Current Market Access to PCSK9 Inhibitors

July 12, 2019

All PCSK9 inhibitors for patients with heterozygous familial hypercholesterolemia are covered under both the pharmacy benefit and medical benefit with some limitations, most frequently prior authorizations and quantity limits. In 2018, Express Scripts Holding Co., now part of Cigna Corp., struck a deal with the manufacturers of Praluent that will give the PBM a lower net price on the drug in exchange for streamlined patient access and an exclusive spot on the PBM’s national formulary. Overall, since last July, market access to Praluent for all payers under commercial and exchange formularies saw a significant decrease.

by Jinghong Chen

All PCSK9 inhibitors for patients with heterozygous familial hypercholesterolemia are covered under both the pharmacy benefit and medical benefit with some limitations, most frequently prior authorizations and quantity limits. In 2018, Express Scripts Holding Co., now part of Cigna Corp., struck a deal with the manufacturers of Praluent that will give the PBM a lower net price on the drug in exchange for streamlined patient access and an exclusive spot on the PBM’s national formulary. Overall, since last July, market access to Praluent for all payers under commercial and exchange formularies saw a significant decrease. For all four medications on the market, more than 60% of covered lives are under the preferred tier/preferred with prior authorization or step therapy and covered tier/covered with PA/ST. Payer pharmacy benefit formularies require ST for 93% of the covered lives and PA for 88% of the covered lives.

NOTE: Under the pharmacy benefit, the numbers of total covered lives under commercial, health exchange, Medicare and Medicaid formularies are 108.9 million, 10.2 million, 33.2 million and 62.0 million, respectively. Under the medical benefit, the numbers of total covered lives under commercial, health exchange, Medicare and Medicaid policies are 184.9 million, 10.2 million, 44.5 million and 62.0 million, respectively.

SOURCE: Managed Markets Insight & Technology, LLC database as of July 2018 and July 2019.

Datapoint: New Hampshire Delays Medicaid Work Requirements

July 11, 2019

New Hampshire Governor Chris Sununu (R) announced he is halting rollout of the state’s Medicaid work requirements program until November, due to lack of participation that would have led to sweeping cuts from the Medicaid rolls. About 18,000 people in the target population, the state’s approximately 50,000 adult Medicaid expansion enrollees, did not meet any of the reporting requirements. Many enrollees still were not aware of the new rules despite outreach efforts, according to state officials. Of New Hampshire’s 175,234 Medicaid beneficiaries, about 28.5% are required to participate in the community engagement program.

New Hampshire Governor Chris Sununu (R) announced he is halting rollout of the state’s Medicaid work requirements program until November, due to lack of participation that would have led to sweeping cuts from the Medicaid rolls. About 18,000 people in the target population, the state’s approximately 50,000 adult Medicaid expansion enrollees, did not meet any of the reporting requirements. Many enrollees still were not aware of the new rules despite outreach efforts, according to state officials. Of New Hampshire’s 175,234 Medicaid beneficiaries, about 28.5% are required to participate in the community engagement program.

Source: AIS’s Directory of Health Plans

Trump Abandons Drug Pricing Proposal That Would Have Ended Certain Drug Rebates

July 11, 2019

The Trump administration on Wednesday abandoned one of its signature drug-pricing efforts: a ban on many of the rebates that drug companies pay to pharmacy benefit managers under Medicare.

A White House spokesman confirmed the news to STAT after it was first reported by Axios.

“Based on careful analysis and thorough consideration, the President has decided to withdraw the rebate rule,” spokesman Judd Deere said.

The Trump administration on Wednesday abandoned one of its signature drug-pricing efforts: a ban on many of the rebates that drug companies pay to pharmacy benefit managers under Medicare.

A White House spokesman confirmed the news to STAT after it was first reported by Axios.

“Based on careful analysis and thorough consideration, the President has decided to withdraw the rebate rule,” spokesman Judd Deere said.

While the White House had argued eliminating rebates would result in drug manufacturers charging lower list prices, the proposal has been controversial since its unveiling in January. Drug manufacturers had largely supported it, while middlemen known as pharmacy benefit managers and insurers were vocally opposed….

Read the full Stat article

Trump’s Assault on Obamacare Could Undermine His Own Health Initiatives

July 11, 2019

In court, the Trump administration is trying to get all of Obamacare erased. But at the White House, President Trump and his health officials are busily using the law to pursue key proposals.

Last week, the president highlighted a policy in the works meant to narrow the gaps between what drugs cost in the United States and overseas. On Wednesday, he signed an executive order to transform care for patients with kidney disease.

In court, the Trump administration is trying to get all of Obamacare erased. But at the White House, President Trump and his health officials are busily using the law to pursue key proposals.

Last week, the president highlighted a policy in the works meant to narrow the gaps between what drugs cost in the United States and overseas. On Wednesday, he signed an executive order to transform care for patients with kidney disease.

Both measures were made possible by a provision in the Affordable Care Act, and both would be effectively gutted if the administration’s position prevailed in court.

In between, administration lawyers told a receptive panel of judges in New Orleans that the entire Affordable Care Act should be overturned….

Read the full The New York Times article

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.

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.

By Angela Maas

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.

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.”