Patients’ “Access to Medicines” Journey, Pricing Take Many Turns

What I ‘heard’ from the CMS Patient-Focused Listening Sessions

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As part of the Inflation Reduction Act (IRA) under the prescription drug law, Medicare can negotiate directly [Medicare Drug Price Negotiation Program] with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs.? As such, the Centers for Medicare & Medicaid Services (CMS) conducted virtual patient-focused listening sessions that provided an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of Medicare Drug Price Negotiations.

I listened to all of them and following are my takeaways:

• Process:? Pros and Cons:? From a “listener” perspective – appreciated the process in that it was less than an hour and each had only 3 minutes to make their case.? There were issues – which are noted at the National Pharmaceutical Council.?
• Focus ALSO on chronic use of medicines and those organizations as they address broad policy -- Several policy-focused patient organizations spoke at almost all the sessions and represented people with primarily chronic health conditions. They often represented people taking more than one class of medicine. These groups included:

o?? Mended Hearts

? o?? Alliance for Aging Research

o?? National Forum for Heart Disease and Stroke Prevention

o?? Chronic Care Policy Alliance

o?? Partnership to Fight Chronic Disease

o?? Survivors for Solutions

• Individual patients, physicians and physicians representing physician groups also were included. Two organizations/individuals that have been more vocal about issues (pricing and intellectual property rights/patents) with pharmaceutical companies also spoke (David Mitchell/Patients for Affordable Drugs; and James Love/Knowledge Ecology International)

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• Key messages:

o?? Transitions from one life stage to another create ‘eye-opening’ challenges in terms of money and access:? From one life stage/associated healthcare systems to another is extremely challenging and difficult to manage (e.g., going from parents’ health insurance to cover diabetes meds to adult needing health insurance/not being able to afford it prompts them to ration insulin/crowdsource for insulin) Likewise, going from commercial health insurance to Medicare causes prompts significant change in access and some patients have foregone medicine, rationed care, etc.)? Companies’ access initiatives are not applicable under Medicare (versus via commercial insurance)

o?? Restrictive pricing will deter companies from looking at additional uses of medicines/limiting access to effective therapies and that has enabled medicines to have greater benefit – particularly for more rare conditions

o?? Pharmacy Benefit Managers and concern over utilization management:? remove from formularies, change the tiering structure, STEP protocols

o?? Co-use of IRA identified medications: Some patients may be taking ‘several’ medicines on the CMS Drug Negotiation list and concern over the impact to patients

o?? All patients are different and react differently to different medications.? You cannot assume all patients can take one drug vs another – particularly when it comes to biologics

o?? Medicines on the list have made a significant impact to patients and they want to continue using them

o?? Price, cost and managing that is a key issue particularly on fixed incomes

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Here are my key takeaways:?

• Efficacy of the medicines and the ongoing investigation of them is highly regarded.? Efficacy is not the issue other than its alignment with different patients react to different drugs differently and therefore options are critical
• Managing their health overall is complex and exhausting for patients and they will focus attention on that.? However, managing financial access to just ‘live’ is an additional burden that saps their time and energy. Patients may forego treatment, ration treatment, crowdsource treatment (in the case with insulin) as it may be ‘easier’ than searching out additional ways to address finances (if they exist)
• Concern over how PBMs will address price issue and how that relates to access to specific medicines overall is a key issue
• Issue of intellectual patent rights/patents, government-‘funded’ medicines and pricing will become greater issues under current administration as both have been addressed by the Biden Administration.? This is a particular issue of KEI/James Love and may become a more prominent issue

This clearly isn’t everything, but thought it would be ‘helpful’ to share some very topline thoughts from a “listen only” mode participant.