Radar on Drug Benefits

FDA Approves New Treatments for nr-axSpA, But Coverage May Be Tricky

July 1, 2020

The FDA’s approval of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis (nr-axSpA) offers providers new options for patients who are intolerant of non-steroidal anti-inflammatory medications (NSAIDs) and other therapies.

Axial spondyloarthritis (axSpA), an inflammatory arthritis of the spine, was reclassified into two categories. In the more commonly known ankylosing spondylitis (AS), also called radiographic axial spondyloarthritis (r-axSpA), damage to the spine is visible on an X-ray. In the earlier-stage form of the disease, non-radiographic axial spondyloarthritis (nr-axSpA), joint deterioration is not yet evident on an X-ray.

By Jane Anderson

The FDA’s approval of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis (nr-axSpA) offers providers new options for patients who are intolerant of non-steroidal anti-inflammatory medications (NSAIDs) and other therapies.

Axial spondyloarthritis (axSpA), an inflammatory arthritis of the spine, was reclassified into two categories. In the more commonly known ankylosing spondylitis (AS), also called radiographic axial spondyloarthritis (r-axSpA), damage to the spine is visible on an X-ray. In the earlier-stage form of the disease, non-radiographic axial spondyloarthritis (nr-axSpA), joint deterioration is not yet evident on an X-ray.

“It’s possible that with the emerging trend of biologics gaining expanded indications to treat non-radiographic axial spondyloarthritis, payers will respond by choosing a preferred agent from the three [biologics] approved,” says Mesfin Tegenu, R.Ph., president of PerformRx. “However, expanded indications for biologics in the treatment of non-radiographic axial spondyloarthritis, being a less advanced form of ankylosing spondyloarthritis, might cause no changes to formularies.”

Nicole Kjesbo, Pharm.D., principal clinical program pharmacist at Prime Therapeutics LLC, says that although Taltz and Cosentyx provide a new mechanism of action to treat nr-axSpA, “at this time, their FDA approvals for this indication will not change the course of therapy, as they were already recommended for off-label use by guidelines.”

The two newly approved biologics are listed in clinical guidelines as third-line treatments, behind NSAIDs and tumor necrosis factor inhibitors (TNFis), Kjesbo says, and according to the guidelines, “TNFis are recommended over Taltz or Cosentyx.”

“NSAIDs are most commonly used for axial SpA (AS and nr-axSpA), and in many patients this is the only drug ever needed,” Tegenu says. “Most NSAIDs are available generically.”

“Second-line therapy is any tumor necrosis factor inhibitor (TNFi),” adds Tegenu. And Kjesbo explains that “TNFi treatment is recommended over treatment with Taltz, Cosentyx or [Pfizer Inc.’s] Xeljanz/XR (tofacitinib).”

Only one other drug was previously labeled to treat nr-axSpA: UCB’s TNFi, Cimzia (certolizumab pegol). In patients who try and fail or have contraindications to NSAIDs and to TNFis, the two IL-17A inhibitors — Taltz and Cosentyx — are indicated for AS, Tegenu says.

CMS Proposes New Medicaid Best Price Rules for Pricey Therapies

June 29, 2020

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

By Peter Johnson

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

New curative therapies present a novel financial challenge for payers. Curative therapies eliminate the need for intensive treatment of chronic and terminal conditions, which create substantial savings for payers, patients and providers alike.

However, their high up-front cost is borne by payers and patients, and the initial payer may not see the entire financial benefit of the curative therapy. What’s more, under a traditional payment model, insurers are unable to recoup costs if a new, experimental therapy with curative potential has limited effect.

In order to spread risk and value across all stakeholders involved, some drug benefit industry leaders have called for broad adoption of the value-based pricing methods CMS’s proposed rule seeks to create, backed by a reinsurance mechanism.

Avalere Health principal Mike Schneider tells AIS Health that, although CMS’s proposal does not include a reinsurance mechanism, it should advance adoption of curative therapies. He says that, as they are currently implemented, Medicaid’s best price rules have made it difficult for commercial payers to negotiate with drug manufacturers to include outcomes and proof of concept in purchasing agreements.

Though the proposed rule applies directly to state Medicaid plans, Schneider says that the rule could have a substantial impact on the commercial market as plans bidding on Medicaid contracts gain experience with the new paradigm.

Still, barriers remain in adopting new curative therapies. Drug Channels Institute CEO Adam Fein points out that the rule does not address the challenge presented by copay accumulators to patients who might benefit from expensive, new specialty drugs — which suggests the rule might not speed up curative therapy adoption as quickly as patients might hope.

Pricey Treatments Face Challenges on Cost Sharing and Data Analysis

June 18, 2020

Genomic, curative drugs for chronic and terminal diseases are perhaps the most exciting new treatments in medicine. But even though these highly tailored therapies come to market with the potential to save costs for the health care system, the industry is struggling to pay for them because of their high up front costs.

Neil Lund, chief actuary and vice president emeritus of CVS Health Corp., observes that PBMs are already perceived as honest brokers by the plans they contract with. He says PBMs are a possible conduit to share the information necessary for the evaluations of health care products and services with all stakeholders.

By Peter Johnson

Genomic, curative drugs for chronic and terminal diseases are perhaps the most exciting new treatments in medicine. But even though these highly tailored therapies come to market with the potential to save costs for the health care system, the industry is struggling to pay for them because of their high up front costs.

Neil Lund, chief actuary and vice president emeritus of CVS Health Corp., observes that PBMs are already perceived as honest brokers by the plans they contract with. He says PBMs are a possible conduit to share the information necessary for the evaluations of health care products and services with all stakeholders.

