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.
- Express Scripts announces launch of Patient Assurance Program, capping out-of-pocket insulin costs.
- Michigan Pharmacists Association releases report analyzing pharmacy benefit manager (PBM) spread pricing. Spread margins on oral solid generic drugs rose from 2% of managed care’s cost in Q1 2016 to 34% of managed care’s cost in Q1 2018.
- CVS Health releases 2018 Drug Trend Report, cites 3.3% commercial drug trend.
- MedImpact releases 2018 Drug Trend Report, cites 1.5% commercial drug trend.
- WellDyne releases 2018 Drug Trend Report, cites 0.3% commercial drug trend.
- Zolgensma produces more positive results in phase 3 trial as FDA approval decision draws closer. Treatment could cost $1.5 million to $5 million dollars.
FDA approvals and launches
- Duaklir Pressair (aclidinium bromide and formoterol fumarate) is approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
- Dovato (dolutegravir/lamivudine) is approved as a complete regimen for treating HIV in treatment-naïve patients.
- Teva receives approval for first generic naloxone nasal spray, a drug used to treat opioid overdose.
- Teva launches generic versions of AndroGel (testosterone gel) and VESIcare (solifenacin succinate).
- Balversa (erdafitinib) is approved to treat certain forms of advanced bladder cancer.
- AbbVie’s Skyrizi (risankizumab-rzaa) is approved for treatment of moderate-severe plaque psoriasis.
- Evenity (romosozumab) is approved to treat osteoporosis in postmenopausal women with a high risk of fracture.
- Plenity (Gelesis100) is approved as a weight management aid in overweight and obese adults.
- Combination lotion Duobrii (halobetasol/tazarotene) is approved for the treatment of plaque psoriasis.
- Eticovo (etanercept-ykro) is approved as a biosimilar to Enbrel (etanercept).
Express Scripts announces launch of Patient Assurance Program, capping out-of-pocket insulin costs
- Program ensures that members pay no more than $25 for a 30-day supply of insulin.
- Express Scripts cites the 2018 average out-of-pocket insulin cost as $41.50 for a 30-day supply.
Michigan Pharmacists Association releases report analyzing the effects of in-state PBM spread pricing
- Spread margin on oral solid generic drugs rose from 2% of managed care’s cost in Q1 2016 to 34% of managed care’s cost in Q1 2018.
- Report suggests not using Average Wholesale Prices (AWPs) as price references and instead recommends that Michigan implement a “…transparent, full pass-through model within Medicaid managed care that is based on actual acquisition cost, plus a dispensing fee…”
CVS Health releases 2018 Drug Trend Report, cites 3.3% commercial drug trend driven by adherence improvements and utilization increases
- CVS Health notes drug pricing inflation to be four times greater than overall U.S. inflation.
- Specialty drugs account for 1% of claims but 45% of total spend.
MedImpact releases 2018 Drug Trend Report, cites 1.5% commercial drug trend
- MedImpact reports sharp increases in manufacturer pricing and specialty drug costs, adding that “[t]he prices of nearly 400 generic drugs skyrocketed more than 1,000% over the past five years.”
WellDyneRx releases 2018 Drug Trend Report, cites 0.3% commercial drug trend
- The PBM predicts that, by 2021, specialty drugs will account for almost 50% of overall drug spend.
- Over 50% of WellDyneRx clients experienced a negative overall drug trend.
Congress passes Right Rebate Act, aiming to prevent drug manufacturers from misclassifying drugs under the Medicaid Drug Rebate Program
- Right Rebate Act emphasizes the importance of generic versus brand drug classification in regard to discount and rebate contracting.
Amazon applies Alexa voice skills to healthcare, launches six new functions
- One of the six new functions allows Express Scripts members to manage home delivery prescriptions.
Federal government indicts Indivior for fraudulently marketing Suboxone (buprenorphine/naloxone)
- Indictment claims that the company deceived healthcare providers and benefit programs into believing the drug was “safer, less divertible, and less abusable than other opioid-addiction treatment drugs.”
Sanofi announces expansion of Insulins Valyou Savings Program
- Starting in June, program will provide $99 monthly access to certain insulin products for cash-paying patients.
- Products included in the program: Toujeo (insulin glargine), Lantus (insulin glargine), Admelog (insulin lispro), and Apidra (insulin glulisine).
FDA adds Black Box Warning to Lunesta (eszopiclone), Sonata (zaleplon), and Ambien (zolpidem) labeling
- FDA cites “rare but serious” injuries involving sleepwalking, sleep driving, and other complex sleep behaviors.
Clinical trials and research
Zolgensma (onasemnogene abeparvovec) associated with prolonged event-free survival and rapid improvements in neuromuscular function according to new data from phase 3 STR1VE trial
- Novartis has estimated that the one-time spinal muscular atrophy (SMA) treatment would be cost-effective at $4 million to $5 million dollars whereas the Institute for Clinical and Economic Review (ICER) cites a threshold of $1.5 million dollars.
- Current SMA treatment involves Spinraza (nusinersen), which carries a list price of $750,000 for the initial year and $375,000 per year thereafter.
- FDA approval decision is anticipated in May 2019.
Praluent (alirocumab) expands label to include cardiovascular benefits
- Label expansion levels the field with in-class competitor Repatha (evolocumab), which received FDA approval for the same indication in December 2017.