 could exacerbate workforce shortages and may impact quality of care.²

Royal Australasian College of General Practitioners (RACGP) Victoria Chair Dr Anita Muñoz says, “COVID is still a concern for GPs, particularly when they are treating vulnerable people like the elderly or those with pre-existing conditions. I feel it’s important for GPs to have an awareness of the broader impacts of COVID, as they remain at the frontline of caring for Australians with COVID. The countermeasures in this report are valuable in preparing for emerging variants and future waves should they arise.”

Professor with the Australian National University Quentin Grafton FASSA says, “We believe the costs of COVID are ongoing and require multiple interventions including but not limited to on-going vaccinations or boosters for all age groups and improved indoor air quality (with monitoring) to prevent or to reduce the severity of infections. It is our view that the benefits of these measures in reducing infections greatly exceed the costs of such interventions.”

Prashant Nikam Managing Director, MSD Australia and New Zealand says, “COVID-19 continues to have a significant impact on elderly and at-risk populations, and the consequences extend beyond just health issues. This situation is made even more challenging by what you refer to as “pandemic amnesia,” which is the tendency for people to forget the severity of the pandemic as time goes on. This report shows the direct and indirect burden on the economy is
indeed substantial. A better understanding of these economic impacts may help improve how we navigate the future course of COVID-19 in the community in Australia.”

The report also highlighted the uneven distribution of costs across three different segments within each market studied; vulnerable populations, individuals affected by long COVID, and workforces of critical industries.² Vulnerable populations such as those over 60 to 65 years, and adults under 60 with one or more comorbidities such as high blood pressure, cancer, and diabetes were likely to be disproportionately impacted.³ Furthermore Australia’s Indigenous communities were more susceptible to severe COVID-19 due to high rates of chronic illness and inequalities faced in accessing health services.²

Meanwhile, individuals affected by long COVID experience prolonged productivity losses (increasing indirect costs) and reliance on health services (increasing direct costs).² This in turn exerts a substantial burden on the health system, both in terms of capacity requirement and economic costs.²

The health workforce is impacted by high levels of absenteeism and a risk of infection greater than that of the wider community.² This has consequences for health system capacity and quality of care.² Travel and tourism, as well as logistics sectors have also been heavily impacted due to workforce shortages.²

The report also reviews potential policy countermeasures that could mitigate the ongoing and future economic impact of COVID-19 including community measures such as contact tracing and mask-wearing mandates, other infection control strategies, or medical responses like vaccines and medicines.² Policymakers who strengthen their toolkit of countermeasures will be in a stronger position to ease the high costs of COVID-19, ensuring populations and economies are equipped to better manage future health challenges.²

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1. A Neglected Burden: The Ongoing Economic Costs of COVID-19 in Australia, Taiwan, South Korea, Singapore, and Hong Kong https://www.covid19economicimpact.com/
2. A Neglected Burden: The Ongoing Economic Costs of COVID-19 in Australia. MSD. Data on file. August 2023 https://www.msd-australia.com.au/company-overview/policies-positions/
3. Yashadhana A., Pollard-Wharton N., Zwi A., Biles B. Indigenous Australians at increased risk of COVID-19 due to existing health and socioeconomic inequities. The Lancet Regional Health – Western Pacific [Internet]. July 2020; 1:100007. Available at: https://www.thelancet.com/journals/lanwpc/ article/PIIS2666-6065(20)30007-9/fulltext

On 18 August 2023 KEYTRUDA (pembrolizumab) received a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) for the treatment of early-stage triple-negative breast cancer in patients who have not received prior systemic therapy.¹

This is a meaningful step towards having funded access to KEYTRUDA via the Pharmaceutical Benefits Scheme (PBS) for patients with this aggressive type of breast cancer.

Natasha Cauchi knows firsthand what it’s like to receive a triple-negative breast cancer diagnosis. At the age of 29, while holidaying with her now-husband Daniel, she noticed a small lump that rapidly grew to the size of a cricket ball within weeks. Upon her return to Australia, she was diagnosed with triple-negative breast cancer.

She believes people living with triple-negative breast cancer need to be their own advocate, speak up and get a second opinion if they feel they need to. “Don’t wait. Get yourself an appointment and if you feel no one’s listening to you, push for answers, and understand your treatment options.”

Natasha and Daniel welcomed their first child, Oliver in March this year. “I hope I remain cancer-free, but if my cancer were to return, I’d want to be able to have access to all treatment options via the PBS.”

