Featured Health Business Daily Story, Jan. 16, 2017

Deep Dive on Use, Persistency Data Can Help With Contracting

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By Angela Maas, Managing Editor
January 6, 2017Volume 18Issue 1

Armed with data from a pair of studies, Prime Therapeutics LLC is approaching manufacturers to see if they’d be willing to enter into innovative new contracts with the PBM. Drilling down on data such as whether use of a drug follows its indication and how the conditions that drugs are treating break down can help with managing some high-cost specialty drugs in particular.

The first study looked at patterns of use and persistency among people using Pfizer Inc.’s oral rheumatoid arthritis (RA) treatment Xeljanz (tofacitinib). Pat Gleason, Pharm.D., director of health outcomes at Prime and a co-author of the study, points out that the first author is a student at the University of Pittsburgh School of Pharmacy who is sponsored by Pfizer. Researchers looked at whether it “was used in accordance with its label,…if methotrexate was being tried first” and if people had tried disease-modifying antirheumatic drugs (DMARDs) before trying Xeljanz.

Researchers analyzed data from 887 members of 12 Blue Cross and Blue Shield commercially insured populations who had at least one Xeljanz claim between Dec. 1, 2012, and Dec. 31, 2015 — the FDA approved the tablet Nov. 6, 2012 — as well as at least one medical claim that could be used to identify the member’s diagnosis. Almost all of them — 862, or 97.2% — had an RA diagnosis.

Drug Benefit News

Xeljanz is indicated for use as a second-line treatment in people with RA who have not responded adequately to or who do not tolerate treatment with methotrexate. It can be used as a stand-alone treatment or in combination with methotrexate or other nonbiologic DMARDs, but it is contraindicated in use with biologic DMARDs or “potent immunosuppressants such as azathioprine and cyclosporine,” according to Xeljanz’s label.

Researchers found that in the year before members started Xeljanz, 771, or 89.4%, had a claim for any DMARD, and 432, or 50.1%, had a methotrexate claim.

Although nine of out every 10 members had tried a DMARD first, “we would like to see 100%,” says Gleason, who maintains there is “room for improvement.” Specifically, he says, tactics such as “step therapy and prior authorization can get that number higher.” For example, step therapy could require “evidence of a trial of methotrexate or another preferred product, and then the claim will go through,” while providers could be required to obtain prior authorization for the drug to make sure its use is appropriate before a claim is approved.

With a wholesale acquisition cost of more than $42,000 annually, Xeljanz is certainly not inexpensive, although its price is similar to other RA biologics.

Data for both studies were presented in posters at a recent Academy of Managed Care Pharmacy event.

The first study also examined rates of persistency on Xeljanz. Researchers considered the therapy discontinued when there was a gap of more than 90 days between the end of a claim’s supply and the filling of the next Xeljanz claim. Data showed that at the six-month mark, three of 10 members (30.2%) had discontinued Xeljanz, while more than four of 10 members (44.3%) had halted the drug at 12 months. At 18 months, 53.2% had discontinued and 57.1% at 24 months.

According to the poster, “As RA is a chronic disease, this is a high discontinuation rate after a short period of therapy. Providers and payers should look for ways to improve persistency and consider outcomes based contracts where managed care organization reimbursement from pharmaceutical manufacturers is linked to tofacitinib adherence and persistency.”

Asked if Prime is following that recommendation, Gleason tells DBN that the PBM is “pursuing outcomes-based contracts with pharmaceutical manufacturers” across multiple drug classes. Such deals would entail “reimbursement for treatment failures.…If individuals are not going to be persistent, there should be reimbursement to the payer for the cost of the drug,” he says, adding that “$40,000 is a lot to spend to try something else.” At Prime, “We want people to take the medication they’ve been prescribed and to feel better.”

“We are aware of the Prime Therapeutic analysis and have reviewed the abstract,” a spokesperson for Pfizer tells DBN. “It is important to remember that Prime’s formulary design requires failure of two preferred TNFs (Enbrel and Humira) prior to use of other agents,” based on data from Managed Markets Insight & Technology, LLC, which is the parent company of AIS Health. “Given that RA patients must fail both Enbrel and Humira prior to being placed on Xeljanz, Prime’s formulary design relegates use of Xeljanz to a more severe patient population potentially making comparisons of outcomes and adherence less meaningful given that Xeljanz is indicated post MTX [i.e., methotrexate]. The Prime analysis is an important reminder of why formulary design is so important to the effective management of patient care.”

PBM Scrutinized Autoimmune Drugs’ Use

Another group of researchers from Prime studied the autoimmune specialty therapy class, which ranks at the top of the specialty drug spend categories for many payers. That’s particularly the case when taking into account both pharmacy and medical data. Armed with comprehensive data across specific indications and specific drugs, Prime is talking to manufacturers about pursuing indication-specific arrangements.

