| Gamida Cell Inc. |
73441080004 |
Omisirge Cultured Fraction =8.0x10^8 TVNC and Non-Cultured Fraction =4.0x10^8 TVNC Intravenous, 1 each |
Brand |
FDA |
2023-04-18 |
338000.0000 |
OMISIRGE® will be promoted by our account management team to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits and through online channels such as websites. Pricing was established by performing extensive market research and analysis on our clinical and healthcare resource utilization data. Additionally, it involved years of product development investments and various operational costs.
Gamida Cell’s detailed marketing or pricing plans for OMISIRGE® are not publicly available. |
None |
2200 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242015901 |
1 mg/1 mL vial |
Brand |
FDA |
2023-01-09 |
594.0600 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
589 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242014201 |
30 mg/30 mL vial |
Brand |
FDA |
2023-01-09 |
17821.7800 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
589 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242012701 |
Columvi 10mg/10mL Vial |
Brand |
FDA |
2023-06-27 |
10218.9800 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
216 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242012501 |
Columvi 2.5mg/2.5mL Vial |
Brand |
FDA |
2023-06-27 |
2554.7400 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
216 |
None |
1 |
None |
None |
None |
None |
None |
None |
| GENMAB US, INC. |
82705001001 |
EPKINLY 48mg/0.8mL Injection |
Brand |
FDA |
2023-05-31 |
15225.5600 |
Marketing Plan
Activities that support the launch of EPKINLY™ (epcoritamab-bysp) include interactions with healthcare professionals, patients, and payers. These activities are designed to raise awareness and understanding of the approved indication, efficacy and safety data contained in the medicine's FDA approved label. Awareness of EPKINLY™ will be raised through educational websites, print and digital media, and the use of sales representatives to educate about the FDA-approved indication.
Pricing Plan
At Genmab, we are driven by patient impact. We positively impact the lives of people with cancer when our transformational science becomes medicine, and our medicines reach the people who need them and help them live better.
The price of our medicines reflects the novelty of our science, its impact on patients, and our commitment to bringing that science to patients.
The price of EPKINLY™ (epcoritamab-bysp) takes into consideration its transformational potential as the first and only T-cell engaging bispecific antibody treatment administered subcutaneously for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), which is an aggressive disease with limited treatment options. |
None |
30400 |
None |
1 |
None |
None |
None |
None |
EPKINLY™ (epcoritamab-bysp) is the first-and-only bispecific antibody given by subcutaneous injection and approved to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back or that didn't respond after 2 or more prior treatments. DLBCL is the most common type of Non-Hodgkin’s lymphoma (NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. Exact information for the EPKINLY™ indicated patient population is not available in the public domain. |
None |
| GENMAB US, INC. |
82705000201 |
EPKINLY 4mg/0.8mL Injection |
Brand |
FDA |
2023-05-31 |
1268.8000 |
Marketing Plan
Activities that support the launch of EPKINLY™ (epcoritamab-bysp) include interactions with healthcare professionals, patients, and payers. These activities are designed to raise awareness and understanding of the approved indication, efficacy and safety data contained in the medicine's FDA approved label. Awareness of EPKINLY™ will be raised through educational websites, print and digital media, and the use of sales representatives to educate about the FDA-approved indication.
Pricing Plan
At Genmab, we are driven by patient impact. We positively impact the lives of people with cancer when our transformational science becomes medicine, and our medicines reach the people who need them and help them live better.
The price of our medicines reflects the novelty of our science, its impact on patients, and our commitment to bringing that science to patients.
