Only Some US Prescription Drug Prices are 10X Higher than Other Countries
A common talking point in US drug pricing discussions is that US residents pay 10 times as much for prescription medicines than people in other nations. While this is true for many drugs, the picture is more complex. Making such an analysis is complicated by the comparator nations, the drugs studied, and whether they are brand name.
NICE Recommends Expanding Approval for AstraZeneca’s Heart Failure Med
The UK’s National Institute for Health and Care Excellence (NICE) has recommended that Astrazeneca’s heart failure med Forixga (dapagliflozin) should have its indication expanded to adults regardless of the degree of their left ventricular ejection fraction (LVEF). The drug was previously indicated with patients with reduced LVEF of 40% or lower.
FTC Requests Information from Group Purchasers in PBM Probe
During its ongoing probe into the pharmacy benefit manager (PBM) industry, the US Federal Trade Commission (FTC) requested information regarding two group purchasing organizations, which negotiate discounts for PBMs. The two companies included Zinc Health and Ascent Health Services, adding to the growing list of companies interrogated in the probe.
Exploring Insulin Pricing Practices and Their Effects on Patients
Shortly after the passage of the US Inflation Reduction Act, which capped the price of insulin for some patients, three major drugmakers pledged to drop list prices for their insulin products. In a new IQVIA article, learn more about the role of insulin in diabetes management, the underlying forces driving insulin prices, and how this affects patients.
US Court of Appeals Considering Limiting Access to Mifepristone
Comments from Republican-appointed federal judges on the US Court of Appeals for the Fifth Circuit reveal their openness to restricting access to mifepristone, a key component for medication abortions. The judges and the plaintiffs, a group of conservative care providers, noted that the drug is more dangerous than decades of real-world evidence (RWE) indicate. In addition, the judges’ comments revealed they were largely unaware of the approval process of the Food and Drug Administration (FDA) and did not understand how telehealth worked.
Max Foundation and BeiGene to provide Free Brukinsa to 29 LMICs
The Max Foundation, a Seattle-based organization dedicated to health equity, is collaborating with the biotech BioGene to provide Brukinsa to patients with chronic lymphocytic leukemia (CLL) in 29 lower- and middle-income countries (LMICs). The program will last for 3 years and will also provide education on disease management and diagnosis at participating treatment sites.
India’s NPPA Announces New Price Caps for Similar Drugs Sold by Same Drugmaker
India’s National Pharmaceutical Pricing Authority (NPPA) has rolled out a new policy capping prices on similar drugs sold by the same pharma company to the price of the least expensive version. The agency made the move based on the Drug Price Control Order, which it used previously to make medical devices like stents and knee implants more affordable to patients.
NICE Recommends Gilead’s Bulevertide for Hepatitis Delta Virus
The UK’s National Institute for Health and Care Excellence (NICE) has announced its approval of Gilead Sciences’ bulevirtide for the treatment of hepatitis delta virus (HDV) in adults with compensated liver disease. This recommendation comes after the US Food and Drug Administration (FDA) shot down Gilead’s application for issues with manufacturing and delivery.
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.
Exploring the Impact of PBMs on High Drug Prices
The US pays the highest amount per capita on prescription drugs than any other nation. Several factors interact to drive prices up in the nation. Since a major portion of pharmaceutical development occurs in the US, drugmakers argue high prices are necessary to offset research costs and promote exclusivity. In addition, pharmacy benefit managers (PBMs) play a large role in setting drug prices because they negotiate formularies and drug rebates.
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).
Bipartisan US PBM Reform Bill Moves Forward
A bipartisan bill including reforms to the Food and Drug Administration (FDA) and the pharmacy benefit manager (PBM) industry has been advanced by the US Senate Health, Education, Labor, and Pensions committee. The bill, approved with an 18-3 vote, picked up several amendments in the mark-up session before it was advanced.
PBMs and Pharma Leaders Point Fingers During US Senate HELP Committee
At yesterday’s US Senate Health, Education, Labor, and Pensions (HELP) Committee hearing, representatives from pharma and the pharmacy benefit manager (PBM) industry are blaming one another for high prescription drug prices. While PBMs argue that drugmakers could lower list prices on their own, pharma reps argue that PBMs’ practices drive drug prices up.
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.
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.
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.
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.
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.
US PBM Bill Markup Hearing Postponed Until May 11th
US Senators were geared up for a hearing to markup a bill targeting practices of the pharmacy benefit manager (PBM) industry that are alleged to be anticompetitive and drive up drug prices. However, this meeting has been delayed until May 11th so that the markup can occur after a May 10th hearing featuring testimony from major pharma and PBM leaders.
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.
