| Macrogenics, Inc. |
74527002202 |
MARGENZA™ (margetuximab-cmkb) 25mg/mL per Vial {1 Vial per Pack} |
2021-03-04 |
2077.0000 |
None |
1 |
7000 |
None |
None |
None |
None |
None |
None |
Confidential Trade Secret Information of MacroGenics, not for public disclosure: We estimate that there are approximately 7,000 patients in the U.S. with metastatic HER2 positive breast cancer that are in the third or later line of therapy for their metastatic disease.
Confidential Trade Secret Information of MacroGenics, not for public disclosure: The marketing plans for the launch of MARGENZA include a product website, creation of various physical and electronic marketing brochures, and web advertising for the product. In addition, commercial personnel will have virtual and in-person meetings with potential MARGENZA customers including healthcare professionals, hospital and healthcare systems, and payors to discuss the product. The pricing plan for the launch of MARGENZA includes listing the WAC price for the product in major pricing compendia. MacroGenics will also provide appropriate product discounts off of the WAC price to contracted customers, and to contracted GPO members. MARGENZA is only approved at this time in the United States, and it is not at this time anticipated MARGENZA will be approved outside the United States in 2021, and therefore it is not anticipated there will be sales of MARGENZA in 2021 outside of the United States.t. |
None |
| Macrogenics, Inc. |
74527002203 |
MARGENZA™ (margetuximab-cmkb) 25mg/mL per Vial {4 Vials per Pack} |
2021-03-10 |
8308.0000 |
None |
1 |
7000 |
None |
None |
None |
None |
None |
None |
Confidential Trade Secret Information of MacroGenics, not for public disclosure: The marketing plans for the launch of MARGENZA include a product website, creation of various physical and electronic marketing brochures, and web advertising for the product. In addition, commercial personnel will have virtual and in-person meetings with potential MARGENZA customers including healthcare professionals, hospital and healthcare systems, and payors to discuss the product. The pricing plan for the launch of MARGENZA includes listing the WAC price for the product in major pricing compendia. MacroGenics will also provide appropriate product discounts off of the WAC price to contracted customers, and to contracted GPO members. MARGENZA is only approved at this time in the United States, and it is not at this time anticipated MARGENZA will be approved outside the United States in 2021, and therefore it is not anticipated there will be sales of MARGENZA in 2021 outside of the United States.t.
Confidential Trade Secret Information of MacroGenics, not for public disclosure: We estimate that there are approximately 7,000 patients in the U.S. with metastatic HER2 positive breast cancer that are in the third or later line of therapy for their metastatic disease. |
None |
| Mayne Pharma Inc |
51862069010 |
Tavaborole Topical Solution 5% 10mL (Mayne Label) |
2021-02-15 |
1284.2200 |
NDC change from previous listed Encube ND (21922002012). |
None |
53356 |
None |
None |
2020-12-08 |
204000.0000 |
None |
None |
Estimated number of patients is based off IMS MAT TRx script data.
