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Radar On Market Access: Analysts Question Issues Surrounding Beovu’s Uptake in Full Anti-VEGF Market

November 12, 2019

Last month, 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.

Last month, 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.

However, while anticipation for Beovu continued to be high after the HAWK and HARRIER clinical trial results were released, analysts questioned the drug’s label and what it does — and doesn’t — contain.

According to BioPharma Dive, “unlike Eylea, Beovu doesn’t have a four-week dosing regimen, which Piper Jaffray analyst Christopher Raymond claims could limit uptake among patients who need more frequent injections. The drug’s label included data that showed worse rates of inflammation and immunogenicity than Eylea, while also excluding secondary endpoint results that showed Beovu outperforming Eylea on several measures of eye health.”

The price also could dampen pickup. Another potential impact on the anti-VEGF class is expected biosimilar competition over the next few years.

Radar On Market Access: Some Insurers Cover Acupuncture to Combat Opioid Epidemic

November 7, 2019

Insurers seeking non-opioid alternatives to treat chronic pain increasingly are opting to cover acupuncture, despite scant medical evidence for its effectiveness. In many cases, plans are classifying acupuncture benefits as part of their wellness program instead of as medical benefits, and members don’t need a diagnosis to have sessions covered, AIS Health reported.

Insurers seeking non-opioid alternatives to treat chronic pain increasingly are opting to cover acupuncture, despite scant medical evidence for its effectiveness. In many cases, plans are classifying acupuncture benefits as part of their wellness program instead of as medical benefits, and members don’t need a diagnosis to have sessions covered, AIS Health reported.

The acute need for alternatives to opioids to treat chronic pain is a major reason for new acupuncture coverage, insurers say, and acupuncture is also a member-pleasing bonus.

Blue Cross Blue Shield of Massachusetts (BCBSMA) will offer a new acupuncture benefit starting Jan. 1 for all members except for those in Medicare Advantage (MA) plans.

According to Ken Duckworth, M.D., medical director for behavioral health at BCBSMA, combating opioid abuse isn’t the only rationale behind adding acupuncture as a benefit, but “this could also be another step in helping to reduce the number of inappropriate opioid prescriptions being written in Massachusetts.”

Independence Blue Cross began covering acupuncture in January, says Ginny Calega, M.D., vice president of medical affairs. Acupuncture is a covered benefit for Independence large-group commercial plans, she says. It can be used as part of a comprehensive treatment plan for patients with chronic pain.

Cigna Corp., meanwhile, will offer limited acupuncture sessions to select MA members beginning in 2020. The insurer’s rationale is different than reasons offered by Independence and the Massachusetts Blues plan: it’s hoping that the benefit could help lure seniors who are on the fence about which MA plan to choose.

CMS also has proposed to cover acupuncture, but only for fee-for-service Medicare beneficiaries enrolled in certain clinical trials.

Radar On Market Access: Study Highlights Racial Bias in Optum Risk-Prediction Algorithm

November 5, 2019

To improve care for patients with the most complex health needs, many providers and payers turn to risk-prediction tools that use an algorithm to determine which patients need more intense care management. But a recent study, published in the journal Science, found that one such widely used algorithm exhibits significant racial bias by assigning black patients the same level of risk as white patients even when they are far sicker, AIS Health reported.

To improve care for patients with the most complex health needs, many providers and payers turn to risk-prediction tools that use an algorithm to determine which patients need more intense care management. But a recent study, published in the journal Science, found that one such widely used algorithm exhibits significant racial bias by assigning black patients the same level of risk as white patients even when they are far sicker, AIS Health reported.

This study garnered significant media attention, and at least one state’s regulators launched an investigation into UnitedHealth Group, whose Optum subsidiary sells Impact Pro, the data analytics program that researchers studied.

Brian Powers, M.D., one of the study’s authors and a researcher at Brigham and Women’s Hospital, says that “the algorithm did a great job of what it was specifically designed to do, which was predict future health care costs.” The problem is that the organizations deploying the tool often “use health care costs as a proxy for health care need,” he says, and black patients tend to cost the health system less because of a “lack of access to care due to structural inequalities, and a variety of other issues that have been well documented.” So while there is a correlation between high-risk patients and high health care spending, just looking at expenditures doesn’t paint a truly accurate picture of patients’ health care needs.

Rich Caruana, a Microsoft Corp. senior researcher who studies machine learning in health care, says he was “not at all surprised” to learn that researchers uncovered hidden bias in a predictive algorithm.

“Most of what machine learning is doing is right, but in addition to these things it’s doing really right, roughly 5% of what it’s learning are these sort of silly, wrong things,” he continues. “These are known as treatment effects — we’re seeing patients’ risk as more or less based on the treatment that they receive.”

Perspectives on Pelosi Drug Pricing Legislation

October 31, 2019

Although there is bipartisan support for drug pricing reform and recent bills introduced in the House and the Senate share some concepts, conservatives and pharmaceutical manufacturers have found plenty to dislike about the drug pricing legislation unveiled in September by House Speaker Nancy Pelosi (D-Calif.), AIS Health reported.

