Growth Hormone: Drug companies are growing less generous in helping patients pay for meds

For 14 years, Encino resident Ed Wright received an expensive prescription medication for free through a drug-industry program intended to assist people with limited or fixed incomes.

Now he’s rationing his doses after a change to the program that imposed a $1,100 deductible before he can get a refill.

“I can’t afford that,” Wright, 75, told me. “When I run out in a few weeks, that’s going to be it.”

He isn’t alone. Industry watchers say soaring drug prices have prompted many pharmaceutical companies to rethink long-standing programs to help subsidize purchases or even give meds away for free.

“More and more people have become aware of these programs, and demand has gone up,” said David P. Wilson, president of PRAM Insurance Services, a Brea firm that helps employers with prescription-drug benefits.

This means trouble for patients who, like Wright, can’t handle sticker shock at the drugstore.

He suffered a head injury 17 years ago that damaged his pituitary gland. In 2003, he was diagnosed as having an abnormally low level of growth hormone, which caused him to suddenly become overwhelmed with fatigue.

That’s a potentially life-threatening condition if an episode should occur while driving, walking down stairs or performing some other physical activity.

Wright’s doctor prescribed the self-injected human growth hormone Humatrope, manufactured by Eli Lilly & Co.

The cost, however, was out of reach for Wright, even with Medicare Part D. According to the drug-pricing website GoodRX, a 6-milligram cartridge of Humatrope — a one month’s supply — runs about $700.

Luckily, Wright’s fixed income made him eligible for a program called Lilly Cares, which made the drug available free of charge. He and his doctor would renew the paperwork annually, and for 14 years Wright had no difficulty receiving the med.

That’s no longer the case with the new $1,100 deductible, which requires Wright to spend that amount on prescription drugs before he can access his free Humatrope.

Wright requires few other drugs, so the deductible is an almost insurmountable barrier to maintaining normal quality of life.

Most drugmakers offer what are known as patient assistance programs, through which the company may provide meds directly to patients at little or no cost. Or the company may assist with co-payments — the patient’s out-of-pocket expense that’s not covered by an insurer.

2009 study published in the journal Health Affairs found that most patient assistance programs run by drug companies were reluctant to disclose details of the number of people they serve or the program’s eligibility requirements.

These programs “exist to provide patients with access to a wide variety of medications,” researchers concluded. However, “many details about these programs remain unclear. As a result, the extent to which these programs provide a safety net to patients is poorly understood.”

Aaron Tidball, chief Medicare advisor for the Illinois consulting firm Allsup, which assists individuals and businesses in navigating the public insurance system, said Lilly Cares “has been more generous than some programs we’ve seen.”

He said that, until now, people who qualified for Lilly’s assistance were able to receive whatever specialty meds that were prescribed by their doctor without cost or co-pay.

It should be noted, though, that Lilly has structured its program so the company benefits as well. Rather than provide drugs directly to patients, as many companies do, Lilly donates its medications to a private foundation, the Lilly Cares Foundation, which in turn deals with the public.

This allows Lilly to deduct the value of its donated drugs from its taxes. According to the nonprofit foundation’s 2015 tax return, which by law must be made public, the Lilly Cares Foundation received more than $408 million worth of drugs from the company. That figure represented the “fair market value” of the meds.

“That’s obviously a lot more than the cost to produce the drugs,” observed Jeff Geida, a Los Angeles estate lawyer who specializes in nonprofit foundations and who examined the most recent Lilly Cares tax return at my request.

In other words, Lilly was able to reduce its taxable income for the year by $408 million, although the actual expense of manufacturing the donated drugs almost certainly was just a fraction of the deducted amount.

“It’s a very good deal,” Geida said.

To be sure, the company is still doing enormous good by making millions of dollars worth of drugs available to people in need. But the inflated figures highlight the lack of transparency surrounding the true cost of prescription meds.

Julie Williams, a Lilly spokeswoman, declined to answer my questions about the Lilly Cares Foundation. But she forwarded a statement from Steven Stapleton, the foundation’s president.

