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.

Pituitary ACTH Hypersecretion (Cushing’s Disease)

Browse Complete Report with TOC:

http://www.reportbazzar.com/product/pituitary-acth-hypersecretion-cushings-disease-pipeline-review-h1-2015/

Summary

This report provides comprehensive information on the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and special features on late-stage and discontinued projects.

Report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Request Sample Report:  Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H1 2015

Scope

– The report provides a snapshot of the global therapeutic landscape of Pituitary ACTH Hypersecretion (Cushing’s Disease)

– The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

– The report reviews key players involved in the therapeutics development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and enlists all their major and minor projects

– The report summarizes all the dormant and discontinued pipeline projects

– A review of the Pituitary ACTH Hypersecretion (Cushing’s Disease) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

– Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

– A detailed assessment of monotherapy and combination therapy pipeline projects

– Coverage of the Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline on the basis of target, MoA, route of administration and molecule type

– Latest news and deals relating related to pipeline products

Reasons to buy

– Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

– Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

– Develop strategic initiatives by understanding the focus areas of leading companies

– Identify and understand important and diverse types of therapeutics under development for Pituitary ACTH Hypersecretion (Cushing’s Disease)

– Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

– Devise corrective measures for pipeline projects by understanding Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline depth and focus of Indication therapeutics

– Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

– Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline”

 

 

From http://www.medgadget.com/2015/10/pituitary-acth-hypersecretion-cushings-disease-pipeline-review-h1-2015-by-reportbazzar.html

Endocrine Society Releases Guidelines on Treatment of Cushing’s Syndrome

To lessen the risk for comorbidity and death, the Endocrine Society’s newly published guidelines on the treatment of Cushing’s syndrome focus on surgical resection of the causal tumor with the goal of normalizing cortisol levels. Furthermore, there is increased emphasis on individualizing treatment options when choosing a second-line treatment.

In July 2015, the Endocrine Society published treatment guidelines to assist endocrinologists in appropriately initiating treatment or referring patients with Cushing’s syndrome to treatment. A task force of experts compiled evidence from systematic reviews and graded the strength of the recommendations.

“We hope that it will lead to improved treatment of comorbidities both before and after definitive treatment of the syndrome, and to increased individualization of patient treatment,” said chair of the task force Lynnette Nieman, MD, who is chief of the Endocrinology Consultation Service at the National Institutes of Health Clinical Center.

“There are two new drugs that were approved in 2012, and so I think that is what prompted the review. Still, medications are not the first line of treatment, but we have some new therapeutic options, and I think the idea was to help people understand where to use them,” Julie Sharpless, MD, assistant professor and director of the UNC Multidisciplinary Pituitary Adenoma Program, told Endocrinology Advisor.

“The primary treatment is surgical resection of the causal tumor(s). If that cannot be done (because the tumor is occult or metastatic) or is not successful, then the choice of secondary treatment should be individualized to the patient. The comorbidities of Cushing’s syndrome, for example hypertension and diabetes, should be treated separately as well,” Nieman said.

For example, the guidelines recommend surgical removal of the causative lesion, with the exception of cases which are unlikely to cause a drop in glucocorticoids or in patients who are not surgical candidates.

Likewise, in patients with benign unilateral adrenal adenoma, adrenalectomy by an experienced surgeon has a high rate of cure in children and adults. Because of the poor prognosis associated with adrenal carcinoma, the guidelines highlight the need for complete resection and possibly medical treatment to stabilize cortisol levels.

Other first-line treatment options include recommending surgical resection of ectopic ACTH-secreting tumors; referring to an experienced pituitary surgeon for transsphenoidal selective adenomectomy; treatments to block hormone receptors in bilateral micronodular adrenal hyperplasia; and surgical removal in bilateral adrenal disorders.

The elevated mortality rate seen in patients with Cushing’s syndrome is due to infection, venous thrombosis and cardiovascular disease (CVD). Appropriately lowering cortisol levels improves hypertension, insulin resistance, dyslipidemia and obesity in patients with Cushing’s syndrome. Therefore, the guidelines highlight the need for restoring cortisol levels and treating the associated comorbidities.

Nevertheless, the task force specifically recommends against treatment without an established diagnosis or when there are no signs of Cushing’s syndrome and hypothalamic-pituitary-adrenal laboratory studies are borderline.

