The document discusses breast cancer in India, including prevalence rates, HER2 expression, presentation at different ages, and treatment with trastuzumab. It notes that breast cancer accounts for 14% of cancers in Indian women. HER2 overexpression is associated with poor prognosis, and addition of trastuzumab to chemotherapy improves survival rates. However, trastuzumab is expensive and was used in only 8.6% of eligible Indian patients. The document advocates for insurance coverage of trastuzumab and price reductions to increase accessibility of this effective treatment for HER2-positive breast cancer in India.
The document discusses breast cancer in India, including prevalence rates, HER2 expression, presentation at different ages, and treatment with trastuzumab. It notes that breast cancer accounts for 14% of cancers in Indian women. HER2 overexpression is associated with poor prognosis, and addition of trastuzumab to chemotherapy improves survival rates. However, trastuzumab is expensive and was used in only 8.6% of eligible Indian patients. The document advocates for insurance coverage of trastuzumab and price reductions to increase accessibility of this effective treatment for HER2-positive breast cancer in India.
The document discusses breast cancer in India, including prevalence rates, HER2 expression, presentation at different ages, and treatment with trastuzumab. It notes that breast cancer accounts for 14% of cancers in Indian women. HER2 overexpression is associated with poor prognosis, and addition of trastuzumab to chemotherapy improves survival rates. However, trastuzumab is expensive and was used in only 8.6% of eligible Indian patients. The document advocates for insurance coverage of trastuzumab and price reductions to increase accessibility of this effective treatment for HER2-positive breast cancer in India.
The document discusses breast cancer in India, including prevalence rates, HER2 expression, presentation at different ages, and treatment with trastuzumab. It notes that breast cancer accounts for 14% of cancers in Indian women. HER2 overexpression is associated with poor prognosis, and addition of trastuzumab to chemotherapy improves survival rates. However, trastuzumab is expensive and was used in only 8.6% of eligible Indian patients. The document advocates for insurance coverage of trastuzumab and price reductions to increase accessibility of this effective treatment for HER2-positive breast cancer in India.
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BREAST CANCER
OBJECTIVES:
• REDUCE MORTALITY RATES
• IMPROVE QUALITY OF LIFE INDEX
• IMPROVE MORBIDITY RATES
• IMPROVE STATISTICS OF THE STATE/COUNTRY
PREVALENCE: • Breast cancer accounts for 14% of cancers in Indian women. It is reported that with every four minutes, an Indian woman is diagnosed with breast cancer. • Post cancer survival for women with breast cancer was reported 60% for Indian women, as compared to 80% in the U.S. • Mortality-to-incidence ratio was found to be as high as 66 in rural registries whereas as low as 8 in urban registries. HER 2 EXPRESSION • HER2 is a member of the human epidermal growth factor receptor family. Amplification or over-expression of this oncogene has been shown to play an important role in the development and progression of certain aggressive types of breast cancer. In recent years the protein has become an important biomarker and target of therapy for approximately 30% of breast cancer patients. BREAST CANCER PRESENTATION AT DIFFERENT AGE HER2 EXPRESSION IN BREAST CANCER HER-2 TYPE • 35% of HER2-positive patients reported recurrence in an average duration of 36 months, whereas 25.88% of patients diagnosed with HER2-negative showed recurrences in an average duration of 48.8 months. • There are a number of reasons that may explain the aggressiveness of HER2-positive as compared to HER2- negative including, but not limited to stages at diagnosis, size and grade of tumour, lymph node involvement, ER/PR status, overall health, smoker, non-smoker, response to therapy etc. TRASTUZUMAB
Trastuzumab is a monoclonal antibody. Monoclonal antibodies are a
relatively new type of "targeted" cancer therapy. Antibodies are part of the immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) entering the body. The antibodies attach to the antigen in order to mark it for destruction by the body's immune system. In the laboratory, scientists analyze specific antigens on the surface of cancer cells (target) to determine a protein to match the antigen. Then, using animal and human proteins, scientists work to create a special antibody that will attach to the target antigen. Antibodies will attach to matching antigens like a key fits a lock. This technology allows treatment to target specific cells, causing less toxicity to healthy cells. Monoclonal antibody therapy can be done only for cancers in which antigens (and the respective antibodies) have been identified.
