Industry Trends

Trends That Matter for New Acute Migraine Medications

January 2, 2020

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.”

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

Perspectives on Dual Eligible SNPs

December 26, 2019

Through strategic acquisitions, product launches and geographic expansions, Medicare Advantage insurers across the U.S. are offering new Special Needs Plans (SNPs) aimed at improving the lives of members who are dually eligible for Medicare and Medicaid, AIS Health reported.

Through strategic acquisitions, product launches and geographic expansions, Medicare Advantage insurers across the U.S. are offering new Special Needs Plans (SNPs) aimed at improving the lives of members who are dually eligible for Medicare and Medicaid, AIS Health reported.

According to an analysis of the 2020 “landscape” files posted by CMS in September, Chicago health care consultancy Clear View Solutions, LLC, estimates that there are 171 net new SNP IDs, up from 60 net new plans in 2019. And 97 of those net new plans are dual eligible SNPs, compared with 47 D-SNPs that were introduced for 2019.

“I do think there is some ‘pent up energy’ from plans, and now that there is clarity with permanency and the requirements for integration, plans are ready to move forward,” Cheryl Phillips, M.D., CEO of the SNP Alliance, says in an email to AIS Health.

Phillips says plans may also be “working to better position themselves” for managed long-term services and supports, as states sharpen their focus on rebalancing their long-term care populations and shift more of the responsibility to managed care organizations.

A review of the new D-SNP offerings for 2020 indicates that larger players such as Anthem, Inc., Centene Corp., Humana Inc., Molina Healthcare, Inc. and UnitedHealthcare are leading the charge, but numerous plans have been introduced on a local level.

For instance, UCare, the largest provider of SNPs in Minnesota, said it is expanding its UCare Connect + Medicare plans to mirror the 62-county UCare Connect service area. And Priority Health is preparing to launch its first D-SNP, which will serve all 68 counties of Michigan’s lower peninsula.

Trends That Matter for Anti-VEGF Market

December 19, 2019

In October 2019, the FDA approved Beovu (brolucizumab-dbll) from Novartis Pharmaceuticals Corp. for the treatment of neovascular (wet) age-related macular degeneration (AMD). The intravitreal injection will compete in a fairly crowded anti-vascular endothelial growth factor (anti-VEGF) market that is led by Eylea (aflibercept) from Regeneron Pharmaceuticals, Inc., AIS Health reported.

In October 2019, the FDA approved Beovu (brolucizumab-dbll) from Novartis Pharmaceuticals Corp. for the treatment of neovascular (wet) age-related macular degeneration (AMD). The intravitreal injection will compete in a fairly crowded anti-vascular endothelial growth factor (anti-VEGF) market that is led by Eylea (aflibercept) from Regeneron Pharmaceuticals, Inc., AIS Health reported.

Novartis priced Beovu at $1,850 per vial — the same per-dose price as Eylea. Following three initial monthly doses, Beovu can be administered every eight to 12 weeks. Eylea also has three initial monthly doses and then may be administered every four, eight or 12 weeks..

For the Managed Care Biologics and Injectables Index: Q4 2018, Zitter surveyed pharmacy and therapeutics (P&T) committee members who work for 51 commercial payers with 139.8 million covered lives between Nov. 30, 2018, and Jan. 7, 2019. When asked about how they would manage Beovu and Eylea, 49% said they were more likely than unlikely or significantly likely to manage the two drugs at parity.

Thirty-five percent said they were more likely than unlikely or significantly likely to start discussions with Regeneron to prefer Eylea over Beovu. Sixteen percent said it was likely or significantly likely that they would prefer Beovu over other anti-VEGF agents besides Eylea.

The graphic below shows the current market access to age-related macular degeneration medications for all payers under the pharmacy benefit.

Radar On Market Access: UnitedHealth Makes Deal to Buy Diplomat as Industry Consolidation Enters ‘Second Phase’

December 17, 2019

Diplomat Pharmacy, Inc., which has been in a tailspin amid mounting financial losses, agreed to a deal with UnitedHealth Group on Dec. 9 that will see the larger firm’s OptumRx division purchase the midsized specialty pharmacy provider/PBM, AIS Health reported.