He said the foundation imposed the $1,100 deductible for Medicare Part D beneficiaries “after benchmarking our program with other similar programs, helping Lilly Cares to balance all the criteria for the program and to try to help as many people as possible.”

That’s just gibberish to my ear — and doesn’t address the fact that Lilly still helps itself to that whopping tax deduction while making it considerably harder for low-income people to receive assistance.

I called the foundation and spoke with a service rep, but she said she didn’t know why the deductible was put in place. Nor could she explain how it’s in the best interest of patients with limited incomes to have to spend $1,100 on drugs before being eligible to receive a needed medicine.

Stapleton said notifications were sent to program participants in the fall of 2015 and 2016, but Wright told me he couldn’t recall receiving any such notice. The office manager of his doctor’s practice said she too was caught by surprise.

Lilly Cares made the situation even more inexplicable when it sent a notice to Wright last month formally dropping him from the program. The only reason it gave was “inactivity,” which made no sense considering that he’s been using Humatrope steadily for 14 years.

Williams, the Lilly spokeswoman, said she couldn’t discuss an individual patient.

Wright told me that, after I started poking around, he received a call from a Lilly representative. She advised him to contact the Partnership for Prescription Assistance, an industry-sponsored service intended to help people find subsidy programs that can help cover the high cost of their meds.

Wright contacted four subsidy programs through the service. Each one turned him down.

Lilly says it’s balancing all the criteria for Lilly Cares, which undoubtedly will make the company more profitable.

Wright, and the many other patients in similar positions, are a secondary consideration.

From http://www.latimes.com/business/lazarus/la-fi-lazarus-prescription-drug-assistance-20170815-story.html

Cushing’s Disease Treatment Market to Witness an Outstanding Growth by 2017 – 2025

Cushing disease is caused by tumour in the pituitary gland which leads to excessive secretion of a hormone called adrenocorticotrophic (ACTH), which in turn leads to increasing levels of cortisol in the body. Cortisol is a steroid hormone released by the adrenal glands and helps the body to deal with injury or infection. Increasing levels of cortisol increases the blood sugar and can even cause diabetes mellitus. However the disease is also caused due to excess production of hypothalamus corticotropin releasing hormone (CRH) which stimulates the synthesis of cortisol by the adrenal glands.

The condition is named after Harvey Cushing, the doctor who first identified the disease in 1912. Cushing disease results in Cushing syndrome. Cushing syndrome is a group of signs and symptoms developed due to prolonged exposure to cortisol.

Signs and symptoms of Cushing syndrome includes hypertension, abdominal obesity, muscle weakness, headache, fragile skin, acne, thin arms and legs, red stretch marks on stomach, fluid retention or swelling, excess body and facial hair, weight gain, acne, buffalo hump, tiredness, fatigue, brittle bones, low back pain, moon shaped face etc.

Symptoms vary from individual to individual depending upon the disease duration, age and gender of the patient.  Disease diagnosis is done by measuring levels of cortisol in patient’s urine, saliva or blood. For confirming the diagnosis, a blood test for ACTH is performed. The first-line treatment of the disease is through surgical resection of ACTH-secreting pituitary adenoma, however disease management is also done through medications, Cushing disease treatment market comprises of the drugs designed for lowering the level of cortisol in the body. Thus patients suffering from Cushing disease are prescribed medications such as ketoconazole, mitotane, aminoglutethimide metyrapone, mifepristone, etomidate and pasireotide.

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Cushing’s disease treatment market revenue is growing with a stable growth rate, this is attributed to increasing number of pipeline drugs. Also increasing interest of pharmaceutical companies to develop Cushing disease drugs is a major factor contributing to the revenue growth of Cushing disease treatment market over the forecast period. Current and emerging players’ focuses on physician education and awareness regarding availability of different drugs for curing Cushing disease, thus increasing the referral speeds, time to diagnosis and volume of diagnosed Cushing disease individuals. Growing healthcare expenditure and increasing awareness regarding Cushing syndrome aids in the revenue growth of Cushing’s disease treatment market. Increasing number of new product launches also drives the market for Cushing’s disease Treatment devices. However availability of alternative therapies for curing Cushing syndrome is expected to hamper the growth of the Cushing’s disease treatment market over the forecast period.

