Product Release

Perspectives on Remdesivir’s $3,120 Price Tag

August 6, 2020

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

“So they’re saying by shortening hospital stays, the system is going to save all these monies, but I always ask the question, ‘Why is it that the drug company should get to pocket all or some substantial portion of that savings?'” says Jack Hoadley, Ph.D., a research professor emeritus at Georgetown University’s Health Policy Institute. “That’s a savings we should accumulate for consumers, for payers [and] everybody else.”

Hoadley is not alone in those views. The advocacy group Patients for Affordable Drugs, in a June 29 statement, wrote that “Gilead’s price for remdesivir shows once again that we can’t trust Big Pharma to act responsibly — even in the face of a global pandemic.”

The U.S. government helped fund the development of remdesivir, and dexamethasone — a generic steroid — is priced at less than $1 per day even though it ‘showed promise for combating severe COVID-19 cases and reducing potential mortality rates,” the organization said.

The Institute for Clinical and Economic Review (ICER) also brought up dexamethasone in its statement. The U.S. price range of $2,340 to $3,120 is “is largely in line with ICER’s independent assessment suggesting that a price of approximately $2,800 would be reasonable in proportion to the added benefits for patients and the cost offsets in the health system now that dexamethasone is rapidly becoming standard of care,” wrote ICER President Steven D. Pearson, M.D.

Leerink analyst Geoffrey Porges, in a June 29 note to investors, pointed out that the U.S. commercial price set for remdesivir was below his firm’s expectations. Still, “we believe the disclosed [remdesivir] pricing is reasonable, and should provide significant value to the Gilead shareholders and still deflect much of the criticism the company might face in this emergency,” Porges wrote.

Perspectives on How Drug Pricing Legislation Impacts Innovation

November 14, 2019

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis, AIS Health reported.

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis, AIS Health reported.

One of the proposals is the International Pricing Index, an effort by HHS to bring payments for Medicare Part B closer to what 16 other “developed economies” pay for these drugs. The Senate’s Prescription Drug Pricing Reduction Act of 2019 proposes multiple changes to Medicare Part B and Part D, as well as Medicaid. And the House’s Lower Drug Costs Now Act proposes, among other things, requiring HHS to negotiate the prices of up to 250 drugs in Medicare without competitors. Companies not coming to an agreement would be subject to financial penalties.

Drugmakers have vociferously pushed back on many of the proposals, with one of the arguments against them being that the efforts would have a chilling effect on pharma R&D.

“Empirical evidence” exists to support the idea that “lower spending on pharmaceuticals will lead to lower R&D spending and lower yield of innovative drugs,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. But “there isn’t enough evidence either way” to say whether “there aren’t policies besides spending that can impact innovation.”

“Additional patent protections and favorable tax treatment of R&D expenditures for drugs designated to treat ‘orphan’ indications appear have resulted in a large push among manufacturers and investors to bring those products to market,” he notes.

According to Lisa Kennedy, Ph.D., chief economist and managing principal at Innopiphany LLC, “the biopharmaceutical industry is responsible for approximately 70% of all innovation within health care. Price fixing of pharmaceuticals has been shown in several studies to have a knock-on effect on innovation.”

She also asserts that oncology, one of the most productive and exciting areas of innovation in the biopharmaceutical industry, could be hit particularly hard.

Radar On Market Access: Would Drug Pricing Legislation Impact Innovation?

October 17, 2019

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis, AIS Health reported.

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis, AIS Health reported.

One of the proposals is the International Pricing Index, an effort by HHS to bring payments for Medicare Part B closer to what 16 other “developed economies” pay for these drugs. The Senate’s Prescription Drug Pricing Reduction Act of 2019 proposes multiple changes to Medicare Part B and Part D, as well as Medicaid. And the House’s Lower Drug Costs Now Act proposes, among other things, requiring HHS to negotiate the prices of up to 250 drugs in Medicare without competitors. Companies not coming to an agreement would be subject to financial penalties.

Drugmakers have vociferously pushed back on many of the proposals, with one of the arguments against them being that the efforts would have a chilling effect on pharma R&D.

“Empirical evidence” exists to support the idea that “lower spending on pharmaceuticals will lead to lower R&D spending and lower yield of innovative drugs,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. But “there isn’t enough evidence either way” to say whether “there aren’t policies besides spending that can impact innovation.”

“Additional patent protections and favorable tax treatment of R&D expenditures for drugs designated to treat ‘orphan’ indications appear have resulted in a large push among manufacturers and investors to bring those products to market,” he notes.

According to Lisa Kennedy, Ph.D., chief economist and managing principal at Innopiphany LLC, “the biopharmaceutical industry is responsible for approximately 70% of all innovation within health care. Price fixing of pharmaceuticals has been shown in several studies to have a knock-on effect on innovation.”

She also asserts that oncology, one of the most productive and exciting areas of innovation in the biopharmaceutical industry, could be hit particularly hard.

2019 Specialty Pharmacy Patient Choice Awards Winners Announced

October 16, 2019

On October 16, 2019, MMIT and Zitter Insights host the 2019 Specialty Pharmacy Patient Choice Awards. The webinar acknowledged and honored the achievements of the top two specialty pharmacies (top payer/PBM and top non-payer/PBM).

