Radar on Specialty Pharmacy

With companies trying to keep their prescription drug spending down, some have turned to alternate funding companies. While their approaches may seem appealing initially, some — such as ones that carve out certain specialty drugs and seek coverage from patient assistance funds — may not be worth the investment, say industry sources, who encourage companies to take a closer look at what their savings actually are.

During a July 29 webinar titled Specialty Drugs Update: Trends, Controversies, and Outlook, longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, noted that while the use of copay accumulators and maximizers has risen, “there is another newer trend that’s even scarier, and that’s the business of what some people call specialty carve-outs,” he said, calling this “the shady business of specialty carve-outs.” Vendors such as ImpaxRX, Paydhealth, SHARx, PayerMatrix and Script Sourcing get payers to exclude specialty drugs and then get those drugs covered via patient assistance programs at manufacturers or charitable foundations. If patients are denied patient assistance, coverage reverts to the company’s payer/PBM/specialty pharmacy.

As spending on specialty drugs continues to rise, payers are implementing various utilization management strategies in an effort to rein in their costs. While prior authorization and step therapy are perhaps the most common tactics, other approaches, such as quantity limits, site-of-care optimization and dose optimization also can be successful tools, as evidenced by one specialty pharmacy’s recent announcement.

In September, AllianceRx Walgreens Pharmacy revealed that its use of dose optimization resulted in $6.2 million in savings in 2021. The strategy reduces the number of dispensed units of an oral, injectable or infusible agent while delivering the same appropriate dose. Some manufacturers charge the same or similar price for different doses of a drug, so if a patient is given a prescription for two 10 mg tablets per day, and a 20 mg tablet is available, it can be more efficient and economical for the patient to take the single 20 mg tablet.

A new formulation of a narcolepsy drug may get uptake among providers, according to Zitter Insights research. But payers indicate that they are likely to require patients to fail at least one generic drug before getting access to the new agent and other branded medications. Still, the agent’s less onerous dosing may allow it to pull market share from similar medications within the class.

On July 19, Avadel Pharmaceuticals plc said that the FDA had granted tentative approval to its Lumryz (sodium oxybate) for the treatment of excessive daytime sleepiness or cataplexy — an abrupt loss of muscle tone that can be triggered by strong emotion — in adults with narcolepsy. The drug — which is also known as FT218 — is a once-at-bedtime extended-release version of Jazz Pharmaceuticals plc’s Xyrem, a drug that requires one dose at bedtime and then another dose between two-and-a-half to four hours later.

After increasing its share in Shields Health Solutions last year, Walgreens Boots Alliance, Inc. has entered into an agreement to purchase the remaining stake of the health system-owned specialty pharmacy integrator. The move, says one industry expert, may represent one more step in putting independent specialty pharmacies out of business.

After making incremental investments in Shields, Walgreens said on Sept. 20 that it would purchase the remaining 30% stake for approximately $1.37 billion. Shields — which partners with health systems to help them create and grow a hospital-owned specialty pharmacy program — has served more than 1 million people and has almost 80 health system partners that represent nearly 1,000 hospitals across the U.S. Shields will operate as a separate business and brand within Walgreens.

Sept. 9: The FDA approved Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The agent is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. The recommended dosage of the tablet is 6 mg once daily. The list price for a 30-day supply is $6,164.

Sept. 9: The FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The manufacturer says it is the first novel long-acting granulocyte colony-stimulating factor (G-CSF) approved in more than 20 years. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle. The company says it expects the product to be available in fourth-quarter 2022.