Radar on Specialty Pharmacy

✦ Oct. 7: The FDA expanded the label of BioMarin Pharmaceutical Inc.’s Palynziq (pegvaliase-pqpz) to increase the maximum allowable dose to 60 mg for the treatment of adults with phenylketonuria. The agency initially approved the drug with a maximum dose of 40 mg on May 24, 2018 (RSP 6/18, p. 8). The recommended initial dosing of the phenylalanine (Phe)-metabolizing enzyme is 2.5 mg subcutaneously once weekly for four weeks. Then dosage should be titrated in a stepwise manner over at least five weeks to achieve a dosage of 20 mg once daily. That can be increased to 40 mg once daily after 24 weeks in people who have not achieved blood Phe control. Dosing can be increased to 60 mg once daily in people who have been on the 40 mg dose for at least 16 weeks and not achieved blood Phe control. Website Drugs.com lists the price of one syringe for all three doses — 2.5 mg/0.5 mL, 10 mg/0.5 mL and 20 mg/mL — as $541.94. Visit www.palynziq.com.

✦ Oct. 14: The FDA gave another approval to Harmony Biosciences Holdings, Inc.’s Wakix (pitolisant) for the treatment of cataplexy in adults with narcolepsy. The agency initially approved the selective histamine 3 (H3) receptor antagonist/inverse agonist on Aug. 15, 2019 (RSP 9/19, p. 8). Dosing in the first week is initiated with 8.9 mg once daily, then increased to 17.8 mg once daily in the second week and then increased to the maximum recommended dosage of 35.6 mg once daily in the third week. Website GoodRx lists the price of 60 17.8 mg tablets as more than $11,223. Visit https://wakix.com.

✦ Teva Pharmaceuticals USA, Inc. launched the first generics of Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate). Emtricitabine/tenofovir disoproxil fumarate is indicated for the treatment of HIV-1 in combination with other antiretroviral agents in people weighing at least 37 pounds, as well as for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk people weighing at least 77 pounds. Efavirenz/emtricitabine/tenofovir disoproxil fumarate is indicated for the treatment of HIV-1 infection in people weighing at least 88 pounds either as a complete regimen or in combination with other antiretroviral agents. The wholesale acquisition cost for a tablet of 200 mg/300 mg emtricitabine/tenofovir disoproxil fumarate is $48.51 — or $1,455.30 for 30 days — and 600 mg/200 mg/300 mg efavirenz/emtricitabine/tenofovir disoproxil fumarate’s WAC is $78.86 per tablet, or $2,365.80 for 30 days. Website Drugs.com lists the price of 30 tablets of all four dosages of Truvada as $1,932.84, and the price of 30 600 mg/200 mg/300 mg tablets of Atripla as $3,135.98. Teva has savings cards for both drugs for eligible commercially insured patients available for download; the offers expire March 29, 2021. Visit www.tevahivgenerics.com.

✦ The United States realized $2.2 billion in savings from biosimilar use in 2019, according to the Association for Accessible Medicines report Securing Our Access & Savings: 2020 Generic Drug & Biosimilars Access & Savings in the U.S. Report. The total savings from 2010 to 2019 was almost $4.5 billion. But with 28 biosimilars approved and only 17 on the market, those delayed launches have cost the U.S. health system $9.8 billion in lost savings since 2015, according to the report, which was published Sept. 29. Download it at https://accessiblemeds.org/2020-Access-Savings-Report.

✦ 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: