Specialty Drugs

Plan sponsors’ overall satisfaction with their PBMs increased from 8.0 on a 1-10 scale in 2020 to 8.2 in 2021, according to Pharmaceutical Strategies Group’s 2021 Pharmacy Benefit Manager Customer Satisfaction Report. Based on surveys completed by 291 plan sponsors who provide pharmacy benefits to their employees, the report found that PBMs with 20 million or fewer members tend to have higher satisfaction ratings than larger PBMs. Average satisfaction was highest for PBMs’ opioid management programs, while gene therapy financial protection programs rated the lowest and only 13% of the respondents used such programs. Among PBMs with more than 20 million members, MedImpact scored the highest overall satisfaction rate (8.5).

A review of market access for colorectal cancer treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions. Around 28% of the lives under Medicare formularies are not covered for at least one of the drugs.

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses. Boehringer Ingelheim’s Phase III VOLTAIRE-X clinical trial found no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety over multiple switches between Humira and Cyltezo. Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.

The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). Oncologists showed much more interest in the agent than did payers when Zitter Insights surveyed both stakeholder groups.

On Oct. 29, the FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of CML in two indications: (1) adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors (TKIs), which was given accelerated approval, and (2) adults with PH+ CML-CP with the T315I mutation, which was granted full approval. It is the first FDA approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor.

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

In its third-quarter results, Biogen reported in a Securities and Exchange Commission filing that Aduhelm revenues totaled $300,000, citing the fact that many clinicians don’t want to prescribe the drug. Meanwhile, Eli Lilly & Co.’s donanemab is under an accelerated approval process. That process will include a Phase III study comparing donanemab directly to Aduhelm, according to Daniel Skovronsky, M.D., Ph.D., a Lilly senior vice president and its chief scientific and medical officer.

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 1, the FDA gave another indication to Gilead Sciences, Inc. division Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel) for the treatment of people 18 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). According to a Zitter Insights survey, oncologists said they are likely to prescribe the drug over certain therapies for that indication. Industry experts tell AIS Health, a division of MMIT, that the agent may be a game changer for certain patients, as it fills a treatment gap.

Many people fighting cancer must get their oral oncolytics from a central fill specialty pharmacy, which can add to the time it takes for a prescription to be filled, as well as potential waste when an oncologist changes a medication. Prime Therapeutics LLC recently unveiled a new program known as IntegratedRx - Oncology that the PBM says will help coordinate care for members and streamline the treatment process.

Prime serves more than 33 million people. It is collectively owned by 19 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans.

Oct. 13: The FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ­>20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.

Oncopeptides AB is voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company disclosed on Oct. 22. The FDA gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. The company said that the decision follows the Phase III OCEAN study, which “the FDA does not consider…meets the criteria of a confirmatory study.”