Pharmacy Briefing is a monthly summary of select FDA approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
- Congressional Budget Office (CBO) projects that the proposed change to pharmaceutical rebate legislation would increase federal spending by $177 billion over a period of ten years
- Connecticut Attorney General files multi-state antitrust lawsuit against nation’s largest generic manufacturers and industry executives
- New York State Senate releases investigative report detailing PBM practices
- Zolgensma (onasemnogene abeparvovec-xioi) is approved, carries a $2.125 million price tag
- Eli Lilly launches Insulin Lispro Injection as a cheaper, generic alternative to Humalog (insulin lispro)
FDA Approvals and Launches
- Zolgensma (onasemnogene abeparvovec-xioi) is approved for the treatment of spinal muscular atrophy.
- Novartis quotes a list price of $2.125 million for the one-time treatment.
- Eli Lilly launches Insulin Lispro Injection as a cheaper, generic alternative to Humalog (insulin lispro).
- Vyndaquel (tafamidis meglumine) and Vyndamax (tafamidis) are approved for the treatment of transthyretin amyloid cardiomyopathy, a rare heart disease.
- Ruzurgi (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients between the ages of 6 and 17.
- Ruzurgi (amifampridine) may compete with Firdapse (amifampridine), an expensive drug with an annual list price of $375,000.
- Nayzilam (midazolam) nasal spray is approved for the treatment of certain types of seizures.
- Solirux (calcipotriene) foam is approved for the treatment of plaque psoriasis.
- Piqray (alpelisib) is approved to treat certain forms of breast cancer.
- Triple-therapy Qternmet XR (dapagliflozin/saxagliptin/metformin) is approved for use in patients with type 2 diabetes mellitus.
Congressional Budget Office (CBO) projects that the proposed change to pharmaceutical rebate legislation would increase federal spending by $177 billion over a period of ten years
- CBO also cites a Milliman analysis that presents the impact of several possible scenarios, focusing on the impact to stakeholders in the Medicare Part D program.
Connecticut Attorney General files multi-state antitrust lawsuit against nation’s largest generic manufacturers and industry executives
- 44-state coalition accuses certain manufacturers of participating in a national conspiracy to raise drug prices for more than 100 different generic drugs.
- Lawsuit claims that “defendants use terms like “fair share,” “playing nice in the sandbox,” and “responsible competitor” to describe how they unlawfully discouraged competition, raised prices and enforced an ingrained culture of collusion.”
New York State Senate releases investigative report detailing PBM practices
- The Committee on Investigations and Government Operations states that, “[i]t is the opinion of the Committee that PBMs often employ controversial utilization and management tools to generate revenue for themselves in a way that is detrimental to health plan sponsors, patients, and pharmacies.”
- Report suggests statewide legislative reform in regards to spread pricing, mandatory use of specialty and mail order pharmacies, adequate and transparent pharmacy reimbursement, and transparency of maximum allowable cost (MAC) appeals.
Gilead Sciences announces donation of pre-exposure prophylaxis (PrEP) drugs to U.S. Centers for Disease Control and Prevention (CDC)
- Donation is intended to “create an opportunity for state and local partnerships to develop and implement protocols that are intended to ensure uninsured people at risk for HIV are given access to PrEP at no cost.”
IQVIA publishes review of 2018 national medicine use and spending
- IQVIA notes a 2.7% increase in 30-day equivalent prescriptions compared to 2017.
- Growth in total medicine spending net of rebates, discounts, and other concessions increased 4.5%.
Kentucky Attorney General files lawsuit against Eli Lilly, Sanofi, and Novo Nordisk over insulin pricing
- Lawsuit claims that “estimated manufacturing cost of most insulin ranges from $2.28 to $6.34 per vial” and that “the average wholesale price of insulin is now almost $300.”
Pharmacy benefit managers (PBMs) ProCare and MC-21 merge to create MC-Rx
- MC-Rx will have clients in all 50 states, Puerto Rico, St. Thomas, and the U.S. Virgin Islands.
Centers for Medicare and Medicaid Services (CMS) announces Part D changes to increase drug pricing transparency
- Changes, effective January 1, 2020, include mandatory implementation of point-of-care prescription pricing tools for clinicians and monthly Explanation of Benefits documents that inform enrollees of drug pricing increases and lower-cost alternatives.
Colorado governor signs legislation capping out-of-pocket insulin costs for patients with insurance
- Covered patients must pay no more than $100 per 30-day supply of insulin, regardless of amount or type.
Proposed Senate bill attempts to reduce health care costs, includes PBM-related reforms
- Bipartisan legislation mandates “pass-through” PBM pricing and revises Hatch-Waxman 180-day exclusivity periods for generic drugs, among other reforms.
Clinical Trials and Research
Retrospective study identifies Fournier gangrene as a possible safety concern in patients receiving sodium-glucose cotransporter-2 (SGLT2) inhibitor therapy
- Common SGLT2 inhibitors include Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin).
Integrity and accuracy of World Health Organization (WHO) opioid prescription guidelines are questioned in Congressional report
- Report accuses Purdue Pharma of exerting influence over several WHO publications.