NCSL Prescription Drug Policy Resource Center

9/2/2019

Cost and Pricing

Prescription drugs account for 10 percent of overall health spending in the U.S. National trends in prescription drug expenditures and projections published for 2017 summarizes "total U.S. prescription sales for the 2016 calendar year at $448.2 billion, a 5.8 percent increase" compared with 2015. Prescription expenditures in clinics totaled nearly $64 billion, a 12 percent increase from 2015. Hospital drug spending was almost $35 billion, up 3 percent from 2015. [Finance details online]

State and federal governments have focused on successfully managing these costs through a variety of approaches. These include widespread use of increased manufacturer rebates, use of preferred drug lists, prior authorization, state-initiated bulk purchasing and large retailers’ competition to offer $4-$10 prescriptions for many widely used drugs. States are changing the way they calculate their Medicaid prices and also addressing industry and consumer price transparency and provider education.

In May 2018, the Trump administration announced a Blueprint to Lower Prices and Reduce Out-of-Pocket Costs, including more than 25 elements labeled "Improved competition; Better Negotiation; Incentives for Lower List Prices and Lower out-of-pocket Costs." | Read: Fact Sheet | Blueprint Report, 41 pp. The Blueprint strongly favors value-based pricing, saying “[v]alue-based transformation of our entire healthcare system is a top HHS priority.” Value-based pricing is a popular idea, and one that requires reconciling with the best price aspect of the MDRP. | Adopted from KFF brief, 5/30/2018.

Resources from NCSL

Prohibiting PBM “Gag Clauses” that Restrict Pharmacists from Disclosing Price Options: Recent State Legislation 2016-2018.  

Read full PBM overview full report in Web format - Nov. update - or archive [PDF,18 pp.] showing 31 enacted "gag clause" state laws (between 2004-2018) and at least 41 states that have engaged in legislation. Published by NCSL, updated October 2018. 

State Legislation on "Essential Generic Drugs" and Anti-Price Gouging.

Last May, Maryland became the first state to enact a law protecting consumers who rely on essential generic drugs. The state law (See MD H 631 of 2017) prohibits a manufacturer or wholesale distributor from engaging in price gouging in the sale of an essential off-patent or generic drug, establishes that it is not a violation of a provision of the act for a wholesale distributor to increase a price of an essential off-patent or generic drug under certain circumstances, and requires the manufacturer of an essential off-patent or generic drug to submit financial material to the attorney general, with potential legal action for violations. However the Maryland law was struck down by a federal appeals court on April 13, 2018 in a decision that found that the law violated the Constitution’s “dormant commerce clause” because it would have regulated sales outside of the state. According to in-state sources, "The Maryland price gouging bill has been appealed to the Supreme Court. Justice Gorsuch wrote an appeal which would suggest he is in favor of allowing states to set rates."

NCSL's Anti-Price Gouging online updated analysis (July 2018) describes that other states have expressed interest in a state law similar to Maryland’s, that could block or restrict generic drug price gouging. There were similar bills filed in at least 16 other states – Colorado, Illinois, Louisiana, Massachusetts, Minnesota, New Jersey, New York, Rhode Island, Tennessee (study & report only), Vermont, Virginia and Wisconsin." See related news articles:

  • Federal Appeals Court Puts Chill On Maryland Law To Fight Drug Price-Gouging. NCSL cited. Kaiser Health News, 4/17/2018: "A negative court ruling will put a damper or a pause on state activities," says Richard Cauchi, NCSL's health program director. "Unless this topic is your number one priority of the year, your legislators are juggling multiple bills, multiple strategies. When bill three gets in trouble, they move to bill four.".
  • "Federal Appeals Court Finds State's Drug Price-Gouging Law Unconstitutional": NCSL is cited. Read article in Health News From NPR.

Rx_anti_Price_Gouging State Legislation-17 states-2018

  • Prescription Drug Affordability Board Legislation to Become Law series - Publised by the Maryland Citizens' Health initiative. Ongoing. Maryland legislation to create the nation’s first Prescription Drug Affordability Board will become law, giving the state a tool to establish maximum costs for certain drugs purchased by state and local governments. Governor Larry Hogan announced today he would neither veto nor sign the measure, which means it will go into effect July 1stThis new Prescription Drug Affordability Board will have the authority to establish costs for some of the most expensive medications that state and local governments purchase for their employees and programs. View the article series here.
  • State Legislation affecting pharmaceutical importation to achieve consumer cost savings

