PBMs/Pharmacy Benefit Managers

The Cigna Group’s Express Scripts PBM announced on Nov. 14 that it’s launching a new “cost-plus” prescription drug pricing model for its clients. With the Express Scripts ClearNetwork, “clients pay a straight-forward estimated acquisition cost for individual medications, in addition to a small markup for pharmacy dispensing and service costs.” Express Scripts plans on launching the model in early 2024 and applying it toward generic, branded and specialty drugs. The move comes amid rising scrutiny from regulators over PBMs’ standard business practices like spread pricing, which allows PBMs to pocket the difference when pharmacies charge less for filling prescriptions than payers reimburse.

Five health care organizations, including AHIP and the American Medical Association, have launched the Common Health Coalition: Together for Public Health, according to a Nov. 9 press release. The coalition is “focused on translating the hard-won lessons and successes of the COVID-19 pandemic response into actionable strategies that will strengthen the partnership between our health care and public health systems.” The other founding members are the Alliance of Community Health Plans, American Hospital Association and Kaiser Permanente. Dave A. Chokshi, M.D., a physician at Bellevue Hospital and former New York City Commissioner, is chair of the Common Health Coalition.

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.”

Major payer coverage policies across select categories often met fair access criteria for cost sharing, clinical eligibility, step therapy and provider restrictions, according to the third annual “Barriers to Fair Access” assessment published by the Institute for Clinical and Economic Review (ICER).

The analysis examined coverage policies for 18 drugs across 10 commercial formularies, eight Affordable Care Act exchange plans and the Veterans Health Administration national formulary, representing 42 million enrollees in total. ICER asked the payers for coverage policy information and leveraged the MMIT Analytics Market Access Database for additional information. (MMIT is the parent company of AIS Health, which maintains journalistic independence and did not play a role in producing the report.)

In its annual assessment of whether prescription drug formularies overly restrict access to select medications, the Institute for Clinical and Economic Review (ICER) gave insurers high marks. While it acknowledges that coverage policy information needs to be much more transparent, this year’s report concludes that “major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions.”

However, ICER President-Elect Sarah Emond says the nonprofit research institute is fully aware that its analysis can only do so much to examine all the myriad, complicated facets of what truly defines “fair access.” Therefore, she adds, ICER is actively working on how to make future reports more comprehensive.

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.

The Big Three PBMs — The Cigna Group’s Express Scripts, UnitedHealth Group’s Optum Rx and CVS Health Corp.’s Caremark — all delivered positive results during the third quarter of 2023, and in some ways helped offset underperformance for the firms’ health benefits businesses.

Wall Street analysts were generally positive about the performance of the firms’ PBM subsidiaries, but they had questions about the way each firm plans to manage the cost of glucagon-like peptide 1 (GLP-1) agonists for their clients.

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 Senate Finance Committee on Nov. 8 unanimously approved legislation to block pharmacy benefit manager practices that result in higher cost-sharing for beneficiaries.

The bill does not include provisions that were included in an earlier draft that would ensure “high discount” biosimilars get favorable formulary tiering. But those policies may be added back before the bill reaches the Senate floor for a vote.

The committee is planning to combine the bill with other PBM reform legislation it approved in July which includes a policy that would de-link PBM compensation from the list price of drugs.

Major payer coverage policies across select categories often met fair access criteria for cost sharing, clinical eligibility, step therapy and provider restrictions, according to the third annual “Barriers to Fair Access” assessment published by the Institute for Clinical and Economic Review (ICER).

The analysis examined coverage policies for 18 drugs across 10 commercial formularies, eight Affordable Care Act exchange plans and the Veterans Health Administration national formulary, representing 42 million enrollees in total. ICER asked the payers for coverage policy information and leveraged the MMIT Analytics Market Access Database for additional information. (MMIT is the parent company of AIS Health, which maintains journalistic independence and did not play a role in producing the report.)

The Cigna Group posted results for the third quarter of 2023 that impressed Wall Street, driven by a lower-than-expected medical loss ratio (MLR). However, Cigna executives faced questioning from analysts on potential PBM regulations.

Cigna enjoyed relatively low care utilization, with MLR at 80.5%, beating the Wall Street consensus projection by 12 basis points. The managed care division’s adjusted revenues were $12.7 billion, up 14% year over year.

“Our medical care ratio was better than expectations, driven by our U.S. commercial business. More specifically, our favorable [MLR] performance was a reflection of ongoing disciplined pricing and continued affordability initiatives,” said Cigna Chief Financial Officer Brian Evanko during a Nov. 2 earnings call.