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Radar On Market Access: CMS ‘Meaningfully Walks Back’ on Key Drug Pricing Proposals

May 28, 2019

When CMS issued the final rule on Medicare Advantage and Part D drug pricing on May 16, the agency touted its policy changes as ensuring consumers get greater transparency into the cost of Part D prescription drugs and enabling MA plans to negotiate better prices for physician-administered medicines in Part C. Yet, after receiving 4,000-plus comments related to pharmacy price concessions on negotiated price, CMS held back, saying it won’t implement this policy for 2020 — or follow through on proposed exceptions to Part D protected drug classes, AIS Health reported.

When CMS issued the final rule on Medicare Advantage and Part D drug pricing on May 16, the agency touted its policy changes as ensuring consumers get greater transparency into the cost of Part D prescription drugs and enabling MA plans to negotiate better prices for physician-administered medicines in Part C. Yet, after receiving 4,000-plus comments related to pharmacy price concessions on negotiated price, CMS held back, saying it won’t implement this policy for 2020 — or follow through on proposed exceptions to Part D protected drug classes, AIS Health reported.

Among numerous provisions, CMS’s final rule implements the statutory prohibition against gag clauses in pharmacy contracts, barring Part D plans from penalizing pharmacies that disclose a lower cash price to enrollees. But the agency decided against implementing a policy redefining negotiated price as the lowest possible, baseline payment to pharmacies.

Leerink analyst Ana Gupte sees industry winners across the board. CMS “did not follow through on its proposal to exclude certain protected drug classes, offering a win for the biopharma industry,” she said in a May 17 note. “Managed Care and PBMs also garnered a win as CMS did not follow through on the proposals to pass through pharmacy pricing concessions in the form of DIR [direct and indirect remuneration] fees to patients through reduced cost sharing.”

Dea Belazi, Pharm.D., president and CEO of AscellaHealth, offers a blunter assessment. “I think the final Part D rule is more rhetoric than anything,” he tells AIS Health.

As for negotiated price, “They’re not ready to do anything on pricing at this point,” Belazi says. “I think CMS, with HHS, opened up a Pandora’s box and realized this is not as easy as it seems and they need more time.”

Radar On Market Access: Generic Advair May Help Reduce COPD Costs

May 21, 2019

A new generic alternative for GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization, AIS Health reported.

A new generic alternative for GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization, AIS Health reported.

Advair Diskus, a combination long-acting beta-agonist and an inhaled corticosteroid, has been one of the most common drugs used for COPD, a condition largely dominated by brand products. The generic, marketed by Mylan and approved Jan. 30, joins generics for two additional COPD devices: a generic for Ventolin HFA (albuterol) and one for Proair HFA (albuterol).

All three have the potential to save payers and patients significant money. Charline Shan, R.Ph., vice president, access experience team at payer insights and strategy firm Precision for Value, says plans have multiple options for structuring their formularies with the amount of generic options available.

Generics are typically included, with brand drugs placed on preferred or nonpreferred tiers based on price, “but not all are required or have to be on the formulary since there are many branded and therapeutic equivalent options,” she says.

Most people with COPD are covered by Medicare, and CMS requires that a minimum of two products for each category or class be available on the formulary. However, Medicare Part D plans may also consider additional factors when structuring their formularies for COPD patients, including the total cost of care, and that may lead them to implement more selective branded choices on formularies than commercial plans, Shan says.

Perspectives on BioScrip/Option Care Deal

May 16, 2019

Two of the country’s largest independent infusion services providers recently unveiled that they have entered into a merger agreement. After coming together, BioScrip, Inc. and Option Care Enterprises, Inc. would be the No. 2 home/alternate site infusion provider in the United States, AIS Health reported.

Two of the country’s largest independent infusion services providers recently unveiled that they have entered into a merger agreement. After coming together, BioScrip, Inc. and Option Care Enterprises, Inc. would be the No. 2 home/alternate site infusion provider in the United States, AIS Health reported.

Under the terms of the deal, publicly traded BioScrip would issue new shares to Madison Dearborn Partners, LLC and Walgreens Boots Alliance, Inc., which are the Option Care shareholders, giving them 80% of BioScrip’s stock, with current BioScrip shareholders holding the remaining 20%. The new company would be publicly traded.

“Scale is critical to succeed in home infusion/alternate site services,” says Bill Sullivan, principal consultant for Specialty Pharmacy Solutions LLC. “Opportunity to build scale…is important for payer access and better cost-of-goods pricing through wholesalers and in some cases direct with manufacturers.”

“From the pharma side, I’m not going to say it’s easy from a distribution standpoint, but with limited-distribution drugs…and an entity that covers 96% of the U.S. population, it’s easy for a company to pick a partner like this,” says Pat Clifford, managing director at The Braff Group.

“Considering that the home/site infusion industry has been growing at two to three times the rate of U.S. GDP [i.e., gross domestic product], we think it is no surprise that a national player would emerge eventually,” remarks Bill Bolding, an analyst at Provident.

Benefits of the deal include the fact that “integrating patient care from outpatient through the home setting has the potential to improve outcomes significantly, all while minimizing the traditional waste/cost that comes with the patient transition,” Bolding tells AIS Health.

While cost cutting is an additional benefit of the arrangement, it also may prove to be a challenge, says Clifford. “In markets with duplicate locations,” they would be able to combine them, “but if they are overlapping a lot, some locations may need to be shut down.”

Another potential challenge is the fact that “no individual player has controlled 10%-25% [of the] infusion market to date, depending on how you measure the space,” says Bolding. “There is no playbook that this executive team can copy to merge site and home infusion at this scale, and as always, reimbursement risk should be considered.”

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.