Radar on Specialty Pharmacy

With more than 4,000 cell and gene therapies (CGTs) in development, plan sponsors should not be ignoring or underestimating the potential impact of these agents, not only on their beneficiaries’ health but also on their own bottom lines. A recent report by Pharmaceutical Strategies Group (PSG), an EPIC company, found that some improvement is needed in this area.

Sponsored by Prescryptive Health and published June 11, “2024 Trends in Drug Benefit Design Report,” examines trends among traditional — or nonspecialty — drug benefits, as well as gene therapies.

June 7: The FDA expanded the treatment area of Almirall, LLC’s Klisyri (tirbanibulin) from up to 25 cm² of the face or scalp to up to 100 cm² for the treatment of adults with actinic keratosis.  The agency first approved the microtubule inhibitor on Dec. 14, 2020. Dosing is one unit-dose packet on the face or scalp once daily for five consecutive days. Drugs.com lists the price of five packets of the ointment as more than $1,179.

June 10: The FDA gave another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Kevzara (sarilumab) for the treatment of people weighing at least 63 kg with active polyarticular juvenile idiopathic arthritis. The agency initially approved the interleukin-6 (IL-6) receptor antagonist on May 22, 2017. The recommended dose is 200 mg via subcutaneous injection every two weeks. Drugs.com lists the price of both the 150 mg/1.14 mL and 200 mg/1.14 mL as more than $4,582.

BCS Financial Corp. unveiled the Gene Therapy Rider on its EssentialCare Critical Illness insurance policy, the company said on June 18. The offering by the insurance and financial services company, which is owned by all 34 Blues plans, can pay the entire policy face value amount when a beneficiary is diagnosed with a covered disease and chooses to undergo treatment with an FDA-approved gene therapy. “The payments, which are based on the policy's face value, are made directly to the insured to use how they see fit,” says the company.

Prime Therapeutics LLC and Magellan Rx Management launched the technology-enabled specialty pharmacy solution Pharmacy Match, the companies said June 19. The offering, which is powered by Free Market Health’s cloud-based technology platform, is designed to drive competition by comparing prices across the market for specialty drugs and identifying the specialty pharmacy “best suited to meet their needs.” It also tracks each claim through fulfillment.

The FDA recently approved the second gene therapy for hemophilia B, Pfizer Inc.’s Beqvez (fidanacogene elaparvovec-dzkt). While the agent offers an additional treatment option with the potential for freedom from regular infusions of factor therapy, its price — which is equal to that of its competitor — may be too high for many payers, according to a Zitter Insights survey. Industry experts say that it may suffer from some of the challenges other cell and gene therapies have faced in gaining a foothold in the U.S. market.

On April 25, the FDA approved Beqvez for the treatment of adults with moderate to severe hemophilia B who use factor IX prophylaxis therapy; have current or historical life-threatening hemorrhage; or have repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to adeno-associated virus (AAV) serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. The manufacturer launched a warranty program for the intravenous infusion based on durability of patient response to treatment.

Specialty drugs are still taken by only a small percentage of people but represent more than half of total drug costs. Anti-inflammatory specialty therapies continue to be a huge driver of those costs, according to the recently released 2023 Drug Trend Report from PBM analytics firm Xevant. The specialty pipeline remains strong, and payers should expect these agents to continue to affect their costs, says one industry expert.

Based on Xevant’s book of business for 2022 and 2023, the company observed an 11% increase in the number of prescriptions filled for specialty drugs. The plan-paid amounts for those agents rose 19%, slightly less than nonspecialty medications’ 22% plan-paid costs. In addition, the average plan cost per specialty prescription rose from $6,100 in 2022 to $6,700 in 2023.