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New House Bill Focuses on Healthcare Price Transparency
New House Bill Focuses on Healthcare Price Transparency
New House Bill Focuses on Healthcare Price Transparency
September 11, 2023
This House bill combines aspects of previously submitted bills — specifically on transparency related to prices on hospital services, laboratory tests, healthcare coverage and PBMs — into one package.
Scripius Removes Dupixent from Formulary
Scripius Removes Dupixent from Formulary
Scripius Removes Dupixent from Formulary
September 7, 2023
The decision by Scripius (previously Select Health Prescriptions) was made based on the cost of Dupixent, as well as because of an increased demand to use Dupixent for mild atopic dermatitis when the primary patient population is those with moderate to severe disease.
Long-term Study Shows Gardasil 9 Effective Against HPV-Related Cancers
Long-term Study Shows Gardasil 9 Effective Against HPV-Related Cancers
September 7, 2023
In a 10-year, follow-up study in patients vaccinated with Gardasil 9, no cases of HPV-related cancers or genital warts were seen.
FDA Accepts BLA for Crovalimab for Rare Blood Condition
FDA Accepts BLA for Crovalimab for Rare Blood Condition
September 6, 2023
If approved, crovalimab will be the first monthly subcutaneous treatment for patients with paroxysmal nocturnal hemoglobinuria, a rare, life-threatening condition.
X4 Pharmaceuticals Submits NDA of Mavorixafor for Rare Immunodeficiency Disease
X4 Pharmaceuticals Submits NDA of Mavorixafor for Rare Immunodeficiency Disease
X4 Pharmaceuticals Submits NDA of Mavorixafor for Rare Immunodeficiency Disease
September 5, 2023
If approved, mavorixafor would be the first therapy to address the genetic defect that results in WHIM syndrome, an ultra-rare disease that can cause recurrent lung infections, papillomavirus-related warts, and an increased risk of developing certain types of cancer.
FDA Grants Tentative Approval of Triumeq PD Generic for Children with HIV
FDA Grants Tentative Approval of Triumeq PD Generic for Children with HIV
FDA Grants Tentative Approval of Triumeq PD Generic for Children with HIV
September 5, 2023
With this tentative approval of abacavir/dolutegravir/lamivudine, Viatris aims to help adherence to HIV treatment in low- and middle-income countries.
State Medicaid Programs Look to Value-Based Contracts for Gene Therapies
State Medicaid Programs Look to Value-Based Contracts for Gene Therapies
State Medicaid Programs Look to Value-Based Contracts for Gene Therapies
September 1, 2023
Magellan Rx Management has begun providing a multi-state solution in which they negotiate with drug manufacturers for value-based contracts for high-cost gene and cell therapies.
New Analysis Suggests Current Rebates Will Influence Medicare Savings for Negotiated Drugs
New Analysis Suggests Current Rebates Will Influence Medicare Savings for Negotiated Drugs
New Analysis Suggests Current Rebates Will Influence Medicare Savings for Negotiated Drugs
September 1, 2023
For most drugs, the statutory minimum discounts under the Inflation Reduction Act will not be enough to achieve the savings projected by the Congressional Budget Office.
Label Mix Up Leads to Recall of Digoxin
Label Mix Up Leads to Recall of Digoxin
Label Mix Up Leads to Recall of Digoxin
August 31, 2023
The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Digoxin is used to treat patients with heart failure and chronic atrial fibrillation.
What We’re Reading: Appealing Insurance Denials; the Sackler Bankruptcy Settlement; Medicare Advantage Enrollment
What We’re Reading: Appealing Insurance Denials; the Sackler Bankruptcy Settlement; Medicare Advantage Enrollment
What We’re Reading: Appealing Insurance Denials; the Sackler Bankruptcy Settlement; Medicare Advantage Enrollment
August 31, 2023
KFF: 82% of Adults Say Prescription Drug Costs are Unreasonable
KFF: 82% of Adults Say Prescription Drug Costs are Unreasonable
KFF: 82% of Adults Say Prescription Drug Costs are Unreasonable
August 31, 2023
About three in 10 adults report not taking their medicines as prescribed at some point in the past year because of the cost, according to a survey by KFF.
FDA Issues CRL for Bevacizumab to Treat Wet AMD
FDA Issues CRL for Bevacizumab to Treat Wet AMD
FDA Issues CRL for Bevacizumab to Treat Wet AMD
August 30, 2023
The anti-cancer drug bevacizumab is used off-label to treat wet AMD. Outlook Therapeutics had developed an ophthalmic formulation of bevacizumab for intravitreal injection.
BCBS of Massachusetts to Cover OTC Narcan Nasal Spray
BCBS of Massachusetts to Cover OTC Narcan Nasal Spray
BCBS of Massachusetts to Cover OTC Narcan Nasal Spray
August 30, 2023
Nonprescription Narcan will be available beginning in September in pharmacies and grocery stores, as well as online retailers and have a suggested cost of $44.99.
FDA Approves First Generics of ADHD Drug Vyvanse
FDA Approves First Generics of ADHD Drug Vyvanse
FDA Approves First Generics of ADHD Drug Vyvanse
August 30, 2023
At least 15 manufacturers have received approval for both capsule and chewable tablet generic versions of Vyvanse.
Legal Challenges Likely for Drugs Listed for Medicare Price Negotiation
Legal Challenges Likely for Drugs Listed for Medicare Price Negotiation
Legal Challenges Likely for Drugs Listed for Medicare Price Negotiation
August 29, 2023
Experts expect more lawsuits challenging CMS’s authority to negotiate drug prices for Medicare Part D.