NDC change from 21922002012. No WAC change. |
None |
| Mayne Pharma Inc |
51862051260 |
Calcipotriene Foam 0.005% |
2021-04-29 |
765.1000 |
None |
1 |
3693 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is purely an estimate based on the Sorilux brand (51862037660) IMS TRx data. Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information. |
None |
| Mayne Pharma Inc |
68308057530 |
ISOtretinoin Oral Capsule 40 MG 30 count |
2021-09-03 |
1036.6000 |
None |
1 |
173179 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Mayne Pharma Inc |
68308057030 |
ISOtretinoin Oral Capsule 10 MG 30 count |
2021-09-24 |
963.4400 |
None |
1 |
7975 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Mayne Pharma Inc |
68308057130 |
ISOtretinoin Oral Capsule 20 MG 30 count |
2021-09-24 |
963.4400 |
None |
1 |
43797 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Mayne Pharma Inc |
68308057330 |
ISOtretinoin Oral Capsule 30 MG 30 count |
2021-09-24 |
1036.6000 |
None |
1 |
220707 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Meitheal Pharmaceuticals, Inc. |
71288012820 |
Clofarabine Injection 20mg 20 mL (1mg/mL) SDV |
2021-03-24 |
800.0000 |
Meitheal markets generic clofarabine as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
3000 |
None |
None |
None |
None |
None |
None |
Because its clofarabine product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed clofarabine. As such, given clofarabine's primary use for the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients under the age of 21, Meitheal's best estimate regarding a patient population can be derived from the Centers for Disease Control and Prevention's ("CDC") tracking of ALL diagnoses within the United States. According to the CDC's most recent data (in 2017), the number of new cases of ALL in pediatric patients is 3,000 or more. (https://www.cdc.gov/mmwr/volumes/66/wr/mm6636a3.htm). |
None |
| Meitheal Pharmaceuticals, Inc. |
71288012902 |
Dactinomycin for Injection, USP 500mcg (0.5mg) 2mL SDV |
2021-04-20 |
1400.0000 |
Meitheal markets generic dactinomycin as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
200000 |
None |
None |
None |
None |
None |
None |
Because its dactinomycin product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed dactinomycin. In addition, there are several indications where the use of dactinomycin is approved to treat a number of conditions. Meitheal reasonably estimates, based on information publicly available on cancer.org via the American Cancer Society, that there is potential for approximately 200,000 prescriptions of dactinomycin annually for treatment for a number of diseases. |
None |
| Meitheal Pharmaceuticals, Inc. |
71288080506 |
Isosulfan Blue Injection 1% 50mg 5mL (10mg/mL) SD Vial |
2021-11-03 |
800.0000 |
Meitheal markets generic isosulfan blue 1% as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal primarily markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. The target users for isosulfan blue are large cancer centers, teaching hospitals and cancer clinics. |
None |
80000 |
None |
None |
None |
None |
None |
None |
IIsosulfan blue injection 1% is a diagnostic product and is not a therapeutic used to treat a specific condition. It is used as an aid (or adjunct)in a procedure called lymphography (medical imaging procedure) to test how well the lymphatic system is working in certain parts of the body. It is used to find: lymphedema, chyluria, chylous ascites, chylothorax, and cancer of the lymph nodes. Isosulfan blue is a dye made in the laboratory that helps identify the sentinel lymph node (the first lymph node that cancer spreads to from a primary tumor). Based on IMS (IQVIA) prescription data, Meitheal estimates that there are 80,000 units sold in the US each year. Meitheal also estimates that there are 80,000 patients prescribed this product annually. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=562 |
| Melinta Therapeutics, LLC |
70842022501 |
KIMYRSA is supplied as sterile, lyophilized powder containing 1,200 mg of oritavancin (as oritavancin diphosphate) in a single-dose clear glass vial, which must be reconstituted and further diluted prior to intravenous administration. One vial is packaged |
2021-07-07 |
4884.0000 |
None |
1 |
705600 |
None |
None |
None |
None |
None |
None |
This drug was not acquired. In regard to the estimated number of patients, KIMYRSA™ (oritavancin) for Injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only). Available literature on disease incidence generally focuses on skin and skin structure infections (SSTIs), which are acute or chronic infections of the skin and underlying tissue without a minimum lesion size requirement. SSTIs covers a broader array of skin infections and includes, for example, ABSSSIs, necrotizing fasciitis, and infections caused by gram-negative and anaerobic pathogens. The estimated annual incidence of patients who receive intravenous antibiotics for SSTI is 705,600 (8.4M annual patient visits for purulent SSTI, with 8.4% receiving an intravenous antibiotic). (Reference: Fritz SA, Shapiro DJ, Hersh AL. National Trends in Incidence of Purulent Skin and Soft Tissue Infections in Patients Presenting to Ambulatory and Emergency Department Settings, 2000-2015. Clin Infect Dis. 2020 Jun 10;70(12):2715-2718. doi: 10.1093/cid/ciz977. PMID: 31605485.) |
None |
| Merck & Co., Inc. |
00006533101 |
belzutifan, tablet, 90, 40 mg |
2021-08-30 |
26400.0000 |
Marketing Description: Promotional activities for WELIREG will primarily include detailing of the product by Merck sales representatives to health care professionals including physicians, pharmacists, payers, and other healthcare providers. WELIREG will also be marketed in the US with print distribution and digital resources to health care professionals and patients.