Diplomat Pharmacy, Inc., which has been in a tailspin amid mounting financial losses, agreed to a deal with UnitedHealth Group on Dec. 9 that will see the larger firm’s OptumRx division purchase the midsized specialty pharmacy provider/PBM, AIS Health reported.

Diplomat’s difficulties began to come into focus earlier this year, when the firm disclosed customer losses in its PBM business and “increased competitive pressure in the specialty market.” In August, Diplomat said it was “reviewing strategic alternatives” to maximize shareholder value. Then on Dec. 9, UnitedHealth disclosed that it agreed to pay $4 per share for Diplomat’s outstanding stock and assume its debt. Equities analysts noted that Diplomat’s stock was trading at $5.81 as of market close on the Friday before the transaction was unveiled.

Adam Fein, Ph.D., CEO of Pembroke Consulting, Inc.’s Drug Channels Institute, says that “the specialty pharmacy market is reaching maturity, as PBMs and insurers dominate specialty drug dispensing channels.” Diplomat, he says, “was unable to navigate the industry’s evolution.”

“Diplomat’s sale at a bargain basement price signals that the shakeout is underway,” Fein adds. “Fewer new specialty pharmacies are starting up, the bigger companies are getting acquired, and market share is concentrating further with the biggest players.”

Ashraf Shehata, KPMG’s national sector leader for health care and life sciences, says that the purchase of Diplomat comes as the rivalry is intensifying between UnitedHealth and its two big consolidated rivals, CVS Health Corp. and Cigna Corp.

Now that those companies have completed major transactions to assemble their assets — with CVS buying health insurer Aetna and Cigna acquiring the PBM Express Scripts — “we’re kind of seeing what I call the second phase right now of the competition really heating up between the big players,” he says.

Growth continues to be the “name of the game” for those three companies, Shehata says, but it’s difficult to come by in an industry that’s already so consolidated. Because of that, “now you might see some growth on the edges” in the same vein as the UnitedHealth/Diplomat deal, he adds.

Perspectives on Preferred Cost-Sharing Pharmacy Networks

December 12, 2019

In the Medicare Part D market in 2020, preferred cost-sharing pharmacy networks continue to be king. But because independent pharmacies often find themselves shut out of such arrangements, recently introduced legislation is seeking to change that dynamic.

In the Medicare Part D market in 2020, preferred cost-sharing pharmacy networks continue to be king. But because independent pharmacies often find themselves shut out of such arrangements, recently introduced legislation is seeking to change that dynamic.

“The Part D plans have fully adopted preferred networks over the last few years,” Adam Fein, Ph.D., president of Pembroke Consulting, Inc., and CEO of Drug Channels Institute, tells AIS Health. “The [retail] chains obviously have some different strategies but are looking for the foot traffic” that comes from offering lower cost sharing as part of a preferred network.

Meanwhile, many independent pharmacies and the pharmacy services administrative organizations (PSAOs) that represent them in negotiations with health plans are moving away from preferred Part D networks.

Fein says they “have concluded that the incremental traffic they’re going to get is not worth the profit they’re going to sacrifice.”

Ultimately, “I think the open question is, will this create access problems to preferred networks, and does CMS care?” he says.

The National Community Pharmacists Association (NCPA) isn’t counting on regulatory intervention. The organization is supporting a bill — introduced last month by U.S. Reps. Peter Welch (D-Vt.) and Morgan Griffith (R-Va.) — which would allow any pharmacy located in an underserved area to participate in a Part D preferred network as long as that pharmacy accepts the terms and conditions.

“We’re not asking for different terms and conditions, [or] higher reimbursement; we’re just asking to be able to see what the terms and conditions are to be in the preferred network and then make our best decision if we want to participate or not,” says Ronna Hauser, the president of policy and government affairs operations at NCPA.

The Pharmaceutical Care Management Association opposes the bill.

“The proposed any willing pharmacy provisions threaten the effectiveness of selective contracting with pharmacies as a tool for lowering costs,” says as statement from the PBM trade group.

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.