Market Access

Radar On Market Access: In Win for Managed Care, Trump Administration Drops Rebate Rule

July 18, 2019

In a move that Wall Street analysts deemed a win for the managed care industry, the Trump administration decided to withdraw a proposed rule that would have overhauled the prescription drug rebate system in Medicare Part D, AIS Health reported.

In a move that Wall Street analysts deemed a win for the managed care industry, the Trump administration decided to withdraw a proposed rule that would have overhauled the prescription drug rebate system in Medicare Part D, AIS Health reported.

The proposed rule, first released in February, would have removed safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs, Part D plans and Medicaid managed care organizations, and it would have created a new safe-harbor protection for point-of-sale drug discounts.

Citi analyst Ralph Giacobbe told investors his firm expects the news “to be favorable most specifically to entities with larger PBM exposure (Cigna Corp., CVS Health Corp./Aetna and UnitedHealth Group) as it eliminates the uncertainty and overhang that the rebate rule had on those companies.”

Meanwhile, industry experts expressed surprise at the administration’s pullback on the rebate proposal and its timing.

“My initial reaction is it’s surprising given the amount of capital the administration has put into this policy,” says Matt Kazan, a principal in Avalere Health’s policy practice. He adds dropping the rebate rule increases the likelihood that the Trump administration will move forward on other proposals to show progress in its vow to lower drug costs.

Kazan points to various implications for health plans in the rebate rule’s demise. “Certainly, a lot of the uncertainty about 2020 and 2021 goes away in terms of bidding and Part D,” he says. But if Congress makes structural changes to Part D that it’s considering, he says there could be greater liability for plans in the catastrophic phase of the benefit.

Radar On Market Access: In Medicare Part D, Generic Drugs May Not Always Be Cheaper

July 16, 2019

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

The study found that, assuming a 61% discount between brand-name and generic drugs, Part D beneficiaries with prescriptions costing between $22,000 and $80,000 per year would have lower out-of-pocket spending if they use brand-name drugs over a generic, AIS Health reported.

“That’s really frustrating for consumers because you may actually not be in a plan that allows you to switch to a branded drug” if it’s cheaper than the generic, says Stacie Dusetzina, one of the study authors and an associate professor at Vanderbilt University.

“The other practical thing is, that would a terrible thing for us to be trying to get people to do because generally we want to encourage people to use generic drugs because they’re the best deal for us as a society,” she says.

Sharon Jhawar, chief pharmacy officer at California-based SCAN Health Plan, points out that because most generic prescriptions filled by seniors are not pricey specialty ones, “this kind of nuance that’s happening [with the Part D benefit] is kind of narrow and limited in scope.”

“But we know that the specialty pipeline is robust,” and so taking a look at the problem and figuring out solutions “does make sense,” she says.

However, well-intentioned policy changes don’t always turn out as planned, notes Kelly Brantley, a managing director at Avalere.

“Part D is so complicated, it’s hard to know what sort of fixes drive other quote-unquote problems,” she says.

MMIT Reality Check on Bipolar Disorder (Jul 2019)

July 12, 2019

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

According to our recent payer coverage analysis for bipolar disorder treatments, 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 bipolar disorder treatments shows that under the pharmacy benefit, about 43% of the lives under commercial and Medicare formularies are covered with utilization management restrictions.

Trends: The market contains multiple strong oral generics. Competition amongest brand name products after failure of oral generics is expected.

Radar On Market Access: Plans Must Cover PrEP at No Cost After USPSTF Recommendation

July 11, 2019

A few recent actions, as well as one expected next year, are expected to help bring down rates of HIV infection. And while the efforts should make it easier for certain populations to gain access to preexposure prophylaxis (PrEP) that helps prevent them from acquiring HIV, some issues are likely to stand in the way of eliminating all infections, AIS Health reported.

A few recent actions, as well as one expected next year, are expected to help bring down rates of HIV infection. And while the efforts should make it easier for certain populations to gain access to preexposure prophylaxis (PrEP) that helps prevent them from acquiring HIV, some issues are likely to stand in the way of eliminating all infections, AIS Health reported.

The FDA initially approved Gilead Sciences, Inc.’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in 2004 to treat HIV infection. But in 2012, the agency approved it to reduce the risk of HIV infection in adults, the only therapy indicted for this use.
In its final recommendation, published June 11, the U.S. Preventive Services Task Force (USPSTF) recommended that “clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition,” giving the recommendation an “A” rating. This grade, the highest one possible, means that the USPSTF recommends the service, as “there is high certainty that the net benefit is substantial.”

The grade also means that, per the Affordable Care Act, “a group health plan and a health insurance issuer offering group or individual health insurance coverage” must provide coverage for free of items or services that the USPSTF gives an “A” or “B” ranking.

Payers will still be able to impose “reasonable medical management techniques,” such as prior authorization, notes Elan Rubinstein, Pharm.D., principal, EB Rubinstein Associates.

“Making PrEP available without cost-sharing eliminates a major barrier to this landmark HIV prevention tool,” said Michael Ruppal, executive director of The AIDS Institute. “At a time when out-of-pocket costs are rising for patients as they seek access to medications, this recommendation is a win both for patients and public health.”

Radar On Market Access: Expensive Drugs Launched After OCM Baseline Period Are Hamstringing Providers, Study Shows

July 9, 2019

CMS’s Oncology Care Model (OCM) is about halfway through its five-year pilot. Developed by the CMS Center for Medicare & Medicaid Innovation, the voluntary pilot is aimed at providing better quality and more coordinated cancer care for Medicare fee-for-service beneficiaries, as well as other payers, while at a lower cost.

CMS’s Oncology Care Model (OCM) is about halfway through its five-year pilot. Developed by the CMS Center for Medicare & Medicaid Innovation, the voluntary pilot is aimed at providing better quality and more coordinated cancer care for Medicare fee-for-service beneficiaries, as well as other payers, while at a lower cost.

One criticism of the model is that providers’ costs are compared with targeted costs that are based partly on their spending from 2012 to 2015, the OCM baseline period. When the actual costs come in below the targeted costs, that earns providers a performance-based payment. But with so many costly oncology therapies launching after the baseline period, this is making it hard for providers to gain a performance-based payment, AIS Health reported.

That was the focus of a poster presentation by Tennessee Oncology at last month’s American Society of Clinical Oncology meeting. Researchers maintained that “when avoidable inpatient, post-acute, and emergency department (ED) costs are minimized, a practice’s actual costs should be lower than target costs, allowing practices the opportunity for shared and performance-based savings. However, we hypothesized that the ability for an oncology practice to successfully meet target costs may be hampered by the skyrocketing prices of novel therapy drugs implemented into clinical practice after baseline period cost calculations.”

They examined Tennessee Oncology patients with non-small cell lung cancer and bladder cancer treated during the second performance period (January through June 2017). The researchers concluded that the use of expensive novel therapies in concordance with NCCN guidelines in indications approved after the OCM baseline period “poses significant challenges to practices. Future value-based care initiatives in oncology need more accurate ways to account for rising drug costs and expanding treatment indications to prevent penalties for following guideline appropriate care.”

MMIT Reality Check on Psoriatic Arthritis (Jul 2019)

July 5, 2019

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

According to our recent payer coverage analysis for psoriatic arthritis treatments, 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 psoriatic arthritis treatments shows that under the pharmacy benefit, about 74% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Manufacturers with franchises across indications often hold contracting power and improved positio, which is everything in this market. In terms of contracting, Humira is the product to beat, and Enbrel battles for the second place.