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FTC to Consider Some Drug Rebates as Bribes
FTC to Consider Some Drug Rebates as Bribes
FTC to Consider Some Drug Rebates as Bribes
June 17, 2022
The Federal Trade Commission said that paying or accepting rebates or fees in exchange for excluding lower cost drugs on formularies could be considered commercial bribery.
Study: Higher Out-of-Pocket Costs Lead to Nonadherence
Study: Higher Out-of-Pocket Costs Lead to Nonadherence
Study: Higher Out-of-Pocket Costs Lead to Nonadherence
June 16, 2022
A literature review by AmerisourceBergen's Xcenda identifies a link between high cost sharing and patient nonadherence to medication regimens.
FDA Committee Recommends Expanding COVID-19 Vaccines to Infants, Children
FDA Committee Recommends Expanding COVID-19 Vaccines to Infants, Children
FDA Committee Recommends Expanding COVID-19 Vaccines to Infants, Children
June 16, 2022
The committee recommended Moderna’s and Pfizer’s COVID-19 vaccines were recommended for children 6 months to five years, as well as Moderna’s vaccine for children ages 7 to 16.
Crenezumab Fails to Show Benefit for Alzheimer’s Disease
Crenezumab Fails to Show Benefit for Alzheimer’s Disease
Crenezumab Fails to Show Benefit for Alzheimer’s Disease
June 16, 2022
Genentech’s anti-amyloid crenezumab did not slow or prevent cognitive decline in people with early-onset Alzheimer’s disease.
A High-Touch Approach to Utilization Management
A High-Touch Approach to Utilization Management
A High-Touch Approach to Utilization Management
June 15, 2022
Joe Murad, president and CEO of the pharmacy benefit manager WithMe Health, talks about how consumer-driven healthcare requires access, transparency, and easier navigation.
Study: Manufacturers Device Hop to Extend Patent Protection
Study: Manufacturers Device Hop to Extend Patent Protection
Study: Manufacturers Device Hop to Extend Patent Protection
June 15, 2022
Researchers writing in Health Affairs have found that new patents for updated devices have delayed generic competition in asthma and COPD treatments.
Prime Therapeutics Removes Three Drugs from Medicare Formularies
Prime Therapeutics Removes Three Drugs from Medicare Formularies
Prime Therapeutics Removes Three Drugs from Medicare Formularies
June 14, 2022
A generic is available for one, and Centers for Medicare & Medicaid Services has removed two others from Medicare Part D coverage.
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
June 14, 2022
Amvuttra is expected to launch in July, and the developer, Alnylam, plans to make this available through value-based agreements.
 FDA Approves Olumiant to Treat Patients with Alopecia
 FDA Approves Olumiant to Treat Patients with Alopecia
FDA Approves Olumiant to Treat Patients with Alopecia
June 14, 2022
Olumiant is the first systemic therapy available to treat alopecia.
Mallinckrodt Resubmits Application for Terlipressin
Mallinckrodt Resubmits Application for Terlipressin
Mallinckrodt Resubmits Application for Terlipressin
June 13, 2022
In February 2022, the FDA had issued a complete response letter in order to inspect a new third-party packaging and labeling facility.
FDA Advisory Committee Supports Approval of Gene Therapy for Blood Disease
FDA Advisory Committee Supports Approval of Gene Therapy for Blood Disease
FDA Advisory Committee Supports Approval of Gene Therapy for Blood Disease
June 11, 2022
If approved, beti-cel will be the first potentially curative gene therapy for people with beta-thalassemia who require regular red blood cell transfusions. The PDUFA date is Aug. 19, 2022.
FDA Advisory Committee Endorses Gene Therapy for Neurogenerative Disease
FDA Advisory Committee Endorses Gene Therapy for Neurogenerative Disease
FDA Advisory Committee Endorses Gene Therapy for Neurogenerative Disease
June 10, 2022
If approved, elivaldogene autotemcel will be the first gene therapy to address the underlying genetic cause of cerebral adrenoleukodystrophy, a rare disease that affects young boys.
Hemophilia A Treatment Earns Breakthrough Therapy Designation
Hemophilia A Treatment Earns Breakthrough Therapy Designation
Hemophilia A Treatment Earns Breakthrough Therapy Designation
June 10, 2022
Efanesoctocog alfa is a new class of factor VIII therapy with once-weekly prophylactic dosing. The application for approval expected to be filed mid year.
Nephron Recalls More Than 2 Million Doses of Epinephrine, Other Injections
Nephron Recalls More Than 2 Million Doses of Epinephrine, Other Injections
Nephron Recalls More Than 2 Million Doses of Epinephrine, Other Injections
June 9, 2022
The recalls were made because the medications failed sterility testing.
Studies: Adherence to CF, UC/Crohn’s Meds Lowered Hospitalizations, Costs
Studies: Adherence to CF, UC/Crohn’s Meds Lowered Hospitalizations, Costs
Studies: Adherence to CF, UC/Crohn’s Meds Lowered Hospitalizations, Costs
June 9, 2022
Two studies conducted by AllianceRx Walgreens Prime call attention to the importance of adherence for reducing risk of negative health outcomes and financial costs.
FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine
FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine
FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine
June 9, 2022
Novavax’s COVID-19 vaccine demonstrated 90.4% efficacy with a low number of serious and severe adverse events, including myocarditis.
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.
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.
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