T1DF president files motion in support of PBM/insurer track in the insulin class action

T1DF president files motion in support of PBM/insurer track in the insulin class action

On Friday, April 6, 2018, T1DF president Julia Boss, as an individual pro se plaintiff, challenged the attempt by several class action law firms, led by Steve Berman and James Cecchi, to curtail the right of people with type 1 and other insulin-dependent diabetes to seek immediate relief from alleged insurer and PBM co-conspirators. She asked the Court to rule on establishing a concurrent litigation track against insurers/PBMs. Such a ruling would create a dual-track process similar to that already existing in the ongoing EpiPen litigation.

This brief, filed in New Jersey federal court (Civil Action No. 17-699-BRM-LHG) supports the previously filed Motion for Reconsideration of the Consolidation Order (Dkt. Entry 89) and responds to the opposition brief (Dkt. Entry 133) filed on April 2, 2018, by interim co-lead counsel and all law firms supporting their manufacturer-only litigation strategy, including Hagens Berman, Keller Rohrback (T1DF's former counsel retained in February 2017 to establish a PBM/insurer track), Weitz & Luxenberg, and Carella, Byrne, Cecchi, Olstein, Brody & Agnello (concurrently representing Novo Nordisk's shareholders) and Berman Tabacco. 

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T1DF president moves to establish a PBM/insurer litigation track in the insulin class action

T1DF president moves to establish a PBM/insurer litigation track in the insulin class action

On Friday, March 16, in New Jersey federal court, Julia Boss, president of the Type 1 Diabetes Defense Foundation, moved to establish a litigation track against PBMs and insurers in the insulin class action (In Re Insulin Pricing Litigation, Case No. 3:17-cv–00699-BRM-LHG). She thus challenged interim co-lead counsel Steve Berman and James Cecchi’s and Keller Rohrback’s coordinated attempt to prevent T1DF from implementing a dual-track litigation against PBMs and insurers, concurrent with the manufacturer-only consolidated complaint filed in December 2017. PBM rebating expert Larry Abrams recently wrote on his blog that Berman and Cecchi’s manufacturer-only consolidated complaint “makes no sense.” In light of increasing public knowledge and expert consensus, throughout 2017, regarding the impact of insurers’ failure to pass through rebates, Boss argued on Friday that pursuing a PBM/insurer track parallel to the manufacturer track is “critical to delivering immediate, tangible relief to the class.”

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T1DF Comments on Medicare Part D Access to Negotiated Price

T1DF Comments on Medicare Part D Access to Negotiated Price

The Type 1 Diabetes Defense Foundation (T1DF) has submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed rule entitled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program,” published in the Federal Register on November 28, 2017 (file code CMS–4182–P). T1DF demands strict implementation of individual beneficiary access to negotiated net price as defined under and mandated by MMA legislation.

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Take Action

Take Action

Six million Americans have type 1 and other insulin dependent diabetes.

That’s over six million people to stand together against inflated drug prices, discrimination in access to health care and insurance (including inflated cost sharing), discrimination in school or employment. T1DF was created to safeguard and, if necessary, fight for your rights. But we can't do it without your help.

Our civil rights and consumer protection programs depend on people like you who are willing to take action. 

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T1DF on FDA Draft Guidance for Industry: “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin”

T1DF on FDA Draft Guidance for Industry: “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin”

The Type 1 Diabetes Defense Foundation (“T1DF”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) Draft Guidance entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin” issued on October 4, 2017 (“Draft Guidance”). Effective implementation of the Biologics Price Competition and Innovation Act (“BPCI Act”) is of importance to the individuals T1DF represents, and we greatly appreciate the FDA’s efforts to provide clarity on the interplay between the new drug approval pathways under the BPCI Act and the existing approval pathways under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). 

As detailed below, we do have concerns about (1) the agency’s arbitrary reduction of the scope of “biological products,” as defined in the Public Health Service Act (“PHS Act”) and as amended by the BPCI Act, to a class solely based on the number of amino acids; (2) the resulting misclassification of glucagon as a molecule governed by the FD&C Act instead of the PHS Act; and (3) the bifurcation of approval pathways for analogous biological products, e.g. analog glucagon and analog insulin. 

