FDA Grants Tentative Approval to Extended-Release Narcolepsy Agent

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.

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Specialty Pharmacy’s Dose Optimization Program Saved More Than $6 Million Last Year

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.

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Questions Exist Around Some Alternate Funding Companies That Carve Out Specialty Drugs

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.

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2023 MA Landscape Features Geographic Expansions, Duals Offerings and Part B Givebacks

Medicare beneficiaries in nearly every state will have more Medicare Advantage plans to choose from and see lower premiums this fall when shopping for coverage, according to CMS’s recently released landscape files for the 2023 plan year. And both major insurers and regional plans at press time were touting new offerings such as Part B buyback plans, flexible spending features that include allowances for utilities, and enhanced dental coverage.

“What we’re seeing is kind of a continuation of what we’ve seen in the past several years, which is expanding of not only the big five but also of the smaller insurers as well, and then increased focus on supplemental benefits and the Special Supplemental Benefits for the Chronically Ill (SSBCI), and continued expansion into the D-SNP [Dual-Eligible Special Needs Plan] market,” observes Betsy Seals, co-founder and CEO of Rebellis Group, LLC.

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Delaware Is Latest State to Face Retiree Pushback on MA Transition

A newly formed retiree advocacy group called RISE Delaware has filed a lawsuit to stop the “unilateral implementation” of a private Medicare Advantage plan that will replace state retirees’ current health care coverage in Delaware. Highmark Blue Cross Blue Shield of Delaware in February was awarded a three-year contract to serve some 30,000 retired state employees and has reportedly made accommodations to address retirees’ concerns, but the plan’s opponents maintain that it was established by the State Employee Benefits Committee (SEBC) in a clandestine manner without proper input from stakeholders and without consideration for a suitable alternative proposed by a separate committee. And, like a lawsuit in New York City, the group is concerned about the extent to which beneficiary care will be subject to prior authorization under MA.

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2023 MA Landscape Features Geographic Expansions, Duals Offerings and Part B Givebacks

Medicare beneficiaries in nearly every state will have more Medicare Advantage plans to choose from and see lower premiums this fall when shopping for coverage, according to CMS’s recently released landscape files for the 2023 plan year. And both major insurers and regional plans at press time were touting new offerings such as Part B buyback plans, flexible spending features that include allowances for utilities, and enhanced dental coverage.

“What we’re seeing is kind of a continuation of what we’ve seen in the past several years, which is expanding of not only the big five but also of the smaller insurers as well, and then increased focus on supplemental benefits and the Special Supplemental Benefits for the Chronically Ill (SSBCI), and continued expansion into the D-SNP [Dual-Eligible Special Needs Plan] market,” observes Betsy Seals, co-founder and CEO of Rebellis Group, LLC.

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West Coast Public Sector Plan Sponsors Will Coordinate More Closely Through Purchaser Group

The Purchaser Business Group on Health (PBGH) for the first time has created a public purchaser advisory committee. The decision, part of the purchaser group’s newly announced five-year plan, is meant to align the needs of its public members and integrate them with private purchasers.

PBGH is a nonprofit coalition representing nearly 40 public and private purchasers that collectively spend $350 billion annually on health care services. While the group’s members include major corporations such as Apple, Inc., Microsoft Corp. and the Walt Disney Co., PBGH is different from other purchasing organizations in that it also represents public purchasers, according to Elizabeth Mitchell, PBGH’s chief president and chief executive officer.

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AHIP Cheers Ruling in Dialysis Payment Case, but Congress Could Step In

Recently, health insurance trade group AHIP highlighted an under-the-radar Supreme Court ruling that centered on who should pay the bulk of the costs associated with treating some of the sickest patients: those with end-stage renal disease (ESRD). However, industry experts tell AIS Health, a division of MMIT, that what seems to be a victory for employer-based plans may be short-lived if Congress weighs in on the issue.

The case, Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., concerned whether an employer-based health plan violated the Medicare Secondary Payer Statute (MSPS) by offering limited outpatient dialysis benefits to its enrollees. Specifically, the health plan in question had no in-network dialysis providers, capped reimbursement at 87.5% of the Medicare rate, and “imposed utilization management restrictions, such as claims audits and reviews,” health law attorney and Georgetown University research professor Katie Keith noted in a June article for Health Affairs.

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Holistic Approach to Prior Authorization for Genetic Testing Is Key in Making Sure People Get Right Tests, Best Care in Timely Manner

Genetic testing is becoming a greater part of health care, as providers can take advantage of it to help inform patients’ diagnosis and treatment. Multiple tests are now available, and many health plans are covering their costs if certain criteria are met. But that’s a tall order with more than 77,000 genetic tests available and new tests constantly coming to market.

Many payers have prior authorization for genetic tests: An AHIP industry survey conducted between September and December 2019 found that genetic testing was the third most common treatment for prior authorization behind specialty drugs and high-tech imaging.

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Payers Report Cost Savings From Shifting to Biosimilars

As FDA approval of biosimilars continues and agents are expanding into new indications, more payers are using these drugs and seeing cost savings through that utilization, according to Zitter Insights.

When the FDA approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk) on Sept. 1, it was the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency had approved. It also was the 38th biosimilar approved since the first one, Novartis Pharmaceutical Corp. division Sandoz’s Zarxio (filgrastim-sndz), was approved March 6, 2015, referencing Amgen’s Neupogen (filgrastim).

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