Resolution: S-20-13: IMPROVING INSULIN AFFORDABILITY

Forums Spring 2020 Resolution Forum Resolution: S-20-13: IMPROVING INSULIN AFFORDABILITY

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      Valerie Lile
      Keymaster

      1  WHEREAS, Diabetes Type 1 is one of the most common chronic diseases starting in early childhood
      2  in the United States that is fatal without lifelong insulin treatment1; and

      3  WHEREAS, over 1.4 million American children and adults are living with Type I diabetes mellitus and
      4  7.4 million Americans with diabetes use one or more formulations of insulin2; and

      5  WHEREAS, the number of youth with Type 1 diabetes is projected to increase by 23% in 20503; and

      6  WHEREAS, the researchers who discovered insulin, Richard Banting, J. B. Collip, and Charles Best,
      7  sold their patent rights for only $1 each because their goal was to ensure the quality, purity, and potency
      8  of insulin sold on the market rather than to profit4; and

      9  WHEREAS, the first license to manufacture insulin was granted for humanitarian purposes rather than
      10  for profit5; and

      11  WHEREAS, counter to the spirit of the initial sale and licensure of insulin, the global insulin market
      12  was a $24 million industry in 2014 and will top $48 billion by 20206; and

      13  WHEREAS, the cost of insulin has tripled over a mere decade from 2002-2013, despite only
      14  incremental added benefits of new insulin products on the market7,8,9; and

      15  WHEREAS, 39% of insulin users reported an increase in the amount they personally pay for insulin in
      16  the past year, including 52% of insulin-dependent children10; and

      17  WHEREAS, an uninsured person pays up to $480 per vial of insulin, with varying out-of-pocket
      18  expenses for insured persons11; and

      19  WHEREAS, the out-of-pocket expense for insulin has doubled per prescription11; and

      20  WHEREAS, it costs uninsured patients ten times more for insulin treatment at $7,000 annually versus
      21  $700 annually with insurance12; and

      22  WHEREAS, the diabetes related costs from the Medicare eligible population is expected to skyrocket
      23  to $171 billion in 2034, an increase of 380% from 200913; and

      24  WHEREAS, one in four insulin dependent diabetics with associated poor glycemic control reported
      25  insulin underuse or rationing due to cost12,14,15,16; and

      26  WHEREAS, those who regularly take less insulin than prescribed or miss doses report being forced to
      27  choose between affording insulin versus essentials like housing, utilities, transportation, and even other
      28  health related purchases, such as doctors visits10; and

      29  WHEREAS, one-third of patients with lower incomes who report cost-related insulin underuse also
      30  report difficulty affording diabetes equipment, thus increasing the risk for hospitalization16; and

      1  WHEREAS, many uninsured and underinsured patients are not only rationing insulin but also resorting
      2  to black market purchases of discounted insulin on unregulated classified advertisement websites such
      3  as Craigslist17,18; and

      4  WHEREAS, diabetics who are forced to ration their insulin have developed preventable complications
      5  like diabetic ketoacidosis with some resulting in diabetic coma or death12,14,15,19; and

      6  WHEREAS, diabetic ketoacidosis is a complication that could be avoided with adequate insulin
      7  treatment, but costs $26,566 per hospitalization, resulting in a healthcare burden of $5.1 billion2; and

      8  WHEREAS, an increasing number of patients are dying due to inability to afford insulin with diabetes
      9  being the 7th leading cause of death in 20172,21; and

      10  WHEREAS, deaths related to insulin rationing occurs even amongst middle class individuals with
      11  health insurance coverage22,32; and

      12  WHEREAS, the expansion of Medicaid eligibility in some states addressing gaps in affordable access to
      13  diabetes medication and treatment has resulted in a significant increase in insulin prescriptions being
      14  filled22,24; and

      15  WHEREAS, the pharmaceutical industry engages in evergreening, making incremental improvements
      16  to keep the cost of insulin expensive after the original patent has expired, which goes against SOMA
      17  policy S-18-12 designed to combat pharmaceutical evergreening; and

      18  WHEREAS, when primary patents expired in 2015 for Sanofi’s Lantus, the world’s most widely
      19  prescribed insulin and the world’s leading drug for Type 1 Diabetics, more than 70 secondary patent
      20  applications were filed in an effort to maintain its market monopoly25,26,27; and

      21  WHEREAS, market share holding pharmaceutical companies consistently file lawsuits against other
      22  companies over plans to produce and sell a generic form of insulin, claiming that patents will be
      23  violated and that rights will be infringed upon25,27; and

