HealthEconomics.Com Connected. Community. Fri, 07 Aug 2020 21:50:22 +0000 en-US hourly 1 2 of 3 Americans Reveal Healthcare Insecurity and Problems Paying for Prescription Drugs Sat, 08 Aug 2020 14:00:09 +0000 The COVID-19 pandemic has caused severe healthcare insecurity for millions of Americans, according to CoverMyMeds’ 2020 Medication Access Report. As of early June 2020, more than 44 million people — over a quarter of the U.S. workforce — had filed for first-time unemployment benefits since March 2020. This figure is six times the unemployment claim number experienced at the peak of the Great Recession.  Two out of three Americans have made financial or personal sacrifices in order to afford prescription medications. Providers note that about 30% of their patients cannot pay for their drugs.

The report found that 29% admit to abandoning their medications because they cannot afford them. One in 10 patients wait 8 weeks or more to receive their first dose of therapy as a result of prior authorizations or barriers to access associated with specialty pharmaceuticals.

More here.

(Source:, Accessed August 7, 2020, original report:

BCBSA Exec Aronson Calls for Desperately Needed Validated Outcome Measures for Coverage Decisions Sat, 08 Aug 2020 13:30:39 +0000 Naomi Aronson, Executive Director for Clinical evaluation at the Blue Cross and Blue Shield Association, didn’t mince words in a recent webinar on the use of real-world evidence for coverage, calling for validated outcome measures across multiple conditions, stating that these are “desperately” needed in order to make appropriate coverage decisions. Aronson spoke on a webinar that addressed the use of RWE for coverage, hosted by the Medical Device Innovation Consortium (MDIC).

Aronson went on to describe persistent issues with evidence, including challenges with study populations that differ from the typical population that would receive the intervention in typical clinical care, as well as the use of study comparator treatments that do not reflect the real world. However, it was her opinion that the lack of validated outcome measures was the “largest issue of all”, and suggested that a core set of validated outcome measures for various conditions was sorely needed.  Device makers need this if they want to reduce the delay in gaining coverage for their medical device.

Eleanor Perfetto, executive vice president of strategic initiatives at the National Health Council, weighed in, suggesting that outcomes measures need not be completely identical across studies and registries, but acknowledged that a core outcome construct would be beneficial.  A related series of core measures and endpoints would solve many challenges.

Perfetto said that adding that these concepts would provide a common platform that would “help us to put our resources in the right place.”

The MDIC webinar also featured Jeff Farkas, senior director of health policy and payment for Dublin-based Medtronic plc, who noted that device makers see private payers as persistently hesitant to make use of RWE for coverage decisions. Gregory Daniel, head of U.S. health care policy at Edwards Lifesciences Corp., said RWE can also be used to support value-based program (VBP) design. Claims data are limited because they do not provide patient-reported outcomes, and discussed the use of electronic health records (EHRs).

Aronson wrapped up by reinforcing that payers and health plans are not wary of real-world evidence, citing their acceptance of these data in organ transplants dating back to the 1980s.  However, there is a philosophical roadblock; payers see themselves as purchasers of care, and perceive evidence development as the sponsor’s responsibility. Any deviation from that approach is seen as a case of cost shifting, Aronson said.

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(Source:  McCarty M, BioWorld, August 6, 2020)

NPC Comments on NQF’s Draft Report on Patient-reported Outcomes (PROs) Sat, 08 Aug 2020 13:00:27 +0000 The National Quality Forum (NQF) released a draft report on June 1, 2020 entitled “Patient-Reported Outcomes: Best Practices on Selection and Data Collection”.  The National Pharmaceutical Council (NPC) submitted comments to NQF on the draft report, as follows:

  • Applauding the emphasis on patient engagement and recommending the inclusion of caregivers during measure selection and implementation
  • Using more inclusive terminology: “patient-reported measures” (PRMs) and “patient-reported performance measures” (PR-PMs)
  • Adding domains to capture socioeconomic status and multiple facets of the patient experience
  • Supporting the inclusion of the attribute grid with suggestions to expand and clarify
  • Supporting implementation recommendations with additional discussion of funding

NPC has a long history of conducting research in patient-reported outcomes in oncology, working in partnership with Discern Health, and this partnership has released a 2019 white paper: Improving Patient-reported Measures in Oncology.

For more information, click here.