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T1DF's letter to the U.S. Senate H.E.L.P. Committee and follow-up questions regarding the nomination of Alex Azar

T1DF's letter to the U.S. Senate H.E.L.P. Committee and follow-up questions regarding the nomination of Alex Azar

Dear H.E.L.P. Committee Chairman, Ranking Member, and Committee Members:

As you and your staff are preparing follow-up questions to submit to Mr. Azar by Friday, we hope you will take into consideration the clarifications we offer below and the potential follow-up questions we list at the end of this letter.

I’d like to begin by thanking members of the H.E.L.P. committee for their bipartisan attention during yesterday’s hearing to the crisis now facing Americans with type 1 diabetes, for whom access to insulin and glucagon emergency kits isn’t an issue of choice or convenience, but a matter of life and death. As accurately described by Mr. Azar during a November 2016 talk at the Manhattan Institute, current drug-channel actors have collectively created a pricing crisis for the uninsured, and a “cost-sharing” crisis for those insured under high deductible and high cost-sharing benefit designs. 

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Robbing Peter to keep Paul's premiums from going up

Robbing Peter to keep Paul's premiums from going up

Senator Hassan (D-N.H.): Where is your indictment of insurers’ exploitation of Americans with chronic medical conditions such as diabetes? Missing from your comments on Wednesday was an acknowledgment of the harmful effect of the current overcharging on the financial but also medical welfare of your constituents with chronic medical conditions. Insurers have been misleadingly messaging to the public that premium increases are caused by the skyrocketing list prices of diabetes drugs—while in fact these commercial insurers pay only a fraction of the list price, sometimes as low as 25% in the case of analog insulin. That this overcharging may, as T1DF’s lawsuits allege, be fraudulent, makes the oversight even more troubling. There is no evidence that rebates received by manufacturers, and accounted as general revenues, are actually used by insurers to lower premiums instead of increasing profits. In fact, enforcing cost transparency, and thus accountability—across the entire channel, from manufacturers to insurers—would likely reduce costs across all plans. Your unqualified statement that reduced cost- sharing would drive up premiums condones payers’ current discriminatory practices. These payers turn your constituents with diabetes into scapegoats.

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T1DF Letter to the U.S. Senate H.E.L.P. Committee regarding the nomination of Alex Azar

T1DF Letter to the U.S. Senate H.E.L.P. Committee regarding the nomination of Alex Azar

The Type 1 Diabetes Defense Foundation has reached out to Senator Lamar Alexander (R-TN), Chairman of the U.S. Senate H.E.L.P. Committee, and Senator Patty Murray (D-WA), Ranking Democratic Member, and other members of the HELP Committee, in anticipation of the full committee hearing scheduled for November 29 on the nomination of Alex Azar to serve as Secretary of Health and Human Services. 

T1DF has asked committee members, on behalf of their constituents with type 1 and other insulin dependent diabetes, to consider with all serious deliberation whether Alex Azar is the right choice to solve America’s current drug-pricing crisis. 

The Type 1 Diabetes Defense Foundation is deeply concerned by the nomination of Alex Azar to lead the Department of Health and Human Services. Over the years Mr. Azar has cultivated a public persona as an advocate of efficient market solutions and consumer empowerment. Yet as president of Lilly USA, he also demonstrated a willingness to sacrifice patient welfare in order to claim and retain for Lilly market domination in diabetes drugs. We are skeptical that an Azar-led HHS would deliver the most meaningful solution: downward pressure on list prices via regulatory enforcement of point-of-sale consumer protections, including transparency on net drug cost to insurance plans.

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Alex Azar, in his own words, on consumer overpayments, drug pricing and opaque reimbursement schemes

Alex Azar, in his own words, on consumer overpayments, drug pricing and opaque reimbursement schemes
"It’s a complicated and opaque system.  All consumers deserve to know the cost and quality of what they are purchasing . . .  They have tremendous amounts of price and quality data on all sorts of things—except for health care.  Our vision for health care is to fix that and give Americans the tools they need to become educated consumers." 

— Alex Azar, Deputy Secretary of Health and Human Services (2007)

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