Payer

Radar On Market Access: Use of Biologics, Biosimilars Showed Rapid Uptake in 2018

May 16, 2019

Almost 5.8 billion prescriptions were dispensed in the United States in 2018, an increase of 2.7% over the previous year, according to the IQVIA Institute for Human Data Science’s report Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023, AIS Health reported.

Almost 5.8 billion prescriptions were dispensed in the United States in 2018, an increase of 2.7% over the previous year, according to the IQVIA Institute for Human Data Science’s report Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023, AIS Health reported.

Retail and mail pharmacies dispensed 127 million specialty prescriptions last year, an increase of 15 million since 2014. In 2018, for the second year in a row, specialty prescription volume grew more than 5% although the medicines accounted for only 2.2% of prescriptions overall. With an increase in the availability of oral and self-injected specialty therapies, these drugs “are increasingly dispensed through retail pharmacies,” said Murray Aitken, executive director of the institute, during a May 6 press call.

Researchers found that there has been rapid uptake of the programmed cell death-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors. In 2014, following the FDA approval of Merck & Co., Inc.’s Keytruda (pembrolizumab) in September, there were 2,403 people treated with an immuno- oncology checkpoint inhibitor. That number rose to 212,473 in 2018, with six products on the market boasting numerous indications.

The use of biosimilars — which the institute defines on a broader basis than only those therapies approved through the 351(k) pathway — “in terms of volume is still modest,” said Aitken, with these therapies representing less than 2% of the total biologics market in 2018. But in those areas where a biosimilar is available, “there is reasonably rapid uptake.”

Radar On Market Access: CBO Says Proposed Rebate Rule Will Cost Government $177B

May 14, 2019

When HHS unveiled a proposed rule in late January aimed at eliminating drug rebates in Medicare Part D and Medicaid managed care, the proposal was met with mixed responses. A recently released score from the Congressional Budget Office (CBO) calls into question whether the administration chooses to move forward with the proposal in its current form, AIS Health reported.

When HHS unveiled a proposed rule in late January aimed at eliminating drug rebates in Medicare Part D and Medicaid managed care, the proposal was met with mixed responses. A recently released score from the Congressional Budget Office (CBO) calls into question whether the administration chooses to move forward with the proposal in its current form, AIS Health reported.

The proposal would do away with the safe harbor protection in the anti-kickback statute for rebates negotiated between manufacturers and PBMs starting Jan. 1, 2020.

In the CBO’s report, the agency projects that if the rule is implemented as proposed, it will increase federal spending by approximately $177 billion from 2020 to 2029. Of that total, spending on Medicare Part D premiums would increase by about $170 billion. Without rebates to keep premiums low, beneficiaries would face higher premiums. The agency anticipates that “rather than lowering list prices, manufacturers would offer the negotiated discounts in the form of chargebacks,” which are shared with beneficiaries via a manufacturer payment to a pharmacy.

The report, however, also concludes that “no current system could both meet the proposed rule’s standards and facilitate chargebacks.”

If “rebates could no longer be paid to PBMs in Medicare Part D,” but “systems are not available to support retail pharmacy chargebacks,…this would be an untenable situation,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, making it “reasonable to delay” the proposed implementation date.

“The increase in premiums was expected by many, but the growth in federal spending was somewhat surprising given that lower upfront prices would generally benefit the end payer, which in this case is the federal government,” says Jeremy Schafer, Pharm.D., senior vie president, director, access experience team at Precision for Value. “It seems changing the safe harbor may not accomplish patient savings or reduced government spending as hoped for by the administration.”

MMIT Reality Check on Narcolepsy (May 2019)

May 10, 2019

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

According to our recent payer coverage analysis for narcolepsy 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 narcolepsy treatments shows that under the pharmacy benefit, more than 66% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2019, the FDA approved Jazz Pharmaceuticals plc’s Sunosi (solriamfetol) to improve wakefulness in adults with excessive daytime sleepiness from narcolepsy or obstructive sleep apnea. Via AIS Health.

