- 2 years ago
29 July 2024
He was the first employee to join the independent research organisation and is one of the key reasons it is, and remains, a leading voice in health technology assessment (HTA) globally.
A clinical epidemiologist and health economist, Ollendorf was consulting for the life sciences industry in 2007 when ICER founder Steven Pearson asked him to join ICER as its inaugural Chief Scientific Officer.
A trip to the UK for a research fellowship at NICE had inspired Pearson to establish the US not-for-profit, Ollendorf saying he joined because of its independence although it is clear his intellect, innate sense of social justice, and desire to deliver equitable health outcomes in the US made him perfect for the job – something Pearson was undoubtedly aware of.
“I did everything,” Dr Ollendorf says of his early days at ICER. “I made photocopies, found a freelance graphic designer to design our logo and sat with the academic health economists who did the modelling with us. I recall having to calm them down when they realised we were operating on an eight to nine month timeline to get work done.
“At first we focused most of our attention on devices and procedures. The proof of concept came when our first independent reports were published and payers started to take notice, realising they could use our evidence-based approach instead of facing criticism for ‘cherry picking’ to support a coverage decision.”
Pearson’s vision had been for ICER to objectively scrutinise clinical evidence for new products and deliver an independent assessment of the cost effectiveness that could spark a public conversation about the value proposition.
This vision has remained at the core of ICER, invariably the first HTA body globally to assess a product, its team of just 35 people publishing around 10 reports a year released around the time the FDA decides on approval.
While ICER was inspired by NICE, the US healthcare system is very different to the UK’s legislative mandate for HTA, meaning ICER’s recommendations are only adopted by payers, health systems and manufacturers if they so choose, hence why making its HTA reports publicly available around regulatory approval is so important to ICER.
The organisation’s acceptance has been positive from inception but a pivot point came in 2014 with the approval of hepatitis C antivirals. ICER assessed them as highly cost-effective but a funding nightmare due to the size of the patient population and consequent budget impact. Its report attracted the attention of billionaire philanthropist John D. Arnold who was concerned about rising drug prices in the US and felt ICER could play a greater role in managing this.
Arnold offered significant sponsorship for ICER to review medicines as well as diagnostics, and almost overnight an HTA force in the US pharmaceutical sector emerged. It didn’t take long before it sparked controversy, ICER’s analysis of PCSK9 inhibitors delivered in 2015 stating they potentially offered significant benefits but were not cost-effective at the proposed launch price drawing anger from sponsors.
Likewise, ICER’s verdict on Eisai and Biogens’ first Alzheimer’s therapy, ADUHELM (aducanumab), was that if there was a benefit, it was very modest in line with clinical opinion but at odds with the FDA. Its assessment of the companies’ latest therapy, LEQEMBI (lecanemab), is that the benefit was still modest but the evidence more compelling, and the sponsors set a price near ICER’s recommended level, indicative of ICER’s standing in the US market.
Another controversial area is gene therapies with ICER concluding in several assessments the evidence supported a multimillion dollar price tag while its unsolicited submission of a special assessment to the Biden Administration’s Inflation Reduction Act and efforts around pricing negotiation for Medicare is another example of independent thinking.
Yet it is this detachment from political and corporate influences and ability to speak out where it feels there is a need that makes ICER so unique and well regarded – in no small part due to Dr Ollendorf’s contribution over its 17-year history.
While he left in 2018 to Chair of the HTAi Global Policy Forum and work with the highly regarded Tufts Centre for the Evaluation of Value and Risk in Health on projects such as Bellberry’s accelerated access workshop and paper, Dr Ollendorf returned to ICER last November, adding Director of HTA Methods and Engagement to his CSO responsibilities.
“Having been there from the very beginning, I never really got ICER out of my blood,” he explains. “I’m a huge proponent of HTA.”
Dr Ollendorf continues to be a leading voice in HTA both in the US and globally, his five years as HTAi Global Policy Forum Chair seeing him lead discussions on topics such as deliberative processes in HTA and lifecycle approaches to promoting engagement and efficiency in HTA.
For its part, ICER has taken the lead in stakeholder engagement, its strategy of proactively reaching out to stakeholders considered world-leading while other agencies are also looking to it for best practice in horizon scanning and topic selection.
Yet there is room for improvement, says Dr Ollendorf, who credits Australia’s PBAC Deputy Chair Jo Watson for her stakeholder engagement work while admitting to being “a little bit jealous” of the government mandate Australian HTA agencies enjoy while ICER relies on actions of payers and manufacturers to effect change.
He says NICE claims the lead for transparency, the UK agency having taken big steps to pull back the veil on its decision-making, while Germany’s IQWIG can fund a clinical trial to deliver more evidence – the dream of every HTA agency.
Every system has its pluses and minuses and no one system has everything right, which is why HTA has become like a global sport where each individual team needs to take into account its own country’s circumstances. For example, ICER’s cost-effectiveness thresholds are far more generous than most, designed to recognise the role the pharmaceutical industry plays in the US but the lack of affordability of medicines in America is leading to pressure for ICER to lower its thresholds.
“The problem is our prices are so much higher than the rest of the world, and those prices are not typically tied to value,” Dr Ollendorf says.”At the end of the day, the individual patient is the one absorbing the hit.
“We are the only country in the world where medical bankruptcy is an issue and we feel using a more liberal price range and opportunity cost threshold is a reasonable compromise, rewarding innovation and subsidising global R&D while protecting patients.
“The true opportunity cost threshold in the US is probably closer to around US$65,000, but it is a difficult argument to have as other health service costs in the US are also very high – and rising. At ICER, we are at the knife’s edge of all kinds of arguments about refining our methods, whether that be the quality-adjusted life year (QALY) or the need to incorporate novel elements of value into our equations.
“Our problem is we don’t know what the empirical basis is for much of this, so I started some thinking around creating an independent advisory group to delve into these topics in detail and find out whether there is an empiric basis or whether it’s just a way to argue for higher prices.”
It seems Dr Ollendorf’s time away from ICER has failed to blunt his enthusiasm for HTA and his return will only accelerate ICER’s world-leading independent thinking and reputation for solving problems and embracing innovation.
“I’ve got a good few years left in me,” Dr Ollendorf says cheerfully. “I’m really hoping to help solidify ICER’s presence and role in the US ecosystem, and I’m hopeful there will be more of a national embrace of the kinds of principles we espouse.”
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