United States map of 2019 State Legislation for Prescription Drug Importation

  • Prescription Drugs - An NCSL  State Legislative Update- Resources from an April 2018 Seminar
    Prescriptions drugs provide life-saving treatments and help control diseases and debilitating conditions. They also present legislators with challenges, including affording some of the new “miracle drugs” for Medicaid patients and state employees. This session highlighted a range of 2018 prescription drug issues.
    Speakers: Dick Cauchi, Health program director, NCSL; Steve Fitton, Michigan Medicaid & principal, Health Management Associates; Kipp Snider, vice president, State Advocacy, PhRMA  - Download or view slides | Powerpoint Presentation | PDF file-27 pages

  • "Costly Cures:" Hep C Sets the Bar | Effective but very expensive drugs are forcing state Medicaid to make tough decisions. NCSL State Legislatures Magazine, Feb. 2017.
  • Pharmaceuticals: Facts, Policies and NCSL Resources | View full resource report | Extended list of NCSL-related publications and events, 2008-2018
  • Archive onlyState Legislation Related to Cost and Price Transparency for Prescription Drugs, 2015-16
  • "Increases in Drug Spending Slow" | Top trends article in NCSL State Legislatures Magazine, April 2017.
  • Bulk Purchasing of Prescription Drugs - NCSL | Research shows there were five operating multi-state bulk buying pools, plus additional variations and single state-initiatives.
  • Recent Medicaid Prescription Drug Laws and Strategies |  View full report  | NCSL
  • Mapping and Tracking Prescription Drugs- by NCSL, 2016 | PDF |
  • Resources for Prescription Drugs and Cost Containment |  View full report Part of the NCSL's Health Cost Containment and Efficiencies series, updated 2017.
    • Use of Generic Prescription Drugs and Brand-Name Discounts | PDF File | Initially published by NCSL, June 2010
    • Prescription Drug Agreements and Volume Purchasing (Preferred Drug Lists, Rebates, Multi-state Purchasing and Effectiveness Review of Medicine) |  PDF File | Published by NCSL, June 2010.

Map of Medicaid State Supplemental Rebates -2017

Expert and Stakeholder Reports and Views

  • Major Events in the Life Course of New Drugs, 2000–2016 by Reed F. Beall, Ph.D., Thomas J. Hwang, A.B., and Aaron S. Kesselheim, M.D., J.D., M.P.H. published March 14, 2019. This interactive graphic allows viewers to explore data — gathered by Reed F. Beall, Thomas J. Hwang, and Aaron S. Kesselheim — on the time required for investigational drugs to reach important U.S. milestones, such as new drug applications, FDA approval, expiration of market exclusivity, and market entry of a generic version. Data may be viewed by individual drug, therapeutic class, approval pathway, and approval year, as well as in aggregate.

  • Getting to Lower Prescription Drug Prices in The United States: How Do Other Countries Do It?Teleconference online sponsored by the Commonwealth Fund with information distributed by NCSL, 9/21/2018

 1. Value-based Rx Purchasing -December 2017 two live Health Sessions at NCSL Capitol Forum with presenter slides and handouts,

 2. Drug Effectiveness and SMART-D Alternative Payments for Medicaid: Innovative drugs are being introduced at an accelerating pace. At the same time, the high prices of the new therapies pose a challenge for all healthcare payers’ budgets, especially state Medicaid programs. Explore alternative payment models for drug purchasing in Medicaid.

 3. NCSL Value-Based-Rx Intro - Slide overview by Richard Cauchi  |  Value-Based-Rx-Purchasing -NCSL blog Nov. 9. 2017

  •  "Prescription Drugs and Costs" Aug. 2016—NCSL live session at Legislative Summit, Chicago: Breakthrough products such as biologics and specialty drugs promise extended lives or first-ever cures for individuals. Yet some price tags in this $310 billion U.S. market have shocked those who foot the bill – including state governments, Medicaid, employers, health insurers and patients themselves. States are considering a variety of legislation to rein in costs, assist consumers or shift the burden. Terms such as "medically necessary," "medication adherence," "fail first," "preferred drug lists," "value-based purchasing" and "interchangeable biosimilar substitution" make state capitals sound like pharmacies. Hear state and medical experts sort out the headlines, the noise and the results so far. Download speaker and session resources:
  • Prescription-Session-Resources | August 2016 | PDF |
  • Chuck Shih, Pew Charitable Trusts: Perspectives on Pharmaceutical Costs in the U.S.; slides | Specialty Drugs Report | 2016
  • Richard Ascroft of Takeda, for PhRMA: Slides-NCSL Aug-9-2016 | PhRMA: Five Fact Flyers | PDF |
  • Steve Fitton, former Michigan Medicaid director; principal at HMA: Medicaid Rx slides 8-9-2016 
  • Lower Drug Costs: The Next Frontier for State Flexibility. Published in Health Affairs blog, Feb. 16, 2018. This article describes how the federal government can help states address rising Medicaid prescription drug costs. The blog describes options for CMS from a recent Commonwealth Fund sponsored NASHP forum on this topic.
    View related discourse paper (6 pp, PDF) How the Federal Government Can Help States Address Rising Prescription Drug Costs. February 2018
  • 10 Most Expensive Drugs in the U.S. Retail Market- View list with a price update option; posted by Good Rx. Added Sept. 2018
  • "Drugs Don’t Work If People Can’t Afford Them: The High Price Of Tisagenlecleucel"  | View full article | by Health Affairs blog, Feb. 8, 2018
  • Curbing Unfair Drug Prices: A Primer for States | View full report | PDF - published by Global Health Justice Partnership, Yale University, Aug. 2017.
  • Details

