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MMIT Reality Check on Chronic Lymphocyctic Leukemia (Dec 2019)

December 6, 2019

According to our recent payer coverage analysis for chronic lymphocyctic leukemia (CLL) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for chronic lymphocyctic leukemia (CLL) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for CLL treatments shows that under the pharmacy benefit, almost 48% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The FDA has approved two biosimilars for Biogen and Genentech’s Rituxan (rituximab), and both are indicated for CLL. Teva Pharmaceuticals USA, Inc. and Celltrion, Inc.’s Truxima (rituximab-abbs) launched in November 2019, and Pfizer Inc.’s Ruxience (rituximab-pvvr), approved in July 2019, will launch in January 2020.

Trends That Matter for New Cystic Fibrosis Medication

December 5, 2019

The FDA recently approved a drug therapy for cystic fibrosis (CF) that is being viewed as a “game-changer” for the roughly nine in 10 patients with the rare, progressive disease who might benefit from it. Where does this leave payers facing rising specialty drug costs across the board? Industry experts predict that most payers likely will cover this latest cystic fibrosis treatment option despite an annual price tag topping $300,000, AIS Health reported.

The FDA recently approved a drug therapy for cystic fibrosis (CF) that is being viewed as a “game-changer” for the roughly nine in 10 patients with the rare, progressive disease who might benefit from it. Where does this leave payers facing rising specialty drug costs across the board? Industry experts predict that most payers likely will cover this latest cystic fibrosis treatment option despite an annual price tag topping $300,000, AIS Health reported.

Vertex Pharmaceuticals, Inc.’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), taken as a twice-daily pill regimen, is the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. The drug directly addresses the underlying cause of the illness — mutations in the CFTR protein.

The FDA approved Trikafta for patients 12 years and older with at least one F508del mutation in the CFTR gene, which is estimated to represent 90% of the cystic fibrosis population — many of whom have had no approved therapeutic options previously.

“From a utilization management standpoint, there is nothing in the marketplace that will be more effective or significantly less costly” than Trikafta, says Yusuf Rashid, R.Ph., vice president of pharmacy and vendor relationship management at Community Health Plan of Washington.

Manu Jain, M.D., professor of medicine and pediatrics at Northwestern University’s Feinberg School of Medicine and director of Northwestern’s adult CF program, expects the payer community generally will approve Trikafta. But coverage “definitely will be uneven,” he says.

The graphics below show the current market access to CF medications for all payers under the pharmacy benefit.

Radar On Market Access: New Acute Migraine Medications May Not Shake Up Formularies

December 5, 2019

New oral medications for acute migraine — one pending launch and two more that could be approved in the coming months — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts tell AIS Health.

New oral medications for acute migraine — one pending launch and two more that could be approved in the coming months — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts tell AIS Health.

Eli Lilly and Co. on Oct. 11 received FDA approval for its drug Reyvow (lasmiditan), an oral medication that’s the first serotonin (5-HT)1F receptor agonist to be approved for migraine. Meanwhile, Allergan on Nov. 19 said it’s on track for December FDA consideration of ubrogepant, an oral CGRP receptor antagonist for acute migraine. Biohaven Pharmaceuticals also has applied for FDA approval on its oral CGRP antagonist rimegepant.

Mesfin Tegenu, R.Ph., president of PerformRx, doesn’t expect widespread uptake of Reyvow. “The launch of lasmiditan will likely not change the formulary status quo when it hits the market, as it most likely will become a niche medication for patients inadequately controlled on triptans, or for those who cannot take triptans,” Tegenu tells AIS Health. “This is primarily due to warnings on the label for driving impairment and central nervous system depression.”

PBMs could have the chance to consider how to handle Reyvow and ubrogepant soon, although it’s not clear how soon. Eli Lilly hasn’t yet set a launch date for Reyvow, while Allergan said it expects ubrogepant to be the first approved oral CGRP receptor antagonist for the acute treatment of migraine.

“As with any new product, [ubrogepant] will need to be analyzed as part of the class of drugs for this indication,” Tegenu says. “Since this is the first oral version of a CGRP antagonist, it does have some administration advantages over injectable products.”

Payers can implement utilization management programs that direct use of these new drugs to those who have failed or cannot tolerate triptans, says Nicole Kjesbo, principal clinical program pharmacist with Prime Therapeutics LLC. “Additionally, payers will consider exclusion strategies and potentially value-based contracts as a means to manage cost and appropriate therapy,” she says.

Radar On Market Access: Amid Budget Standoff, North Carolina Delays Medicaid Transformation

December 3, 2019

In the middle of an epic budget standoff between the state’s Democratic governor and the Republican-controlled legislature over Medicaid expansion and teacher pay, North Carolina’s plan to transfer some 1.6 million Medicaid enrollees into managed care in February is now indefinitely delayed, the North Carolina Dept. of Health and Human Services (DHHS) said on Nov. 19.

In the middle of an epic budget standoff between the state’s Democratic governor and the Republican-controlled legislature over Medicaid expansion and teacher pay, North Carolina’s plan to transfer some 1.6 million Medicaid enrollees into managed care in February is now indefinitely delayed, the North Carolina Dept. of Health and Human Services (DHHS) said on Nov. 19.

Because the North Carolina General Assembly adjourned on Nov. 15 without providing the needed funds and program authority for a Feb. 1, 2020, managed care start date, said DHHS, it has suspended implementation and open enrollment, which began for part of the state in July and went statewide in October.

With an estimated annual spend of approximately $13 billion, North Carolina is the largest state in terms of Medicaid expenditures that has not yet made the move to managed care. And the five managed care organizations taking part in North Carolina’s Medicaid transformation began enrolling beneficiaries on Oct. 14.

Taylor Griffin, a spokesperson for the NC Association of Health Plans, tells the AIS Health that the MCOs are ready to go live on schedule. “Once the state approves a budget, health plans are fully prepared to serve North Carolina’s Medicaid managed care recipients,” he tells AIS Health.

AmeriHealth Caritas North Carolina, one of the insurers contracted to serve the new Medicaid program, said it “remains committed to helping North Carolina bring about its innovative plan for Medicaid transformation” and does not intend to lay off any staff, as one GOP lawmaker had suggested insurers would be forced to do.

But one industry expert cautions against the statewide implementation. “When you push everything statewide all at once, your problems tend to magnify and it becomes very, very challenging for a state to manage not just the beneficiaries — figuring out where to go, how to go, all of that — but the state to manage their five contracted [payers],” remarks Jeff Myers, former Medicaid Health Plans of America president and founder of health care consultancy OptDis.

MMIT Reality Check on Crohn’s Disease (Nov 2019)

November 29, 2019

According to our recent payer coverage analysis for Crohn’s disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Crohn’s disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for Crohn’s disease treatments shows that under the pharmacy benefit, almost 58% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2019, the FDA approved Samsung Bioepis Co., Ltd.’s Hadlima (adalimumab-bwwd) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Merck & Co., Inc. will commercialize the drug in the U.S. It is expected to launch after June 30, 2023.