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Study Finds Express Scripts’ Exclusions Based on Contracts
Study Finds Express Scripts’ Exclusions Based on Contracts
Study Finds Express Scripts’ Exclusions Based on Contracts
June 8, 2022
In some cases, the exclusions favored brand medicines that were more expensive than the excluded generics.
Study Finds New Drugs are Increasingly Launched with Higher Prices
Study Finds New Drugs are Increasingly Launched with Higher Prices
Study Finds New Drugs are Increasingly Launched with Higher Prices
June 8, 2022
This trend in prescription drug pricing outpaces growth in prices for other healthcare services.
FTC Launches Investigation of PBMs
FTC Launches Investigation of PBMs
FTC Launches Investigation of PBMs
June 8, 2022
The commission will review PBM business practices, including the impact of rebates on formulary design, the costs of prescription drugs to patients, and methods to determine pharmacy reimbursement.
FDA Approves Dupixent for Young Children with Atopic Dermatitis
FDA Approves Dupixent for Young Children with Atopic Dermatitis
FDA Approves Dupixent for Young Children with Atopic Dermatitis
June 8, 2022
Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.
Halozyme Launches the Testosterone Replacement Tlando
Halozyme Launches the Testosterone Replacement Tlando
Halozyme Launches the Testosterone Replacement Tlando
June 7, 2022
Approved in March, Tlando is an oral testosterone that doesn’t require dose titration.
Report Updates Number of Rare Diseases
Report Updates Number of Rare Diseases
Report Updates Number of Rare Diseases
June 7, 2022
A more accurate number of rare diseases is more than 10,000, and just 500 of these disorders have treatment options available for patients, according to RARE-X.
PBM Exclusions Increasing, Finds New Analysis
PBM Exclusions Increasing, Finds New Analysis
PBM Exclusions Increasing, Finds New Analysis
June 7, 2022
Xcenda’s review of the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—finds they are excluding medicines in classes where generics are not available or for serious conditions, such as oncology and autoimmune disorders.
Myovant Selects Onco360 as Specialty Pharmacy for Orgovyx
Myovant Selects Onco360 as Specialty Pharmacy for Orgovyx
Myovant Selects Onco360 as Specialty Pharmacy for Orgovyx
June 6, 2022
The FDA approved Orgovyx in December 2021 to treat patients with advanced prostate cancer.
FDA Approves the Biosimilar Riabni for Rheumatoid Arthritis
FDA Approves the Biosimilar Riabni for Rheumatoid Arthritis
FDA Approves the Biosimilar Riabni for Rheumatoid Arthritis
June 6, 2022
Riabni is now approved to treat all available Rituxan indications.
Survey: ICER Assessments Impact Payer Decision-Making
Survey: ICER Assessments Impact Payer Decision-Making
Survey: ICER Assessments Impact Payer Decision-Making
June 6, 2022
An Xcenda survey of payers found that cost-effectiveness analyses from the Institute for Clinical and Economic Review (ICER) are used in price negotiations and to implement prior authorizations.
BMS Withdraws sBLA for Reblozyl for Rare Blood Disorder
BMS Withdraws sBLA for Reblozyl for Rare Blood Disorder
BMS Withdraws sBLA for Reblozyl for Rare Blood Disorder
June 5, 2022
Reblozyl was being reviewed to treat anemia in adults with non-transfusion dependent beta thalassemia, an inherited blood disorder. BMS indicated it couldn’t appropriately address FDA’s questions about risk-benefit.
New Generic Launches
New Generic Launches
New Generic Launches
June 4, 2022
New launches this week include: new strength of Alimta, a generic of Esbriet, a generic of Toradol, and a generic of Florinef.
FDA Extends Review of ALS Therapy
FDA Extends Review of ALS Therapy
FDA Extends Review of ALS Therapy
June 3, 2022
The FDA has extended review time to allow for review of additional analyses of data from the company’s clinical studies. The new PDUFA date is Sept. 29, 2022.
BMS Updates Vidaza Label After Pediatric Indication Approval
BMS Updates Vidaza Label After Pediatric Indication Approval
BMS Updates Vidaza Label After Pediatric Indication Approval
June 3, 2022
The label now includes a new section about the risk of substituting an oral azacitidine product, Onureg, for the injection therapy.
FDA Issues Refusal to File Letter for Pegzilarginase
FDA Issues Refusal to File Letter for Pegzilarginase
FDA Issues Refusal to File Letter for Pegzilarginase
June 3, 2022
The FDA is asking for additional data to support effectiveness of pegzilarginase to treat a rare metabolic disease. If approved, pegzilarginase would be the first treatment for ARG1 deficiency.