Pricing Plan Description: Merck considers several factors in determining the price of our medications. These factors are listed below and are largely based on the value of the product, as well as the competitive landscape, and market for the medication.
•Value provided to patients: To what extent does a new medicine or vaccine establish a new standard of care that has the potential to significantly extend and improve patient lives?
•Value provided to healthcare systems: To what extent does a new medicine or vaccine reduce the costs associated with hospitalization and other costly complications of disease if not appropriately (or optimally) treated?
•Unmet need: Does a new medicine or vaccine address a critical unmet medical need for large numbers of people,
where few or no treatments exist?
•Access and Affordability: How can we assure that various customers-including national, regional or local institutional payers, physicians, employers and patients-can afford to pay for our products?
•R&D sustainability: Given the long-term risk and cost of capital, are we appropriately compensating our investors to ensure that we can continue the risky and capital-intensive biopharmaceutical research and development that will bring forward medically-important breakthroughs?
•Competition: What are the costs of other treatments and interventions currently on the market relative to the value provided by Merck's products? |
None |
6000 |
1 |
1 |
2019-07-11 |
1200000000.0000 |
None |
•This drug was acquired in development stage from clinical-stage biopharmaceutical company.
•Merck made an upfront payment of $1.2 billion for the asset acquisition of Peloton.
•Research and development expenses recorded at acquisition were $993 million. |
Marketing/Pricing Plan (Non Public):
Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Estimated Patients:
WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Von Hippel-Lindau (VHL) disease is a rare hereditary tumor syndrome affecting an estimated 1/36,000 live births globally [NORD. Accessed January 28, 2021. https://rarediseases.org/rare-diseases/von-hippel-lindau-disease/ ]. It is estimated that 2020 US prevalence of VHL disease is 10,000 patients. At any given time, renal cell carcinoma (RCC) may affect up to 30% of VHL patients in the US [Chittiboina P, Lonser RR. Handb Clin Neurol. 2015;132:139–156.]. For patients with tumors that reach greater than 3cm in size, a partial nephrectomy may be performed to reduce the risk of metastasis while maintaining kidney function[Varshney N et al. J Kidney Cancer VHL. 2017;4:20–29.]. Additionally, it is estimated Central nervous system (CNS) hemangioblastomas affecting 60% to 80% of all patients [Varshney N, Kebede AA, Owusu-Dapaah H, et al. A review of von Hippel-Lindau syndrome. J Kidney Cancer VHL. 2017;4(3):20–29.] Finally, pancreatic neuroendocrine tumors (pNET) affect approximately 15% of VHL patients [Michael Charlesworth, Caroline S Verbeke, Gavin A Falk, et al. Pancreatic lesions in von Hippel-Lindau disease? A systematic review and meta-synthesis of the literature. J Gastrointest Surg. 2012 Jul;16(7):1422-8. doi: 10.1007/s11605-012-1847-0. Epub 2012 Feb 28.] However, we do not expect all of these patients would be eligible for therapy and not all of these patients will receive WELIREG. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=553 |
| Micro Labs USA, Inc. |
72485011310 |
Isoproterenol HCl Injection, USP 1 mg/5 mL (0.2 mg/mL) 10 Ampules Pack |
2021-09-09 |
8495.0000 |
Marketing partner - Armas intends to engage with purchasing organizations and bring savings to convert customers to Armas product |
None |
8810 |
None |
None |
None |
None |
None |
None |
Estimated Number of Patients is based on the past 12 month`s IMS data. Column 10 to 13 intentionally left blank as its not applicable. |
None |
| Mirum Pharmaceuticals |
79378011001 |
Product Name – Maralixibat oral solution Dosage Strength – 9.5mg/mL Package Size – 30mL Bottle Dosage Form – Oral |
2021-09-29 |
46500.0000 |
None |
1 |
2500 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mitsubishi Tanabe Pharma America, Inc. |
70510220102 |
Exservan (riluzole) oral film |
2021-05-12 |
3143.0000 |
None |
1 |
400 |
None |
None |
2021-01-21 |
None |
1 |
None |
None |
None |
| Mylan Institutional Inc |
67457038681 |
Mycophenolate Mofetil 500mg LYO 4PK |
2021-01-26 |
290.0000 |
None |
1 |
35381 |
None |
None |
None |
None |
None |
None |
Please note that, although not all courses of treatment of the Product trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Product triggers the threshold only when taking into account the maximum recommended dose as listed in the Product Prescribing Information.