“We intentionally looked at [the autoimmune specialty drug class] because it’s one of the highest drug spend classes,” explains Gleason, who was co-author of the poster. In terms of annual spending on specific drugs, Enbrel and Humira “are almost always up there.” And Remicade “is one of the top expenses in the medical benefit.”

The firm wanted to see what the trend for the class has been, and the study looked at 14 specialty drugs from 2012 to 2015 among a 4.4-million-patient population, of which 27,341 used an autoimmune specialty therapy during those four years. The study broke down the specialty drug-treated autoimmune categories into Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis and RA.

Prime wanted to leverage “our integrated medical and pharmacy data” in order to provide “proof of concept…to show we have the capability” to understand the entire trend landscape, including which benefit the costs are coming from, Gleason tells DBN.

Researchers found that there was a 38.8% increase in the number of people using these drugs, from 16,247 in 2012 to 22,543 in 2015. But payments for these treatments rose 102.7% over those four years, from $360 million to $729 million, an increase of $6.74 per member per month to $13.66 PMPM. In 2012, the class itself made up 8.1% of total drug costs across the medical and pharmacy benefits, rising to 9.9% last year.

“We were somewhat surprised at the doubling of per-member per-month” costs from 2012. Another important finding is that “25% of the expenditures are coming through the medical benefit,” says Gleason. “If you’re not looking at the medical benefit, you’re missing one-quarter of the drug spend.”

The study also broke down drug use by indication, and Gleason notes that for inflammatory bowel disease, which consists of Crohn’s disease and ulcerative colitis — conditions that have a lot of medical spend due to their high use of Remicade — “you’re missing half the spend if you only look at the pharmacy benefit.”

Looking solely at the pharmacy benefit “doesn’t seem to be the best way to manage these drugs,” says Gleason, although that’s what some companies in fact do. “Our goal is to understand where the spend is…and where the trend is.”

“This drug class is about $1 of every $10 of all drugs,” says Gleason. “The only other class that’s kind of like that is diabetes, which also is $1 of every $10 of all drugs. Taking the two classes together represents $1 of every $5. If we understand where our expenses are, we can optimize the use of medications.”

Of the $13.66 PMPM spent on the class overall, researchers found that 26% of that was spent on the two inflammatory bowel disease conditions, 32% on psoriasis and psoriatic arthritis and 34% on RA. Another finding was about Enbrel and Humira — “only one-third of the spend for these drugs is in rheumatoid arthritis,” notes Gleason. People often assume these are just RA drugs, which is a “common misperception.” The study revealed that people with Crohn’s and ulcerative colitis actually had high Humira use.

Drugs Had ‘Substantial Price Increases’

Over the four years, there was a 38.8% increase in utilization, points out Gleason, so essentially a “10% increase year over year.” The remaining 60% increase in PMPM costs was “primarily driven by inflation.…There clearly is an increase in utilization, but there were also substantial price increases over the four years.” The increased utilization could be due to a couple of factors, including just the fact that more therapies are available, as well as “a movement to use specialty autoimmune drugs earlier in the course of treatment.”

Now that Prime has this comprehensive information on the autoimmune class, “we are pursuing” creating an indication-based formulary, says Gleason. “We are talking with pharmaceutical manufacturers” to show them the “comprehensiveness of our medical data.” At Prime, “we have that capability [to look across both the medical and pharmacy benefits], but others do not.…So now we’re seeing if companies have interest” in Prime preferring their products. Prime has asked its pharmacy and therapeutics committee to determine how many therapies each condition needs and “what do we need to cover by name?…We’re dealing with a diverse list of autoimmune conditions.”

The category now also includes an additional specialty drug, Taltz (ixekizumab), which was approved in March 2016, after the study time frame, as well as biosimilar versions of three drugs:

(1) Inflectra (infliximab-dyyb), a biosimilar Remicade approved in April (DBN 4/8/16, p. 8);

(2) Erelzi (etanercept-szzs), a biosimilar Enbrel approved in August; and

(3) Amjevita (adalimumab-atto), a biosimilar Humira approved in September.

While Inflectra launched in November, Erelzi and Amjevita have not yet come onto the U.S. marketplace.

Copyright © 2017 Managed Markets Insight & Technology, LLC. All Rights Reserved.

Portions of this article were excerpted from DBN sister publication Specialty Pharmacy News, which includes news and strategies to help health plans, PBMs, providers and employers contain costs and improve outcomes related to high-cost specialty products. Learn more at the AIS Health Marketplace.

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