2015-2019 Prescription Drug Legislation Database

NCSL sponsors this state legislation online database, tracking major policies affecting prescription drugs and biologic medicines. The new feature allows policymakers to view more than 5,600 filed bills and resolutions. This resource also highlights more than 880 signed laws and resolutions since it was launched, according to specific topics such pharmaceutical patient access and affordability, specialty pharmaceuticals, compounding pharmacy regulation, Medicaid and health insurance coverage and reimbursement, and the right-to-try investigational drugs for the terminally ill. This first-in-the-nation state resource is available to all NCSL members and the interested public, providing search by state, bill status, and topics, using simple check boxes, plus full text access. Latest tally: 130 Enacted laws for 2019.
Updated weekly

View the Database

Benefits and Coverage + Medicaid

In recent years, coverage of and access to many pharmaceuticals has expanded significantly.  The Affordable Care Act makes prescription drugs a required Essential Health Benefit in all 50 states, but with variations of available products across states and some variation among offered plans. Medicaid pharmaceuticals provide a decades-old but significantly expanded safety-net for 70 million more people. Medicare Part D coverage, state pharmaceutical assistance programs, large retailer discounts, combined with manufacturer patient discount programs have benefitted tens of millions. 

  • Medicaid Prescription Drug Laws and Strategies  | NCSL overview and state examples, with 25 links to key resources. A top-10 popular health web page.
  • Medicare Prescription Drug Coverage (Part D): NCSL Tools for State Legislatures | NCSL overview, updated 2018.
  • State Pharmaceutical Assistance Programs: Features tables summarizing all current and recent historical state subsidy (SPAP) and discount programs, for seniors, disabled, uninsured and others. Updated periodically, 2018.  (22 pages).
  • Prescription Drugs: NCSL Overview and Update - NCSL Slides by Richard Cauchi.
  • Medication Adherence: Taking Pills Safely as Ordered  | NCSL online resource, 2016
  • Medication Therapy Management - combining Health, Safety and Savings  | NCSL Overview and state examples, updated September 2016.
  • 340B Drug Pricing Program and States- The federal 340B Drug Pricing Program provides access to reduced price prescription drugs to over 35,000 individual health care facilities and sites (as of mid 2016) certified by the U.S.. Department of Health and Human Services (HHS) as "covered entities." These clinics, centers and hospitals in turn serve more than 10 million people in all 50 states, plus commonwealths and territories. NCSL reoprt, updated 2018.

     

Medicaid Pharmaceutical Policy: Coverage and Benefits

  • Webinar Recording: Reference-Based Pricing – Leveraging State Purchasing Power to Lower Health Care Spending - March 7, 2019 by the National Academy of State Health Policy (NASHP).State spending on health care for employees, retirees and health plans for teachers, university and municipal employees continues to challenge state budgets and raises questions about how best to allocate resources. It is also known that prices in the United States exceed those in other developed nations and that there is significant variation in prices paid by payers. In this webinar, we will hear from state health policy officials who are working to standardize prices paid to hospitals to maintain access and keep spending in check. This webinar will provide descriptions of two state models, and provide an opportunity to discuss the challenges these initiatives face and how they may be overcome. View the webinar and download the slides.

  • Webinar: Medicaid Alternative Payment Models for Prescription Drugs: A Look at Three States - May 9, 2019 by the National Academy of State Health Policy (NASHP). As states struggle with the increasing cost of prescription drugs, they are testing various alternative payment models (APMs) to curb costs. The Oklahoma Health Care Authority is a national leader with four APMs through direct contracts with pharmaceutical manufacturers. These contracts are each based on a specific drug, agreed upon outcomes, and approaches to measurement. Since Oklahoma began implementation, Michigan and Colorado had State Plan Amendments approved to advance similar APMs. View the webinar.