Radar On Market Access: CMS Extends Options to States to Test Innovative Dual-Eligible Care Models

May 9, 2019

Although independent evaluations of ongoing demonstrations to integrate care for dual-eligible Medicare-Medicaid beneficiaries are still underway, an April 24 letter from CMS Administrator Seema Verma signaled the agency’s commitment to proving the value of the models as well as testing alternatives, AIS Health reported.

Although independent evaluations of ongoing demonstrations to integrate care for dual-eligible Medicare-Medicaid beneficiaries are still underway, an April 24 letter from CMS Administrator Seema Verma signaled the agency’s commitment to proving the value of the models as well as testing alternatives, AIS Health reported.

In the letter to state Medicaid directors, CMS extended three new opportunities to “test state-driven approaches” for integrating duals’ care:

(1) For interested states with capitated Financial Alignment Initiative (FAI) model demos, CMS said it is “open to partnering on revisions.”

(2) For interested states without capitated demos, CMS said it welcomes interest in testing the model through new demos in additional states.

(3) CMS said it is open to partnering with states on testing new state-developed models to better serve dual eligibles and invited states to respond with ideas, concept papers and/or proposals.

Kevin Malone, a senior counsel in the Health Care and Life Sciences practice in the Washington, D.C., office of Epstein Becker & Green, P.C. and a former duals officer at CMS, predicts that, for states with existing demos, they will not only revisit their memoranda of understanding that outline the terms of their agreements with CMS, but will use it as a chance to amend their three-way contracts with CMS and plans. This presents a unique opportunity for the plans to suggest changes around certain programmatic requirements or provider training that may reduce some of their burden and streamline some of the technical details of their arrangements.

Radar On Market Access: Magellan Sees Success With Infliximab Biosimilars

May 7, 2019

Magellan Rx Management saw a significant shift in utilization from Janssen Biotech, Inc.’s Remicade (infliximab) to biosimilars after it implemented a comprehensive utilization management (UM) program, resulting in 34% drug cost savings, the PBM reported.

Magellan Rx Management saw a significant shift in utilization from Janssen Biotech, Inc.’s Remicade (infliximab) to biosimilars after it implemented a comprehensive utilization management (UM) program, resulting in 34% drug cost savings, the PBM reported.

The program, which began in late 2017, involves any patient prescribed an infliximab product for any indication, and is available to all payer clients as an opt-in option, Steve Cutts, senior vice president and general manager, tells AIS Health.

When Magellan Rx began the infliximab program in the fourth quarter of 2017, 100% of the PBM’s patients receiving an infliximab product received Remicade and none took biosimilars, the PBM said. In the third quarter of 2018, the last quarter for which Magellan has data, 86% of patients got the biosimilar and 14% took the brand-name drug.

The FDA approved the first infliximab biosimilar, Pfizer, Inc.’s Inflectra (infliximab-dyyb), in April 2016. The agency now lists three approved infliximab biosimilars: Inflectra; Merck & Co., Inc.’s Renflexis (infliximab-abda); and Pfizer’s Ixifi (infliximab-qbtx). Pfizer is not launching Ixifi in the U.S. since it already has Inflectra on the market, so only Inflectra and Renflexis are being sold in the U.S.

Magellan Rx works with both infliximab biosimilar manufacturers, Cutts says, and can “offer multiple options to our clients regarding which biosimilar or combination of biosimilars will work best for their unique situation.”

The Magellan Rx infliximab UM program aims to overcome reluctance on the part of physicians to prescribe biosimilars by emphasizing that they provide the same level of clinical efficacy and safety, with the added benefit of cost savings.

“Likely the most important factor [in the Magellan Rx utilization management program] is obtained provider acceptance that the biosimilar is going to deliver the same results as the innovator product,” says Daniel Malone, R.Ph., Ph.D., professor at the University of Arizona College of Pharmacy.

MMIT Reality Check on Low Testosterone (May 2019)

May 3, 2019

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

According to our recent payer coverage analysis for low testosterone 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 low testosterone treatments due to chronic kidney disease shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2019, the FDA approved Jatenzo (testosterone undecanoate) for the treatment of males with low testosterone levels because of specific genetic disorders or pituitary gland-damaging tumors. Via AIS Health.