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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.

MMIT Reality Check on Uveitis (Nov 2019)

November 8, 2019

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

According to our recent payer coverage analysis for uveitis 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 uveitis treatments shows that under the pharmacy benefit, almost 45% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In June 2019, the FDA granted orphan drug designation to Palatin Technologies, Inc.’s PL-8177 for the treatment of noninfectious intermediate, posterior, pan and chronic anterior uveitis.

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.”

MMIT Reality Check on Carcinoid Syndrome (Nov 2019)

November 1, 2019

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

According to our recent payer coverage analysis for carcinoid syndrome 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 carcinoid syndrome treatments shows that under the pharmacy benefit, almost 56% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In June 2019, the FDA approved a new prefilled syringe for Ipsen Biopharmaceuticals, Inc.’s Somatuline Depot (lanreotide), which includes updated features to help health care providers administer the injection.

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.”