TNBC is a particularly aggressive form of breast cancer which can grow quickly.^2,3 It tends to have a poor prognosis^2,4 with a higher likelihood of having already spread upon diagnosis, and a greater tendency to come back after treatment than other types of breast cancer.²

Treating TNBC can be challenging because of limited treatment options and in some patients the cancer no longer responding to chemotherapy.⁴

TNBC occurs more often in patients who are under 50 years of age⁵ and around 10-15% of all breast cancer cases are triple-negative breast cancers.^2,3 An estimated 2,500 new cases of TNBC are diagnosed in Australia each year.⁶

Professor Fran Boyle, medical oncologist says, “We’ve seen significant improvements in treatments for women with hormone receptor breast cancer. However, when it comes to triple-negative breast cancer, it’s only recently that treatments have emerged and it’s my hope that these treatments are made available to patients through the PBS, as soon as possible.”

Dr. Jacqui Thomson, a leading expert in breast cancer clinical trials and a medical oncologist, says, “The goal for treating the cancer before surgery is to leave little to no trace of the disease at the time of the operation. I welcome the PBAC recommendation to fund access to new treatments for TNBC, that often impacts a younger demographic of patients.”

In Australia, it can take up to 442 days on average for a cancer medicine to be listed on the PBS after TGA registration.⁷ Sadly, some cancer patients may not have this time.

MSD Australia strongly believes that eligible patients should be able to access the medicines they need in an affordable and timely manner. We are of the view that the best way to ensure affordable and equitable medicines access is through reimbursement on the PBS.

We continue to work in partnership with the Australian Government, patient groups, clinicians, and industry to implement much needed policy reform to accelerate affordable access to medicines through the PBS – in particular, reforms that could deliver funded access via the PBS for new medicines within 90 days of TGA registration.

Indication for triple-negative breast cancer (TNBC).⁸ KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.

KEYTRUDA Minimum Consumer Medicine Information.⁹ KEYTRUDA contains the active ingredient pembrolizumab. KEYTRUDA is a medicine that may treat certain cancers by working with the immune system. KEYTRUDA may be given in combination with other anticancer medicines. Not everybody is suitable to have KEYTRUDA as a treatment for their cancer. Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn’s, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage. If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby. Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed. Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. Sometimes these problems can become severe or life-threatening. More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended. These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands (especially thyroid, pituitary, and adrenal glands) and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening. Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.9 Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, low levels of thyroid hormone, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma. These are not the only side effects that occur with KEYTRUDA.

For further information read the KEYTRUDA Consumer Medicine Information available at www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI-01513-1 and speak to your doctor.

PBS information: KEYTRUDA (pembrolizumab) is not listed on the Pharmaceutical Benefits scheme for triple-negative breast cancer.

Copyright ©2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113. AU-OBR-00146 Issued August 2023

References

1. Australia Government. Department of Health. Pharmaceutical Benefits Scheme. www.pbs.gov.au. Accessed August 2023.
2. American Cancer Society. www.cancer.org/cancer/breast-cancer/about/types-of-breast-cancer/triple-negative.html Accessed November 2022
3. Breast Cancer Trials. Australia. https://www.breastcancertrials.org.au/triple-negative-breast-cancer/ Accessed November 2022
4. Porta FM, et al. Immune Biomarkers in Triple-Negative Breast Cancer: Improving the Predictivity of Current Testing Methods. J Pers Med. 2023 Jul 23;13(7):1176. doi: 10.3390/jpm13071176. PMID: 37511789; PMCID: PMC10381494.
5. Dolle JM, et al. Risk factors for triple-negative breast cancer in women under the age of 45 years. Cancer Epidemiol Biomarkers Prev. 2009 Apr;18(4):1157-66. doi: 10.1158/1055-9965.EPI-08-1005. Epub 2009 Mar 31. PMID: 19336554; PMCID: PMC2754710.
6. Cancer Council Australia. A targeted approach to triple-negative breast cancer. www.cancercouncil.com.au/research-pt/a-targeted-approach-to-triple-negative-breast cancer/#:~:text=Triple%2Dnegative%20breast%20cancer%20(TNBC,TNBC%20in%20Australia%20each%20year. Accessed November 2022
7. Medicines Matter 2022. Australia’s access to medicines, 2016-2021. Medicines Australia. www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2023/04/Medicines-Matter-2022-FINAL.pdf Accessed August 2023
8. KEYTRUDA (pembrolizumab) Product information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-PI-01512-1&d=20230821172310101 Accessed August 2023
9. KEYTRUDA (pembrolizumab) Consumer Medicine Information. www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI-01513-1 Accessed August 2023

MSD Australia is proud to announce a significant achievement at their Macquarie Park Headquarters in Sydney as it receives the WELL Platinum and WELL Equity certification from the International WELL Building Institute™. This double certification sets a precedent for Australian companies and the pharmaceutical sector, with MSD being the first global pharmaceutical company to receive a double certification.

