Trends That Matter

Trends That Matter for Atopic Dermatitis Medications

June 3, 2021

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical drugs first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors, AIS Health reported.

The FDA extended the review period to early in the third quarter of 2021 for Pfizer Inc.’s abrocitinib for the treatment of adults and adolescents with moderate to severe AD. The agency also extended review to the third quarter of Eli Lilly and Co.’s and Incyte’s supplemental New Drug Application for Olumiant (baricitinib) for the treatment of adults with moderate to severe AD, saying it wants to gather additional cost-benefit and safety data.

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical drugs first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors, AIS Health reported.

The FDA extended the review period to early in the third quarter of 2021 for Pfizer Inc.’s abrocitinib for the treatment of adults and adolescents with moderate to severe AD. The agency also extended review to the third quarter of Eli Lilly and Co.’s and Incyte’s supplemental New Drug Application for Olumiant (baricitinib) for the treatment of adults with moderate to severe AD, saying it wants to gather additional cost-benefit and safety data.

Meanwhile, the FDA requested additional data on LEO Pharma A/S’s biologic tralokinumab, intended for adults with moderate to severe AD, but only on a device component, not on efficacy or safety, the company said in April. Tralokinumab would offer a novel mechanism of action for AD, noted the latest quarterly Drug Pipeline Insights Report from UnitedHealth Group’s OptumRx, although it also pointed out that “efficacy appears more modest than competing existing treatment options like Dupixent.”

Finally, a topical JAK inhibitor, Incyte’s ruxolitinib, was accepted for FDA priority review in February, with a target FDA action date in late June.

“The new oral and injectable therapies may bring new formulary options compared to Dupixent,” says Mesfin Tegenu, CEO and chairman at RxParadigm. “Depending upon how these new products are priced, market forces may play a role to bring down the annual cost for Dupixent. However, for any responsible prescriber there’s an abundance of generic topical corticosteroids available for treatment.”

At Prime Therapeutics, Dupixent is preferred on the PBM’s standard formulary as a specialty medication, says April Kunze, Pharm.D., senior director of clinical program development. It is subject to utilization management, Kunze says, adding, “there has been more awareness to this category, and biologics such as Dupixent have been approved with good efficacy results.”

Meanwhile, Eucrisa (crisaborole), a steroid-free topical treatment from Anacor Pharmaceuticals, Inc., is preferred on Prime’s standard A-Series NetResults formulary with no utilization management in place, Kunze adds.

The newer agents are unlikely to shake up treatment of most patients, according to Tegenu. “Treatment starts with the more conventional options, as there is much more data available and cost is significantly lower,” he says.

by Jane Anderson

 

Trends that Matter for Medicare Prescription Drug Spending

May 20, 2021

An April 19 analysis by the Kaiser Family Foundation (KFF) found that a small number of drugs accounted for the majority of drug spending in Medicare, and that negotiating drug prices could lower overall spending in the program, AIS Health reported.

According to the report, the 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition accounted for 60% of net total Part D spending, while the top 50 drugs covered under Medicare Part B accounted for 80% of total Part B drug spending.

An April 19 analysis by the Kaiser Family Foundation (KFF) found that a small number of drugs accounted for the majority of drug spending in Medicare, and that negotiating drug prices could lower overall spending in the program, AIS Health reported.

According to the report, the 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition accounted for 60% of net total Part D spending, while the top 50 drugs covered under Medicare Part B accounted for 80% of total Part B drug spending.

While the report concludes that negotiating drug prices could save the public money, there is a potential tradeoff to negotiating all drug prices, report coauthor Juliette Cubanksi, Ph.D., tells AIS Health. Cubanski is deputy director of KFF’s Program on Medicare Policy.

KFF cannot estimate “what the administrative burden would be for HHS in the process of negotiation,” Cubanksi explains, observing that Part D covers about 3,000 drugs, including many generics.

“Negotiating the price of 3,000 prescription drug products is going to be a massive undertaking that for the majority of those products is not likely to get you much savings,” she adds.

“You’re likely getting the most bang for the buck if you focus on drugs that account for a relatively large share of program spending and that don’t have a generic or biosimilar equivalent,” Cubanski says. “If you’ve only got one manufacturer and the price is pretty high, that makes an easier target than inexpensive products with multiple, competing manufacturers.”

However, there are additional considerations to price negotiation. Cubanski says that it’s “entirely possible” that lower prices in Medicare could result in manufacturers ratcheting up prices in the commercial market to offset losses. Cubanski also observes that pharma companies have argued they would not be able to fund as much research and development if their Medicare profits were eroded, though she is not sure that is the case.

by Peter Johnson

 

Trends that Matter for Evernorth Drug Trend Report

May 6, 2021

In the 2020 Drug Trend Report recently released by Evernorth, the Cigna Corp. division added yet another chapter to the growing volume of data detailing the profound effects that the COVID-19 pandemic has had on health care, AIS health reported.