The Cushing’s disease Treatment market is segment based on the product type, technology type and end user

Cushing’s disease Treatment market is segmented into following types:

By Drug Type

  • Ketoconazole
  • Mitotane
  • Aminoglutethimide
  • Metyrapone
  • Mifepristone
  • Etomidate
  • Pasireotide

By End User

  • Hospital Pharmacies
  • Retail Pharmacies
  • Drug Stores
  • Clinics
  • e-Commerce/Online Pharmacies

Cushing’s disease treatment market revenue is expected to grow at a good growth rate, over the forecast period. The market is anticipated to perform well in the near future due to increasing awareness regarding the condition. Also the market is anticipated to grow with a fastest CAGR over the forecast period, attributed to increasing investment in R&D and increasing number of new product launches which is estimated to drive the revenue growth of Cushing’s disease treatment market over the forecast period.

Depending on geographic region, the Cushing’s disease treatment market is segmented into five key regions: North America, Latin America, Europe, Asia Pacific (APAC) and Middle East & Africa (MEA).

North America is occupying the largest regional market share in the global Cushing’s disease treatment market owing to the presence of more number of market players, high awareness levels regarding Cushing syndrome. Healthcare expenditure and relatively larger number of R&D exercises pertaining to drug manufacturing and marketing activities in the region. Also Europe is expected to perform well in the near future due to increasing prevalence of the condition in the region.

Asia Pacific is expected to grow at the fastest CAGR because of increase in the number of people showing the symptoms of Cushing syndrome, thus boosting the market growth of Cushing’s disease treatment market throughout the forecast period.

Some players of Cushing’s disease Treatment market includes CORCEPT THERAPEUTICS, HRA Pharma, Strongbridge Biopharma plc, Novartis AG, etc. However there are numerous companies producing branded generics for Cushing disease. The companies in Cushing’s disease treatment market are increasingly engaged in strategic partnerships, collaborations and promotional activities to capture a greater pie of market share.

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Day 14, Cushing’s Awareness Challenge 2016

Way back when we first got married, my husband thought we might have a big family with a lot of kids.  He was from a family of 6 siblings, so that’s what he was accustomed to.  I am an only child so I wasn’t sure about having so many.

I needn’t have worried.

In January, 1974 I had a miscarriage.  I was devastated. My father revealed that my mother had also had a miscarriage.  I had no idea.

At some point after this I tried fertility drugs.  Clomid and another drug.  One or both drugs made me very angry/depressed/bitchy (one dwarf I left off the image)  Little did I know that these meds were a waste of time.

Eventually,  I did get pregnant and our wonderful son, Michael was born.  It wasn’t until he was seven that I was finally, actually diagnosed with Cushing’s.

When I had my early Cushing’s symptoms, I thought I was pregnant again but it was not to be.

I’ll never forget the fall when he was in second grade.  He was leaving for school and I said goodbye to him.  I knew I was going into NIH that day for at least 6 weeks and my future was very iffy.  The night before, I had signed my will – just in case.  He just turned and headed off with his friends…and I felt a little betrayed.

Michael wrote this paper on Cushing’s when he was in the 7th grade. From the quality of the pages, he typed this on typing paper – no computers yet!

Click on each page to enlarge.

When Michael started having headache issues in middle school, I had him tested for Cushing’s.  I had no idea yet if it could be familial but I wasn’t taking any chances.  It turned out that my father had also had some unnamed endocrine issues.  Hmmm…

I survived my time and surgery at NIH and Michael grew up to be a wonderful young man, if an only child.  🙂

After I survived kidney cancer (Day Twelve, Cushing’s Awareness Challenge 2015) Michael and I went zip-lining – a goal of mine after surviving that surgery.  This photo was taken in a treetop restaurant in Belize.

For the mathematically inclined, this is his blog.  Xor’s Hammer.  I understand none of it.  He also has a page of Math and Music, which I also don’t understand.