IQVIA Finds New Cancer Clinical Trials are Increasing
IQVIA Finds New Cancer Clinical Trials are Increasing
IQVIA Finds New Cancer Clinical Trials are Increasing
June 2, 2022
More than 5,700 trials worldwide are investigating PD-1/PD-L1 inhibitors, and new trials of these therapies were of combination regimens.
Biogen/Samsung Bioepis Launch the Biosimilar Byooviz
Biogen/Samsung Bioepis Launch the Biosimilar Byooviz
Biogen/Samsung Bioepis Launch the Biosimilar Byooviz
June 2, 2022
Byooviz, the first FDA approved ophthalmology biosimilar for macular degeneration, will be priced 40% lower than the reference product. It will be commercially available on July 1, 2022.
FDA Puts Hold on Trial for Cialis OTC
FDA Puts Hold on Trial for Cialis OTC
FDA Puts Hold on Trial for Cialis OTC
June 2, 2022
The regulatory agency indicated there is an issue surrounding the protocol design.
FDA Accepts Dupixent Application for Treating Skin Lesions
FDA Accepts Dupixent Application for Treating Skin Lesions
FDA Accepts Dupixent Application for Treating Skin Lesions
June 1, 2022
If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.
FDA Withdraws Approval of Ukoniq
FDA Withdraws Approval of Ukoniq
FDA Withdraws Approval of Ukoniq
June 1, 2022
The FDA indicated the risk of death outweighs the benefits of Ukoniq, which was approved in February 2021 to treat specific lymphomas.
Study: COPD Patients with High Deductibles More Likely to Abandon Prescriptions
Study: COPD Patients with High Deductibles More Likely to Abandon Prescriptions
Study: COPD Patients with High Deductibles More Likely to Abandon Prescriptions
June 1, 2022
In high-deductible plans, patients had the highest out-of-pockets costs and abandoned and discontinued therapy at greater rates than other benefit designs.
FDA Approves Evrysdi in Pre-symptomatic Newborns with SMA
FDA Approves Evrysdi in Pre-symptomatic Newborns with SMA
FDA Approves Evrysdi in Pre-symptomatic Newborns with SMA
May 31, 2022
Evrysdi is now approved to treat spinal muscular atrophy in children and adults of all ages.
FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer
FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer
FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer
May 31, 2022
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers.
Bipartisan Bill Aims to Require Transparency Among PBMs
Bipartisan Bill Aims to Require Transparency Among PBMs
Bipartisan Bill Aims to Require Transparency Among PBMs
May 31, 2022
The bill would allow the Federal Trade Commission to impose penalties on PBMs of up to $1 million for unfair and deceptive practices.
FDA Approves Kymriah for Adults with Follicular Lymphoma
FDA Approves Kymriah for Adults with Follicular Lymphoma
FDA Approves Kymriah for Adults with Follicular Lymphoma
May 30, 2022
Kymriah is now approved in three indications and is the only CAR-T cell therapy approved in both adult and pediatric settings.
New Global Coalition Aims to Improve Access to Cancer Medicines
New Global Coalition Aims to Improve Access to Cancer Medicines
New Global Coalition Aims to Improve Access to Cancer Medicines
May 28, 2022
The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.
FDA Approves Amneal’s Biosimilar of Neulasta
FDA Approves Amneal’s Biosimilar of Neulasta
FDA Approves Amneal’s Biosimilar of Neulasta
May 27, 2022
This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.
FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia
FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia
FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia
May 27, 2022
The FDA has assigned a Prescription Drug User Fee Act target action date of Nov. 30, 2022. Regulators indicated they plan to hold an advisory committee meeting to discuss the application.
FDA Approves Tibsovo Combination for Older Patients with Leukemia
FDA Approves Tibsovo Combination for Older Patients with Leukemia
FDA Approves Tibsovo Combination for Older Patients with Leukemia
May 26, 2022
Tibsovo is the first therapy targeting cancer metabolism for patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
FDA Issues Second CRL for Poxvirus Treatment
FDA Issues Second CRL for Poxvirus Treatment
FDA Issues Second CRL for Poxvirus Treatment
May 26, 2022
Deficiencies at the contract manufacturing company are, for the second time, holding up approval of VP-102 to treat molluscum contagiosum, a mild skin infection.
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