Supreme Court Refuses to Hear Teva & GSK’s Skinny Label Case
The US Supreme Court has rejected Teva’s bid to take up its case with GSK over skinny labels, which approve a generic for some, but not all, of the indications of the reference drug. Teva was sued by GSK in 2014 after it added an indication for congestive heart failure for its generic version of GSK’s heart drug Coreg.
ICER Announces Upcoming Value-Assessment for Pulmonary Arterial Hypertension Treatment
The Institute for Clinical and Economic Review (ICER) has announced it will perform a value-assessment for Merck’s sotatercept for the treatment of pulmonary arterial hypertension. The organization has been in talks with patient groups, clinical specialists, manufacturers, and patient advocates and will present its report at the Midwest CEPAC meeting this coming December.
ARS Pharmaceuticals Notches Win with FDA Adcomm Vote Recommending EpiPen Alternative
ARS Pharmaceuticals scored a win yesterday, May 11th, with a 16-6 Food and Drug Administration (FDA) advisory committee vote recommending the approval of its epinephrine nasal spray. Not only would this be the first nasal spray of the drug, but it would also represent a major challenger to Epipen’s dominance in the market.
ImmunityBio’s Marketing Application for Bladder Cancer Medication Shot Down by FDA
ImmunityBio took a loss today after receiving news its marketing application for its bladder cancer drug Anktiva was rejected by the US Food and Drug Administration (FDA). The decision came primarily because of issues with manufacturing facilities. The agency also wants more safety data and information on the duration of treatment response.
Takeda Anticipates Revenue Losses as End of Vyvanse Exclusivity Looms Large
Takeda is preparing for a substantial drop in revenue as two of its major drugs approach patent cliffs this summer. The first is the company’s attention deficit hyperactivity disorder (ADHD) drug Vyvanse, which will lose US exclusivity this August. Takeda’s hypertension medication Azilva will lose exclusivity in Japan this June. The combined hit of the two losses is expected to reach $2.4 billion (330 billion yen).
Talking Immunology Biosimilars and Managed Care with Dr. Colby Evans
Biosimilars have taken an increasingly prominent role in healthcare in recent years, representing a significant point of savings for patients and managed care organizations (MCOs). However, there are still some significant challenges to increase their utilization. In a new AJMC interview, Dr. Colby Evans of Evans Dermatology Partners discusses these hurdles. The first is that patients and providers are often unwilling to make the change from more expensive reference drugs.
Pharma Prepares for Legal Battle Over US Drug Price Reform
As the upcoming Medicare drug pricing negotiations loom large over the industry, pharma companies are preparing to challenge the government in court. One sticking point for the companies is that they aren’t allowed to talk about negotiations, facing heavy fines for any infractions. Another issue is how drugs to be negotiated are chosen.
EQRx Dashes Plans to Drive US Drug Pricing Reform
EQRx is moving on from its previous goal to change the drug pricing landscape in the US, letting go of over half its employees in the process. The company’s mission was to cut costs through developing drugs in categories with known safety profiles, cutting research timelines and expenses by up to 50%. They are now moving towards a market-based pricing strategy moving forward.
Challenges Bringing Drugs to All EU Member States Worry Pharma
As the European Commission prepares for a major revamp to drug legislation, pharma executives and thought leaders worry that even with the new laws, rolling out new drugs to all 27 member states in a short timeframe will be a difficult task to achieve. The proposed law would offer pharma companies an additional years of data protection if new drugs reach all EU markets within 2-3 years of launch, which will be complicated if reimbursement decisions must be made in that period.
FDA On the Fence About OTC Birth Control
The US Food and Drug Administration (FDA) recently met to discuss whether to approve Opill, Perrigo’s hormonal contraceptive, for over-the-counter (OTC) use. Although reproductive rights advocates contend that the move would expand access to contraceptives to people who don’t have a primary care clinician, some religious advocates and committee members argued against it.
Real-World Data Study Investigates HER2-Low Vs HER2-Zero Triple-Negative Breast Cancer
A newly published real-world data (RWD) study in Breast Cancer: Targets and Therapy takes a look at the clinical factors and sociodemographics of patients with HER2-low and HER2-zero triple-negative breast cancer at the Brazilian National Cancer Institute. Analysis shows that that there were no significant differences between the two groups in terms of sociodemographic traits, survival outcomes, and clinical behavior.
India Negotiating Generic Export Prices with UAE
The Indian government is currently negotiating drug external reference pricing (ERP) with the United Arab Emirates (UAE). To cap drug prices, the UAE uses an ERP based primarily on wealthy European nations and the US. Officials contend that this practice and vaccine import rules that exclude Indian generics barriers to exporting generics and vaccines.
Advisory Committee Changes May Be on the Horizon for Orphan Drug Approval
The US Food and Drug Administration (FDA) relies on recommendations from its several advisory committees when weighing whether to approve a drug. However, Congress is placing extra scrutiny on the composition of these committees when debating orphan drugs, as laid out in an explanatory statement in the 2023 FY Consolidated Appropriations Act. Currently, they are expected to be populated with experts in the general field, but there is no provision to make sure rare disease experts are on the panel.
