Radar on Specialty Pharmacy

✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma. The agency gave the application priority review, and the review was conducted through the Real-Time Oncology Review (RTOR) pilot program. The FDA first approved the programmed cell death-1 (PD-1) inhibitor on Sept. 4, 2014. The recommended dose of Keytruda is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The list price for the every-three-weeks dosing is $9,869.94; for every six weeks, it’s $19,739.88.

✦ May 14: The FDA approved Apellis Pharmaceuticals, Inc.’s Empaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who are treatment naïve, as well as people switching from any C5 inhibitors, including Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz). Empaveli is the first C3 inhibitor for PNH. The agency gave the drug priority review, as well as fast track and orphan drug designations. The recommended dose is 1,080 mg twice weekly via subcutaneous infusion using an infusion pump. The drug’s annual wholesale acquisition cost is $458,000.

Although there are more than 20 FDA-approved disease-modifying therapies (DMTs) for multiple sclerosis (MS), companies continue to bring new products to market. Zitter Insights found that the majority of payers expect to manage the newest entrant, the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod), to label.

On March 19, the FDA approved Ponvory to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The approval was based in part on the Phase III OPTIMUM study, which showed the product reduced annual relapses by 30.5%, compared with Sanofi’s Aubagio (teriflunomide). It also reduced brain lesions by more than 50%.

Blue Cross and Blue Shield of Minnesota recently launched a new value-based agreement with VillageHealth focused on certain members with chronic kidney disease (CKD) or end-stage renal disease (ESRD). By working with VillageHealth, a DaVita Inc. subsidiary, the Blues plan hopes to improve member outcomes and reduce their total cost of care.

The Centers for Disease Control and Prevention estimates that more than one in seven adults in the U.S. — or 37 million people — have CKD, but most of them do not realize it. When the kidneys are damaged, this can result in high blood pressure, heart disease, stroke and early death. If the condition is not treated, it can progress to ESRD, which requires a transplant or dialysis.

From 2009 to 2019, commercial per-member per-month costs have almost doubled, from $17.28 to $32.73, an increase of 89%, according to the latest Medical Pharmacy Trend Report from Magellan Rx Management. The report also found that the cost of Remicade (infliximab), the top commercial drug, has grown two-and-a-half times during that same period.

For the first time, the top five PMPM commercial drugs have changed, with Ocrevus (ocrelizumab) ranked in the No. 3 spot, displacing Avastin (bevacizumab), which fell to the seventh spot. Researchers found that out of 32 surveyed payers, 72% preferred Avastin’s biosimilars over the reference product (see chart below).

More than 20 multiple sclerosis (MS) disease-modifying drugs (DMDs) currently are available in the U.S. But even with all the competition, prices for most of the agents are around $80,000 per year. Following updated professional treatment guidelines and the FDA approval of new therapies, including generics, Prime Therapeutics LLC recently conducted a study to determine spend and use of the agents over a two-year period. Spending for the class remained fairly steady, as generic use helped offset some costs. Payers should encourage use of these products to help contain their spend on this class, maintains a source from the PBM.

All of the drugs in the study are approved to treat relapsing forms of MS, the most common disease course. Only one — ocrelizumab — also is approved to treat primary progressive MS.