The price of EPKINLY™ (epcoritamab-bysp) takes into consideration its transformational potential as the first and only T-cell engaging bispecific antibody treatment administered subcutaneously for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), which is an aggressive disease with limited treatment options. |
None |
30400 |
None |
1 |
None |
None |
None |
None |
EPKINLY™ (epcoritamab-bysp) is the first-and-only bispecific antibody given by subcutaneous injection and approved to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back or that didn't respond after 2 or more prior treatments. DLBCL is the most common type of Non-Hodgkin’s lymphoma (NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. Exact information for the EPKINLY™ indicated patient population is not available in the public domain. |
None |
| Gilead Sciences, Inc. |
61958300201 |
SUNLENCA® (lenacapavir), sterile solution for injection, 309 mg/mL, 1.5 mL/vial, 2 vial kit |
Brand |
FDA |
2023-01-09 |
19500.0000 |
None |
1 |
5000 |
1 |
1 |
None |
None |
None |
None |
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available.
Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed. |
None |
| Gilead Sciences, Inc. |
61958300101 |
SUNLENCA® (lenacapavir), tablet, 300 mg, 4 count, blister pack |
Brand |
FDA |
2023-01-09 |
3250.0000 |
None |
1 |
5000 |
1 |
1 |
None |
None |
None |
None |
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available.
Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed. |
None |
| Gilead Sciences, Inc. |
61958300102 |
SUNLENCA® (lenacapavir), tablet, 300 mg, 5 count, blister pack |
Brand |
FDA |
2023-01-09 |
4062.5000 |
None |
1 |
5000 |
1 |
1 |
None |
None |
None |
None |
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available.
Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed. |
None |
| GlaxoSmithKline |
00173090913 |
ZEJULA TABLET, 100 mg, 30 EA |
Brand |
FDA |
2023-07-17 |
17289.3000 |
None |
1 |
10348 |
None |
None |
None |
None |
None |
None |
GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513).
Sources
1. https://seer.cancer.gov/statfacts/html/ovary.html
2. Cortez, Alexander J., et al. "Advances in ovarian cancer therapy." Cancer chemotherapy and pharmacology 81 (2018): 17-38.
3. Kemp, Z., and J. A. Ledermann. "Update on first-line treatment of advanced ovarian carcinoma." International journal of women's health (2013): 45-51. |
None |
| GlaxoSmithKline |
00173091213 |
ZEJULA TABLET, 200 mg, 30 EA |
Brand |
FDA |
2023-07-17 |
17289.3000 |
None |
1 |
10348 |
None |
None |
None |
None |
None |
None |
GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513).
Sources
1. https://seer.cancer.gov/statfacts/html/ovary.html
2. Cortez, Alexander J., et al. "Advances in ovarian cancer therapy." Cancer chemotherapy and pharmacology 81 (2018): 17-38.
3. Kemp, Z., and J. A. Ledermann. "Update on first-line treatment of advanced ovarian carcinoma." International journal of women's health (2013): 45-51. |
None |
| GlaxoSmithKline |
00173091513 |
ZEJULA TABLET, 300 mg, 30 EA |
Brand |
FDA |
2023-07-17 |
17289.3000 |
None |
1 |
10348 |
None |
None |
None |
None |
None |
None |
GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513).
Sources
1. https://seer.cancer.gov/statfacts/html/ovary.html
2. Cortez, Alexander J., et al. "Advances in ovarian cancer therapy." Cancer chemotherapy and pharmacology 81 (2018): 17-38.
3. Kemp, Z., and J. A. Ledermann. "Update on first-line treatment of advanced ovarian carcinoma." International journal of women's health (2013): 45-51. |
None |
| GlaxoSmithKline |
58160084811 |
AREXVY (Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted Vaccine) INJECTION; 120mcg; Package of 10 Doses |
Brand |
FDA |
2023-07-26 |
2800.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
GSK has not released AREXVY's (NDC: 58160084811) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
GSK is limiting its response to information that which is otherwise in the public domain or publicly available per California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). We are unable to identify specific and accurate information in the public domain regarding the estimated volume of patients who may be prescribed AREXVY (NDC: 58160084811) for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older. The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making. Shared clinical decision making empowers patients in consultation with their healthcare providers to determine whether RSV vaccination is appropriate for them.
