Market Access

Radar On Market Access: New Heart Failure Drugs Offer More Therapy Options

March 2, 2021

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis’ Entresto (sacubitril/valsartan) and Amgen’s Corlanor (ivabradine) — are important additions to prescribers’ clinical arsenals against the high-mortality condition, industry insiders tell AIS Health.

“Generic heart failure drugs, including beta blockers, ACE inhibitors, and ARBs [angiotension receptor blockers] have historically been used and continue to be the backbone of therapy,” says April Kunze, Pharm.D., senior director of clinical program development for Prime Therapeutics. “However, in the past few years, additional treatment options have become available. Entresto is now recommended as a first-line treatment option in patients with an ejection fraction <= 40%."

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis’ Entresto (sacubitril/valsartan) and Amgen’s Corlanor (ivabradine) — are important additions to prescribers’ clinical arsenals against the high-mortality condition, industry insiders tell AIS Health.

“Generic heart failure drugs, including beta blockers, ACE inhibitors, and ARBs [angiotension receptor blockers] have historically been used and continue to be the backbone of therapy,” says April Kunze, Pharm.D., senior director of clinical program development for Prime Therapeutics. “However, in the past few years, additional treatment options have become available. Entresto is now recommended as a first-line treatment option in patients with an ejection fraction <= 40%.”

Novartis said Feb. 16 that Entresto won an expanded indication from the FDA to reduce the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure. “Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal,” the drugmaker said.

Prime Therapeutics currently prefers Entresto on formulary, and the PBM recommends that plans remove prior authorizations for Entresto in order to encourage its use, Kunze says.

Mesfin Tegenu, CEO and chairman of RxParadigm, says that Entresto, which has an average retail price of around $600 per month, typically is placed on formularies as a preferred brand drug. Meanwhile, Amgen’s Corlanor can be beneficial in reducing heart failure-associated hospitalization for patients with symptomatic (NYHA Class II-III) stable chronic heart failure with a left ventricular ejection fraction of less than or equal to 35% who are receiving a maximal tolerated targeted dose of a beta blocker and in sinus rhythm with a heart rate of 70 beats per minute or greater at rest, Tegenu says.

“The target for Colanor is to slow down heart rate,” Tegenu explains, adding that Corlanor typically is placed on formularies as a preferred or non-preferred brand, and may be started when the patient’s condition is not being adequately controlled on optimally dosed beta blocker therapy.

Entresto and Corlanor represent advances in treatment for chronic heart failure, Tegenu says. “Both therapies were poised to change the landscape of treatment for patients with heart failure, given their unique mechanisms of action,” he says.

Health plans also are turning to targeted disease and care management programs to focus on preventing hospital readmission, reducing mortality and reducing costs in heart failure, Tegenu adds.

MMIT Reality Check on HIV (Feb 2021)

February 26, 2021

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

According to our recent payer coverage analysis for HIV 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 HIV treatments shows that under the pharmacy benefit, about 74% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In January 2021, the FDA approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine) for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in people who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.

Trends That Matter for Rx Benefits in Medicaid

February 25, 2021

Beginning in April, California and New York will join a growing list of states that have opted to carve out prescription drug benefits from their Medicaid contracts with insurers, wagering that the state can do a better job at negotiating drug prices with manufacturers than managed care organizations and their contracted PBMs, AIS Health reported.

“I think the pharmacy benefit overall will be something that states are looking at in order to find savings in some way — whether through carveouts or through another policy — just because there are limited levers that the state is going to be able to pull to save money,” says Rachel Dolan, a senior policy analyst with the Kaiser Family Foundation’s Program on Medicaid and the Uninsured.

Beginning in April, California and New York will join a growing list of states that have opted to carve out prescription drug benefits from their Medicaid contracts with insurers, wagering that the state can do a better job at negotiating drug prices with manufacturers than managed care organizations and their contracted PBMs, AIS Health reported.

“I think the pharmacy benefit overall will be something that states are looking at in order to find savings in some way — whether through carveouts or through another policy — just because there are limited levers that the state is going to be able to pull to save money,” says Rachel Dolan, a senior policy analyst with the Kaiser Family Foundation’s Program on Medicaid and the Uninsured.

Other states that have carved out their drug benefits from managed care contracts include Missouri, North Dakota, Tennessee, West Virginia and Wisconsin, and Nevada plans to carve out the prescription drug benefit in fiscal year 2023 when its MCO contracts are renewed.