Global Experiences: Use of HTA for Health Benefit Packages Development, an ISPOR webinar Sat, 08 Aug 2020 12:30:40 +0000 Health technology assessment (HTA) is increasingly used to inform universal health coverage (UHC), including financing and priority setting for benefit packages.  HEOR and HTA are essential components for informing UHC decision-making.  ISPOR is holding a webinar, open to members and non-members, on August 26, 2020 at 8am EDT with the following learning objectives:

  • Gain a broad understanding of the role of HTA in Universal Health Coverage (UHC)
  • Learn how HTA is being used to inform the design of UHC benefits packages
  • Become familiar with the challenges and issues associated with using HTA in UHC

Featured speakers include global health policy researchers from international governmental and private organizations from Spain, Poland, Taiwan and Mexico.  A maximum of 500 registrants are allowed.

Register here.

Real-world Evidence Put to the Test: Medicare’s New Codes for Remdesivir Sat, 08 Aug 2020 12:00:56 +0000 The Centers for Medicare & Medicaid Services (CMS) has created new ICD-10-PCS procedure reimbursement codes to facilitate the generation of critical real-world evidence data on the effectiveness of COVID products. However, they warned that these will likely suffer from a “claims lag”. The codes, which went into effect on 1 August, ‘will enable CMS to conduct real-time surveillance and obtain real-world evidence on how these drugs are working and provide critical information on their effectiveness and how they can protect patients,’ the agency announced 30 July. The new codes are the Health Insurance Portability and Accountability Act-designated code set for reporting hospital inpatient procedures, and are developed and maintained by CMS but can be used by other private health insurers as well.

Read more.

(Source:  Kelly C, Pink Sheet, August 6, 2020; subscription required)

FDA Commissioner: COVID-19 Vaccine Must Adhere to Standards for Safety and Efficacy Fri, 07 Aug 2020 21:00:25 +0000 Stephen Hahn, commissioner of the Food and Drug Administration penned an editorial in the August 5 issue of The Washington Post, stating: ” But let’s be clear: The development effort must adhere to standards that will ensure any COVID-19 vaccine’s safety and effectiveness.”  The FDA stated that any authorized or approved COVID-19 vaccine must demonstrate that it prevents the disease or decreases its severity in at least 50 percent of people who are vaccinated, suggesting that this 50% threshold is appropriate for the current pandemic.

FDA has also stated a testing requirement that assures vaccine clinical development include diverse populations most affected by COVID-19, including racial and ethnic minorities, elderly, and people with medical conditions.  Many of these populations are often excluded from typical drug development.

The FDA has stated that they will closely monitor the safety of any vaccine after authorization or approval.

The editorial makes no mention of trial design or the use of real-world evidence trials.

(Source: Hahn SM, Washington Post, August 5, 2020)

COVID-19 Vaccine Pricing: Are the Manufacturers Signaling their Intent? Fri, 07 Aug 2020 20:30:00 +0000 The Wall Street Journal is reporting that vaccine manufacturers are signaling the price for coronavirus vaccines, with prices ranging from as low as $4 per dose to greater than $70 for a regimen.  In their Q2 review Wednesday morning, Moderna says its vaccine is commanding a relatively high price, with small supply deals being struck at a rate of $32 to $37 per dose. Larger volume deals will come at a discount to that. That would put the high-end price at up to $32 billion to $37 billion per billion doses, with a world clamoring for billions of doses to quell the pandemic.

Moderna rationalized its price with an internal cost-effectiveness model using a $50,000 per QALY willingness-to-pay threshold. The Institute for Clinical and Economic Review (ICER) has a different view, stating that cost-effectiveness isn’t necessarily the “correct” framework for thinking about the price of a COVID-19 vaccine, particularly one that was largely funded by the government. ICER has outlined multiple approaches to pricing in a pandemic in their July White Paper and in a series of webinars.

In other news, Moderna has failed to comply with disclosure requirements and publicly report development costs of a vaccine that is being funded by the Biomedical Advanced Research and Development Authority (BARDA), who awarded the company $955 million to develop a vaccine based on its mRNA technology and jointly invented with the National Institutes of Health. Moderna’s approach may spur rebuke from critics who point out that Moderna has been heavily subsidized by the US government.

Moderna CEO Stéphane Bancel noted that their vaccine “will be priced well below value, given the pandemic.” And he added that the price is in line with what any company would charge for an “innovative vaccine.” Bancel said that after the current outbreak has subsided, they will reprice their vaccine with more traditional pricing strategies suggesting that the company will increase the price.

J&J has outlined a deal with the US government to produce 100 million doses of their vaccine at around $10/dose, and state that this is their “not-for-profit” pricing.

Pfizer, in contrast, is getting $19.50 a dose, or $39 for a full course, in their US contract for 100 million doses. And that would be the base price Pfizer expects to charge in all of its contracts.