On the one hand, the massive amount of deferred routine and elective health care utilization had a dampening effect on the number of new medication users that Evernorth — which houses the PBM Express Scripts — recorded in 2020. New users of asthma/COPD medications dropped the most, by 7.1% year over year, likely reflecting the avoidance of clinical settings among a group that is at particular risk of contracting severe COVID-19.

In the 2020 Drug Trend Report recently released by Evernorth, the Cigna Corp. division added yet another chapter to the growing volume of data detailing the profound effects that the COVID-19 pandemic has had on health care, AIS health reported.

On the one hand, the massive amount of deferred routine and elective health care utilization had a dampening effect on the number of new medication users that Evernorth — which houses the PBM Express Scripts — recorded in 2020. New users of asthma/COPD medications dropped the most, by 7.1% year over year, likely reflecting the avoidance of clinical settings among a group that is at particular risk of contracting severe COVID-19.

Yet for commercial plans managed by Evernorth, the overall drug utilization trend increased by 3.1%, compared with just 1.4% in 2019.

“We saw higher utilization of prescription drugs to treat mental health issues associated with the pandemic — anxiety, insomnia, and depression,” says Evernorth Chief Innovation Officer Glen Stettin, M.D. “Among people with previously diagnosed and common chronic conditions, such as diabetes, high blood pressure and heart disease, many of which are risk factors for hospitalization and death from COVID-19, we also saw an increase in utilization. This utilization was driven by higher medication adherence, itself a result of more people choosing to fill their medication for 90 day vs. 30 day supplies, and the convenience and safety of having their medication delivered to their homes.”

Evernorth’s report also included statistics that are typical of drug trend reports in more normal years. The Cigna division reported 4% total trend across its commercial plans, 3% trend in Medicare, 1.4% in Medicaid and 5.5% in health insurance exchange plans.

by Leslie Small

 

Trends That Matter for Copay Accumulator Programs

April 22, 2021

Thanks to recent regulatory moves and the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector, AIS Health reported.

Copay accumulators work by preventing any monetary assistance that pharmaceutical companies offer commercially insured patients from counting toward their deductible or out-of-pocket maximum. Their close cousin, copay maximizers, take the total amount of a manufacturer’s copay offset program and divide it by 12, and that amount becomes the new monthly copayment for all patients on any given drug over the course of a year.

Thanks to recent regulatory moves and the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector, AIS Health reported.

Copay accumulators work by preventing any monetary assistance that pharmaceutical companies offer commercially insured patients from counting toward their deductible or out-of-pocket maximum. Their close cousin, copay maximizers, take the total amount of a manufacturer’s copay offset program and divide it by 12, and that amount becomes the new monthly copayment for all patients on any given drug over the course of a year.

From insurers’ perspective, the goal of copay accumulators/maximizers is to help steer patients toward lower-cost drugs. However, copay accumulator programs have been fiercely criticized by the pharmaceutical industry and patient advocates, who argue that they lead to higher costs for consumers and thus limit access to life-saving medications.

Data collected by AIS Health’s parent company, MMIT, show that copay accumulators and maximizers are gaining steam across the commercial insurance space. Of insurers covering a collective 127.5 million lives, 41% had implemented a copay accumulator program and 32% had implemented a copay maximizer program prior to 2020, and another 26% and 24%, respectively, implemented such programs in 2020.

Recent revisions to federal regulations may be contributing to the increasing prevalence of copay accumulators. In its Notice of Benefit and Payment Parameters (NBPP) for 2021, CMS allowed non-grandfathered group and individual market plans to use copay accumulator policies even when a generic equivalent to a drug isn’t available.

A Feb. 23 analysis from Avalere Health also pointed to a December 2020 rule aimed at facilitating value-based contracts for prescription drugs in Medicaid managed care, which “created new risks for manufacturers when copay accumulator or maximizers are applied to their products.”.

Trends That Matter for Partial Orphan Drugs

April 8, 2021

A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.

The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.

A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.

The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.

The new paper found that 70.7% of spending on drugs designated as orphan drugs went “to nonorphan indications,” and noted that in 2017, 25% of U.S. prescription drug spending was for orphan drugs.

Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, asserts that the orphan drug designation is being abused by drug companies.

“They [orphan drugs] treat a small number of patients, but at the same time they can be used to treat much more common diseases. So they [drugmakers] can still charge a high price and take the tax credit, while at the same time enjoying their impressive commercial success,” Bai says.

Bai adds that drugmakers have become adept at coordinating outside pressure to convince the FDA to expand orphan drug designations beyond their intended purpose.

Trends That Matter for New Heart Failure Drugs

March 25, 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 graphic below show how key chronic heart failure medications are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.