Radar on Market Access

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.”

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.”

Radar On Market Access: States Plow Ahead on ‘Subscription’ Models for Hep C Therapy

July 3, 2019

Last month, CMS approved Medicaid state plan amendments for Louisiana and Washington state, thus allowing the states to launch innovative value-based purchasing arrangements. Both states’ programs are aimed at working with partnering drug manufacturers to better handle the high costs for curative hepatitis C treatments, and may be the harbinger of similar initiatives by additional states.

Last month, CMS approved Medicaid state plan amendments for Louisiana and Washington state, thus allowing the states to launch innovative value-based purchasing arrangements. Both states’ programs are aimed at working with partnering drug manufacturers to better handle the high costs for curative hepatitis C treatments, and may be the harbinger of similar initiatives by additional states.

Louisiana “put the bow” on its plan to get hepatitis C treatment to Medicaid enrollees and incarcerated individuals over the next five years via a “Netflix”-like subscription model, a state official tells AIS Health.

On June 26, CMS approved Louisiana’s Medicaid state plan amendment authorizing the state to negotiate supplemental rebate agreements from prescription drug manufacturers, using a “modified subscription” model that initially focuses on antiviral agents for hepatitis C.

Meanwhile, Washington state was scrambling to finalize its agreement with AbbVie in time to launch its hepatitis C subscription-model program for Medicaid by July 1. On June 12, CMS gave the green light to Washington state’s Medicaid state plan amendment proposal to negotiate supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers.

“It’s clear from the recent developments in Washington [state] and Louisiana that payers are looking for innovative ways to pay for the increasing number of promising but costly medications coming to market, including the curative Hep C therapies,” Academy of Managed Care Pharmacy Chief Operating Officer Cynthia Reilly said in a statement to AIS Health.

“The subscription model is one of several models being implemented in real-world settings,” Reilly said. “It’s hard to say if it will become the dominant model. It’s more likely that we will continue to see experimentation and refinements, including with subscription-based, value-based and outcomes-based models.”

Radar On Market Access: New York Bill Targets on Pricing Transparency from PBMs

July 2, 2019

Lawmakers in New York in June approved wide-ranging legislation designed to require pricing transparency from PBMs and to eliminate key PBM practices. But the bill could potentially limit plans’ ability to respond to pricing moves by manufacturers, one consultant tells AIS Health.

Lawmakers in New York in June approved wide-ranging legislation designed to require pricing transparency from PBMs and to eliminate key PBM practices. But the bill could potentially limit plans’ ability to respond to pricing moves by manufacturers, one consultant tells AIS Health.

The New York bill (S.B. 6531) would require that PBMs disclose key pricing and rebate information and pass through all rebates and discounts to the plans and payers, and that they act in the best interests of the covered individual and the health plan or provider.

The New York Health Plan Association, which did not support the legislation, is particularly concerned with the “best interests” section, which imposes a fiduciary relationship on PBMs “in all but name,” says Ashley Stuart, director of government affairs for the association.

The legislation also would prohibit mid-year formulary changes and drug substitutions, and it would require PBMs operating in the state to be licensed beginning next year.

Josh Golden at Arthur J. Gallagher & Co.’s Solid Benefit Guidance says, “formulary strategies are designed to help keep drug costs in check. In moving forward with this legislation, the state potentially limits the ability of health plans to apply pricing pressure on pharmaceutical manufacturers throughout the year.”

More generally, the legislation will lead to higher health insurance premiums for employers and consumers, warned New York Health Plan Association President and CEO Eric Linzer in a statement.

The legislation comes at a time when several states are considering efforts to rein in PBMs. “At least four or five states are looking at the impact of Medicaid [pharmacy benefit] price transparency,” says Alex Shekhdar, founder of Sycamore Creek Healthcare Advisors. “It goes back to the larger fundamental conversation of what states should be looking at — they recognize there’s money under the table, especially in the PBM space.”

Radar On Market Access: CMS Requires Part D Plans to Offer RTBT

June 27, 2019

CMS in a final Medicare Advantage and Part D drug pricing rule posted last month may have notably walked back proposals around “protected” drug classes and pharmacy price concessions, but the agency finalized the requirement that Part D sponsors implement an electronic Real-Time Benefit Tool (RTBT). While the tool offers the potential to accelerate electronic prescribing, improve formulary adherence and lower prescription drug spending, it may pose a heavy information technology burden for some plans and require effort on the part of plans to encourage prescriber adoption, AIS Health reported.

CMS in a final Medicare Advantage and Part D drug pricing rule posted last month may have notably walked back proposals around “protected” drug classes and pharmacy price concessions, but the agency finalized the requirement that Part D sponsors implement an electronic Real-Time Benefit Tool (RTBT). While the tool offers the potential to accelerate electronic prescribing, improve formulary adherence and lower prescription drug spending, it may pose a heavy information technology burden for some plans and require effort on the part of plans to encourage prescriber adoption, AIS Health reported.

According to the rule, each Part D sponsor must implement at least one RTBT capable of integrating with at least one prescriber’s e-prescribing system or electronic health record (EHR) to “provide prescribers who care for its enrollees complete, accurate, timely and clinically appropriate patient-specific real-time formulary and benefit (F&B) information (including cost, formulary alternative and utilization management requirements)” by Jan. 1, 2021.

For proponents of e-prescribing like Point-of-Care Partners, LLC, the new requirement is “really exciting,” says Tony Schueth, CEO and managing partner of the health IT management consulting firm. “We have been trying to include formulary in the e-prescribing process for a long time, and the way we were doing formulary in the past just wasn’t patient-specific enough. So we’re at a really important juncture in the evolution of electronic prescribing and the benefit information being integrated.”

Heidi Harmon, a senior consultant with Gorman Health Group, says pushing back the start date of the RTBT to 2021 was very good news for plans because it will involve a “massive IT undertaking.” CMS had originally proposed that sponsors have the tool ready by Jan. 1, 2020, but pushed back the deadline after hearing from concerned stakeholders, the majority of which suggested delaying the start date until an industry standard becomes available. Harmon also notes that the requirement that a plan have a tool that can work with one prescriber’s system could be interpreted as one prescriber group’s system.