| Medexus Pharma, Inc |
59137036501 |
GRAFAPEX™ (treosulfan) for injection 5g/vial |
2025-02-24 |
3050.0000 |
None |
1 |
66 |
None |
None |
None |
None |
None |
None |
None |
None |
| Merck Sharp & Dohme LLC |
00006508501 |
PREVYMIS 120 mg/packet oral pellets 30 packets |
2025-01-15 |
2058.0000 |
Marketing Plan
•Promotional activities of PREVYMIS to physicians and other health professionals (HCPs) include detailing of all formulations of PREVYMIS by Merck sales representatives, print and digital educational resources, media placements, congress sponsorships and exhibit booths, and other related activities. In addition, Merck Medical Forums (educational speaker programs) for PREVYMIS will be available.
•Direct-to-consumer (DTC) promotional activities for PREVYMIS currently include a consumer website promoting the tablet and injection formulations of PREVYMIS. This is subject to change.
Pricing Plan
The new pellet formulation approved by the FDA on August 30, 2024, extends use to the pediatric population for previously approved adult indications based on age and weight parameters, allogeneic hematopoietic stem cell transplant (HSCT) ages 6mo-18yrs and kidney transplant (KT) recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) ages 12-18 years old. The company has made the decision to maintain pricing parity for the new pellet formulation to the tablet on a per milligram basis. |
None |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated number of Patients: Merck estimates that nationally there are approximately 2,000 patients annually who will undergo qualifying transplants that could potentially make them eligible to receive one of the oral pellet formulations of PREVYMIS, based on the latest publicly available data from Organ Procurement & Transplant Network’s databases. Merck does not know how many patients might be prescribed the drug as not all such patients may be a candidate for the oral pellet formulation of PREVYMIS. |
None |
| Merck Sharp & Dohme LLC |
00006508601 |
PREVYMIS 20 mg/packet pellets 30 packets |
2025-01-15 |
342.9000 |
Marketing Plan
•Promotional activities of PREVYMIS to physicians and other health professionals (HCPs) include detailing of all formulations of PREVYMIS by Merck sales representatives, print and digital educational resources, media placements, congress sponsorships and exhibit booths, and other related activities. In addition, Merck Medical Forums (educational speaker programs) for PREVYMIS will be available.
•Direct-to-consumer (DTC) promotional activities for PREVYMIS currently include a consumer website promoting the tablet and injection formulations of PREVYMIS. This is subject to change.
Pricing Plan
The new pellet formulation approved by the FDA on August 30, 2024, extends use to the pediatric population for previously approved adult indications based on age and weight parameters, allogeneic hematopoietic stem cell transplant (HSCT) ages 6mo-18yrs and kidney transplant (KT) recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) ages 12-18 years old. The company has made the decision to maintain pricing parity for the new pellet formulation to the tablet on a per milligram basis. |
None |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated number of Patients: Merck estimates that nationally there are approximately 2,000 patients annually who will undergo qualifying transplants that could potentially make them eligible to receive one of the oral pellet formulations of PREVYMIS, based on the latest publicly available data from Organ Procurement & Transplant Network’s databases. Merck does not know how many patients might be prescribed the drug as not all such patients may be a candidate for the oral pellet formulation of PREVYMIS. |
None |
| Mesoblast Inc. |
73648011101 |
Ryoncil (remestemcel-l-rknd) 1 Kit (1 Single Use Vial) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011202 |
Ryoncil (remestemcel-l-rknd) 1 Kit (2 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011303 |
Ryoncil (remestemcel-l-rknd) 1 Kit (3 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011401 |
Ryoncil (remestemcel-l-rknd) 1 Kit (4 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011502 |
Ryoncil (remestemcel-l-rknd) 1 Kit (5 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011603 |
Ryoncil (remestemcel-l-rknd) 1 Kit (6 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011704 |
Ryoncil (remestemcel-l-rknd) 1 Kit (7 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011802 |
Ryoncil (remestemcel-l-rknd) 1 Kit (8 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mylan Pharmaceuticals Inc |
00378289520 |
Ferric Citrate 210mg |
2025-03-20 |
1411.7800 |
None |
1 |
5764480 |
None |
None |
None |
None |
None |
None |
Mylan’s Ferric Citrate product is an authorized generic of the Auryxia product. Ferric Citrate is indicated for the control of serum phosphorous levels in patients with chronic kidney disease on dialysis. Based on current literature, ~555,000 Americans are currently on dialysis. Of these patients, ~69% experience serum phosphorous levels above normal range (>4.5mg/dl). This means ~382,950 Americans undergoing dialysis for chronic kidney disease are eligible for prescription of Ferric Citrate to control serum phosphorous levels. Ferric Citrate is also indicated for the treatment of iron deficiency anemia in adults with chronic kidney disease not on dialysis. Given that only 555,000 of the ~35,000,000 Americans with chronic kidney disease are currently on dialysis, ~34,945,000 Americans living with chronic kidney disease are not on dialysis. Of these patients, ~15.4% are estimated to have anemia. Thia means ~5,381,530 Americans not undergoing dialysis for chronic kidney disease are eligible for prescription of Ferric Citrate to treat iron deficiency anemia. Altogether between these indications, ~5,764,480 Americans are eligible for prescription of Ferric Citrate 210mg. |
None |