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MMIT Reality Check on Epilepsy (Dec 2018)

December 28, 2018

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

According to our recent payer coverage analysis for epilepsy 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 epilepsy treatments shows that almost 29% of the covered lives under the pharmacy benefit in commercial formularies have utilization management restrictions on epilepsy medications.

Trends: Epidiolex, the first FDA-approved treatment that contains a purified drug substance derived from marijuana, is now available in the U.S. Via AIS Health.

Perspectives on Drug-Price Action

December 27, 2018

Representatives — President Trump said he hoped to work with lawmakers on the other side of the aisle to lower the cost of prescription drugs.

Representatives — President Trump said he hoped to work with lawmakers on the other side of the aisle to lower the cost of prescription drugs.

Some industry analysts, though, are skeptical that sentiment will be enough to enact meaningful change, at least on the legislative front, AIS Health reported.

“A Democratic House might have an interest in working with President Trump to pass legislation calling for drug re-importation or direct negotiation, both of which the President has expressed interest in,” Credit Suisse’s A.J. Rice wrote in a note to investors. “The issue, however, would be that the Senate is highly unlikely to have any interest in moving legislation relating to re-importation or direct government negotiation over drug prices, which makes legislation highly unlikely.”

Robert Laszewski of Health Policy and Strategy Associates, LLC, pointed out in a client bulletin that some of Trump’s early progress on the issue — such as getting drug company executives, like Pfizer Inc.’s CEO, to freeze prices in 2018 — has been short-lived. In a recent earnings call, Pfizer’s CEO said the company did not plan to freeze prices for 2019.

Some Wall Street analysts predicted that HHS, rather than Congress, will be the most active on the drug-pricing front.

“We do not believe we will see any fundamental shift on drug pricing given the Trump Administration has been very active through executive action (e.g., Secretary Azar’s Part B proposal and possible rebate elimination),” Leerink analyst Ana Gupte wrote in a research note. “We expect to see continued aggressive negotiation tactics from the Trump administration to rein in drug prices.”

Either way, any action on drug-pricing reform is likely to fall into three main buckets, according to Ashraf Shehata, a principal at KPMG’s life science advisory practice. Those could target:

  • Overall Medicare drug spending, which could involve increasing transparency around pricing and contract negotiation;
  • “Egregious pricing” for medicines that affect public health and safety; and
  • Innovation and R&D, with the goal of getting more drugs — and thus more competition — into the market, especially for high-cost drugs like biologics.

Radar On Market Access: GAO Recommends FDA Improve Orphan Label Application Reviews

December 27, 2018

The Orphan Drug Act (ODA) offers multiple incentives to manufacturers that bring a drug to market with an orphan designation. A recently released U.S. Government Accountability Office (GAO) report revealed that while the number of applications both received and granted for this designation has grown, FDA reviewers were not consistently recording or evaluating required information that is mandated to consider granting this designation, AIS Health reported.

The Orphan Drug Act (ODA) offers multiple incentives to manufacturers that bring a drug to market with an orphan designation. A recently released U.S. Government Accountability Office (GAO) report revealed that while the number of applications both received and granted for this designation has grown, FDA reviewers were not consistently recording or evaluating required information that is mandated to consider granting this designation, AIS Health reported.

The report, titled Orphan Drugs: FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue (GAO-19-83), shows that from 2008 to 2017, both orphan designation applications received as well as orphan designations granted rose.

The report, titled Orphan Drugs: FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue (GAO-19-83), shows that from 2008 to 2017, both orphan designation applications received as well as orphan designations granted rose.

Of the 3,690 orphan drug designation applications that the FDA received from 2008 to 2017, about 71% were granted that designation by April 2018; 21% were deemed pending, 5% were denied, and 2% were withdrawn.

In June 2017, the FDA issued the Orphan Drug Modernization Plan, intended to eliminate within 90 days the backlog of 138 applications for the designation that had been pending for more than 120 days. In addition, it sought to ensure that future applications would be reviewed within 90 days of the agency’s receiving them. The FDA achieved the first goal, and, as of July 20, 2018, had “overall met its 90-day timeliness goal for reviewing designation applications since mid-September 2017 and has completed most application reviews within 60 days of receipt,” according to the GAO report.

Researchers also assessed whether FDA reviewers were using consistent criteria to evaluate applications. On this, however, reviewers’ performance left a bit to be desired.

From October to December 2017, after the implementation of the modernization plan, the agency analyzed 148 review templates. According to the GAO report, “of the five review template sections where reviewers are required to record information, we found that OOPD [i.e., the Office of Orphan Products Development] does not ensure that all required information is consistently recorded in the background information section and evaluated when making designation decisions.”

Of the 148 templates, the FDA granted orphan designation to 26 applications that were missing required information. GAO recommends that the “FDA should ensure that all required information for reviews of orphan designation applications is consistently recorded and evaluated. The agency concurred with our recommendation.”

MMIT Reality Check on Alpha-1 Antitrypsin Deficiency (Dec 2018)

December 21, 2018

According to our recent payer coverage analysis for alpha-1 antitrypsin deficiency treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for alpha-1 antitrypsin deficiency 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 alpha-1 antitrypsin deficiency treatments shows that among the four medications covered under the medical benefit, only 16% of the lives have utilization management restrictions under Medicare policies.

Trends: The FDA allowed marketing of 23and Me, Inc’s Personal Genome Service Genetic Health Risk tests in 2017. The tests look for generic variants in a person’s saliva whose presence or absence can indicate a heightened risk for 10 conditions, including alpha-1 antitrypsin deficiency.

Trends That Matter for Crohn’s Disease Medications

December 20, 2018

New biosimilars for Janssen Biotech, Inc.’s Remicade (infliximab) have helped to moderate costs for Crohn’s disease as they’ve launched over the last two years, but plans still rely on utilization management strategies to keep the cost of treating the condition under control, experts tell AIS Health.

New biosimilars for Janssen Biotech, Inc.’s Remicade (infliximab) have helped to moderate costs for Crohn’s disease as they’ve launched over the last two years, but plans still rely on utilization management strategies to keep the cost of treating the condition under control, experts tell AIS Health.

Additional biosimilars — notably, three biosimilars for AbbVie Inc.’s Humira (adalimumab) — eventually will enter the marketplace as well, but the Humira biosimilars currently are mired in patent litigation and likely won’t launch until 2023, says April Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC.

Even though biosimilars don’t reduce the cost of care as much as generics, “more competition has led to decreases in costs,” Kunze says. Immunomodulator biosimilars Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda) both have launched over the last two years in the U.S. — Pfizer Inc.’s Inflectra in late 2016 and Merck & Co. Inc.’s Renflexis in mid-2017.

Biologics represent the biggest slice of Crohn’s drug costs. Most of the non-biologic agents have generic equivalents available, while the biologics are dominated by brand name products, even though over the past year or so, infliximab biosimilars have introduced competition to Remicade, says Beckie Fenrick, Pharm.D., senior partner-consulting, RemedyOne.