FDA Approves Reblozyl as First-Line Treatment in MDS-Related Anemia
FDA Approves Reblozyl as First-Line Treatment in MDS-Related Anemia
FDA Approves Reblozyl as First-Line Treatment in MDS-Related Anemia
August 29, 2023
In head-to-head study, Reblozyl nearly doubled the percent of patients achieving primary endpoint of concurrent transfusion independence and hemoglobin increase vs. epoetin alfa.
Janssen Seeks Full Approval for Balversa for Urothelial Carcinoma
Janssen Seeks Full Approval for Balversa for Urothelial Carcinoma
Janssen Seeks Full Approval for Balversa for Urothelial Carcinoma
August 28, 2023
The FDA granted accelerated approval to Balversa in 2019. Patients who received Balversa in Janssen’s confirmatory study achieved a median overall survival of more than one year. It reduced the risk of death by 36%.
EmpiRx Health to Scale Its Value-Driven Pharmacy Program
EmpiRx Health to Scale Its Value-Driven Pharmacy Program
EmpiRx Health to Scale Its Value-Driven Pharmacy Program
August 28, 2023
Using AI-powered population health analytics, EmpiRx’s model aims to drive better health and financial outcomes with clinical-based pharmacy care.
AbbVie Submits Skyrizi to FDA, EMA for Ulcerative Colitis Indication
AbbVie Submits Skyrizi to FDA, EMA for Ulcerative Colitis Indication
August 28, 2023
The submissions to both the FDA and the EMA are supported by two phase 3 trials demonstrating Skyrizi achieved the primary endpoint of clinical remission. Skyrizi is already available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
FDA Approves First Biosimilar of MS Drug Tysabri
FDA Approves First Biosimilar of MS Drug Tysabri
FDA Approves First Biosimilar of MS Drug Tysabri
August 25, 2023
Sandoz’s Tyruko, the first biosimilar to Biogen’s Tysabri, is expected to be available as soon as possible. Pricing has not yet been made available.
Switching to Long-Acting Injectable Paliperidone is Not Cost-Effective in Stable Schizophrenia
Switching to Long-Acting Injectable Paliperidone is Not Cost-Effective in Stable Schizophrenia
Switching to Long-Acting Injectable Paliperidone is Not Cost-Effective in Stable Schizophrenia
August 25, 2023
Long-acting injection formulations of paliperidone improve health outcomes in adults with schizophrenia but that might not be enough to offset their substantial costs, new study finds.
Humira Biosimilar Hadlima Making Coverage Inroads on Formularies
Humira Biosimilar Hadlima Making Coverage Inroads on Formularies
Humira Biosimilar Hadlima Making Coverage Inroads on Formularies
August 24, 2023
Both commercial and Medicaid plans have added Hadlima to their formularies. Hadlima in both high- and low-concentrations has a price that is 85% off Humira.
Specialty Drugs Driving Increase in Hospital Pharmacy Spend
Specialty Drugs Driving Increase in Hospital Pharmacy Spend
Specialty Drugs Driving Increase in Hospital Pharmacy Spend
August 23, 2023
Carina Dolan, Pharm.D., talks about the trends that are driving both the acute and non-acute spending in hospitals for the next year.
FDA Grants Priority Review to Xtandi for Earlier Treatment in Prostate Cancer
FDA Grants Priority Review to Xtandi for Earlier Treatment in Prostate Cancer
FDA Grants Priority Review to Xtandi for Earlier Treatment in Prostate Cancer
August 23, 2023
If approved, Xtandi would be the first hormonal therapy for non-metastatic patients with increasing PSA levels. The FDA has assigned an action date in the quarter of 2023.
FDA Sets Review Date for First-in-Class Therapy for MDS
FDA Sets Review Date for First-in-Class Therapy for MDS
FDA Sets Review Date for First-in-Class Therapy for MDS
August 22, 2023
The FDA set an action date of June 16, 2024, for imetelstat to treat transfusion-dependent anemia in myelodysplastic syndromes. Regulators said they plan to hold an advisory committee meeting as part of their review.
FDA Approves Abrysvo to Prevent RSV in Infants
FDA Approves Abrysvo to Prevent RSV in Infants
FDA Approves Abrysvo to Prevent RSV in Infants
August 22, 2023
Abrysvo is the first RSV vaccine approved to be given to pregnant women at 32 to 36 weeks to prevent infection in infants.
FDA Approves Ingrezza for Disorder Associated with Huntington’s Disease
FDA Approves Ingrezza for Disorder Associated with Huntington’s Disease
FDA Approves Ingrezza for Disorder Associated with Huntington’s Disease
August 21, 2023
In addition to tardive dyskinesia, Ingrezza now also treats chorea associated with Huntington’s disease, which is a movement disorder that effects coordination, gait, swallowing and speech.
FDA Approves Higher Dose Eylea
FDA Approves Higher Dose Eylea
FDA Approves Higher Dose Eylea
August 21, 2023
The higher dose of Eylea allows longer intervals between injections for patients with macular degeneration and diabetic retinopathy. It will have a list price of $2,625 per single-use vial.
FDA Approves Veopoz for Hereditary Immune Disease
FDA Approves Veopoz for Hereditary Immune Disease
FDA Approves Veopoz for Hereditary Immune Disease
August 21, 2023
Veopoz is the first treatment for CHAPLE disease, which causes damage to blood and lymph vessels along the upper digestive tract. The list price is $34,615.38 per single-use vial.
FDA Sets PDUFA Date for Full Approval of Tarpeyo
FDA Sets PDUFA Date for Full Approval of Tarpeyo
FDA Sets PDUFA Date for Full Approval of Tarpeyo
August 18, 2023
The FDA granted accelerated approval to Tarpeyo in December 2021 to treat patients with primary IgA nephropathy, a rare disease that attacks the kidneys. The action date for full approval is Dec. 20, 2023.
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