      24  WHEREAS, Eli Lilly agreed to make an ‘authorized generic’ known as insulin Lispro available for
      25  purchase at a 50% price reduction, but a spot check found it was only stocked in 17% of pharmacies
      26  across the country in favor of Eli Lilly’s ‘name brand’ drug known as Humalog, which offer a larger,
      27  more profitable rebate to insurance companies28; and

      28  WHEREAS, cheaper forms of insulin being made available are older formulations or analog insulins
      29  that are now rarely prescribed because it takes too long to take effect and then stays in the bloodstream
      30  for over 8 hours postprandial, increasing the risk for hypoglycemic events29; and

      31  WHEREAS, unbranded biosimilar versions of insulin are projected to be priced at 10-51% less than
      32  name brand biologic insulins, with a cost saving potential of between $25 billion to $150 billion over
      33  ten years30,31; and

      34  WHEREAS, unbranded biosimilar drugs have been available in Europe for years, pharmaceutical
      35  companies are distorting safety concerns to delay or prohibit the introduction of biosimilars into the
      36  American market30; and

      1  WHEREAS, pharmaceutical companies have resorted cutting deals with makers of biosimilars to
      2  prevent or delay the entry of lower cost biosimilars into the American market30,32; and

      3  WHEREAS, forty-five states and Puerto Rico have enacted laws protecting patients’ rights to try a
      4  biosimilar drug and protecting the substitution of biosimilar products by pharmacists33; and

      5  WHEREAS, two Congressional bills aimed at protecting against industry collusion to keep biosimilars
      6  out of the American market and at advancing public awareness and education on biosimilars have had
      7  no actions taken since they were introduced in 201934,35; and

      8  WHEREAS, the Food and Drug Administration has set standards for biosimilar drugs that protect
      9  against concerns of safety, efficacy, and quality36; and

      10  WHEREAS, the Senate Finance Committee Chairman initiated an investigation into the price spikes
      11  and high cost of insulin for people with diabetes in January 2019, but the only action taken to date is
      12  seeking insulin cost data from the Centers for Medicare and Medicaid Services Administrator37,38,39;”
      13  and

      14  WHEREAS, the Chairman of the House Committee on Oversight and Reform confirmed in January
      15  2019 that “there is a strong bipartisan consensus that we must do something to rein in out-of-control
      16  price increases…” by the pharmaceutical industry40;” and

      17  WHEREAS, two Congressional bills aimed at making insulin affordable have had no actions taken
      18  since they were introduced in January and February 201941,42; and

      19  WHEREAS, Colorado and Illinois are the first two states to enact laws that cap insulin co-pays43,44,45,46;
      20  and

      21  WHEREAS, Virginia recently passed a bill capping insulin copays that is pending their governor’s
      22  signature into law, which would make it the third state in the country to pass a law capping the cost of
      23  insulin and it would be the lowest cap set by any state at $50 per month47,48; and

      24  WHEREAS, the bills in Colorado, Illinois, and Virginia only apply to patients who have health
      25  insurance coverage and only those who are covered through state-regulated commercial insurance
      26  plans43,44,45,46,47,48; and

      27  WHEREAS, 28 U.S. Code § 1498 grants the U.S. federal government the right to use or manufacture a
      28  patented drug at reasonable compensation to the patent owner49,50; and

      29  WHEREAS, 28 U.S. Code § 1498 affords patent owners the right to petition the Court of Federal
      30  Claims for compensation, which would allow pharmaceutical companies the ability to seek a reasonable
      31  amount while prohibiting them from unilaterally setting predatory market prices on insulin50,51; and

      32  WHEREAS, 28 U.S. Code § 1498 was frequently used for crucial drugs in the 1960s and 1970s,
      33  including a Department of Defense purchase of an antibiotic directly from a generic manufacturer at
      34  28% of the price charged by the patent holder, Pfizer49; and

      35  WHEREAS, the government’s use of 28 U.S. Code § 1498 has waned not due to decreased need but
      36  due to the increasing strength of the pharmaceutical lobby49; and

      1  WHEREAS, Medicare is prohibited from negotiating drug prices due to language inserted into
      2  legislation that was written by the pharmaceutical lobby49,52; and

      3  WHEREAS, 28 U.S. Code § 1498 provides a reasonable counterweight to Medicare’s inability to
      4  negotiate drug prices, allowing the government to negotiate prices directly with the manufacturer and
      5  function as a free market buyer49,52,53; and

      6  WHEREAS, 28 U.S. Code § 1498 continues to be applied today in areas outside of prescription drugs,
      7  such as patented methods of hazardous waste clean up, electronic passport technology, and genetically
      8  mutated mice in scientific research449,50; and