Companies turn to the WELL Building Standard™ to prioritise the health and safety of their people and enhance the performance of their businesses. A recent study published in the Journal of Building and Environment highlighted that occupants in WELL-certified spaces report improved workplace satisfaction, productivity, and overall well-being. The study showed WELL certification leads to nearly 30% higher occupant satisfaction, 26% better-perceived well-being, a 10% boost in mental health, and a median increase of 10 points in productivity.¹

Lisa Onsley, Director of Human Resources, Australia & New Zealand says “Companies can promote wellness and productivity by designing a workplace that fosters physical and mental well-being. MSD’s purpose is inventing for life, and we want to ensure our workspace reflects this – and is an inviting, invigorating, and inspirational space for employees.”

Lisa James-Holmes, Associate Director and Global WELL Project Lead says, “The MSD WELL project team are proud of this achievement. These certifications demonstrate MSD’s unwavering dedication to innovation, wellbeing, and excellence. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, safety, and teamwork of our employees. To this end, we work to create an environment of mutual respect, inclusion, and accountability – our workspace can help foster this culture.”

“MSD is the first global pharmaceutical company in Asia-Pacific region and the world to achieve the accreditation, and we have plans to roll out WELL certification across 42 commercial sites in the next 5 years”, she added.

-ENDS-

1. Impact of WELL certification on occupant satisfaction and perceived health, well-being, and productivity: A multi-office pre- versus post-occupancy evaluation. September 2022.Journal of Building and Environment.224(3):109539 DOI:10.1016/j.buildenv.2022.109539

Eligible Australians with persistent, recurrent, or metastatic cervical cancer now have access another cancer treatment option.

Immuno-oncology therapy KEYTRUDA® (pembrolizumab) has been listed on the Australian Register of Therapeutic Goods (ARTG) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.¹

Australia is a long-standing world leader in cervical cancer prevention and control with nationwide screening introduced in 1991; the adoption of the first national human papillomavirus (HPV) vaccination program in 2007; and is first country to offer self-testing swabs to all women due for their cervical cancer screening from 1 July 2022.^2,3

However, despite the success of these initiatives, inequities in cervical cancer remain. Women living in remote or very remote areas, or of socioeconomic disadvantage and of younger age (25-39 years) were disproportionately affected (2007–2013).²

More than 70% of cervical occurs in women who had never screened or who were lapsed screeners.⁴

Mortality rates were almost 3 times higher in women in indigenous versus non-indigenous women.²

In 2021 the incidence rate for cervical cancer was estimated to increase with age, peaking at age group 40–44 years and then decreasing.⁵ Women diagnosed with metastatic cervical cancer face a poor prognosis with only a 17.6% 5-year survival rate.⁶

Dr Janine Lombard, Medical Oncology, Calvary Mater Hospital says, “Navigating a metastatic cervical cancer diagnosis can be overwhelming. From dealing with the symptoms from the cancer itself to the realisation their cancer may be incurable, patients can suffer.”

“Over the past two decades there have been very few advances in the treatment of metastatic cervical cancer. An additional treatment option we can offer patients who have been diagnosed with this disease can offer hope,” she added.

Prashant Nikam, Managing Director, MSD Australia & New Zealand says, “We are proud to be able to make KEYTRUDA available as a treatment option for eligible advanced cervical cancer patients in Australia.”