  • Webinar: How States Pay for Hep C Drugs Using a “Netflix-style” Subscription ModelMay 15, 2019 by the National Academy of State Health Policy (NASHP). Faced with costly and effective treatment for hepatitis C, states are exploring innovative alternative payment methodologies (APMs) to expand access to treatment and generate savings. Using a “Netflix-style” subscription model, Louisiana and Washington are negotiating agreements with drug manufacturers to get unlimited access to hepatitis C drugs for a fixed, predetermined cost. Join this NASHP webinar to hear about Louisiana and Washington’s innovative APMs as well as related research into hepatitis C from the Patient-Centered Outcomes Research Institute (PCORI). View the webinar and download the slides.

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  • Recent Medicaid Prescription Drug Laws and Strategies by NCSL |  
    A one-stop-shop of various state-based approaches to coverage and costs  
    View full report  | NCSL updated 2018

  • State Medicaid Alternative Reimbursement and Purchasing Test for High-cost Drugs (SMART-D)  "This report analyzes the options available to state Medicaid agencies to purchase and pay for high-cost specialty drugs under current federal law. Drug prices are set by manufacturers, and Medicaid price and coverage regulation is most clearly within the domain of federal policy and legislation, so this report cannot offer a quick solution to high drug launch prices. Rather, in this first phase of SMART-D, the Center for Evidence-based Policy has sought to identify tools and techniques that states can use under current law to enable patient access to needed drugs while being an effective steward of scarce public dollars." [View full summary report, PDF, 43 pp] Published by the Center for Evidence-based Policy, September 2016.  Posted 10/1/2017

  • SMART-D, the State Medicaid Alternative Reimbursement and Purchasing Test for High-Cost Drugs. SMART-D, part of a series of grants from the Laura and John Arnold Foundation in Texas, addresses the rising cost of pharmaceutical drugs. The project aims to help develop a better menu of options for states to consider in purchasing high cost drugs in Medicaid. This 2016 article by Milbank Memorial Fund provides information about phase one of the project. Published 6/24/2016.

  • Louisiana (2018) subscription-based payment model for Hepatitis C
    The Louisiana Department of Health is pursuing innovative payment models which will enable the state to dramatically expand access to the drug with the goal of eventually eliminating Hepatitis C as a public health problem.  The Department seeks comments from the public, healthcare professionals, pharmaceutical companies, and others on a plan that will bring us much closer to the goal of Hepatitis C elimination for vulnerable populations.  Through a Request for Information, the Louisiana Department of Health is asking for public input on the creation of a subscription-based payment model for Hepatitis C medication. Under this payment model, the state would pay a drug manufacturer or manufacturers for unlimited access to the treatment for the individuals in Louisiana who are enrolled in Medicaid or in Louisiana’s correctional system. The payment to the manufacturer would be equal to or less than what the state is currently spending to provide the antiviral medication to these populations. “A successful subscription-based model would create an incentive for us to find and treat as many people as possible. For the drug manufacturer, this model would guarantee a fixed purchase price for a contracted period of time, and would allow the drug manufacturer to expand their product reach into populations that otherwise would not have received treatment,” said Dr. Rebekah Gee, secretary of the Louisiana Department of Health. LA state news release, 8/7/2018.

  • Oklahoma (2018):  Value-Based Contracting approved. On June 27, 2018 CMS approved a state plan amendment to "allow the state to negotiate supplemental rebate agreements involving value-base purchasing agreements with drug manufacturers that could produce extra rebates for the state if clinical outcomes are not achieved." This is the first-in-the-nation approval of this approach. (CMS release, 6/27/2018)
    • NCSL held three meeting sessions in 2017 discussing value-based purchasing and contracting - see descriptions online.

  • Massachusetts (2018), by agency executive action, requested a Section 1115 Medicaid waiver that would allow the state to choose which prescription drugs to cover based on the majority of beneficiaries’ needs and which medicines prove to be the most cost effective. The state wants the power to negotiate discounts for the drugs it purchases and to exclude drugs with limited treatment value. According to the most recent data, Medicaid spending on prescription drugs increased about 25 percent in 2014 and nearly 14 percent in 2015. The Department of Health and Human Services declined to approve the plan, June 27, but state officials were examining variations and amendments.
    ​       • As States Try To Rein In Drug Spending, Feds Slap Down One Bold Medicaid Move.  - Analysis pubished by KHN and NPR, Sep. 21, 2018.
    CMS denied a proposal from Massachusetts "that was seen as the boldest attempt yet to control Medicaid drug spending.  Massachusetts planned to exclude expensive drugs that weren’t proven to work better than existing alternatives. The state said Medicaid drug spending had doubled in five years. Massachusetts wanted to negotiate prices for about 1 percent of the highest-priced drugs and stop covering some of them. CMS rejected the proposal without much explanation, beyond saying Massachusetts couldn’t do what it wanted and continue to receive the deep discounts drugmakers are required by law to give state Medicaid programs." 
           •  “A Setback For Massachusetts In States' Drive To Contain Medicaid Drug Spending”- Analysis and commentary by NPR. “Massachusetts planned to exclude expensive drugs that weren't proven to work better than existing alternatives. The state said Medicaid drug spending had doubled in five years. Massachusetts wanted to negotiate prices for about 1 percent of the highest-priced drugs and stop covering some of them. CMS rejected the proposal without much explanation beyond saying Massachusetts couldn't do what it wanted and continue to receive the deep discounts drugmakers are required by law to give state Medicaid programs.”- September 12, 2018.
           •   States want control over drug prices. Will feds give it to them? - by Governing Magazine, 5/7/2018 -"In an attempt to lower health-care costs, Massachusetts is seeking to exclude certain drugs from its Medicaid program."