In patients who are not surgical candidates or in cases of noncurative resection, the decision on whether to consider second-line treatment options such as medical therapy, radiation, bilateral adrenalectomy or repeat transsphenoidal surgery should be based on several factors. For instance, the guidelines recommend taking into consideration location and size of the tumor, patient desires, goals of treatment and level of biochemical control.

The guidelines note medical therapy should be based on cost, efficacy and individualization of treatment. Endocrinologists can approach medical therapy with a goal of establishing normal cortisol levels or reducing cortisol levels to very low levels and replacing to achieve desired levels.

Remission in Cushing’s syndrome is associated with notable improvement; however, long-term follow-up is recommended for osteoporosis, CVD and psychiatric conditions.

After treatment, patients may experience reductions in weight, blood pressure, lipids and glucose levels that may allow reduction or discontinuation of medications. Even so, patients with a history of Cushing’s syndrome tend to have higher rates of hypertension, hyperlipidemia and diabetes. Likewise, rates of myocardial infarction are higher in this population, further emphasizing the need for treatment and management of diabetes and hypertension.

Sharpless highlighted that Cushing’s syndrome is rare.

“There are multiple studies that have shown that patients do better when they are treated in a specialty center where people see a lot of cases of this. So in that sense, treatment is not usually going to fall to the general practitioner,” she said.

She continued that the guidelines are helpful and provide guidance to endocrinologist who “can’t readily refer their patient to a pituitary center.”

Sharpless went on to describe the multidisciplinary care involved in Cushing’s syndrome including endocrinologists, neurosurgeons, radiologists, counselors and radiation oncologist.

“When the care is complicated, you want to ensure all of your providers have reviewed your case together and figured out the best plan.”

The guidelines were co-sponsored by the European Society of Endocrinology. Nieman received salary support for her work on the manuscript from the Intramural Research Program of the Eunice Kennedy Shiver Institute of Child Health and Human Development. Members of the task force reported multiple disclosures.

Reference

  1. Nieman LK et al. J Clin Endocrinol Metab. 2015;100(8):2807-2831.

From http://www.endocrinologyadvisor.com/adrenal/cushings-syndrome-endocrine-society-guidelines/article/434307/

Day Fifteen, Cushing’s Awareness Challenge 2015

Way back when we first got married, my husband thought we might have a lot of kids.  He was from a family of 6 siblings, so that’s what he was accustomed to.  I am on 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 my 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 good bye 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 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.

Global Pituitary ACTH Hypersecretion (Cushing’s Disease) Therapeutics Pipeline Review 2014

DUBLIN–(BUSINESS WIRE)–Research and Markets (http://www.researchandmarkets.com/research/zp4qhh/pituitary_acth) has announced the addition of the “Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H1 2014” report to their offering.

“Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H1 2014”

This report provides comprehensive information on the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and special features on late-stage and discontinued projects.

The report enhances decision making capabilities and help to create effective counter-strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Scope

  • The report provides a snapshot of the global therapeutic landscape of Pituitary ACTH Hypersecretion (Cushing’s Disease)
  • The report reviews key pipeline products under drug profile section which includes product description, MoA and R&D brief, licensing and collaboration details & other developmental activities
  • The report reviews key players involved in the therapeutics development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and enlists all their major and minor projects
  • The report summarizes all the dormant and discontinued pipeline projects
  • A review of the Pituitary ACTH Hypersecretion (Cushing’s Disease) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources
  • Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages
  • A detailed assessment of monotherapy and combination therapy pipeline projects
  • Coverage of the Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline on the basis of target, MoA, route of administration and molecule type
  • Latest news and deals relating related to pipeline products

Companies Involved in Therapeutics Development

  • Isis Pharmaceuticals, Inc.
  • Ipsen S.A.
  • Novartis AG
  • Corcept Therapeutics Incorporated
  • HRA Pharma, SA
  • Cortendo Invest AB
  • Orphagen Pharmaceuticals, Inc.
  • ElexoPharm GmbH

Drug Profiles

  • mifepristone
  • ketoconazole
  • pasireotide LAR
  • LCI-699
  • DG-3173
  • ISIS-GCCRRx
  • Next Generation Cortisol Inhibitor
  • Small Molecule to Inhibit CYP11B1 for Cushing Disease
  • Peptides to Antagonize ACTH Receptor for Cushing Syndrome
  • Steroidogenic Factor-1 Antagonists
  • Drug to Inhibit Melanocortin Receptor 2 for Cushing Disease

For more information visit http://www.researchandmarkets.com/research/zp4qhh/pituitary_acth

Contacts

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceuticals

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