Australia is expected to be the first country to achieve WHO’s definition of cervical cancer elimination (target incidence of <4 per 100,000) as a public health problem, potentially as early as 2028.^2,7 The Australian Government has also committed $5.8 million to support the aim of being the first nation in the world to eliminate cervical cancer.⁷

About KEYTRUDA¹

Cervical cancer indication: KEYTRUDA (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.¹

KEYTRUDA contains the active ingredient pembrolizumab.⁸ KEYTRUDA is a medicine that may treat certain cancers by working with the immune system.⁸ KEYTRUDA may be given in combination with other anticancer medicines.⁸ Not everybody is suitable to have KEYTRUDA as a treatment for their cancer.⁸

Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn’s, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage.⁸ If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby.⁸ Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed.⁸

Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them.⁸ KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work.⁸ Sometimes these problems can become severe or life-threatening.⁸ More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended.⁸ These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening.⁸ Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.⁸ Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma.⁸ These are not the only side effects that occur with KEYTRUDA.⁸

For further information read the KEYTRUDA Consumer Medicine Information available at www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 and speak to your doctor.

PBS information: This product is not listed on the Pharmaceutical Benefits Scheme (PBS) for advanced cervical cancer.

References

1. KEYTRUDA (pembrolizumab) Product Information www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01639-1&d=20220902172310101 Accessed September 2022
2. National Health and Medical Research Council (NHMRC), 2021 Cervical Cancer Elimination report. www.cervicalcancercontrol.org.au Accessed June 2022
3. Australian Government Department of Health. Self-collection to increase choice within the National Cervical Screening Program. www.health.gov.au/news/self-collection-to-increase-choice-within-the-national-cervical-screening-program Accessed June 2022
4. Australian Institute of Health and Welfare (AIHW). Analysis of cervical cancer and abnormality outcomes in an era of cervical screening and HPV vaccination in Australia. Release date: 02 Sep 2019. www.aihw.gov.au/reports/cancer-screening/analysis-of-cervical-cancer-and-abnormality/summary Accessed June 2022
5. Australian Government. Cancer Australia. Cervical cancer in Australia statistics. www.canceraustralia.gov.au/cancer-types/cervical-cancer/statistics Accessed June 2022
6. US National Cancer Institute. The Surveillance, Epidemiology, and End Results (SEER) database website: https://seer.cancer.gov/statfacts/html/cervix.html Accessed March 2022
7. Australian Government Department of Health. Australia backs commitment to lead the world in eliminating cervical cancer www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/australia-backs-commitment-to-lead-world-in-eliminating-cervical-cancer Accessed June 2022
8. KEYTRUDA Consumer Medicine Information http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 Accessed September 2022

MSD Australia today celebrated National Carers Week by taking time out to share stories of caring. Running from 16–22 October 2022, National Carers Week is a time to recognise and celebrate the 2.65 million Australians who provide care and support to a family member or friend.

MSD leader Zoe Armstrong is known for her resilience and a big heart. Zoe became involved caring for her mum, Sally, who was diagnosed with cancer at the age of 68. Sally battled her disease for a bit over a year before becoming terminal late 2021. Today alongside other MSD employees, Zoe spoke about how even resilient people like herself can have tough days, and the need to reach out for support.

Zoe travelled the cancer journey with her mum from her first appointment with an oncologist through to palliative care at home. And while Zoe’s dad and sister were the primary support for her mum based in Newcastle, caring took a toll on them all – not just physically, but emotionally.

“It wasn’t until mum had sadly passed that I realised the impact caring had taken, not just on me but on our family. But I also realised how our time together meant so much to mum, and helped us all process a very difficult time”.

“I was quite open about why I decided to step down from a senior leadership role to work part-time so that I could care for mum and manage my own family, but it wasn’t an easy decision. Looking back, I have no regrets. I had precious time with my mum, dad, and sister when it mattered most.”

Lisa Onsley, Director of Human Resources says, “At MSD ‘Patients Can’t Wait’ is our guiding principle. Through our everyday work, many of us have grown to understand how precious time is for people living with a life-impacting health condition like cancer, and their loved ones.”

“We are aware of the importance of wellbeing – both mental and physical. Taking on the role as a carer can be a significant change in someone’s life. We also understand that caring can take many forms, including being a new parent, growing your family, caring for parents, so at MSD we offer flexibility, so our people have an opportunity to meet their work and caring responsibilities,” she added.

MSD offers paid and unpaid leave options, formal and informal flexible work options from compressed hours to temporary or permanent part-time, a comprehensive employee and family assistance program, and an in-house toolkit which provides support individuals and their managers to have quality conversations around pivotal moments in one’s life  and direct them to helpful support options and resources. This toolkit covers extended leave for any reason, flexibility, as well as returning to work, and more.

The National Carers Week event was hosted by MSD’s Next Generation Network (NGN). The NGN serves as a resource group for employees of all ages to connect with the next generation, to new insights, and to each other across all generations within MSD. Our mission is to utilise cultural and generational insights to promote diversity of talent and an inclusive environment, to foster an engaged and empowered workforce regardless of age and to explore and highlight intergenerational issues and opportunities.