  • Michigan (November 2018) The Michigan Medicaid program is the second state to have its waiver (termed State Plan Amendment) for value-based agreements for pharmaceuticals approved by CMS. The new amendment will allow the state run insurance program to enter into health outcome-based arrangements with pharmaceutical companies for drugs used by Medicaid beneficiaries. All new contracts must again be approved by CMS and follow federal drug rebate agreements, including still sharing higher rebates obtained through the new arrangements with the federal government. The CMS administrator applauded the move as one additional tool to lower drug prices, saying that along with “innovation in biomedicine, it is incumbent on us to also modernize payment policies. (See article by Fierce Pharma, 11/14/201

  • Medicaid Payment for Outpatient Prescription Drugs- View the full report - MACPAC Issue Brief, March 2017

  • Bulk Purchasing of Prescription Drugs - NCSL research for 2018 shows there are five operating multi-state bulk buying pools, primarily serving about half the Medicaid programs in the U.S., plus additional variations and single state-initiatives.
    US Map of Medicaid state pharmaceutical rebates-2018

Diseases and Medical Conditions: Coverage

  • Epinephrine medication to counteract severe allergic reactions
    • Feds finalize $465M Mylan settlement for EpiPen overcharges. "Resolving an issue that fueled nationwide debate over soaring drug costs, the agreement ends an investigation that found Mylan avoided paying state Medicaid programs higher EpiPen rebates by improperly classifying the brand name drug as a generic medication. Prices increased 400% between 2010 and 2016. Full article, published in USA Today, 8/18,2017.
    • HHS revealed $1.3 billion in EpiPen overcharges - Excerpt from trade journal BioPharmaDive, 8/17/2017.
    • Increasing Access to Epinephrine. NCSL LegisBrief by Ashley Noble - - published April 2016 [may require password]
    • Children and Food Allergies. NCSL LegisBrief by Ashley Noble - - published August 2014.
    • Beyond EpiPen: Prices of Lifesaving Epinephrine Products Soar. This September 2016 report discusses how "Competition has failed to drive down prices, leaving policymakers demanding answers." By The Pew Charitable Trusts, Sept. 22, 2016.

2019 Prescription Drug Legislation Database

NCSL sponsors this state legislation online database, tracking major policies affecting prescription drugs and biologic medicines, from 2015 to the present. The new feature allows policymakers to view more than 5,600 filed bills and resolutions. This resource also highlights more than 980 signed laws and resolutions since it was launched, according to specific topics such pharmaceutical patient access and affordability, pecialty pharmaceuticals, compounding pharmacy regulation, Medicaid and health insurance coverage and reimbursement, and the right-to-try investigational drugs for the terminally ill. This first-in-the-nation state resource is available to all NCSL members and the interested public, providing search by state, bill status, and topics, using simple check boxes, plus full text access. [Updated weekly 

View the Database

Brands and Generics

Buying more generic prescription drugs instead of their brand-name equivalents and purchasing brand-name drugs with discounts can significantly reduce overall prescription drug expenditures. Federal actuaries recently reported that the use of generic medications and an increase in Medicaid prescription drug rebates would continue to slow spending. Eighty-seven percent of all prescription medications dispensed in 2017 were classified as generic drugs, an increase of 20 percent from 2007. At the same time. many newer drugs, including all biological products, have no approved generic equivalent and can play a central role in life-extending situations.

Consumers’ use of generic drugs reflects the fact that: 
• 93 percent of generic prescriptions are filled at $20 or less and
• the average copay for generic drugs is $6.06, compared to a copay of $40.30 for brand-name versions.  (verified/added 9/7/2018)

  • Resources for Prescription Drugs and Cost Containment. Part of the NCSL's Health Cost Containment and Efficiencies series, updated 2018.
    • Use of Generic Prescription Drugs and Brand-Name Discounts | PDF File -Archive edition, 2010
    • Prescription Drug Agreements and Volume Purchasing (Preferred Drug Lists, Rebates, Multi-state Purchasing and Effectiveness Review of Medicine) | PDF File-Archive edition, 2010, Published by NCSL.
  • HHS/FDA Announces new accelerated efforts to approve and use generics and biosimilars. Commissioner Scott Gottlieb, on July 18, 2018, stated:
    "Generic drugs, for instance, represent 90 percent of all prescriptions in the U.S.1 Generic competition facilitated by the 1984 Hatch Waxman Act provided savings of more than $1 trillion to the U.S. health care system over a decade and generated $265 billion in savings in 2017 alone. However, until relatively recently, the FDA lacked a statutory pathway to approve follow-on versions of biological products. 
          Biologic medicines play a critical role in the treatment of many serious illnesses, such as cancer and genetic disorders. (However) While these products offer much therpeutic primse and benefit, they often come at great expense. In fact, biologics represent almost 40 percent of all prescription drug spending. And, they accounted for 70 percent of growth in drug spending from 2010 to 2015.3
     
  • Lower Drug Costs: The Next Frontier for State Flexibility. Published in Health Affairs blog, Feb. 16, 2018. This article describes how the federal government can help states address rising prescription drug costs. The blog describes options for CMS from a recent Commonwealth Fund sponsored NASHP forum on this topic.
    ♦ View related discourse paper (6 pp, PDF) How the Federal Government Can Help States Address Rising Prescription Drug Costs. February 2018
  • GPhA: Generic Drugs Savings  PDF |
  • State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars. At least 40 states have established new statutory standards for substituting interchangeable biologics. Updated for 2018.
  • H&HS FEATURE: State Legislation on "Essential Generic Drugs" and Anti-Price Gouging. NCSL Description and Report | State analysis (July 2018).
  • 2018 Generic Drug Access and Savings Report- Read and download the report by AAM.
    In 2017, generics generated a total of $265 billion in savings. Savings for Medicare and Medicaid amounted to $82.7 billion and $40.6 billion, respectively, which translates to an average $1,952 for every Medicare enrollee and $568 for every Medicaid enrollee.
  • Generics Report 2018 -PDF

Expert Reports and Opinions

Prescription Drugs are 10-percent share of total health expenditures):
Growth in retail prescription drug spending slowed in 2016, increasing 1.3 percent to $328.6 billion. The slower growth in 2016 follows two years of strong growth in 2014 and 2015, 12.4 percent and 8.9 percent, respectively. This strong growth reflected increased spending on new medicines and price growth for existing brand-name drugs, particularly for drugs used to treat hepatitis C. Growth slowed in 2016 primarily due to fewer new drug approvals, slower growth in brand-name drug spending as spending for hepatitis C drugs declined, and a decline in spending for generic drugs as price growth slowed. – Figures released by CMS, Dec. 2017

The NCSL Prescription Drug Policy Resource Center is supported in part by a grant from the Laura and John Arnold Foundation. Editorial content is the sole responsibility of NCSL.

 

Specialty Drugs

In the past five years, a new category of drugs has rapidly expanded on the U.S. market, gaining attention as more effective but also significantly more costly.

Expert Reports and Analysis

Prescription Drugs are 10-percent share of total health expenditures:
Growth in retail prescription drug spending slowed in 2016, increasing 1.3 percent to $328.6 billion. The slower growth in 2016 follows two years of strong growth in 2014 and 2015, 12.4 percent and 8.9 percent, respectively. This strong growth reflected increased spending on new medicines and price growth for existing brand-name drugs, particularly for drugs used to treat hepatitis C. Growth slowed in 2016 primarily due to fewer new drug approvals, slower growth in brand-name drug spending as spending for hepatitis C drugs declined, and a decline in spending for generic drugs as price growth slowed. – Figures released by CMS, Dec. 2017

Amgen's money-back outcomes-based payment offer on isn't all that meaningful, researchers find
On the face of it, Amgen Inc.'s offer to insurers of a money-back guarantee for its expensive cholesterol drug Repatha looks to be the type of solution that could help align price with the clinical benefit a patient actually experiences. But new research published April 3 in the Annals of Internal Medicine suggests Amgen's outcomes-based payment scheme would only marginally improve the cost-effectiveness of the drug to reduce the risk of major adverse heart events by 15% in patients with atherosclerotic cardiovascular disease (ASCVD). Repatha, along with Sanofi SA and Regeneron Pharmaceuticals Inc.'s rival PCSK9 inhibitor Praluent, carry list prices of roughly $14,000 a year — sparking criticism and payer resistance. In response, the drugmakers have sought to win broader coverage by extending concessions on drug cost. Read full article, BioPharma Dive, Apr. 4, 2018

