To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program.

Medicare Negotiation and Competitive Licensing Act of 2019

This bill requires the Centers for Medicare & Medicaid Services (CMS) to negotiate with pharmaceutical companies regarding prices for drugs covered under the Medicare prescription drug benefit. (Current law prohibits the CMS from doing so.)

The CMS must take certain factors into account during negotiations, including the clinical- and cost-effectiveness of the drug, the financial burden on patients, and unmet patient needs. If the CMS is unable to negotiate the price of a drug, such drug is subject to competitive licensing in order to further its sale under Medicare, notwithstanding existing government-granted exclusivities.

Additionally, for one year after a drug is provided under a competitive license, such drug is also subject to specified price limitations; if the drug is not offered at such prices, the drug is subject to additional licensing that furthers its sale under any federal program (e.g., Medicaid).

Alkermes Plc

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed drug products and a clinical pipeline of products that address central nervous system ("CNS") disorders such as schizophrenia, depression, addiction and multiple sclerosis ("MS"). Headquartered in Dublin, Ireland, Alkermes has a research and development ("R & D") center in Waltham, Massachusetts; an R & D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.  The key marketed products discussed below are expected to generate significant revenues for us. None Commercialized by Alkermes in the U.S. Alcohol dependence and Opioid dependence  Russia and Commonwealth of Independent States ("CIS") 5 Summary information regarding products that use our proprietary technologies: Product Indication(s)  Treatment to improve walking in patients with MS, as demonstrated by an increase in walking speed  We develop and commercialize products designed to address the unmet needs of patients suffering from addiction and schizophrenia.  ARISTADA ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injectable suspension approved in the U.S. for the treatment of schizophrenia. ARISTADA is the first of our products to utilize our proprietary LinkeRx technology. ARISTADA is a prodrug; once in the body, ARISTADA is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. ARISTADA is the first atypical antipsychotic with once-monthly, once-every-six-weeks and once-every-two-months dosing options to deliver and maintain therapeutic levels of medication in the body. ARISTADA has four dosing options (441 mg, 662 mg, 882 mg and 1064 mg) and is packaged in a ready-to-use, pre-filled product format. ARISTADA 1064 mg, our two-month dosing option, was approved by the U.S. Food and Drug Administration (the "FDA") in June 2017. We developed ARISTADA and manufacture and commercialize it in the U.S.  Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million Americans over the age of 18 have schizophrenia in a given year, with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia. Studies have demonstrated that as many as 75% of patients with schizophrenia have difficulty taking their oral medication on a regular basis, which can lead to worsening of symptoms.  VIVITROL VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly, non-narcotic, injectable medication approved in the U.S., Russia and certain countries of the CIS for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL uses our polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through one intramuscular injection every four weeks. We developed and exclusively manufacture VIVITROL. What are opioid dependence and alcohol dependence?  Opioid dependence is a serious and chronic brain disease characterized by compulsive, prolonged self-administration of opioid substances that are not used for a medical purpose.