| Regeneron Pharmaceuticals, Inc. |
61755001001 |
EVKEEZA (evinacumab-dgnb) 1200 mg/8 mL (150mg/ mL) |
2021-02-16 |
37500.0000 |
Marketing
Planned marketing activities that will support the approval of EVKEEZA™ (evinacumab-dgnb) include raising awareness about homozygous familial hypercholesterolemia (HoFH) and EVKEEZA among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media.
Pricing
Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles.
First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients.
Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients.
Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness.
Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access. |
None |
1300 |
1 |
1 |
None |
None |
None |
None |
All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure. |
None |
| Regeneron Pharmaceuticals, Inc. |
61755001301 |
EVKEEZA (evinacumab-dgnb) 345 mg/2.3 mL (150mg/mL) |
2021-02-16 |
10781.2500 |
Marketing
Planned marketing activities that will support the approval of EVKEEZA™ (evinacumab-dgnb) include raising awareness about homozygous familial hypercholesterolemia (HoFH) and EVKEEZA among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media.
Pricing
Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles.
First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients.
Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients.
Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness.
Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access. |
None |
1300 |
1 |
1 |
None |
None |
None |
None |
All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure. |
None |
| Rhythm Pharmaceuticals Inc. |
72829001001 |
Imcivree Injection 10 mg/ml |
2021-03-05 |
3300.0000 |
Marketing: Imcivree is the first and only FDA approved treatment for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. Rhythm's approach will focus on educating health care providors on how to diagnose and treat patients efficently to relieve symptoms for patients. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Imcivree to ensure rapid access to life saving therapy
Pricing: Imcivree (Setmelanotide injection) has been developed for the treatment of obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the melanocortin-4 (MC4) receptor pathway. Imcivree provides an option where there is none currently and delivers a safe, effective treatment that reduces the symptoms in patients. Imcivree is priced responsibly compared to similar orphan agents with significant clinical benefit and disease modification. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Rhythm demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
200 |
1 |
1 |
None |
None |
None |
None |
None |
None |