Spotlight on Market Access

FDA Approval of Biogen’s Alzheimer’s Drug Stirs Up Heated Debate, Cost Questions

The FDA on June 7 delivered its much-anticipated approval of Biogen Inc.’s Aduhelm (aducanumab-avwa), immediately stirring up a furor over its high cost, reigniting doubts about its effectiveness, and spurring speculation about how public and private payers will approach coverage for the first novel treatment approved for Alzheimer’s disease since 2003.

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Fee Scheduler Aids in Medical Benefit Drug Reimbursement

MMIT has launched its new Fee Scheduler solution. The product provides a simplified, self-serve workflow for payers to select appropriate pricing methodologies to reimburse medically covered pharmaceuticals. The product will replace payers’ manual processes today across dozens of fee schedules to free up internal resources, streamline the flow of fee schedules to third party vendors and provide clients with the ability to establish custom class pricing to handle biosimilars and other exceptions — all backed by RJ Health data.

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Current Market Access to Alzheimer’s Disease Medications

The FDA on June 7 approved Biogen Inc.’s Aduhelm (aducanumab) to treat Alzheimer’s disease, the first novel therapy approved in this indication since 2003. The accelerated approval of Aduhelm was controversial as results of two Phase III trials in patients with early-stage and mild Alzheimer’s contradicted each other. There are a host of other Alzheimer’s medications on the market, all of which are covered under the pharmacy benefit. The majority of insured people under commercial and Medicaid formularies have plans that put Alzheimer’s drugs under the preferred/preferred (prior authorization and/or step therapy) tier and covered/covered (PA/ST) tiers. More than half of payer pharmacy benefit formularies do not require step therapy or prior authorization for Alzheimer’s medications.

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OEP Winners Credit Year-Round Marketing, Outreach

Medicare Advantage enrollment grew just 1% during the 2021 Open Enrollment Period (OEP) that ran from January to March, compared with growth of 7% during the preceding Annual Election Period (AEP), according to AIS’s Directory of Health Plans (DHP). While the large MA insurers continued to nab the bulk of OEP signups (see infographic, p. 7), an AIS Health analysis finds that of the top 25 OEP performers, regional players followed their AEP successes with OEP gains that were impressive relative to their size.

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Top Payers Jockey Behind UnitedHealthcare in 2021 Medicare Open Enrollment Period

Medicare Advantage enrollment grew by about 257,000 lives during the 2021 Open Enrollment Period (OEP), according to CMS’s May data release and AIS’s Directory of Health Plans. As in the Annual Election Period (AEP), UnitedHealthcare dominated, holding about 32% of the overall OEP gains. Still, there were some shakeups among the other largest MA payers. In terms of membership gains, Centene Corp. (including enrollment from its WellCare brands) jumped from the No. 4 spot in the AEP to the No. 2 spot in the OEP, while Kaiser Permanente rose from No. 7 to No. 5. Cigna Corp., meanwhile, lost much of its momentum from the AEP, dropping from No. 9 to No. 20. See the top 25 OEP performers in the chart below.

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Zeposia May Have Challenges Within Ulcerative Colitis Class

A new entrant to the ulcerative colitis therapeutic class brings a new mechanism of action. However, according to payers responding to a survey by Zitter Insights, the treatment, Bristol Myers Squibb’s Zeposia (ozanimod), may have some challenges breaking into the space.

On May 27, the FDA gave an additional indication to Zeposia for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. The agency initially approved the capsule on March 26, 2020, for relapsing forms of multiple sclerosis (MS). Three other oral S1Ps are approved for MS: Gilenya (fingolimod) and Mayzent (siponimod), both from Novartis Pharmaceuticals Corp., and new entrant Ponvory (ponesimod), from the Janssen Pharmaceutical Companies of Johnson & Johnson.

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Next-Best Omnichannel Programs Are Transforming Sales, Marketing Teams

The pharma industry is seeing an increased use of rules-based algorithms and insights driven by artificial intelligence/machine learning (AI/ML), which are transforming sales and marketing. Speakers at a recent webinar discussed how companies can implement such approaches and how that information can be useful through “next-best” programs.

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Multiple Myeloma Continues to Pose Management Challenges for Payers

Multiple myeloma, an incurable blood disease that starts in the bone marrow and can be a relatively rare cancer, has an array of products available to treat it, and new agents — including the first gene therapy for the disease — continue to gain FDA approval. However, as the therapies are different types of drugs, management of the space can be challenging.

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Small Business Owners Want Big Changes to Lower Drug Costs

Almost 90% of small business owners said the cost of prescription drugs is too high and 63% have an unfavorable view of pharmaceutical companies, according to a recent survey of 1,052 small business owners conducted by the lobbying group Small Business for America’s Future. Among the survey respondents, 66% said the current prescription drug market is in need of a major overhaul and 93% agree that the market needs some changes. Survey respondents supported a variety of solutions to bring down prescription drug costs, with the largest share backing a ceiling for out-of-pocket drug costs for Medicare beneficiaries.

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Dupixent Gains Market Share in Atopic Dermatitis, but New Drugs Loom

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors.

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