Specialty Pharmacy

In the latest version of its annual Unsupported Price Increases (UPI) report, the Institute for Clinical and Economic Review (ICER) found that eight high-expenditure drugs with substantial, unjustified net price increases in 2022 cost insurers and patients nearly $1.3 billion.

“After some reduction in net price increases last year, we're again seeing many increases in net prices for drugs with large budget impacts,” ICER Chief Medical Officer David Rind, M.D., tells AIS Health, a division of MMIT. However, Rind says that recent legislative changes could make a difference in future years.

The recent approvals of the first two gene therapies for sickle cell disease represent potential major breakthroughs for patients who have faced significant burdens associated with the condition. However, there are still questions about how and whether payers will cover the high-cost treatments and how many patients will be open to taking the new treatments.

The FDA on Dec. 8 approved Casgevy (exagamglogene autotemcel) from CRISPR Therapeutics and Vertex Pharmaceuticals Inc. and Lyfgenia (lovotibeglogene autotemcel) from bluebird, Inc. for patients who are 12 or older and have recurrent vaso-occlusive events (VOEs), the term for severe pain and organ damage. The agency noted about 100,000 people in the U.S. have sickle cell disease and that VOEs “can lead to life-threatening disabilities and/or early death.”

Since the FDA approved the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, then a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved more than 40 additional agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). This past year has been especially busy in the space, with highlights including the launch of nine biosimilars of AbbVie Inc.’s Humira (adalimumab) and approvals of the first biosimilars of three different biologics: Biogen’s Tysabri (natalizumab), Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group and Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson. As the FDA approves more biosimilars, uptake of these agents will continue to increase, say industry experts.

“2023 was a banner year for the biosimilar market,” contends Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth. “The availability of biosimilars across multiple therapeutic areas provides opportunities for physicians, patients and payers to have additional clinical and cost-saving treatment choices.”

Since the FDA approved the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, then a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved more than 40 additional agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). This past year has been especially busy in the space, with highlights including the launch of nine biosimilars of AbbVie Inc.’s Humira (adalimumab) and approvals of the first biosimilars of three different biologics: Biogen’s Tysabri (natalizumab), Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group and Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson. As the FDA approves more biosimilars, uptake of these agents will continue to increase, say industry experts.

As the PBM and specialty pharmacy worlds have become more integrated, PBMs now are providing more specialty management services than they previously did. Only 15% of respondents to a recent survey said they carve out specialty drugs from the PBM that is providing their pharmacy benefit management, while 26% said they were considering taking this step, according to the 2023 Pharmacy Benefit Manager Customer Satisfaction Report from Pharmaceutical Strategies Group (PSG), an EPIC company.

The 85% of respondents whose PBMs provide both specialty and traditional pharmacy benefit management ranked formulary management of specialty drugs and financial reporting in the pharmacy benefit as the services they were most satisfied with, while they were least satisfied with management of specialty agents in the medical benefit and offering competitive discounts on specialty medications.

The first biosimilar for the treatment of multiple sclerosis recently received FDA approval, and when it launches, Tyruko (natalizumab-sztn) from Polypharma Biologics and Sandoz Inc. will enter a competitive therapeutic class that is a high priority for management. Payers have said they expect the new treatment to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

Findings from a study jointly conducted by AllianceRx Walgreens Pharmacy and Walgreen Co. reveal the importance of adherence to non-infused biologics for the treatment of rheumatoid arthritis (RA). Specifically, researchers found a connection between adherence and lower medical costs, rates of hospitalization and length of stay (LOS).

Researchers presented the findings on Sept. 20 at the National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo, which was held Sept. 18-21.

The study used data from 2019-2020 in the MarketScan Commercial Claims and Encounters databases for patients with commercial coverage, and Supplemental or Coordination of Benefits databases for Medicare beneficiaries. It also used the reporting metric of proportion of days covered (PDC) from the Pharmacy Quality Alliance (PQA), an independent non-profit organization focused on improving safety, adherence and appropriate use of medications.

Prominent insurance brokers are expecting large percentage increases in employer-plan costs next year, brought on by factors like rising labor costs and higher health care utilization. But there isn’t likely to be any relief in coming years, and experts say plan sponsors will have to be creative and disruptive if they hope to cushion the blow of increasing expenses.

Brokers Mercer Inc., Aon PLC and WTW PLC project that average employer plan costs will increase between 5.4% and 8.5% in plan year 2024.

And while employers don’t have to pass that onto employees in the form of higher monthly plan rates, some industry experts expect rising premiums are on the horizon, too.

A Sept. 26 potential class action lawsuit brought by independent pharmacists accuses CVS Health Corp. of charging excessive direct and indirect remuneration (DIR) fees for Medicare Part D claims administered by the firm’s Caremark PBM division. The suit, filed in the U.S. District Court for the Western District of Washington, calls the DIR fees charged by Caremark “unconscionable,” and says that the vertically integrated managed care, retail and pharmacy giant breached “the covenant of good faith and fair dealing.” In a Sept. 27 press release, the National Community Pharmacists Association (NCPA) — a trade group of independent pharmacists that has recently lobbied in favor of strict regulation of PBMs — backed the lawsuit. “It’s payback time,” said NCPA CEO B. Douglas Hoey. “Finally, community pharmacies have a chance to recover DIR fees that were unfairly taken. PBMs have been gaming the system for a long time, and it’s time to turn the tables.”

PBMs are increasingly deriving profits from collecting fees and from their specialty pharmacies as opposed to manufacturer rebates and spread pricing, according to an analysis published on Sept. 18 from Nephron Research. Eric Percher, the report’s author and a Nephron research analyst, tells AIS Health, a division of MMIT, that the findings suggest PBMs have shifted their business model in recent years even as they receive scrutiny from state and federal government officials for old tactics.

Nephron received compensation for the survey design and independent data analysis from the Pharmaceutical Research and Manufacturers of America (PhRMA), the leading trade group for drug manufacturers. Percher maintains that Nephron had full editorial control of the report.