Mycophenolate mofetil for injection is indicated for prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. Based on the literature, in 2020, 22,817 had kidney transplants, 3,658 had heart transplants, and 8,906 had liver transplants (https://unos.org/data/transplant-trends/). Therefore, an estimated (using available data) 35,381 patients in the United States could potentially use this product during the current year.
The product was not a result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378233078 |
Rufinamide Tablets USP, 200 mg |
2021-06-01 |
1367.0600 |
None |
1 |
48000 |
None |
None |
None |
None |
None |
None |
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults (see US Prescribing Information). Based on the literature, approximately 48,000 children and adults in the United States suffer from LGS. (https://www.lgsfoundation.org/epidemiology). Therefore, an estimated (using available data) 48,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378233178 |
Rufinamide Tablets USP, 400 mg |
2021-06-01 |
2734.1100 |
None |
1 |
48000 |
None |
None |
None |
None |
None |
None |
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults (see US Prescribing Information). Based on the literature, approximately 48,000 children and adults in the United States suffer from LGS. (https://www.lgsfoundation.org/epidemiology). Therefore, an estimated (using available data) 48,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378163193 |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution, 30 ct. |
2021-06-22 |
481.2600 |
None |
1 |
16400000 |
None |
None |
None |
None |
None |
None |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Based on the literature, in 2018, 16.4 million people reported a diagnosis of any type of COPD (chronic bronchitis, emphysema, or COPD). (https://www.cdc.gov/copd/index.html). Therefore, an estimated (using available data) 16.4 million patients in the United States could potentially use this product during the current year.
Mylan reserves the right to reassess reporting requirements under the definition of a "new prescription drug" in any future submissions. This authorized generic Product is marketed under an NDA that was previously approved in 2007 and did not receive an initial approval under an original NDA. |
None |
| Mylan Pharmaceuticals Inc |
00378163191 |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution, 60 ct. |
2021-06-22 |
962.4700 |
None |
1 |
16400000 |
None |
None |
None |
None |
None |
None |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Based on the literature, in 2018, 16.4 million people reported a diagnosis of any type of COPD (chronic bronchitis, emphysema, or COPD). (https://www.cdc.gov/copd/index.html). Therefore, an estimated (using available data) 16.4 million patients in the United States could potentially use this product during the current year.
