The Challenges of Complying With the 340B Drug Pricing Program

At Covance, we know that you, the pharmaceutical manufacturer, must deal with an increasingly complex marketplace. One of the current challenges is the 340B Drug Pricing Program (340B). In this article, we briefly review 340B and then discuss three aspects that affect you:

  • The major challenges you face under this program
  • Strategic recommendations for dealing with these challenges
  • Important criteria to consider when selecting a partner to assist you with the 340B program

The 340B Drug Pricing Program

What is 340B?
The 340B program is a drug-pricing plan administered by the Health Resources & Services Administration (HRSA), a division of the Department of Health and Human Services (HHS). Eligible drugs include FDA-approved drugs, OTC written on a prescription, biological products that can be dispensed only by a prescription (excluding vaccines), and FDA-approved insulin. Continue reading

Reducing the Variability in Multiple Myeloma Testing

IFE-PEP-2_blogMultiple myeloma is a blood cancer that typically affects those aged 70 years and older. Although considered an uncommon disease, the American Cancer Society estimates that 24,050 new cases will be diagnosed in the United States this year. Global studies show a worldwide incidence of 86,000 cases per year.

The high five-year patient survival rate makes this type of cancer an ideal target for research and treatment studies. Pharmaceutical companies have also embraced the search for treatment of multiple myeloma, since the availability of a successful therapy would enable patients to live significantly improved and productive lives. Continue reading

Health Insurance Exchange Enrollment Nearing Deadline, What’s Next?

HealthCareSignupDeadlineThe deadline to purchase insurance through the state and federal exchanges is March 31, 2014, which is less than two weeks away. From the start of open enrollment on October 1, 2013, to the end of February 2014, an estimated 4.2 million individuals have signed up for insurance through an exchange, while more than 4.4 million have signed up for Medicaid and the Children’s Health Insurance Program (CHIP). People who are not exempt from the individual mandate and fail to sign up by the deadline may face a penalty of $95 per adult and $47.50 per child up to a maximum of $285 per family or 1.0% of family income, whichever is greater. Despite the millions who have enrolled in an exchange or Medicaid, many people will remain uninsured. Many low-income people, some of whom would qualify for premium subsidies and cost-sharing assistance, have never held an insurance policy. They do not understand the concept of copayments, deductibles, and monthly premiums. In fact, many have chosen to forego enrollment this go-around. Continue reading

How Will 340B Changes Affect You?

Under the Health and Human Services (HHS) 340B Drug Pricing Program, drug manufacturers who participate in the Medicaid Drug Rebate program must also provide covered outpatient drugs to eligible Covered Entities (CE) at considerably reduced prices. Manufacturers face several challenges when participating in the 340B program.

Covered Entities

pills_money_340BFirst, manufacturers need accurate accounting from Covered Entities (CE) for refund payments. Health Resources and Services Administration (HRSA) has increased scrutiny around the program and conducted targeted audits. CEs are performing internal audits to better understand any non-compliance, taking steps to “self disclose’ non-compliance activity, and proactively sending manufacturers refund payments. However, the supporting data provided by the CE may lack adequate information for manufacturers to accurately account and apply the refund payment. It is also possible that government pricing restatements will be required. Continue reading

The Integrated Role of the Project Pathologist

The Integrated Role of the Project Pathologist

When you think of a pathologist, you may picture a scientist peering through a microscope, viewing slides and making notes about a disease state, then moving on to the next sample. Indeed, the classic role of many contract pathologists is to evaluate large numbers of tissue slides and author pathology reports. However at Covance, the Lead Optimization Pathology group plays a much greater role in drug development.

The Lead Optimization Pathology group offers Project Pathologists—a staff pathologist with therapeutic area expertise who is assigned to a project and intimately involved in supporting the early drug development in both efficacy and non-GLP toxicity studies. As ACVP board certified veterinary pathologists with Ph.D. degrees and past experience working in large pharmaceutical companies, the staff can offer in-depth pathology support for both small and big clients. Continue reading

Examining Tau Phosphorylation as a Potential Alzheimer’s Disease Biomarker

tauWe are always on the lookout to apply the latest research to our work and contribute additional findings to the scientific community. This month we will present a poster studying the regulation of Tau phosphorylation at the upcoming 2013 Society for Neuroscience conference in San Diego.

The interest in this research was first sparked at last year’s 2012 Alzheimer’s Association International conference in Vancouver, Canada, where we heard discussions on the effects of anesthesia on Alzheimer’s disease (AD) patients. Continue reading

The Individual Health Care Mandate of the Affordable Care Act: To Be or Not To Be?

ACA_forblogDebates are gripping Capitol Hill regarding the individual mandate of the Affordable Care Act (ACA). The mandate requires individuals to sign up for private insurance or Medicaid by March 31, 2014 or face a penalty of $95 per adult and $47.50 per child up to a maximum of $285 per family or 1.0% of family income, whichever is greater. Continue reading

The Role of the CRO in Frontloading Cardiovascular Safety

The Role of the CRO in Frontloading Cardiovascular SafetyCardiovascular safety remains a leading cause of drug attrition during preclinical and clinical development, accounting for discontinuation of approximately one third of marketed drugs.

These liabilities, which pertain to both cardiovascular- and non-cardiovascular-targeted drugs, can be identified during early development by addressing cardiovascular safety endpoints prior to the selection of a drug candidate, a process known as ‘frontloading’. Although not mandated by the key regulatory guidance for safety pharmacology (ICH S7A; US FDA, 2001), an increasing number of companies choose to conduct early non-GLP cardiovascular safety studies in support of decisions on the progression of their compounds. Continue reading

Optimize the Patient Journey

Connect with your patient at every stage of their journey

Covance Patient and Provider Services understands the patient journey and provider needs. We bring you industry-leading consultative insight to help you maximize your product value as patients navigate their treatment journey. We keep patients connected to your product at every stage along the way.

Navigating the patient journey successfully takes a team effort

Patient Journey

Learn more about Patient & Provider services.

A Biotech’s Path to Achieving your Molecule’s Full Potential at Proof of Concept (PoC)

POCcompleteViewGraphicThroughout my career at Aventis, Hoffmann-La Roche and Alcon (a Novartis company), we focused on the proof of concept (PoC) as the critical milestone when considering when to partner with or purchase a compound from a small biotech.

Your potential pharma partner is looking for answers to key development questions surrounding the mechanism of action and your compound, how your company has addressed those, the robustness of the results and the quality of the data. This drives their evaluation of the real stage of development and the valuation. Continue reading