Roche's New Timesaving Formulation of trastuzumab Approved in Indonesia for the Treatment of HER2-Positive Breast Cancer

Subcutaneous formulation is administered in 2 to 5 minutes,rather than 30 to 90 minutes with the standard intravenous form1

Subcutaneous formulation offers greater convenience to patients and reduces overall healthcare costs compared to standard IV infusion

JAKARTA,Indonesia,July 11,2018 --Roche Indonesia announced today that trastuzumab Subcutaneous (trastuzumab SC) is now available in Indonesia after approval from Indonesia's National Agency of Drug and Food Control (BPOM) on 23 May 2018.Trastuzumab,which was previously only available in the form of intravenous (IV) infusion,is an established treatment for HER2-positive breast cancer,which affects around 22.8% of all the women who are diagnosed with breast cancer in Indonesia.2 The drug has already made a significant impact on improving survival and reducing the risk of recurrence for women with certain types of early breast cancer,as well as improving both quality and length of life in women who have advanced breast cancer.2,3,4

Panel discussion. Left - right: Lucia Erniawati,Head of Market Access & Corporate Affairs,PT Roche Indonesia (Moderator); Dr. dr. Nugroho Prayogo,SpPD-KHOM,Investigator SafeHER Indonesia; Zr. Musrini,S.ST,Oncology Specialist Nurse; Dr. Diah Ayu Puspandari Apt. M.Kes,MBA,Center for Health Financing Policy and Insurance Management (KPMAK)

Dr. Binay Swarup,Country Medical Director,said: "The approval of subcutaneous trastuzumab brings good news for patients as it delivers faster overall treatment experience due to less administration time and also frees up clinic resources,creating admission capacity and cost-savings for hospitals."

Research showed that the administration of trastuzumab in subcutaneous form provides added value for patients,healthcare professionals,as well as healthcare organizations.5

Trastuzumab SC is delivered via an injection on the patient's upper thigh,taking only 2 to 5 minutes to be fully administered rather than 30 to 90 minutes as is the case for IV.1

This reduces patient idle time by 26% and HCP contact time by 58%,6 allowing patients to spend less time in the hospital and have a higher quality of life.4

Senior Oncology Nurse Zr. Musrini S.ST,who has more than 20 years of experience,said: "Patients could now gain up to more than an hour from each visit to the hospital for their anti-cancer therapy and 19 hours over the course of their treatment. This is valuable time and has the potential to liberate patients,enabling them to get on living their lives without the feeling of being shackled to an intravenous infusion. It also means that the relatively invasive central line or cannula would no longer need to be inserted into the patient every three weeks as is the current standard practice."

In addition to the advantages to patients,the hospitals could profit from savings up to 35% per patients per year.6 The benefits could be realised through savings in drug costs and consumables,as well as time saved in preparing and administering trastuzumab SC and reducing drug wastage compared to IV.6 These savings could go some way to solving the increasing capacity burden the BPJS is currently facing in its chemotherapy suites.

Dr. Nugroho Prayogo,SpPD-KHOM said,"This faster,less invasive method of receiving trastuzumab is a major step forward in the treatment of HER2-positive breast cancer. As well as being better for patients,the new formulation of trastuzumab will free up time of specialist cancer nurses and hospital pharmacies. Thus,there are better,practical,time-saving opportunities that benefit patients,health workers and hospitals."

References

1.

Herceptin Product Information. Version 23 May 2018.

2.

Pathmanathan N,et al. Human epidermal growth factor receptor 2 status of breast cancer patients in Asia: Results from a large,multicountry study. 2016. Available on: https://www.ncbi.nlm.nih.gov/pubmed/27334915. Accessed on: 8 July 2018.

3.

Edward H. Romond,M.D.,et al. Trastuzumab Plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer. The New England Journal of Medicine. 2005. Available on: https://www.nejm.org/doi/pdf/10.1056/NEJMoa052122. Accessed on 8 July 2018

4.

Hope Rugo,Melissa Brammer,Fan Zhang,Deepa Lalla. Effect of Trastuzumab on Health-Related Quality of Life in Patients with HER2-Positive Metastatic Breast Cancer: Data from Three Clinical Trials. Clinical Breast Cancer. 2010. Available on https://www.sciencedirect.com/science/article/pii/S1526820911700404?via%3Dihub. Accessed on July 8 2018.

5.

Burcombe,R.,Chan,S.,Simcock,Samanta,K.,Percival,F. and Barrett-Lee,P. (2013) Subcutaneous Trastuzumab (Herceptin®): A UK Time and Motion Study in Comparison with Intravenous Formulation for the Treatment of Patients with HER2-Positive Early Breast Cancer. Advances in Breast Cancer Research,2,133-140. doi: 10.4236/abcr.2013.24022.

6.

Time and Motion Study for The Use of Trastuzumab Subcutaneous Injection in Indonesia (presented at Roche Media Health Forum 11 July 2018). Kebijakaan Pembiayaan dan Manajemen Asurasi Kesehatan. Version 21 May 2018.

About Trastuzumab

Trastuzumab is a humanised monoclonal antibody,designed to target and block the function of HER2,a protein produced by a specific gene with cancer-causing potential when it is overexpressed. Trastuzumab's activates the body's immune system and suppresses HER2 signalling to target and destroy the tumour. Trastuzumab has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy,trastuzumab has been shown to improve overall survival,response rates and disease-free survival while maintaining quality of life in women with HER2-positive breast cancer. Trastuzumab is marketed in the United States by Genentech,in Japan by Chugai Pharmaceuticals,and internationally by Roche. Since 1998,trastuzumab has been used to treat more than 1.2 million people with HER2-positive breast cancer worldwide.

About Roche

Roche is the world's largest biotech company,with truly differentiated medicines in oncology,immunology,infectious diseases,ophthalmology,and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics,and a frontrunner in diabetes management.

Founded in 1896,Roche continues to search for better ways to prevent,diagnose,and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines,among them life-saving antibiotics,antimalarials,and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals,Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group,headquartered in Basel,Switzerland,is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017,Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech,In the United States,is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical,Japan. For more information,please visit www.roche.com.

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