| Reata Pharmaceuticals, Inc. |
73179025090 |
Skyclarys 50 mg 90 count |
Brand |
FDA |
2023-06-28 |
30833.3300 |
Because there has been no FDA-approved drug for Friedrich's ataxia (FA) until SKYCLARYS, most patients seek routine care by their local neurologist or primary care physician.? Important commercial launch targets include CCRN centers, or Collaborative Clinical Research Network sites, ataxia centers and HCPs with FA patients linked to their practice. Through the evaluation of ICD-10 claims data, we've identified healthcare providers treating patients with Friedrich's ataxia today.???
We also have marketing outreach efforts through digital, social, email, and print to reach additional practicing neurologists to raise awareness of SKYCLARYS’ approval as newly diagnosed patients are identified and others return to their neurologist for treatment.?
With SKYCLARYS approval, our commercial team began to inform the FA network of patients, caregivers, and healthcare providers. Omni-channel outreach efforts started with the launch of our brand websites, online search, social media, and digital campaigns that went live upon drug approval.??
Our sales organization consists of a team of region business directors and neurology account managers responsible for educating HCPs. Our field access team consists of national account directors focused on SKYCLARYS coverage by national and regional payers, and the patient access liaisons team hired to support practice level access needs.??
We offer Reata REACH or the Reata Education, Access, and Care Helpline as an integrated, exclusive specialty pharmacy and patient services program. It will serve as the single point of contact for HCPs prescribing SKYCLARYS, FA patients receiving drug and their caregivers. REACH is designed to create a simple and positive experience through new patient start process, insurance navigation, therapy adherence, and access.
A WAC price of $30,833.33 per bottle (30 day supply) was established for SKYCLARYS. |
None |
4500 |
None |
1 |
None |
None |
None |
None |
acquisition price is N/A |
None |
| Regeneron Pharmaceuticals, Inc. |
61755005001 |
EYLEA® HD (aflibercept) Injection 8mg Vial Kit |
Brand |
FDA |
2023-08-21 |
2625.0000 |
Marketing
Planned marketing activities that will support the approval of EYLEA® HD (aflibercept) Injection 8mg include raising awareness about the extended dosing regimens while maintaining noninferior BCVA-ETDRS letter gains to EYLEA® (aflibercept) Injection 2mg at week 48, with a safety form consistent to EYLEA for the treatment of wet age related macular degeneration and diabetic macular edema, and EYLEA® HD (aflibercept) Injection 8mg 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 indications. 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 |
600000 |
None |
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. |
61755001401 |
VEOPOZ™ (pozelimab-bbfg) 400 mg/2 mL (200 mg/mL) |
Brand |
FDA |
2023-09-01 |
34615.3800 |
Marketing
Planned marketing activities that will support the approval of VEOPOZ™ (pozelimab-bbfg) include raising awareness about CD55-deficient protein losing enteropathy (also known as CHAPLE disease) and VEOPOZ™ among healthcare professionals through physician-focused product website and other digital media to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused disease awareness 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 |
3 |
None |
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.
VEOPOZ™ (pozelimab-bbfg) Injection is approved for the treatment of CHAPLE disease, an ultra-rare disease for which there are no reliable estimates on prevalence in the United States. The response provided in Column 7 herein reflects Regeneron’s good faith attempt to estimate the patient population such disease in the United States.” |
None |
| RISING PHARMA HOLDINGS, INC. |
64980058851 |
Edetate Calcium Disodium injection, USP 5 mL single-dose vial (NDC 64980-588-05) containing 200 mg of edetate calcium disodium per mL (1000 mg per vial), in boxes containing 5 vials (NDC 64980-588-51). |
Generic |
FDA |
2023-07-15 |
32609.0000 |
None |
1 |
400 |
None |
None |
None |
None |
None |
None |
None |
None |
| RISING PHARMA HOLDINGS, INC. |
16571081205 |
TRIENTINE CAP 500 MG 50CT |
Generic |
FDA |
2023-09-29 |
19166.8000 |
The product is an additional strength to an already existing 250mg Trientine in the market that is highly generic. We do not have a field sales force and do not market directly to Physicians. Pricing was also recently reduced by 50%. |
None |
300 |
None |
None |
None |
None |
None |
None |
None |
None |