There are an estimated 55.8 million people aged 65 and older in the US1 who are at increased risk of RSV, a common, contagious virus that can lead to serious respiratory illness.2 RSV causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in this age group in the US each year.2,3,4 For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalisation.5,6 Older adults, including those with underlying medical conditions*, such as chronic heart disease, chronic lung disease or diabetes, are at high risk of severe RSV illness and account for the majority of RSV hospitalisations.5
* According to the CDC, adults aged 60 and older at even greater risk of severe respiratory illness include those with chronic lung diseases, chronic cardiovascular diseases, immune-compromise, hematologic disorders, neurologic disorders, endocrine disorders, kidney and liver disorders and other factors 7
References
1. United States Census Bureau. The older population: 2020. Accessed May 2023. Available at: https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-07.pdf
2. Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Accessed May 2023. Available at: www.cdc.gov/rsv/high-risk/older-adults.html
3. National Foundation for Infectious Diseases. Respiratory Syncytial Virus. Accessed May 2023. Available at: www.nfid.org/infectious-disease/rsv/
4. Falsey AR, et al. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med 2005; 352:1749-1759.
5. Tseng HF, et al. Severe morbidity and short- and mid- to long-term mortality in older adults hospitalized with respiratory syncytial virus infection. J Infect Dis. 2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361. ?
6. Belongia EA, et al. Clinical features, severity, and incidence of RSV illness during 12 consecutive seasons in a community cohort of adults =60 years old. Open Forum Infect Dis. 2018;5(12):ofy316. doi:10.1093/ofid/ofy316.
7. CDC presentation. 21 June 2023. Available at: www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/07-RSV-Adults-Britton-508.pdf" |
None |
| GlaxoSmithKline |
81864010330 |
OJJAARA TABLET, 100 mg, 30 EA |
Brand |
FDA |
2023-09-25 |
26900.0000 |
None |
1 |
8958 |
None |
None |
2022-07-01 |
1900000000.0000 |
None |
The stated acquisition price is representative of the acquisition of Sierra Oncology, including lat- stage asset momelotinib |
GSK has not released OJJAARA's (NDC: 81864010330) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. There are an estimated 20,845 cases of MF per year1 in US adults based on 2020 census data2. 87.7% are intermediate/high risk3, and 49% have anemia3,4. Given that, there are an estimated 8,958 new patients eligible for OJJAARA each year. Eligible patients may or may not be prescribed OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with OJJAARA (NDC: 81864010330, 81864010230, and 81864010130).
Sources
1. Verstovsek S, Yu J, Scherber RM, et al. Changes in the incidence and overall survival of patients with myeloproliferative neoplasms between 2002 and 2016 in the United States. Leuk Lymphoma. 2022;63(3):694-702. doi:http://dx.doi.org/10.1080/10428194.2021.1992756
2. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html
3.Tefferi A, Lasho TL, Jimma T, et al. One thousand patients with primary myelofibrosis: the Mayo Clinic experience. Mayo Clin Proc. 2012;87(1):25-33.
4. Nicolosi M, Mudireddy M, Lasho TL, et al. Sex and degree of severity influence the prognostic impact of anemia in primary myelofibrosis: analysis based on 1109 consecutive patients. Leukemia. 2018;32(5):1254-1258. |
None |
| GlaxoSmithKline |
81864010230 |
OJJAARA TABLET, 150 mg, 30 EA |
Brand |
FDA |
2023-09-25 |
26900.0000 |
None |
1 |
8958 |
None |
None |
2022-07-01 |
1900000000.0000 |
None |
The stated acquisition price is representative of the acquisition of Sierra Oncology, including lat- stage asset momelotinib |
GSK has not released OJJAARA's (NDC: 81864010330) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. There are an estimated 20,845 cases of MF per year1 in US adults based on 2020 census data2. 87.7% are intermediate/high risk3, and 49% have anemia3,4. Given that, there are an estimated 8,958 new patients eligible for OJJAARA each year. Eligible patients may or may not be prescribed OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with OJJAARA (NDC: 81864010330, 81864010230, and 81864010130).
