The Rare Disease Legislative Advocates (RDLA) held its monthly webinar on May 20, 2021. The primary focus of the webinar was a discussion and overview of drug pricing proposals that are currently being floated in the halls of Congress. Drug prices in the US are widely perceived as being out of control and exorbitantly expensive. Therefore, new laws that place new controls on drug pricing are urgently needed.
Sarah Lloyd-Stevenson from Faegre Drinker Consulting provided an overview on the two primary bills that have been drawn up to regulate drug pricing: HR 3 and HR 19. While there is agreement from both political parties that there is a need to regulate the price of drugs, the two parties have both introduced their own proposals that different in certain details while also sharing certain similarities. HR 3 is the Democrat sponsored bill and HR 19 is the Republican one. Both of these bills originated in the House and neither have been seen by the Senate.
Both of these bills were first introduced in 2019 and were both reintroduced again last month.
HR 3
- Inflation payback
- Assist patients with coinsurance
- companies have to lower cost or pay the price above inflation to the Treasury directly
- Medicare drug price negotiation for up to 250 drugs
- Max price for a negotiated drug using an international market index
- Fees/penalties for pharma company non-compliance
- Eliminate coverage gap, $2,000 out of pocket limit
- Fund NIH with savings
- Specifically targets the most expensive drugs, meaning a significant impact for cancer/rare disease therapies
HR 19
- Medicare Part B Changes:
- Caps part B add-on payments
- Variable average sales price payment rate to incentivize prescribing cheaper medicines
- Hospital neutral site payment at PFS rate
- Medicare Part D Changes:
- Eliminate coverage gap, $3,100 out of pocket limit
- Coverage discount program
- $50 post deductible limit for insulin and related supplies
- Wholesale acquisition cost reporting requirements
- Pricing agreement pathway based on value
- Expand the definition of outpatient covered drugs
- Price increases must be reported to HHS
Jennifer Dexter of the National Health Council says that both of these bills, while a step in the right direction, are still in urgent need of improvement. She emphasized the importance of lawmakers seeking direct patient input when developing drug pricing legislation. Ultimately, the patient community should be setting the priorities in this discussion. Transparency that is understandable to the community is essential for a successful process.
Mike Eging of the Rare Access Action Project says that any proposed legislation has to take into account the diverse needs of the rare disease community, as the needs of patients can vary greatly both on an individual level, but also between different disease states. His organization also provided an analysis that showed how these laws would increase costs for drug companies.
Jamie Sullivan from the EveryLife Foundation also reflected on the bills. There is no doubt that rare disease poses a massive economic burden and prescription drugs are a huge part of that number, which is projected at nearly a trillion dollars annually. New laws need to uphold the regulatory role of the FDA and maintain the currently available incentive structures that have helped accelerate rare disease therapy development in recent years. Meanwhile, they also shouldn’t provide exploits or loopholes for pharma companies.
Additionally, Jamie emphasized that new laws shouldn’t place rare disease patients in a position to be exploited as guinea pigs for medical experimentation and should maintain current safety guardrails. However, decreasing cost and time barriers should be a top priority when possible.
Adrian Palau-Tejeda from EveryLife also announced the establishment of the organization’s Rare Diversity Hub. Click here to check it out.
