The infrastructure bill text uses offsets from delaying Trump’s Part D rebate rule and refunding discarded drugs.

The two drug related offsets are estimated to save $52 billion, $49 billion of which comes from delaying the Trump administration’s rebate rule. CBO previously scored the rebate rule to cost approximately $180 billion over a decade; Congress is still considered a full repeal to use the remaining savings in the reconciliation bill. The additional $3 billion in savings comes from requiring drug companies to pay Part B back for unused product in vials, as manufacturers often increase amount of the product in a single vial to ensure leftovers. To read the full article, click here.  

The Senate Judiciary Committee advanced four bipartisan bills to lower costs and improve access to prescription drugs.

The four bills advanced by the committee include the Stop STALLING Act (S. 1425), the Preserving Access to Affordable Generics and Biosimilars Act (S. 1428), the Prescription Pricing for the People Act (S. 1388), and the Affordable Prescriptions for Patients Act (S. 1435). The bills address patent system gaming by large brand manufacturers and encourage the entry of generic and biosimilar products. To read Ranking Member Grassley’s press release on the bills, click here.

• The Stop STALLING Act is intended to prevent large brand manufacturers from filing sham petitions with the FDA to prevent regulatory approval of generics and biosimilars. To read the bill text of S. 1425, click here.
• The Preserve Access to Affordable Generics and Biosimilars Act would limit pay-for-day deals that prevent the entry of generics and biosimilars. To read the bill text of S. 1428, click here.
• The Prescription Pricing for the People Act would require the FTC to examine PBM consolidation. To read the bill text of S. 1388, click here.
• The Affordable Prescriptions for Patients Act would curb product hopping and evergreening abuses. To read the bill text of S. 1435, click here.

A bipartisan group of senators urged Secretary Becerra to allow for importation of drugs from Canada.

Senators Klobuchar (D-MN), Grassley (R-IA), King (I-ME), and Collins (R-ME) wrote in their letter that the personal importation of certain prescription drugs from Canada is a clear way to reduce costs for American patients. The senators cited urged Becerra to include importation in the upcoming proposal to lower drug costs resulting from President Biden’s executive order on competition. To read the full letter, click here.

The FDA approved the U.S.’s first interchangeable biosimilar: Mylan’s Semglee insulin.

Mylan’s biosimilar, Semglee, is now interchangeable with Sanofi’s Lantus insulin. Interchangeable biosimilars can be substituted for at the pharmacy, without prescriber intervention. This “pharmacy-level substitution” is how generics are substituted for brand name drugs in most states. According to the FDA’s press release, biosimilars in the US have been launched at list prices 15% to 35% lower than the reference product. A previous IQVIA report projected the US will save more than $100 billion from 2020-2024 due to increasing use of biosimilars. To read the full press release, click here.

- To review IQVIA’s September 2020 report on biosimilars, click here.

CMS projected an increase in Medicare Part D premiums for 2022.

Currently, the average Part D premium is $31.47, but CMS has projected a 4.9% increase to $33 for 2022. The nearly 5% increase comes shortly after premiums had declined by 12% from 2017 to 2020. The projection is based on an estimation of plans’ per capita drug spending for the year. CMS expects to release final premium and cost-sharing information in September. To read the full news alert, click here.

The Committee for a Responsible Federal Budget (CRFB) released analyses on two ways to reduce prescription drug costs.

The analyses offer proposals to redesign the physician-administered Part B drug payment system and how to limit manufacturers from evergreening brand prescription drugs. The first proposal would bundle all physician-administered drugs that are within the same therapeutic class and set the price to the weighted average of all comparable drugs. This policy was estimated to save $122 billion in just three classes, from 2021-2030. The second proposal would eliminate market exclusivity awarded to new formulations if the reformulation cannot be proven to be more clinically beneficial than the previous version. This proposal was estimated to reduce federal deficits by at least $10 billion from 2021-2030, due to increased generic competition. To read the full analyses on Part B reform and evergreening, click here and here, respectively.

CIDSA Experts in the News

Stacie Dusetzina spoke with reporters at Fortune on illegal kickbacks to patients. The article discusses the implications that Pfizer’s lawsuit, which is expecting a ruling shortly, could have on the entire pharmaceutical industry. Pfizer alleges that covering patients’ costs for expensive drugs should be legal, however these illegal kickbacks induce more patients to take the more expensive option, rather than looking for less expensive alternatives. In 2018, Pfizer paid $24 million to settle allegations that the manufacturer was paying these kickbacks and is now fighting to make them legal. To read the entire article, click here.  

Rachel Sachs spoke with reporters on the role of the accelerated approval pathway. The accelerated pathway allows drugs to enter the market before the manufacturer confirms the drug’s efficacy, as long as the manufacturer conducts post-approval studies to verify the drug’s clinical benefit. Sachs claims that some companies take advantage of the accelerated pathway to be able to market drugs without necessarily being safe. To read the entire article, click here.