Will COVID-19 clog generics, biologics pipeline?

The drug pipeline for 2020 is heavy on generics, biosimilars and 505(b) (2) drugs that are slight variations of existing products. But whether those launches will be affected by the ongoing COVID-19 pandemic is a bit more difficult to predict, industry experts noted during an AMCP webinar.

A number of notable generic launches are expected in 2020, said Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, who are both vice presidents of pharmacy for the research organization IPD Analytics.

Generics for emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead); dimethyl fumarate (Tecfidera, Biogen); dexlansoprazole (Dexilant, Takeda); and fingolimod (Gilenya, Novartis) could drive drug prices down significantly, Dr. Casberg said.

Six potential generic entrants are in the works for the smoking cessation medicine varenicline (Chantix, Pfizer), which is expected to lose patent exclusivity this year, Dr. Fish said. Payors are looking forward to lower-cost options for the widely used drug, with sales of $702 million, she noted.

Nine potential generics could hit the market for fesoterodine (Toviaz, Pfizer), an antispasmodic for the treatment of overactive bladder symptoms, which also is expected to lose patent exclusivity this year. A number of other generics and branded drugs are available to treat the condition, Dr. Fish noted, making this an area ripe for drug utilization management.

505(b)(2)s and Biosimilars In the Pipeline

About a dozen notable 505(b)(2) drugs have been approved or have approvals pending, the speakers said. These include ethinyl estradiol-levonorgestrel (Twirla, Agile), a transdermal birth control system approved in February, and apomorphine (APL-130277, Sunovion), an oral dopamine receptor agonist for the offperiods experienced by patients with Parkinson’s disease, pending approval in May. Given that 40% to 60% of these patients develop off-periods that can worsen and a transdermal product is seen as more convenient than apomorphine injection (Apokyn, US WorldMeds), this product could be used extensively, Dr. Fish said.

This year also should see a number of launches of biosimilars, the speakers predicted. This includes HSP-130 (Hospira/Pfizer) and Rolontis (Hanmi Pharma/Spectrum) for pegfilgrastim, expected between June and October; SB8 (Samsung Bioepis/Merck) for bevacizumab, expected in September;

and ABP 798 (Amgen/Allergan) for rituximab, expected in the fourth quarter, Dr. Fish said. They’ll join six approved biosimilars for pegfilgrastim, three for bevacizumab and three for rituximab.

“We believe with this many biosimilars in the market, we will see decreased cost, but the decrease will be seen through increasing rebates and better contracting in both the brand and biosimilar space,” Dr. Fish said.

New Branded Products

The presenters also referenced a number of new branded products that have been approved or are expected to be approved this year. These include bempedoic acid (Nexletol, Esperion) and bempedoic acid-ezetimibe (Nexletol, Esperion), approved as a firstin-class adjunctive therapy for patients requiring additional cholesterol lowering beyond that seen with standard treatments, and inclisiran (Novartis), an experimental subcutaneous PCSK9 inhibitor expected to be approved in the fourth quarter.

Pandemic Pressures

The COVID-19 pandemic could affect new drug approvals, Dr. Fish said during a question-and-answer period. The FDA has been back and forth, saying there would or would not be delays, she noted. As of April 17, the agency announced that everything coming to near term, especially oncology and orphan medications, and those for serious diseases, will not be delayed, she said. However, several manufacturers have reported they were going to slow down or delay clinical studies because they are shifting gears to work on potential COVID-19 therapies. It’s also difficult now for study participants to get to their physicians for checkups or lab tests, Dr. Fish said. Combined, she said, these factors could result in a larger number of medications being approved in 2021. —Karen Blum

The speakers were scheduled to present at AMCP’s Managed Care & Specialty Pharmacy annual meeting, which was canceled because of the COVID-19 pandemic. The organization made the information available via a webinar instead. Other than their employment, the speakers reported no relevant fi nancial relationships.

Marketplace Shakeup

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Mr. Long cited prescription abandonment rates as an example of a particularly concerning market trend that could worsen during the COVID-19 pandemic. Bailing on a prescription is primarily a function of cost pressures, he explained: as a patient’s cost exposure rises due to copays and other cost-shifting factors, abandonment skyrockets. IQVIA data show, for example, that when patient out-of-pocket costs reach approximately $250, new patient abandonment rates approach 80%. And it’s not just a problem at the high end: even when patient

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costs are in the $50 to $75 range, abandonment rates approach 30%, according to IQVIA data.

James T. Kenney, MBA, RPh, a managed care pharmacy consultant and the 2019-2020 AMCP president, who moderated the presentation, agreed that prescription abandonment is a major cause for concern, both before the COVID-19 pandemic hit and beyond. “This is something we worry about, trying to balance the benefit design with the patient’s out-of-pocket costs, and the [IQVIA] data identified a significant percentage abandonment rate starting in the $75 to $125 threshold,” Mr. Kenney said.

