[Ip-health] WH 2017 Budget on drug pricing; other pharmaceutical issues relevant to the list

Steven Knievel sknievel at citizen.org
Tue Feb 9 08:49:41 PST 2016


I performed a brief review of the White House budget released today and pulled out certain snips I thought were important to those participating in this listserv. 

My apologies if I left out anything significant. I have not read the whole thing yet, and only pulled out things I caught that I found particularly relevant for those on this list. If I've made any glaring omissions, please let me know.

All the best,

Page 62 on Part D negotiation:

"In order to decrease waste, fraud, and abuse and strengthen program integrity in the Medicare prescription drug program, the Budget also provides the Secretary the authority to suspend coverage and payment for questionable Part D prescriptions and establishes a program to reduce prescription drug abuse in Medicare."

Pages 64-65 on HIV & HCV services:

"Strengthening HIV and Hepatitis C Services. The Budget expands access to HIV prevention and treatment activities for millions of Americans through the continued implementation of the updated National HIV/AIDS Strategy, with a focus on three key elements of the Strategy. First, the updated Strategy calls for providing more people with highly effective prevention services such as pre-exposure prophylaxis (PrEP) to reduce new HIV infections. PrEP has been shown to reduce the risk of HIV infection by up to 92 percent in people who are at high risk. The Budget also includes $20 million for a new innovative pilot program to increase access to PrEP and allow grantees to use a portion of funds to purchase treatment and other health care services as the payer of last resort. Second, the Strategy calls for improved screening for Hepatitis C, which disproportionally affects Americans living with HIV. The Budget includes funding for a new initiative to increase screening and expands access to Hepatitis C care and treatment among people living with HIV. Third, the Strategy calls for prioritizing HIV/AIDS resources within high-burden communities and among high-risk groups, including gay and bisexual men, Blacks/African Americans, and Latino Americans, which is reflected throughout the Budget."

Page 65 on antibiotic resistance: 

"Combating Antibiotic Resistant Bacteria (CARB). The Budget includes $1.1 billion across the Federal Government to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria and to support research on innovative ways to reduce or manage resistance. These resources would also help support the advancement of rapid diagnostics and new types of therapies for the treatment of bacterial infections, including managing the patient's microbiome and targeting bacterial virulence factors, as outlined in the CARB National Strategy and National Action Plan. The Budget also continues to support implementation of surveillance, prevention, and stewardship activities as outlined in the Strategy and the Action Plan."

Pages 65-66 on High Cost of Drugs; other Part D & Medicaid cost-lowering measures: 

"Addressing the High Cost of Drugs 

The Administration is deeply concerned about rapidly growing prescription drug prices, driven in part by the shift to specialty therapeutics, the slowdown in patent expirations, and challenges in measuring drug value. To address this issue, the Budget includes a package of proposals focused on Medicare, Medicaid, and drug price transparency.

"Improving Quality and Lowering Drug Costs for the Medicare Program. The Budget includes proposals to lower drug costs while improving transparency and evidence development in the Medicare Part D program. The Budget proposes to increase data collection to demonstrate the effectiveness of medications in the Part D program in the Medicare population and to inform real world clinical treatment. The Budget continues to provide the Secretary of HHS the authority to negotiate drug prices for biologics and high-cost drugs in Medicare Part D and includes a new proposal to incentivize Part D plan sponsors to better manage care provided to beneficiaries with high prescription drug costs. 

To help ensure access and affordability of treatments, the Budget proposes to accelerate discounts for brand name drugs for seniors who fall into Medicare's coverage gap by increasing manufacturer rebates from 50 percent to 75 percent in 2018. In addition, the Budget proposes to require drug manufacturers to provide rebates generally consistent with Medicaid rebate levels for drugs provided to low-income Part D beneficiaries. Together, these proposals would save Medicare approximately $140 billion over 10 years.

Lowering Medicaid Drug Costs for States and the Federal Government. The Budget includes targeted policies to lower drug costs in Medicaid. It provides States with a new, voluntary tool to negotiate lower drug prices through the creation of a Federal-State Medicaid negotiating pool for high-cost drugs. In addition, the Budget continues to support and build on
previously proposed reforms to the Medicaid drug rebate program. These reforms enhance manufacturer compliance with rebate requirements, and improve access to medications. In addition, the Budget corrects and improves the ACA Medicaid rebate formula for new drug formulations, such as by exempting abuse deterrent formulations. These proposals are projected to save the Federal Government approximately $11.4 billion over 10 years.

Increasing Transparency of Prescription Drug Pricing and Ensuring Access to Generic Medications. The Budget proposes to provide the Secretary of HHS with the authority to require drug manufacturers to publicly disclose certain information, including research and development costs, discounts, and other data as determined through regulation. It also includes three previously proposed reforms designed to increase access to generic drugs and biologics by stopping companies from entering into anti-competitive deals intended to block consumer access to safe and effective generics, by awarding brand biologic manufacturers seven years of exclusivity, rather than 12 years under current law, and by prohibiting additional periods of exclusivity for brand biologics due to minor changes in product formulations. These proposals would save the Federal Government $21 billion over 10 years."

On pages 133-137 of the budget (pdf pages 141-145), line items of savings from these proposals, among others involving prescription drug reforms, are included - rather than typing them all out here check it out and tilt your head 90 degrees counterclockwise (or print it): https://www.whitehouse.gov/sites/default/files/omb/budget/fy2017/assets/budget.pdf 

Steven Knievel
Campaign Coordinator | Global Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7769
1600 20th St. NW, Washington, DC 20009
URL: http://www.citizen.org/access  
Twitter: @PCMedsAccess

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