Preview: RADAR on Drug Benefits

Will Rx Startup Targeting Cash-Paying Patients Succeed?

September 9, 2021

A new startup, DiRx, has entered the prescription-drug-delivery fray, and will target un- and underinsured consumers with low-cost, generic maintenance medications. Experts say that the market is worth pursuing, but they observe that more established and better capitalized players such as Amazon.com Inc. and GoodRx have a head start on reaching those consumers.

DiRx launched in late 2020 with a $5 million seed round, and the firm’s CEO, Satish Srinivasan, tells AIS Health that they will close a Series A funding round in coming weeks. Srinivasan says the firm buys drugs directly from manufacturers and wholesalers, then sells directly to consumers. He adds that DiRx does not contract with PBMs and does not accept insurance.

A new startup, DiRx, has entered the prescription-drug-delivery fray, and will target un- and underinsured consumers with low-cost, generic maintenance medications. Experts say that the market is worth pursuing, but they observe that more established and better capitalized players such as Amazon.com Inc. and GoodRx have a head start on reaching those consumers.

DiRx launched in late 2020 with a $5 million seed round, and the firm’s CEO, Satish Srinivasan, tells AIS Health that they will close a Series A funding round in coming weeks. Srinivasan says the firm buys drugs directly from manufacturers and wholesalers, then sells directly to consumers. He adds that DiRx does not contract with PBMs and does not accept insurance.

“It’s about rewiring the model,” Srinivasan tells AIS Health, a division of MMIT. “Most pharmacies operate on a reimbursement basis. And when you step into reimbursement, you know, there’s a whole lot of things that come in that inflate the cost: There are PBMs and all of that. Most of us have come to think that there’s health insurance that will take care of everything.”
Srinivasan also argues many patients don’t have adequate pharmacy benefits.

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PhRMA Takes Aim at Medicare Price Negotiation as HHS Digs In

September 9, 2021

Policies aimed at slowing price growth in the most expensive drug categories could result in slightly fewer drugs coming to market, according to an analysis of the issue prepared by the Congressional Budget Office (CBO). While the pharmaceutical industry has used the report to back up its longstanding claims that drug development would be irreparably harmed by federal intervention on prices, employer plan sponsors and other payer groups insist that the impact of drug pricing policies on drug development would be marginal at most.

“The model uses estimates of changes in expected future profits or development costs to estimate the percent change in the number of drug candidates entering the various stages of human clinical trials,” the report says. “The paper considers a legislative change that lowers expected returns for the top-earning drugs. A 15 percent to 25 percent reduction in expected returns for drugs in the top quintile of expected returns is associated with a 0.5 percent average annual reduction in the number of new drugs entering the market in the first decade under the policy, increasing to an 8 percent annual average reduction in the third decade.”

Policies aimed at slowing price growth in the most expensive drug categories could result in slightly fewer drugs coming to market, according to an analysis of the issue prepared by the Congressional Budget Office (CBO). While the pharmaceutical industry has used the report to back up its longstanding claims that drug development would be irreparably harmed by federal intervention on prices, employer plan sponsors and other payer groups insist that the impact of drug pricing policies on drug development would be marginal at most.

“The model uses estimates of changes in expected future profits or development costs to estimate the percent change in the number of drug candidates entering the various stages of human clinical trials,” the report says. “The paper considers a legislative change that lowers expected returns for the top-earning drugs. A 15 percent to 25 percent reduction in expected returns for drugs in the top quintile of expected returns is associated with a 0.5 percent average annual reduction in the number of new drugs entering the market in the first decade under the policy, increasing to an 8 percent annual average reduction in the third decade.”

Following on the heels of that analysis, the Biden administration on Sept. 9 issued its long-awaited plan to lower prescription drug prices — a plan that explicity endorses “legislation that would allow the Secretary of HHS to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical companies and make those prices available to other purchasers.”

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More Anal Cancer Drugs Are Coming Despite Incyte Stumble

September 9, 2021

This summer, Incyte Corp. hit a roadblock in the company’s quest to have its drug retifanlimab become the first FDA-approved treatment of its kind for patients with the most common type of anal cancer.

Retifanlimab is an immune checkpoint inhibitor (also known as immunotherapy) that aims to treat adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed after receiving platinum-based chemotherapy or who were intolerant of that type of chemotherapy. Currently, there are no approved treatment options available to patients who meet these criteria, according to Incyte.