About National Carers Week 2022. This year ‘Millions of Reasons to Care’ aims to broaden the awareness of the 2.65 million Australians caring for family members, friends, and people in the community by highlighting the data that defines carers and the caring role. Through this, ‘Millions of Reasons to Care’, aims to broaden the communities understanding of the caring role, increase carer identification and provide the community with more reasons to care about carers.

For more information, visit carersweek.com.au

Around 550 eligible Australians with head and neck squamous cell carcinoma (HNSCC) could receive access to immuno-oncology therapy KEYTRUDA (pembrolizumab) as a first-line treatment option via the Pharmaceutical Benefits Scheme (PBS).¹

KEYTRUDA as a first-line treatment option for certain eligible patients with HNSCC will be available via the PBS from 1 October 2022.^1,2

Head and neck squamous cell carcinomas (HNSCCs) are an aggressive, genetically complex, and difficult to treat group of cancers – and in some cases a debilitating and symptomatic disease.^3,4,5Approximately 50% of patients relapse after treatment in the locally advanced setting, and may require further treatment.⁴

Professor Michael Boyer, Chief Clinical Officer, Chris O’Brien Lifehouse says, “Head and neck cancer is a complex and sometimes difficult to treat cancer, and patients with advanced stage disease often have a poor prognosis.”

“An additional first-line treatment option could give oncologists a treatment option for patients whose disease has spread or recurred after early treatment,” he added.

Patients may require intensive treatment that is often disfiguring – leaving them with poor speech articulation, difficulties in chewing and swallowing, and cosmetic disfigurement, as well as loss of taste.³This can lead to serious psycho-social impacts including low self-esteem and a sense of isolation with patients anxious about interacting with others.⁶ Their caregivers can also experience high rates of psychological distress.⁷

Furthermore, given that HNSCC survivors can be disabled as a result of their condition and treatment and unable to return to work, the economic and societal costs associated with this type of cancer can be significant.³

Nadia Rosin, CEO, Head and Neck Cancer Australia says, “Many people haven’t even heard of head and neck cancer until they, or someone they love, is diagnosed. The reality of advanced head of neck cancer in Australia is that it is a life-altering and for some a life-limiting cancer.”

In 2021, an estimated 5,104 Australians were diagnosed with head and neck cancer and approximately 1,201 died from the disease.^8,9 There are 18 different cancer sites categorised as head and neck cancers – including mouth, throat, voice box, nasal, and sinus cancers. It is not uncommon that a patient may have multiple cancers in different regions of the head and neck.⁹

The most common risk factors for head and neck cancer are tobacco and alcohol use. Other risk factors include human papillomavirus (HPV) status, age, and male gender.⁸ As their condition is often associated with avoidable behaviours such as smoking, drinking, and sexual practices, people with this cancer may experience stigma because of their diagnosis.¹⁰

TGA indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) indication: KEYTRUDA (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.²

About KEYTRUDA. KEYTRUDA contains the active ingredient pembrolizumab.¹¹ KEYTRUDA is a medicine that may treat certain cancers by working with the immune system.¹¹ KEYTRUDA may be given in combination with other anticancer medicines.¹¹ Not everybody is suitable to have KEYTRUDA as a treatment for their cancer.¹¹

Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn’s, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage.¹¹ If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby.¹¹ Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA.¹¹ Tell your health care provider if you are breastfeeding or plan to breastfeed.¹¹

Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them.¹¹ KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work.¹¹Sometimes these problems can become severe or life- threatening.¹¹ More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended.¹¹ These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening.¹¹ Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.¹¹ Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain.¹¹ These are not the only side effects that occur with KEYTRUDA.¹¹

For further information read the KEYTRUDA Consumer Medicine Information available at www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 and speak to your doctor.

PBS information: KEYTRUDA for HNSCC is not currently listed on the PBS.