• Trastuzumab works by targeting the HER2/neu receptor on cancer cells. The HER2 gene produces a protein receptor on the cell surface that signals normal cell growth by telling the cell to divide and multiply. Some cancerous breast tissue has too much HER2 (HER2/neu overexpression), triggering the cells to divide and multiply very rapidly. Trastuzumab attaches to the HER2 receptors to prevent cells from multiplying, preventing further cancer growth and slowing cancer progression. It may also work by stimulating an immune mechanism. In addition, trastuzumab suppress angiogenesis both by induction of antiangiogenic factors and repression of proangiogenic factors. • Breast cancer is the most common cancer among women in India and accounts for 27% of all cancers in that country. Overexpression of the oncogene human epidermal growth factor receptor 2 (HER2/neu) is associated with poor prognosis and high risk of recurrence. Addition of the HER2-targeted monoclonal antibody trastuzumab to chemotherapy in adjuvant treatment has been shown to improve disease-free survival (DFS) by 50% and overall survival (OS) by 30%. However, trastuzumab is an expensive drug. It was reported to have been used in only 8.6% of eligible patients, half of who were enrolled in a clinical trial. • The low rate of Trastuzumab use raises the important question of whether public resources should be used to make this treatment routinely accessible in India.
• This question is highly relevant because of the recently
announced ambitious Indian health insurance program, Ayushman Bharat, which includes coverage of chemotherapy for cancer treatment under the Prime Minister’s Jan Aarogya Yojana (PMJAY) component.
COST
• The use of Trastuzumab for 1 year would incur an incremental cost of INR 156,291 (US$2,235) and INR 178,877 (US$2,558)
• The lifetime and incremental costs per patient with Trastuzumab were INR 3,37,935 (US$4,833) and INR 2,27,784 (US$3,258), respectively. FIVE YEAR SURVIVAL RATE WITH TRASTUZUMAB SOLUTION • Given the evidence from studies, it is recommended that insurance schemes provide for 9-week trastuzumab treatment for patients with HER2/neu-positive breast cancer.
• The National Pharmaceutical Pricing Authority should
consider reducing the price of trastuzumab by at least 35%, such that 1-year trastuzumab use would also become cost effective. The network of cancer hospitals as part of the National Cancer Grid could develop a mechanism for common procurement of chemotherapy drugs, which would likely bring down prices BIOSIMILARS:
• Trastuzumab comes with a relatively high price tag compared
with traditional cytotoxic chemotherapy and contributes to healthcare budgets. • Three engineered products related to trastuzumab—2 antibody-drug conjugates, ado-trastuzumab emtansine and fam-trastuzumab deruxtecan-nxki, as well as the subcutaneous trastuzumab/hyaluronidase—have since been approved and have expanded the treatment options for this patient population. The approval of 5 trastuzumab biosimilars as of the end of 2019 holds the promise of considerable cost savings . • Indian-based Pharmaceuticals have launched trastuzumab biosimilars. The new product will bring down the cost of breast cancer treatment by nearly 65%.
• Presently, the MRP of most of the trastuzumab brands in India
ranges between Rs.58, 000‒Rs.63, 000 per 440 mg vial. Based on 18 cycles of trastuzumab therapy, cost of treatment is about 10 lakh rupees. 65% reduction of cost will bring the treatment cost to 4 lakh rupees, enabling many more patients to benefit from trastuzumab treatment.
SOCIAL IMPLICATIONS • In India, it is the family that provides crucial support to a woman with breast cancer during her ordeal with the disease and its treatment. • Breast cancer has implications on the psychosocial support beyond the cancer patients alone, it includes the immediate family and aspects of finance and social adjustments are critical in addition to the routine medical aspects of the disease. KEY DECISION MAKERS FOR TREATMENT PYSCHOSOCIAL PRESSURES • A woman is expected to play different roles as daughter, wife, mother, or mother-in-law based on the context. During the time of treatment (surgery, chemotherapy, and radiation therapy), her ability to fulfill these roles and responsibilities are severely impacted. Due to the treatment and its side effect, the patient has to deal with multiple issues such as disfigurement of her body, sexual intimacy with the husband, and the ability to care for her children. This leads to psychological disturbance, 38% of the cancer patients are identified with anxiety and depression, and also to distress, adjustment disorders, delirium and posttraumatic stress disorder.
• Diagnosis of breast cancer poses a significant financial and psychosocial
burden not only on patients, but also on the immediate family members. Family plays a vital role in the lives of breast cancer patients through managing their finance, decision making, providing emotional support and remaining involved throughout the course of the disease. Involving the family in planned psychosocial interventions might produce better results than merely patient focused strategies.
The financial, social, mental and familial pressure that a woman faces as a cancer patient or cancer survivor in our country is very high. The resources available to these women in our country are slim to none at best. The high cost of cancer treatment along with the late presentation and neglect on the patient’s side has led to the higher incidence of breast cancer fatalities in our country. A multi pronged cohesive treatment and awareness program is the only way to go forward.