Communications During Drug Development
Helping physicians and patients get access to new drugs and medical devices requires more than showing that a product works. In this article, we focus on the hurdles that the biopharmaceutical industry faces. Similar challenges face the medical device industry; however, as they say, the devil is in the details.
Typically, the first hurdles facing the biopharmaceutical industry are demonstrating that the product is safe and effective and that it can be consistently and reliably manufactured. However, a successful product launch also requires surmounting the hurdles of reimbursement and commercialization. Continue reading
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
The 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
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 First, 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
Debates 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
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
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Are your infrastructure, staff and processes up to the task of tracking today’s managed market contracts, chargebacks and rebates, and complying with government regulations?
Protect your revenue
Changes in managed markets are imposing the development of even more complex contracts with distributors, pharmacy benefits managers (PBMs), third-party payers and government agencies. Add to that the cost pressures that reduce available resources, and the required new investment in technology to track it, you’re facing a harder time achieving goals and staying profitable.
Learn more about protecting your revenue.
Pharmaceutical manufacturers are operating in a highly competitive, complex and regulated market where the effective management of contracts, pricing, and rebates is vital to the overall health of their business. Without the right contracting infrastructure and processes in place, companies risk losing visibility and control over the contract lifecycle management, which can ultimately lead to revenue loss and non-compliance with government regulations.
Currently, the economic environment is challenging pharmaceutical manufacturers to grow amidst the reality of budget cuts and staff reductions. As contract scenarios become more complex, and companies lack the resources they once had, greater visibility into contract performance is even more critical. Administrative costs for pharmaceutical manufacturers are also increasing. A study conducted in 2012 by Deloitte confirmed that the cost for managing chargebacks and the rebate process is targeted to increase approximately 54% over the next five years. Continue reading
All biopharmaceutical companies have at least three hurdles to leap before a new product can launch: safety, efficacy, and quality. Small biopharmas have an additional hurdle, however: market access (sometimes referred to as access and reimbursement). The goal of small biopharmas, where much of the drug discovery and development is now being done, is to sell or license the drug or company at the highest possible price. To accomplish this, you must develop the capability to bound right over that fourth hurdle of market access.
As a small biopharma, you should begin developing a strong market access strategy at the end of your Phase I clinical trials. The difference in how this is done can determine whether your product will launch successfully or fail miserably. Adopting a good strategy early can also significantly affect the selling price for the company or product. While safety, efficacy, and quality are critical to a product’s success, so is the integration of market access into all strategic planning. Continue reading