From a health plan perspective, “you want patients to take the medications as prescribed,” he added. “But in fairness, if new treatments cost $30,000, $40,000 or $50,000 a year, insurers are not necessarily going to offer them at a $5 to $10 copay. There’s an expectation that a patient on a much higher cost medication would have to pay a bit more.”

Mr. Long discussed one final COVID-19 trend before moving on to a broader look at the health care market: the explosion of telehealth brought on by the pandemic. Before COVID-19, telehealth was used mostly for treating mental illness, depression and anxiety, whereas more recently it has been adopted for managing asymptomatic chronic conditions such as hypertension, type 2 diabetes and high cholesterol. Overall, telehealth claims were up about 1,000% from March 13 to March 27, Mr. Long said, mainly driven by prescribers who are new to the technology. This mode of care could become a regular part of how outpatients are treated as more people become comfortable with these visits, even after the pandemic resolves. –11.6

Mr. Long discussed medication usage trends for 12 months ending February 2020, noting that specialty growth is outpacing traditional product growth and now has about a 48% share of the total, non-discounted drug spend. In February alone, the specialty spend grew by 10.5% while traditional spend increased just 0.3%, he said. The impact of COVID-19 on these numbers is yet to be seen.

Three therapeutic areas have been responsible for two-thirds of the absolute growth and domination of new launches from 2018 to 2019: autoimmune, oncology and diabetes. Anticoagulants also are growing. By contrast, the pain and mental health categories had less volume, in part because mental health has some generics, and it is now harder to get pain prescriptions, Mr. Long said.

Adjusted prescription growth rates through February 2020 were up 5%, with a bigger jump projected for March due to more people obtaining 90-day supplies of their medicines. About 90% of prescriptions for 2020 were dispensed as unbranded generics through February.

Vaccines, including those for flu and shingles, helped the business of new therapy starts in 2018 and 2019, particularly in the retail setting, Mr. Long noted. These vaccines made up 6.8 million of 7.5 million new starts in 2018. Other new starts in conditions such as chronic obstructive pulmonary disease, autoimmune diseases, diabetes and atopic dermatitis grew slightly in the same period.

During the COVID-19 pandemic, however, fewer vaccines have been administered because more people are staying at home and not going to their doctors’ offices, he said.

The top 10 therapy areas, led by antihypertensive agents, mental health and lipid regulators, are growing at about a 0.3 Artificially inflated by Kaletra a , which is being used as a potential treatment for COVID-19 (-8.5% without Kaletra) a AbbVie 3% rate, while the top 10 products, led by atorvastatin, lisinopril and levothyroxine, are growing at a 4.8% rate.

Real net per-capita spending on drugs grew by only $44 from 2009 to 2018, he added, even while the specialty spend nearly doubled during that time and traditional spend declined. Generics that were launched in the U.S. market from 2009 to 2018 have generated about $375 billion in cumulative savings.

2020 Rx Pipeline a Bit Murky

Drug manufacturers launched a record number of innovative medicines in 2018, bringing 59 new treatment options to patients. According to Mr. Long, 2019 also was a good year, but it is difficult to predict what will happen in 2020, with the FDA slowed down and some manufacturers choosing not to launch their products. The late-stage pipeline was dominated by oncology drugs in 2018, he said, but included specialty and niche therapies

across a range of diseases.

There have been slight shifts in meth

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ods of payment for prescriptions over the

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Autoimmune Cholesterol CKD/ESRD Depression Diabetes Epilepsy HIV Hypertension past two years, with cash remaining flat, declines among third-party and Medicaid payments, and a continued increase in discount cards, which now make up 4.8% of adjusted prescriptions.

Several strong forces are driving changes in health care, Mr. Long noted: a steadily aging population creating more demand for mental health care, home care and assistance; an increasing prevalence of common, chronic

Figure. Declines in new therapy starts.

CKD, chronic kidney disease; ESRD, end-stage renal disease. Data analysis through March 27, 2020. Source: Doug Long, IQVIA

Explosion of Telehealth

A Broader Look

diseases; medication nonadherence or noncompliance, which remains the largest avoidable cost for health care systems; rising cost of care and increasing scrutiny around value; and increasing connectivity and health care consumerism. In addition, he said, patients are becoming more involved in their health care decision making and more vocal about about what they want in new therapies. —Karen Blum

The sources reported no relevant fi nancial relationships.

Doug Long’s 8 Key COVID-19 Disruptions

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A sharp decline in physician office visits and lab diagnostics

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A downturn in new diagnoses and new therapy starts affecting nearly every therapeutic area

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A surge in telehealth volume (falls short of total lost volume of patient visits) 4. An increase in unemployment that has been pushing more patients onto Medicaid and into economic uncertainty

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Providers are financially strained due to decreased office and clinic visits, elective surgeries and reimbursement rates Some practices have closed temporarily and physicians have stopped providing any routine care Hospitals have been losing money on COVID-19 treatment; rural locations in danger of closing Patients lack access to health care, diagnostics and surgeries, potentially compromising clinical outcomes

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