Denise Myshko

Patient and patient advocate Beth Waldron used her social media platform to criticize CVS Caremark’s removal of Eliquis (apixaban) from its national formulary. CVS took notice.

In COVID-19 news, FDA issued an EUA for COVID-19 breath tests. The agency also okayed a third biosimilar of Avastin, extended the review of REGEN-COV, cleared first generic of Elcys, and accepted the BLA for Rolontis.

ICER said Bluebird Bio could use an outcome-based pricing plan of five yearly payments totaling $2.1 million for patients treated with beti-cel who no longer need blood transfusions.

The FDA approves novel therapy for schizophrenia and bipolar and grants accelerated approval to treat rare disorder. The agency also accepted the sBLA and has granted priority review for Actemra or the treatment of COVID-19 and has extended the PDUFA date for vutrisiran.

The FDA authorizes second COVID-19 booster and approves a higher does of Ozempic, Cabenuva for adolescents with HIV, a therapy for rare seizer disorder, and an oral testosterone replacement. The agency issues a complete response letter for a therapy for anemia related to chronic kidney disease, and an advisor committee votes down a drug for ALS.

Insurers need a better understanding of patients’ adherence and discontinuation of medication for primary biliary cholangitis, according to AllianceRx Walgreens Prime study.

Keytruda gets another indication, the first targeted therapy for advanced prostate cancer is approved, BMS snags approval for Opdualag, the FDA misses PDUFA date for Reblozyl and issues CRLs for sintilimab and Natpara.

FDA approves first generic of Symbicort for asthma and COPD and first therapy for rare seizure disorder, Rinvoq and Lynparza get nods for new indications, the agency approves a new delivery system for Alzheimer’s therapy, regulators extend review for Opzelura for skin condition and issue CRL for Fasenra for chronic rhinosinusitis.

ICER also reviewed, plinabulin, which is development chemotherapy-induced neutropenia (CIN) and would achieve common thresholds for cost-effectiveness if priced between $1,100 and $1,600 per dose.

A meta-analysis finds that providing both parents and children with asthma with information about managing their disease can reduce emergency room visits and hospitalizations.

The agency plans to convene an advisory committee to review the application of Nuplazid to treat Alzheimer’s psychosis. The FDA also approved an indication for Opdivo, okays a third biosimilar to blockbuster cancer treatment Neupogen, and issues complete response letter for long-acting HIV therapy.

JAK inhibitors, such as Jakafi (ruxolitinib), have helped improve outcomes and survival of patients with the rare blood cancer.

2021 was a year in which investigators, government officials and drug companies overcame immense challenges to develop successful vaccines against COVID-19. That spirit of innovation is expected to carry over into this year.

In COVID-19 news, FDA grants EUA to AstraZeneca’s monoclonal antibody to prevent infection and the FDA extends EUA of Pfizer/BioNTech Booster to those 16 and 17 years of age. The regulatory agency also approved a therapy for spasticity resulting from multiple sclerosis, and is requiring an updated boxed warning on three top-selling JAK inhibitors for rheumatoid arthritis. And FDA committee votes no on kidney disease drug.

In this diagnostic proof-of-concept trial, an emerging imaging approach that uses a handheld laser demonstrated the ability to visualize muscle degeneration in children with SMA.

Drugs in development and newly approved drugs for non-small cell lung cancer are based on research that has identified driver mutations leading to runaway cell growth and division that characterize cancer.

The pandemic has been associated with an increase in public health spending, rising mental health issues and a record number of overdose deaths, according to a report from the philanthropic arm of UnitedHealth Group.

In COVID-19 news, an advisory committee recommends approval of oral antiviral after Merck releases updated data. The FDA made three approvals this week: an imaging agent to detect ovarian cancer and a vaccine for hepatitis B, and Darzalex Faspro is given an additional indication. New regulatory applications include: Lynparza for early breast cancer; the psoriasis therapy deucravacitinib, a pneumococcal vaccine for children, and an anemia therapy. The regulatory agency also paused the updated clozapine REMS program.

ICER’s first scorecard of the barriers to fair access to medications found, of the policies that could be reviewed, most were structured to support fair access to medications.

A new meta-analysis of research finds that a history of previous cardiac events puts children with hypertrophic cardiomyopathy at risk for cardiac death.

New research confirms that regardless of age or severity of COVID-19 infection, prolonged effects on cognitive function are possible.

In COVID-19 news, FDA expands EUA for Moderna/Pfizer boosters and Pfizer seeks EUA for oral antiviral. Keytruda receives another indication, first therapy is approved for dwarfism, FDA extends review of mavacamten, and Gilead submits application for chronic hepatitis therapy.

People from racial and ethnic minority groups had higher risks of COVID-19 infections, but outcomes varied based on access to primary care physicians and insurance.

Collaboration among stakeholders is needed to increase transparency of pharmacy payment programs and to better align the design of these models with good patient care.

Investigators in Japan have developed a new, noninvasive method for screening for spinal muscular atrophy using saliva analyzed with conventional PCR as an alternative to blood-based genetic screening.

President Biden nominates new FDA commissioner, and the agency has approved a liquid form of a seizure medication and a new treatment for a rare blood disease. The FDA also accepted a supplemental NDA for Jardiance this week.

The high cost and limited clinical evidence for cell and gene therapies have led U.S. health plans and countries outside the United States to limit access.

At a placeholder cost equal to Ozempic, tirzepatide scored lower in a measure of cost-effectiveness compared with Ozempic but higher than Jardiance.

In COVID-19 news, Merck receives UK authorization for oral antiviral, its first approval, and the FDA rejects EUA for COVID-19 respiratory failure therapy. In cancer news, the FDA has approved a novel therapy for chronic myeloid leukemia and extended the review of Janssen’s CAR T therapy for multiple Myeloma. The agency also approved a therapy for age-related blurry vision.

ICER’s analysis finds that Tezspire, which is under review at the FDA, provides clinical benefit for patients with severe asthma, but with increased costs to the healthcare system.