Radar on Specialty Pharmacy

Highmark’s New Hemophilia Initiative Aims to Improve Care, Reduce Costs

December 9, 2019

With an eye on reducing spending and improving care among members with hemophilia, Highmark Inc. will launch a comprehensive program focused on the condition on Jan. 1. The health plan will partner exclusively with three companies — Option Care Health, Inc., Soleo Health and the Hemophilia Center of Western Pennsylvania — on the initiative, which has the potential to improve member care, reduce costs and cut down on fraud, waste and abuse.

By Angela Maas

With an eye on reducing spending and improving care among members with hemophilia, Highmark Inc. will launch a comprehensive program focused on the condition on Jan. 1. The health plan will partner exclusively with three companies — Option Care Health, Inc., Soleo Health and the Hemophilia Center of Western Pennsylvania — on the initiative, which has the potential to improve member care, reduce costs and cut down on fraud, waste and abuse.

Highmark chose hemophilia to focus on for a few reasons, says Sean Burke, manager of specialty pharmacy services at the plan. “We have a pretty comparatively high population” of people with hemophilia, and “clients were coming to us” for effective management strategies. New therapies — as well as a crowded pipeline — mean there is “a big opportunity to potentially save money.”

Of Highmark’s 4.5 million members, approximately 190 have a hemophilia diagnosis, and the health plan says it spends about $80 million annually on their care, with pharmacy costs making up about 90% of that.
The partners will be able to obtain the therapies at competitive rates, in large part because they “have more volume,” says Ned Finn, director of specialty pharmacy services at the insurer.

Highmark and the providers have performance guarantees and oversight protocols in place. Plan members not only will receive better care, but members and health plan clients will see potential cost savings of “15% or so,” says Burke.

“There are a number of guarantees,” Drew Walk, Soleo’s CEO, says, that are “focused on reducing waste and overall cost of care,” as well as “improving patient outcomes.…There are clinical and financial outcomes measurements.” Hemophilia is a “unique” condition which requires “monitoring individual patient response,” he notes. The key, he maintains, is to “not be too obtrusive” in management but to “intervene when necessary and provide a good patient experience. It’s more than just dispensing the product.”

If a product experiences a shortage or goes off the market temporarily, “we have direct lines of communication with the providers” to handle the situation, says Burke. “These pharmacies are very experienced with knowing how to handle this.”

Analysts Question Issues Surrounding Beovu’s Uptake in Full Anti-VEGF Market

November 11, 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.

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.

By Angela Maas

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.

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.

Would Drug Pricing Legislation Impact Innovation?

October 17, 2019

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis.

By Angela Maas

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis.

One of the proposals is the International Pricing Index, an effort by HHS to bring payments for Medicare Part B closer to what 16 other “developed economies” pay for these drugs. The Senate’s Prescription Drug Pricing Reduction Act of 2019 proposes multiple changes to Medicare Part B and Part D, as well as Medicaid. And the House’s Lower Drug Costs Now Act proposes, among other things, requiring HHS to negotiate the prices of up to 250 drugs in Medicare without competitors. Companies not coming to an agreement would be subject to financial penalties.

Drugmakers have vociferously pushed back on many of the proposals, with one of the arguments against them being that the efforts would have a chilling effect on pharma R&D.

“Empirical evidence” exists to support the idea that “lower spending on pharmaceuticals will lead to lower R&D spending and lower yield of innovative drugs,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. But “there isn’t enough evidence either way” to say whether “there aren’t policies besides spending that can impact innovation.”

“Additional patent protections and favorable tax treatment of R&D expenditures for drugs designated to treat ‘orphan’ indications appear have resulted in a large push among manufacturers and investors to bring those products to market,” he notes.

According to Lisa Kennedy, Ph.D., chief economist and managing principal at Innopiphany LLC, “the biopharmaceutical industry is responsible for approximately 70% of all innovation within health care. Price fixing of pharmaceuticals has been shown in several studies to have a knock-on effect on innovation.”

She also asserts that oncology, one of the most productive and exciting areas of innovation in the biopharmaceutical industry, could be hit particularly hard.

