Radar on Market Access

Radar On Market Access: Independent Pharmacies Push Bill to Increase Access to Part D Preferred Networks

November 19, 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.

Radar On Market Access: ‘Breakthrough’ Cystic Fibrosis Drug Could See High Demand

November 14, 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.

According to Jain, certain people on Kalydeco won’t be candidates for the new drug; but most on Symdeko or Orkambi likely will switch to Trikafta.

During Vertex’s third-quarter 2019 earnings call, Vertex’s Chief Commercial Officer Stuart Arbuckle said the first patients have already been prescribed Trikafta by their physicians, “underscoring the strong interest in the medicine.” But he added that such demand for the new product might prompt launch delays.

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.”

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