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Radar On Market Access: New Hep C Approach Might Not Save Money, PBM Execs Warn

January 10, 2019

A small study suggests it might be possible to shorten the length of expensive drug treatment for chronic hepatitis C virus (HCV), potentially cutting treatment time in half for 50% of patients. But managed care pharmacy clinicians say the results are far from ready to implement widely, and it’s possible the new approach might not even save money, AIS Health reported.

A small study suggests it might be possible to shorten the length of expensive drug treatment for chronic hepatitis C virus (HCV), potentially cutting treatment time in half for 50% of patients. But managed care pharmacy clinicians say the results are far from ready to implement widely, and it’s possible the new approach might not even save money, AIS Health reported.

The study, conducted at Loyola University Chicago and three medical centers in Israel, involved only 22 patients. It used a technique called modeling-based response-guided therapy, which estimated how long it would take to completely eliminate the hepatitis C virus.

“There’s a potential to save up to 20% of the costs of hepatitis C drugs,” says study author and Loyola researcher Harel Dahari, Ph.D.

However, April Kunze, Pharm.D., senior director of clinical formulary development and trend management strategy for Prime Therapeutics LLC, says that if PBMs or health plans apply policies that use the Loyola study’s data, the result may not necessarily be lower prices for hepatitis C therapy. “Drug pricing may vary significantly based on contracts and utilization,” she says. “Additionally, patients who relapse may require additional therapy, which could increase the overall cost of treatment.”

The proof-of-concept pilot study showed that using response-guided therapy to reduce treatment times is feasible, study authors said. To validate the results, a large multi-center trial is underway in Israel.

Dahari said that in addition to cutting overall costs, shorter treatment regimens would make it easier to treat hepatitis C patients who have limited drug benefits.

Still, Mesfin Tegenu, R.Ph., president of PerformRx, says that current FDA-approved protocol for treating hepatitis C is for either eight or 12 weeks, and “it will not be easy to change current protocol” for treating hepatitis C, since “all the clinical work done by drugmakers to receive approval was done for eight or 12 weeks.”

Regardless of the prospects for the response-guided therapy approach, there could be more price upheaval coming to the HCV antiviral market in 2019. Gilead said in September that it will soon launch steeply discounted generic versions of two of its HCV drugs.

Radar On Market Access: PBMs May Be Able to Handle Pressure From State Medicaid Programs

January 8, 2019

As states take a hard look at how they can reduce prescription drug spending in their Medicaid programs, they’ve put an already heavily scrutinized type of organization in their crosshairs: PBMs, AIS Health reported.

As states take a hard look at how they can reduce prescription drug spending in their Medicaid programs, they’ve put an already heavily scrutinized type of organization in their crosshairs: PBMs, AIS Health reported.

Ohio, for example, is forcing PBMs to abandon their current “spread pricing” models — in which PBMs pocket the difference between the amount they reimburse a pharmacy for a drug and the (usually higher) amount they charge a plan sponsor. Instead, they’ll move to a “pass-through” model, where PBMs will be paid an administrative fee by the Medicaid program and have to pay pharmacists the same amount that they bill the state for drugs, The Columbus Dispatch reported.

Most recently, Pennsylvania Auditor General Eugene DePasquale (D) released a report that advocates for legislation that would trade a spread-pricing model for a flat-fee model and allow the state’s Medicaid program to directly manage its prescription drug benefits instead of contracting with managed care organizations.
It might seem as though PBMs are facing a considerable threat from these moves, but industry experts say they are likely to be able to adjust to states’ changing preferences.

“I’d say that the PBMs’ business model could definitely change if more payers move toward this pass-through pricing model, but it doesn’t necessarily eliminate their role entirely,” says Tiernan Meyer, a director at Avalere Health. States can often be strapped for resources, and having a contractor administer pharmacy benefits instead of using their own resources to do so, “can be useful,” she adds.

What’s more, “the PBMs are very much used to this from other contracts that they hold, and they can certainly make money in a transparent environment,” says Robert Ferraro, R.Ph., a principal at the consulting firm Buck’s national pharmacy practice. “I think they would prefer a traditional model where their revenue wasn’t so easily identified by all their customers, but that doesn’t mean they can’t earn a very good living in a transparent or pass-through model.”

A more transparent approach to PBM contracting also helps smaller PBMs compete with the likes of UnitedHealth Group’s OptumRx, CVS Health Corp. and Cigna Corp.-owned Express Scripts Holding Co., because it simplifies the procurement process to an examination of administrative fees, he says.

MMIT Reality Check on Immune Globulin PID (Jan 2019)

January 4, 2019

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

According to our recent payer coverage analysis for immune globulins for primary immunodeficiency (PID), 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 market access breakdown reveals that more than 38% of the covered lives under the pharmacy benefit in commercial and health exchange formularies have utilization management restrictions

Trends: 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

Radar On Market Access: Judge OKs CVS Plan to Keep Aetna Separate Pending Review

January 3, 2019

Facing an unexpected judicial roadblock in the plan to combine their two business, CVS Health Corp. and Aetna Inc. successfully negotiated a deal to keep their PBM and health insurance operations separate for at least the next few months, AIS Health reported.

Facing an unexpected judicial roadblock in the plan to combine their two business, CVS Health Corp. and Aetna Inc. successfully negotiated a deal to keep their PBM and health insurance operations separate for at least the next few months, AIS Health reported.

At the heart of the holdup is U.S. District Court Judge Richard Leon, who has the right to review the agreement that CVS and Aetna struck with the DOJ to resolve antitrust concerns with their deal.

CVS said it is currently operating Aetna’s health insurance business separately from CVS’s retail pharmacy and PBM business units, with Aetna maintaining control over pricing and product offerings. Aetna personnel will also retain their current compensation and benefits, and CVS will maintain a firewall to prevent the exchange of competitively sensitive information between the two companies.

Leon issued a Dec. 21 order accepting CVS’s plan, saying he’s satisfied that “so long as these measures remain in place, the assets involved in the challenged acquisition will remain sufficiently separate” to facilitate his review of the deal.

John Matthews, KPMG’s strategy leader for health care and life sciences, points out that if the restrictions remain in place for a long time — or potentially permanently — “then I think it actually really undermines the strategic rationale and value creation proposition for what the deal is intended to do.”

In particular, if the firms have to keep their PBM separate from their insurance business — in terms of both product offerings and data sharing — that could stymie “what was going to be exciting and different about the deal, which was it allowed them to combine pharmacy and benefit data to really understand total cost of care for certain key conditions,” he adds.

Whether that comes to pass largely depends upon timing, according to Matthews. “I think if they start getting into six, nine, 12 months, then it starts becoming a problem, even if it’s not a permanent injunction,” he says.

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.