100% Focused on Market Access

MMIT brings transparency and guidance to pharmacy and medical benefit information

Manage with confidence. Decide with information. Communicate with certainty.
MMIT

MMIT Reality Check on Immune Globulin (CIDP) (Nov 2019)

November 15, 2019

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

According to our recent payer coverage analysis for immune globulin (CIDP) 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 immune globulin (CIDP) treatments shows that under the pharmacy benefit, almost 40% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2018, the FDA gave an additional approval to Hizentra (immune globulin subcutaneous [human]) as a maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy to prevent relapse of neuromuscular disability and impairment.

Perspectives on How Drug Pricing Legislation Impacts Innovation

November 14, 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, AIS Health reported.

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, AIS Health reported.

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.

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.

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.