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July 8, 2022

INSULIN Act

How it Could Work

The Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, introduced by Senators Shaheen (D-NH) and Collins (R-ME) aims to increase access to insulin by lowering the high costs for insured patients.  

The INSULIN Act encourages manufacturers to reduce their list prices to 2021 average net Part D prices (after rebates) by requiring commercial and Medicare plans to cover all products with reduced list prices on formulary with no management or prior authorization. This would lock in today’s net prices and would allow for price increases in line with inflation.

CIDSA experts were given the section-by-section summary of this bill to review for the following survey.

What Experts Think

The majority of CIDSA experts believed this policy would increase drug spending, but others differed. Five experts believed this policy would increase drug spending, two believed it would have no impact, and the final expert believed it would minimally reduce spending. While the majority of experts agreed that this policy would significantly decrease drug list prices, they also agreed this policy would moderately increase drug net prices. There was overall consensus that this policy would moderately increase drug access for patients with Medicare and commercial insurance, as well as uninsured patients and large patient groups. Rare disease patients and patients with Medicaid would be unaffected by this policy.

The CIDSA experts unanimously agreed that this bill would advance the drug spending policy landscape, with the majority (7) indicating a minimal advancement. The vast majority of the experts agreed that the ability for the policy to be implemented and the size of the affected population should be considered strengths of the policy. However, the experts agreed that the evidence base in support of the policy and the precedent-setting value of the policy are still unknown. Finally, there was no consensus on whether the magnitude of the impact that this policy would have on drug spending would be a weakness or still remains unknown.

*Only 8 experts were able to complete this survey.

How likely would this policy be to reduce drug spending?
Would Increase Drug Spending
Would Not Affect Drug Spending
Would Minimally Reduce Drug Spending
Would Moderately Reduce Drug Spending
Would Significantly Reduce Drug Spending
Would Substantially Reduce Drug Spending
How likely would this policy be to reduce drug prices?
Would Significantly Increase Drug Prices
Would Moderately Increase Drug Prices
Would Not Affect Drug Prices
Would Moderately Decrease Drug Prices
Would Significantly Decrease Drug Prices
List Prices
Net Prices
How likely would this policy be to increase patient drug access?
Would Significantly Reduce Drug Access
Would Moderately Reduce Drug Access
Would Not Affect Drug Access
Would Moderately Increase Drug Access
Would Significantly Increase Drug Access
Medicare
Medicaid
Privately-Insured
Uninsured
Rare Disease
Large Patient Groups
How significant is this policy in the evolution of US drug spending policy?
Does Not Advance Drug Spending Policy
Minimally Advances Drug Spending Policy
Moderately Advances Drug Spending Policy
Significantly Advances Drug Spending Policy
Ground-Breaking Shift in Drug Spending Policy
What are strengths and weakness of this policy?
Weakness
Unknown
Strength
Implementability
Size of Affected Population
Evidence Base in Support of Policy
Precedent-Setting Value
Magnitude of Drug Spending Impact
How important are the following in your analysis of the policy's impact?
Not Important
A Little Important
Somewhat Important
Very Important
Competitive response regarding bundled discounts
What the potential increase to Medicare premiums might be and the subsequent impact on access
Whether manufacturers will voluntarily participate in the program
The willingness of physicians and patients to switch insulins
The increased market share that manufacturers could capture from certification
The potential impact certified insulin products may have on biosimilar insulins
Potential net price reductions foregone by locking in 2021 net prices (before interchangeable biosimilars have a chance to gain traction)
The Part D Senior Savings Model status and number of Medicare beneficiaries who need insulin who are NOT already in those plans (where $35/copay is the per-fill cost)
Impact of highly-concentrated insulin formulations (currently specialty tier in many Part D plans) being included in net price estimates. 

Considerations for Policymakers

Experts highlighted many considerations for policymakers. The primary concerns that the experts brought up were the potential net price reductions that would be foregone by locking in 2021 net prices, before interchangeable biosimilars have a chance to gain any significant traction, and the uncertainty of whether manufacturers will voluntarily participate. Other considerations are the potential increase to Medicare premiums and the subsequent impact on access, the willingness for physicians and patients to switch insulins, and the potential impact on biosimilars. Final minor concerns that the experts had with the policy are its effectiveness in light of the existing Part D Senior Savings Model status, the impact that highly-concentrated insulin formulations would have in net price estimates, and the increased market share that manufacturers could capture from certification.