Trends That Matter

Trends That Matter for FDA Orphan Label Application Reviews

January 17, 2019

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.

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.”

Trends That Matter for Migraine Drugs

January 3, 2019

Therapy for chronic migraine — a condition that’s been notoriously difficult to treat and which often leads to significant direct and indirect health care costs — has been upended with the recent approval of three injectable monoclonal antibody products in a new preventive medication class that’s significantly more effective than older preventive migraine drugs, a researcher says.

Therapy for chronic migraine — a condition that’s been notoriously difficult to treat and which often leads to significant direct and indirect health care costs — has been upended with the recent approval of three injectable monoclonal antibody products in a new preventive medication class that’s significantly more effective than older preventive migraine drugs, a researcher says.

These new calcitonin gene-related peptide (CGRP) inhibitors — Amgen, Inc. and Novartis AG’s Aimovig (erenumab), Teva Pharmaceuticals’ Ajovy (fremanezumab) and Eli Lilly and Co.’s Emgality (galcanezumab) — also may usher in an era of value-based contracting for migraine products, with plan sponsors willing to pay more to get better results, Machaon Bonafede, Ph.D., outcomes research practice leader at IBM Watson Health, told attendees Oct. 23 at the Academy of Managed Care Pharmacy Nexus annual meeting, AIS Health reported.

Express Scripts Holding Co. already has inked a value-based deal for two of the three drugs in the new migraine class. The PBM’s new SafeGuardRx Migraine Care Value program, which starts April 1, will cover Aimovig and Emgality. It will include a comprehensive clinical care program with access to CGRP inhibitors. In addition, Express Scripts is offering what’s in effect a money-back guarantee for plan sponsors when a patient discontinues therapy in the first 90 days.

These new medications have the potential to remake migraine treatment, the direct and indirect costs of which have been estimated at $36 billion annually in the U.S., Bonafede said. Indirect costs — such as lost productivity — can be difficult to capture and quantify, he added.

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.

Trends That Matter for HIV Treatments

December 6, 2018

At the annual Medicaid Health Plans of America conference, Express Scripts Holding Co. Senior Vice President and Chief Medical Officer Steve Miller, M.D., had a simple message for health plan leaders: “You have to think long term if you’re going to have better outcomes,” AIS Health reported.

At the annual Medicaid Health Plans of America conference, Express Scripts Holding Co. Senior Vice President and Chief Medical Officer Steve Miller, M.D., had a simple message for health plan leaders: “You have to think long term if you’re going to have better outcomes,” AIS Health reported.

One area in which Medicaid is not heeding that call, Miller said, is how it approaches treating and preventing HIV.

While the number of HIV patients is decreasing, the amount spent on treating HIV has risen in recent years — and the culprit is rising drug costs, Miller said. Thus, Medicaid programs and plans are often choosing to cover the least expensive medications, which tend to be multi-tablet regimens, rather than pricier single-tablet therapies, he said.

While that approach may cost less in the near term, patients treated this way are less likely to be adherent to their treatment plans than those who get a single-tablet therapy.

Commercial health plans, which have less of an issue with finances than Medicaid, almost always choose single-tablet regimens for patients, according to Miller. Medicaid beneficiaries with HIV, on the other hand, are getting single-tablet regimens less than 60% of the time.

“So the reality is we’re sub-optimizing that care, and therefore we’re actually going to cost ourselves a lot more in the long run,” he added.

Trends That Matter for Drug Prices

November 22, 2018

Pharmaceuticals are expected to undergo a 4.92% price increase from 2018 to 2019, according to the July-August 2018 Drug Price Forecast from Vizient. That’s actually a slowing from the 7.61% increase for 2018, AIS Health reported.

Pharmaceuticals are expected to undergo a 4.92% price increase from 2018 to 2019, according to the July-August 2018 Drug Price Forecast from Vizient. That’s actually a slowing from the 7.61% increase for 2018, AIS Health reported.

The company conducted its analysis using price and volume data from hospital and non-acute facilities participating in its Vizient Pharmacy Program. Among Vizient members, therapeutic classes with the highest spend include many with specialty drugs.

Disease-modifying antirheumatic agents lead the way with an estimated 8.57% increase, followed by the immunomodulatory agents for multiple sclerosis, at 7.33%. According to the report, “Based on the total amount of spend across care environments, the types of molecular entities approved by the FDA, and the investigational products in the development pipeline, it is certain that specialty pharmaceuticals will continue to play an increasingly important role in pharmacy budgeting.”

Trends That Matter for Sensor-Equipped Pills

November 8, 2018

In a move that one expert says Medicaid plans will be watching closely, Magellan Health and the drug manufacturer Otsuka America Pharmaceutical, Inc. said in August that they will work together to allow “select regional provider networks” contracted through Magellan to opt into a program involving the Abilify MyCite system, AIS Health reported.

In a move that one expert says Medicaid plans will be watching closely, Magellan Health and the drug manufacturer Otsuka America Pharmaceutical, Inc. said in August that they will work together to allow “select regional provider networks” contracted through Magellan to opt into a program involving the Abilify MyCite system, AIS Health reported.

Abilify (aripiprazole) treats schizophrenia and other mental illnesses. The MyCite system comprises Abilify tablets embedded with sensors; patches that detect and record the date and time of the pill’s ingestion as well as physiological data like activity level; an app that lets patients review their data and enter additional information; and a web-based dashboard that lets providers and caregivers display and track a patient’s drug ingestion patterns over time.

One in five Medicaid enrollees has been diagnosed with a serious mental illness or other behavioral health issue, and there’s likely another one in five who are undiagnosed, says Jeff Myers, president and CEO of Medicaid Health Plans of America. “So anything the plans can get [in their] tool belt to ensure adherence to their drug regimen, to do what we can to keep them well, is something the plans are going to look at very carefully.”