This summer, Incyte Corp. hit a roadblock in the company’s quest to have its drug retifanlimab become the first FDA-approved treatment of its kind for patients with the most common type of anal cancer.

Retifanlimab is an immune checkpoint inhibitor (also known as immunotherapy) that aims to treat adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed after receiving platinum-based chemotherapy or who were intolerant of that type of chemotherapy. Currently, there are no approved treatment options available to patients who meet these criteria, according to Incyte.

But in a 13-4 decision on June 24, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted to defer a regulatory decision on retifanlimab until more data emerges from an ongoing confirmatory trial called POD1UM-303. Information gleaned from a previous trial — POD1UM-202 — is far from sufficient to support the drug’s approval, the committee said, highlighting questions about the drug’s effectiveness and issues such as the trial enrolling too few HIV-positive patients and racial minorities.

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Study Examines Pandemic’s Effect on Cancer Diagnoses

September 9, 2021

Risk of a COVID-19 infection and problems with hospital capacity led to a substantial decline in new cancer cases diagnosed early in the pandemic. Though medical practices reopened after early lockdowns, the number of newly diagnosed patients remained below prepandemic level through March 2021, according to a JAMA Network Open research letter. The study analyzed patients newly diagnosed with eight cancer types in four periods: prepandemic (January 2019 to February 2020), first pandemic period (March to May 2020), second period (June to October 2020) and third period (November 2020 to March 2021). During the first pandemic period, the average monthly number of new diagnoses fell 29.8% from 32,407 to 22,748 for the eight cancers combined. During the second period, the average number only declined 9.6%, statistically at the same level as it was before the pandemic for all cancers except prostate cancer. However, during the third period, average diagnoses showed a significant decline, dropping by 19.1% compared with prepandemic. “Our findings call for planning to address the consequences of delayed diagnoses, including strengthened clinical telehealth offerings supporting patient-clinician interactions,” the study authors wrote.

By Jinghong Chen

Risk of a COVID-19 infection and problems with hospital capacity led to a substantial decline in new cancer cases diagnosed early in the pandemic. Though medical practices reopened after early lockdowns, the number of newly diagnosed patients remained below prepandemic level through March 2021, according to a JAMA Network Open research letter. The study analyzed patients newly diagnosed with eight cancer types in four periods: prepandemic (January 2019 to February 2020), first pandemic period (March to May 2020), second period (June to October 2020) and third period (November 2020 to March 2021). During the first pandemic period, the average monthly number of new diagnoses fell 29.8% from 32,407 to 22,748 for the eight cancers combined. During the second period, the average number only declined 9.6%, statistically at the same level as it was before the pandemic for all cancers except prostate cancer. However, during the third period, average diagnoses showed a significant decline, dropping by 19.1% compared with prepandemic. “Our findings call for planning to address the consequences of delayed diagnoses, including strengthened clinical telehealth offerings supporting patient-clinician interactions,” the study authors wrote.

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Experts Mull How Life Sciences Firms Can Prep for ‘New Normal’

September 9, 2021

The COVID-19 pandemic has dramatically altered health care delivery patterns. Hospitals have had to exhaust their resources caring for COVID patients, while other important health care services, like cancer screening, have taken a back seat.

While the pandemic is not over, vaccination efforts continue and lockdown orders have eased, allowing experts the chance to look back at how the pandemic has affected the patient journey and what this means for a post-pandemic world. Health care stakeholders, including life sciences companies, are starting to ask about lessons learned and what changes need to be made to provide better patient support.

The COVID-19 pandemic has dramatically altered health care delivery patterns. Hospitals have had to exhaust their resources caring for COVID patients, while other important health care services, like cancer screening, have taken a back seat.

While the pandemic is not over, vaccination efforts continue and lockdown orders have eased, allowing experts the chance to look back at how the pandemic has affected the patient journey and what this means for a post-pandemic world. Health care stakeholders, including life sciences companies, are starting to ask about lessons learned and what changes need to be made to provide better patient support.

During a July 22 webinar, experts from Avalere Health discussed subjects including how the pandemic affected health care utilization, how life sciences firms can help patients return to baseline levels of screening and how to address challenges that existed in health care before the onset of the pandemic.

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