| Novartis |
00078116147 |
Mekinist® (trametinib) for oral solution 4.7MG |
Brand |
FDA |
2023-05-16 |
1548.9800 |
Novartis considered many factors in determining the price of Mekinist. Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Mekinist for this patient population. |
None |
400 |
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 |
00078115421 |
Tafinlar® (dabrafenib) tablets for oral suspension 10MG 210 |
Brand |
FDA |
2023-05-16 |
3663.2700 |
Novartis considered many factors in determining the price of Tafinlar. Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Tafinlar for this patient population. |
None |
400 |
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 |
00078107068 |
COSENTYX SYRINGE 300MG/2ML |
Brand |
FDA |
2023-08-07 |
6924.2600 |
Novartis considered many factors in determining the price of Cosentyx. Cosentyx® (secukinumab) is the first new biologic treatment for hidradenitis suppurativa (HS) in nearly a decade, offering clinically meaningful results across the most debilitating symptoms. An international Phase IIIb study showed treatment with Cosentyx® (secukinumab) 300 mg in a 2 mL autoinjector (UnoReady® pen) resulted in high efficacy and convenient administration in adults with moderate to severe plaque psoriasis. Novartis patient support is a comprehensive support program designed to help patients get started on Cosentyx and stay on treatment. Cosentyx was priced to the healthcare value provided by this innovative medicine. |
None |
30673 |
None |
None |
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 |
00078116861 |
COSENTYX VIAL 125MG/5ML |
Brand |
FDA |
2023-10-25 |
2115.0000 |
Novartis considered many factors in determining the price of Cosentyx IV. To arrive at a fair price recommendation, the US team assessed several considerations, including patient accessibility and insurance/health plan coverage as well as the market basket of branded and biosimilar agents. Recommended price aligns with clinical value Cos IV brings as the 1st IV IL-17 available, filling unmet needs for patients & health professionals. The marketing for Cosentyx IV includes promotion of the drug to physicians or other health professionals, as well as patient promotional activities. |
None |
45000 |
None |
None |
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 |
00078118920 |
FABHALTA HGC 200MG 60 |
Brand |
FDA |
2023-12-08 |
45205.4800 |
Novartis considered many factors in determining the price of Fabhalta (Iptacopan). Fabhalta is an efficacious treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH) and the first and only oral monotherapy to become available for patients. Fabhalta, now available for both previously treated and treatment-naive patients, is the only FDA-approved Factor B inhibitor of the immune system's complement pathway, which drives complement-mediated hemolysis in PNH. The price for FABHALTA reflects the benefits it may provide people living with PNH and also considers the overall value FABHALTA may provide to the healthcare system compared to currently available therapies. The branded therapies used for reference were Ultomiris and Soliris from Alexion and Empaveli from Apellis. The marketing for Fabhalta includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). |
None |
6 |
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 |
| Novo |
00169203011 |
Sogroya® 10 mg/1.5 mL (6.7 mg/mL) pen; 1.5mL in 1 prefilled syringe |
Brand |
FDA |
2023-06-09 |
2635.8000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
"Sogroya® is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1).
Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1).
The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf.
According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies
Sogroya® was developed by Novo Nordisk. " |
None |
| Novo |
00169203711 |
Sogroya® 15 mg/1.5 mL (10 mg/mL) pen; 1.5mL in 1 prefilled syringe |
Brand |
FDA |
2023-06-09 |
3953.7000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
"Sogroya® is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1).
Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1).
The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf.
According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies
Sogroya® was developed by Novo Nordisk. " |
None |
| Novo |
00169203511 |
Sogroya® 5 mg/1.5 mL (3.3 mg/mL) pen; 1.5mL in 1 prefilled syringe |
Brand |
FDA |
2023-06-09 |
1317.9000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
"Sogroya® is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1).
Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1).
The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf.
According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies
Sogroya® was developed by Novo Nordisk. " |
None |