Sources
1. Verstovsek S, Yu J, Scherber RM, et al. Changes in the incidence and overall survival of patients with myeloproliferative neoplasms between 2002 and 2016 in the United States. Leuk Lymphoma. 2022;63(3):694-702. doi:http://dx.doi.org/10.1080/10428194.2021.1992756
2. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html
3.Tefferi A, Lasho TL, Jimma T, et al. One thousand patients with primary myelofibrosis: the Mayo Clinic experience. Mayo Clin Proc. 2012;87(1):25-33.
4. Nicolosi M, Mudireddy M, Lasho TL, et al. Sex and degree of severity influence the prognostic impact of anemia in primary myelofibrosis: analysis based on 1109 consecutive patients. Leukemia. 2018;32(5):1254-1258. |
None |
| GlaxoSmithKline |
81864010130 |
OJJAARA TABLET, 200 mg, 30 EA |
Brand |
FDA |
2023-09-25 |
26900.0000 |
None |
1 |
8958 |
None |
None |
2022-07-01 |
1900000000.0000 |
None |
The stated acquisition price is representative of the acquisition of Sierra Oncology, including lat- stage asset momelotinib |
GSK has not released OJJAARA's (NDC: 81864010330) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. There are an estimated 20,845 cases of MF per year1 in US adults based on 2020 census data2. 87.7% are intermediate/high risk3, and 49% have anemia3,4. Given that, there are an estimated 8,958 new patients eligible for OJJAARA each year. Eligible patients may or may not be prescribed OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with OJJAARA (NDC: 81864010330, 81864010230, and 81864010130).
Sources
1. Verstovsek S, Yu J, Scherber RM, et al. Changes in the incidence and overall survival of patients with myeloproliferative neoplasms between 2002 and 2016 in the United States. Leuk Lymphoma. 2022;63(3):694-702. doi:http://dx.doi.org/10.1080/10428194.2021.1992756
2. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html
3.Tefferi A, Lasho TL, Jimma T, et al. One thousand patients with primary myelofibrosis: the Mayo Clinic experience. Mayo Clin Proc. 2012;87(1):25-33.
4. Nicolosi M, Mudireddy M, Lasho TL, et al. Sex and degree of severity influence the prognostic impact of anemia in primary myelofibrosis: analysis based on 1109 consecutive patients. Leukemia. 2018;32(5):1254-1258. |
None |
| GlaxoSmithKline |
00173091413 |
JESDUVROQ Tablet, 8 mg, 30EA |
Brand |
FDA |
2023-10-04 |
938.4000 |
None |
1 |
512000 |
None |
None |
None |
None |
None |
None |
GSK has not released JESDUVROQ's (NDC: 00173091413) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
JESDUVROQ (NDC: 00173091413 and other strengths not required for reporting) is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. There are an estimated 938,000 cases of end-stage renal disease in the US in based on the US population in 2020.1,2 Of those, around 72.9% are patients receiving dialysis.1 Approximately 75% of these patients are treated with ESAs for anemia.3 Given that, there are an estimated 512,000 patients that would be eligible for JESDUVROQ. Eligible patients may or may not be prescribed JESDUVROQ (NDC: 00173091413 and other strengths not required for reporting) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with JESDUVROQ (NDC: 00173091413 and other strengths not required for reporting).
Sources
1. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2022. https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
2. https://www.census.gov/quickfacts/fact/table/US/POP010220
3. 2021 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2021. https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/3-clinical-indicators-and-preventive-care |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462012190 |
NICARDIPINE HCL CAP 30MG 90 |
Generic |
FDA |
2023-01-09 |
1046.1400 |
None |
1 |
3352 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending November 22 is 3,352 prescriptions for 30 mg. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462072790 |
Saxagliptin, 5 MG, 90 |
Generic |
FDA |
2023-08-14 |
1257.2900 |
None |
1 |
149261 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending June 2023 is 149,261 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462072690 |
Saxagliptin, 2.5 MG, 90 |
Generic |
FDA |
2023-08-16 |
1257.2900 |
None |
1 |
149261 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending June 2023 is 149,261 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |