Arbiter of Value
ICER has the laudable mission of being an independent, trusted source of value assessment for medicines. We spoke to Chief Scientific Officer, Dan Ollendorf, about controversy, criticism and the power of collaboration.
As Chief Scientific Officer at ICER, Dan Ollendorf has the perhaps unenviable task of supporting all of ICER’s stakeholders in discussions around the value of new drugs. “Pharma and device manufacturers are incredibly important stakeholders, in part because they know their own products better than anyone else. We have developed several steps throughout our process, that have evolved over time, to encourage manufacturers to get involved.”
ICER also seeks to be “as open and as transparent as possible”, he says, for example, it has an ‘open-input’ period at the very outset of every project that allows any stakeholder to offer input and guidance. “This includes any concerns they may have with our approach,” he says. “The next step after that is to start our scoping process and that involves setting a series of conversations with key stakeholders to help us develop and refine our scope for any given project. Those always include individual discussions with manufacturers affected by each topic, so we definitely seek their input and openly welcome full participation.”
ICER also opens its scoping document to public comment and, once analyses are completed, presents the preliminary findings to manufacturers of the product under review as well as key patient advocacy groups. “They get a chance to look at our preliminary results, and raise questions and concerns for clarification. We integrate as much of that as we can into the draft that gets publicly posted. Again, they have a chance to publicly comment when that draft is posted as we want to encourage ongoing conversation and comment,” says Ollendorf.
Even before it presents preliminary results, ICER also works with modelling collaborators to form a data request list that is sent to the manufacturers, he says. “We recognize, particularly with drugs that are coming through the FDA or other regulatory authorities, there may not be a lot data out in print yet around those products but manufacturers may have data on file that they might be willing to share.”
In spite of these measures, some pharma companies have criticized ICER’s framework and called for more openness and transparency in its methods. Taking action on these points is as an organizational priority, says Ollendorf. “We try to be as responsive as possible and have made several changes based on feedback, and will be publicly describing some key revisions very soon. We also get a large volume of public comments when we post a report. In the past, we posted a summary response to those comments, but we recognize that this didn’t necessarily make clear to a given stakeholder how any individual comments were being addressed. Now, we produce a point-by-point response to comments so that stakeholders understand what we did or did not do in response, and our rationale. We’re trying to be as responsive as possible to all stakeholders’ needs, but we all have to recognize that we may be saying things in a report that stakeholders are not necessarily going to like. We can’t back off from our principal research conclusions.”
In response to Amgen’s request that it change its calculations to avoid making a drug’s cost the “main determinant of health system value”, Ollendorf is clear. “We look at budgetary impact over a five-year time horizon, which is relatively long for most health authorities, and we give credit to a drug that will produce cost offsets. For example, if a drug is more expensive but is likely to reduce the need for hospitalization or emergency room services, those cost offsets are included in our budgetary impact calculations. In addition, the main determinant of value is actually the longterm value to the patient. The budget impact analysis simply serves as a signal that additional steps at the system level might need to be taken to ensure access to an intervention of high value to the patient.”
ICER hopes to be one voice among many in decision making, he says. “It is our hope that we can be seen as a valued, independent, third-party producer of data. Most of the payers in the US who are aware of us use our reports as an input to their decision making. It’s certainly not the only input but because they are publicly available and free to anyone for their own purposes, they can use this information to supplement their own work.”
For Ollendorf, calculating the value of oncology drugs presents unique challenges, not least the additive nature of the cost. “You might have regimens for different cancers that are already very expensive and when a new innovation is introduced, it doesn’t necessarily replace that regimen, with costs becoming exponentially larger. In addition, for certain cancers, there is a clinical trend towards using these treatments essentially indefinitely, unless there is some signal that the disease is progressing and there’s a need to switch. For example, you may have a regimen studied for a fixed number of cycles in clinical trials but which, in practice, is used for a much longer period for fear that the cancer may return or that another aspect of quality of life may be diminished.”
One potential solution is a package discounts approach, where manufacturers in a combination regimen decide to offer a discount for all the drugs involved. “There also needs to be experimentation around whether the introduction of drug holidays or fixed treatment durations might still produce comparable medical outcomes and reduce the cost. In comparable sets of patients, if you get similar outcomes in terms of survival or progression-free survival with six cycles as opposed to an indefinite treatment paradigm, then there is no need to continue with indefinite treatment.”
Pricing itself is a complex issue, says Ollendorf. “There are a number of things going on with drug prices in the US that pose a challenge. One is price on market entry but the other is year-on-year increases for existing branded products, part of which is driven by the number of middlemen who are taking their slice as the drug makes its way to market, such as wholesalers, distributors and PBM companies. There is no one single source for high drug pricing and there are many ways to encourage innovation and so reduce the need for pharma companies to increase their prices to fund future R&D. These include tax incentives or changes to drug exclusivity laws or, in the case of rare and deadly diseases, a government patent buyout, an idea that has been talked about. At the end of the day, these price increases are felt most prominently by patients, and, if patients cannot afford their medications, there’s no purpose in innovating to create them in the first place.”
Looking to the future, will ICER continue to be the main arbiter of value in the US? “Given the outcome of the election, it seems reasonably safe to say that most impactful HTA will continue to be done in the private sector. One of the original hopes for Patient-Centered Outcomes Research Institute was that it would become the HTA arbiter for the nation but that never occurred, in part because agencies like NICE in the UK and HIQA in Ireland are seen by many in the US as rationing care and limiting choice,” he says.
“We do have a healthcare agency – the Agency for Healthcare Research and Quality – that does HTA but does not consider economic value, so it’s largely going to be groups like ICER that will continue to produce this information, and that’s going to be the case for the foreseeable future.”
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