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.
Highlights
- Express Scripts and
Prime Therapeutics announce three-year collaboration - Department of
Justice files lawsuit against Omnicare, alleges fraudulent billing practices
using invalid prescriptions - OptumRx acquires
specialty pharmacy Diplomat for $300 million - Louisiana Department
of Health reports positive results from "Netflix model" pricing of Hepatitis C
drugs
FDA Approvals and Launches
- Vascepa (icosapent ethyl) receives additional indication to reduce risk of cardiovascular (CV) events in people with elevated triglyceride levels and either established CV disease or type 2 diabetes and two or more CV risk factors.
- Mylan launches Ogivri (trastuzumab-dkst), the second available biosimilar to Herceptin (trastuzumab).
- Toujeo (insulin glargine) receives expanded approval to treat children as young as 6 years of age with Type 1 diabetes.
- Xeljanz XR (tofacitinib) is approved as a once-daily treatment for ulcerative colitis.
- PADCEV (enfortumab vedotin-efjv) is approved for the treatment of locally advanced or metastatic urothelial cancer.
- Arazlo (tazarotene) lotion is approved to treat acne vulgaris.
- Ubrelvy (ubrogepant) is approved for the acute treatment of migraine.
News
Express Scripts and Prime Therapeutics announce three-year
collaboration
- Express Scripts will provide Prime with retail
pharmacy network and pharmaceutical manufacturer contracting services. - Prime will continue supplying PBM services to
its clients and customers.
Department of Justice files lawsuit against Omnicare, alleges
fraudulent billing practices using invalid prescriptions
- The CVS-affiliated
long-term care pharmacy is accused of failing to obtain new prescriptions after
existing prescriptions had expired or run out of refills, electing to instead
re-use invalid existing prescriptions.
OptumRx acquires specialty pharmacy Diplomat for $300 million
- The deal follows the
recent trend of industry consolidation and expands OptumRx's specialty pharmacy
and infusion service capabilities.
Louisiana Department of Health reports positive results from
"Netflix model" pricing of Hepatitis C drugs
- Through the state's
Medicaid and Department of Corrections programs, more Louisiana residents have
received Hepatitis C treatment in the first 75 days of the pricing plan's
implementation than in all of the fiscal year 2019.
Proposed rule describes procedures for the importation of
prescription drugs
- The federal government is accepting comments on
the proposed rule, which would allow for the importation of certain
prescription drugs from Canada.
CMS Office of the Actuary Releases 2018 National Health
Expenditures
- Retail prescription
drug spending grew 2.5% in 2018 compared to 1.4% in 2017. - The increased growth
rate was driven by non-price factors such as drug mix and utilization.
Senators Elizabeth Warren and Richard Blumenthal release report
titled "Inaccessible Insulin: The Broken Promise of Eli Lilly's Authorized
Generic"
- Report raises
questions about the availability and consumer benefits of the newly introduced
Humalog (insulin lispro) authorized generic.
Blue Cross Blue Shield of Massachusetts integrates PillPack into
member app and website
- Integration allows members easier utilization of
the online pharmacy, decreasing reliance on traditional brick and mortar pharmacies.
CVS Health launches Transform Oncology Care program
- The program uses
genomic testing results at point-of-prescribing to match patients with
appropriate treatments.- Testing results are also used to support the enrollment of patients into
clinical trials.
- Testing results are also used to support the enrollment of patients into
Clinical Trials and Research
Jardiance (empagliflozin) produces negative results in EMPERIAL
heart failure trial
- In-class competitor
Farxiga (dapagliflozin) is indicated to reduce risk of hospitalization for
heart failure in adults with type 2 diabetes and established cardiovascular disease
or multiple cardiovascular risk factors.
BMJ study finds that up to 43% of antibiotic prescriptions were
prescribed without an appropriate indication
- Healthcare providers
often inappropriately prescribe antibiotics for viral infections, contributing
to antimicrobial resistance and wasteful spending.
Treatment Guidelines
CDC Vital Signs report outlines treatment target goals of proposed
HIV treatment initiative
- 18% of people at risk for HIV transmission have a PrEP prescription.
- Target goal: 50%
- 86% of people with HIV know they have it.
- Target goal: 95%
- 63% of people who know they have HIV have reached viral suppression.
- Target goal: 95%