Product Release

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.”

Radar On Market Access: Sensor-Equipped Pills Draw Plans’ Interest

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 Aug. 30 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 Aug. 30 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.
A 30-day supply of all the components in Abilify MyCite costs $1,650, says John A. Bardi, vice president of public affairs and digital medicine business development for Otsuka.
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.”
Down the road, if states consider adding Abilify MyCite to their carved-out formularies, or if managed care plans begin to roll it into their formularies, “the states are going to have some questions about how are you going to manage the benefit, and are we going to get the value out of spending this extra money,” Myers says.
To that end, insurers are particularly interested in learning whether the Abilify MyCite system can reduce hospital stays among the population that Magellan and Otsuka study, he adds.

Radar On Market Access: Sensor-Equipped Pills Draw Plans’ Interest

September 25, 2018

The In a move that one expert says Medicaid plans will be watching closely, Magellan Health and the drug manufacturer Otsuka America Pharmaceutical, Inc. said Aug. 30 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;

The In a move that one expert says Medicaid plans will be watching closely, Magellan Health and the drug manufacturer Otsuka America Pharmaceutical, Inc. said Aug. 30 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.
A 30-day supply of all the components in Abilify MyCite costs $1,650, says John A. Bardi, vice president of public affairs and digital medicine business development for Otsuka.
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.”
Down the road, if states consider adding Abilify MyCite to their carved-out formularies, or if managed care plans begin to roll it into their formularies, “the states are going to have some questions about how are you going to manage the benefit, and are we going to get the value out of spending this extra money,” Myers says.
To that end, insurers are particularly interested in learning whether the Abilify MyCite system can reduce hospital stays among the population that Magellan and Otsuka study, he adds.

Radar On Market Access: New EpiPen Generic May Avert Shortages

August 28, 2018

The FDA recently approved Teva Pharmaceuticals’ generic version of Mylan N.V.’s EpiPen — a move the FDA says will provide a lower-cost option, though Teva hasn’t released pricing details, AIS Health reported.

“The approved ANDA [abbreviated new drug application] generic for EpiPen is a welcomed addition to the market,” says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “While it is not out yet and we are not certain of the pricing,

The FDA recently approved Teva Pharmaceuticals’ generic version of Mylan N.V.’s EpiPen — a move the FDA says will provide a lower-cost option, though Teva hasn’t released pricing details, AIS Health reported.

“The approved ANDA [abbreviated new drug application] generic for EpiPen is a welcomed addition to the market,” says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “While it is not out yet and we are not certain of the pricing, we are assuming it will be priced at the minimum similar or cheaper than the authorized generic manufactured by Mylan.”

Tegenu says the timing is good for bringing the new generic EpiPen to market. “While we do not anticipate the Teva product being significantly less expensive than the Mylan product, it does come at a time when there are some shortages of supply,” he says. “Shortages can be problematic, particularly around the time that students go back to school.”

In May, after consumers around the country reported difficulties in finding EpiPens to treat severe allergic reactions, the FDA announced shortages of two brands of epinephrine auto-injectors: Mylan Inc.’s EpiPen and Impax Laboratories, LLC’s Adrenaclick.

“We are hoping that the increased competition may at least prevent shortages and keep the price from rising if not slightly decreasing over time,” he adds.

Other generic manufacturers are unlikely to enter the market in the near future. This is due to the requirements from the FDA to demonstrate bioequivalence through qualitative and quantitative studies.

At this time only Teva completed this requirement. Sandoz had started the process but dropped out, presumably due to patent litigation and FDA requirements.