| Immunomedics, Inc. |
55135013201 |
TRODELVY (sacituzumab govitecan-hziy) 180 mg vial |
2020-04-28 |
2012.5000 |
None |
1 |
9000 |
1 |
1 |
None |
None |
None |
None |
Specific to Introduced to Market Date (4/28/2020) TRODELVY was FDA approved on 4/22/2020, which is the date provided to Medispan. However, the date of product availability (or Product Launch Date) into the U.S. market was 4/28/2020.
Specific to Estimated Number of Patients Immunomedics is providing the following additional information that is publicly available:
Breast cancer is the most commonly diagnosed cancer in women in the US.
Source: Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69(1):7-34.
Based on data from the NCI’s SEER program, approximately 260,000 new cases of breast cancer were diagnosed in women in the US in 2019.
Source: National Cancer Institute. Cancer Stat Facts: Female Breast Cancer 2019; https://seer.cancer.gov/statfacts/html/breast.html. Accessed December 17, 2019
Of all new cases of breast cancer, approximately 10-15% are diagnosed with TNBC.
Source: American Cancer Society. Triple-negative breast cancer. https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/types-of-breast-cancer/triple-negative.html
Approximately 6-10% of new breast cancer cases are initially Stage 4 or metastatic. This is sometimes called “de novo” metastatic disease, meaning from the beginning.
Source: Metastatic Breast Cancer Network. Incidence and incidence rates. http://mbcn.org/education/category/incidence-and-incidence-rates
Approximately 30-40% of new breast cancer cases (Stage 1, Stage 2, and Stage 3) will progress to Stage 4 or metastatic stage.
Source: Zeichner SB, et al. Breast Cancer Bas Clin Res. 2016;10:25-36
Combining the two data points (de novo metastatic and those who progress to Stage 4) arrives at approximately 10,000 to 11,000 patients. Applying descending treatment rates sequentially from 1L to 2L to 3L you arrive at approximately 8,000 - 9,000 addressable patients. It is important to note that the initial indication for Trodelvy is for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Due to various external factors and dynamics, Immunomedics does not reasonably know how many patients will actually be prescribed TRODELVY.
Immunomedics does not publicly disclose the Marketing/Pricing Plan of TRODELVY. Thus, consistent with 22 C.C.R. §96076(c), Immunomedics has left that field blank.
Because this drug was not acquired, the fields "acquisition date," "acquisition price" and "acquisition price comment" have been left blank. |
None |
| Incyte Corporation |
50881002801 |
Pemazyre 13.5mg 14 count bottle |
2020-04-20 |
17000.0000 |
To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population.
At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options.
- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago
- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 7:
While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives.
Comment regarding Field 8: Acquisition date - n/a
Comment regarding Field 9: Acquisition price - n/a
General Comment:
In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17.
Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Incyte Corporation |
50881002601 |
Pemazyre 4.5mg 14 count bottle |
2020-04-20 |
17000.0000 |
To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population.
At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options.
- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago
- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 7:
While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives.
Comment regarding Field 8: Acquisition date - n/a
Comment regarding Field 9: Acquisition price - n/a
General Comment:
In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17.
Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Incyte Corporation |
50881002701 |
Pemazyre 9.0mg 14 count bottle |
2020-04-20 |
17000.0000 |
To market PEMAZYRE, Incyte designed activities to increase awareness and understanding with healthcare providers about the first FDA-approved product for these patients. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers. There is a consumer-directed website to educate patients on the disease state and PEMAZYRE, and Incyte intends to limit other direct-to-consumer advertising activities given the limited patient population.
At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
- Cholangiocarcinoma (CCA) is an orphan disease with limited treatment options.
- PEMAZYRE is the first treatment innovation for patients with cholangiocarcinoma since chemotherapy was approved 25 years ago
- It is a targeted treatment approved in the United States for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 7:
While Incyte's estimated volume of patients who may be prescribed PEMAZYRE is not available in the public domain, Cholangiocarcinoma (CCA) is a rare disease with a poor prognosis. Epidemiology studies suggest that the incidence rate of CCA ranges between 2.2 to 2.8 per 100,000 lives. CCA is a molecular target-rich disease with FGFR2 fusions and rearrangements representing 10-16% of intrahepatic CCA patients. FGFR2 fusions and rearrangements are rare in extrahepatic CCA. Patients with unresectable, previously treated iCCA with an FGFR2 fusion or rearrangement translate to ~1 per 1 million lives.
Comment regarding Field 8: Acquisition date - n/a
Comment regarding Field 9: Acquisition price - n/a
General Comment:
In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17.
Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Ingenus Pharmaceuticals, LLC |
50742052005 |
Cyclophosphamide Injection 1gm/5ml |
2020-07-31 |
732.5000 |
Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case. |
None |
218623 |
None |
None |
None |
None |
None |
None |
As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable. The total therapeutic WAC for this both SKUs of this product reaches the specified $670.00 amount |
None |
| Ingenus Pharmaceuticals, LLC |
50742051902 |
Cyclophosphamide Injection 500mg/2.5ml |
2020-07-31 |
366.2500 |
Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case. |
None |
36174 |
None |
None |
None |
None |
None |
None |
As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable. The total therapeutic WAC for this both SKUs of this product reaches the specified $670.00 amount |
None |
| Intra-Cellular Therapies, Inc. |
72060014230 |
Caplyta, 42 mg, capsule, 30 pack |
2020-03-18 |
1320.0000 |
None |
1 |
2400000 |
None |
None |
None |
None |
None |
None |
None |
None |