References

1. MSD Data on file.
2. KEYTRUDA (pembrolizumab) Product Information. www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01639-1&d=20220923172310101 Accessed September 2022
3. Jethwa AR, Khariwala SS. Tobacco-related carcinogenesis in head and neck cancer. Cancer Metastasis Rev. 2017 Sep;36(3):411-423. doi: 10.1007/s10555-017-9689-6. PMID: 28801840; PMCID: PMC5709040.
4. Borel C, Jung AC, Burgy M. Immunotherapy Breakthroughs in the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Cancers (Basel). 2020;12(9):2691. Published 2020 Sep 21. doi:10.3390/cancers12092691
5. Alsahafi, E., Begg, K., Amelio, I. et al. Clinical update on head and neck cancer: molecular biology and ongoing challenges. Cell Death Dis 10, 540 (2019). doi.org/10.1038/s41419-019-1769-9
6. Lo Nigro C, Denaro N, Merlotti A, Merlano M. Head and neck cancer: improving outcomes with a multidisciplinary approach. Cancer Manag Res. 2017 Aug 18;9:363-371. doi: 10.2147/CMAR.S115761. PMID: 28860859; PMCID: PMC5571817.
7. Badr H, Gupta V, Sikora A, Posner M. Psychological distress in patients and caregivers over the course of radiotherapy for head and neck cancer. Oral Oncol. 2014 Oct;50(10):1005-11. doi: 10.1016/j.oraloncology.2014.07.003. Epub 2014 Aug 3. PMID: 25091150; PMCID: PMC4165786.
8. Australian Government. Cancer Australia. Head and neck cancer in Australia statistics www.cancer.gov.au/cancer-types/head-and-neck-cancer/statistics Accessed June 2022
9. Australian Institute of Health and Welfare. Head and neck cancers Australia. Cancer series. Number 83. www.aihw.gov.au/reports/cancer/head-neck-cancers-australia/summary Accessed June 2022
10. Lebel, S., Castonguay, M., Mackness, G., Irish, J., Bezjak, A. and Devins, G.M. (2013), The psychosocial impact of stigma in people with head and neck or lung cancer. Psycho-Oncology, 22: 140-152. doi.org/10.1002/pon.2063
11. KEYTRUDA (pembrolizumab) Consumer Medicine Information www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1. Accessed September 2022

An estimated 1,500 eligible Australians with triple-negative breast cancer (TNBC) could receive access to immuno-oncology therapy KEYTRUDA (pembrolizumab) as a first-line treatment option. ^1,2

KEYTRUDA is now listed on the Australian Register of Therapeutic Goods (ARTG) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery; and in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.²

TNBC is a particularly aggressive form of breast cancer which means it can grow quickly.^3,4,5 TNBC has a poor prognosis^5,6 and is more like to recur within two to three years of diagnosis, as opposed to 10 to 15 years for those with estrogen receptor – positive breast cancer.⁴

While the average age of first being diagnosed with breast cancer in Australia is 61,⁴ TNBC occurs more often in patients who are under 50 years of age.⁷

Around 10-15% of all breast cancer cases are triple-negative breast cancers^4,7,8 and there are around 2,500 new cases of TNBC in Australia each year.⁹

Professor Fran Boyle, Medical Oncologist at the Mater Hospital Sydney and Director of the Patricia Ritchie Centre for Cancer Care and Research says, “Many of these women will be below the usual age at which screening occurs. As TNBC has the potential to grow quickly, the cancer can reach a significant size before patients are diagnosed.”

Dr Sally Baron-Hay, Medical Oncologist, Royal North Shore Hospital, Sydney, says “There have been limited treatment options in the management of women with early stage TNBC. The addition of an immunotherapy option to neoadjuvant chemotherapy treatment gives medical oncologists and their patients an additional treatment option for those with this aggressive subtype of breast cancer.”

“As a medical oncologist it is rewarding to be able to offer this treatment option that could provide hope to women with early stage TNBC,” she added.

A survey of women with a TNBC diagnosis found that they experience increased levels of fear and anxiety at diagnosis compared to non-TNBC patients.^10,11

Sarah Powell, CEO of Pink Hope says, “We encourage adult women of all ages to perform breast self-checks at least once a month as a preventative measure. We know that triple-negative breast cancer can occur in younger women. That’s why it’s crucial for women to become familiar with their breasts and learn how to spot any changes and speak to their GP if they notice anything unusual”.

Known risk factors for TNBC include having a BRCA1 or BRCA2 positive gene mutation, being pre-menopausal, being of African American and African descent, or having a family history of breast cancer.^7,12

Treatments in both early and advanced TNBC remain a significant unmet need.⁸ Early-stage treatment means the treatment of cancer before it has spread or metastasised beyond the part of the body where the cancer originated.¹³

Early treatment includes neoadjuvant therapy – treatment given as a first step to shrink a tumour before surgery; or adjuvant therapy – additional cancer treatment given after surgery.¹⁴

Prashant Nikam, Managing Director, MSD Australia & New Zealand says, “This news is a meaningful step as it offers an additional treatment option for women with triple-negative breast cancer. We are committed to women’s cancers and MSD is rapidly expanding our extensive clinical development program in this area.”

“Patients can’t wait. We know that it can take 610 days on average for a cancer treatment to be listed on the Pharmaceutical Benefits Scheme in Australia after registration. Sadly, some cancer patients may not have this time,” he continued.

“We are committed to working collaboratively with the Pharmaceutical Benefits Advisory Committee to ensure eligible Australians with TNBC have funded access to this treatment option via the Pharmaceutical Benefits Scheme as soon as possible,” he added.

TGA indication: Triple-negative breast cancer: KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.²

About KEYTRUDA. KEYTRUDA contains the active ingredient pembrolizumab.¹⁵ KEYTRUDA is a medicine that may treat certain cancers by working with the immune system.¹⁵ KEYTRUDA may be given in combination with other anticancer medicines. Not everybody is suitable to have KEYTRUDA as a treatment for their cancer.¹⁵ Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn’s, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage.¹⁵ If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby.¹⁵ Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed.¹⁵ Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them.¹⁵ KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work.¹⁵ Sometimes these problems can become severe or life-threatening. More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended.¹⁵  These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening.¹⁵  Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.¹⁵  Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma.¹⁵  These are not the only side effects that occur with KEYTRUDA.¹⁵  

For further information read the KEYTRUDA Consumer Medicine Information available at www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 and speak to your doctor.

PBS information: KEYTRUDA (pembrolizumab) not listed on the Pharmaceutical Benefits Scheme for triple-negative breast cancer.

1. MSD Data on file.
2. KEYTRUDA (pembrolizumab) Product Information. www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01639-1&d=20220822172310101 Accessed September 2022
3. American Cancer Society. www.cancer.org/cancer/breast-cancer/about/types-of-breast-cancer/triple-negative.html Accessed August 2022
4. Breast Cancer Trials. Australia. https://www.breastcancertrials.org.au/triple-negative-breast-cancer/ Accessed August 2022
5. Dent, R., Trudeau, M., Pritchard, K. I., Hanna, W. M., Kahn, H. K., Sawka, C. A., et al. (2007). Triple-negative Breast Cancer: Clinical Features and Patterns of Recurrence. Clin. Cancer Res. 13, 4429–4434. doi:10.1158/1078-0432.ccr-06-3045
6. Scott LC, et al. Update on triple-negative breast cancer disparities for the United States: A population-based study from the United States Cancer Statistics database, 2010 through 2014. Cancer. 2019 Oct 1;125(19):3412-3417. doi: 10.1002/cncr.32207. Epub 2019 Jul 8. PMID: 31282032; PMCID: PMC6744285.
7. Dolle JM, et al. Risk factors for triple-negative breast cancer in women under the age of 45 years. Cancer Epidemiol Biomarkers Prev. 2009 Apr;18(4):1157-66. doi: 10.1158/1055-9965.EPI-08-1005. Epub 2009 Mar 31. PMID: 19336554; PMCID: PMC2754710.
8. Won KA, Spruck C. Triple‑negative breast cancer therapy: Current and future perspectives (Review). Int J Oncol. 2020 Dec;57(6):1245-1261. doi: 10.3892/ijo.2020.5135. Epub 2020 Oct 16. PMID: 33174058; PMCID: PMC7646583.
9. Cancer Council Australia. A targeted approach to triple-negative breast cancer. www.cancercouncil.com.au/research-pt/a-targeted-approach-to-triple-negative-breast cancer/#:~:text=Triple%2Dnegative%20breast%20cancer%20(TNBC,TNBC%20in%20Australia%20each%20year. Accessed August 2022
10. Susman, Ed. Study Shows Extra Emotional Effects of Diagnosis of Triple-Negative Breast Cancer. Oncology Times: February 25, 2015 – Volume 37 – Issue 4 – p 48-49 doi: 10.1097/01.COT.0000461875.30493.48
11. Swiger, K et al. (2015). Abstract P5-17-06: Emotional/psychological characteristics of women with triple-negative breast cancer: Do socioeconomic, demographic, and provider variables impact emotional change from diagnosis to post-treatment? Cancer Research. 75. P5-17. 10.1158/1538-7445.SABCS14-P5-17-06.
12. Almansour NM. Triple-Negative Breast Cancer: A Brief Review About Epidemiology, Risk Factors, Signaling Pathways, Treatment and Role of Artificial Intelligence. Front Mol Biosci. 2022 Jan 25;9:836417. doi: 10.3389/fmolb.2022.836417. PMID: 35145999; PMCID: PMC8824427.
13. NIH. National Cancer Institute. www.cancer.gov/publications/dictionaries/cancer-terms/def/early-stage-cancer Accessed August 2022
14. Mayo Clinic. Treatment to keep cancer from returning. www.mayoclinic.org/diseases-conditions/cancer/in-depth/adjuvant-therapy/art-20046687#:~:text=Immunotherapy.,abnormalities%20present%20within%20cancer%20cells Accessed August 2022
15. KEYTRUDA (pembrolizumab) Consumer Medicine Information. www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 Accessed September 2022