Congratulations to this year’s Specialty Pharmacy Patient Choice Award winners, Humana Specialty Pharmacy (PBM/Payer) and Vanderbilt University Medical Center Specialty Pharmacy (Non-PBM/Payer).

On October 16, 2019, MMIT and Zitter Insights host the 2019 Specialty Pharmacy Patient Choice Awards. The webinar acknowledged and honored the achievements of the top two specialty pharmacies (top payer/PBM and top non-payer/PBM).

Congratulations to this year’s Specialty Pharmacy Patient Choice Award winners, Humana Specialty Pharmacy (PBM/Payer) and Vanderbilt University Medical Center Specialty Pharmacy (Non-PBM/Payer).

The Specialty Pharmacy Patient Choice Award was created to recognize specialty pharmacies and their commitment to patient satisfaction. The criteria for this award were formulated by a committee comprised of individuals representing pharmaceutical manufacturers, health plans, pharmacy benefit managers (PBMs), trade organizations, consultants and equity research firms.

MMIT and Zitter Insights look forward to continuing the Patient Choice Awards and recognizing specialty pharmacies at Asembia 2020. To learn more about this event, click here.

Radar On Market Access: Study Shows Growing IL-17 Use in Psoriasis

October 15, 2019

For many years, the psoriasis treatment landscape was dominated by tumor necrosis factor (TNF) inhibitors. But with the FDA’s approval of three interleukin-17 (IL-17) inhibitors — as well as other drugs with different mechanisms of action — for the condition, those therapies are becoming more common among treatment regimens, AIS Health reported.

For many years, the psoriasis treatment landscape was dominated by tumor necrosis factor (TNF) inhibitors. But with the FDA’s approval of three interleukin-17 (IL-17) inhibitors — as well as other drugs with different mechanisms of action — for the condition, those therapies are becoming more common among treatment regimens, AIS Health reported.

The first IL-17 inhibitor on the U.S. market was Cosentyx (secukinumab) from Novartis Pharmaceuticals Corp., which launched in 2015. The next therapy was Taltz (ixekizumab) from Eli Lilly and Co., and then on Feb. 15, 2017, the agency approved Siliq (brodalumab) from Ortho Dermatologics.

An AllianceRx Walgreens Prime study sampled 5,215 members who started on an IL-17 from January 2016 through December 2017. The study showed that 2,218, or 42.5%, switched from a prior biologic, while 2,997, or 57.5%, started on an IL-17 as their first psoriasis biologic. Among those who started their biologic regimens on an IL-17 inhibitor, 2,266 started on Cosentyx, followed by 725 who initiated on Taltz and six who started on Siliq.

Researchers also examined 180-day adherence outcomes among members who switched to an IL-17 inhibitor from another biologic, as determined by proportion of days covered (PDC). The mean PDC increase after moving to an IL-17 was 6.4%.

Among those moving to an IL-17, 45.7% said their outcomes were better, 26.5% said they were the same, 5.3% said they were worse, and 22.6% said they were inconsistent.

According to Renee Baiano, Pharm.D., clinical program manager at AllianceRx Walgreens Prime and the lead author of the poster, the main takeaway for payers is that “by [the] last quarter of 2017, IL-17 inhibitors may have gained clinical acceptance in the treatment of psoriasis, given the increase in patients prescribed as their first biologic.” She adds that “it is important for payers to be aware they may see more of their members being prescribed IL-17 inhibitors and will need to determine the appropriate placement of these newer agents within their formulary.”

Radar On Market Access: Despite Approval of New Parkinson’s Drugs, Plans Still Prefer Generics

October 3, 2019

Although three new drugs for Parkinson’s disease have been approved over the last year, plans generally are sticking with the drugs they’ve included on formularies for several years, most of which are generic, experts tell AIS Health.

Although three new drugs for Parkinson’s disease have been approved over the last year, plans generally are sticking with the drugs they’ve included on formularies for several years, most of which are generic, experts tell AIS Health.

That may change in the long term as new gene therapies that currently are in development are approved and come online. But none of those potential new treatments are close to market right now, says Mesfin Tegenu, R.Ph., president of PerformRx.

“Many commonly used therapies for Parkinson’s disease — carbidopa-levodopa, MAO-Bs, dopamine agonists — have available generics, which on most plans would be considered formulary options, or one generic product within each class would be selected as formulary,” Tegenu tells AIS Health.

The FDA in August approved Kyowa Kirin, Inc.’s Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing motor fluctuations. In February, the FDA approved Osmotica Pharmaceutical US LLC’s Osmolex ER (amantadine) for the treatment of Parkinson’s disease. And in late December, the FDA approved Accorda Therapeutics’ Inbrija (levodopa inhalation powder) for intermittent treatment of off episodes in people with Parkinson’s disease taking carbidopa/levodopa.

Still, plans are stocking their formularies with less expensive generic medications. Parkinson’s disease treatment generally progresses through drugs that have a moderate effect but fewer side effects to drugs that are more effective, but have more significant side effects, Tegenu says.

“Choice of which pharmacotherapy to use initially is individualized based on the characteristics of the patient, the disease and the drugs,” he says. “There is no single preferred therapy, and trade-offs are common.”

Plans aren’t expected to cover Inbrija, Tegenu says. “Members would be able to request an exception through the prior authorization process for these products,” he adds. For Osmolex ER, plans generally require failure on trials of immediate-release amantadine.