Specialty Drugs

Newly released results of a Prime Therapeutics LLC oncology program suggest that if the PBM were to expand its highly coordinated oral oncology dispensing model beyond the pilot population, cost savings could exceed $1 million. And these promising results signal that the model may be on the brink of expanding into more disease states.

Prime’s medically integrated dispensing (MID) model, which takes a high-touch, care coordination-intensive approach, cut waste by limiting overfills, according to a Prime study released June 2. Compared with the traditional central specialty pharmacy dispensing of oral oncology drugs, the MID pilot involving 627 patients across three commercial insurance plans showed the potential to cut $1,800 in costs “per medication dose change,” according to the results.

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

A new drug to treat plaque psoriasis is the first topical novel chemical entity launched in the U.S. for the condition in 25 years. Both payers and dermatologists have expressed interest in the agent, according to Zitter Insights.

On May 23, the FDA approved Roivant Sciences subsidiary Dermavant Sciences, Inc.’s Vtama (tapinarof) cream for the topical treatment of plaque psoriasis in adults, regardless of disease severity. The company says the agent is the first and only FDA-approved steroid-free topical medication in its class. Dosing of the aryl hydrocarbon receptor agonist is once daily on affected areas, and the drug has no restrictions on length of use. The price for one tube of the drug is $1,325.

The Oncology Care Model (OCM) that CMS’s Center for Medicare & Medicaid Innovation (CMMI) launched almost six years ago is nearing its June 30 end. And while CMMI introduced its Oncology Care First model in November 2019 with an eye on the OCM successor launching before its predecessor’s end, it is unclear what the program’s status is at this point. OCM participants tell AIS Health, a division of MMIT, that their overall experience has been good as they await next steps from CMMI.

The OCM voluntary pilot started in July 2016 with 17 payers and 196 practices; five payers and 126 practices currently are participating. While it began as a five-year program, CMMI extended it for one additional year in 2020 due to the COVID-19 pandemic. The program reimburses providers for episodes of care in the form of a per-beneficiary per-month payment, as well as a possible performance-based payment, if Medicare expenditures are below a target price for an episode. The amount of the payment is tied to a provider’s achievement on various quality measures. All participants began with one-sided risk but could shift to two-sided risk in 2017. Following the 2018 introduction of an alternative two-sided risk arrangement, starting in January 2020, practices that did not earn at least one performance-based payment had to enter one of the two-sided risk options or leave the OCM. Practices that earned at least one performance-based payment could remain in one-sided risk.

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

The FDA recently gave an additional indication to AbbVie Inc.’s Rinvoq (upadacitinib) in ulcerative colitis, broadening that therapeutic class even more. And while a study revealed some concerns around another agent with a similar mechanism of action, payers and gastroenterologists last year expressed interest in Rinvoq over other late-stage pipeline agents.

On March 16, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) blocker. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. The recommended starting dose for the tablet is 45 mg once daily for eight weeks, followed by a maintenance dose of 15 mg once daily. The wholesale acquisition cost for a 30-day supply is $5,671.26.

In the U.S., orphan diseases are conditions impacting fewer than 200,000 people. There are more than 7,000 of these rare conditions affecting an estimated 30 million Americans — and more than 300 million people globally — and new diseases continue to be discovered. Most of them are inherited conditions caused by gene mutations, but some can be caused by environmental factors. These diseases may be serious and even life-threatening, and about half of them affect children.

Before the Orphan Drug Act was passed in 1983, not much research was done into treatments for rare diseases. But that law created financial incentives for pharmaceutical manufacturers, and since then, hundreds of orphan drugs have been developed. As of early 2020, the FDA had approved therapies for more than 800 rare diseases.

May 10: The FDA granted full approval to Eli Lilly and Co.’s Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. The agency first approved the Janus kinase (JAK) inhibitor on May 31, 2018. The drug has been available for COVID treatment since Nov. 19, 2020, under Emergency Use Authorization (EUA). The EUA remains in place for hospitalized people between the ages of 2 and 18 years old who require various degrees of oxygen support. The recommended dose of the tablet for the newest use is 4 mg once daily for 14 days or until hospital discharge, whichever occurs first. Alternative modes of administration via oral dispersion, gastrostomy tube, nasogastric tube or orogastric tube are available. The drug’s list price for a 30-day supply of 2 mg tablets is $2,497.20.

Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz (ranibizumab-nuna), and the medication will be commercially available “through major distributors across the U.S.” on July 1. The drug is the first FDA-approved ophthalmology biosimilar and references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

Now that many large employers have finalized employee health benefits for 2023, some clear trends are emerging, pharmacy benefit consultants tell AIS Health. Among them: many plan sponsors have traditional drug benefits on auto-pilot but are hyper-focused on high-cost specialty drugs.

For non-specialty drugs, the cost trend is pretty flat, says Paul Burns, a pharmacy practice leader at the HR consulting firm Buck. “There’s been some increases over the pandemic, but it’s not wildly spiking — and that’s where 98% of the utilization is.”