Radar on Market Access

Radar On Market Access: Post-Rebate Rule, Trump Administration Mulls ‘Any and All Tools’

July 25, 2019

With only six months to go until a planned implementation date of Jan. 1, 2020, HHS on July 11 pulled its controversial rule that would have eliminated pharmaceutical manufacturer rebates in Medicare and Medicaid, leaving Part D stakeholders to ponder the Trump administration’s next moves on lowering prescription drug pricing.

With only six months to go until a planned implementation date of Jan. 1, 2020, HHS on July 11 pulled its controversial rule that would have eliminated pharmaceutical manufacturer rebates in Medicare and Medicaid, leaving Part D stakeholders to ponder the Trump administration’s next moves on lowering prescription drug pricing.

Although news of its withdrawal appeared to surprise the investment community, the rebate rule had too much stacked against it to become final, Larry Kocot, a principal at KPMG, LLP, tells AIS Health. “[T]here were a lot of challenges,” starting with the Congressional Budget Office’s (CBO) estimate that the rule as proposed would have increased federal spending by about $177 billion over the next decade.

Looking ahead to the 2020 elections, President Trump is under the gun to deliver a solution to rising drug prices. While HHS is likely to finalize its proposed International Pricing Index model for Part B drugs, Senate leadership at press time was reportedly considering drug reimportation as well as a proposal that would essentially penalize manufacturers if their drug prices went up by more than a certain inflation factor by making them pay rebates on a percentage of the overage.

At the same time, Congress could advance a House proposal to restructure the Part D benefit such that manufacturers would have to provide more discounts in the catastrophic coverage phase and insurers would have more responsibility for catastrophic spending because of a reduction in federal reinsurance.

Meanwhile, drug reimportation from other countries could be a slippery slope, warns Wayne Miller, R.Ph., vice president for pharmacy solutions with Gorman Health Group. “That’s going to have a short-term effect and pharmaceutical companies will compensate by adjusting their prices,” he predicts.

Radar On Market Access: Plans Offer More $0 Copay Drugs to Boost Adherence

July 23, 2019

As various players in the health care industry sharpen their focus on disease prevention, some experts tell AIS Health they’re seeing health plans offering more and more “preventive” drugs at no cost to members.

As various players in the health care industry sharpen their focus on disease prevention, some experts tell AIS Health they’re seeing health plans offering more and more “preventive” drugs at no cost to members.

Dean Health Plan recently said it’s “adding even more preventive drugs to our list of drugs available to [members] for $0.” Additions to the list, which total more than 200, include Advair inhalers (fluticasone propionate and salmeterol) for asthma, the diabetes drug Januvia (sitagliptin), and Alendronate for osteoporosis, says Kevin Engelien, manager of large group product and market research at the Wisconsin-based insurer.

To decide what goes on that list, Dean Health Plan works with its PBM, Navitus Health Solutions, in a “no less than monthly” process of reviewing the utilization and effectiveness of drugs, as well as any changing mandates, Engelien says.

It’s not just smaller regional insurers like Dean Health Plan that are making more drugs available to members at no cost.

“I do think there is a trend in non-grandfathered self-insured clients offering preventive drug lists, and also kind of widening their preventive drug lists,” says Stephen Wolff, a pharmacy consultant in Milliman’s Chicago office.

While Wolff attributes the expansion of those lists to the rise of high-deductible health plans in the employer-sponsored insurance market.

“I think the driving force, to the plans that I consult to, is more in trying to make sure that people with chronic conditions get the treatment necessary,” he says. “So even if you have a deductible, you can get first-dollar coverage on diabetes meds, for example.”

In fact, the Internal Revenue Service recently issued new guidance that expands the list of services and medications that patients in high-deductible health plans can access before meeting their deductible.

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.

Perspectives on the First NASH Drugs

July 11, 2019

Doctors trying to treat patients with nonalcoholic steatohepatitis (NASH) — a serious type of nonalcoholic fatty liver disease (NAFLD) that, if left untreated, may progress to cardiovascular disease, cirrhosis, cancer and possibly the need for a liver transplant — soon may have new options in their arsenal beyond promoting exercise and diet. The first-ever NASH drugs are expected to hit the U.S. market as early as 2020 to help address this increasingly prevalent, complex disease spawned largely by the obesity epidemic and surge of type 2 diabetes in the U.S., AIS Health reported.

Doctors trying to treat patients with nonalcoholic steatohepatitis (NASH) — a serious type of nonalcoholic fatty liver disease (NAFLD) that, if left untreated, may progress to cardiovascular disease, cirrhosis, cancer and possibly the need for a liver transplant — soon may have new options in their arsenal beyond promoting exercise and diet. The first-ever NASH drugs are expected to hit the U.S. market as early as 2020 to help address this increasingly prevalent, complex disease spawned largely by the obesity epidemic and surge of type 2 diabetes in the U.S., AIS Health reported.

Douglas Dieterich, M.D., director of the Institute for Liver Medicine at Mount Sinai Health System, says the entry of first-ever NASH medications will “definitely” offer significant benefit to patients. “There’s no question [the drugs will help] — in combination with diet and exercise,” he says. “It will have to be the whole package.”

Multiple drugs are in phase 3 clinical trials for NASH. A front-runner is Intercept Pharmaceuticals, Inc.’s drug, Ocaliva (obeticholic acid), already on the market to treat another liver condition. But the FDA isn’t expected to approve Intercept’s drug for NASH until the second quarter of 2020, Dieterich notes.

Dieterich says he expects NASH medications will “undoubtedly” be marketed as specialty drugs that will be “strictly controlled” by PBMs and insurance companies. He expects such drugs to become available only to the sickest patients, possibly only after a diagnostic liver biopsy is performed.

From a plan perspective, Yusuf Rashid, R.Ph., vice president of pharmacy and vendor relationship management at Community Health Plan of Washington, says NASH “has similarities to other recent new breakthrough therapies where the outcome we are trying to avoid is costly and potentially fatal but not all patients…will even progress to fibrosis. The reason why NASH is more significant is the sheer number of patients that may qualify for treatment.”

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.”