Mylan reserves the right to reassess reporting requirements under the definition of a "new prescription drug" in any future submissions. This authorized generic Product is marketed under an NDA that was previously approved in 2007 and did not receive an initial approval under an original NDA. |
None |
| Mylan Pharmaceuticals Inc |
00378000585 |
Everolimus Dispersible Tablets, 2mg |
2021-10-01 |
12894.9800 |
None |
1 |
50000 |
None |
1 |
None |
None |
None |
None |
Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378000685 |
Everolimus Dispersible Tablets, 3mg |
2021-10-01 |
13024.1400 |
None |
1 |
50000 |
None |
1 |
None |
None |
None |
None |
Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378000785 |
Everolimus Dispersible Tablets, 5mg |
2021-10-01 |
13555.5200 |
None |
1 |
50000 |
None |
1 |
None |
None |
None |
None |
Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378438591 |
Naproxen and Esomeprazole Magnesium DR Tablets 375mg/20mg |
2021-11-22 |
1613.4300 |
None |
1 |
3354920 |
None |
1 |
None |
None |
None |
None |
Naproxen component of Naproxen and Esomeprazole is indicated for relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults, and juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Based on the literature, the occurrence of rheumatoid arthritis and ankylosing spondylitis in the general population has a frequency between 0.3% and 1.5% (https://www.ncbi.nlm.nih.gov/books/NBK532288/). With the available United States population data of 333,880,005, that is an average of 3,004,920 patients (https://www.worldometers.info/world-population/us-population/). In the United States, about 350,000 new cases of peptic ulcers are diagnosed each year (https://pubmed.ncbi.nlm.nih.gov/6378441/). Therefore, an estimated (using available data) 3,354,920 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378438691 |
Naproxen and Esomeprazole Magnesium DR Tablets 500mg/20mg |
2021-11-22 |
1613.4300 |
None |
1 |
3354920 |
None |
1 |
None |
None |
None |
None |
Naproxen component of Naproxen and Esomeprazole is indicated for relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults, and juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Based on the literature, the occurrence of rheumatoid arthritis and ankylosing spondylitis in the general population has a frequency between 0.3% and 1.5% (https://www.ncbi.nlm.nih.gov/books/NBK532288/). With the available United States population data of 333,880,005, that is an average of 3,004,920 patients (https://www.worldometers.info/world-population/us-population/). In the United States, about 350,000 new cases of peptic ulcers are diagnosed each year (https://pubmed.ncbi.nlm.nih.gov/6378441/). Therefore, an estimated (using available data) 3,354,920 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Specialty LP |
49502025080 |
Semglee® (insulin glargine-yfgn) 1000IU/10mL 1PK Vial |
2021-11-15 |
269.3800 |
None |
1 |
34200000 |
None |
None |
None |
None |
None |
None |
*Please note that, although not all courses of treatment of the Products trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Products may trigger the threshold depending on the units a patient may use in a 30-day period.
Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Based on the literature and assuming all type 1 and type 2 patients will be insulin dependent, approximately 34.2 million people of all ages had diagnosed diabetes in the United State (https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf). However, not all type 2 diabetes patients are in need of insulin. All 1.6 million patients with type 1 diabetes will need insulin (https://www.diabetes.org/resources/statistics/statistics-about-diabetes). Therefore, an estimated (using available data) 34.2 million patients in the United States could potentially use this product during the current year. |
None |
| Mylan Specialty LP |
49502025175 |
Semglee® (insulin glargine-yfgn) 300IU/3ML 5PK Pen |
2021-11-15 |
404.0400 |
None |
1 |
34200000 |
None |
None |
None |
None |
None |
None |
*Please note that, although not all courses of treatment of the Products trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Products may trigger the threshold depending on the units a patient may use in a 30-day period.
Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Based on the literature and assuming all type 1 and type 2 patients will be insulin dependent, approximately 34.2 million people of all ages had diagnosed diabetes in the United State (https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf). However, not all type 2 diabetes patients are in need of insulin. All 1.6 million patients with type 1 diabetes will need insulin (https://www.diabetes.org/resources/statistics/statistics-about-diabetes). Therefore, an estimated (using available data) 34.2 million patients in the United States could potentially use this product during the current year. |
None |
| Myovant Sciences Inc. |
72974041501 |
MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) 28 tablets |
2021-06-17 |
974.5400 |
None |
1 |
5000000 |
None |
None |
None |
None |
None |
None |
MYFEMBREE is a combination of relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. |
None |