RADAR on Specialty Pharmacy

✦ Over the past five years, biosimilars created competition that resulted in savings of $9.8 billion. That’s according to Amgen Inc.’s 2021 Biosimilar Trends Report, its eighth edition. The therapies also have the potential to save people out-of-pocket costs of $238 million in the nine classes in which the agents have been approved. The drugs are launching with wholesale acquisition costs that are generally between 15% and 37% less than those of their reference products.

✦ The average compound annual growth rate (CAGR) of biologics from 2015 to 2019 was 14.6%, according to the 2021 Medication Access Report: Complex Care & Specialty Medications Edition from CoverMyMeds. That’s compared with a CAGR of 1.6% for nonbiologics. From 2010 to 2015, the use of the buy and bill model for in-practice administration of therapies decreased 15 percentage points, while the use of white bagging increased 18 percentage points. More than half of people who are prescribed a specialty drug wait more than a week between the initial prescription and their first dose.

✦ The FDA is requiring revisions to the labels of Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib) following the agency’s review of a large, randomized safety clinical trial of Xeljanz. The trial compared Xeljanz with tumor necrosis factor (TNF) inhibitors in people with rheumatoid arthritis and showed an increased risk of blood clots and death with a lower dose of Xeljanz. A prior study showed the same results but only at a higher dose. While Olumiant and Rinvoq were not studied, they are also Janus kinase (JAK) inhibitors indicated for inflammatory conditions, so the FDA says they might have similar risks. The agency also is limiting all of the drugs’ approved uses to people who have not responded to or cannot tolerate one or more TNF inhibitors.

✦ A group of 16 patient-advocacy organizations wrote a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure requesting that they enact a zero-copay policy for Medicare Part B beneficiaries taking a biosimilar. “These therapies represent an opportunity to improve the health and well-being of millions of Americans and, at the same time, save U.S. taxpayers billions in health care costs,” wrote the organizations, which include the Crohn’s & Colitis Foundation and International Myeloma Foundation. They noted that almost 15% of Part B enrollees pay a 20% coinsurance for reference biologics, and supplemental insurance covers only a portion of that amount. Implementing such a policy would result in savings up to $3.3 billion in out-of-pocket costs and as much as $5.2 billion in taxpayer dollars over 10 years, they wrote.

In 2020, specialty trend — which consists of utilization and cost trend components — continued to increase, but it did so at a slower pace than that of the past five years. That’s one of the findings of Pharmaceutical Strategies Group (PSG), an EPIC company, in its State of Specialty: Spend and Trend Report, published in August. The report, which is based on PSG’s Artemetrx platform and uses integrated pharmacy and medical claims data, also found that biosimilars finally are beginning to produce real savings.

Artemetrx analyzed 62.1 million medical claims and 50.4 million pharmacy claims from its book of business for the report. From 2018 to 2019, the specialty trend was 14.8%, while from 2019 to 2020, it was 11.8%. Most of the percentage was driven by claims utilization, at 9.0%, with cost per claim responsible for the remainder. The per-member per-year trend in the pharmacy benefit increased 17.3% compared with a PMPY trend in the medical benefit of 3.7%. Within the latter benefit, home infusion PMPY trend rose 8.8%, followed by outpatient hospital at 4.0% and physician office at 1.7%.

✦ July 30: The FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kinase inhibitor (TKI) therapies for non-small cell lung cancer (NSCLC) targeting EGFR and KRAS wild-type tumor tissue for metastatic colorectal cancer patients. The in vitro diagnostic kit is intended to be used on the Illumina MiSeq Dx instrument.

✦ Aug. 2: The FDA approved Astra-Zeneca’s Saphnelo (anifrolumab-fnia) to treat adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. It is the first type I interferon (type I IFN) receptor antagonist to gain FDA approval and the first product approved for the most common form of lupus in more than 10 years. The recommended dose is 300 mg via a 30-minute intravenous infusion every four weeks. Drugs.com lists the price of one 100 mg vial as more than $1,799.00.

The FDA recently expanded the indication of a drug for certain types of urothelial cancer, the most common form of bladder cancer. Payers and oncologists appear to be divided, however, on the drug’s place in a treatment regimen. But in a therapeutic class with limited therapeutic options, the approvals are a welcome addition, particularly in the second-line setting.

On July 9, the FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have received at least one line of therapy. The agency also converted the Nectin-4-directed antibody and microtubule inhibitor conjugate’s accelerated approval, granted Dec. 18, 2019, to regular approval for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic urothelial cancer setting.