2015-2019 Prescription Drug Legislation Database

NCSL sponsors this state legislation online database, tracking major policies affecting prescription drugs and biologic medicines. The new feature allows policymakers to view more than 5,700 filed bills and resolutions. This resource also highlights more than 980 signed laws and resolutions since it was launched, according to specific topics such pharmaceutical patient access and affordability, specialty pharmaceuticals, compounding pharmacy regulation, Medicaid and health insurance coverage and reimbursement, and the right-to-try investigational drugs for the terminally ill. This first-in-the-nation state resource is available to all NCSL members and the interested public, providing search by state, bill status, and topics, using simple check boxes, plus full text access. [Updated weekly]

View the Database

Biologics/Biosimilars

Regulating biologic medications raises new issues for both state and federal policymakers because of their complexity, especially when or how they can be interchanged. In 2015 the first rival biosimilar was approved by the FDA; by early-2018 there were eight such biosimilars, but they await an additional step to be determined interchangeable. Forty-two states have enacted laws defining an interchangeable process. 

  • State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars. NCSL reports that at least 45 states have established new standards for substituting interchangeable biologics. Updated for October 2018.
  • States and Specialty Pharmaceuticals: 2015-2018 | NCSL Overview online.
  • State Laws and Legislation to allow "Right to Try" unapproved medications for terminally ill patients: Forty states have enacted separate "Right to Try" not-yet-approved drugs state laws. A summary review, updated 2018
  • "Biotechnology and State Roles" | NCSL session at Legislative Summit in Boston, Aug. 8, 2017 | View session resources.  "Biotech research is growing fast. In Massachusetts, more than 63,000 biopharma employees are working on more than 1,600 potential new medicines. Learn how new models for pricing and research are hoping to bring down the cost."
       Moderator: Susan Dentzer, Network for Excellence in Health Innovation (NEHI), Massachusetts.
       Panelists: Robert Coughlin, Massachusetts Biotechnology Council (MassBio); Alice Moore, Executive Office of Health & Human Services, Massachusetts; Michael Sherman, MD, Harvard Pilgrim Health Care, Massachusetts; Martin Zagari, MD, Amgen, California | Biotechnology Faculty Biographies
       Downloads: Biotechnology and State Roles - video of the session at NCSL's 2017 Legislative Summit
    Dentzer_Value Based Contracting | PDF |
  • HHS and FDA Unveil a Biosimilar Action Plan - Read the Plan, 11 pp PDF, July 18, 2018
  • Map of state legislation on Biologics and Biosimilars

Abuse and Misuse

As overdose deaths from opioids—including prescription drugs—continue to rise, strategies to confront the epidemic are likely to stay at the forefront during the 2017-2018 legislative sessions. Legislators considered at least 536 bills across 47 states related to prescription drug abuse prevention in 2016, according to NCSL’s tracking.

  • UPDATE: The August 2018 Summit session on Opioids: Lessons Learned from the States is now live video online via Facebook. 
  • Opioid Deep Dive page - 2017
  • Prescribing Policies: States Confront Opioid Overdose Epidemic -Highlighting 2017-2018 legislative action-Updated April 2018
  • Prescribing Limits Brief, September 2017
  • "Going to the MAT to Fight Opioid Crisis", State Legislatures Magazine, April 2018 - an update on Medication-Assisted Treatment by Sydne Enlund
  • Injury Prevention database

    Through this interactive database, find up-to-date information about injury prevention legislation, including opioid misuse and overdose prevention, that is pending and enacted across the country. You can search legislation by state, topic, keyword, year, status or primary sponsor. Injury prevention topics include six categories related to prescription drug abuse: 

    • Prescription Drug Monitoring Programs
    • Prescribing Guidelines and Limits
    • Provider Education or Training
    • Rescue Drugs (i.e., Naloxone)
    • Pain Clinics and Pain Management
    • Other Prescription Drug Abuse Topics

State Legislative Database

2015-2019 Prescription Drug Legislation Database

NCSL sponsors this state legislation online database, tracking major policies affecting prescription drugs and biologic medicines. The new feature allows policymakers to view more than 5,700 filed bills and resolutions. This resource also highlights more than 9800 signed laws and resolutions since it was launched, according to specific topics such pharmaceutical patient access and affordability, specialty pharmaceuticals, compounding pharmacy regulation, Medicaid and health insurance coverage and reimbursement, and the right-to-try investigational drugs for the terminally ill. This first-in-the-nation state resource is available to all NCSL members and the interested public, providing search by state, bill status, and topics, using simple check boxes, plus full text access.

  • 2019 filed and pending legislation. Use the "2019" checkbox below. As of August there were more than 880 measures in all 50 states, Puerto Rico and DC listed for consideration in 2019. So far at least 130 new laws have been signed in at least 42 states and and Puerto Rico. Bills carried over from 2018 are included. 

