Radar on Specialty Pharmacy

As Step Therapy Becomes More Popular, Opinions Vary on Its Usefulness

February 10, 2020

Step therapy has long been a go-to utilization management strategy for payers, as it is often applied to specialty drugs. But as more and more costly medications come onto the market, the practice has become nearly ubiquitous, prompting some pushback from various stakeholders.

By Angela Maas

Step therapy has long been a go-to utilization management strategy for payers, as it is often applied to specialty drugs. But as more and more costly medications come onto the market, the practice has become nearly ubiquitous, prompting some pushback from various stakeholders.

“Step therapy can be a very good method of ensuring that patients always get the treatment that is clinically best for them,” states Lisa Kennedy, Ph.D., chief economist and managing principal at Innopiphany LLC. “In theory it should ensure that they consistently receive the safest, most effective and best tolerated treatment.”

Larry Kocot, the national leader of KPMG’s Center for Healthcare Regulatory Insight, tells AIS Health that “when used effectively, step therapy can help prevent the use of more costly, unnecessary medications, thereby helping to control overall prescription costs and ensuring that patients receive the most economical and effective treatment for them.”

A study by consulting group Visante Inc. that was commissioned by the Pharmaceutical Care Management Association (PCMA) and released in January 2019 found that step therapy can result in savings of more than 10% for targeted categories. PCMA is a PBM advocacy group.

However, notes Kocot, there is “some evidence that although step therapy often results in reduced prescription drug spending, outpatient services spending can increase.”

Step therapy, “like other prior-authorization requirements, complicates prescriber decision making and reduces prescriber and office efficiency,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. Kocot adds that while the clinical evidence used to establish step-therapy protocols “may be applicable to most patients, it is possible that certain individuals may not have typical responses or protocols.”

“The problem arises when step therapy is applied for cost reasons in the absence of clinical rationale and even worse when there is a financial rebate for drugs on a formulary, requiring patients to step through treatments not because of clinical reasons but because a payer or PBM receives a financial rebate for this (e.g., in commercial plans),” Kennedy says.

In addition, she says, “if a patient is subject to stepping through treatments, and this delays getting the correct treatment on time, this can have a monumental impact on outcomes and is a perfect example of where misapplied, step therapy can result in sicker patients who suffer more and are placed at greater risk of death.”

New Oncology Biosimilar Launches Could Prompt Preferencing

February 3, 2020

So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products and, in turn, realizing savings in some costly therapeutic classes.

By Angela Maas

So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products and, in turn, realizing savings in some costly therapeutic classes.

Although the FDA had approved 26 biosimilars as of the end of January, only half of them are available in the U.S., with many of the drugmakers tied up in patent litigation with reference drug manufacturers.

2019 saw the launch of the first oncology biosimilars when Amgen and Allergan plc launched Kanjinti (trastuzumab-anns), a Herceptin (trastuzumab) biosimilar, and Mvasi (bevacizumab-awwb), an Avastin (bevacizumab) biosimilar, on July 18. Both reference drugs are from Genentech USA, Inc., a Roche Group unit. Then, on Nov. 7, Teva Pharmaceuticals USA, Inc. and Celltrion launched Truxima (rituximab-abbs), with reference drug Rituxan (rituximab) from Genentech and Biogen.

The Dec. 2 launch of Mylan N.V. and Biocon Ltd.’s Ogivri (trastuzumab-dkst) brought a second biosimilar of Herceptin onto the U.S. market, with a third — Pfizer’s Trazimera (trastuzumab-qyyp) — expected Feb. 15. Also expected to launch in the first part of this year are Ontruzant (trastuzumab-dttb) from Samsung Bioepis Co., Ltd. and Herzuma (trastuzumab-pkrb) from Celltrion and Teva.

A second Avastin biosimilar came onto the U.S. market Dec. 31 when Pfizer launched Zirabev (bevacizumab-bvzr). Rituxan also had additional biosimilar competition on Jan. 23 when Pfizer’s Ruxience (rituximab-pvvr) launched.

Kanjinti is priced 15% less than Herceptin, and its average sales price (ASP) is 13% below the reference drug. Ogivri’s price is “at a competitive discount,” according to Mylan and Biocon. Mvasi is priced 15% less than Avastin, and its ASP is 12% less than that of the reference drug. Zirabev is priced 23% less than Avastin, and Ruxience is 24% less than Rituxan.

“As more health plans set biosimilars on a preferred status, adoption and utilization should increase,” says Martin Burruano, R.Ph., vice president, pharmacy services at Independent Health. “As more become available, there will be opportunity to plan formulary selection to drive costs down. Projections are modest at 12%-15% cost savings initially but will potentially reach 70% cost savings in five years.”

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.