Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
- AbbVie acquires Allergan in $63 billion deal
- Navitus releases 2018 Drug Trend Report, touts “industry-leading” cost savings, 0.3% drug trend
- Senate Health Committee approves Lower Health Care Costs Act targeting surprise medical bills and PBMs
- JAMA study links long-term anticholinergic drug use to an increased risk of dementia
FDA Approvals and Launches
- Emgality (galcanezumab-gnlm) receives new indication approval for the treatment of episodic cluster headaches.
- Drug was first FDA-approved in September 2018 for the preventive treatment of migraines.
- Two new methods for administering asthma drug Nucala (mepolizumab) are approved, now allowing patients to self-administer treatment with an auto-injector or a prefilled syringe.
- Vyleesi (bremelanotide) is approved to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women.
- Jazz Pharmaceuticals announces July launch of excessive daytime sleepiness drug Sunosi (solriamfetol) after Schedule IV controlled substance designation.
Teva and Analog Pharma launch generic versions of Diclegis (doxylamine/pyridoxine), a drug used to treat morning sickness.
AbbVie acquires Allergan in $63 billion deal
- Combined product line includes Humira (adalimumab), Botox (onabotulinumtoxinA), and Restasis (cyclosporine ophthalmic emulsion).
Navitus releases 2018 Drug Trend Report, touts “industry-leading” cost savings, 0.3% drug trend
- Across its commercial line of business, Navitus “achieved an industry-leading total net cost per member per month (PMPM) of $75.83…which is 15% lower than the industry average of $88.97.”
Senate Health Committee approves Lower Health Care Costs Act targeting surprise medical bills and PBMs
- Components of the legislation include protections against out-of-network cost-sharing amounts and surprise air ambulance bills, PBM transparency mandates, and the creation of a national all-payer claims database.
- Lower Health Care Costs Act now moves to the full Senate for consideration.
Evaluate releases 2019 edition of World Preview, projecting global trends in prescription drug sales
- The report projects Humira (adalimumab), Keytruda (pembrolizumab), and Eliquis (apixaban) to be the top three best-selling products in terms of revenue in 2024.
- Prescription drug sales for 2010 through 2018 grew at a compound annual growth rate (CAGR) of 2.3%. The forecast annual CAGR for 2019 through 2024 is 6.9%.
Insys Therapeutics settles with U.S. Department of Justice for $225 million in regard to the promotion of Subsys (fentanyl) sublingual spray
- Criminal investigations stemmed from “Insys’s payment of kickbacks and other unlawful marketing practices in connection with the marketing of Subsys. “
President Trump signs executive order intended to increase healthcare quality and improve pricing transparency
- Executive order outlines multiple goals, setting deadlines for federal agencies to take various actions such as the drafting of proposals, guidance, or reports.
California, the District of Columbia, Hawaii, and Maine sue Purdue Pharma for the company’s role in the opioid crisis
- Over 40 states have filed lawsuits against the company.
Federal court issues injunction preventing the release of generic Gilenya (fingolimod)
- Novartis is currently involved in a patent dispute to extend the drug’s brand exclusivity until 2027.
- Gilenya (fingolimod) produced $3.3 billion in net sales in 2018.
Clinical Trials and Research
JAMA study links long-term anticholinergic drug use to an increased risk of dementia
- The three most common anticholinergic drugs prescribed within the study population were Compazine (prochlorperazine), Elavil (amitriptyline), and Chlor-Trimeton (chlorpheniramine).
- Associations with dementia were strongest for anticholinergic antidepressants, bladder antimuscarinics, antipsychotics, and antiepileptics.
SPIRIT-H2H trial demonstrates superiority of Taltz (ixekizumab) over Humira (adalimumab) in patients with active psoriatic arthritis
- Taltz (ixekizumab) achieved both primary and secondary endpoints in the head-to-head, phase 3b/4 study.
World Health Organization (WHO) retracts opioid treatment guidelines
- U.S. legislators previously released a report linking Purdue Pharma and WHO, suggesting that the published opioid guidelines had questionable integrity and accuracy.