I know it doesn’t fit into a Cushing’s awareness post but just because I’m a very proud mama – Michael got a PhD in math from Cornell and his thesis was Using Tree Automata to Investigate Intuitionistic Propositional Logic

 

proud-mom

 

Preclinical Data for ALD1613 at ENDO 2016

Alder BioPharmaceuticals, Inc. (“Alder”) (NASDAQ:ALDR), today announced that preclinical data on ALD1613, its anti-adrenocorticotropic hormone (ACTH) antibody for the treatment of congenital adrenal hyperplasia (CAH) and Cushing’s disease, were presented today by Andrew L. Feldhaus, Ph.D., in a poster presentation at ENDO 2016, the Endocrine Society’s 98th Annual Meeting in Boston, Mass. The presentation entitled “A Novel Anti-ACTH Antibody (ALD1613) Neutralizes ACTH Activity and Reduces Glucocorticoids in Rats and Nonhuman Primates” was presented as a late-breaking abstract.

Key Points:

  • In vitro, ALD1613 inhibits ACTH-induced cortisol secretion in a mouse adrenal cell line.
  • ALD1613 administration in rats with artificially elevated ACTH and corticosterone levels resulted in a rapid and durable reduction of plasma corticosterone levels.
  • In non-human primates, ALD1613 demonstrated stable and durable reductions in plasma cortisol levels by >50%.

Quote:

Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder, said, “Existing therapeutic options for patients with congenital adrenal hyperplasia and Cushing’s disease comprise treatments that provide limited disease control and involve significant side effects. We believe these limitations indicate a clear need for new therapies such as ALD1613, which targets ACTH to diminish the overproduction of cortisol. The data presented today demonstrate the capacity of ALD1613 to reduce corticosteroid levels in preclinical settings. We intend to use these studies as part of an IND filing that we plan to submit to the FDA in the second half of 2016.”

From https://globenewswire.com/news-release/2016/04/03/825231/0/en/Alder-Presents-Preclinical-Data-for-ALD1613-at-ENDO-2016.html

Novartis Pharmaceuticals Health Policy Monthly Update : October

Presidential Candidates Release Proposals to Impact Drug Prices

Democratic candidates for President Hillary Clinton and Sen. Bernie Sanders introduced separate proposals that would impact pharmaceutical pricing and potentially inhibit innovation. The proposals include providing Medicaid-level rebates in Medicare Part D; allowing importation of drugs from other countries; reducing the exclusivity period for biologics; requiring negotiation with the federal government for Part D rebates; preventing certain patent settlements between innovator and generics companies; requiring pharmaceutical companies to invest a specific percentage of revenue in R&D; removing tax deductions for direct-to-consumer advertising; and pushing drug companies to price based on the value of treatments assessed via comparative effective analysis.
 
House Speaker Resigns, Government Shutdown Averted

John Boehner, Speaker of the House of Representatives, announced that he will resign from Congress, effective October 31. With his resignation, Speaker Boehner was able to put forth a bill to avert a partial government shutdown that would have begun October 1, 2015 if Congress had not passed legislation to provide funding to keep the government functioning. Previously, Speaker Boehner had faced threats to his leadership position if he put forward the bill, which included funding for Planned Parenthood. On September 30, legislation providing funding for the government until December 11 was passed by both the House and Senate and was signed by President Obama.
 
NCQA Releases Health Plan Ratings

The National Committee for Quality Assurance (NCQA) released a new health plan rating system, using a 1.0 to 5.0 scale with 5.0 indicating higher performance. This new rating system replaces their previous health plan ranking system. Evaluating more than 1,000 plans, including commercial, Medicaid, and Medicare Part D plans, the new rating system assesses three major performance categories, consumer satisfaction, prevention, and treatment and it provides a simple way for consumers to gauge the quality of care being provided by a health plan. The new plan rating system shows that Maine, Massachusetts, New Hampshire, New York, Pennsylvania, Rhode Island, Vermont, Michigan, Minnesota, and Wisconsin had the highest percentage of plans receiving a 4.5 or 5.0 rating.