MSD Australia welcomes the Australian Government’s decision to broaden the Pharmaceutical Benefits Scheme (PBS) eligibility criteria for oral antiviral medicine LAGEVRIO (molnupiravir) which is used to treat COVID-19 in adult patients who are at high risk of hospitalisation or death from their condition.^1,2,3

Dr Gary Jankelowitz, Medical Director, MSD Australia & New Zealand says, “MSD welcomes the decision made by the PBAC to change the PBS restrictions for LAGEVRIO. This will ensure more Australians have timely and affordable access to this treatment option following a COVID-19 diagnosis.”

“The changes could allow further ‘at-risk’ people to be treated at home, help ease pressure on our hospital system, as well as provide an additional treatment option to help manage COVID-19 cases in the community,” he added.

Updated PBS Eligibility criteria

Patients eligible for COVID-19 medications under the updated restrictions include:

• Adults 70 years of age or older, with no further risk factors for progression to severe disease
• Adults with mild to moderate COVID-19 who are:
  • People 50 years of age or older, with two additional risk factors for developing severe disease;
  • People aged 30 years of age or older, identifying as Aboriginal or Torres Strait Islander, with two additional risk factors for developing severe disease; and
  • People 18 years of age or over, with moderate to severe immunocompromise.

Access to LAGEVRIO through the PBS for the above patients is permitted irrespective of vaccination status.

LAGEVRIO was first made available through the PBS on 1 March 2022 for eligible adults who test positive for COVID-19 and are at risk of progressing to severe disease.¹

About LAGEVRIO (molnupiravir)²

LAGEVRIO contains the active ingredient molnupiravir. LAGEVRIO has provisional approval to treat COVID-19 in adults who are at increased risk for hospitalisation or death. The decision to approve this medicine has been made on the basis of results of data available at the time of provisional approval.

LAGEVRIO treatment should be commenced as soon as possible after a diagnosis of COVID-19 and within 5 days of symptom onset.

Before using LAGEVRIO check with your doctor if you have any other medical conditions; take any medicines for any other condition; have any allergies. Do not take LAGEVRIO if you are allergic to molnupiravir or any of the other ingredients. Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect LAGEVRIO. LAGEVRIO is not recommended in pregnancy. Discuss the need for a pregnancy test with your doctor if you are of childbearing potential and sexually active. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control while you are taking LAGEVRIO and for 4 days after the last dose of LAGEVRIO if there is a possibility of you getting pregnant. It is not known if LAGEVRIO gets into breast milk and will be passed to the baby. Tell your doctor if you are breastfeeding or plan to breastfeed before taking LAGEVRIO. Breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO. If you are a male who is sexually active with a partner who has the potential to become pregnant, use a reliable method of contraception during treatment and for 3 months after the last dose of LAGEVRIO.

All medicines can have side effects. Common side effects associated with LAGEVRIO are diarrhoea, nausea, dizziness.

For more information on LAGEVRIO (molnupiravir) refer to the Consumer Medicine Information or speak with your doctor.

PBS Information: STREAMLINED authority required. Refer to the PBS Schedule for full authority information.

1. Pharmaceutical Benefits Scheme. https://www.pbs.gov.au/info/news/2022/03/lagevrio-molnupiravir-pbs-listing Accessed July 2022
2. LAGEVRIO (molnupiravir) Consumer Medicine Information www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-01048-1 Accessed July 2022
3. LAGEVRIO Australian Approved Product Information, https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-PI-01047-1 22nd April 2022.