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Radar On Market Access: Drug-Pricing Transparency, Vertical PBM Deals Are Top of Mind for Employers in 2019

January 22, 2019

As they look to win over employer clients this year, PBMs should be prepared to face stiff competition and embrace emerging trends such as value-based formularies and rebate-free models, benefits consultants tell AIS Health.

As they look to win over employer clients this year, PBMs should be prepared to face stiff competition and embrace emerging trends such as value-based formularies and rebate-free models, benefits consultants tell AIS Health.

“I’ve heard more interest about RFPs and going out, looking for or market-checking vendors than I have in a while — particularly on the PBM side,” says Suzanne Taranto, a principal and consulting actuary for Milliman, Inc.

Companies are also considering how the vertical integration in the PBM space is “reshaping the landscape,” says Renya Spak, who leads Mercer’s Center for Health Innovation.

“The main players in the pharmacy and medical space are all going to start operating a little bit differently,” Spak says. “We thought we knew how they operated and their business model, but now that they’re vertically integrated, I think we need to apply a whole new lens to understanding how they will operate and what will drive their business forward in the future.”

That said, many of the same themes that employers are focused on will apply, including greater transparency around drug pricing and rebates, and even rebate-free models, she says. Presumably in response to that demand, CVS in early December unveiled a Guaranteed Net Cost PBM model, under which it will pass 100% of rebates to plan sponsors.

Along similar lines, Spak says she’s seeing renewed interest in formularies that are based on the value that certain drugs deliver versus how rebates flow.

Another trend that Taranto is seeing involves “more care management programs, more interest in the specialty space and looking at alternative ways to procure those drugs,” she says.

Specialty drug spending is always a high-attention area, Taranto explains, but now there more tools and different options available — not only from the “usual suspects,” PBMs — but also from other vendors that are offering to help manage these pricey medications.

For employers that are large enough, that may mean they consider a different contract, she says. But “if you’re smaller, you may be looking at a number of specialty pharmacy providers outside of the standard PBM, on a carve-out basis, who promise better pricing, better deals.”

MMIT Reality Check on PCSK9 (Jan 2019)

January 18, 2019

According to our recent payer coverage analysis for PCSK9 inhibitors, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for PCSK9 inhibitors, 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 review of market access for PCSK9 inhibitors shows that more than 90% of the lives under the pharmacy benefit in commercial and health exchange formularies have utilization management restrictions.

Trends: In October 2018, Amgen said that it would reduce the price of its Repatha SureClick autoinjector to $5,850 per year.

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.”

Radar On Market Access: Vermont Pushes Ahead on Canadian Drug Importation

January 17, 2019

A new report concludes that if Vermont undertakes wholesale importation of prescription drugs from Canada, such a program could achieve cost savings for the state’s commercial payers. But achieving benefits requires an emphasis on program mechanics, and Vermont’s own effort is far from a done deal — with the state’s largest health insurer pointing out that administrative costs and hurdles, which may be significant, are not quantified in this feasibility study, AIS Health reported.

A new report concludes that if Vermont undertakes wholesale importation of prescription drugs from Canada, such a program could achieve cost savings for the state’s commercial payers. But achieving benefits requires an emphasis on program mechanics, and Vermont’s own effort is far from a done deal — with the state’s largest health insurer pointing out that administrative costs and hurdles, which may be significant, are not quantified in this feasibility study, AIS Health reported.

The state’s 14-page report on the preliminary design of the “Canadian Rx Drug Import Supply Program,” written with the National Academy for State Health Policy’s (NASHP) technical assistance, estimates savings of $1 million to $5 million annually, based on just 17 high-spend drugs identified for two of the state’s three major carriers.

Blue Cross and Blue Shield of Vermont was among the three major carriers in the state asked to voluntarily identify top-spend prescription drugs for the second quarter of 2018, excluding drugs such as narcotics, biologics, and IV and infused drugs that are not eligible for importation under federal law. MVP Health Care also provided data, but Cigna Corp. opted not to do so.

While NASHP Executive Director Trish Riley declined to identify by name the 17 high-spend drugs contained in the report, she says they are used for contraception, chronic obstructive pulmonary disease, diabetes, hepatitis C, HIV/AIDS, multiple sclerosis, arthritis and venous thromboembolism prevention, along with one cancer drug.

Payers also were asked to calculate net savings from importation, with NASHP adding a “conservatively-high estimated mark-up” for program administration of 45% on top of the Canadian price. To determine savings, plans were asked to determine their net spend (net of rebates) on the 17 drugs, comparing it to the would-be net spend for the same drugs if they were imported from Canada with a 45% mark-up.

Even with the 45% mark-up, plans reported savings ranging from $2.61 to $2.82 per member per month, or $1 million to $5 million annually, the report says. But it notes these savings for commercial payers, post mark-up, don’t take into consideration the state’s costs in operating the importation program.

Broadly speaking, the Vermont Blues plan supports efforts to reduce prescription drug costs for its members, says its spokesperson Sara Teachout. Yet she notes the complexity of the issue, pointing out that “some of the administrative hurdles [for Canadian drug importation in Vermont] are significant.”

Radar On Market Access: Don’t Expect Major Action on Drug Prices in 2019, Experts Say

January 15, 2019

As 2019 gets under way, public outrage over high prescription drug prices does not appear to have abated, especially in light of recent news reports indicating manufacturers are raising prices on hundreds of drugs this month, AIS Health reported.

As 2019 gets under way, public outrage over high prescription drug prices does not appear to have abated, especially in light of recent news reports indicating manufacturers are raising prices on hundreds of drugs this month, AIS Health reported.

Yet there are plenty of reasons why this concern over drug prices might not result in any significant legislative or regulatory action, experts tell AIS Health. And whatever does occur might benefit health plans and PBMs more than challenge them.

Walid Gellad at the University of Pittsburgh says there’s sure to be a lot of drug-pricing bills proposed — and even passed — by the House, but it’s not certain that any will become law. He says that’s because many Senate Republicans aren’t likely to be very interested in passing legislation that harms the pharmaceutical industry. “The real uncertainty is whether the president would get behind one of those bills, and if so, that could change things,” Gellad says.

One hot topic on Democrats’ legislative agenda will be allowing Medicare to negotiate drug prices with manufacturers. While the idea of broad-based Medicare price negotiation probably has little chance of passing, “there could be a tie-in between negotiation and external reference prices for Part D,” says Gerard Anderson, professor at Johns Hopkins University Bloomberg School of Public Health.

In fact, Sen. Bernie Sanders (I-Vt.) and other left-leaning lawmakers introduced a trio of drug-pricing bills on Jan. 10, one of which would direct HHS to negotiate lower prices for Part D drugs, and another that would peg the price of prescription drugs in the U.S. to the median price in five major countries.

Overall, Anderson says he expects most potential actions to lower drug prices will benefit the managed care sector, as the result could be lower costs for such companies.

On the regulatory front, Gellad says he expects “small changes here and there…[but] nothing that’s going to radically change prices now or over the next two years — or until the next election.” However, “the big one for me is whether there will be big action around rebates,” he adds.

If the prescription drug rebate structure changes fundamentally, “it’s going to create a challenge for PBMs and their underwriting strategies, because they have been driven by rebates over the last couple years,” says Brian Anderson, a principal with Milliman, Inc.