 
CMS Announces Medicare Advantage Value-Based Insurance Design

On September 1, 2015, the Centers for Medicare & Medicaid Services (CMS) announced the Medicare Advantage Value-Based Insurance Design (VBID) Model, which will test the hypothesis that giving Medicare Advantage plans flexibility to offer targeted extra supplemental benefits or reduced cost sharing to enrollees who have specified chronic conditions can lead to higher quality and more cost-efficient care. The VBID Model will begin January 1, 2017 and run for five years. CMS will test the model in seven states: Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania, and Tennessee. Upon approval from CMS, eligible Medicare Advantage plans in these states can offer varied plan benefit design for enrollees who fall into the following clinical categories: diabetes, congestive heart failure, chronic obstructive pulmonary disease (COPD), past stroke, hypertension, coronary artery disease, and mood disorders.
 
Medicare Advantage and Part D Markets Largely Stable from 2015-2016

On September 21, 2015, CMS announced that premiums for Medicare Advantage (MA) plans will remain stable in 2016. CMS estimates that the average MA premium will decrease by $0.31 next year, from $32.91 on average in 2015 to $32.60 in 2016. Enrollment in MA is projected to increase to approximately 17.4 million enrollees, which represents about 32 percent of the Medicare population. Earlier this year, CMS announced that the average basic Medicare prescription drug plan premium in 2016 is projected to remain stable at $32.50 per month. The Annual Election Period for Medicare health and drug plans begins on October 15, 2015 and ends December 7, 2015.
 
CMS Announces the Enhanced Medication Therapy Management Model

On September 28, 2015, the Center for Medicare and Medicaid Innovation (CMMI) announced a five-year model to test approaches to improve Medicare Part D beneficiary medication use. The Part D Enhanced Medication Therapy Management (MTM) Model will test whether changes to the Part D program can help to better align the interests of plan sponsors with those of the federal government. Eligible basic stand-alone prescription drug plans (PDPs), upon approval from CMS, can vary the intensity and types of MTM items and services based on beneficiary risk level and seek out a range of strategies to individualize beneficiary and prescriber outreach and engagement. An initial five-year performance period will begin January 1, 2017 in five Part D regions spanning 11 states: Region 7 (Virginia), Region 11 (Florida), Region 21 (Louisiana), Region 25 (Iowa, Minnesota, Montana, Nebraska, North Dakota, South Dakota, Wyoming), and Region 28 (Arizona).

 
HHS Releases Latest Exchange Enrollment Numbers

The U.S. Department of Health and Human Services (HHS) has released their latest enrollment numbers for both the federal and state exchanges. As is to be expected, actual enrollment is down slightly from the March report. Almost 9.9 million people had paid their first month’s premium as of June 30, slightly above the projected enrollment of 9.1 million people. Of those paying their premiums, 84%, or 8.3 million, received premium tax credits and 5.5 million people also received cost sharing subsidies. Premium tax credits averaged $270 a month. Approximately 423,000 people had their 2015 coverage terminated for failure to provide the necessary documentation of citizenship or legal immigrant status. More than 6.7 million people enrolled in a silver tiered plan, 2.1 million enrolled in bronze or catastrophic, almost 700,000 selected a gold tier and 332,000 picked platinum. In early September, CMS reported that Medicaid and CHIP enrollment had reached 72 million. The increase in both public and private insurance programs has dropped the national uninsured rate to below 10%.

 
HHS Issues Proposed Rule Regarding ACA’s Non-discrimination Provisions

HHS issued a draft rule providing clarity to the Affordable Care Act’s prohibition on discrimination in insurance coverage on the basis of race, color, age, national origin, sex, and disability. The proposed rule covers consumers’ rights under the ACA, obligations of covered entities, the inclusion of gender identify discrimination as a form of sex discrimination, requirements for effective communication to those with disabilities, and language assistance for those with limited English proficiency. Discriminatory practices in benefit plan design, marketing and cost sharing are prohibited. The proposed regulations apply to health insurers participating in the federal and state-based exchanges, Medicare Advantage and Medicaid programs. These protections are extended to all individual and group products sold by a participating insurer. As drafted, the proposed regulations are a step forward in eliminating discriminatory practices that prevent patients with chronic conditions from accessing necessary medication but opportunities for more specific language in the final regulations remain.

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