Product Release

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.

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.”

Radar On Market Access: FDA Approves Second Tissue-Agnostic Drug; Refund Is Available

December 18, 2018

As the FDA continues to approve drugs targeted toward specific biomarkers, the agency has granted accelerated approval to another tissue-agnostic oncology treatment. While the gene fusion is fairly rare, Loxo Oncology, Inc. and Bayer Corp.’s Vitrakvi (larotrectinib) has shown high overall response rates across multiple solid tumors. Not surprisingly, the medication comes with a high price tag — but also a refund for qualified patients who do not respond within three months of initiating treatment, AIS Health reported.

As the FDA continues to approve drugs targeted toward specific biomarkers, the agency has granted accelerated approval to another tissue-agnostic oncology treatment. While the gene fusion is fairly rare, Loxo Oncology, Inc. and Bayer Corp.’s Vitrakvi (larotrectinib) has shown high overall response rates across multiple solid tumors. Not surprisingly, the medication comes with a high price tag — but also a refund for qualified patients who do not respond within three months of initiating treatment, AIS Health reported.

On Nov. 26, the FDA gave accelerated approval to Vitrakvi for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative therapies or that have progressed after treatment.

“It definitely is an exciting development within the oncology treatment arena, but where it’s going to fit into treatment” in terms of guidelines and protocols “is yet to be seen,” says Beckie Fenrick, Pharm.D., senior partner at RemedyOne.

The drug is available as a capsule, dosed at 100 mg twice daily, as well as a liquid formulation for certain pediatric patients, with dosing 100 mg/m2 twice daily. Bayer set the monthly wholesale acquisition cost for a 30-day supply of 100 mg capsules at $32,800, and the WAC for the liquid formulation at $11,000 monthly.

Multiple programs through TRAK Assist are in place to help people afford the medication:

  • TRAK Assist $0 Co-Pay Program will be available for eligible patients with commercial or private insurance.
  • VITRAKVI Bridge Program will provide the drug for free to people who have coverage delayed or who have a temporary coverage lapse during the period without coverage.
  • TRAK Assist will refer publicly insured patients to third-party assistance programs.
  • A patient assistance foundation will help qualified uninsured or underinsured people.

In addition, in a situation where a patient does not have a clinical benefit within 90 days of starting the drug, the cost of up to two months of Vitrakvi will be refunded to each entity that made a payment for the drug — patients, payers and third-party organizations — through the Vitrakvi Commitment Program.

Radar On Market Access: New Migraine Drugs Could Spark Value-Based Contracting

November 29, 2018

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.

“Prior to the approval of CGRPs, migraine preventive therapy was characterized by poor treatment persistence and medication, frankly, because of use of products that were never developed for or intended to treat migraine,” Bonafede said.

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.

According to Institute for Clinical and Economic Review (ICER), it is reasonable for payers to develop prior authorization criteria to ensure prudent use of CGRP inhibitors. ICER also urged drug manufacturers to exercise restraint in pricing and price negotiation so that net prices for the new therapies align with added benefits.

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.

Radar On Market Access: New Biosimilars Help Crohn’s Cost, but Boost Oversight Needs

November 27, 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, including site-of-service programs, 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, including site-of-service programs, 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.
Plans employ utilization management to ensure appropriate drug use — “the right drug for the right patient based on clinical guidelines,” Kunze says. “Selection of formulary agents will depend on their guideline recommendations, cost and utilization.”
Mesfin Tegenu, R.Ph., president of PerformRx, notes that prior authorization is required for the anti-TNF inhibitors and biologic products, and that generics are available for some of the products. Meanwhile, he adds, rebates traditionally have been used to reduce unit cost for expensive brand name products, which then lowers overall costs.
Fenrick says that in addition to prior authorization and care management, plans also may employ site-of-service strategies for the infused products, ensuring members have access to the medications in the most cost-effective sites. Finally, “payers are looking at indication-based contracts, given that many of the biologics have a variety of indications with varying levels of clinical efficacy,” Kunze says.

Radar On Market Access: FDA’s OK of Opioid Makes ‘Diversion of Even One Tablet’ Risky

November 15, 2018

When a highly potent new opioid formulation was approved by his agency on Nov. 2, FDA Commissioner Scott Gottlieb, M.D., downplayed safety concerns about AcelRx’s Dsuvia. He stressed the importance of the painkiller for military use and the “very tight restrictions being placed on the distribution and use of this product,” AIS Health reported.

When a highly potent new opioid formulation was approved by his agency on Nov. 2, FDA Commissioner Scott Gottlieb, M.D., downplayed safety concerns about AcelRx’s Dsuvia. He stressed the importance of the painkiller for military use and the “very tight restrictions being placed on the distribution and use of this product,” AIS Health reported.
In general, PBM and health plan experts say such restrictions likely will hold and keep the drug within its proper niche, and the regulatory green light for Dsuvia shouldn’t interfere with broad ongoing efforts to better manage opioid use in the U.S.
Dsuvia is a sublingual formulation of an established drug, sufentanil, that is delivered through a disposable, pre-filled, single-dose applicator. It’s seen as ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible, including its potential use on the battlefield. Gottlieb notes that this opioid formulation, along with Dsuvia’s delivery device, was “a priority medical product” for the Pentagon because it fills a specific, though limited, unmet medical need.
“A single-dose applicator could potentially prevent abuse due to the complexity of removing it [i.e., the medication] from the applicator,” says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “However, because it is 10 times more potent than fentanyl and 1,000 times more potent than morphine, the diversion of even one tablet can be risky.”
Tegenu adds that restricting the sites where Dsuvia can be administered “is a good step in preventing misuse. However, there is no guarantee that such a diversion will not occur and contribute to the opioid crisis.”
Yet Sharon Jhawar, Pharm.D., chief pharmacy officer for SCAN Health Plan, doesn’t anticipate a significant problem with diversion of the strong medication.
“Our perspective on Dsuvia is it’s been approved only in specific health care settings by someone who is medically trained, and is really for severe, acute pain in which other opioids would not be enough,” she says. “And because of the requirement of the setting and who needs to give it, this isn’t a medication you’re going to see insurers have on their formulary.”