Radar on Drug Benefits

Generic Advair May Help Reduce COPD Costs

May 15, 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.

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).

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.

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.

California Insurers Show Concern about Medicaid Pharmacy Carve Out Plan

May 1, 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.

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.

By Judy Packer-Tursman

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.

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.

Diabetic Drug Reportedly Reduces Kidney Failure Risk, Impact on Treatment May Be Limited

April 29, 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.

By Judy Packer-Tursman

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.

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.”

CMS Boosts Medicare Advantage Rates, Unveils Part D Policies to Address Opioid Abuse

April 18, 2019

CMS recently released its annual payment information and policy updates for Medicare Advantage, MA Prescription Drug (MA-PD) and stand-alone Prescription Drug Plans, underscoring the need for a better approach to opioid monitoring and management.

Yet overall, industry experts say perhaps the most eye-catching features of CMS’s 2020 MA and Part D Rate Announcement and final Call Letter are the better-than-anticipated pay rate and the lack of worrisome new mandates, policy changes or major technical issues.

By Judy Packer-Tursman

CMS recently released its annual payment information and policy updates for Medicare Advantage, MA Prescription Drug (MA-PD) and stand-alone Prescription Drug Plans, underscoring the need for a better approach to opioid monitoring and management.

Yet overall, industry experts say perhaps the most eye-catching features of CMS’s 2020 MA and Part D Rate Announcement and final Call Letter are the better-than-anticipated pay rate and the lack of worrisome new mandates, policy changes or major technical issues.

By incorporating an underlying “coding trend,” which CMS says will boost risk scores by 3.3%, on average, MA plans likely will see somewhere in the neighborhood of a 5.5% rate hike on average year over year, says Tim Courtney, director and senior consulting actuary of Wakely Consulting LLC.

“There just weren’t a lot of notable, earth-shaking changes this year [for the Part D program], which is good,” says Wayne Miller, R.Ph., vice president of pharmacy solutions for Gorman Health Group LLC.

“I think there’s more change coming in the [Medicare quality] star ratings measures being implemented around the opioids,” he adds, pointing to CMS’s addition of a 2020 display measure on how plans manage members’ use of opioids at higher dosages.

The agency in its 2020 final Call Letter urges Medicare plans to take voluntary steps to improve drug utilization review controls for opioids. It also says that it is “encouraging” Part D plan sponsors “to include at least one naloxone product on a generic or Select Care Tier.”

PBM Trade Group Offers Alternative to Proposed Drug Rebate Changes

April 15, 2019

One day before executives from the country’s largest PBMs testified on Capitol Hill about rising drug prices, the Pharmaceutical Care Management Association (PCMA), which lobbies on behalf of PBMs, submitted a comment letter telling the Trump administration in no uncertain terms that a proposed rule aiming to upend the prescription drug rebate system will do more harm than good.

The proposed rule, released Jan. 31, would remove safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs, Part D plans and Medicaid managed care organizations, and it would create a new safe-harbor protection for point-of-sale drug discounts.

By Leslie Small

One day before executives from the country’s largest PBMs testified on Capitol Hill about rising drug prices, the Pharmaceutical Care Management Association (PCMA), which lobbies on behalf of PBMs, submitted a comment letter telling the Trump administration in no uncertain terms that a proposed rule aiming to upend the prescription drug rebate system will do more harm than good.

The proposed rule, released Jan. 31, would remove safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs, Part D plans and Medicaid managed care organizations, and it would create a new safe-harbor protection for point-of-sale drug discounts.

PCMA argues that the proposed regulation would significantly increase premiums for all Part D beneficiaries, raise taxpayer costs for the program and destabilize Medicare Part D.

The trade group also takes issue with the proposal’s attempt to set up a system in which “a yet-to-be-determined third-party administers chargebacks within some newly created infrastructure.” PCMA says such a process would be “long, costly, and complicated” and duplicate some of the work PBMs are already doing. Instead, it suggests that PBMs themselves should administer point-of-sale price concessions using the infrastructure that already exists.

According to Deb Devereaux, senior vice president of pharmacy at Gorman Health Group, the approach that PCMA is proposing makes sense.

“I don’t see a way that the PBM would not be involved,” she says.