Study Shows Growing IL-17 Use in Psoriasis

October 14, 2019

For many years, the psoriasis treatment landscape was dominated by tumor necrosis factor (TNF) inhibitors. But with the FDA’s approval of three interleukin-17 (IL-17) inhibitors — as well as other drugs with different mechanisms of action — for the condition, those therapies are becoming more common among treatment regimens.

The first IL-17 inhibitor on the U.S. market was Cosentyx (secukinumab) from Novartis Pharmaceuticals Corp., which launched in 2015. The next therapy was Taltz (ixekizumab) from Eli Lilly and Co., and then on Feb. 15, 2017, the agency approved Siliq (brodalumab) from Ortho Dermatologics.

By Angela Maas

For many years, the psoriasis treatment landscape was dominated by tumor necrosis factor (TNF) inhibitors. But with the FDA’s approval of three interleukin-17 (IL-17) inhibitors — as well as other drugs with different mechanisms of action — for the condition, those therapies are becoming more common among treatment regimens.

The first IL-17 inhibitor on the U.S. market was Cosentyx (secukinumab) from Novartis Pharmaceuticals Corp., which launched in 2015. The next therapy was Taltz (ixekizumab) from Eli Lilly and Co., and then on Feb. 15, 2017, the agency approved Siliq (brodalumab) from Ortho Dermatologics.

An AllianceRx Walgreens Prime study sampled 5,215 members who started on an IL-17 from January 2016 through December 2017. The study showed that 2,218, or 42.5%, switched from a prior biologic, while 2,997, or 57.5%, started on an IL-17 as their first psoriasis biologic. Among those who started their biologic regimens on an IL-17 inhibitor, 2,266 started on Cosentyx, followed by 725 who initiated on Taltz and six who started on Siliq.

Researchers also examined 180-day adherence outcomes among members who switched to an IL-17 inhibitor from another biologic, as determined by proportion of days covered (PDC). The mean PDC increase after moving to an IL-17 was 6.4%.

Among those moving to an IL-17, 45.7% said their outcomes were better, 26.5% said they were the same, 5.3% said they were worse, and 22.6% said they were inconsistent.

According to Renee Baiano, Pharm.D., clinical program manager at AllianceRx Walgreens Prime and the lead author of the poster, the main takeaway for payers is that “by [the] last quarter of 2017, IL-17 inhibitors may have gained clinical acceptance in the treatment of psoriasis, given the increase in patients prescribed as their first biologic.” She adds that “it is important for payers to be aware they may see more of their members being prescribed IL-17 inhibitors and will need to determine the appropriate placement of these newer agents within their formulary.”

With More AML Therapies Available, Payers Apply Various Management Tactics

September 19, 2019

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup.

“Prior to two years ago, we had no new drugs for over a decade, and now we have eight new drugs approved in just the last two years, so the whole field has changed,” said Daniel J. DeAngelo, M.D., Ph.D., chief, division of leukemia, institute physician, professor of medicine, Harvard Medical School, in an interview published on the website obroncology.com.

By Angela Maas

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup.

“Prior to two years ago, we had no new drugs for over a decade, and now we have eight new drugs approved in just the last two years, so the whole field has changed,” said Daniel J. DeAngelo, M.D., Ph.D., chief, division of leukemia, institute physician, professor of medicine, Harvard Medical School, in an interview published on the website obroncology.com.

Many of the newer drugs are oral formulations, which, “in general, are easier to administer,” points out Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “Rather than having to go into a hospital or clinic for treatment, a patient can simply take a medication orally for their condition.”

Payers utilize a variety of management tactics with AML therapies. “Payers often require prior authorization of these therapies due to safety, concern for off-label usage and cost,” says Tegenu. A variety of drugs are used off-label for certain patient populations, he notes.

Asked if AML is a condition suited for value-based contracting, Tegenu asserts that “all therapies associated with high cost should have some kind of value-based payment models to make drug manufacturers an integral part of the health care delivery system. We plan to initiate this discussion with all leading pharmaceutical companies.”

According to Winston Wong, Pharm.D., president of W-Squared Group., the newer drugs would be better candidates for such deals due to AML’s heterogenicity and the fact that “the treatment foundation is still conventional chemotherapy, which for the most part is available as a generic.”