      9  WHEREAS, 28 U.S. Code § 1498 continues to be applied for prescription drugs in cases of extreme
      10  need or urgency, such as the anthrax scare in 200149; and

      11  WHEREAS, just the threat of 28 U.S. Code § 1498 from the federal government to purchase a generic
      12  version of the antibiotic ciprofloxacin during the anthrax scare in 2001 prompted the patent holder,
      13  Bayer, to cut the selling price in half49,54; and

      14  WHEREAS, there is growing support of exercising 28 U.S. Code § 1498 to procure Hepatitis C
      15  treatment drugs, which have been priced by the patent holder, Gilead, at $80,000 per person for the full
      16  course of treatment, earning them $36 billion in just two years, well above the initial cost of research
      17  and development49,50,55,56; and

      18  WHEREAS, the costs of initial research and development can ultimately amount to as little as 4% of
      19  profits51,53; and

      20  WHEREAS, the American Medical Association (AMA) enacted H110.984 to support and encourage
      21  government efforts to make insulin affordable; and

      22  WHEREAS, the American Osteopathic Association (AOA) enacted H339-A/19 to support increased
      23  regulation of pharmacy benefit managers as a way to make life-saving medications, including but not
      24  limited to insulin, free for all uninsured patients and fully covered for all insured patients, but has no
      25  broader policy directly aimed at insulin cost control; now, therefore, be it

      26  RESOLVED, that the SOMA, the AOA, and the AMA advocate for legislation capping insulin copays
      27  with every state legislature via their respective state medical societies; and, be it further

      28  RESOLVED, that the SOMA, the AOA, and the AMA advocate for legislation that protects the
      29  introduction of biosimilar insulin products into the American market and patient access to biosimilars;
      30  and, be it further

      31  RESOLVED, that the SOMA, the AOA, and the AMA advocate for the United States government to
      32  invoke 28 U.S. Code §1498 for recent and medically effective short-acting and long-acting forms of
      33  insulin to address affordability and accessibility for all diabetic patients, including the uninsured.

      Explanatory Statement

      While there is bipartisan support for solutions to this issue, attempts at new and comprehensive federal legislation have stalled.  There have been recent movements in the right direction from a handful of state legislatures capping the cost of insulin.  This is a realistic interim solution for insured individuals and this proposal aims to support the implementation of similar bills in remaining states.  The limitation is that these legislations do not benefit uninsured individuals.  Therefore, to address insulin affordability more broadly, this proposal seeks legislation that protects the introduction of biosimilars that would foster the market competition in insulin costs.  Finally, gaps in insulin affordability is a long-standing, drastic problem that requires a drastic solution.  This proposal, rather than seeking a wholly new legislation, seeks enforcement of an existing law that the federal government can invoke at its discretion.

      Relevant Existing Policies:
      SOMA Policy: S-18-12

      Policy of Other Organizations Named in the Resolved Statements (AOA/AMA/etc):
      AOA Policy: H339-A/19
      AMA Policy: H110.984

      References

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      55. Tribble, S. J. (2017, May 4). Louisiana proposes tapping A federal law to slash hepatitis C drug prices. Kaiser Health News Retrieved on March 8, 2020, from https://khn.org/news/louisiana-proposes-tapping-a-federal-law-to-slash-hepatitis-c-drug-prices/
      56. Gee, R. E. (2017). Hepatitis C in louisiana is increasing and an important health equity issue. Baton Rouge, LA: Louisiana Department of Health. Retrieved on March 8, 2020, from https://khn.org/wp-content/uploads/sites/2/2017/04/gee-letter-4_12_17.pdf

      Submitted by:

      Jennifer S. Lee, OMS III – Touro College of Osteopathic Medicine – Middletown
      Oksana Levchenko, OMS II – Touro College of Osteopathic Medicine – Middletown
      Naomi Isaac, OMS II – Touro College of Osteopathic Medicine – Middletown
      Victoria Siracusa, OMS I – Touro College of Osteopathic Medicine – Middletown
      Sapan Patel, OMS I – Touro College of Osteopathic Medicine – Middletown
      John Zakhary, OMS I – Touro College of Osteopathic Medicine – Middletown
      Odolphe Augustin, OMS I – Touro College of Osteopathic Medicine – Middletown
      AliAsghar Diwan, OMS I – Touro College of Osteopathic Medicine – Middletown
      Marrian Sedrak, OMS IV – Touro College of Osteopathic Medicine – Middletown

      Action Taken: [ ]
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