Although there is bipartisan support for drug pricing reform and recent bills introduced in the House and the Senate share some concepts, conservatives and pharmaceutical manufacturers have found plenty to dislike about the drug pricing legislation unveiled in September by House Speaker Nancy Pelosi (D-Calif.), AIS Health reported.

In addition to restructuring the Part D benefit to include an out-of-pocket cap, the Lower Drug Costs Now Act (H.R. 3) would allow the HHS secretary to negotiate drug prices for at least 250 drugs where there is no effective competition. Manufacturers would be subject to certain transparency requirements and a “noncompliance fee.” Moreover, the bill would require that the negotiated price should be no more than 1.2 times the weighted average of the price in six other countries.

Speaking at AHIP’s 2019 National Conference on Medicare, held Sept. 23-24 in Washington, D.C., American Action Forum President Douglas Holtz-Eakin called H.R. 3 a “terrible bill” and said the structure of an upper limit and a noncompliance penalty is not negotiation but is “price fixing and extortion.” He also argued that its proposed inflation rebate would only incentivize manufacturers to create high launch prices.

Also speaking at the conference, PhRMA Senior Vice President for Policy and Research Jennifer Bryant said that while Pelosi’s bill is being presented as a “benign and fairly incremental approach,” the proposed structure is “not actually one of negotiation at all and is about tying prices in the U.S. to prices internationally.” Moreover, she challenged AHIP, which released a statement in support of the Pelosi bill, to make a case for an “alternative that reduces costs through competition.”

Radar On Market Access: CMS Updates Medicare Plan Finder Amid Advocates’ Concerns

October 31, 2019

Having already rolled out a major redesign of the Medicare Plan Finder in August, CMS recently revealed additional updates it made before the start of Medicare open enrollment on Oct. 15 — including a feature that advocates have said is critical to helping people find the best Part D plan, AIS Health reported.

Having already rolled out a major redesign of the Medicare Plan Finder in August, CMS recently revealed additional updates it made before the start of Medicare open enrollment on Oct. 15 — including a feature that advocates have said is critical to helping people find the best Part D plan, AIS Health reported.

In an Oct. 11 email, a CMS spokesperson said the agency “added a feature that allows Medicare Plan Finder users to sort plans by the total cost of estimated annual drug costs plus premiums.”

SSo did CMS’s plan finder update ease Medicare beneficiary advocacy organizations’ concerns about the redesigned tool? Partially, says Ann Kayrish, the National Council on Aging’s senior program manager for Medicare. She says while it’s good that the sort function is back, the total-cost feature is not available on the plan-comparison page — which makes comparing plans more complicated than it was before.

“In general, the opening week of open enrollment has been rocky as some of the basic information like extra help subsidy levels and copay have been inaccurate, [and] pharmacy status and cost information inconsistent,” she adds. “To increase confidence in plan selections, counselors are spending time contacting the plan or Medicare to confirm coverage information.”

In its Oct. 11 email, CMS noted that it also implemented several other changes to the Medicare Plan Finder prior to open enrollment, including:

  • The ability to display drug tier costs;
  • A footnote for excluded drugs;
  • An option to add mail order on the pharmacy selection page;
  • A note about over-the-counter drugs on the drug lookup page; and
  • An option to compare a third retail pharmacy when mail order isn’t selected

Radar On Market Access: Walgreens Joins Centene in Pact With Cloud-Based PBM RxAdvance

October 29, 2019

A recently announced partnership between Centene Corp., Walgreen Co. and the technology-focused PBM RxAdvance promises “an innovative model for pharmacy management that aims to increase transparency, enhance customer experience and ultimately result in better health outcomes at lower costs.” AIS Health reported.

A recently announced partnership between Centene Corp., Walgreen Co. and the technology-focused PBM RxAdvance promises “an innovative model for pharmacy management that aims to increase transparency, enhance customer experience and ultimately result in better health outcomes at lower costs.” AIS Health reported.

While retail pharmacy-PBM-insurer combinations are “going to be par for the course” now, what makes this move unique is the fact that Centene is taking that model beyond the commercial space and into Medicaid, says Ashraf Shehata, a principal in KPMG’s health care life sciences advisory practice and the firm’s Global Healthcare Center of Excellence.

In Shehata’s view, the cloud-based PBM platform that all three organizations will use is key to the alliance, since it eventually will allow advanced point-of-care capabilities for pharmacists.

“The idea would be to use that platform to evolve it even further. This is an area where we’re going to start to see more and more technological enhancements,” he says, which is key to “getting to a patient-centered, member-centered design.”

The new partnership builds on Centene’s initial investment in RxAdvance back in 2018. The insurer has now increased its stake in RxAdvance, and Walgreens has “made a small investment” in the firm.

Centene Chairman and CEO Michael Neidorff said during the insurer’s third-quarter earnings call on Oct. 22 that his company chose to deepen its existing partnership with Walgreens because its business niche aligns well with Centene’s.

“Walgreens has done a particularly good job in urban areas and is recognized for it in the inner cities, where we have a large population,” he said.

Asked which payers might be interested in such a model, Shehata points to Blue Cross Blue Shield plans that don’t contract with the Blues-owned PBM Prime Therapeutics, LLC. The products emerging from the partnership also could be of interest to provider-owned health plans, he notes.