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Patient Rx Access & Use

When patients cannot afford medication, government, industry and charities can help through State Pharmaceutical Assistance Programs. This webpage features current and recent historical state subsidy and discount programs, for seniors, disabled, uninsured and others. 

Rx Drug Return and Reuse laws -2017

  • Legislation Related to Cost Transparency of Prescription Drugs, by NCSL | 2016 update - PDF
  • Right to Try” Experimental Prescription Medicines State Laws and Legislation, All 50 states considered bills, with recent laws now in 40 states as of August 2018. Latest law: Wisconsin S 84.
    • The latest in the FDA's court battle over "right to try." "March 9, 2018 was the deadline for the FDA to explain to a court why it doesn’t want to offer any more details on an internal decision to allow at least two American patients with Ebola to take an unapproved drug. The Goldwater Institute, a libertarian think tank, went to court in 2015 to force the FDA to cough up more information on its decision to approve the use of experimental Ebola drugs. So far, the FDA has refused to elaborate to the judge’s satisfaction.Goldwater’s interest is political — the think tank has pushed to pass “right-to-try” laws and hopes to show that the FDA didn’t stick to protocols in the case of the Ebola crisis. That could potentially undermine the idea that the current approval process is good enough, which has been used to swat away attempts at passing new bills." Posted by Stat, 3/9/2018.
    • On May 30, 2018 Right-to-Try became federal law, "establishing an alternative pathway to the FDA’s Expanded Access Program via which certain patients can access drugs in development without FDA approval." Here is FDA commissioner Scott Gottlieb’s statement on the U.S. Congress enactment and President Trump's signing of Rightto Try as S.204.

Safety and Efficacy

Drugs can save lives or create unintended results. States have been proactive and reactive in initiating programs to protect patients and require safe practices

  • Medication Adherence: Taking Pills Safely as Ordered | NCSL online resource, updated March 2016
  • Medication Therapy Management—combining Health, Safety and Savings | NCSL Overview and state examples, updated September 2016
  • States and Compounding Pharmacies | NCSL Overview online. 2017
  • Right to Try” Experimental Prescription Medicines State Laws and Legislation, All 50 states considered bills, with recent laws now in 40 states as of May 2018.
    • The latest in the FDA's court battle over "right to try." "March 9, 2018 was the deadline for the FDA to explain to a court why it doesn’t want to offer any more details on an internal decision to allow at least two American patients with Ebola to take an unapproved drug. The Goldwater Institute, a libertarian think tank, went to court in 2015 to force the FDA to cough up more information on its decision to approve the use of experimental Ebola drugs. So far, the FDA has refused to elaborate to the judge’s satisfaction.Goldwater’s interest is political — the think tank has pushed to pass “right-to-try” laws and hopes to show that the FDA didn’t stick to protocols in the case of the Ebola crisis. That could potentially undermine the idea that the current approval process is good enough, which has been used to swat away attempts at passing new bills." Posted by Stat, 3/9/2018
    • 50-state map of Right to Try laws 2018
    • On May 30, 2018 Right-to-Try became federal law, "establishing an alternative pathway to the FDA’s Expanded Access Program via which certain patients can access drugs in development without FDA approval." Here is FDA commissioner Scott Gottlieb’s statement on the U.S. Congress enactment and President Trump's signing of Rightto Try as S.204.
    • During the signing ceremony, the president praised Congress’s success in getting a RTT bill to his desk and predicted that “hundreds of thousands of lives will be saved,” as STAT reported. (That figure was upped to 1 million in a White House fact sheet.). A fact-check reporter for the New York Times questioned the claim in “Trump Oversells New ‘Right to Try’ Law.” Qiu talked to CUPA co-chair Alison Bateman-House, who called the figure “extremely unlikely,” and linked to Bateman-House and her CUPA colleague Lisa Kearns’s research on unethical provisions in state RTT laws (sub. req.). The following day Bateman-House discussed the bill on CBS This Morning and Art Caplan expressed concerns about the financial liabilities patients will face under the new law for Quartz

 

2015-2019 Prescription Drug Legislation Database

NCSL sponsors this state legislation online database, tracking major policies affecting prescription drugs and biologic medicines. The new feature allows policymakers to view more than 5,700 filed bills and resolutions. This resource also highlights more than 980 signed laws and resolutions since it was launched, according to specific topics such pharmaceutical patient access and affordability, specialty pharmaceuticals, compounding pharmacy regulation, Medicaid and health insurance coverage and reimbursement, and the right-to-try investigational drugs for the terminally ill. This first-in-the-nation state resource is available to all NCSL members and the interested public, providing search by state, bill status, and topics, using simple check boxes, plus full text access. [Updated weekly]

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