May 13, 2014
To Fund or Not to Fund: A Question of Ethics
Perspective of Payers, Patients and Pharma
At this last meeting of the season, we were privileged by having Dr Margaret Somerville as the moderator of a panel of speakers. Dr Somerville is an expert in the field of ethics and is the Founding Director of the Centre of Medicine, Ethics and Law at McGill. She began the meeting by saying that sometimes one must choose between competing harms, termed a “world of competing sorrows”, and that this is often the case in healthcare. Each speaker was given the floor to make an opening statement about their perspective on the single most important criterion in making funding decisions.
The first speaker, providing the patient perspective, was Christine Janus, CEO and Executive Director at the Canadian Skin Patient Alliance (CSPA) and Canadian Association of Psoriasis Patients (CAPP). She began by saying that Canadian patients want access to the best medications when they need them and they feel entitled to them. She said that not all patients want the newest medication, and that improvements in quality of life and ease of use are also important and sometimes trump efficacy. From a patient group perspective, Christine said that patient submissions can often tip the scale between positive or negative responses by CDR or PCODER. The ethical question facing patient groups is whether they should accept funding from pharma for a submission under review. Such considerations create conflict, as patient groups need funding support to survive, as submissions strain resources and take time away from other projects.
The second speaker was Dennis Chan, Principal of Pathway Advisory Services, Supplier Relations & Systems Branch, of the Pharmaceutical Services Division of the B.C. Ministry of Health and he provided the payer perspective. He began by saying that the goal of payers is to allocate finite resources as best they can, meaning they are looking for things that distinguish diseases and patient groups, such as disease severity and the stage of life at which it attacks. The issue payers face is prioritizing competing interests.
The last speaker was Jennifer Chan, Executive Director of Policy & Communication at Merck Canada, providing the pharma industry perspective. She began by saying that her core beliefs are reflected in a quote by George W. Merck: “We try to remember that medicines are for the patient. We try never to forget that medicine is for the people. It is not for profit. The profits follow. And if we remember that, they have never failed to appear.” She felt that pharma’s ethical responsibility is doing what’s right for the patient. She said that one of the potential solutions in today’s environment would be to look at innovative pricing and reimbursement models and new forms of evidence to improve the benefit-risk assessment.
Dr Somerville then posed some questions to the panel. The first was: “How would you define your current role in the process of review and recommendations of new innovative therapies? And should that role evolve from what it is now?” Christine said that her role is working with pharma to provide submissions to HTA reflecting the patient perspective on what it’s like to live with a disease and how they’ve fared on treatments they’ve tried. She said the challenge is that it’s often hard to reach those patients within tight timelines. Dennis encouraged public payers to have an “open door” kind of relationship with industry manufacturers and patient groups, so that all the groups can understand their interests and work together. Jennifer said that industry should look for opportunities to get patient and payer input as early on in the drug development process as possible, so that the drug program can be designed to incorporate what’s valued. Christine added that it would be helpful to involve patients when creating study designs.
Dr Somerville’s second question was: “What are the key ethical dilemmas or gaps that you’re challenged with when it comes to health technology assessment?” Dennis said that it’s rare disease drugs, because they tend to be prohibitively expensive and only benefit a small group of patients. This means saying “no” to a lot of other patients when the decision is made to fund such a drug. Jennifer said that, from a manufacturer’s perspective, every product should be looked at individually on a case-by-case assessment. She felt that if a handful of patients can benefit from a product, and it’s the only product for that disease, a way should be found to make it available. Christine pointed out that the painful reality is that not all drugs can be funded and, from the payer perspective, where should the focus their energies: to the life-saving drug or the life-improving drug? She said that we all try to work together, but it’s difficult when we’re all competitors for funding and approvals.
The next question was: “How do you define the value of a new innovative therapy and how should this be assessed?” Jennifer began by saying that the value is in the eye of the beholder, but there has to be a demonstration of patient outcomes and value innovation. It’s important to get the perspectives of the patient, payers and healthcare professionals in order to properly evaluate a product’s value. The public health and economic benefits also need to be considered. Christine said that value for patients means that the product meets their needs in a way that others don’t currently, which could mean many things. She said that HTA bodies don’t necessary appreciate that, as they look at efficacy and cost-effectiveness.
Dr Somerville then asked: “What is the single most important criterion when it comes to decision-making about access to new therapies?” Christine said that it’s the ability of the doctor to write the prescription that will fit the patient’s needs. Dennis said it’s the product’s efficacy and affordability and then, does it meet an unmet need, and if so, is the price acceptable? Jennifer added that there has to be a health benefit for the patient, but clinical value is also important.
Dr Somerville’s last question was: “How can we better manage uncertainty around limited evidence about potential benefits? What are the ethics of decision-making in areas of uncertainty?” Dennis said that one of his favourite ways to deal with this is to come up with arrangements where the risk is shared between payers and manufacturers, so they pay for performance. Jennifer said that she didn’t think price volume agreements manage risk, as they are lose-lose scenarios. She felt that a lot of thought needed to be put into new models, where parties involved could work collectively to improve patient health outcomes. Christine said, “There’s no way to eliminate uncertainty and that’s a certainty”. She wondered if certainty could be increased through patient involvement, registries or surveillance.
Dr Somerville concluded the meeting by saying that the answer to all of these issues is that they must pass ethical muster. She said that pharma is a business like no other; it has privileges and ethical obligations that might not apply to other businesses. She finished by saying that when we are faced with something uncomfortable, we must look at the ethical obligations.
Tuesday, April 20, 2021
Green Shoots of Opportunity:
How to Find and Harvest Green Shoots in Pharma
Time: 6:00 p.m. - 7:30 p.m.
Tel: (514) 486-3458
Fax: (514) 486-4794
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