Radar on Specialty Pharmacy

✦ Sept. 16: The FDA expanded the use of Roche’s CINtec PLUS Cytology test to help clinicians determine which women who test positive for human papillomavirus (HPV) via cobas 6800/8800 Systems require further diagnostic procedures to prevent disease progression. The test can detect two biomarkers associated with HPV infections that are transforming and can, if left untreated, progress to cervical precancer or cancer. The FDA initially approved the test in March (RSP 4/20, p. 8). Visit https://bit.ly/32YFreW.

✦ Sept. 25: The FDA gave an additional indication to GlaxoSmithKline plc’s Nucala (mepolizumab) for the treatment of people at least 12 years old with hypereosinophilic syndrome (HES) for at least six months without an identifiable nonhematologic secondary cause. The agency says this is the first approval for people with HES in almost 14 years. The FDA gave the product priority review, as well as orphan drug and fast track designations for this use. The agency initially approved the medication in November 2015 (RSP 11/15, p. 6). Dosing for the newest indication is 300 mg as three separate 100 mg subcutaneous injections once every four weeks. Website Drugs.com lists the price of one 100 mg vial as $3,218.84. Visit www.nucala.com.

Prime Therapeutics LLC recently rolled out a tool that will help members proactively identify opportunities for saving money on drugs. The PBM joins multiple other companies offering the Rx Savings Solution platform to their members.

The tool provides people with personalized drug cost savings opportunities based on their formularies and plan designs, reaching out through email, text message or direct mail. Prime uses members’ benefit details and drug claim history to populate the tool, which also has information on current drug prices at in-network pharmacies located near the member. Users may see savings based on suggestions such as a therapeutic alternative, generic substitution or alternate pharmacy.

When the FDA approved Novo Nordisk, Inc.’s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency on Aug. 28, it became the only long-acting agent on the market (RSP 9/20, p. 8). A survey by Zitter Insights shows that many endocrinologists expect to shift prescribing to such agents from the short-acting growth hormones. And many payers say they expect to manage at least one long-acting agent at parity with short-acting growth hormones.

There are seven short-acting growth hormones currently available to treat adults with growth hormone deficiency, all of them branded forms of somatropin:

As the COVID-19 pandemic wears on, it’s more important than ever for people to have the ability to perform needed actions from home. To help with this, AllianceRx Walgreens Prime has released some digital clinical assessments that allow people with certain illnesses to manage their conditions online and remain adherent to therapy.

The assessments are available for people with chronic inflammatory disease, cystic fibrosis, idiopathic pulmonary fibrosis, lipid and blood disorders, multiple sclerosis and organ transplants. Asked how the company decided upon those conditions, James Adams, chief information officer at AllianceRx Walgreens Prime, says that it “took a strategic approach” that “was based on patient volume, diseases and conditions with lower risk, as well as stability of patients. The chronic inflammatory disease (CID) space was our first program to implement digitally with patients already established on therapy. This included patients with conditions such as rheumatoid arthritis, psoriasis, atopic dermatitis, ulcerative colitis, ankylosing spondylitis and others.”

As the focus on drug prices continues (see story above), California recently took a step that it hopes will “increase patient access to affordable drugs,” according to a bill recently signed by the governor. But industry experts differ on the potential impact the law ultimately will have.

On Sept. 28, California Gov. Gavin Newsom (D) signed SB-852, which will create Cal Rx, a state-sponsored generic prescription drug label. The law charges the California Health and Human Services Agency (CHHSA) to enter into partnerships to produce or distribute generic prescription drugs — including biosimilars — and at least one form of insulin, “provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings.” The drugs will be available for “public and private purchasers, providers and suppliers,” including pharmacies and PBMs, and at “a transparent price and without rebates, other than federally required rebates.” CHHSA will enter only those partnerships that “produce a generic prescription drug at a price that results in savings, targets failures in the market for generic drugs, and improves patient access to affordable medications.” The law also is aimed at dealing with drug shortages.