(Sources:  Carroll J, Endpoint News, August 5, 2020;  The Motley Fool, August 5, 2020;  Silverman E, STAT Pharmalot, August 4, 2020;  ICER, July 2, 2020; Loftus P, WSJ, August 5, 2020)

Patient Drug Costs Increased as Health Plans Promote Deductibles and Coinsurance, Says IQVIA Study Fri, 07 Aug 2020 20:00:09 +0000 A decade ago, most patients were responsible for only their copay on a brand medication. However, the past few years have seen commercial health plans transitioning away from copays.

In a recent IQVIA analysis requested by PhRMA, private insurance patients now pay most of their out-of-pocket spending for brand medicines in the form of deductibles and coinsurance. The study reported that two therapeutic areas, oncology and multiple sclerosis, the deductibles, and coinsurance accounted for more than 90% of out-of-pocket costs paid by patients. In the other five areas studied, deductible/co-insurance accounted for almost one-half to two-thirds of out-of-pocket spending. Across the seven therapeutic areas in the IQVIA analysis, patients with deductibles or coinsurance paid as much as 25 or 30 times more out of pocket annually for brand medicines than patients with copays only.

Health plans and pharmacy benefit managers (PBMs) typically negotiate large rebates with pharma that reduce the cost PBMs pay for the brand medication, but patients with deductibles and coinsurance do not typically benefit from these savings since cost-sharing is based on the full undiscounted price.  Rebates and discounts to health plans, PBMs, and government agencies totaled about $175 billion in 2019 and reduced the price paid by an average of 45% compared to list price. However, because health plans typically do not factor in these significant savings when calculating the deductible and coinsurance amounts patients must pay, out-of-pocket costs for these patients can be significantly higher than they otherwise would be if based on the discounted cost of the medicine.

The IQVIA analysis demonstrates that “the increasing use of deductibles and coinsurance by health plans disproportionately burdens patients with chronic conditions who are prescribed brand medicines, who are often some of the most vulnerable in the health system.”

Read the PhRMA summary here

Read the PhRMA full report here

Real-world Data Takes Center Stage in COVID-19 Response: Evidence Accelerator Community Tool Featured in Webinar by DIA Fri, 07 Aug 2020 19:22:40 +0000 A webinar on “Real-World Data to Inform COVID-19 Response: Collaborating in the COVID-19 Evidence Accelerator” is taking place on Tuesday, August 11, 10:30-11:30am ET as part of DIA NOW.  DIA NOW is a comprehensive, personalized resource for trends and updates on a wide variety of critical issues in the Life Sciences arena. Webinar attendees can take advantage of a one-month free trial of DIA NOW, with searchable, interactive access to session recordings, peer-reviewed journal articles, podcasts, among other resources. Members of DIA NOW can access recorded sessions from the more than 60 global meetings taking place around the world annually and receive breaking news and analysis from DIA’s publishing group.

Register for the webinar here.

Learn more about DIA NOW here.

The U.S. Food and Drug Administration (FDA) is harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. Two Evidence Accelerator projects have been launched: the COVID-19 Diagnostics Evidence Accelerator and the Therapeutic Evidence Accelerator.  The Diagnostics Evidence Accelerator is a multi-stakeholder collaborative project to advance the development of diagnostics, and is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. The Diagnostics Evidence Accelerator is the companion project to the previously announced Therapeutic Evidence Accelerator which brings together leading experts in health data aggregation and analytics in a unified, collaborative effort to share insights, compare results and answer key questions to inform the collective COVID-19 response.

RWE Challenges in Latin America featured in ISPOR Webinar on 10 August Fri, 07 Aug 2020 17:56:22 +0000 The ISPOR Latin America Consortium Industry Committee is presenting a webinar “The Usage of Real-World Evidence (RWE): Monitoring and Managing Health Technologies In Latin America – Where We Are and Where We Are Heading” on August 10, 2:00pm EDT (7:00pm GMT).  RWE in the LATAM (Latin America) region are important, yet scarce, with important barriers in usage, interpretation, methodology and data availability. In this webinar, a holistic multi-stakeholder discussion about the stage of RWE and how its use could improve the performance of healthcare systems in LATAM, including priority setting, health technology assessment (HTA), effectiveness and safety measurement, and innovative access models. The webinar will cover:

  • Regional trends in the use of RWE.
  • Current stage, challenges, and opportunities for the use of RWE in the regional decision-making process.
  • Technical challenges for RWE from both global and regional perspectives.

The webinar will feature industry experts from LATAM, consultants, and academia.

Register for the webinar here: