| Novadoz Pharmaceuticals, LLC |
72205004601 |
Thiotepa for Injection 100mg, 1 per pack |
2020-04-10 |
4250.0000 |
None |
1 |
451 |
None |
None |
2020-03-04 |
0.0000 |
1 |
This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz. |
None |
None |
| Novadoz Pharmaceuticals, LLC |
72205004501 |
Thiotepa for Injection 15mg, 1 per pack |
2020-04-10 |
700.0000 |
None |
1 |
3100 |
None |
None |
2020-03-04 |
0.0000 |
1 |
This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz. |
None |
None |
| Novadoz Pharmaceuticals, LLC |
72205005030 |
Toremifene Citrate Tablets 60mg |
2020-10-19 |
1144.5000 |
None |
1 |
6089 |
None |
None |
None |
None |
None |
None |
This product was not acquired. MSN is the contract manufacturer for Novadoz. MSN owns the ANDA but the labeler code is owned by Novadoz. |
None |
| Novartis |
00078070956 |
Tabrecta (Capmatinib) 56 tabs of 150mg |
2020-05-06 |
8975.0000 |
Novartis considered many factors in determining the price of Tabrecta. Tabrecta is the treatment specifically for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation with disease progression on or after platinum-based chemotherapy. We priced in parity to other treatments in this class and are focused on access to Tabrecta for this patient population. |
None |
192200 |
1 |
1 |
None |
None |
None |
None |
Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078071656 |
Tabrecta (Capmatinib) 56 tabs of 200mg |
2020-05-06 |
8975.0000 |
Novartis considered many factors in determining the price of Tabrecta. Tabrecta is the treatment specifically for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation with disease progression on or after platinum-based chemotherapy. We priced in parity to other treatments in this class and are focused on access to Tabrecta for this patient population. |
None |
192200 |
1 |
1 |
None |
None |
None |
None |
Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078100768 |
Kesimpta (Ofatumumab) 20mg/0.4mL (auto injector) |
2020-08-21 |
6916.6700 |
The marketing for Kesimpta includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). KESIMPTA is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta is the first B-cell therapy for patients with relapsing forms of multiple sclerosis or RMS that can be self-administered at home using an autoinjector pen. We priced in parity to other treatments in this class and are focused on access to Kesimpta for this patient population. |
None |
500000 |
None |
1 |
None |
None |
None |
None |
Novartis estimates there are 500,000 Multiple sclerosis patients in the United States. Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Noven Therapeutics, LLC |
68968017203 |
Asenapine 3.8 mg/ 24 hours transdermal system |
2020-03-02 |
1200.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Noven Therapeutics, LLC |
68968017303 |
Asenapine 5.7 mg/ 24 hours transdermal system |
2020-03-02 |
1200.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Noven Therapeutics, LLC |
68968017403 |
Asenapine 7.6 mg/ 24 hours transdermal system |
2020-03-02 |
1200.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Novo |
00169810001 |
Esperoct® 1000 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169815001 |
Esperoct® 1500 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169820001 |
Esperoct® 2000 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169830001 |
Esperoct® 3000 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| Novo |
00169850001 |
Esperoct® 500 IU |
2020-02-03 |
2.2300 |
None |
1 |
8000 |
None |
None |
None |
None |
None |
None |
Regarding the reported wholesale acquisition cost (WAC), NNI reports the WAC of Esperoct® on a per International Unit (IU) basis, including in the primary public pricing databases (e.g., MediSpan Price Pro). Accordingly, the WAC for the Esperoct® NDC-11s at issue also will be publicly listed as $2.23. The amount of IUs prescribed is based on patient bodyweight. Based on dosages set forth in the FDA-approved labeling, we expect that, for all patients, a course of therapy will exceed the $670 threshold for a Medicare Part D Specialty Drug. The Prescribing Information for Esperoct®, which includes the FDA-approved dosages, is available here: https://www.novo-pi.com/esperoct.pdf.
Regarding the reported patient estimate, Esperoct® is a coagulation Factor VIII concentrate indicated for use in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Per the Hemophilia Foundation of America, Hemophilia A affects nearly 20,000 people in the U.S. For the estimated patients requirement, market data indicates there are approximately 8,000 Hemophilia A patients on factor replacement therapy that could potentially use Esperoct® in the United States. It is not an estimate of prescriptions that might be written for Esperoct®.
Esperoct® was developed by Novo Nordisk. |
None |
| NS Pharma, Inc. |
73292001101 |
Viltepso |
2020-08-21 |
1410.0000 |
None |
1 |
328 |
None |
None |
2020-04-01 |
None |
1 |
the “per vial” cost it is not a set dollar amount - the acquisition is set at 29,763 yen for this fiscal year (April 2020 – March 2021) and average exchange rate of the prior month of the shipment is used to calculate US$ amount. Thus the acquisition price fluctuates. |
Duchenne Muscular Dystrophy (DMD), is an ultra-orphan disease with a very small patient population, estimates put the patient volume at an estimated 0.000001% of US population, or 328 patients nationally. |
None |