Radar on Specialty Pharmacy

✦ Bristol Myers Squibb will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an April meeting of the agency’s Oncologic Drugs Advisory Committee to discuss whether to keep certain indications for a handful of checkpoint inhibitors that target programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) and received accelerated approval but had not met post-marketing requirements demonstrating confirmatory benefit. Opdivo received a negative vote for this indication, as did Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy. Merck said recently that it would voluntarily withdraw that indication in the U.S.

✦ Bristol Myers Squibb also will withdraw the indication for Istodax (romidepsin) as monotherapy for the treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy. The FDA initially gave the drug from Celgene Corp., now a Bristol Myers Squibb subsidiary, accelerated approval. A confirmatory Phase III trial did not meet the primary efficacy endpoint of progression free survival.

✦ 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. Dosing for both indications is 1.25 mg/kg via a 30-minute intravenous infusion on days one, eight and 15 of a 28-day cycle. Website Drugs.com lists the price of a 20 mg lyophilized powder as more than $2,380.00.

✦ July 12: The FDA granted another indication to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one line of therapy, including lenalidomide and a proteasome inhibitor. The agency initially approved the anti-CD38 monoclonal antibody on May 1, 2020. The recommended dosage is 1,800 mg/30,000 units subcutaneously into the abdomen over approximately three to five minutes weekly for weeks one to eight, every two weeks from weeks nine to 24 and then every four weeks. Drugs.com lists the price of an 1,800 mg/30,000 per 15 mL vial as more than $8,290.

Employers have long been concerned about costs for specialty therapies, but some may have been hesitant about putting too many restrictions on them. However, as these drugs continue to come onto the market with higher and higher price tags, employers should become more familiar with these therapies in order to properly manage them, industry experts suggest.

Over the past three years, specialty drugs have made up almost two-thirds of all new drug approvals, points out Katie Asch, Pharm.D., senior director and U.S. consulting pharmacy practice lead at Willis Towers Watson. And as these drugs make up the bulk of the pharma pipeline, employers should expect their utilization to continue to rise, she says. “Furthermore, specialty drugs are becoming more widely used in disease states like asthma or eczema that have historically been treated with less expensive inhalers or topical creams,” which also will result in increased utilization.

While specialty pharmacy merger and acquisition activity has certainly slowed, one independent specialty pharmacy continues to snap up other complementary organizations — and, as a result, may find the M&A focus on itself.

BioMatrix Specialty Pharmacy revealed in early July that it had acquired InfuCare LTD, an infusion-focused specialty pharmacy. Located in Tyler, Texas, InfuCare provides BioMatrix with a physical location in what the latter calls a “key geographic area,” providing “access to additional covered lives in one of the nation’s largest states,” according to a company press release. It also brings expertise in chronic, complex conditions that require home infusion with therapies such as intravenous immune globulin (IVIG) and parenteral nutrition.

While total Medicare spending on all Part B drugs continued to rise from 2018 to 2019, a Medicare Payment Advisory Commission (MedPAC) report found that average sales prices (ASPs) for some traditionally costly drugs actually decreased, a trend that may be due to biosimilar competition, posits the recent report.

The report, titled Health Care Spending and the Medicare Program, was published in July 2021. In 2018, total Part B drug spending was just shy of $35 billion, an amount that rose to more than $39 billion the following year. Among the top 10 drugs, 2018 total spend was almost $15 billion, increasing to more than $16 billion in 2019 — or about 41% of all Part B spending for the year.