Radar on Market Access

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.”

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.

Radar On Market Access: Calif. Insurers Fear lll Effects if Medicaid Pharmacy Is Carved Out

May 2, 2019

California is quietly plowing ahead on plans by Gov. Gavin Newsom, a Democrat, to create a statewide bulk purchasing system for prescription drugs — and to transition pharmacy services for Medi-Cal, the state’s Medicaid program, from managed care to fee-for-service (FFS) by January 2021, AIS Health reported.

California is quietly plowing ahead on plans by Gov. Gavin Newsom, a Democrat, to create a statewide bulk purchasing system for prescription drugs — and to transition pharmacy services for Medi-Cal, the state’s Medicaid program, from managed care to fee-for-service (FFS) by January 2021, AIS Health reported.

In the latest development related to the initiatives, Los Angeles County tentatively has agreed “to sit at the same bargaining table” with Newsom’s administration to negotiate prices with drug manufacturers, the Los Angeles Times reported April 17.

The California Association of Health Plans (CAHP) says its main concerns relate to ongoing work on the Medi-Cal pharmacy services “carve-out.”

In its April 5 report, the state Legislative Analyst’s Office (LAO) says the state’s Medicaid pharmacy carve out plan likely will generate net savings to the state. But it notes many details have yet to be released concerning how the carve out will be implemented and how the administration believes it will affect Medi-Cal spending and stakeholders. Thus, the LAO recommends that “the Legislature withhold approval of future new state operations resources to implement the carve out until the administration provides key information that adequately answers major outstanding questions.”

According to CAHP spokesperson Mary Ellen Grant, the LAO report “says the state may save money [by shifting Medi-Cal’s pharmacy benefit from managed care to FFS], but there are a lot of trade-offs and even the savings are uncertain.”

She notes that analyses by The Menges Group and other researchers have found transitioning the drug benefit back to FFS would be costly to state Medicaid programs.

Radar On Market Access: Diabetic Drug’s Kidney Benefit May Not Be Game-Changer

April 30, 2019

The potential use of Invokana (canagliflozin) for chronic kidney disease as well as type 2 diabetes, its current indicated use, recently attracted national headlines. If Janssen Pharmaceuticals, Inc.’s supplemental indication for its medication is approved by the FDA, “it would be the first new treatment for diabetic kidney disease in decades,” the National Kidney Foundation said.

The potential use of Invokana (canagliflozin) for chronic kidney disease as well as type 2 diabetes, its current indicated use, recently attracted national headlines. If Janssen Pharmaceuticals, Inc.’s supplemental indication for its medication is approved by the FDA, “it would be the first new treatment for diabetic kidney disease in decades,” the National Kidney Foundation said.

The kidney foundation points out that diabetes is a key risk factor for chronic kidney disease. The group says it anticipates strong uptake of Invokana by clinicians and payers facing “high costs and management challenges” in treating advanced kidney disease in people with type 2 diabetes, AIS Health reported.

But Mesfin Tegenu, R.Ph., president of PerformRx, LLC, doesn’t expect a major impact on treatment. That’s because Invokana joins Jardiance (empagliflozin) and Farxiga (dapagliflozin), among others, in a class of type 2 diabetes medications called SGLT2 inhibitors — and some rival products already provide similar benefits, he says.

In 2018, the American Diabetes Association and European Association for the Study of Diabetes issued a consensus statement that “already recommends Jardiance in diabetic CKD [i.e., chronic kidney disease] patients due to the renal benefit,” Tegenu adds.

In the recently announced results for Invokana’s CREDENCE study, Invokana was found to reduce the risk of dialysis or the need for a kidney transplant, which Tegenu says is “good news for plan payers and patients since in addition cardiovascular benefits were also found.”

“However,” he adds, “[cardiovascular] benefits have been known for at least a year and guidelines already recommend these drugs in [chronic kidney disease] patients.”