One catalyst for the carveouts may be the increasing scrutiny on spread pricing, which occurs when PBMs charge payers more for prescription drugs than the amount they reimburse pharmacies and retain the difference.

“It also allows the state more control over their formulary and their payment policy, and it can also help them potentially negotiate more supplemental rebates with manufacturers if basically all the drugs are in one big pool covered by the state,” Dolan adds.

For Medicaid MCOs, there are a host of important considerations when states opt to carve out their pharmacy benefits, notes Brian Anderson, a principal with Milliman. For example, such a move will generally hinder MCOs’ ability to influence prescribing practices, which “have a profound impact on drug utilization and drug mix,” he says. Pharmacy networks are another key issue, as MCOs often use closed networks but some states have any-willing-provider regulations for pharmacy participation in networks.

MMIT Reality Check on Type 2 Diabetes (GLP-1 and Combo) (Feb 2021)

February 19, 2021

According to our recent payer coverage analysis for type 2 Diabetes (GLP-1 and Combo) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for type 2 Diabetes (GLP-1 and Combo) 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 type 2 Diabetes (GLP-1 and Combo) treatments shows that under the pharmacy benefit, almost 46% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Access to Novo Nordisk’s Rybelsus (semaglutide) — the first oral glucagon-like peptide-1 receptor agonist (GLP-1) to treat adults with type 2 diabetes — got a major boost in January 2020 when Novo said Express Scripts, part of Cigna Corp., would cover the agent.

Radar On Market Access: Pass-Through Rebate Models Need to Demonstrate Value

February 18, 2021

With the Trump administration’s rebate rule delayed and possibly slated for repeal by Democrats in Congress, major changes in how the PBM industry distributes rebate revenue will have to come from the private sector, AIS Health reported.

The Biden administration will suspend implementation until 2023 of the so-called “rebate rule,” a Trump administration regulation that would have revamped the Medicare prescription drug rebate system, and DC insiders expect the regulation will be repealed by Congress before then. Meanwhile, a growing number of PBMs that deal in the commercial market have pitched plan sponsors on a 100% pass-through rebate structure, in which the PBM collects its compensation through a fee or surcharges rather than diverting a share of rebate revenue.

With the Trump administration’s rebate rule delayed and possibly slated for repeal by Democrats in Congress, major changes in how the PBM industry distributes rebate revenue will have to come from the private sector, AIS Health reported.

The Biden administration will suspend implementation until 2023 of the so-called “rebate rule,” a Trump administration regulation that would have revamped the Medicare prescription drug rebate system, and DC insiders expect the regulation will be repealed by Congress before then. Meanwhile, a growing number of PBMs that deal in the commercial market have pitched plan sponsors on a 100% pass-through rebate structure, in which the PBM collects its compensation through a fee or surcharges rather than diverting a share of rebate revenue.

Jeff Levin-Scherz, M.D., national co-leader of the health management practice at Willis Towers Watson, says that passed-through rebates can flow in two directions after they are in employers’ hands.

“Employers have been moving to pass-through rebates where the PBM will give 100% of the rebate to the employer,” which the employer can then spend on its larger medical benefit, lowering premiums, Levin-Scherz says. “Point of care or point of sale rebates are different, where the rebate is essentially put into the purchase price [of a drug].”

Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, says that passing through rebates better aligns the incentives of a PBM and a plan sponsor.

“I think for the large, self-funded employers, the issue is more about product selection,” Bai says. “And the employers are frustrated by some inefficient product selection choices made by the PBMs on the formulary….it’s one reason why employers want the rebate pass-through — it will reduce the PBM’s incentive to make money from high-price, high-rebate drugs.”

However, Bai also says that explains why some employers opt for a traditional rebate model: for firms that don’t expect to have high levels of drug spending by members, the lower premium offered by the traditional rebate model may be more appealing.

Like Bai, Daniel Nam, Pharm.D., associate principal for pharmacy policy at Avalere Health, says that prices and premiums will ultimately decide which approach becomes dominant in the marketplace.

“I think it really depends on the bottom-line price that the PBM is willing to offer to the employer or the health plan,” he says.

MMIT Reality Check on Rheumatoid Arthritis (Feb 2021)

February 12, 2021

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

According to our recent payer coverage analysis for rheumatoid arthritis 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 rheumatoid arthritis treatments shows that under the pharmacy benefit, about 69% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2020, the FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency has approved — in both prefilled syringe and auto-injector presentations.