FDA Approves First Ever RSV Vaccine by GSK
For the first time ever, a vaccine for respiratory syncytial virus (RSV) has been approved by the US Food and Drug Administration (FDA). GSK’s vaccine, named Arexvy, is now approved for adults over 60 years of age based on strong data showing it reduced infections and severe cases of the disease. The move comes as an RSV candidate from Pfizer faces an imminent decision.
The End of the COVID-19 PHE Draws Near
The COVID-19 public health emergency (PHE) is set to expire in the US next week, leaving much up in the air. The pandemic-era pause on Medicare redeterminations will hit patients soon, kicking millions off of healthcare coverage. In addition, vaccines and treatments for COVID will hit the private market, although uninsured Americans will still have access to the drugs free of charge.
Negative Makena Confirmatory Data Didn’t Affect Reimbursement
Negative confirmatory data for the preterm birth drug Makena did not affect payers’ decisions to reimburse the drug, according to an analysis published in Health Affairs Forefront. The drug was granted accelerated approval by the US Food and Drug Administration (FDA) back in 2011 based on a small sample size. It was then recommended to be pulled from the market last October by the FDA Center for Drug Evaluation and Research advisory committee based on larger pools of post-market data showing no reduction in pre-term births. The agency finalized Makena’s approval withdrawal in early April this year.
US Inflation Reduction Act Places More Financial Liability on Insurers and Drugmakers
Speakers at a panel at the 2023 Specialty Pharmacy Summit in Las Vegas, Nevada discussed how provisions in the Inflation Reduction Act, passed in the US last year, would pass more liability onto drugmakers and payers. One reason for this are inflation-based rebates that drugmakers must pay if they raise the price of drugs higher than inflation for Medicare Part B and D plans.
External Reference Pricing Doesn’t Lower High Drug Launch Prices
A recently published paper in Health Policy OPEN finds that external reference pricing (ERP) policies don’t result in lower drug launch prices. The study, which investigated 100 high-priced drugs, also reported that ERP policies slowed the launch of new drugs, lowering the odds of them hitting the market within 9 months of approval by 73%. ERP policies were, however, associated with decreases in annual cost.
Biogen’s ALS Drug Qalsody Price Tag Set at Over $14,000
Biogen has announced that its new amyotrophic lateral sclerosis (ALS) drug Qalsody will launch with a list price of $14,230 per dose. The drug was just granted accelerated approval by the US Food and Drug Administration (FDA) based on data showing that it reduced levels of neurofilament, a hallmark of the drug that drives disease pathology.
US Senators Weighing Approaches to Lowering Insulin Prices for All
As US Senators continue to debate over plans to lower insulin prices for all Americans, two bills have taken the forefront. One, by Sen. Susan Collins (R-ME) and Sen. Jeanne Shaheen (D-NH) would cap monthly cost-sharing at 25% of list price or $35. It would also force pharmacy benefit managers (PBMs) to make sure 100% of manufacturer rebates and discounts go to payers.
Immunotherapy Utilization Lower at Small and Rural Clinics
A recently published article in JAMA Oncology finds that cancer clinics that are smaller or in rural areas are less likely to use immunotherapy for their patients compared to larger clinics and those in urban and suburban areas. The study, based on Medicare claims data taken from 1700 cancer clinics, also showed that the majority of practices implemented new immunotherapies within 2 years of their approval by the US Food and Drug Administration (FDA).
Pharma Already Bristling at Parts of EU Drug Overhaul
As the EU preps for a massive pharma regulation overhaul, industry groups have already begun levelling complaints. The reforms include simplifying the approval process, cutting approval timelines, and reducing exclusivity periods from 10 years to 8 years for new drugs, the key sticking point for pharma companies.
FDA Panel Votes for Limited Approval of AstraZeneca and Merck’s Lynparza
AstraZeneca and Merck’s Lynparza looks set for a narrow approval as part of a combination therapy for metastatic castration-resistant prostate cancer (mCRPC). In an 11 to 1 vote, a Food and Drug Administration (FDA) panel supported approval of the drug in combination with a corticosteroid and J&J’s Zytiga only for a small subset of mCRPC patients.
Paying for Legal Psychedelic Therapeutics in Australia
This summer, providers in Australia can legally prescribe psychedelics, MDMA and psilocybin, to patients suffering from post-traumatic stress disorder (PTSD) and depression that has not responded to other treatments. How these drugs will be paid for, however, is still up in the air. Due to a lack of cost-effectiveness analysis, it is unclear whether the therapeutics will be publicly subsidized.
UN Negotiating Price of Takeda’s New Dengue Vaccine
The World Health Organization’s (WHO’s) Pan American Health Organization (PAHO) is working with Takeda to negotiate pricing for the manufacturer’s new dengue vaccine Qdenga, the only one for the widespread illness. A key strategy being proposed is that large nations can pool their resources to purchase the vaccines in bulk at a lower price.