“At the core [of a PBM] is this claims processing engine,” Lund says. “[They have] a lot of real-time electronic data and the ability with really excellent record keeping as the fundamentals involved.”

While the rebate-driven model for purchasing traditional pharmacy products works well for maintenance and incidental treatments, purchasing curative specialty pharmacy products is more complicated. For payers, such therapies have the benefit of reducing the need for chronic care and lessening risk of an inpatient stay, but they also have to front a high capital cost that disproportionately benefits providers and manufacturers, Lund observes.

Yet different metrics can yield different understandings of a new therapy’s value, said Brian Leinwand, an associate principal for health economics at Avalere Health, during a recent webinar on alternative financing models for emergent therapies.

“[Decision-makers] typically evaluate products’ incremental cost per quality-adjusted life-year gained compared to another therapy or therapies. However, a quality-adjusted life-year is not always the most useful metric for decision-makers in these scenarios, [and] other techniques can be employed.”

Lund says member churn adds complication to curative therapy pricing. If a member receives an expensive curative therapy with one plan but departs for a new one a few years later, the new plan benefits but doesn’t share in the cost.

“In the short term, the base case issue here is whoever is covering the person at the time of the very expensive treatment, in the way we handle everything today, is on the hook for the full cost,” Lund observes. “Subsequent insurers or organizations reap the benefit of that, not the organization that necessarily footed the bill.”

MedImpact’s New Program Aims to Accelerate Pharmacogenomics

June 15, 2020

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

By Leslie Small

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

“Pharmacogenetics, in the most basic sense, is looking at someone’s genes to determine their drug-metabolizing enzymes,” explains Emily Cicali, a clinical assistant professor at the University of Florida’s College of Pharmacy. For people who have lower levels of drug-metabolizing enzymes, certain medications may be less effective or ineffective, and for those have too much of those enzymes, that could overactivate drugs and “put people at risk for toxicity,” Cicali adds.

The concept of a PBM having a PGx program isn’t new, MedImpact acknowledges in its release. But up until now, most PGx programs generally operated along the lines of “one gene being tested for one drug at one point in time” to determine if there’s a potential conflict, says Karen Geary, the company’s vice president of strategy and innovation. MedImpact’s program, however, screens for genetic interactions with more than 240 commonly prescribed medications and then reviews all future prescriptions for potential drug-gene issues.

Michael Schneider, a principal at Avalere Health, says that if a program like MedImpact’s is able to significantly avert problems like adverse drug events, “then I think this type of analysis could have a big impact on the PBM industry and potentially become the standard of care.”

However, if genetic testing becomes more commonplace across wider swaths of the population, there could be downsides, he suggests. For example, the expense of large-scale genetic testing might trickle down from plan sponsors to consumers in the form of higher premiums.

Since MedImpact rolled out its new program, client interest has been high, Geary says. However, “the challenge that I’ve recently run into is that employers are sitting there looking at what would be a benefit enrichment while, because of COVID-19, they’re having to lay off staff,” she adds.

1.7K Plans Apply for Trump Admin’s Fixed-Insulin-Copay Program for Seniors

June 4, 2020

The Trump administration on May 26 shared new details about a program that offers diabetic seniors access to a variety of insulin products for a maximum $35-per-month copay.

More than 88 health insurers offering about 1,750 standalone Medicare Part D Prescription Drug Plans and Medicare Advantage plans with prescription drug coverage have now applied to participate in the Part D Senior Savings Model, which CMS unveiled in mid-March. Medicare beneficiaries in all 50 states, the District of Columbia and Puerto Rico will be able to enroll in a participating plan during the Medicare open enrollment period that lasts from Oct. 15 to Dec. 7, 2020, for Part D coverage that begins on Jan. 1, 2021.

By Leslie Small

The Trump administration on May 26 shared new details about a program that offers diabetic seniors access to a variety of insulin products for a maximum $35-per-month copay.

More than 88 health insurers offering about 1,750 standalone Medicare Part D Prescription Drug Plans and Medicare Advantage plans with prescription drug coverage have now applied to participate in the Part D Senior Savings Model, which CMS unveiled in mid-March. Medicare beneficiaries in all 50 states, the District of Columbia and Puerto Rico will be able to enroll in a participating plan during the Medicare open enrollment period that lasts from Oct. 15 to Dec. 7, 2020, for Part D coverage that begins on Jan. 1, 2021.

That “widespread voluntary participation” from health plans “was essential for the program’s success,” says Marc Guieb, Pharm.D., a consultant at Milliman, Inc. Still, “many plans were hesitant to participate in the inaugural year of this program due to uncertainty around its financial impact,” he says. “It is likely that, in future years, more plans will jump on the bandwagon.”

CMS estimates that Medicare beneficiaries who use insulin and join a plan participating in the Part D Senior Savings Model could save an average of $446 annually on out-of-pocket insulin costs, or 66%. Three insulin manufacturers — Eli Lilly and Co., Novo Nordisk Inc. and Sanofi U.S. — have agreed to participate.

On the one hand, the concept of a fixed insulin copay should be attractive to seniors and can improve medication adherence, says Brian Anderson, a principal at Milliman. Still, “the benefit coordination and claims processing is going to be tricky,” he suggests, adding that “the pharmacy reimbursements, manufacturer payments, application of the Part D benefit phases and reinsurance will all come into play.”

“Overall, this has the opportunity to improve the Part D benefit and drive formulary competition from a cost standpoint,” Anderson concludes.

America’s Health Insurance Plans (AHIP) gave the program a glowing assessment. “Innovative voluntary programs like this Part D Senior Savings Model are an excellent example of public-private partnerships where everyone wins, but especially patients,” AHIP President and CEO Matt Eyles said in a statement released May 26.